---
kind: "range"
citation: "42 U.S.C. §§ 247d–247d–7b"
title: "42"
from: "247d"
to: "247d–7b"
count: 22
release: "119-102"
url: "https://uscodex.org/usc/42/247d..247d-7b"
---

# §247d. Public health emergencies

- (a) **Emergencies—** If the [Secretary](/usc/42/201.md?p=c) determines, after consultation with such public health officials as may be necessary, that—
  - (1) a disease or disorder presents a public health emergency; or
  - (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists,

  the [Secretary](/usc/42/201.md?p=c) may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the [cause](/usc/42/9908.md?p=c-2), [treatment](/usc/42/11851.md?p=11), or prevention of a disease or disorder as described in paragraphs [(1)](#a-1) and [(2)](#a-2). Any such determination of a public health emergency terminates upon the [Secretary](/usc/42/201.md?p=c) declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the [Secretary](/usc/42/201.md?p=c), whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the [Secretary](/usc/42/201.md?p=c) (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the [Secretary](/usc/42/201.md?p=c) shall submit to the Congress written notification of the determination.

- (b) **Public Health Emergency Fund—**
  - (1) **In general—** There is established in the Treasury a [fund](/usc/42/12854.md?p=3) to be designated as the “Public Health Emergency [Fund](/usc/42/12854.md?p=3)” to be made available to the [Secretary](/usc/42/201.md?p=c) without fiscal year limitation to carry out [subsection (a)](#a) only if a public health emergency has been declared by the [Secretary](/usc/42/201.md?p=c) under such subsection or if the [Secretary](/usc/42/201.md?p=c) determines there is the significant potential for a public health emergency, to allow the [Secretary](/usc/42/201.md?p=c) to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency. The [Secretary](/usc/42/201.md?p=c) shall plan for the expedited distribution of [funds](/usc/42/12854.md?p=3) to appropriate agencies and entities. There is authorized to be appropriated to the [Fund](/usc/42/12854.md?p=3) such sums as may be necessary.
  - (2) **Uses—** The [Secretary](/usc/42/201.md?p=c) may use amounts in the [Fund](/usc/42/12854.md?p=3) established under [paragraph (1)](#b-1), to—
    - (A) facilitate coordination between and among Federal, [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial entities and public and private health care entities that the [Secretary](/usc/42/201.md?p=c) determines may be affected by a public health emergency or potential public health emergency referred to in [paragraph (1)](#b-1) (including communication of such entities with relevant international entities, as applicable);
    - (B) make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting [programs](/usc/42/274l–1.md?p=4) under section [247d–3a](/usc/42/247d–3a.md), [247d–3b](/usc/42/247d–3b.md), or [247d–3c](/usc/42/247d–3c.md) of this title;
    - (C) facilitate and accelerate, as applicable, [advanced research and development](/usc/42/247d–6b.md?p=h-1) of [security countermeasures](/usc/42/247d–6d.md?p=i-9) (as defined in [section 247d–6b of this title](/usc/42/247d–6b.md)), [qualified countermeasures](/usc/42/247d–6a.md?p=a-2-A) (as defined in [section 247d–6a of this title](/usc/42/247d–6a.md)), or [qualified pandemic or epidemic products](/usc/42/247d–6d.md?p=i-7) (as defined in [section 247d–6d of this title](/usc/42/247d–6d.md)), that are applicable to the public health emergency or potential public health emergency under [paragraph (1)](#b-1);
    - (D) strengthen biosurveillance capabilities and [laboratory](/usc/42/300jj.md?p=10) capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under [section 247d–4 of this title](/usc/42/247d–4.md);
    - (E) support initial emergency operations and assets related to preparation and deployment of intermittent [disaster](/usc/42/5204.md?p=2) response personnel under [section 300hh–11 of this title](/usc/42/300hh–11.md) and the Medical Reserve [Corps](/usc/42/12626.md?p=3) under [section 300hh–15 of this title](/usc/42/300hh–15.md);
    - (F) support the initial deployment and distribution of contents of the Strategic National Stockpile, as appropriate; and
    - (G) carry out other activities, as the [Secretary](/usc/42/201.md?p=c) determines applicable and appropriate.
  - (3) **Report—** Not later than 90 days after the end of each fiscal year, the [Secretary](/usc/42/201.md?p=c) shall prepare and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on [Commerce](/usc/42/6311.md?p=7) and the Committee on Appropriations of the House of [Representatives](/usc/42/3058f.md?p=5) a report describing—
    - (A) the expenditures made from the Public Health Emergency [Fund](/usc/42/12854.md?p=3) in such fiscal year, including—
      - (i) the amount obligated;
      - (ii) the [recipient](/usc/42/2996a.md?p=6) or [recipients](/usc/42/2996a.md?p=6) of such obligated [funds](/usc/42/12854.md?p=3);
      - (iii) the specific response activities such obligated [funds](/usc/42/12854.md?p=3) will support; and
      - (iv) the declared or potential public health emergency for which such [funds](/usc/42/12854.md?p=3) were obligated; and
    - (B) each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which was conducted or supported by expenditures from the [Fund](/usc/42/12854.md?p=3).
  - (4) **Review—** Not later than 2 years after June 24, 2019, the [Secretary](/usc/42/201.md?p=c), in coordination with the Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response, shall conduct a review of the [Fund](/usc/42/12854.md?p=3) under this section and provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) and the Committee on Appropriations of the House of [Representatives](/usc/42/3058f.md?p=5) on policies to improve such [Fund](/usc/42/12854.md?p=3) for the uses described in [paragraph (2)](#b-2).
  - (5) **GAO report—** Not later than 4 years after June 24, 2019, the Comptroller General of the [United States](/usc/42/403.md?p=k) shall—
    - (A) conduct a review of the [Fund](/usc/42/12854.md?p=3) under this section, including its uses and the resources available in the [Fund](/usc/42/12854.md?p=3); and
    - (B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) of the House of [Representatives](/usc/42/3058f.md?p=5) a report on such review, including recommendations related to such review, as applicable.
- (c) **Supplement not supplant—** [Funds](/usc/42/12854.md?p=3) appropriated under this section shall be used to rapidly respond to public health emergencies or potential public health emergencies and supplement and not supplant other Federal, [State](/usc/42/300gg–91.md?p=d-14), and local public [funds](/usc/42/12854.md?p=3) provided for activities under this chapter or [funds](/usc/42/12854.md?p=3) otherwise provided for emergency response.
- (d) **Data submittal and reporting deadlines—** In any case in which the [Secretary](/usc/42/201.md?p=c) determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to [subsection (a)](#a), individuals or public or [private entities](/usc/42/12181.md?p=6) are unable to comply with deadlines for the submission to the [Secretary](/usc/42/201.md?p=c) of data or reports required under any law administered by the [Secretary](/usc/42/201.md?p=c), the [Secretary](/usc/42/201.md?p=c) may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly after granting such an extension or waiver, the [Secretary](/usc/42/201.md?p=c) shall notify the Congress of such action and publish in the Federal Register a notice of the extension or waiver.
- (e) **Temporary reassignment of State and local personnel during a public health emergency—**
  - (1) **Emergency reassignment of federally funded personnel—** Notwithstanding any other provision of law, and subject to [paragraph (2)](#e-2), upon request by the [Governor](/usc/42/6372.md?p=1) of a [State](/usc/42/300gg–91.md?p=d-14) or a [tribal organization](#e-7-A) or such [Governor](/usc/42/6372.md?p=1) or [tribal organization](#e-7-A)’s designee, the [Secretary](/usc/42/201.md?p=c) may authorize the requesting [State](/usc/42/300gg–91.md?p=d-14) or [Indian tribe](#e-7-A) to temporarily reassign, for purposes of immediately addressing a public health emergency in the [State](/usc/42/300gg–91.md?p=d-14) or [Indian tribe](#e-7-A), [State](/usc/42/300gg–91.md?p=d-14) and local public health department or agency personnel funded in whole or in part through [programs](/usc/42/274l–1.md?p=4) authorized under this chapter, as appropriate.
  - (2) **Activation of emergency reassignment—**
    - (A) **Public health emergency—** The [Secretary](/usc/42/201.md?p=c) may authorize a temporary reassignment of personnel under [paragraph (1)](#e-1) only during the period of a public health emergency determined pursuant to [subsection (a)](#a).
    - (B) **Contents of request—** To seek authority for a temporary reassignment of personnel under [paragraph (1)](#e-1), the [Governor](/usc/42/6372.md?p=1) of a [State](/usc/42/300gg–91.md?p=d-14) or a [tribal organization](#e-7-A) shall submit to the [Secretary](/usc/42/201.md?p=c) a request for such reassignment flexibility and shall include in the request each of the following:
      - (i) An assurance that the public health emergency in the [geographic area](/usc/42/11360.md?p=9) of the requesting [State](/usc/42/300gg–91.md?p=d-14) or [Indian tribe](#e-7-A) cannot be adequately and appropriately addressed by the public health workforce otherwise available.
      - (ii) An assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of [State](/usc/42/300gg–91.md?p=d-14) and local personnel described in [paragraph (1)](#e-1).
      - (iii) An assurance that the requested temporary reassignment of personnel is consistent with any applicable All-[Hazards](/usc/42/5165f.md?p=a-3) Public Health Emergency Preparedness and Response Plan under [section 247d–3a of this title](/usc/42/247d–3a.md).
      - (iv) An identification of—
        - (I) each Federal [program](/usc/42/274l–1.md?p=4) from which personnel would be temporarily reassigned pursuant to the requested authority; and
        - (II) the number of personnel who would be so reassigned from each such [program](/usc/42/274l–1.md?p=4).
      - (v) Such other information and assurances upon which the [Secretary](/usc/42/201.md?p=c) and [Governor](/usc/42/6372.md?p=1) of a [State](/usc/42/300gg–91.md?p=d-14) or [tribal organization](#e-7-A) agree.
    - (C) **Consideration—** In reviewing a request for temporary reassignment under [paragraph (1)](#e-1), the [Secretary](/usc/42/201.md?p=c) shall consider the degree to which the [program](/usc/42/274l–1.md?p=4) or [programs](/usc/42/274l–1.md?p=4) funded in whole or in part by [programs](/usc/42/274l–1.md?p=4) authorized under this chapter would be adversely affected by the reassignment.
    - (D) **Termination and extension—**
      - (i) **Termination—** A [State](/usc/42/300gg–91.md?p=d-14) or [Indian tribe](#e-7-A)’s temporary reassignment of personnel under [paragraph (1)](#e-1) shall terminate upon the earlier of the following:
        - (I) The [Secretary](/usc/42/201.md?p=c)’s determination that the public health emergency no longer exists.
        - (II) Subject to [clause (ii)](#e-2-D-ii), the expiration of the 30-day period following the date on which the [Secretary](/usc/42/201.md?p=c) approved the [State](/usc/42/300gg–91.md?p=d-14) or [Indian tribe](#e-7-A)’s request for such reassignment flexibility.
      - (ii) **Extension of reassignment flexibility—** The [Secretary](/usc/42/201.md?p=c) may extend reassignment flexibility of personnel under [paragraph (1)](#e-1) beyond the date otherwise applicable under [clause (i)(II)](#e-2-D-i-II) if the public health emergency still exists as of such date, but only if—
        - (I) the [State](/usc/42/300gg–91.md?p=d-14) or [Indian tribe](#e-7-A) that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment; and
        - (II) the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to [subparagraph (B)](#e-2-B).
  - (3) **Voluntary nature of temporary reassignment of State and local personnel—**
    - (A) **In general—** Unless otherwise provided under the law or regulation of the [State](/usc/42/300gg–91.md?p=d-14) or [Indian tribe](#e-7-A) that receives [authorization](/usc/42/4370m.md?p=3) for temporary reassignment of personnel under [paragraph (1)](#e-1), personnel eligible for reassignment pursuant to such [authorization](/usc/42/4370m.md?p=3)—
      - (i) shall have the opportunity to volunteer for temporary reassignment; and
      - (ii) shall not be required to agree to a temporary reassignment.
    - (B) **Prohibition on conditioning Federal awards—** The [Secretary](/usc/42/201.md?p=c) may not condition the award of a grant, contract, or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) under this chapter on the requirement that a [State](/usc/42/300gg–91.md?p=d-14) or [Indian tribe](#e-7-A) require that personnel eligible for reassignment pursuant to an [authorization](/usc/42/4370m.md?p=3) under [paragraph (1)](#e-1) agree to such reassignment.
  - (4) **Notice to Congress—** The [Secretary](/usc/42/201.md?p=c) shall give notice to the Congress in conjunction with the approval under this subsection of—
    - (A) any initial request for temporary reassignment of personnel; and
    - (B) any request for an extension of such temporary reassignment.
  - (5) **Guidance—** The [Secretary](/usc/42/201.md?p=c) shall—
    - (A) not later than 6 months after March 13, 2013, issue proposed guidance on the temporary reassignment of personnel under this subsection; and
    - (B) after providing notice and a 60-day period for public comment, finalize such guidance.
  - (6) **Report to Congress—** Not later than 4 years after March 13, 2013, the Comptroller General of the [United States](/usc/42/403.md?p=k) shall conduct an independent evaluation, and submit to the appropriate committees of the Congress a report, on temporary reassignment under this subsection, including—
    - (A) a description of how, and under what circumstances, such temporary reassignment has been used by [States](/usc/42/300gg–91.md?p=d-14) and [Indian tribes](#e-7-A);
    - (B) an analysis of how such temporary reassignment has assisted [States](/usc/42/300gg–91.md?p=d-14) and [Indian tribes](#e-7-A) in responding to public health emergencies;
    - (C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies;
    - (D) an analysis of the extent to which, if any, Federal [programs](/usc/42/274l–1.md?p=4) from which personnel have been temporarily reassigned have been adversely affected by the reassignment; and
    - (E) recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity.
  - (7) **Definitions—** In this subsection—
    - (A) the terms “Indian tribe” and “tribal organization” have the meanings given such terms in [section 5304 of title 25](/usc/25/5304.md); and
    - (B) the term “[State](/usc/42/300gg–91.md?p=d-14)” includes, in addition to the entities listed in the definition of such term in [section 201 of this title](/usc/42/201.md), the Freely Associated [States](/usc/42/300gg–91.md?p=d-14).
  - (8) **Sunset—** This subsection shall terminate on December 31, 2026.
- (f) **Determination with respect to Paperwork Reduction Act waiver during a public health emergency—**
  - (1) **Determination—** If the [Secretary](/usc/42/201.md?p=c) determines, after consultation with such public health officials as may be necessary, that—
    - (A)
      - (i) the criteria set forth for a public health emergency under paragraph [(1)](#a-1) or [(2)](#a-2) of subsection (a) has been met; or
      - (ii) a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and
    - (B) the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of [chapter 35](/usc/44/ch35.md) of title 44 (commonly referred to as the Paperwork Reduction Act),

    then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time.

  - (2) **Transparency—** If the [Secretary](/usc/42/201.md?p=c) determines that a waiver is necessary under [paragraph (1)](#f-1), the [Secretary](/usc/42/201.md?p=c) shall promptly post on the Internet website of the Department of Health and Human [Services](/usc/42/201.md?p=a) a brief justification for such waiver, the anticipated period of time such waiver will be in effect, and the agencies and [offices](/usc/42/3058f.md?p=1) within the Department of Health and Human [Services](/usc/42/201.md?p=a) to which such waiver shall apply, and update such information posted on the Internet website of the Department of Health and Human [Services](/usc/42/201.md?p=a), as applicable.
  - (3) **Effectiveness of waiver—** Any waiver under this subsection shall take effect on the date on which the [Secretary](/usc/42/201.md?p=c) posts information on the Internet website as provided for in this subsection.
  - (4) **Termination of waiver—** Upon determining that the circumstances necessitating a waiver under [paragraph (1)](#f-1) no longer exist, the [Secretary](/usc/42/201.md?p=c) shall promptly update the Internet website of the Department of Health and Human [Services](/usc/42/201.md?p=a) to reflect the termination of such waiver.
  - (5) **Limitations—**
    - (A) **Period of waiver—** The period of a waiver under [paragraph (1)](#f-1) shall not exceed the period of time for the related public health emergency, including a public health emergency declared pursuant to [subsection (a)](#a), and any immediate postresponse review regarding the public health emergency consistent with the requirements of this subsection.
    - (B) **Subsequent compliance—** An [initiative](/usc/42/19131.md?p=1) subject to a waiver under [paragraph (1)](#f-1) that is ongoing after the date on which the waiver expires, shall be subject to the requirements of subchapter I of [chapter 35](/usc/44/ch35.md) of title 44 and the [Secretary](/usc/42/201.md?p=c) shall ensure that compliance with such requirements occurs in as timely a manner as possible based on the applicable circumstances, but not to exceed 30 calendar days after the expiration of the applicable waiver.
- (g) **Certain appointments to support public health emergency responses—**
  - (1) **In general—** In order to support the initial response to a public health emergency declared by the [Secretary](/usc/42/201.md?p=c) under this section, the [Secretary](/usc/42/201.md?p=c) may, subject to [paragraph (2)](#g-2) and without regard to [sections 3309 through 3318](/usc/5/3309..3318.md) of title 5, appoint individuals directly to positions in the Department of Health and Human [Services](/usc/42/201.md?p=a) for which the [Secretary](/usc/42/201.md?p=c) has provided public notice in order to—
    - (A) address a critical hiring need directly related to responding to a public health emergency declared by the [Secretary](/usc/42/201.md?p=c) under this section; or
    - (B) address a severe shortage of candidates that impacts the operational capacity of the Department of Health and Human [Services](/usc/42/201.md?p=a) to respond in the event of a public health emergency declared by the [Secretary](/usc/42/201.md?p=c) under this section.
  - (2) **Number of appointments—** Each fiscal year in which the [Secretary](/usc/42/201.md?p=c) makes a determination of a public health emergency under [subsection (a)](#a) (not including a renewal), the [Secretary](/usc/42/201.md?p=c) may directly appoint not more than—
    - (A) 400 individuals under [paragraph (1)(A)](#g-1-A); and
    - (B) 100 individuals under [paragraph (1)(B)](#g-1-B).
  - (3) **Compensation—** The annual rate of basic pay of an individual appointed under this subsection shall be determined in accordance with [chapter 51](/usc/42/ch51.md) and subchapter III of [chapter 53](/usc/5/chptIII-sptD-ch53.md) of title 5.
  - (4) **Reporting—** The [Secretary](/usc/42/201.md?p=c) shall establish and maintain records regarding the use of the authority under this subsection, including—
    - (A) the number of positions filled through such authority;
    - (B) the types of appointments of such positions;
    - (C) the titles, occupational series, and grades of such positions;
    - (D) the number of positions publicly noticed to be filled under such authority;
    - (E) the number of qualified applicants who apply for such positions;
    - (F) the qualification criteria for such positions; and
    - (G) the demographic information of individuals appointed to such positions.
  - (5) **Notification to Congress—** In the event the [Secretary](/usc/42/201.md?p=c), within a [single](/usc/42/2304.md?p=m) fiscal year, directly appoints more than 50 percent of the individuals allowable under either subparagraph [(A)](#g-2-A) or [(B)](#g-2-B) of paragraph (2), the [Secretary](/usc/42/201.md?p=c) shall, not later than 15 days after the date of such action, notify the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) of the House of [Representatives](/usc/42/3058f.md?p=5). Such notification shall, in a manner that protects personal privacy, to the extent required by applicable Federal and [State](/usc/42/300gg–91.md?p=d-14) privacy law, at a minimum, include—
    - (A) information on each such appointment within such fiscal year;
    - (B) a description of how each such position relates to the requirements of subparagraph [(A)](#g-1-A) or [(B)](#g-1-B) of paragraph (1); and
    - (C) the additional number of personnel, if any, the [Secretary](/usc/42/201.md?p=c) anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in [paragraph (1)](#g-1) within such fiscal year.
  - (6) **Reports to Congress—** Not later than September 30, 2023, and annually thereafter for each fiscal year in which the authority under this subsection is used, the [Secretary](/usc/42/201.md?p=c) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) of the House of [Representatives](/usc/42/3058f.md?p=5) a report describing the total number of appointments filled under this subsection within the fiscal year and a description of how the positions relate to the requirements of subparagraph [(A)](#g-1-A) or [(B)](#g-1-B) of paragraph (1).
  - (7) **Sunset—** The authority under this subsection shall expire on September 30, 2028.
- (h) **Stockpile depletion reporting—** The [Secretary](/usc/42/201.md?p=c) shall, not later than 30 days after the deployment of contents of the Strategic National Stockpile under [section 247d–6b(a) of this title](/usc/42/247d–6b.md?p=a) to respond to a public health emergency declared by the [Secretary](/usc/42/201.md?p=c) under this section or an emergency or [major disaster](/usc/42/5302.md?p=a-25) declared by the President under the Robert T. Stafford [Disaster](/usc/42/5204.md?p=2) Relief and Emergency Assistance Act [[42 U.S.C. 5121](/usc/42/5121.md) et seq.], and every 30 days thereafter until the expiration or termination of such public health emergency, emergency, or [major disaster](/usc/42/5302.md?p=a-25), submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) and the Committee on Appropriations of the House of [Representatives](/usc/42/3058f.md?p=5) on—
  - (1) the deployment of the contents of the stockpile in response to [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal requests;
  - (2) the amount of such products that remain within the stockpile following such deployment; and
  - (3) plans to replenish such products, as appropriate, including related timeframes and any barriers or limitations to replenishment.

# §247d–1. Vaccine tracking and distribution

- (a) **Tracking—** The [Secretary](/usc/42/201.md?p=c), together with relevant [manufacturers](/usc/42/300aa–33.md?p=3), wholesalers, and distributors as may agree to cooperate, may track the initial distribution of federally purchased influenza vaccine in an influenza pandemic, or other federally purchased vaccine to address another pandemic. Such tracking information shall be used to inform Federal, [State](/usc/42/300gg–91.md?p=d-14), local, and tribal decision makers during an influenza pandemic or other pandemic.
- (b) **Distribution—** The [Secretary](/usc/42/201.md?p=c) shall promote communication between [State](/usc/42/300gg–91.md?p=d-14), local, and tribal public health officials and such [manufacturers](/usc/42/300aa–33.md?p=3), wholesalers, and distributors as agree to participate, regarding the effective distribution of seasonal influenza vaccine. Such communication shall include estimates of high priority populations, as determined by the [Secretary](/usc/42/201.md?p=c), in [State](/usc/42/300gg–91.md?p=d-14), local, and tribal jurisdictions in order to inform Federal, [State](/usc/42/300gg–91.md?p=d-14), local, and tribal decision makers during vaccine shortages and supply disruptions.
- (c) **Confidentiality—** The information submitted to the [Secretary](/usc/42/201.md?p=c) or its contractors, if any, under this section or under any other section of this chapter related to vaccine distribution information shall remain confidential in accordance with the exception from the public disclosure of trade secrets, commercial or financial information, and information obtained from an individual that is privileged and confidential, as provided for in [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4), and subject to the penalties and exceptions under sections [1832](/usc/18/1832.md) and [1833](/usc/18/1833.md) of title 18 relating to the protection and theft of trade secrets, and subject to privacy protections that are consistent with the [regulations](/usc/42/201.md?p=d) promulgated under [section 264(c)](/usc/42/264.md?p=c) of the Health Insurance Portability and Accountability Act of 1996. None of such information provided by a [manufacturer](/usc/42/300aa–33.md?p=3), wholesaler, or distributor shall be disclosed without its consent to another [manufacturer](/usc/42/300aa–33.md?p=3), wholesaler, or distributor, or shall be used in any manner to give a [manufacturer](/usc/42/300aa–33.md?p=3), wholesaler, or distributor a proprietary advantage.
- (d) **Guidelines—** The [Secretary](/usc/42/201.md?p=c), in order to maintain the confidentiality of relevant information and ensure that none of the information contained in the systems involved may be used to provide proprietary advantage within the vaccine market, while allowing [State](/usc/42/300gg–91.md?p=d-14), local, and tribal health officials access to such information to maximize the delivery and availability of vaccines to high priority populations, during times of influenza pandemics or other pandemics, vaccine shortages, and supply disruptions, in consultation with [manufacturers](/usc/42/300aa–33.md?p=3), distributors, wholesalers and [State](/usc/42/300gg–91.md?p=d-14), local, and tribal health departments, shall develop guidelines for subsections [(a)](#a) and [(b)](#b).
- (e) **Authorization of appropriations—** There are authorized to be appropriated to carry out this section, $30,800,000 for each of fiscal years 2019 through 2023.
- (f) **Report to Congress—** As part of the National Health Security Strategy described in [section 300hh–1 of this title](/usc/42/300hh–1.md), the [Secretary](/usc/42/201.md?p=c) shall provide an update on the implementation of [subsections (a) through (d)](#a..d).

# §247d–2. Earlier development of diagnostic tests


The [Secretary](/usc/42/201.md?p=c) may contract with public and [private entities](/usc/42/12181.md?p=6), as appropriate, to increase capacity in the rapid development, validation, [manufacture](/usc/42/300aa–33.md?p=3), and dissemination of diagnostic tests, as appropriate, to [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an emerging infectious disease with respect to which a public health emergency is declared under [section 247d of this title](/usc/42/247d.md), or that has significant potential to [cause](/usc/42/9908.md?p=c-2) such a public health emergency.


# [§247d–3. Repealed. Pub. L. 109–417, title II, § 204(b)(1), Dec. 19, 2006, 120 Stat. 2851 — repealed]



# §247d–3a. Improving State and local public health security

- (a) **In general—** To enhance the security of the [United States](/usc/42/403.md?p=k) with respect to public health emergencies, the [Secretary](/usc/42/201.md?p=c), acting through the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, shall award cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) to [eligible entities](/usc/42/296.md?p=1) to enable such entities to conduct the activities described in [subsection (d)](#d).
- (b) **Eligible entities—** To be eligible to receive an award under [subsection (a)](#a), an entity shall—
  - (1)
    - (A) be a [State](/usc/42/300gg–91.md?p=d-14);
    - (B) be a political subdivision determined by the [Secretary](/usc/42/201.md?p=c) to be eligible for an award under this section (based on criteria described in [subsection (h)(4)](#h-4)); or
    - (C) be a [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14); and
  - (2) prepare and submit to the [Secretary](/usc/42/201.md?p=c) an application at such time, and in such manner, and containing such information as the [Secretary](/usc/42/201.md?p=c) may require, including—
    - (A) an All-[Hazards](/usc/42/5165f.md?p=a-3) Public Health Emergency Preparedness and Response Plan which shall include—
      - (i) a description of the activities such entity will carry out under the [agreement](/usc/42/1320b–8.md?p=a-3-A) to meet the goals identified under [section 300hh–1 of this title](/usc/42/300hh–1.md), including with respect to chemical, biological, radiological, or nuclear threats, whether naturally occurring, unintentional, or deliberate;
      - (ii) a description of the activities such entity will carry out with respect to pandemic influenza, as a component of the activities carried out under [clause (i)](#b-2-A-i), and consistent with the requirements of paragraphs [(2)](#g-2) and [(5)](#g-5) of subsection (g);
      - (iii) preparedness and response strategies and capabilities that take into account the medical and public health needs of [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B) in the event of a public health emergency;
      - (iv) a description of the mechanism the entity will implement to utilize the Emergency Management Assistance [Compact](/usc/42/2021b.md?p=4), or other mutual aid [agreement](/usc/42/1320b–8.md?p=a-3-A), for medical and public health mutual aid, and, as appropriate, the activities such entity will implement pursuant to [section 247d–7b of this title](/usc/42/247d–7b.md) to improve enrollment and coordination of volunteer health care professionals seeking to provide medical [services](/usc/42/201.md?p=a) during a public health emergency, which may include—
        - (I) providing a public method of communication for purposes of volunteer coordination (such as a phone number);
        - (II) providing for optional registration to participate in volunteer [services](/usc/42/201.md?p=a) during processes related to [State](/usc/42/300gg–91.md?p=d-14) medical licensing, registration, or certification or renewal of such licensing, registration, or certification; or
        - (III) other mechanisms as the [State](/usc/42/300gg–91.md?p=d-14) determines appropriate;
      - (v) a description of how the entity will include the [State](/usc/42/300gg–91.md?p=d-14) [Unit](/usc/42/1395w–114b.md?p=g-2) on Aging in public health emergency preparedness;
      - (vi) a description of how, as appropriate, the entity may partner with relevant public and private stakeholders, including public health agencies with specific expertise that may be relevant to public health security, such as environmental health agencies, in public health emergency preparedness and response;
      - (vii) a description of how, as applicable, such entity may integrate information to account for individuals with behavioral health needs during and following a public health emergency;
      - (viii) a description of how the entity, as applicable and appropriate, will coordinate with [State](/usc/42/300gg–91.md?p=d-14) emergency preparedness and response plans in public health emergency preparedness, including [State](/usc/42/300gg–91.md?p=d-14) education agencies[^1] (as defined in [section 7801 of title 20](/usc/20/7801.md)), [State](/usc/42/300gg–91.md?p=d-14) [child](/usc/42/416.md?p=e) care [lead agencies](/usc/42/9858n.md?p=9) (designated under [section 9858b of this title](/usc/42/9858b.md)), and other relevant [State agencies](/usc/42/1396r–8.md?p=k-9)[^2]
      - (ix) in the case of entities that operate on the [United States](/usc/42/403.md?p=k)-Mexico border or the [United States](/usc/42/403.md?p=k)-Canada border, a description of the activities such entity will carry out under the [agreement](/usc/42/1320b–8.md?p=a-3-A) that are specific to the border area including disease detection, identification, investigation, and preparedness and response activities related to emerging diseases and infectious disease outbreaks whether naturally occurring or due to bioterrorism, consistent with the requirements of this section;
      - (x) a description of any activities that such entity will use to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance, including any utilization of poison control centers;
      - (xi) a description of how the entity will partner with health care [facilities](/usc/42/11049.md?p=4), including [hospitals](/usc/42/1395dd.md?p=e-5) and [nursing homes](/usc/42/1396g.md?p=e-1) and other long-term care [facilities](/usc/42/11049.md?p=4), to promote and improve public health preparedness and response;
      - (xii) a description of how the entity will provide technical assistance to improve public health preparedness and response, as appropriate, to agencies or other entities that operate [facilities](/usc/42/11049.md?p=4) within the entity’s jurisdiction in which there is an increased risk of infectious disease outbreaks in the event of a public health emergency declared under [section 247d of this title](/usc/42/247d.md), such as residential care [facilities](/usc/42/11049.md?p=4), [group homes](/usc/42/1437a.md?p=c-5), and other similar settings; and
      - (xiii) a description of how, as appropriate and practicable, the entity will include critical infrastructure partners, such as utility companies within the entity’s jurisdiction, in planning pursuant to this subparagraph to help ensure that critical infrastructure will remain functioning during, or return to function as soon as practicable after, a public health emergency;
    - (B) an assurance that the entity will report to the [Secretary](/usc/42/201.md?p=c) on an annual basis (or more frequently as determined by the [Secretary](/usc/42/201.md?p=c)) on the evidence-based benchmarks and objective [standards](/usc/42/1320d.md?p=7) established by the [Secretary](/usc/42/201.md?p=c) to evaluate the preparedness and response capabilities of such entity under [subsection (g)](#g);
    - (C) an assurance that the entity will conduct, on at least an annual basis, an exercise or drill that meets any criteria established by the [Secretary](/usc/42/201.md?p=c) to test the preparedness and response capabilities of such entity, including addressing the needs of [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B), and that the entity will report back to the [Secretary](/usc/42/201.md?p=c) within the application of the following year on the strengths and weaknesses identified through such exercise or drill, and corrective actions taken to address material weaknesses;
    - (D) an assurance that the entity will require relevant staff to complete relevant preparedness and response [trainings](/usc/42/285e–2.md?p=b-2), including [trainings](/usc/42/285e–2.md?p=b-2) related to efficient and effective operation during an incident or event within an Incident Command System;
    - (E) an assurance that the entity will provide to the [Secretary](/usc/42/201.md?p=c) the data described under [section 247d–4(c)(3) of this title](/usc/42/247d–4.md?p=c-3) as determined feasible by the [Secretary](/usc/42/201.md?p=c);
    - (F) an assurance that the entity will conduct activities to inform and educate the [hospitals](/usc/42/1395dd.md?p=e-5) within the jurisdiction of such entity on the role of such [hospitals](/usc/42/1395dd.md?p=e-5) in the plan required under [subparagraph (A)](#b-2-A);
    - (G) an assurance that the entity, with respect to the plan described under [subparagraph (A)](#b-2-A), has developed and will implement an accountability system to ensure that such entity makes satisfactory annual improvement and describes such system in the plan under [subparagraph (A)](#b-2-A);
    - (H) a description of the means by which to obtain public comment and input on the plan described in [subparagraph (A)](#b-2-A) and on the implementation of such plan, that shall include an [advisory committee](/usc/42/7703.md?p=9) or other similar mechanism for obtaining comment from the public and from other [State](/usc/42/300gg–91.md?p=d-14), local, and tribal stakeholders; and
    - (I) as relevant, a description of the process used by the entity to consult with local departments of public health to reach consensus, approval, or concurrence on the relative distribution of amounts received under this section.
- (c) **Limitation—** Beginning in fiscal year 2009, the [Secretary](/usc/42/201.md?p=c) may not award a cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) to a [State](/usc/42/300gg–91.md?p=d-14) unless such [State](/usc/42/300gg–91.md?p=d-14) is a [participant](/usc/42/300gg–91.md?p=d-11) in the Emergency System for Advance Registration of Volunteer Health Professionals described in [section 247d–7b of this title](/usc/42/247d–7b.md).
- (d) **Use of funds—**
  - (1) **In general—** An award under [subsection (a)](#a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (2), (4), (5), and (6) of [section 300hh–1(b) of this title](/usc/42/300hh–1.md?p=b).
  - (2) **Effect of section—** Nothing in this subsection may be construed as establishing new regulatory authority or as modifying any existing regulatory authority.
- (e) **Coordination with local response capabilities—** An entity shall, to the extent practicable, ensure that activities carried out under an award under [subsection (a)](#a) are coordinated with activities of relevant Metropolitan Medical Response Systems, local public health departments, the [Cities](/usc/42/12902.md?p=11) Readiness [Initiative](/usc/42/19131.md?p=1), local emergency plans, and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under [section 247d–3c of this title](/usc/42/247d–3c.md).
- (f) **Consultation with Homeland Security—** In making awards under [subsection (a)](#a), the [Secretary](/usc/42/201.md?p=c) shall consult with the [Secretary](/usc/42/201.md?p=c) of Homeland Security to—
  - (1) ensure maximum coordination of public health and medical preparedness and response activities with the Metropolitan Medical Response System, and other relevant activities;
  - (2) minimize duplicative funding of [programs](/usc/42/274l–1.md?p=4) and activities; and
  - (3) analyze activities, including exercises and drills, conducted under this section to develop recommendations and guidance on best [practices](/usc/42/17061.md?p=19) for such activities.
- (g) **Achievement of measurable evidence-based benchmarks and objective standards—**
  - (1) **In general—** Not later than 180 days after December 19, 2006, the [Secretary](/usc/42/201.md?p=c) shall develop or where appropriate adopt, and require the application of, measurable evidence-based benchmarks and objective [standards](/usc/42/1320d.md?p=7) that measure levels of preparedness with respect to the activities described in this section and with respect to activities described in [section 247d–3b of this title](/usc/42/247d–3b.md). In developing such benchmarks and [standards](/usc/42/1320d.md?p=7), the [Secretary](/usc/42/201.md?p=c) shall consult with and seek comments from [State](/usc/42/300gg–91.md?p=d-14), local, and tribal officials and [private entities](/usc/42/12181.md?p=6), as appropriate. Where appropriate, the [Secretary](/usc/42/201.md?p=c) shall incorporate existing objective [standards](/usc/42/1320d.md?p=7). Such benchmarks and [standards](/usc/42/1320d.md?p=7) shall—
    - (A) include outcome goals representing operational achievements of the National Preparedness Goals developed under [section 300hh–1(b) of this title](/usc/42/300hh–1.md?p=b) with respect to all-[hazards](/usc/42/5165f.md?p=a-3), including chemical, biological, radiological, or nuclear threats; and
    - (B) at a minimum, require entities to—
      - (i) measure progress toward achieving the outcome goals; and
      - (ii) at least annually, test, exercise, and rigorously evaluate the public health and medical emergency preparedness and response capabilities of the entity, and report to the [Secretary](/usc/42/201.md?p=c) on such measured and tested capabilities and measured and tested progress toward achieving outcome goals, based on criteria established by the [Secretary](/usc/42/201.md?p=c).
  - (2) **Criteria for pandemic influenza plans—**
    - (A) **In general—** Not later than 180 days after December 19, 2006, the [Secretary](/usc/42/201.md?p=c) shall develop and disseminate to the [chief executive officer](/usc/42/12511.md?p=9) of each [State](/usc/42/300gg–91.md?p=d-14) criteria for an effective [State](/usc/42/300gg–91.md?p=d-14) plan for responding to pandemic influenza. The [Secretary](/usc/42/201.md?p=c) shall periodically update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration of such criteria into the benchmarks and [standards](/usc/42/1320d.md?p=7) described in [paragraph (1)](#g-1).
    - (B) **Rule of construction—** Nothing in this section shall be construed to require the duplication of Federal efforts with respect to the development of criteria or [standards](/usc/42/1320d.md?p=7), without regard to whether such efforts were carried out prior to or after December 19, 2006.[^3]
  - (3) **Technical assistance—** The [Secretary](/usc/42/201.md?p=c) shall, as determined appropriate by the [Secretary](/usc/42/201.md?p=c), provide to a [State](/usc/42/300gg–91.md?p=d-14), upon request, technical assistance in meeting the requirements of this section, including the provision of advice by experts in the development of high-quality assessments, the setting of [State](/usc/42/300gg–91.md?p=d-14) objectives and assessment methods, the development of measures of satisfactory annual improvement that are valid and reliable, and other relevant areas.
  - (4) **Notification of failures—** The [Secretary](/usc/42/201.md?p=c) shall develop and implement a process to notify entities that are determined by the [Secretary](/usc/42/201.md?p=c) to have failed to meet the requirements of paragraph [(1)](#g-1) or [(2)](#g-2). Such process shall provide such entities with the opportunity to correct such noncompliance. An entity that fails to correct such noncompliance shall be subject to [paragraph (5)](#g-5).
  - (5) **Withholding of amounts from entities that fail to achieve benchmarks or submit influenza plan—** Beginning with fiscal year 2019, and in each succeeding fiscal year, the [Secretary](/usc/42/201.md?p=c) shall—
    - (A) withhold from each entity that has failed substantially to meet the benchmarks and performance measures described in [paragraph (1)](#g-1) for either of the 2 immediately preceding fiscal years (beginning with fiscal year 2018), pursuant to the process developed under [paragraph (4)](#g-4), the amount described in [paragraph (6)](#g-6); and
    - (B) withhold from each entity that has failed to submit to the [Secretary](/usc/42/201.md?p=c) a plan for responding to pandemic influenza that meets the criteria developed under [paragraph (2)](#g-2), the amount described in [paragraph (6)](#g-6).
  - (6) **Amounts described—**
    - (A) **In general—** The amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or [section 247d–3b of this title](/usc/42/247d–3b.md):
      - (i) For no more than one of each of the first 2 fiscal years immediately following a fiscal year in which an entity experienced a failure described in subparagraph [(A)](#g-5-A) or [(B)](#g-5-B) of paragraph (5), an amount equal to 10 percent of the amount the entity was eligible to receive for the respective fiscal year.
      - (ii) For no more than one of the first 2 fiscal years immediately following the third consecutive fiscal year in which an entity experienced such a failure, in lieu of applying [clause (i)](#g-6-A-i), an amount equal to 15 percent of the amount the entity was eligible to receive for the respective fiscal year.
    - (B) **Separate accounting—** Each failure described in subparagraph [(A)](#g-5-A) or [(B)](#g-5-B) of paragraph (5) shall be treated as a separate failure for purposes of calculating amounts withheld under [subparagraph (A)](#g-6-A).
  - (7) **Reallocation of amounts withheld—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall make amounts withheld under [paragraph (6)](#g-6) available for making awards under [section 247d–3b of this title](/usc/42/247d–3b.md) to entities described in [subsection (b)(1)](/usc/42/247d–3b.md?p=b-1) of such section.
    - (B) **Preference in reallocation—** In making awards under [section 247d–3b of this title](/usc/42/247d–3b.md) with amounts described in [subparagraph (A)](#g-7-A), the [Secretary](/usc/42/201.md?p=c) shall give preference to [eligible entities](/usc/42/296.md?p=1) (as described in [section 247d–3b(b)(1) of this title](/usc/42/247d–3b.md?p=b-1)) that are located in whole or in part in [States](/usc/42/300gg–91.md?p=d-14) from which amounts have been withheld under [paragraph (6)](#g-6).
  - (8) **Waive or reduce withholding—** The [Secretary](/usc/42/201.md?p=c) may waive or reduce the withholding described in [paragraph (6)](#g-6), for a [single](/usc/42/2304.md?p=m) entity or for all entities in a fiscal year, if the [Secretary](/usc/42/201.md?p=c) determines that mitigating conditions exist that justify the waiver or reduction.
- (h) **Funding—**
  - (1) **Authorization of appropriations—**
    - (A) **In general—** For the purpose of carrying out this section, there is authorized to be appropriated $685,000,000 for each of fiscal years 2019 through 2023 for awards pursuant to [paragraph (3)](#h-3) (subject to the authority of the [Secretary](/usc/42/201.md?p=c) to make awards pursuant to paragraphs [(4)](#h-4) and [(5)](#h-5)).
    - (B) **Requirement for State matching funds—** Beginning in fiscal year 2009, in the case of any [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of two or more [States](/usc/42/300gg–91.md?p=d-14), the [Secretary](/usc/42/201.md?p=c) may not award a cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) under this section unless the [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14) agree that, with respect to the amount of the cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) awarded by the [Secretary](/usc/42/201.md?p=c), the [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14) will make available (directly or through donations from public or [private entities](/usc/42/12181.md?p=6)) non-Federal contributions in an amount equal to—
      - (i) for the first fiscal year of the cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A), not less than 5 percent of such costs ($1 for each $20 of Federal [funds](/usc/42/12854.md?p=3) provided in the cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A)); and
      - (ii) for any second fiscal year of the cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A), and for any subsequent fiscal year of such cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A), not less than 10 percent of such costs ($1 for each $10 of Federal [funds](/usc/42/12854.md?p=3) provided in the cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A)).
    - (C) **Determination of amount of non-Federal contributions—** As determined by the [Secretary](/usc/42/201.md?p=c), non-Federal contributions required in [subparagraph (B)](#h-1-B) may be provided directly or through donations from public or [private entities](/usc/42/12181.md?p=6) and may be in cash or in kind, fairly evaluated, including plant, equipment or [services](/usc/42/201.md?p=a). Amounts provided by the Federal government, or [services](/usc/42/201.md?p=a) assisted or subsidized to any significant extent by the Federal government, may not be included in determining the amount of such non-Federal contributions.
  - (2) **Maintaining State funding—**
    - (A) **In general—** An entity that receives an award under this section shall maintain expenditures for public health security at a level that is not less than the average level of such expenditures maintained by the entity for the preceding 2 year period.
    - (B) **Rule of construction—** Nothing in this section shall be construed to prohibit the use of awards under this section to pay salary and related expenses of public health and other professionals employed by [State](/usc/42/300gg–91.md?p=d-14), local, or tribal public health agencies who are carrying out activities supported by such awards (regardless of whether the primary assignment of such personnel is to carry out such activities).
  - (3) **Determination of amount—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall award cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) under [subsection (a)](#a) to each [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of 2 or more [States](/usc/42/300gg–91.md?p=d-14) that submits to the [Secretary](/usc/42/201.md?p=c) an application that meets the criteria of the [Secretary](/usc/42/201.md?p=c) for the receipt of such an award and that meets other implementation conditions established by the [Secretary](/usc/42/201.md?p=c) for such awards.
    - (B) **Base amount—** In determining the amount of an award pursuant to [subparagraph (A)](#h-3-A) for a [State](/usc/42/300gg–91.md?p=d-14), the [Secretary](/usc/42/201.md?p=c) shall first determine an amount the [Secretary](/usc/42/201.md?p=c) considers appropriate for the [State](/usc/42/300gg–91.md?p=d-14) (referred to in this paragraph as the “base amount”), except that such amount may not be greater than the minimum amount determined under [subparagraph (D)](#h-3-D).
    - (C) **Increase on basis of population—** After determining the base amount for a [State](/usc/42/300gg–91.md?p=d-14) under [subparagraph (B)](#h-3-B), the [Secretary](/usc/42/201.md?p=c) shall increase the base amount by an amount equal to the product of—
      - (i) the amount appropriated under [paragraph (1)(A)](#h-1-A) for the fiscal year, less an amount equal to the sum of all base amounts determined for the [States](/usc/42/300gg–91.md?p=d-14) under [subparagraph (B)](#h-3-B), and less the amount, if any, reserved by the [Secretary](/usc/42/201.md?p=c) under paragraphs [(4)](#h-4) and [(5)](#h-5); and
      - (ii) subject to [paragraph (4)(C)](#h-4-C), the percentage constituted by the ratio of an amount equal to the population of the [State](/usc/42/300gg–91.md?p=d-14) over an amount equal to the total population of the [States](/usc/42/300gg–91.md?p=d-14) (as indicated by the most recent data collected by the Bureau of the Census).
    - (D) **Minimum amount—** Subject to the amount appropriated under [paragraph (1)(A)](#h-1-A), an award pursuant to [subparagraph (A)](#h-3-A) for a [State](/usc/42/300gg–91.md?p=d-14) shall be the greater of the base amount as increased under [subparagraph (C)](#h-3-C), or the minimum amount under this subparagraph. The minimum amount under this subparagraph is—
      - (i) in the case of each of the several [States](/usc/42/300gg–91.md?p=d-14), the District of Columbia, and the Commonwealth of Puerto Rico, an amount equal to the lesser of—
        - (I) $5,000,000; or
        - (II) if the amount appropriated under [paragraph (1)(A)](#h-1-A) is less than $667,000,000, an amount equal to 0.75 percent of the amount appropriated under such paragraph, less the amount, if any, reserved by the [Secretary](/usc/42/201.md?p=c) under paragraphs [(4)](#h-4) and [(5)](#h-5); or
      - (ii) in the case of each of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the Virgin Islands, an amount determined by the [Secretary](/usc/42/201.md?p=c) to be appropriate, except that such amount may not exceed the amount determined under [clause (i)](#h-3-D-i).
  - (4) **Certain political subdivisions—**
    - (A) **In general—** For fiscal year 2007, the [Secretary](/usc/42/201.md?p=c) may, before making awards pursuant to [paragraph (3)](#h-3) for such year, reserve from the amount appropriated under [paragraph (1)](#h-1) for the year an amount determined necessary by the [Secretary](/usc/42/201.md?p=c) to make awards under [subsection (a)](#a) to political subdivisions that have a substantial number of residents, have a substantial local infrastructure for responding to public health emergencies, and face a high degree of risk from bioterrorist attacks or other public health emergencies. Not more than three political subdivisions may receive awards pursuant to this subparagraph.
    - (B) **Coordination with Statewide plans—** An award pursuant to [subparagraph (A)](#h-4-A) may not be made unless the application of the political subdivision involved is in coordination with, and consistent with, applicable Statewide plans described in [subsection (b)](#b).
    - (C) **Relationship to formula grants—** In the case of a [State](/usc/42/300gg–91.md?p=d-14) that will receive an award pursuant to [paragraph (3)](#h-3), and in which there is located a political subdivision that will receive an award pursuant to [subparagraph (A)](#h-4-A), the [Secretary](/usc/42/201.md?p=c) shall, in determining the amount under [paragraph (3)(C)](#h-3-C) for the [State](/usc/42/300gg–91.md?p=d-14), subtract from the population of the [State](/usc/42/300gg–91.md?p=d-14) an amount equal to the population of such political subdivision.
    - (D) **Continuity of funding—** In determining whether to make an award pursuant to [subparagraph (A)](#h-4-A) to a political subdivision, the [Secretary](/usc/42/201.md?p=c) may consider, as a factor indicating that the award should be made, that the political subdivision received public health funding from the [Secretary](/usc/42/201.md?p=c) for fiscal year 2006.
  - (5) **Significant unmet needs; degree of risk—**
    - (A) **In general—** For fiscal year 2007, the [Secretary](/usc/42/201.md?p=c) may, before making awards pursuant to [paragraph (3)](#h-3) for such year, reserve from the amount appropriated under [paragraph (1)](#h-1) for the year an amount determined necessary by the [Secretary](/usc/42/201.md?p=c) to make awards under [subsection (a)](#a) to [eligible entities](/usc/42/296.md?p=1) that—
      - (i) have a significant need for [funds](/usc/42/12854.md?p=3) to build capacity to identify, detect, monitor, and respond to a bioterrorist or other threat to the public health, which need will not be met by awards pursuant to [paragraph (3)](#h-3); and
      - (ii) face a particularly high degree of risk of such a threat.
    - (B) **Recipients of grants—** Awards pursuant to [subparagraph (A)](#h-5-A) may be supplemental awards to [States](/usc/42/300gg–91.md?p=d-14) that receive awards pursuant to [paragraph (3)](#h-3), or may be awards to [eligible entities](/usc/42/296.md?p=1) described in [subsection (b)(1)(B)](#b-1-B) within such [States](/usc/42/300gg–91.md?p=d-14).
    - (C) **Finding with respect to District of Columbia—** The [Secretary](/usc/42/201.md?p=c) shall consider the District of Columbia to have a significant unmet need for purposes of [subparagraph (A)](#h-5-A), and to face a particularly high degree of risk for such purposes, on the basis of the concentration of entities of national significance located within the District.
  - (6) **Funding of local entities—** The [Secretary](/usc/42/201.md?p=c) shall, in making awards under this section, ensure that with respect to the cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) awarded, the entity make available appropriate portions of such award to political subdivisions and local departments of public health through a process involving the consensus, approval or concurrence with such local entities.
  - (7) **Availability of cooperative agreement funds—**
    - (A) **In general—** Amounts provided to an [eligible entity](/usc/42/256a.md?p=l-1) under a cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) under [subsection (a)](#a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such [funds](/usc/42/12854.md?p=3) were provided.
    - (B) **Funds contingent on achieving benchmarks—** The continued availability of [funds](/usc/42/12854.md?p=3) under [subparagraph (A)](#h-7-A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as described in [subsection (g)](#g).
- (i) **Administrative and fiscal responsibility—**
  - (1) **Annual reporting requirements—** Each entity shall prepare and submit to the [Secretary](/usc/42/201.md?p=c) annual reports on its activities under this section and [section 247d–3b of this title](/usc/42/247d–3b.md). Each such report shall be prepared by, or in consultation with, the health department. In order to properly evaluate and compare the performance of different entities assisted under this section and [section 247d–3b of this title](/usc/42/247d–3b.md) and to assure the proper expenditure of [funds](/usc/42/12854.md?p=3) under this section and [section 247d–3b of this title](/usc/42/247d–3b.md), such reports shall be in such standardized form and contain such information as the [Secretary](/usc/42/201.md?p=c) determines and describes within 180 days of December 19, 2006 (after consultation with the [States](/usc/42/300gg–91.md?p=d-14)) to be necessary to—
    - (A) secure an accurate description of those activities;
    - (B) secure a complete record of the purposes for which [funds](/usc/42/12854.md?p=3) were spent, and of the [recipients](/usc/42/2996a.md?p=6) of such [funds](/usc/42/12854.md?p=3);
    - (C) describe the extent to which the entity has met the goals and objectives it set forth under this section or [section 247d–3b of this title](/usc/42/247d–3b.md);
    - (D) determine the extent to which [funds](/usc/42/12854.md?p=3) were expended consistent with the entity’s application transmitted under this section or [section 247d–3b of this title](/usc/42/247d–3b.md); and
    - (E) publish such information on a Federal Internet website consistent with [subsection (j)](#j).
  - (2) **Audits; implementation—**
    - (A) **In general—** Each entity receiving [funds](/usc/42/12854.md?p=3) under this section or [section 247d–3b of this title](/usc/42/247d–3b.md) shall, not less often than once every 2 years, audit its expenditures from amounts received under this section or [section 247d–3b of this title](/usc/42/247d–3b.md). Such audits shall be conducted by an entity independent of the agency administering a [program](/usc/42/274l–1.md?p=4) funded under this section or [section 247d–3b of this title](/usc/42/247d–3b.md) in accordance with the Comptroller General’s [standards](/usc/42/1320d.md?p=7) for auditing governmental organizations, [programs](/usc/42/274l–1.md?p=4), activities, and functions and generally accepted auditing [standards](/usc/42/1320d.md?p=7). Within 30 days following the completion of each audit report, the entity shall submit a copy of that audit report to the [Secretary](/usc/42/201.md?p=c).
    - (B) **Repayment—** Each entity shall repay to the [United States](/usc/42/403.md?p=k) amounts found by the [Secretary](/usc/42/201.md?p=c), after notice and opportunity for a hearing to the entity, not to have been expended in accordance with this section or [section 247d–3b of this title](/usc/42/247d–3b.md) and, if such repayment is not made, the [Secretary](/usc/42/201.md?p=c) may offset such amounts against the amount of any allotment to which the entity is or may become entitled under this section or [section 247d–3b of this title](/usc/42/247d–3b.md) or may otherwise recover such amounts.
    - (C) **Withholding of payment—** The [Secretary](/usc/42/201.md?p=c) may, after notice and opportunity for a hearing, withhold payment of [funds](/usc/42/12854.md?p=3) to any entity which is not using its allotment under this section or [section 247d–3b of this title](/usc/42/247d–3b.md) in accordance with such section. The [Secretary](/usc/42/201.md?p=c) may withhold such [funds](/usc/42/12854.md?p=3) until the [Secretary](/usc/42/201.md?p=c) finds that the reason for the withholding has been removed and there is reasonable assurance that it will not recur.
- (j) **Compilation and availability of data—** The [Secretary](/usc/42/201.md?p=c) shall compile the data submitted under this section and make such data available in a timely manner on an appropriate Internet website in a format that is useful to the public and to other entities and that provides information on what activities are best contributing to the achievement of the outcome goals described in [subsection (g)](#g).
- (k) **Evaluation—**
  - (1) **In general—** Not later than 2 years after June 24, 2019, and every 2 years thereafter, the [Secretary](/usc/42/201.md?p=c) shall conduct an evaluation of the evidence-based benchmarks and objective [standards](/usc/42/1320d.md?p=7) required under [subsection (g)](#g). Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National Health Security Strategy under [section 300hh–1 of this title](/usc/42/300hh–1.md), at such time as such strategy is submitted.
  - (2) **Content—** The evaluation under this paragraph shall include—
    - (A) a review of evidence-based benchmarks and objective [standards](/usc/42/1320d.md?p=7), and associated metrics and targets;
    - (B) a discussion of changes to any evidence-based benchmarks and objective [standards](/usc/42/1320d.md?p=7), and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and, to the extent practicable, the applicable goals of the National Health Security Strategy under [section 300hh–1 of this title](/usc/42/300hh–1.md);
    - (C) a description of amounts received by [eligible entities](/usc/42/296.md?p=1) described in [subsection (b)](#b) and [section 247d–3b(b) of this title](/usc/42/247d–3b.md?p=b), and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and objective [standards](/usc/42/1320d.md?p=7); and
    - (D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective [standards](/usc/42/1320d.md?p=7) to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and [section 300hh–1 of this title](/usc/42/300hh–1.md).

# §247d–3b. Partnerships for State and regional hospital preparedness to improve surge capacity

- (a) **In general—** The [Secretary](/usc/42/201.md?p=c), acting through the Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response, shall award competitive grants or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) to [eligible entities](/usc/42/296.md?p=1) to enable such entities to improve surge capacity and enhance community and [hospital](/usc/42/1395dd.md?p=e-5) preparedness for, and response to, public health emergencies in accordance with [subsection (c)](#c), including, as appropriate, capacity and preparedness to address the needs of [children](/usc/42/256e.md?p=g-2) and other [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B).
- (b) **Eligibility—** To be eligible for an award under [subsection (a)](#a), an entity shall—
  - (1)
    - (A) be a coalition that includes—
      - (i) one or more [hospitals](/usc/42/1395dd.md?p=e-5), at least one of which shall be a [designated trauma center](/usc/42/300d–31.md?p=1), consistent with [section 300d–13(c) of this title](/usc/42/300d–13.md?p=c);
      - (ii) one or more other local health care [facilities](/usc/42/11049.md?p=4), including clinics, health centers, [community health centers](/usc/42/1786.md?p=j-4-A), primary care [facilities](/usc/42/11049.md?p=4), mental health centers, mobile medical assets, or [nursing homes](/usc/42/1396g.md?p=e-1);
      - (iii)
        - (I) one or more political subdivisions;
        - (II) one or more [States](/usc/42/300gg–91.md?p=d-14); or
        - (III) one or more [States](/usc/42/300gg–91.md?p=d-14) and one or more political subdivisions; and
      - (iv) one or more emergency medical [service](/usc/42/201.md?p=a) organizations or emergency management organizations; and
    - (B) prepare, in consultation with the [Chief Executive Officer](/usc/42/12511.md?p=9) and the lead health officials of the [State](/usc/42/300gg–91.md?p=d-14), District, or territory in which the [hospital](/usc/42/1395dd.md?p=e-5) and health care [facilities](/usc/42/11049.md?p=4) described in [subparagraph (A)](#b-1-A) are located, and submit to the [Secretary](/usc/42/201.md?p=c), an application at such time, in such manner, and containing such information as the [Secretary](/usc/42/201.md?p=c) may require; or
  - (2)
    - (A) be an entity described in [section 247d–3a(b)(1) of this title](/usc/42/247d–3a.md?p=b-1); and
    - (B) submit an application at such time, in such manner, and containing such information as the [Secretary](/usc/42/201.md?p=c) may require, including the information or assurances required under [section 247d–3a(b)(2) of this title](/usc/42/247d–3a.md?p=b-2) and an assurance that the [State](/usc/42/300gg–91.md?p=d-14) will adhere to any applicable guidelines established by the [Secretary](/usc/42/201.md?p=c).
- (c) **Use of funds—** An award under [subsection (a)](#a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (3), (4), (5), and (6) of [section 300hh–1(b) of this title](/usc/42/300hh–1.md?p=b) with respect to all-[hazards](/usc/42/5165f.md?p=a-3), including chemical, biological, radiological, or nuclear threats.
- (d) **Preferences—**
  - (1) **Regional coordination—** In making awards under [subsection (a)](#a), the [Secretary](/usc/42/201.md?p=c) shall give preference to [eligible entities](/usc/42/296.md?p=1) that submit applications that, in the determination of the [Secretary](/usc/42/201.md?p=c)—
    - (A) will enhance coordination—
      - (i) among the entities described in [subsection (b)(1)(A)(i)](#b-1-A-i);
      - (ii) among one or more [facilities](/usc/42/11049.md?p=4) in a regional health care emergency system under [section 247d–3c of this title](/usc/42/247d–3c.md); and
      - (iii) between such entities and the entities described in [subsection (b)(1)(A)(ii)](#b-1-A-ii); and
    - (B) include, in the coalition described in [subsection (b)(1)(A)](#b-1-A), a significant percentage of the [hospitals](/usc/42/1395dd.md?p=e-5) and health care [facilities](/usc/42/11049.md?p=4) within the [geographic area](/usc/42/11360.md?p=9) served by such coalition.
  - (2) **Other preferences—** In making awards under [subsection (a)](#a), the [Secretary](/usc/42/201.md?p=c) shall give preference to [eligible entities](/usc/42/296.md?p=1) that, in the determination of the [Secretary](/usc/42/201.md?p=c)—
    - (A) include one or more [hospitals](/usc/42/1395dd.md?p=e-5) that are [participants](/usc/42/300gg–91.md?p=d-11) in the National [Disaster](/usc/42/5204.md?p=2) Medical System;
    - (B) are located in a [geographic area](/usc/42/11360.md?p=9) that faces a high degree of risk, as determined by the [Secretary](/usc/42/201.md?p=c) in consultation with the [Secretary](/usc/42/201.md?p=c) of Homeland Security; or
    - (C) have a significant need for [funds](/usc/42/12854.md?p=3) to achieve the preparedness and response goals described in [section 300hh–1(b)(3) of this title](/usc/42/300hh–1.md?p=b-3).
- (e) **Consistency of planned activities—** The [Secretary](/usc/42/201.md?p=c) may not award a cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) to an [eligible entity](/usc/42/256a.md?p=l-1) described in [subsection (b)(1)](#b-1) unless the application submitted by the entity is coordinated and consistent with an applicable [State](/usc/42/300gg–91.md?p=d-14) All-[Hazards](/usc/42/5165f.md?p=a-3) Public Health Emergency Preparedness and Response Plan and relevant local plans, as determined by the [Secretary](/usc/42/201.md?p=c) in consultation with relevant [State](/usc/42/300gg–91.md?p=d-14) health officials.
- (f) **Limitation on awards—** A political subdivision shall not participate in more than one coalition described in [subsection (b)(1)](#b-1).
- (g) **Coordination—**
  - (1) **Local response capabilities—** An [eligible entity](/usc/42/256a.md?p=l-1) shall, to the extent practicable, ensure that activities carried out under an award under [subsection (a)](#a) are coordinated with activities of relevant local Metropolitan Medical Response Systems, local Medical Reserve [Corps](/usc/42/12626.md?p=3), the local [Cities](/usc/42/12902.md?p=11) Readiness [Initiative](/usc/42/19131.md?p=1), and local emergency plans.
  - (2) **National collaboration—** Coalitions consisting of one or more [eligible entities](/usc/42/296.md?p=1) under this section may, to the extent practicable, collaborate with other coalitions consisting of one or more [eligible entities](/usc/42/296.md?p=1) under this section for purposes of national coordination and collaboration with respect to activities to achieve the preparedness and response goals described under paragraphs (1), (3), (4), (5), and (6) of [section 300hh–1(b) of this title](/usc/42/300hh–1.md?p=b).
- (h) **Maintenance of funding—**
  - (1) **In general—** An entity that receives an award under this section shall maintain expenditures for health care preparedness at a level that is not less than the average level of such expenditures maintained by the entity for the preceding 2 year period.
  - (2) **Rule of construction—** Nothing in this section shall be construed to prohibit the use of awards under this section to pay salary and related expenses of public health and other professionals employed by [State](/usc/42/300gg–91.md?p=d-14), local, or tribal agencies who are carrying out activities supported by such awards (regardless of whether the primary assignment of such personnel is to carry out such activities).
- (i) **Performance and accountability—**
  - (1) **In general—** The requirements of section [247d–3a(g)](/usc/42/247d–3a.md?p=g), [(i)](/usc/42/247d–3a.md?p=i), [(j)](/usc/42/247d–3a.md?p=j), and [(k)](/usc/42/247d–3a.md?p=k) of this title shall apply to entities receiving awards under this section (regardless of whether such entities are described under subsection [(b)(1)(A)](#b-1-A) or [(b)(2)(A)](#b-2-A)) in the same manner as such requirements apply to entities under [section 247d–3a of this title](/usc/42/247d–3a.md). In submitting reports under this paragraph, a coalition shall include information on the progress that the coalition has made toward the implementation of [section 247d–3c of this title](/usc/42/247d–3c.md) (or barriers to progress, if any). A coalition described in [subsection (b)(1)(A)](#b-1-A) shall make such reports available to the lead health official of the [State](/usc/42/300gg–91.md?p=d-14) in which such coalition is located.
  - (2) **Meeting goals of National Health Security Strategy—** The [Secretary](/usc/42/201.md?p=c) shall implement objective, evidence-based metrics to ensure that entities receiving awards under this section are meeting, to the extent practicable, the applicable goals of the National Health Security Strategy under [section 300hh–1 of this title](/usc/42/300hh–1.md).
- (j) **Authorization of appropriations—**
  - (1) **In general—**
    - (A) **Authorization of appropriations—** For purposes of carrying out this section and [section 247d–3c of this title](/usc/42/247d–3c.md), in accordance with [subparagraph (B)](#j-1-B), there is authorized to be appropriated $385,000,000 for each of fiscal years 2019 through 2023.
    - (B) **Reservation of amounts for regional systems—**
      - (i) **In general—** Subject to [clause (ii)](#j-1-B-ii), of the amount appropriated under [subparagraph (A)](#j-1-A) for a fiscal year, the [Secretary](/usc/42/201.md?p=c) may reserve up to 5 percent for the purpose of carrying out [section 247d–3c of this title](/usc/42/247d–3c.md).
      - (ii) **Reservation contingent on continued appropriations for this section—** If for fiscal year 2019 or a subsequent fiscal year, the amount appropriated under [subparagraph (A)](#j-1-A) is such that, after application of [clause (i)](#j-1-B-i), the amount remaining for the purpose of carrying out this section would be less than the amount available for such purpose for the previous fiscal year, the amount that may be reserved under [clause (i)](#j-1-B-i) shall be reduced such that the amount remaining for the purpose of carrying out this section is not less than the amount available for such purpose for the previous fiscal year.
      - (iii) **Sunset—** The authority to reserve amounts under [clause (i)](#j-1-B-i) shall expire on September 30, 2023.
  - (2) **Reservation of amounts for partnerships—** Prior to making awards described in [paragraph (3)](#j-3), the [Secretary](/usc/42/201.md?p=c) may reserve from the amount appropriated under [paragraph (1)(A)](#j-1-A) for a fiscal year and not reserved for the purpose described in [paragraph (1)(B)(i)](#j-1-B-i), an amount determined appropriate by the [Secretary](/usc/42/201.md?p=c) for making awards to entities described in [subsection (b)(1)(A)](#b-1-A).
  - (3) **Awards to States and political subdivisions—**
    - (A) **In general—** From amounts appropriated for a fiscal year under [paragraph (1)(A)](#j-1-A) and not reserved under paragraph [(1)(B)(i)](#j-1-B-i) or [(2)](#j-2), the [Secretary](/usc/42/201.md?p=c) shall make awards to entities described in [subsection (b)(2)(A)](#b-2-A) that have completed an application as described in [subsection (b)(2)(B)](#b-2-B).
    - (B) **Amount—** The [Secretary](/usc/42/201.md?p=c) shall determine the amount of an award to each entity described in [subparagraph (A)](#j-3-A) in the same manner as such amounts are determined under [section 247d–3a(h) of this title](/usc/42/247d–3a.md?p=h).
  - (4) **Availability of cooperative agreement funds—**
    - (A) **In general—** Amounts provided to an [eligible entity](/usc/42/256a.md?p=l-1) under a cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) under [subsection (a)](#a) for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such [funds](/usc/42/12854.md?p=3) were provided.
    - (B) **Funds contingent on achieving benchmarks—** The continued availability of [funds](/usc/42/12854.md?p=3) under [subparagraph (A)](#j-4-A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as required under [subsection (i)](#i).

# §247d–3c. Guidelines for regional health care emergency preparedness and response systems

- (a) **Purpose—** It is the purpose of this section to identify and provide guidelines for regional systems of [hospitals](/usc/42/1395dd.md?p=e-5), health care [facilities](/usc/42/11049.md?p=4), and other public and private sector entities, with varying levels of capability to treat patients and increase medical surge capacity during, in advance of, and immediately following a public health emergency, including threats posed by one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases.
- (b) **Guidelines—** The Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response, in consultation with the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, the [Administrator](/usc/42/4005.md?p=1) of the Centers for Medicare & Medicaid [Services](/usc/42/201.md?p=a), the [Administrator](/usc/42/4005.md?p=1) of the Health Resources and [Services](/usc/42/201.md?p=a) Administration, the [Commissioner](/usc/42/12302.md?p=1) of Food and [Drugs](/usc/42/282.md?p=j-1-A-vii), the Assistant [Secretary](/usc/42/201.md?p=c) for Mental Health and Substance Use, the Assistant [Secretary](/usc/42/201.md?p=c) of Labor for Occupational Safety and Health, the [Secretary](/usc/42/201.md?p=c) of Veterans Affairs, the heads of such other [Federal agencies](/usc/42/300j–6.md?p=d-2) as the [Secretary](/usc/42/201.md?p=c) determines to be appropriate, and [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial public health officials, shall, not later than 2 years after June 24, 2019—
  - (1) identify and develop a set of guidelines relating to [practices](/usc/42/17061.md?p=19) and protocols for all-[hazards](/usc/42/5165f.md?p=a-3) public health emergency preparedness and response for [hospitals](/usc/42/1395dd.md?p=e-5) and health care [facilities](/usc/42/11049.md?p=4) to provide appropriate patient care during, in advance of, or immediately following, a public health emergency, resulting from one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases (which may include existing [practices](/usc/42/17061.md?p=19), such as trauma care and medical surge capacity and capabilities), with respect to—
    - (A) a regional approach to identifying [hospitals](/usc/42/1395dd.md?p=e-5) and health care [facilities](/usc/42/11049.md?p=4) based on varying capabilities and capacity to treat patients affected by such emergency, including—
      - (i) the manner in which the system will coordinate with and integrate the partnerships and health care coalitions established under [section 247d–3b(b) of this title](/usc/42/247d–3b.md?p=b); and
      - (ii) informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such [hospitals](/usc/42/1395dd.md?p=e-5) and health care [facilities](/usc/42/11049.md?p=4) in the community;
    - (B) physical and technological infrastructure, [laboratory](/usc/42/300jj.md?p=10) capacity, staffing, blood supply, and other supply chain needs, taking into account resiliency, geographic considerations, and rural considerations;
    - (C) protocols or best [practices](/usc/42/17061.md?p=19) for the safety and personal protection of workers who handle human remains and health care workers (including with respect to protective equipment and supplies, waste management processes, and decontamination), sharing of specialized experience among the health care workforce, behavioral health, psychological [resilience](/usc/42/300j–19a.md?p=l-1), and [training](/usc/42/285e–2.md?p=b-2) of the workforce, as applicable;
    - (D) in a manner that allows for disease containment (within the meaning of [section 300hh–1(b)(2)(B) of this title](/usc/42/300hh–1.md?p=b-2-B)), coordinated medical triage, [treatment](/usc/42/11851.md?p=11), and transportation of patients, based on patient medical need (including patients in rural areas), to the appropriate [hospitals](/usc/42/1395dd.md?p=e-5) or health care [facilities](/usc/42/11049.md?p=4) within the regional system or, as applicable and appropriate, between systems in different [States](/usc/42/300gg–91.md?p=d-14) or regions; and
    - (E) the needs of [children](/usc/42/256e.md?p=g-2) and other [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B);
  - (2) make such guidelines available on the internet website of the Department of Health and Human [Services](/usc/42/201.md?p=a) in a manner that does not compromise national security; and
  - (3) update such guidelines as appropriate, including based on input received pursuant to subsections [(c)](#c) and [(e)](#e) and information resulting from applicable reports required under the Pandemic and All-[Hazards](/usc/42/5165f.md?p=a-3) Preparedness and Advancing Innovation Act of 2019 (including any amendments made by such Act), to address new and emerging public health threats.
- (c) **Considerations—** In identifying, developing, and updating guidelines under [subsection (b)](#b), the Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response shall—
  - (1) include input from [hospitals](/usc/42/1395dd.md?p=e-5) and health care [facilities](/usc/42/11049.md?p=4) (including health care coalitions under [section 247d–3b of this title](/usc/42/247d–3b.md)), [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial public health departments, and health care or subject matter experts (including experts with relevant expertise in chemical, biological, radiological, or nuclear threats, including emerging infectious diseases), as the Assistant [Secretary](/usc/42/201.md?p=c) determines appropriate, to meet the goals under [section 300hh–1(b)(3) of this title](/usc/42/300hh–1.md?p=b-3);
  - (2) consult and engage with appropriate [health care providers](/usc/42/300jj.md?p=3) and professionals, including [physicians](/usc/42/1395cc–4.md?p=a-2-E), nurses, first responders, health care [facilities](/usc/42/11049.md?p=4) (including [hospitals](/usc/42/1395dd.md?p=e-5), primary care clinics, [community health centers](/usc/42/1786.md?p=j-4-A), mental health [facilities](/usc/42/11049.md?p=4), ambulatory care [facilities](/usc/42/11049.md?p=4), and dental health [facilities](/usc/42/11049.md?p=4)), pharmacies, emergency medical providers, trauma care providers, environmental health agencies, public health [laboratories](/usc/42/300jj.md?p=10), poison control centers, blood banks, tissue banks, and other experts that the Assistant [Secretary](/usc/42/201.md?p=c) determines appropriate, to meet the goals under [section 300hh–1(b)(3) of this title](/usc/42/300hh–1.md?p=b-3);
  - (3) consider feedback related to financial implications for [hospitals](/usc/42/1395dd.md?p=e-5), health care [facilities](/usc/42/11049.md?p=4), public health agencies, [laboratories](/usc/42/300jj.md?p=10), blood banks, tissue banks, and other entities engaged in regional preparedness planning to implement and follow such guidelines, as applicable; and
  - (4) consider financial requirements and potential incentives for entities to prepare for, and respond to, public health emergencies as part of the regional health care emergency preparedness and response system.
- (d) **Technical assistance—** The Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response, in consultation with the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention and the Assistant [Secretary](/usc/42/201.md?p=c) of Labor for Occupational Safety and Health, may provide technical assistance and consultation toward meeting the guidelines described in [subsection (b)](#b).
- (e) **Demonstration project for regional health care preparedness and response systems—**
  - (1) **In general—** The Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response may establish a [demonstration project](/usc/42/16281.md?p=d-2) pursuant to the development and implementation of guidelines under [subsection (b)](#b) to award grants to improve medical surge capacity for all [hazards](/usc/42/5165f.md?p=a-3), build and integrate regional medical response capabilities, improve specialty care expertise for all-[hazards](/usc/42/5165f.md?p=a-3) response, and coordinate medical preparedness and response across [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, territorial, and regional jurisdictions.
  - (2) **Sunset—** The authority under this subsection shall expire on September 30, 2023.

# §247d–4. Facilities and capacities of the Centers for Disease Control and Prevention

- (a) **In general—**
  - (1) **Findings—** Congress finds that the Centers for Disease Control and Prevention has an essential role in defending against and combatting public health threats domestically and abroad and requires secure and modern [facilities](/usc/42/11049.md?p=4), and expanded, improved, and appropriately maintained capabilities related to bioterrorism and other public health emergencies, sufficient to enable such Centers to conduct this important mission.
  - (2) **Facilities—**
    - (A) **In general—** The [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention may design, construct, and equip new [facilities](/usc/42/11049.md?p=4), renovate existing [facilities](/usc/42/11049.md?p=4) (including [laboratories](/usc/42/300jj.md?p=10), [laboratory](/usc/42/300jj.md?p=10) support [buildings](/usc/42/6881.md?p=i-3), scientific communication [facilities](/usc/42/11049.md?p=4), transshipment complexes, secured and isolated parking structures, [office](/usc/42/3058f.md?p=1) [buildings](/usc/42/6881.md?p=i-3), and other [facilities](/usc/42/11049.md?p=4) and infrastructure), and upgrade security of such [facilities](/usc/42/11049.md?p=4), in order to better conduct the capacities described in [section 247d–1 of this title](/usc/42/247d–1.md), and for supporting public health activities.
    - (B) **Multiyear contracting authority—** For any [project](/usc/42/11360.md?p=20) of designing, constructing, equipping, or renovating any [facility](/usc/42/11049.md?p=4) under [subparagraph (A)](#a-2-A), the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention may enter into a [single](/usc/42/2304.md?p=m) contract or related contracts that collectively include the full scope of the [project](/usc/42/11360.md?p=20), and the solicitation and contract shall contain the clause “availability of [funds](/usc/42/12854.md?p=3)” found at [section 52.232–18 of title 48, Code of Federal Regulations](/cfr/48/52.232–18.md).
  - (3) **Improving the capacities of the Centers for Disease Control and Prevention—** The [Secretary](/usc/42/201.md?p=c) shall expand, improve, enhance, and appropriately maintain the capabilities of the Centers for Disease Control and Prevention relating to preparedness for and responding effectively to bioterrorism and other public health emergencies, by—
    - (A) expanding or enhancing the [training](/usc/42/285e–2.md?p=b-2) of personnel;
    - (B) improving communications [facilities](/usc/42/11049.md?p=4) and networks, including delivery of necessary information to rural areas;
    - (C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under [subsection (b)](#b); and
    - (D) improving [laboratory](/usc/42/300jj.md?p=10) [facilities](/usc/42/11049.md?p=4) related to bioterrorism, infectious disease outbreaks, and other public health emergencies, including increasing the security of such [facilities](/usc/42/11049.md?p=4).
  - (4) **Study of resources for facilities and capacities—** Not later than June 1, 2022, the Comptroller General of the [United States](/usc/42/403.md?p=k) shall conduct a study on Federal spending in fiscal years 2013 through 2018 for activities authorized under this subsection. Such study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs [(2)](#a-2) and [(3)](#a-3), including a specific accounting of, and delineation between, obligations and expenditures incurred for the [construction](/usc/42/7479.md?p=2-C), renovation, equipping, and security upgrades of [facilities](/usc/42/11049.md?p=4) and associated contracts under this subsection, and the obligations and expenditures incurred to establish and improve the situational awareness and [biosurveillance](#i) network under [subsection (b)](#b), and shall identify the agency or agencies incurring such obligations and expenditures.
- (b) **Establishment of systems of public health communications and surveillance networks—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), directly or through awards of grants, contracts, or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A), shall provide for the establishment of an integrated system or systems of public health alert communications and surveillance networks between and among—
    - (A) Federal, [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health officials; and
    - (B) public and private health-related [laboratories](/usc/42/300jj.md?p=10), [hospitals](/usc/42/1395dd.md?p=e-5), poison control centers, immunization information systems, and other health care [facilities](/usc/42/11049.md?p=4);[^1]
  - (2) **Requirements—** The [Secretary](/usc/42/201.md?p=c) shall develop a plan to, and ensure that networks under [paragraph (1)](#b-1) allow for the timely sharing and discussion, in a secure manner and in a form readily usable for analytical approaches, of essential, deidentified information concerning bioterrorism or another public health emergency, or recommended methods for responding to such an attack or emergency, allowing for coordination to maximize all-[hazards](/usc/42/5165f.md?p=a-3) medical and public health preparedness and response and to minimize duplication of effort. The [Secretary](/usc/42/201.md?p=c) shall ensure that the activities carried out pursuant to the previous sentence are conducted in a manner that protects personal privacy, to the extent required by applicable Federal and [State](/usc/42/300gg–91.md?p=d-14) information privacy or security law, at a minimum.
  - (3) **Standards—**
    - (A) **In general—** Not later than 1 year after June 24, 2019, the [Secretary](/usc/42/201.md?p=c), in cooperation with [health care providers](/usc/42/300jj.md?p=3), [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial public health officials, and relevant [Federal agencies](/usc/42/300j–6.md?p=d-2) (including the [Office](/usc/42/3058f.md?p=1) of the [National Coordinator](/usc/42/300jj.md?p=11) for [Health Information](/usc/42/300jj.md?p=4) Technology and the National Institute of [Standards](/usc/42/1320d.md?p=7) and Technology), shall, as necessary, adopt technical and reporting [standards](/usc/42/1320d.md?p=7), including [standards](/usc/42/1320d.md?p=7) for interoperability as defined by [section 300jj of this title](/usc/42/300jj.md), for networks under [paragraph (1)](#b-1) and update such [standards](/usc/42/1320d.md?p=7) as necessary. Such [standards](/usc/42/1320d.md?p=7) shall be made available on the internet website of the Department of Health and Human [Services](/usc/42/201.md?p=a), in a manner that does not compromise national security.
    - (B) **Deference to standards development organizations—** In adopting and implementing [standards](/usc/42/1320d.md?p=7) under this subsection and [subsection (c)](#c), the [Secretary](/usc/42/201.md?p=c) shall give deference to [standards](/usc/42/1320d.md?p=7) published by [standards](/usc/42/1320d.md?p=7) development organizations and voluntary consensus-based [standards](/usc/42/1320d.md?p=7) entities.
- (c) **Modernizing public health situational awareness and biosurveillance—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), in collaboration with [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health officials, shall establish, modernize, and improve as applicable and appropriate, a near real-time electronic nationwide public health situational awareness capability through an interoperable network of systems to share data and information that is deidentified, as applicable, to enhance early detection of, rapid response to, and management of, potentially catastrophic infectious disease outbreaks, novel emerging threats, and other public health emergencies that originate domestically or abroad. Such network shall be built on existing [State](/usc/42/300gg–91.md?p=d-14) situational awareness systems or enhanced systems that enable such interoperability, to the extent practicable. The [Secretary](/usc/42/201.md?p=c) shall ensure that the activities carried out pursuant to this paragraph are conducted in a manner that protects personal privacy, to the extent required by applicable Federal and [State](/usc/42/300gg–91.md?p=d-14) information privacy or security law, at a minimum.
  - (2) **Coordination and consultation—** In establishing and improving the network under [paragraph (1)](#c-1), the [Secretary](/usc/42/201.md?p=c) shall—
    - (A) facilitate coordination among agencies within the Department of Health and Human [Services](/usc/42/201.md?p=a) that provide, or have the potential to provide, information and data to, and analyses for, the situational awareness and [biosurveillance](#i) network under [paragraph (1)](#c-1), including coordination among relevant agencies related to health care [services](/usc/42/201.md?p=a), the facilitation of [health information](/usc/42/300jj.md?p=4) [exchange](/usc/42/300gg–91.md?p=d-21) (including the [Office](/usc/42/3058f.md?p=1) of the [National Coordinator](/usc/42/300jj.md?p=11) for [Health Information](/usc/42/300jj.md?p=4) Technology), and public health emergency preparedness and response; and
    - (B) consult with the [Secretary](/usc/42/201.md?p=c) of Agriculture, the [Secretary](/usc/42/201.md?p=c) of [Commerce](/usc/42/6311.md?p=7) (and the [Director](/usc/42/5061.md?p=1) of the National Institute of [Standards](/usc/42/1320d.md?p=7) and Technology), the [Secretary](/usc/42/201.md?p=c) of Defense, the [Secretary](/usc/42/201.md?p=c) of Homeland Security, the [Secretary](/usc/42/201.md?p=c) of Veterans Affairs, and the heads of other [Federal agencies](/usc/42/300j–6.md?p=d-2), as the [Secretary](/usc/42/201.md?p=c) determines appropriate.
  - (3) **Elements—**
    - (A) **In general—** The network described in [paragraph (1)](#c-1) shall include data and information transmitted in a standardized format from—
      - (i) [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health entities, including public health [laboratories](/usc/42/300jj.md?p=10);
      - (ii) Federal health agencies;
      - (iii) zoonotic disease monitoring systems; and
      - (iv) public and private sector health care entities, [hospitals](/usc/42/1395dd.md?p=e-5), pharmacies, poison control centers or professional organizations in the field of poison control, immunization information systems, [community health centers](/usc/42/1786.md?p=j-4-A), health centers, clinical [laboratories](/usc/42/300jj.md?p=10), and public environmental health agencies, to the extent practicable and provided that such data are voluntarily provided simultaneously to the [Secretary](/usc/42/201.md?p=c) and appropriate [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health agencies.
    - (B) **Review—** Not later than 2 years after June 24, 2019, and every 6 years thereafter, the [Secretary](/usc/42/201.md?p=c) shall conduct a review of the elements described in [subparagraph (A)](#c-3-A). Such review shall include a discussion of the addition of any elements pursuant to clause (v), including elements added to advancing new technologies, and identify any challenges in the incorporation of elements under [subparagraph (A)](#c-3-A), and make recommendations to improve the quality of data collected pursuant to [subparagraph (A)](#c-3-A) to ensure complete, accurate, and timely sharing of such data, as appropriate, across such elements as described in [subparagraph (A)](#c-3-A). The [Secretary](/usc/42/201.md?p=c) shall provide such review to the congressional committees of jurisdiction.
  - (4) **Rule of construction—** [Paragraph (3)](#c-3) shall not be construed as requiring separate reporting of data and information from each source listed.
  - (5) **Required activities—**
    - (A) **In general—** In establishing, operating, and updating, as appropriate, the network described in [paragraph (1)](#c-1), the [Secretary](/usc/42/201.md?p=c) shall—
      - (i) utilize applicable interoperability [standards](/usc/42/1320d.md?p=7) as adopted by the [Secretary](/usc/42/201.md?p=c), and in consultation with the [Office](/usc/42/3058f.md?p=1) of the [National Coordinator](/usc/42/300jj.md?p=11) for [Health Information](/usc/42/300jj.md?p=4) Technology and the National Institute of [Standards](/usc/42/1320d.md?p=7) and Technology, through a joint public and private sector process;
      - (ii) define minimal data elements for such network;
      - (iii) in collaboration with [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health officials, integrate and build upon existing [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal capabilities, ensuring simultaneous sharing of data, information, and analyses that is deidentified, as applicable, from the network described in [paragraph (1)](#c-1) with [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health agencies in accordance with applicable Federal and [State](/usc/42/300gg–91.md?p=d-14) privacy and security law;
      - (iv) in collaboration with [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health officials, develop procedures and [standards](/usc/42/1320d.md?p=7) for the collection, analysis, and interpretation of data that [States](/usc/42/300gg–91.md?p=d-14), regions, or other entities collect and report to the network described in [paragraph (1)](#c-1);
      - (v) pilot test [standards](/usc/42/1320d.md?p=7) and implementation specifications, consistent with the process described in [section 300jj–12(b)(3)(C) of this title](/usc/42/300jj–12.md?p=b-3-C), which [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial public health entities may utilize, on a voluntary basis, as a part of the network; and
      - (vi) in collaboration with [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health officials, integrate and update applicable existing public health data systems and networks of the Department of Health and Human [Services](/usc/42/201.md?p=a) to reflect technological advancements, consistent with [section 300hh–33 of this title](/usc/42/300hh–33.md), as applicable.
    - (B) **Public meeting—**
      - (i) **In general—** Not later than 180 days after June 24, 2019, and 180 days after December 29, 2022, the [Secretary](/usc/42/201.md?p=c) shall convene a public meeting for purposes of discussing and providing input on the potential goals, functions, and uses of the network described in [paragraph (1)](#c-1) and incorporating the elements described in [paragraph (3)(A)](#c-3-A).
      - (ii) **Experts—** The public meeting shall include [representatives](/usc/42/3058f.md?p=5) of relevant [Federal agencies](/usc/42/300j–6.md?p=d-2) (including [representatives](/usc/42/3058f.md?p=5) from the [Office](/usc/42/3058f.md?p=1) of the [National Coordinator](/usc/42/300jj.md?p=11) for [Health Information](/usc/42/300jj.md?p=4) Technology and the National Institute of [Standards](/usc/42/1320d.md?p=7) and Technology); [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial public health officials; stakeholders with expertise in [biosurveillance](#i) and situational awareness; stakeholders with expertise in capabilities relevant to [biosurveillance](#i) and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting); experts in [State](/usc/42/300gg–91.md?p=d-14)-based public health data systems; experts in [standards](/usc/42/1320d.md?p=7) and implementation specifications, including transaction [standards](/usc/42/1320d.md?p=7); and experts in privacy and data security.
      - (iii) **Topics—** Such public meeting shall include a discussion of—
        - (I) data elements, including minimal or essential data elements, that are voluntarily provided for such network, which may include elements from public health and public and private health care entities, to the extent practicable;
        - (II) [standards](/usc/42/1320d.md?p=7) and implementation specifications that may improve the collection, analysis, and interpretation of data during a public health emergency;
        - (III) strategies to encourage the access, [exchange](/usc/42/300gg–91.md?p=d-21), and use of information;
        - (IV) considerations for [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial capabilities and infrastructure related to data [exchange](/usc/42/300gg–91.md?p=d-21) and interoperability, including existing public health data systems;
        - (V) privacy and security protections provided at the Federal, [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial levels, and by nongovernmental stakeholders;
        - (VI) opportunities for the incorporation of innovative technologies to improve the network;
        - (VII) strategies to integrate [laboratory](/usc/42/300jj.md?p=10) and public health data systems and capabilities to support rapid and accurate reporting of [laboratory](/usc/42/300jj.md?p=10) test results and associated relevant data;
        - (VIII) strategies to improve the collection, reporting, and dissemination of relevant, aggregated, deidentified demographic data to inform responses to public health emergencies, including identification of at-risk populations and to address potential health disparities; and
        - (IX) strategies to improve the electronic [exchange](/usc/42/300gg–91.md?p=d-21) of [health information](/usc/42/300jj.md?p=4), as appropriate, between [State](/usc/42/300gg–91.md?p=d-14) and local health departments and [health care providers](/usc/42/300jj.md?p=3) and [facilities](/usc/42/11049.md?p=4) to improve the detection of, and responses to, potentially catastrophic infectious disease outbreaks.
  - (6) **Strategy and implementation plan—**
    - (A) **In general—** Not later than 18 months after June 24, 2019, and every 5 years thereafter, the [Secretary](/usc/42/201.md?p=c) shall submit to the congressional committees of jurisdiction a coordinated strategy and an accompanying implementation plan that—
      - (i) is informed by the public meeting under [paragraph (5)(B)](#c-5-B);
      - (ii) includes a review and assessment of existing capabilities of the network and related infrastructure, including input provided by the public meeting under [paragraph (5)(B)](#c-5-B);
      - (iii) identifies and demonstrates the measurable steps the [Secretary](/usc/42/201.md?p=c) will carry out to—
        - (I) develop, implement, and evaluate the network described in [paragraph (1)](#c-1), utilizing elements described in [paragraph (3)(A)](#c-3-A);
        - (II) modernize and enhance [biosurveillance](#i) activities, including strategies to include innovative technologies and analytical approaches (including prediction and forecasting for pandemics and all-[hazards](/usc/42/5165f.md?p=a-3)) from public and [private entities](/usc/42/12181.md?p=6);
        - (III) improve information sharing, coordination, and communication among disparate [biosurveillance](#i) systems supported by the Department of Health and Human [Services](/usc/42/201.md?p=a), including the identification of methods to improve accountability, better utilize resources and workforce capabilities, and incorporate innovative technologies within and across agencies;
        - (IV) test and evaluate capabilities of the interoperable network of systems to improve situational awareness and [biosurveillance](#i) capabilities;
        - (V) improve coordination and collaboration, as appropriate, with other Federal departments to improve the capabilities of the network and reduce administrative burden on [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal entities; and
        - (VI) implement applicable lessons learned from recent public health emergencies to address gaps in situational awareness and [biosurveillance](#i) capabilities;
      - (iv) includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under [clause (iii)](#c-6-A-iii);
      - (v) establishes dates by which each measurable step under [clause (iii)](#c-6-A-iii) will be implemented, including a description of how such steps will further the goals of the network, consistent with [paragraph (1)](#c-1); and
      - (vi) identifies and demonstrates measurable steps the [Secretary](/usc/42/201.md?p=c) will take to further develop and integrate infectious disease detection, support rapid, accurate, and secure sharing of [laboratory](/usc/42/300jj.md?p=10) test results, deidentified as appropriate, during a public health emergency, and improve coordination and collaboration with [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health officials, clinical [laboratories](/usc/42/300jj.md?p=10), and other entities with expertise in public health surveillance.
    - (B) **Annual budget plan—** Not later than 2 years after June 24, 2019, and on an annual basis thereafter, in accordance with the strategy and implementation plan under this paragraph, the [Secretary](/usc/42/201.md?p=c) shall, taking into account recommendations provided by the National Biodefense Science [Board](/usc/42/10261.md?p=2), develop a budget plan based on the strategy and implementation plan under this section. Such budget plan shall include—
      - (i) a summary of resources previously expended to establish, improve, and utilize the nationwide public health situational awareness and [biosurveillance](#i) network under [paragraph (1)](#c-1);
      - (ii) estimates of costs and resources needed to establish and improve the network under [paragraph (1)](#c-1) according to the strategy and implementation plan under [subparagraph (A)](#c-6-A);
      - (iii) the identification of gaps and inefficiencies in nationwide public health situational awareness and [biosurveillance](#i) capabilities, resources, and authorities needed to address such gaps; and
      - (iv) a strategy to minimize and address such gaps and improve inefficiencies.
  - (7) **Consultation with the National Biodefense Science Board—** In carrying out this section and consistent with [section 247d–7g of this title](/usc/42/247d–7g.md), the National Biodefense Science [Board](/usc/42/10261.md?p=2) shall provide expert advice and guidance, including recommendations, regarding the measurable steps the [Secretary](/usc/42/201.md?p=c) should take to modernize and enhance [biosurveillance](#i) activities pursuant to the efforts of the Department of Health and Human [Services](/usc/42/201.md?p=a) to ensure comprehensive, real-time, all-[hazards](/usc/42/5165f.md?p=a-3) [biosurveillance](#i) capabilities. In complying with the preceding sentence, the National Biodefense Science [Board](/usc/42/10261.md?p=2) shall—
    - (A) identify the steps necessary to achieve a national [biosurveillance](#i) system for human health (taking into account zoonotic disease, including gaps in scientific understanding of the interactions between human, animal, and environmental health), with international connectivity, where appropriate, that is predicated on [State](/usc/42/300gg–91.md?p=d-14), regional, and community level capabilities and creates a networked system to allow for two-way information flow between and among Federal, [State](/usc/42/300gg–91.md?p=d-14), and [local government](/usc/42/8401a.md) public health authorities and clinical [health care providers](/usc/42/300jj.md?p=3);
    - (B) identify any duplicative surveillance [programs](/usc/42/274l–1.md?p=4) and gaps in surveillance [programs](/usc/42/274l–1.md?p=4) under the authority of the [Secretary](/usc/42/201.md?p=c), or changes that are necessary to existing [programs](/usc/42/274l–1.md?p=4), in order to enhance and modernize such activities, minimize duplication, strengthen and streamline such activities under the authority of the [Secretary](/usc/42/201.md?p=c), and achieve real-time and appropriate data that relate to disease activity, both human and zoonotic;
    - (C) coordinate with applicable existing [advisory committees](/usc/42/7703.md?p=9) of the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, including such [advisory committees](/usc/42/7703.md?p=9) consisting of [representatives](/usc/42/3058f.md?p=5) from [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal public health authorities and appropriate public and private sector health care entities, animal health organizations related to zoonotic disease, and academic institutions, in order to provide guidance on public health surveillance activities; and
    - (D) provide recommendations to the [Secretary](/usc/42/201.md?p=c) on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with [section 300hh–1 of this title](/usc/42/300hh–1.md).
  - (8) **Situational awareness and biosurveillance as a national security priority—** The [Secretary](/usc/42/201.md?p=c), on a periodic basis as applicable and appropriate, shall meet with the [Director](/usc/42/5061.md?p=1) of National Intelligence to inform the development and capabilities of the nationwide public health situational awareness and [biosurveillance](#i) network.
  - (9) **Rules of construction—**
    - (A) Nothing in this subsection shall be construed to supplant, in whole or in part, [State](/usc/42/300gg–91.md?p=d-14), local, or Tribal activities or responsibilities related to public health surveillance.
    - (B) Nothing in this subsection shall be construed to alter the authority of the [Secretary](/usc/42/201.md?p=c) with respect to the types of data the [Secretary](/usc/42/201.md?p=c) may receive through systems supported or established under this section.
- (d) **State and regional systems to enhance situational awareness in public health emergencies—**
  - (1) **In general—** To implement the network described in [subsection (c)](#c), the [Secretary](/usc/42/201.md?p=c) may award grants to [States](/usc/42/300gg–91.md?p=d-14) or consortia of [States](/usc/42/300gg–91.md?p=d-14) to enhance the ability of such [States](/usc/42/300gg–91.md?p=d-14) or consortia of [States](/usc/42/300gg–91.md?p=d-14) to establish or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and management of potentially catastrophic infectious disease outbreaks and public health emergencies, in collaboration with appropriate public health agencies, environmental health agencies, sentinel [hospitals](/usc/42/1395dd.md?p=e-5), clinical [laboratories](/usc/42/300jj.md?p=10), pharmacies, poison control centers, immunization [programs](/usc/42/274l–1.md?p=4), other health care organizations, and animal health organizations within such [States](/usc/42/300gg–91.md?p=d-14).
  - (2) **Eligibility—** To be eligible to receive a grant under [paragraph (1)](#d-1), the [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14) shall submit to the [Secretary](/usc/42/201.md?p=c) an application at such time, in such manner, and containing such information as the [Secretary](/usc/42/201.md?p=c) may require, including an assurance that the [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14) will submit to the [Secretary](/usc/42/201.md?p=c)—
    - (A) reports of such deidentified data, information, and metrics as the [Secretary](/usc/42/201.md?p=c) may require, in consultation with such [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14);
    - (B) a report on the effectiveness of the systems funded under the grant;
    - (C) a description of the manner in which [grant funds](/usc/42/5106a.md?p=f-1-B) will be used to enhance the timelines and comprehensiveness of efforts to detect, respond to, and manage potentially catastrophic infectious disease outbreaks and public health emergencies, including any public-private partnerships or other partnerships entered into to improve such capacity; and
    - (D) an implementation plan that may include measurable steps to achieve the purposes described in [paragraph (1)](#d-1).
  - (3) **Use of funds—** A [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14) that receives an award under this subsection—
    - (A) shall establish, enhance, or operate a coordinated public health situational awareness system for regional or Statewide early detection of, rapid response to, and management of potentially catastrophic infectious disease outbreaks and public health emergencies;
    - (B) may award grants or contracts to entities described in [paragraph (1)](#d-1) within or serving such [State](/usc/42/300gg–91.md?p=d-14) to assist such entities in improving the operation of information technology systems, facilitating the secure [exchange](/usc/42/300gg–91.md?p=d-21) of data and information, and [training](/usc/42/285e–2.md?p=b-2) personnel to enhance the operation of the system described in [subparagraph (A)](#d-3-A); and
    - (C) may conduct a pilot [program](/usc/42/274l–1.md?p=4) for the development of multi-[State](/usc/42/300gg–91.md?p=d-14) telehealth network test beds that build on, enhance, and securely link existing [State](/usc/42/300gg–91.md?p=d-14) and local telehealth [programs](/usc/42/274l–1.md?p=4) to prepare for, monitor, respond to, and manage the events of public health emergencies, facilitate coordination and communication among medical, public health, and emergency response agencies, and provide medical [services](/usc/42/201.md?p=a) through telehealth [initiatives](/usc/42/19131.md?p=1) within the [States](/usc/42/300gg–91.md?p=d-14) that are involved in such a multi-[State](/usc/42/300gg–91.md?p=d-14) telehealth network test bed.
  - (4) **Limitation—** Information technology systems acquired or implemented using grants awarded under this section must be compliant with—
    - (A) interoperability and other technological [standards](/usc/42/1320d.md?p=7), as determined by the [Secretary](/usc/42/201.md?p=c); and
    - (B) data collection and reporting requirements for the network described in [subsection (c)](#c).
  - (5) **Technical assistance—** The [Secretary](/usc/42/201.md?p=c) may provide technical assistance to [States](/usc/42/300gg–91.md?p=d-14), localities, Tribes, and territories or a [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14), localities, Tribes, and territories receiving an award under this subsection regarding interoperability and the technical [standards](/usc/42/1320d.md?p=7) set forth by the [Secretary](/usc/42/201.md?p=c).
  - (6) **Non-duplication of effort—** The [Secretary](/usc/42/201.md?p=c) shall ensure that activities carried out under an award under this subsection do not unnecessarily duplicate efforts of other agencies and [offices](/usc/42/3058f.md?p=1) within the Department of Health and Human [Services](/usc/42/201.md?p=a).
- (e) **Personnel authorities—**
  - (1) **Specially qualified personnel—** In addition to any other personnel authorities, to carry out subsections [(b)](#b) and [(c)](#c), the [Secretary](/usc/42/201.md?p=c) may—
    - (A) appoint highly [qualified individuals](/usc/42/18032.md?p=f-1-A) to scientific or professional positions at the Centers for Disease Control and Prevention, not to exceed 30 such [employees](/usc/42/300gg–91.md?p=d-5) at any time (specific to positions authorized by this subsection), with expertise in capabilities relevant to [biosurveillance](#i) and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting), and other related scientific or technical fields; and
    - (B) compensate individuals appointed under [subparagraph (A)](#e-1-A) in the same manner and subject to the same terms and conditions in which individuals appointed under 9903[^2] of title 5 are compensated, without regard to the provisions of [chapter 51](/usc/42/ch51.md) and subchapter III of [chapter 53](/usc/42/ch53.md) of such title relating to classification and General Schedule pay rates.
  - (2) **Limitations—** The [Secretary](/usc/42/201.md?p=c) shall exercise the authority under [paragraph (1)](#e-1) in a manner that is consistent with the limitations described in [section 247d–6a(e)(2) of this title](/usc/42/247d–6a.md?p=e-2).
- (f) **Timeline—** The [Secretary](/usc/42/201.md?p=c) shall accomplish the purposes under subsections [(b)](#b) and [(c)](#c) no later than September 30, 2023, and shall provide a justification to the congressional committees of jurisdiction for any missed or delayed implementation of measurable steps identified under [subsection (c)(6)(A)(iii)](#c-6-A-iii).
- (g) **Independent evaluation—** Not later than 3 years after June 24, 2019, the Comptroller General of the [United States](/usc/42/403.md?p=k) shall conduct an independent evaluation and submit to the [Secretary](/usc/42/201.md?p=c) and the congressional committees of jurisdiction a report concerning the activities conducted under subsections [(b)](#b) and [(c)](#c), and provide recommendations, as applicable and appropriate, on necessary improvements to the [biosurveillance](#i) and situational awareness network.
- (h) **Authorization of appropriations—** There are authorized to be appropriated—
  - (1) to carry out [subsection (a)](#a), $25,000,000 for each of fiscal years 2022 and 2023; and
  - (2) to carry out subsections [(b)](#b), [(c)](#c), and [(d)](#d), $136,800,000 for each of fiscal years 2022 and 2023.
- (i) **Definition—** For purposes of this section the term “biosurveillance” means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health, in order to achieve early warning and identification of such health threats, early detection and prompt ongoing tracking of health events, and overall situational awareness of disease activity.

# §247d–4a. Infectious Diseases Rapid Response Reserve Fund


There is established in the Treasury a reserve [fund](/usc/42/12854.md?p=3) to be known as the “Infectious Diseases Rapid Response Reserve [Fund](/usc/42/12854.md?p=3)” (the “Reserve [Fund](/usc/42/12854.md?p=3)”): Provided, That of the [funds](/usc/42/12854.md?p=3) provided under the heading “CDC-Wide Activities and [Program](/usc/42/274l–1.md?p=4) Support” [132 Stat. 3073], $50,000,000, to remain available until expended, shall be available to the [Director](/usc/42/5061.md?p=1) of the CDC for deposit in the Reserve [Fund](/usc/42/12854.md?p=3): Provided further, That amounts in the Reserve [Fund](/usc/42/12854.md?p=3) shall be for carrying out titles II, III, and XVII of the PHS Act [[42 U.S.C. 201](/usc/42/201.md) et seq., 241 et seq., 300u et seq.] to prevent, prepare for, or respond to an infectious disease emergency, including, in connection with such activities, to purchase or lease and provide for the insurance of passenger [motor vehicles](/usc/42/13211.md?p=13) for official use in foreign countries: Provided further, That amounts in the Reserve [Fund](/usc/42/12854.md?p=3) may only be provided for an infectious disease emergency if the infectious disease emergency (1) is declared by the [Secretary](/usc/42/201.md?p=c) of Health and Human [Services](/usc/42/201.md?p=a) under section 319 of the PHS Act [[42 U.S.C. 247d](/usc/42/247d.md)] to be a public health emergency; or (2) as determined by the [Secretary](/usc/42/201.md?p=c), has significant potential to imminently occur and potential, on occurrence, to affect national security or the health and security of [United States](/usc/42/403.md?p=k) citizens, domestically or internationally: Provided further, That amounts in the Reserve [Fund](/usc/42/12854.md?p=3) may be transferred by the [Director](/usc/42/5061.md?p=1) of the CDC to other accounts of the CDC, to accounts of the NIH, or to the Public Health and Social [Services](/usc/42/201.md?p=a) Emergency [Fund](/usc/42/12854.md?p=3), to be merged with such accounts or [Fund](/usc/42/12854.md?p=3) for the purposes provided in this section: Provided further, That the [Director](/usc/42/5061.md?p=1) shall provide to the Committees on Appropriations of the House of [Representatives](/usc/42/3058f.md?p=5) and the Senate, at least 7 days in advance of any transfer or obligation of [funds](/usc/42/12854.md?p=3) made under the authority provided in this section, both a notification on the anticipated uses of [funds](/usc/42/12854.md?p=3) by [program](/usc/42/274l–1.md?p=4), [project](/usc/42/11360.md?p=20), or activity; and a detailed spend plan of anticipated uses of [funds](/usc/42/12854.md?p=3), including estimated personnel and administrative costs, disaggregated by [program](/usc/42/274l–1.md?p=4), [project](/usc/42/11360.md?p=20), or activity: Provided further, That such spend plans shall be updated to include all applicable obligations to date and unobligated amounts and submitted quarterly to such Committees on Appropriations until such [funds](/usc/42/12854.md?p=3) are fully expended: Provided further, That amounts in the Reserve [Fund](/usc/42/12854.md?p=3) shall be in addition to amounts otherwise available to the Department of Health and Human [Services](/usc/42/201.md?p=a) for the purposes provided in this section: Provided further, That the transfer authorities in this section are in addition to any transfer authority otherwise available to the Department of Health and Human [Services](/usc/42/201.md?p=a): Provided further, That products purchased using amounts in the Reserve [Fund](/usc/42/12854.md?p=3) may, at the discretion of the [Secretary](/usc/42/201.md?p=c) of Health and Human [Services](/usc/42/201.md?p=a), be deposited in the Strategic National Stockpile under section 319F–2 of the PHS Act [[42 U.S.C. 247d–6b](/usc/42/247d–6b.md)]: Provided further, That this section shall be in effect as of September 28, 2018, through each fiscal year hereafter.


# §247d–4b. Children’s Preparedness Unit

- (a) **Enhancing emergency preparedness for children—** The [Secretary](/usc/42/201.md?p=c), acting through the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention (referred to in this subsection as the “[Director](/usc/42/5061.md?p=1)”), shall maintain an internal team of experts, to be known as the [Children](/usc/42/256e.md?p=g-2)’s Preparedness [Unit](/usc/42/1395w–114b.md?p=g-2) (referred to in this subsection as the “[Unit](/usc/42/1395w–114b.md?p=g-2)”), to work collaboratively to provide guidance on the considerations for, and the specific needs of, [children](/usc/42/256e.md?p=g-2) before, during, and after public health emergencies. The [Unit](/usc/42/1395w–114b.md?p=g-2) shall inform the [Director](/usc/42/5061.md?p=1) regarding emergency preparedness and response efforts pertaining to [children](/usc/42/256e.md?p=g-2) at the Centers for Disease Control and Prevention.
- (b) **Expertise—** The team described in [subsection (a)](#a) shall include one or more pediatricians, which may be a developmental-behavioral pediatrician, and may also include behavioral scientists, [child](/usc/42/416.md?p=e) psychologists, epidemiologists, biostatisticians, health communications staff, and individuals with other areas of expertise, as the [Secretary](/usc/42/201.md?p=c) determines appropriate.
- (c) **Duties—** The team described in [subsection (a)](#a) may—
  - (1) assist [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial emergency planning and response activities related to [children](/usc/42/256e.md?p=g-2), which may include developing, identifying, and sharing best [practices](/usc/42/17061.md?p=19);
  - (2) provide technical assistance, [training](/usc/42/285e–2.md?p=b-2), and consultation to Federal, [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial public health officials to improve preparedness and response capabilities with respect to the needs of [children](/usc/42/256e.md?p=g-2), including providing such technical assistance, [training](/usc/42/285e–2.md?p=b-2), and consultation to [eligible entities](/usc/42/296.md?p=1) in order to support the achievement of measurable evidence-based benchmarks and objective [standards](/usc/42/1320d.md?p=7) applicable to sections [247d–3a](/usc/42/247d–3a.md) and [247d–3b](/usc/42/247d–3b.md) of this title;
  - (3) improve the utilization of methods to incorporate the needs of [children](/usc/42/256e.md?p=g-2) in planning for and responding to a public health emergency, including public awareness of such methods;
  - (4) coordinate with, and improve, public-private partnerships, such as health care coalitions pursuant to sections [247d–3b](/usc/42/247d–3b.md) and [247d–3c](/usc/42/247d–3c.md) of this title, to address gaps and inefficiencies in emergency preparedness and response efforts for [children](/usc/42/256e.md?p=g-2);
  - (5) provide expertise and input during the development of guidance and clinical recommendations to address the needs of [children](/usc/42/256e.md?p=g-2) when preparing for, and responding to, public health emergencies, including pursuant to [section 247d–3c of this title](/usc/42/247d–3c.md); and
  - (6) carry out other duties related to preparedness and response activities for [children](/usc/42/256e.md?p=g-2), as the [Secretary](/usc/42/201.md?p=c) determines appropriate.

# §247d–5. Combating antimicrobial resistance

- (a) **Task force—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) shall establish an Antimicrobial Resistance [Task Force](/usc/42/242q–4.md?p=3) to provide advice and recommendations to the [Secretary](/usc/42/201.md?p=c) and coordinate Federal [programs](/usc/42/274l–1.md?p=4) relating to antimicrobial resistance. The [Secretary](/usc/42/201.md?p=c) may appoint or select a committee, or other organization in existence as of November 13, 2000, to serve as such a [task force](/usc/42/242q–4.md?p=3), if such committee, or other organization meets the requirements of this section.
  - (2) **Members of task force—** The [task force](/usc/42/242q–4.md?p=3) described in [paragraph (1)](#a-1) shall be composed of [representatives](/usc/42/3058f.md?p=5) from such [Federal agencies](/usc/42/300j–6.md?p=d-2), and shall seek input from public health constituencies, [manufacturers](/usc/42/300aa–33.md?p=3), veterinary and medical professional societies and others, as determined to be necessary by the [Secretary](/usc/42/201.md?p=c), to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance.
  - (3) **Agenda—**
    - (A) **In general—** The [task force](/usc/42/242q–4.md?p=3) described in [paragraph (1)](#a-1) shall consider factors the [Secretary](/usc/42/201.md?p=c) considers appropriate, including—
      - (i) public health factors contributing to increasing antimicrobial resistance;
      - (ii) public health needs to detect and monitor antimicrobial resistance;
      - (iii) detection, prevention, and control strategies for resistant pathogens;
      - (iv) the need for improved information and data collection;
      - (v) the assessment of the risk imposed by pathogens presenting a threat to the public health; and
      - (vi) any other issues which the [Secretary](/usc/42/201.md?p=c) determines are relevant to antimicrobial resistance.
    - (B) **Detection and control—** The [Secretary](/usc/42/201.md?p=c), in consultation with the [task force](/usc/42/242q–4.md?p=3) described in [paragraph (1)](#a-1) and [State](/usc/42/300gg–91.md?p=d-14) and local public health officials, shall—
      - (i) develop, improve, coordinate or enhance participation in a surveillance plan to detect and monitor emerging antimicrobial resistance; and
      - (ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and [exchange](/usc/42/300gg–91.md?p=d-21) antimicrobial resistance data between public health departments.
  - (4) **Meetings—** The [task force](/usc/42/242q–4.md?p=3) described under [paragraph (1)](#a-1) shall convene not less than twice a year, or more frequently as the [Secretary](/usc/42/201.md?p=c) determines to be appropriate.
- (b) **Research and development of new antimicrobial drugs and diagnostics—** The [Secretary](/usc/42/201.md?p=c) and the [Director](/usc/42/5061.md?p=1) of Agricultural Research [Services](/usc/42/201.md?p=a), consistent with the recommendations of the [task force](/usc/42/242q–4.md?p=3) established under [subsection (a)](#a), shall directly or through awards of grants or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) to public or [private entities](/usc/42/12181.md?p=6) provide for the conduct of research, investigations, experiments, demonstrations, and studies in the health sciences that are related to—
  - (1) the development of new therapeutics, including vaccines and antimicrobials, against resistant pathogens;
  - (2) the development or testing of medical diagnostics to detect pathogens resistant to antimicrobials;
  - (3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;
  - (4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the [Director](/usc/42/5061.md?p=1) of the National Institutes of Health in consultation with the [task force](/usc/42/242q–4.md?p=3) established under [subsection (a)](#a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of [Energy](/usc/42/6311.md?p=7); and
  - (5) other relevant research areas.
- (c) **Education of medical and public health personnel—** The [Secretary](/usc/42/201.md?p=c), after consultation with the Assistant [Secretary](/usc/42/201.md?p=c) for Health, the [Surgeon General](/usc/42/201.md?p=b), the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, the [Administrator](/usc/42/4005.md?p=1) of the Health Resources and [Services](/usc/42/201.md?p=a) Administration, the [Director](/usc/42/5061.md?p=1) of the Agency for Healthcare Research and Quality, members of the [task force](/usc/42/242q–4.md?p=3) described in [subsection (a)](#a), professional organizations and societies, and such other public health officials as may be necessary, shall—
  - (1) develop and implement educational [programs](/usc/42/274l–1.md?p=4) to increase the awareness of the general public with respect to the public health threat of antimicrobial resistance and the appropriate use of antibiotics;
  - (2) develop and implement educational [programs](/usc/42/274l–1.md?p=4) to instruct health care professionals in the prudent use of antibiotics; and
  - (3) develop and implement [programs](/usc/42/274l–1.md?p=4) to train [laboratory](/usc/42/300jj.md?p=10) personnel in the recognition or identification of resistance in pathogens.
- (d) **Grants—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) shall award competitive grants to [eligible entities](/usc/42/296.md?p=1) to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resistance.
  - (2) **Eligible entities—** [Eligible entities](/usc/42/296.md?p=1) for grants under [paragraph (1)](#d-1) shall be [State](/usc/42/300gg–91.md?p=d-14) or local public health agencies, [Indian tribes](/usc/42/300f.md?p=14) or [tribal organizations](/usc/42/629a.md?p=a-6), or other public or private nonprofit entities.
  - (3) **Use of funds—** An [eligible entity](/usc/42/256a.md?p=l-1) receiving a grant under [paragraph (1)](#d-1) shall use [funds](/usc/42/12854.md?p=3) from such grant for activities that are consistent with the factors identified by the [task force](/usc/42/242q–4.md?p=3) under [subsection (a)(3)](#a-3), which may include activities that—
    - (A) provide [training](/usc/42/285e–2.md?p=b-2) to enable such entity to identify patterns of resistance rapidly and accurately;
    - (B) develop, improve, coordinate or enhance participation in information systems by which data on resistant infections can be shared rapidly among relevant national, [State](/usc/42/300gg–91.md?p=d-14), and local health agencies and [health care providers](/usc/42/300jj.md?p=3); and
    - (C) develop and implement policies to control the spread of antimicrobial resistance.
- (e) **Grants for demonstration programs—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) shall award competitive grants to [eligible entities](/usc/42/296.md?p=1) to establish demonstration [programs](/usc/42/274l–1.md?p=4) to promote judicious use of antimicrobial [drugs](/usc/42/282.md?p=j-1-A-vii) or control the spread of antimicrobial-resistant pathogens.
  - (2) **Eligible entities—** [Eligible entities](/usc/42/296.md?p=1) for grants under [paragraph (1)](#e-1) may include [hospitals](/usc/42/1395dd.md?p=e-5), clinics, institutions of long-term care, professional medical societies, [schools](/usc/42/6372.md?p=1) or [programs](/usc/42/274l–1.md?p=4) that train medical [laboratory](/usc/42/300jj.md?p=10) personnel, or other public or private nonprofit entities.
  - (3) **Technical assistance—** The [Secretary](/usc/42/201.md?p=c) shall provide appropriate technical assistance to [eligible entities](/usc/42/296.md?p=1) that receive grants under [paragraph (1)](#e-1).
- (f) **Monitoring at Federal health care facilities—** The [Secretary](/usc/42/201.md?p=c) shall encourage reporting on aggregate [antimicrobial](#m) [drug](/usc/42/282.md?p=j-1-A-vii) use and [antimicrobial](#m) resistance to [antimicrobial](#m) [drugs](/usc/42/282.md?p=j-1-A-vii) and the implementation of [antimicrobial](#m) stewardship [programs](/usc/42/274l–1.md?p=4) by health care [facilities](/usc/42/11049.md?p=4) of the Department of Defense, the Department of Veterans Affairs, and the [Indian](/usc/42/6862.md?p=6) Health [Service](/usc/42/201.md?p=a) and shall provide technical assistance to the [Secretary](/usc/42/201.md?p=c) of Defense and the [Secretary](/usc/42/201.md?p=c) of Veterans Affairs, as appropriate and upon request.
- (g) **Report on antimicrobial resistance in humans and use of antimicrobial drugs—** Not later than 1 year after December 13, 2016, and annually thereafter, the [Secretary](/usc/42/201.md?p=c) shall prepare and make publicly available data and information concerning—
  - (1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial [drugs](/usc/42/282.md?p=j-1-A-vii), including such [drugs](/usc/42/282.md?p=j-1-A-vii) approved under [section 356(h) of title 21](/usc/21/356.md?p=h);
  - (2) antimicrobial stewardship, which may include summaries of [State](/usc/42/300gg–91.md?p=d-14) efforts to address antimicrobial resistance in humans to antimicrobial [drugs](/usc/42/282.md?p=j-1-A-vii) and antimicrobial stewardship; and
  - (3) coordination between the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention and the [Commissioner](/usc/42/12302.md?p=1) of Food and [Drugs](/usc/42/282.md?p=j-1-A-vii) with respect to the monitoring of—
    - (A) any applicable resistance under [paragraph (1)](#g-1); and
    - (B) [drugs](/usc/42/282.md?p=j-1-A-vii) approved under [section 356(h) of title 21](/usc/21/356.md?p=h).
- (h) **Information related to antimicrobial stewardship programs—** The [Secretary](/usc/42/201.md?p=c) shall, as appropriate, disseminate guidance, educational materials, or other appropriate materials related to the development and implementation of evidence-based antimicrobial stewardship [programs](/usc/42/274l–1.md?p=4) or [practices](/usc/42/17061.md?p=19) at health care [facilities](/usc/42/11049.md?p=4), such as [nursing homes](/usc/42/1396g.md?p=e-1) and other long-term care [facilities](/usc/42/11049.md?p=4), ambulatory surgical centers, dialysis centers, outpatient clinics, and [hospitals](/usc/42/1395dd.md?p=e-5), including community and rural [hospitals](/usc/42/1395dd.md?p=e-5).
- (i) **Supporting State-based activities to combat antimicrobial resistance—** The [Secretary](/usc/42/201.md?p=c) shall continue to work with [State](/usc/42/300gg–91.md?p=d-14) and local public health departments on statewide or regional [programs](/usc/42/274l–1.md?p=4) related to antimicrobial resistance. Such efforts may include activities to related to—
  - (1) identifying patterns of bacterial and fungal resistance in humans to antimicrobial [drugs](/usc/42/282.md?p=j-1-A-vii);
  - (2) preventing the spread of bacterial and fungal infections that are resistant to antimicrobial [drugs](/usc/42/282.md?p=j-1-A-vii); and
  - (3) promoting antimicrobial stewardship.
- (j) **Antimicrobial resistance and stewardship activities—**
  - (1) **In general—** For the purposes of supporting stewardship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of [section 356(h) of title 21](/usc/21/356.md?p=h), the [Secretary](/usc/42/201.md?p=c) shall—
    - (A) provide a mechanism for [facilities](/usc/42/11049.md?p=4) to report data related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and
    - (B) evaluate—
      - (i) antimicrobial resistance data using a standardized approach; and
      - (ii) trends in the utilization of [drugs](/usc/42/282.md?p=j-1-A-vii) approved under such [section 356(h) of title 21](/usc/21/356.md?p=h) with respect to patient populations.
  - (2) **Use of systems—** The [Secretary](/usc/42/201.md?p=c) shall use available systems, including the National Healthcare Safety Network or other systems identified by the [Secretary](/usc/42/201.md?p=c), to fulfill the requirements or conduct activities under this section.
- (k) **Network of antibiotic resistance regional laboratories—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), acting through the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, shall, as appropriate, maintain a network of antibiotic resistance [laboratory](/usc/42/300jj.md?p=10) sites to ensure the maintenance of appropriate capabilities, within existing [laboratory](/usc/42/300jj.md?p=10) capacity maintained or supported by the Centers for Disease Control and Prevention, to—
    - (A) identify and monitor the emergence and changes in the patterns of antimicrobial-resistant pathogens;
    - (B) detect, identify, confirm, and isolate such resistant pathogens, including, as appropriate, performing such activities upon the request of another [laboratory](/usc/42/300jj.md?p=10) and providing related technical assistance, and, as applicable, support efforts to respond to local or regional outbreaks of such resistant pathogens; and
    - (C) perform activities to support the diagnosis of such resistant pathogens and determine the susceptibility of relevant pathogen samples to applicable [treatments](/usc/42/11851.md?p=11).
  - (2) **Geographic distribution—** The [Secretary](/usc/42/201.md?p=c) shall ensure that such capacity and capabilities are appropriately distributed among the geographical regions of the [United States](/usc/42/403.md?p=k).
  - (3) **Partnerships and nonduplication of current domestic capacity—** Activities supported under this subsection may be based in an academic center, a [State](/usc/42/300gg–91.md?p=d-14) health department, or other [facility](/usc/42/11049.md?p=4) operated by a public or [private entity](/usc/42/12181.md?p=6) that carries out relevant [laboratory](/usc/42/300jj.md?p=10) or public health surveillance activities.
- (l) **International collaboration—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), in coordination with heads of other relevant Federal departments and agencies, shall support activities related to addressing antimicrobial resistance internationally, including by—
    - (A) supporting basic, translational, epidemiological, and clinical research related to antimicrobial-resistant pathogens, including such pathogens that have not yet been detected in the [United States](/usc/42/403.md?p=k), and improving related public health surveillance systems, and [laboratory](/usc/42/300jj.md?p=10) and other response capacity; and
    - (B) providing technical assistance related to antimicrobial resistant infection and control activities.
  - (2) **Awards—** In carrying out [paragraph (1)](#l-1), the [Secretary](/usc/42/201.md?p=c) may award grants, contracts, or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) to public and [private entities](/usc/42/12181.md?p=6), including nongovernmental organizations, with applicable expertise, for purposes of supporting new and innovative approaches to the prevention, detection, and mitigation of antimicrobial-resistant pathogens.
- (m) **Antimicrobial—** For purposes of [subsections (f) through (j)](#f..j), the term “antimicrobial” includes any antibacterial or antifungal [drugs](/usc/42/282.md?p=j-1-A-vii), and may include [drugs](/usc/42/282.md?p=j-1-A-vii) that eliminate or inhibit the growth of other microorganisms, as appropriate.
- (n) **Supplement not supplant—** [Funds](/usc/42/12854.md?p=3) appropriated under this section shall be used to supplement and not supplant other Federal, [State](/usc/42/300gg–91.md?p=d-14), and local public [funds](/usc/42/12854.md?p=3) provided for activities under this section.
- (o) **Authorization of appropriations—** There are authorized to be appropriated to carry out this section, $40,000,000 for fiscal year 2001, $25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006.

# [§247d–5a. Repealed. Pub. L. 114–255, div. A, title III, § 3044(b)(1), Dec. 13, 2016, 130 Stat. 1121 — repealed]



# §247d–6. Public health countermeasures to a bioterrorist attack

- (a) **All-hazards public health and medical response curricula and training—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), in collaboration with the [Secretary](/usc/42/201.md?p=c) of Defense, and in consultation with relevant public and [private entities](/usc/42/12181.md?p=6), shall develop core health and medical response curricula and [trainings](/usc/42/285e–2.md?p=b-2) by adapting applicable existing curricula and [training](/usc/42/285e–2.md?p=b-2) [programs](/usc/42/274l–1.md?p=4) to improve responses to public health emergencies.
  - (2) **Curriculum—** The public health and medical response [training](/usc/42/285e–2.md?p=b-2) [program](/usc/42/274l–1.md?p=4) may include course work related to—
    - (A) medical management of casualties, taking into account the needs of [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B);
    - (B) public health aspects of public health emergencies;
    - (C) mental health aspects of public health emergencies;
    - (D) national incident management, including coordination among Federal, [State](/usc/42/300gg–91.md?p=d-14), local, tribal, international agencies, and other entities; and
    - (E) protecting health care workers and health care first responders from workplace exposures during a public health emergency.
  - (3) **Peer review—** On a periodic basis, products prepared as part of the [program](/usc/42/274l–1.md?p=4) shall be rigorously tested and peer-reviewed by experts in the relevant fields.
  - (4) **Credit—** The [Secretary](/usc/42/201.md?p=c) and the [Secretary](/usc/42/201.md?p=c) of Defense shall—
    - (A) take into account continuing professional education requirements of public health and healthcare professions; and
    - (B) cooperate with [State](/usc/42/300gg–91.md?p=d-14), local, and tribal accrediting agencies and with professional associations in arranging for students enrolled in the [program](/usc/42/274l–1.md?p=4) to obtain continuing professional education credit for [program](/usc/42/274l–1.md?p=4) courses.
  - (5) **Dissemination and training—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) may provide for the dissemination and teaching of the materials described in paragraphs [(1)](#a-1) and [(2)](#a-2) by appropriate means, as determined by the [Secretary](/usc/42/201.md?p=c).
    - (B) **Certain entities—** The education and [training](/usc/42/285e–2.md?p=b-2) activities described in [subparagraph (A)](#a-5-A) may be carried out by Federal public health, medical, or dental entities, appropriate educational entities, professional organizations and societies, private accrediting organizations, and other nonprofit institutions or entities meeting criteria established by the [Secretary](/usc/42/201.md?p=c).
    - (C) **Grants and contracts—** In carrying out this subsection, the [Secretary](/usc/42/201.md?p=c) may carry out activities directly or through the award of grants and contracts, and may enter into interagency [agreements](/usc/42/1320b–8.md?p=a-3-A) with other [Federal agencies](/usc/42/300j–6.md?p=d-2).
- (b) **Advice to the Federal Government—**
  - (1) **Required advisory committees—** In coordination with the working group under [subsection (a)](#a), the [Secretary](/usc/42/201.md?p=c) shall establish [advisory committees](/usc/42/7703.md?p=9) in accordance with paragraphs [(2)](#b-2) and [(3)](#b-3) to provide expert recommendations to assist such working groups in carrying out their respective responsibilities under subsections [(a)](#a) and [(b)](#b).
  - (2) **National Advisory Committee on At-Risk Individuals and Public Health Emergencies—**
    - (A) **In general—** For purposes of [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c) shall establish an [advisory committee](/usc/42/7703.md?p=9) to be known as the National [Advisory Committee](/usc/42/7703.md?p=9) on [At-Risk Individuals](/usc/42/300hh–1.md?p=b-4-B) and Public Health Emergencies (referred to in this paragraph as the “[Advisory Committee](/usc/42/7703.md?p=9)”).
    - (B) **Duties—** The [Advisory Committee](/usc/42/7703.md?p=9) shall provide recommendations regarding—
      - (i) the preparedness of the health care (including mental health care) system to respond to public health emergencies as they relate to [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B);
      - (ii) needed changes to the health care and emergency medical [service](/usc/42/201.md?p=a) systems and emergency medical [services](/usc/42/201.md?p=a) protocols to meet the special needs of [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B); and
      - (iii) changes, if necessary, to the national stockpile under [section 300hh–12 of this title](/usc/42/300hh–12.md) to meet the emergency health security of [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B).
    - (C) **Composition—** The [Advisory Committee](/usc/42/7703.md?p=9) shall be composed of such Federal officials as may be appropriate to address the special needs of the diverse population groups of at-risk populations.
    - (D) **Termination—** The [Advisory Committee](/usc/42/7703.md?p=9) terminates six years after June 12, 2002.
  - (3) **Emergency Public Information and Communications Advisory Committee—**
    - (A) **In general—** For purposes of [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c) shall establish an [advisory committee](/usc/42/7703.md?p=9) to be known as the Emergency Public Information and Communications [Advisory Committee](/usc/42/7703.md?p=9) (referred to in this paragraph as the “EPIC [Advisory Committee](/usc/42/7703.md?p=9)”).
    - (B) **Duties—** The EPIC [Advisory Committee](/usc/42/7703.md?p=9) shall make recommendations to the [Secretary](/usc/42/201.md?p=c) and report on appropriate ways to communicate public [health information](/usc/42/300jj.md?p=4) regarding bioterrorism and other public health emergencies to the public.
    - (C) **Composition—** The EPIC [Advisory Committee](/usc/42/7703.md?p=9) shall be composed of individuals representing a diverse group of experts in public health, medicine, communications, behavioral psychology, and other areas determined appropriate by the [Secretary](/usc/42/201.md?p=c).
    - (D) **Dissemination—** The [Secretary](/usc/42/201.md?p=c) shall review the recommendations of the EPIC [Advisory Committee](/usc/42/7703.md?p=9) and ensure that appropriate information is disseminated to the public.
    - (E) **Termination—** The EPIC [Advisory Committee](/usc/42/7703.md?p=9) terminates one year after June 12, 2002.
- (c) **Expansion of Epidemic Intelligence Service Program—** The [Secretary](/usc/42/201.md?p=c) may establish 20 officer positions in the Epidemic Intelligence [Service](/usc/42/201.md?p=a) [Program](/usc/42/274l–1.md?p=4), in addition to the number of the officer positions offered under such [Program](/usc/42/274l–1.md?p=4) in 2006, for individuals who agree to participate, for a period of not less than 2 years, in the Career Epidemiology Field Officer [program](/usc/42/274l–1.md?p=4) in a [State](/usc/42/300gg–91.md?p=d-14), local, or tribal health department that serves a [health professional shortage area](/usc/42/254c.md?p=b-3) (as defined under [section 254e(a) of this title](/usc/42/254e.md?p=a)), a [medically underserved population](/usc/42/254c.md?p=b-5) (as defined under [section 254b(b)(3) of this title](/usc/42/254b.md?p=b-3)), or a [medically underserved area](/usc/42/254c–14.md?p=a-4) or area at high risk of a public health emergency as designated by the [Secretary](/usc/42/201.md?p=c).
- (d) **Centers for Public Health Preparedness and Response—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), acting through the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, may award grants, contracts, or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) to institutions of higher education, including [accredited](/usc/42/300w–9.md?p=c-2) [schools](/usc/42/6372.md?p=1) of public health, or other nonprofit [private entities](/usc/42/12181.md?p=6) to establish or maintain a network of Centers for Public Health Preparedness and Response (referred to in this subsection as “Centers”).
  - (2) **Eligibility—** To be eligible to receive an award under this subsection, an entity shall submit to the [Secretary](/usc/42/201.md?p=c) an application containing such information as the [Secretary](/usc/42/201.md?p=c) may require, including a description of how the entity will—
    - (A) coordinate relevant activities with applicable [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal health departments and officials, health care [facilities](/usc/42/11049.md?p=4), and health care coalitions to improve public health preparedness and response, as informed by the public health preparedness and response needs of the community, or communities, involved;
    - (B) prioritize efforts to implement evidence-informed or evidence-based [practices](/usc/42/17061.md?p=19) to improve public health preparedness and response, including by helping to reduce the transmission of emerging infectious diseases; and
    - (C) use [funds](/usc/42/12854.md?p=3) awarded under this subsection, including by carrying out any activities described in [paragraph (3)](#d-3).
  - (3) **Use of funds—** The Centers established or maintained under this subsection shall use [funds](/usc/42/12854.md?p=3) awarded under this subsection to carry out activities to advance public health preparedness and response capabilities, which may include—
    - (A) identifying, translating, and disseminating promising research findings or strategies into evidence-informed or evidence-based [practices](/usc/42/17061.md?p=19) to inform preparedness for, and responses to, chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and other public health emergencies, which may include conducting research related to public health preparedness and response systems;
    - (B) improving awareness of such evidence-informed or evidence-based [practices](/usc/42/17061.md?p=19) and other relevant scientific or public [health information](/usc/42/300jj.md?p=4) among health care professionals, public health professionals, other stakeholders, and the public, including through the development, evaluation, and dissemination of [trainings](/usc/42/285e–2.md?p=b-2) and [training](/usc/42/285e–2.md?p=b-2) materials, consistent with [section 300hh–1(b)(2) of this title](/usc/42/300hh–1.md?p=b-2), as applicable and appropriate, and with consideration given to existing [training](/usc/42/285e–2.md?p=b-2) materials, to support preparedness for, and responses to, such threats;
    - (C) utilizing and expanding relevant technological and analytical capabilities to inform public health and medical preparedness and response efforts;
    - (D) expanding activities, including through public-private partnerships, related to public health preparedness and response, including participation in drills and exercises and [training](/usc/42/285e–2.md?p=b-2) public health experts, as appropriate; and
    - (E) providing technical assistance and expertise that relies on evidence-based [practices](/usc/42/17061.md?p=19), as applicable, related to responses to public health emergencies, as appropriate, to [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal health departments and other entities pursuant to [paragraph (2)(A)](#d-2-A).
  - (4) **Distribution of awards—** In awarding grants, contracts, or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) under this subsection, the [Secretary](/usc/42/201.md?p=c) shall support not fewer than 10 Centers, subject to the availability of appropriations, and ensure that such awards are equitably distributed among the geographical regions of the [United States](/usc/42/403.md?p=k).
- (e) **Accelerated research and development on priority pathogens and countermeasures—**
  - (1) **In general—** With respect to pathogens of potential use in a bioterrorist attack, and other agents that may [cause](/usc/42/9908.md?p=c-2) a public health emergency, the [Secretary](/usc/42/201.md?p=c), taking into consideration any recommendations of the working group under [subsection (a)](#a), shall conduct, and award grants, contracts, or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) for, research, investigations, experiments, demonstrations, and studies in the health sciences relating to—
    - (A) the epidemiology and pathogenesis of such pathogens;
    - (B) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the [Director](/usc/42/5061.md?p=1) of the National Institutes of Health in consultation with the working group established in [subsection (a)](#a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of [Energy](/usc/42/6311.md?p=7);
    - (C) the development of [priority countermeasures](#e-4); and
    - (D) other relevant areas of research;

    with consideration given to the needs of [children](/usc/42/256e.md?p=g-2) and other vulnerable populations.

  - (2) **Priority—** The [Secretary](/usc/42/201.md?p=c) shall give priority under this section to the funding of research and other studies related to [priority countermeasures](#e-4).
  - (3) **Role of Department of Veterans Affairs—** In carrying out [paragraph (1)](#e-1), the [Secretary](/usc/42/201.md?p=c) shall consider using the biomedical research and development capabilities of the Department of Veterans Affairs, in conjunction with that Department’s affiliations with health-professions universities. When advantageous to the Government in furtherance of the purposes of such paragraph, the [Secretary](/usc/42/201.md?p=c) may enter into cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) with the [Secretary](/usc/42/201.md?p=c) of Veterans Affairs to achieve such purposes.
  - (4) **Priority countermeasures—** For purposes of this section, the term “priority countermeasure” means a [drug](/usc/42/282.md?p=j-1-A-vii), [biological product](/usc/42/287a.md?p=a-1), device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that the [Secretary](/usc/42/201.md?p=c) determines to be—
    - (A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to [section 262a(a)(1) of this title](/usc/42/262a.md?p=a-1), or harm from any other agent that may [cause](/usc/42/9908.md?p=c-2) a public health emergency; or
    - (B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences or death and may be caused by the administering of a [drug](/usc/42/282.md?p=j-1-A-vii), [biological product](/usc/42/287a.md?p=a-1), device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that is a priority under [subparagraph (A)](#e-4-A).
- (f) **Authorization of appropriations—**
  - (1) **Fiscal year 2007—** There are authorized to be appropriated to carry out this section for fiscal year 2007—
    - (A) to carry out [subsection (a)](#a)—
      - (i) $5,000,000 to carry out [paragraphs (1) through (4)](#f-1..f-4); and
      - (ii) $7,000,000 to carry out paragraph (5);
    - (B) to carry out [subsection (c)](#c), $3,000,000; and
    - (C) to carry out [subsection (d)](#d), $31,000,000.
  - (2) **Subsequent fiscal years—** There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal year 2008 and each subsequent fiscal year.

# §247d–6a. Authority for use of certain procedures regarding qualified countermeasure research and development activities

- (a) **In general—**
  - (1) **Authority—** In conducting and supporting research and development activities regarding countermeasures under [section 247d–6(e) of this title](/usc/42/247d–6.md?p=e), the [Secretary](/usc/42/201.md?p=c) may conduct and support such activities in accordance with this section and, in consultation with the [Director](/usc/42/5061.md?p=1) of the National Institutes of Health, as part of the [program](/usc/42/274l–1.md?p=4) under [section 285f of this title](/usc/42/285f.md), if the activities concern [qualified countermeasures](#a-2-A).
  - (2) **Definitions—** In this section:
    - (A) **Qualified countermeasure—** The term “qualified countermeasure” means a [drug](/usc/42/282.md?p=j-1-A-vii) (as that term is defined by [section 321(g)(1) of title 21](/usc/21/321.md?p=g-1)), [biological product](/usc/42/287a.md?p=a-1) (as that term is defined by [section 262(i) of this title](/usc/42/262.md?p=i)), or device (as that term is defined by [section 321(h) of title 21](/usc/21/321.md?p=h)), that the [Secretary](/usc/42/201.md?p=c) determines to be a priority (consistent with sections [182(2)](/usc/6/182.md?p=2) and [184(a)](/usc/6/184.md?p=a) of title 6)—
      - (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that [cause](/usc/42/9908.md?p=c-2) an [infectious disease](#a-2-B)) or toxin, chemical, radiological, or nuclear agent that may [cause](/usc/42/9908.md?p=c-2) a public health emergency affecting national security;
      - (ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a [drug](/usc/42/282.md?p=j-1-A-vii), [biological product](/usc/42/287a.md?p=a-1), or device that is used as described in this subparagraph; or
      - (iii) is a product or technology intended to enhance the use or effect of a [drug](/usc/42/282.md?p=j-1-A-vii), [biological product](/usc/42/287a.md?p=a-1), or device described in clause [(i)](#a-2-A-i) or [(ii)](#a-2-A-ii).
    - (B) **Infectious disease—** The term “infectious disease” means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a [person](/usc/42/1320a–7k.md?p=d-4-C-i) and that reproduces in that [person](/usc/42/1320a–7k.md?p=d-4-C-i).
  - (3) **Interagency cooperation—**
    - (A) **In general—** In carrying out activities under this section, the [Secretary](/usc/42/201.md?p=c) is authorized, subject to [subparagraph (B)](#a-3-B), to enter into interagency [agreements](/usc/42/1320b–8.md?p=a-3-A) and other collaborative undertakings with other agencies of the [United States](/usc/42/403.md?p=k) Government.
    - (B) **Limitation—** An [agreement](/usc/42/1320b–8.md?p=a-3-A) or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section.
  - (4) **Availability of facilities to the Secretary—** In any grant, contract, or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) entered into under the authority provided in this section with respect to a biocontainment [laboratory](/usc/42/300jj.md?p=10) or other related or ancillary specialized research [facility](/usc/42/11049.md?p=4) that the [Secretary](/usc/42/201.md?p=c) determines necessary for the purpose of performing, administering, or supporting [qualified countermeasure](#a-2-A) research and development, the [Secretary](/usc/42/201.md?p=c) may provide that the [facility](/usc/42/11049.md?p=4) that is the object of such grant, contract, or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) shall be available as needed to the [Secretary](/usc/42/201.md?p=c) to respond to public health emergencies affecting national security.
  - (5) **Transfers of qualified countermeasures—** Each [agreement](/usc/42/1320b–8.md?p=a-3-A) for an award of a grant, contract, or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) under [section 247d–6(e) of this title](/usc/42/247d–6.md?p=e) for the development of a [qualified countermeasure](#a-2-A) shall provide that the [recipient](/usc/42/2996a.md?p=6) of the award will comply with all applicable export-related controls with respect to such countermeasure.
- (b) **Expedited procurement authority—**
  - (1) **Increased simplified acquisition threshold for qualified countermeasure procurements—**
    - (A) **In general—** For any procurement by the [Secretary](/usc/42/201.md?p=c) of property or [services](/usc/42/201.md?p=a) for use (as determined by the [Secretary](/usc/42/201.md?p=c)) in performing, administering, or supporting [qualified countermeasure](#a-2-A) research or development activities under this section that the [Secretary](/usc/42/201.md?p=c) determines necessary to respond to pressing research and development needs under this section, the amount specified in [section 134 of title 41](/usc/41/134.md), as applicable pursuant to [section 3101(b)(1)(A) of title 41](/usc/41/3101.md?p=b-1-A), shall be deemed to be $25,000,000 in the administration, with respect to such procurement, of—
      - (i) [section 3305(a)(1) of title 41](/usc/41/3305.md?p=a-1) and its implementing [regulations](/usc/42/201.md?p=d); and
      - (ii) [section 3101(b)(1)(B) of title 41](/usc/41/3101.md?p=b-1-B) and its implementing [regulations](/usc/42/201.md?p=d).
    - (B) **Application of certain provisions—** Notwithstanding [subparagraph (A)](#b-1-A) and the provision of law and [regulations](/usc/42/201.md?p=d) referred to in such subparagraph, each of the following provisions shall apply to procurements described in this paragraph to the same extent that such provisions would apply to such procurements in the absence of [subparagraph (A)](#b-1-A):
      - (i) [Chapter 37](/usc/40/chstII-ptA-ch37.md) of title 40 (relating to contract work hours and safety [standards](/usc/42/1320d.md?p=7)).
      - (ii) [Section 8703(a) of title 41](/usc/41/8703.md?p=a).
      - (iii) [Section 4706 of title 41](/usc/41/4706.md) (relating to the examination of contractor records).
      - (iv) [Section 3131 of title 40](/usc/40/3131.md) (relating to bonds of contractors of public [buildings](/usc/42/6881.md?p=i-3) or works).
      - (v) [Section 3901 of title 41](/usc/41/3901.md) (relating to contingent fees to middlemen).
      - (vi) [Section 6962 of this title](/usc/42/6962.md).
      - (vii) [Section 1354 of title 31](/usc/31/1354.md) (relating to the limitation on the use of appropriated [funds](/usc/42/12854.md?p=3) for contracts with entities not meeting veterans employment reporting requirements).
    - (C) **Internal controls to be instituted—** The [Secretary](/usc/42/201.md?p=c) shall institute appropriate internal controls for procurements that are under this paragraph, including requirements with regard to documenting the justification for use of the authority in this paragraph with respect to the procurement involved.
    - (D) **Authority to limit competition—** In conducting a procurement under this paragraph, the [Secretary](/usc/42/201.md?p=c) may not use the authority provided for under [subparagraph (A)](#b-1-A) to conduct a procurement on a basis other than full and open competition unless the [Secretary](/usc/42/201.md?p=c) determines that the mission of the BioShield [Program](/usc/42/274l–1.md?p=4) under the [Project](/usc/42/11360.md?p=20) BioShield Act of 2004 would be seriously impaired without such a limitation.
  - (2) **Procedures other than full and open competition—**
    - (A) **In general—** In using the authority provided in [section 3304(a)(1) of title 41](/usc/41/3304.md?p=a-1) to use procedures other than competitive procedures in the case of a procurement described in paragraph (1) of this subsection, the phrase “available from only one responsible source” in such [section 3304(a)(1)](/usc/41/3304.md?p=a-1) shall be deemed to mean “available from only one responsible source or only from a limited number of responsible sources”.
    - (B) **Relation to other authorities—** The authority under [subparagraph (A)](#b-2-A) is in addition to any other authority to use procedures other than competitive procedures.
    - (C) **Applicable government-wide regulations—** The [Secretary](/usc/42/201.md?p=c) shall implement this paragraph in accordance with government-wide [regulations](/usc/42/201.md?p=d) implementing such section 3304(a)(1) (including requirements that offers be solicited from as many potential sources as is practicable under the circumstances, that required notices be published, and that submitted offers be considered), as such [regulations](/usc/42/201.md?p=d) apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or [services](/usc/42/201.md?p=a) needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or [services](/usc/42/201.md?p=a) will satisfy the needs of the agency.
  - (3) **Increased micropurchase threshold—**
    - (A) **In general—** For a procurement described by [paragraph (1)](#b-1), the amount specified in subsections (a), (d), and (e) of [section 1902 of title 41](/usc/41/1902.md) shall be deemed to be $15,000 in the administration of that section with respect to such procurement.
    - (B) **Internal controls to be instituted—** The [Secretary](/usc/42/201.md?p=c) shall institute appropriate internal controls for purchases that are under this paragraph and that are greater than $2,500.
    - (C) **Exception to preference for purchase card mechanism—** No provision of law establishing a preference for using a Government purchase card method for purchases shall apply to purchases that are under this paragraph and that are greater than $2,500.
  - (4) **Review—**
    - (A) **Review allowed—** Notwithstanding [subsection (f)](#f), [section 1491 of title 28](/usc/28/1491.md), and [section 3556 of title 31](/usc/31/3556.md), review of a contracting agency decision relating to a procurement described in [paragraph (1)](#b-1) may be had only by filing a protest—
      - (i) with a contracting agency; or
      - (ii) with the Comptroller General under subchapter V of [chapter 35](/usc/31/chstIII-ch35.md) of title 31.
    - (B) **Override of stay of contract award or performance committed to agency discretion—** Notwithstanding [section 1491 of title 28](/usc/28/1491.md) and [section 3553 of title 31](/usc/31/3553.md), the following [authorizations](/usc/42/4370m.md?p=3) by the head of a procuring activity are committed to agency discretion:
      - (i) An [authorization](/usc/42/4370m.md?p=3) under [section 3553(c)(2) of title 31](/usc/31/3553.md?p=c-2) to award a contract for a procurement described in paragraph (1) of this subsection.
      - (ii) An [authorization](/usc/42/4370m.md?p=3) under section 3553(d)(3)(C) of such title to perform a contract for a procurement described in paragraph (1) of this subsection.
- (c) **Authority to expedite peer review—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) may, as the [Secretary](/usc/42/201.md?p=c) determines necessary to respond to pressing [qualified countermeasure](#a-2-A) research and development needs under this section, employ such expedited peer review procedures (including consultation with appropriate scientific experts) as the [Secretary](/usc/42/201.md?p=c), in consultation with the [Director](/usc/42/5061.md?p=1) of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely contribution to the field of [qualified countermeasure](#a-2-A) research, in place of the peer review and [advisory council](/usc/42/274l–1.md?p=1) review procedures that would be required under sections [241(a)(3)](/usc/42/241.md?p=a-3), [284(b)(1)(B)](/usc/42/284.md?p=b-1-B), [284(b)(2)](/usc/42/284.md?p=b-2), [284a(a)(3)(A)](/usc/42/284a.md?p=a-3-A), [289a](/usc/42/289a.md), and [289c](/usc/42/289c.md) of this title, as applicable to a grant, contract, or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A)—
    - (A) that is for performing, administering, or supporting [qualified countermeasure](#a-2-A) research and development activities; and
    - (B) the amount of which is not greater than $1,500,000.
  - (2) **Subsequent phases of research—** The [Secretary](/usc/42/201.md?p=c)’s determination of whether to employ expedited peer review with respect to any subsequent phases of a research grant, contract, or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) under this section shall be determined without regard to the peer review procedures used for any prior peer review of that same grant, contract, or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A). Nothing in the preceding sentence may be construed to impose any requirement with respect to peer review not otherwise required under any other law or regulation.
- (d) **Authority for personal services contracts—**
  - (1) **In general—** For the purpose of performing, administering, or supporting [qualified countermeasure](#a-2-A) research and development activities, the [Secretary](/usc/42/201.md?p=c) may, as the [Secretary](/usc/42/201.md?p=c) determines necessary to respond to pressing [qualified countermeasure](#a-2-A) research and development needs under this section, obtain by contract (in accordance with [section 3109 of title 5](/usc/5/3109.md), but without regard to the limitations in such section on the period of [service](/usc/42/201.md?p=a) and on pay) the personal [services](/usc/42/201.md?p=a) of experts or consultants who have scientific or other professional qualifications, except that in no case shall the compensation provided to any such expert or consultant exceed the daily equivalent of the annual rate of compensation for the President.
  - (2) **Federal Tort Claims Act coverage—**
    - (A) **In general—** A [person](/usc/42/1320a–7k.md?p=d-4-C-i) carrying out a contract under [paragraph (1)](#d-1), and an officer, [employee](/usc/42/300gg–91.md?p=d-5), or governing [board](/usc/42/10261.md?p=2) member of such [person](/usc/42/1320a–7k.md?p=d-4-C-i), shall, subject to a determination by the [Secretary](/usc/42/201.md?p=c), be deemed to be an [employee](/usc/42/300gg–91.md?p=d-5) of the Department of Health and Human [Services](/usc/42/201.md?p=a) for purposes of [claims](/usc/42/1320a–7a.md?p=i-2) under sections [1346(b)](/usc/28/1346.md?p=b) and [2672](/usc/28/2672.md) of title 28 for money [damages](/usc/42/9601.md?p=6) for personal injury, including death, resulting from performance of functions under such contract.
    - (B) **Exclusivity of remedy—** The remedy provided by [subparagraph (A)](#d-2-A) shall be exclusive of any other civil action or proceeding by reason of the same subject matter against the entity involved ([person](/usc/42/1320a–7k.md?p=d-4-C-i), officer, [employee](/usc/42/300gg–91.md?p=d-5), or governing [board](/usc/42/10261.md?p=2) member) for any act or omission within the scope of the Federal Tort Claims Act.
    - (C) **Recourse in case of gross misconduct or contract violation—**
      - (i) **In general—** Should payment be made by the [United States](/usc/42/403.md?p=k) to any claimant bringing a [claim](/usc/42/1320a–7a.md?p=i-2) under this paragraph, either by way of administrative determination, settlement, or court judgment, the [United States](/usc/42/403.md?p=k) shall have, notwithstanding any provision of [State](/usc/42/300gg–91.md?p=d-14) law, the right to recover against any entity identified in [subparagraph (B)](#d-2-B) for that portion of the [damages](/usc/42/9601.md?p=6) so awarded or paid, as well as interest and any costs of litigation, resulting from the failure of any such entity to carry out any obligation or responsibility assumed by such entity under a contract with the [United States](/usc/42/403.md?p=k) or from any grossly negligent or reckless conduct or intentional or willful misconduct on the part of such entity.
      - (ii) **Venue—** The [United States](/usc/42/403.md?p=k) may maintain an action under this subparagraph against such entity in the district court of the [United States](/usc/42/403.md?p=k) in which such entity resides or has its principal place of business.
  - (3) **Internal controls to be instituted—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall institute appropriate internal controls for contracts under this subsection, including procedures for the [Secretary](/usc/42/201.md?p=c) to make a determination of whether a [person](/usc/42/1320a–7k.md?p=d-4-C-i), or an officer, [employee](/usc/42/300gg–91.md?p=d-5), or governing [board](/usc/42/10261.md?p=2) member of a [person](/usc/42/1320a–7k.md?p=d-4-C-i), is deemed to be an [employee](/usc/42/300gg–91.md?p=d-5) of the Department of Health and Human [Services](/usc/42/201.md?p=a) pursuant to [paragraph (2)](#d-2).
    - (B) **Determination of employee status to be final—** A determination by the [Secretary](/usc/42/201.md?p=c) under [subparagraph (A)](#d-3-A) that a [person](/usc/42/1320a–7k.md?p=d-4-C-i), or an officer, [employee](/usc/42/300gg–91.md?p=d-5), or governing [board](/usc/42/10261.md?p=2) member of a [person](/usc/42/1320a–7k.md?p=d-4-C-i), is or is not deemed to be an [employee](/usc/42/300gg–91.md?p=d-5) of the Department of Health and Human [Services](/usc/42/201.md?p=a) shall be final and binding on the [Secretary](/usc/42/201.md?p=c) and the [Attorney General](/usc/42/14902.md?p=6) and other parties to any civil action or proceeding.
  - (4) **Number of personal services contracts limited—** The number of experts and consultants whose personal [services](/usc/42/201.md?p=a) are obtained under [paragraph (1)](#d-1) shall not exceed 30 at any time.
- (e) **Streamlined personnel authority—**
  - (1) **In general—** In addition to any other personnel authorities, the [Secretary](/usc/42/201.md?p=c) may, as the [Secretary](/usc/42/201.md?p=c) determines necessary to respond to pressing [qualified countermeasure](#a-2-A) research and development needs under this section, without regard to those provisions of [title 5](/usc/5.md) governing appointments in the competitive [service](/usc/42/201.md?p=a), and without regard to the provisions of [chapter 51](/usc/42/ch51.md) and subchapter III of [chapter 53](/usc/42/ch53.md) of such title relating to classification and General Schedule pay rates, appoint professional and technical [employees](/usc/42/300gg–91.md?p=d-5), not to exceed 30 such [employees](/usc/42/300gg–91.md?p=d-5) at any time, to positions in the National Institutes of Health to perform, administer, or support [qualified countermeasure](#a-2-A) research and development activities in carrying out this section.
  - (2) **Limitations—** The authority provided for under [paragraph (1)](#e-1) shall be exercised in a manner that—
    - (A) recruits and appoints individuals based solely on their abilities, knowledge, and skills;
    - (B) does not discriminate for or against any applicant for employment on any basis described in [section 2302(b)(1) of title 5](/usc/5/2302.md?p=b-1);
    - (C) does not allow an official to appoint an individual who is a relative (as defined in section 3110(a)(3) of such title) of such official;
    - (D) does not discriminate for or against an individual because of the exercise of any activity described in paragraph [(9)](/usc/42/2302.md) or [(10)](/usc/42/2302.md) of section 2302(b) of such title; and
    - (E) accords a preference, among equally qualified [persons](/usc/42/1320a–7k.md?p=d-4-C-i), to [persons](/usc/42/1320a–7k.md?p=d-4-C-i) who are preference eligibles (as defined in section 2108(3) of such title).
  - (3) **Internal controls to be instituted—** The [Secretary](/usc/42/201.md?p=c) shall institute appropriate internal controls for appointments under this subsection.
- (f) **Actions committed to agency discretion—** Actions by the [Secretary](/usc/42/201.md?p=c) under the authority of this section are committed to agency discretion.

# §247d–6b. Strategic National Stockpile and security countermeasure procurements

- (a) **Strategic National Stockpile—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), in collaboration with the Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response and the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, and in coordination with the [Secretary](/usc/42/201.md?p=c) of Homeland Security (referred to in this section as the “Homeland Security [Secretary](/usc/42/201.md?p=c)”), shall maintain a [stockpile](#e) or [stockpiles](#e) of [drugs](/usc/42/282.md?p=j-1-A-vii), vaccines and other [biological products](/usc/42/287a.md?p=a-1), medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of [drugs](/usc/42/282.md?p=j-1-A-vii), vaccines and other [biological products](/usc/42/287a.md?p=a-1), medical devices, and diagnostic tests in the [stockpile](#e)) in such numbers, types, and amounts as are determined consistent with [section 300hh–10 of this title](/usc/42/300hh–10.md) by the [Secretary](/usc/42/201.md?p=c) to be appropriate and practicable, taking into account other available sources, to provide for and optimize the emergency health security of the [United States](/usc/42/403.md?p=k), including the emergency health security of [children](/usc/42/256e.md?p=g-2) and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency and, as informed by existing recommendations of, or consultations with, the Public Health Emergency Medical Countermeasure Enterprise established under [section 300hh–10a of this title](/usc/42/300hh–10a.md), make necessary additions or [modifications](/usc/42/7501.md?p=4) to the contents of such [stockpile](#e) or [stockpiles](#e) based on the review conducted under [paragraph (2)](#a-2).
  - (2) **Threat-based review—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall conduct an annual threat-based review (taking into account [at-risk individuals](/usc/42/300hh–1.md?p=b-4-B)) of the contents of the [stockpile](#e) under [paragraph (1)](#a-1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under [section 300hh–10a of this title](/usc/42/300hh–10a.md), review contents within the [stockpile](#e) and assess whether such contents are consistent with the recommendations made pursuant to [section 300hh–10a(c)(1)(A) of this title](/usc/42/300hh–10a.md?p=c-1-A). Such review shall be submitted on June 15, 2019, and on March 15 of each year thereafter, to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) and the Committee on Appropriations of the House of [Representatives](/usc/42/3058f.md?p=5), in a manner that does not compromise national security.
    - (B) **Additions, modifications, and replenishments—** Each annual threat-based review under [subparagraph (A)](#a-2-A) shall, for each new or [modified](/usc/42/7501.md?p=4) countermeasure procurement or replenishment, provide—
      - (i) information regarding—
        - (I) the quantities of the additional or [modified](/usc/42/7501.md?p=4) countermeasure procured for, or contracted to be procured for, the [stockpile](#e);
        - (II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or [modifications](/usc/42/7501.md?p=4) (without disclosing proprietary information), including—
          - (aa) consideration of the effect such additions or [modifications](/usc/42/7501.md?p=4) may have on the availability of such products and ancillary medical supplies on the health care system; and
          - (bb) an assessment of the current supply chain for such products, including information on supply chain redundancies, any known domestic manufacturing capacity for such products, and any related vulnerabilities;
        - (III) the presence or lack of a commercial market for the countermeasure at the time of procurement;
        - (IV) the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats;
        - (V) an assessment of whether the emergency health security threat or threats described in [subclause (IV)](#a-2-B-i-IV) could be addressed in a manner that better utilizes the resources of the [stockpile](#e) and permits the greatest possible increase in the level of emergency preparedness to address such threats;
        - (VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure, or is a new addition to the [stockpile](#e);
        - (VII) a description of how such additions or [modifications](/usc/42/7501.md?p=4) align with projected investments under previous countermeasures budget plans under [section 300hh–10(b)(7) of this title](/usc/42/300hh–10.md?p=b-7), including expected [life-cycle](/usc/42/17061.md?p=14) costs, expenditures related to countermeasure procurement to address the threat or threats described in [subclause (IV)](#a-2-B-i-IV), replenishment dates (including the ability to extend the maximum shelf life of a countermeasure), and the manufacturing capacity required to replenish such countermeasure; and
        - (VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the [State](/usc/42/300gg–91.md?p=d-14) and local level, including plans for relevant capabilities of [State](/usc/42/300gg–91.md?p=d-14) and local entities to dispense, distribute, and administer the countermeasure; and
      - (ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured or replenished under this subsection, the [Secretary](/usc/42/201.md?p=c) completed a review addressing each item listed under this subsection in advance of such procurement or replenishment.
  - (3) **Procedures—** The [Secretary](/usc/42/201.md?p=c), in managing the [stockpile](#e) under [paragraph (1)](#a-1), shall—
    - (A) consult with the working group under [section 247d–6(a) of this title](/usc/42/247d–6.md?p=a) and the Public Health Emergency Medical Countermeasures Enterprise established under [section 300hh–10a of this title](/usc/42/300hh–10a.md);
    - (B) ensure that adequate procedures are followed, regularly reviewed, and updated with respect to such [stockpile](#e) for [inventory](/usc/42/4370m.md?p=14) management and accounting, and for the physical security of the [stockpile](#e);
    - (C) in consultation with Federal, [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal officials, take into consideration the timing and location of special events, and the availability, deployment, dispensing, and administration of countermeasures;
    - (D) review and revise, as appropriate, the contents of the [stockpile](#e) on a regular basis to ensure that—
      - (i) emerging threats, advanced technologies, and new countermeasures are adequately considered;
      - (ii) the potential depletion of countermeasures currently in the [stockpile](#e) is identified and appropriately addressed, including through necessary replenishment; and
      - (iii) such contents are in working condition or usable, as applicable, and are ready for deployment, which may include conducting maintenance [services](/usc/42/201.md?p=a) on such contents of the [stockpile](#e) and disposing of such contents that are no longer in working condition, or usable, as applicable;
    - (E) devise plans for effective and timely supply-chain management of the [stockpile](#e), in consultation with the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, the Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response, the [Secretary](/usc/42/201.md?p=c) of Transportation, the [Secretary](/usc/42/201.md?p=c) of Homeland Security, the [Secretary](/usc/42/201.md?p=c) of Veterans Affairs, and the heads of other appropriate [Federal agencies](/usc/42/300j–6.md?p=d-2); [State](/usc/42/300gg–91.md?p=d-14), local, Tribal, and territorial agencies; and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the [stockpile](#e);
    - (F) deploy the [stockpile](#e) at the discretion of the [Secretary](/usc/42/201.md?p=c), in consultation with, or at the request of, the [Secretary](/usc/42/201.md?p=c) of Homeland Security, to respond to an actual or potential emergency;
    - (G) deploy the [stockpile](#e) at the discretion of the [Secretary](/usc/42/201.md?p=c) to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety;
    - (H) ensure the adequate physical security of the [stockpile](#e);
    - (I) ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under [section 247d–7e of this title](/usc/42/247d–7e.md), including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the [United States](/usc/42/403.md?p=k);
    - (J) provide assistance, including technical assistance, to maintain and improve [State](/usc/42/300gg–91.md?p=d-14)[^1] local, and Tribal public health preparedness capabilities to distribute and dispense medical countermeasures and products from the [stockpile](#e), as appropriate; and
    - (K) convene meetings, not less than once per year, with [representatives](/usc/42/3058f.md?p=5) from [State](/usc/42/300gg–91.md?p=d-14), local, and Tribal health departments or officials, relevant industries, other [Federal agencies](/usc/42/300j–6.md?p=d-2), and other appropriate stakeholders, in a manner that does not compromise national security, to coordinate and share information related to maintenance and use of the [stockpile](#e), including a description of future countermeasure needs and additions, [modifications](/usc/42/7501.md?p=4), and replenishments of the contents of the [stockpile](#e), and considerations related to the manufacturing and procurement of products consistent with the requirements of the with the requirements of[^2] [chapter 83](/usc/41/chstIV-ch83.md) of title 41 (commonly referred to as the “Buy American Act”), as appropriate.
  - (4) **Utilization guidelines—** The [Secretary](/usc/42/201.md?p=c) shall ensure timely and accurate recommended utilization guidelines for [qualified countermeasures](/usc/42/247d–6a.md?p=a-2-A) (as defined in [section 247d–6a of this title](/usc/42/247d–6a.md)), qualified pandemic and epidemic products (as defined in [section 247d–6d of this title](/usc/42/247d–6d.md)), and [security countermeasures](/usc/42/247d–6d.md?p=i-9) (as defined in [subsection (c)](#c)), including for such products in the [stockpile](#e).
  - (5) **Vendor-managed inventory and warm-base surge capacity—**
    - (A) **In general—** For the purposes of maintaining the [stockpile](#e) under [paragraph (1)](#a-1) and carrying out procedures under [paragraph (3)](#a-3), the [Secretary](/usc/42/201.md?p=c) may enter into contracts or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) with vendors, which may include [manufacturers](/usc/42/300aa–33.md?p=3) or distributors of medical products, with respect to medical products intended to be delivered to the ownership of the Federal Government. Each such contract or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A) shall be subject to such terms and conditions as the [Secretary](/usc/42/201.md?p=c) may specify, including terms and conditions with respect to—
      - (i) procurement, maintenance, storage, and delivery of products, in alignment with [inventory](/usc/42/4370m.md?p=14) management and other applicable best [practices](/usc/42/17061.md?p=19), under such contract or cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A), which may consider, as appropriate, costs of transporting and handling such products; or
      - (ii) maintenance of domestic manufacturing capacity and capabilities of such products to ensure additional reserved production capacity and capabilities are available, and that such capacity and capabilities are able to support the rapid [manufacture](/usc/42/300aa–33.md?p=3), purchase, storage, and delivery of such products, as required by the [Secretary](/usc/42/201.md?p=c) to prepare for, or respond to, an existing or potential public health emergency.
    - (B) **Report—** Not later than 2 years after December 29, 2022, and annually thereafter, the [Secretary](/usc/42/201.md?p=c) shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) and the Committee on Appropriations of the House of [Representatives](/usc/42/3058f.md?p=5) a report on any contracts or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) entered into under [subparagraph (A)](#a-5-A) for purposes of establishing and maintaining vendor-managed [inventory](/usc/42/4370m.md?p=14) or reserve manufacturing capacity and capabilities for products intended for the [stockpile](#e), including a description of—
      - (i) the amount of each award;
      - (ii) the [recipient](/usc/42/2996a.md?p=6) of each award;
      - (iii) the product or products covered through each award; and
      - (iv) how the [Secretary](/usc/42/201.md?p=c) works with each [recipient](/usc/42/2996a.md?p=6) to ensure situational awareness related to the manufacturing capacity for, or [inventory](/usc/42/4370m.md?p=14) of, such products and coordinates the distribution and deployment of such products, as appropriate and applicable.
  - (6) **GAO report—**
    - (A) **In general—** Not later than 3 years after June 24, 2019, and every 5 years thereafter, the Comptroller General of the [United States](/usc/42/403.md?p=k) shall conduct a review of any changes to the contents or management of the [stockpile](#e) since January 1, 2015. Such review shall include—
      - (i) an assessment of the comprehensiveness and completeness of each annual threat-based review under [paragraph (2)](#a-2), including whether all newly procured or replenished countermeasures within the [stockpile](#e) were described in each annual review, and whether, consistent with [paragraph (2)(B)](#a-2-B), the [Secretary](/usc/42/201.md?p=c) conducted the necessary internal review in advance of such procurement or replenishment;
      - (ii) an assessment of whether the [Secretary](/usc/42/201.md?p=c) established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or [modifications](/usc/42/7501.md?p=4) to the [stockpile](#e) based on the information provided in such reviews under [paragraph (2)(B)](#a-2-B), including whether such review was conducted prior to procurement, [modification](/usc/42/7501.md?p=4), or replenishment;
      - (iii) an assessment of the plans developed by the [Secretary](/usc/42/201.md?p=c) for the deployment, distribution, and dispensing of countermeasures procured, [modified](/usc/42/7501.md?p=4), or replenished under [paragraph (1)](#a-1), including whether such plans were developed prior to procurement, [modification](/usc/42/7501.md?p=4), or replenishment;
      - (iv) an accounting of countermeasures procured, [modified](/usc/42/7501.md?p=4), or replenished under [paragraph (1)](#a-1) that received [advanced research and development](#h-1) funding from the Biomedical [Advanced Research and Development](#h-1) Authority;
      - (v) an analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, [modified](/usc/42/7501.md?p=4), or replenished under [paragraph (1)](#a-1);
      - (vi) a description of the resources expended related to the procurement of countermeasures (including additions, [modifications](/usc/42/7501.md?p=4), and replenishments) in the [stockpile](#e), and how such expenditures relate to the ability of the [stockpile](#e) to meet emergency health security needs;
      - (vii) an assessment of the extent to which additions, [modifications](/usc/42/7501.md?p=4), and replenishments reviewed under [paragraph (2)](#a-2) align with previous relevant reports or reviews by the [Secretary](/usc/42/201.md?p=c) or the Comptroller General;
      - (viii) with respect to any change in the Federal organizational management of the [stockpile](#e), an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities;
      - (ix) an assessment of whether the processes and procedures described by the [Secretary](/usc/42/201.md?p=c) pursuant to [section 403(b)](/usc/42/403.md?p=b) of the Pandemic and All-[Hazards](/usc/42/5165f.md?p=a-3) Preparedness and Advancing Innovation Act of 2019 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to [subsection (a)](#a) receive the same consideration regardless of whether such countermeasures and products receive or had received funding under [section 247d–7e of this title](/usc/42/247d–7e.md), including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the [United States](/usc/42/403.md?p=k); and
      - (x) with respect to reports issued in 2027 or any subsequent year, an assessment of selected contracts or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) entered into pursuant to [paragraph (5)](#a-5).
    - (B) **Submission—** Not later than 6 months after completing a classified version of the review under [subparagraph (A)](#a-6-A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.
  - (7) **Reimbursement for certain supplies—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) may, at appropriate intervals, make available for purchase excess contents procured for, and maintained within, the [stockpile](#e) under [paragraph (1)](#a-1) to any [Federal agency](/usc/42/300j–6.md?p=d-2) or [State](/usc/42/300gg–91.md?p=d-14), local, or [Tribal government](/usc/42/804.md?p=d-3). The [Secretary](/usc/42/201.md?p=c) shall make such contents available for purchase only if—
      - (i) such contents are in excess of what is required for appropriate maintenance of such [stockpile](#e);
      - (ii) the [Secretary](/usc/42/201.md?p=c) determines that the costs for maintaining such excess contents are not appropriate to expend to meet the needs of the [stockpile](#e); and
      - (iii) the [Secretary](/usc/42/201.md?p=c) determines that such action does not compromise national security and is in the national interest.
    - (B) **Reimbursement and collection—** The [Secretary](/usc/42/201.md?p=c) may require reimbursement for contents that are made available under [subparagraph (A)](#a-7-A), in an amount that reflects the cost of acquiring and maintaining such contents and the costs incurred to make available such contents in the time and manner specified by the [Secretary](/usc/42/201.md?p=c). Amounts collected under this subsection shall be credited to the appropriations account or [fund](/usc/42/12854.md?p=3) that incurred the costs to procure such contents, and shall remain available, without further appropriation, until expended, for the purposes of the appropriation account or [fund](/usc/42/12854.md?p=3) so credited.
    - (C) **Rule of construction—** This paragraph shall not be construed to preclude transfers of contents in the [stockpile](#e) under other authorities.
    - (D) **Report—** Not later than 2 years after December 29, 2022, and annually thereafter, the [Secretary](/usc/42/201.md?p=c) shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) and the Committee on Appropriations of the House of [Representatives](/usc/42/3058f.md?p=5) a report on the use of the authority provided under this paragraph, including details of each action taken pursuant to this paragraph, the account or [fund](/usc/42/12854.md?p=3) to which any collected amounts have been credited, and how the [Secretary](/usc/42/201.md?p=c) has used such amounts.
    - (E) **Sunset—** The authority under this paragraph shall terminate on September 30, 2028.
- (b) **Smallpox vaccine development—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c) shall award contracts, enter into cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A), or carry out such other activities as may reasonably be required in order to ensure that the stockpile under [subsection (a)](#a) includes an amount of vaccine against smallpox as determined by such [Secretary](/usc/42/201.md?p=c) to be sufficient to meet the health security needs of the [United States](/usc/42/403.md?p=k).
  - (2) **Rule of construction—** Nothing in this section shall be construed to limit the private distribution, purchase, or sale of vaccines from sources other than the stockpile described in [subsection (a)](#a).
- (c) **Additional authority regarding procurement of certain countermeasures; availability of special reserve fund—**
  - (1) **In general—**
    - (A) **Use of fund—** A [security countermeasure](#c-1-B) may, in accordance with this subsection, be procured with amounts in the [special reserve fund](#h-2) as defined in [subsection (h)](#h).
    - (B) **Security countermeasure—** For purposes of this subsection, the term “security countermeasure” means a [drug](/usc/42/282.md?p=j-1-A-vii) (as that term is defined by [section 201(g)(1)](/usc/42/201.md) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act ([21 U.S.C. 321(g)(1)](/usc/21/321.md?p=g-1))), [biological product](/usc/42/287a.md?p=a-1) (as that term is defined by [section 262(i) of this title](/usc/42/262.md?p=i)), or device (as that term is defined by [section 201(h)](/usc/42/201.md?p=h) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act ([21 U.S.C. 321(h)](/usc/21/321.md?p=h))) that—
      - (i)
        - (I) the [Secretary](/usc/42/201.md?p=c) determines to be a priority (consistent with sections [182(2)](/usc/6/182.md?p=2) and [184(a)](/usc/6/184.md?p=a) of title 6) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat under [paragraph (2)(A)(ii)](#c-2-A-ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a [drug](/usc/42/282.md?p=j-1-A-vii), [biological product](/usc/42/287a.md?p=a-1), or device against such an agent;
        - (II) the [Secretary](/usc/42/201.md?p=c) determines under [paragraph (2)(B)(ii)](#c-2-B-ii) to be a necessary countermeasure; and
        - (III)
          - (aa) is approved or cleared under chapter V of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 351](/usc/21/351.md) et seq.] or licensed under [section 262 of this title](/usc/42/262.md); or
          - (bb) is a countermeasure for which the [Secretary](/usc/42/201.md?p=c) determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under [paragraph (5)](#c-5); or
      - (ii) is authorized for emergency use under section 564 of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md)].
  - (2) **Determination of material threats—**
    - (A) **Material threat—** The Homeland Security [Secretary](/usc/42/201.md?p=c), in consultation with the [Secretary](/usc/42/201.md?p=c) and the heads of other agencies as appropriate, shall on an ongoing basis—
      - (i) assess current and emerging threats of chemical, biological, radiological, and nuclear agents; and
      - (ii) determine which of such agents present a material threat against the [United States](/usc/42/403.md?p=k) population sufficient to affect national security.
    - (B) **Public health impact; necessary countermeasures—** The [Secretary](/usc/42/201.md?p=c) shall on an ongoing basis—
      - (i) assess the potential public health consequences for the [United States](/usc/42/403.md?p=k) population of exposure to agents identified under [subparagraph (A)(ii)](#c-2-A-ii); and
      - (ii) determine, on the basis of such assessment, the agents identified under [subparagraph (A)(ii)](#c-2-A-ii) for which countermeasures are necessary to protect the public health.
    - (C) **Notice to Congress—** The [Secretary](/usc/42/201.md?p=c) and the [Secretary](/usc/42/201.md?p=c) of Homeland Security shall send to Congress, not later than March 15 of each year, all current material threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) and the Committee on Homeland Security of the House of [Representatives](/usc/42/3058f.md?p=5) that a determination has been made pursuant to subparagraph [(A)](#c-2-A) or [(B)](#c-2-B).
    - (D) **Assuring access to threat information—** In making the assessment and determination required under [subparagraph (A)](#c-2-A), the Homeland Security [Secretary](/usc/42/201.md?p=c) shall use all relevant information to which such [Secretary](/usc/42/201.md?p=c) is entitled under [section 122 of title 6](/usc/6/122.md), including but not limited to information, regardless of its level of classification, relating to current and emerging threats of chemical, biological, radiological, and nuclear agents.
  - (3) **Assessment of availability and appropriateness of countermeasures—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c), in consultation with the Homeland Security [Secretary](/usc/42/201.md?p=c), shall assess on an ongoing basis the availability and appropriateness of specific countermeasures to address specific threats identified under [paragraph (2)](#c-2).
    - (B) **Information—** The [Secretary](/usc/42/201.md?p=c) shall institute a process for making publicly available the results of assessments under [subparagraph (A)](#c-3-A) while withholding such information as—
      - (i) would, in the judgment of the [Secretary](/usc/42/201.md?p=c), tend to reveal public health vulnerabilities; or
      - (ii) would otherwise be exempt from disclosure under [section 552 of title 5](/usc/5/552.md).
  - (4) **Call for development of countermeasures; commitment for recommendation for procurement—**
    - (A) **Proposal to the President—** If, pursuant to an assessment under [paragraph (3)](#c-3), the Homeland Security [Secretary](/usc/42/201.md?p=c) and the [Secretary](/usc/42/201.md?p=c) make a determination that a countermeasure would be appropriate but is either currently not developed or unavailable for procurement as a [security countermeasure](#c-1-B) or is approved, licensed, or cleared only for alternative uses, such [Secretaries](/usc/42/201.md?p=c) may jointly submit to the President a proposal to—
      - (i) issue a call for the development of such countermeasure; and
      - (ii) make a commitment that, upon the first development of such countermeasure that meets the conditions for procurement under [paragraph (5)](#c-5), the [Secretaries](/usc/42/201.md?p=c) will, based in part on information obtained pursuant to such call, and subject to the availability of appropriations, make available the [special reserve fund](#h-2) as defined in [subsection (h)](#h) for procurement of such countermeasure, as applicable.
    - (B) **Countermeasure specifications—** The Homeland Security [Secretary](/usc/42/201.md?p=c) and the [Secretary](/usc/42/201.md?p=c) shall, to the extent practicable, include in the proposal under [subparagraph (A)](#c-4-A)—
      - (i) estimated quantity of purchase (in the form of number of doses or number of effective courses of [treatments](/usc/42/11851.md?p=11) regardless of dosage form);
      - (ii) necessary measures of minimum safety and effectiveness;
      - (iii) estimated price for each dose or effective course of [treatment](/usc/42/11851.md?p=11) regardless of dosage form; and
      - (iv) other information that may be necessary to encourage and facilitate research, development, and [manufacture](/usc/42/300aa–33.md?p=3) of the countermeasure or to provide specifications for the countermeasure.
    - (C) **Presidential approval—** If the President approves a proposal under [subparagraph (A)](#c-4-A), the Homeland Security [Secretary](/usc/42/201.md?p=c) and the [Secretary](/usc/42/201.md?p=c) shall make known to [persons](/usc/42/1320a–7k.md?p=d-4-C-i) who may respond to a call for the countermeasure involved—
      - (i) the call for the countermeasure;
      - (ii) specifications for the countermeasure under [subparagraph (B)](#c-4-B); and
      - (iii) the commitment described in [subparagraph (A)(ii)](#c-4-A-ii).
  - (5) **Secretary’s determination of countermeasures appropriate for funding from special reserve fund—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c), in accordance with the provisions of this paragraph, shall identify specific [security countermeasures](#c-1-B) that the [Secretary](/usc/42/201.md?p=c) determines, in consultation with the Homeland Security [Secretary](/usc/42/201.md?p=c), to be appropriate for inclusion in the stockpile under [subsection (a)](#a) pursuant to procurements made with amounts in the [special reserve fund](#h-2) as defined in [subsection (h)](#h) (referred to in this subsection individually as a “procurement under this subsection”).
    - (B) **Requirements—** In making a determination under [subparagraph (A)](#c-5-A) with respect to a [security countermeasure](#c-1-B), the [Secretary](/usc/42/201.md?p=c) shall determine and consider the following:
      - (i) The quantities of the product that will be needed to meet the stockpile needs.
      - (ii) The feasibility of production and delivery within 10 years of sufficient quantities of the product.
      - (iii) Whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a [security countermeasure](#c-1-B).
  - (6) **Recommendations for procurement—**
    - (A) **Notice to appropriate congressional committees—** The [Secretary](/usc/42/201.md?p=c) shall notify the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) of the House of [Representatives](/usc/42/3058f.md?p=5) of each decision to make available the [special reserve fund](#h-2) as defined in [subsection (h)](#h) for procurement of a [security countermeasure](#c-1-B), including, where available, the number of, the nature of, and other information concerning potential [suppliers](/usc/42/1395cc–4.md?p=a-2-I) of such countermeasure, and whether other potential [suppliers](/usc/42/1395cc–4.md?p=a-2-I) of the same or similar countermeasures were considered and rejected for procurement under this section and the reasons for each such rejection.
    - (B) **Subsequent specific countermeasures—** Procurement under this subsection of a [security countermeasure](#c-1-B) for a particular purpose does not preclude the subsequent procurement under this subsection of any other [security countermeasure](#c-1-B) for such purpose if the [Secretary](/usc/42/201.md?p=c) has determined under [paragraph (5)(A)](#c-5-A) that such countermeasure is appropriate for inclusion in the stockpile and if, as determined by the [Secretary](/usc/42/201.md?p=c), such countermeasure provides improved safety or effectiveness, or for other reasons enhances preparedness to respond to threats of use of a biological, chemical, radiological, or nuclear agent. Such a determination by the [Secretary](/usc/42/201.md?p=c) is committed to agency discretion.
  - (7) **Procurement—**
    - (A) **Payments from special reserve fund—** The [special reserve fund](#h-2) as defined in [subsection (h)](#h) shall be available for payments made by the [Secretary](/usc/42/201.md?p=c) to a vendor for procurement of a [security countermeasure](#c-1-B) in accordance with the provisions of this paragraph.
    - (B) **Procurement—**
      - (i) **In general—** The [Secretary](/usc/42/201.md?p=c) shall be responsible for—
        - (I) arranging for procurement of a [security countermeasure](#c-1-B), including negotiating terms (including quantity, production schedule, and price) of, and entering into, contracts and cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A), and for carrying out such other activities as may reasonably be required, including [advanced research and development](#h-1), in accordance with the provisions of this subparagraph; and
        - (II) promulgating such [regulations](/usc/42/201.md?p=d) as the [Secretary](/usc/42/201.md?p=c) determines necessary to implement the provisions of this subsection.
      - (ii) **Contract terms—** A contract for procurements under this subsection shall (or, as specified below, may) include the following terms:
        - (I) **Payment conditioned on delivery—** The contract shall provide that no payment may be made until delivery of a portion, acceptable to the [Secretary](/usc/42/201.md?p=c), of the total number of [units](/usc/42/1395w–114b.md?p=g-2) contracted for, except that, notwithstanding any other provision of law, the contract may provide that, if the [Secretary](/usc/42/201.md?p=c) determines (in the [Secretary](/usc/42/201.md?p=c)’s discretion) that an advance payment, partial payment for significant milestones, or payment to increase manufacturing capacity is necessary to ensure success of a [project](/usc/42/11360.md?p=20), the [Secretary](/usc/42/201.md?p=c) shall pay an amount, not to exceed 10 percent of the contract amount, in advance of delivery. The [Secretary](/usc/42/201.md?p=c) shall, to the extent practicable, make the determination of advance payment at the same time as the issuance of a solicitation. The contract shall provide that such advance payment is required to be repaid if there is a failure to perform by the vendor under the contract. The contract may also provide for additional advance payments of 5 percent each for meeting the milestones specified in such contract, except that such payments shall not exceed 50 percent of the total contract amount. If the specified milestones are reached, the advanced payments of 5 percent shall not be required to be repaid. Nothing in this subclause shall be construed as affecting the rights of vendors under provisions of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.
        - (II) **Discounted payment—** The contract may provide for a [discounted price](/usc/42/1395w–114c.md?p=g-4-B-i) per [unit](/usc/42/1395w–114b.md?p=g-2) of a product that is not licensed, cleared, or approved as described in [paragraph (1)(B)(i)(III)(aa)](#c-1-B-i-III-aa) at the time of delivery, and may provide for payment of an additional amount per [unit](/usc/42/1395w–114b.md?p=g-2) if the product becomes so licensed, cleared, or approved before the expiration date of the contract (including an additional amount per [unit](/usc/42/1395w–114b.md?p=g-2) of product delivered before the effective date of such licensing, clearance, or approval).
        - (III) **Contract duration—** The contract shall be for a period not to exceed five years, except that, in first awarding the contract, the [Secretary](/usc/42/201.md?p=c) may provide for a longer duration, not exceeding 10 years, if the [Secretary](/usc/42/201.md?p=c) determines that complexities or other difficulties in performance under the contract justify such a period. The contract shall be renewable for additional periods, none of which shall exceed five years. The [Secretary](/usc/42/201.md?p=c) shall notify the vendor within 90 days of a determination by the [Secretary](/usc/42/201.md?p=c) to renew, extend, or terminate such contract.
        - (IV) **Storage by vendor—** The contract may provide that the vendor will provide storage for stocks of a product delivered to the ownership of the Federal Government under the contract, for such period and under such terms and conditions as the [Secretary](/usc/42/201.md?p=c) may specify, and in such case amounts from the [special reserve fund](#h-2) as defined in [subsection (h)](#h) shall be available for costs of shipping, handling, storage, and related costs for such product.
        - (V) **Product approval—** The contract shall provide that the vendor seek approval, clearance, or licensing of the product from the [Secretary](/usc/42/201.md?p=c); for a timetable for the development of data and other information to support such approval, clearance, or licensing; and that the [Secretary](/usc/42/201.md?p=c) may waive part or all of this contract term on request of the vendor or on the [initiative](/usc/42/19131.md?p=1) of the [Secretary](/usc/42/201.md?p=c).
        - (VI) **Non-stockpile transfers of security countermeasures—** The contract shall provide that the vendor will comply with all applicable export-related controls with respect to such countermeasure.
        - (VII) **Sales exclusivity—** The contract may provide that the vendor is the exclusive [supplier](/usc/42/1395cc–4.md?p=a-2-I) of the product to the Federal Government for a specified period of time, not to exceed the term of the contract, on the condition that the vendor is able to satisfy the needs of the Government. During the agreed period of sales exclusivity, the vendor shall not assign its rights of sales exclusivity to another entity or entities without approval by the [Secretary](/usc/42/201.md?p=c). Such a sales exclusivity provision in such a contract shall constitute a valid basis for a sole source procurement under [section 3304(a)(1) of title 41](/usc/41/3304.md?p=a-1).
        - (VIII) **Warm based surge capacity—** The contract may provide that the vendor establish domestic manufacturing capacity of the product to ensure that additional production of the product is available in the event that the [Secretary](/usc/42/201.md?p=c) determines that there is a need to quickly purchase additional quantities of the product. Such contract may provide a fee to the vendor for establishing and maintaining such capacity in excess of the initial requirement for the purchase of the product. Additionally, the cost of maintaining the domestic manufacturing capacity shall be an allowable and allocable direct cost of the contract.
        - (IX) **Contract terms—** The [Secretary](/usc/42/201.md?p=c), in any contract for procurement under this section—
          - (aa) may specify—
            - (AA) the dosing and administration requirements for the countermeasure to be developed and procured;
            - (BB) the amount of funding that will be dedicated by the [Secretary](/usc/42/201.md?p=c) for advanced research, development, and procurement of the countermeasure; and
            - (CC) the specifications the countermeasure must meet to qualify for procurement under a contract under this section; and
          - (bb) shall provide a clear statement of defined Government purpose limited to uses related to a [security countermeasure](#c-1-B), as defined in [paragraph (1)(B)](#c-1-B).
      - (iii) **Availability of simplified acquisition procedures—**
        - (I) **In general—** If the [Secretary](/usc/42/201.md?p=c) determines that there is a pressing need for a procurement of a specific countermeasure, the amount of the procurement under this subsection shall be deemed to be below the threshold amount specified in [section 134 of title 41](/usc/41/134.md), for purposes of application to such procurement, pursuant to [section 3101(b)(1)(A) of title 41](/usc/41/3101.md?p=b-1-A), of—
          - (aa) [section 3305(a)(1) of title 41](/usc/41/3305.md?p=a-1) and its implementing [regulations](/usc/42/201.md?p=d); and
          - (bb) [section 3101(b)(1)(B) of title 41](/usc/41/3101.md?p=b-1-B) and its implementing [regulations](/usc/42/201.md?p=d).
        - (II) **Application of certain provisions—** Notwithstanding [subclause (I)](#c-7-B-iii-I) and the provision of law and [regulations](/usc/42/201.md?p=d) referred to in such clause, each of the following provisions shall apply to procurements described in this clause to the same extent that such provisions would apply to such procurements in the absence of [subclause (I)](#c-7-B-iii-I):
          - (aa) [Chapter 37](/usc/40/chstII-ptA-ch37.md) of title 40 (relating to contract work hours and safety [standards](/usc/42/1320d.md?p=7)).
          - (bb) [Section 8703(a) of title 41](/usc/41/8703.md?p=a).
          - (cc) [Section 4706 of title 41](/usc/41/4706.md) (relating to the examination of contractor records).
          - (dd) [Section 3131 of title 40](/usc/40/3131.md) (relating to bonds of contractors of public [buildings](/usc/42/6881.md?p=i-3) or works).
          - (ee) [Section 3901 of title 41](/usc/41/3901.md) (relating to contingent fees to middlemen).
          - (ff) [Section 6962 of this title](/usc/42/6962.md).
          - (gg) [Section 1354 of title 31](/usc/31/1354.md) (relating to the limitation on the use of appropriated [funds](/usc/42/12854.md?p=3) for contracts with entities not meeting veterans employment reporting requirements).
        - (III) **Internal controls to be established—** The [Secretary](/usc/42/201.md?p=c) shall establish appropriate internal controls for procurements made under this clause, including requirements with respect to documentation of the justification for the use of the authority provided under this paragraph with respect to the procurement involved.
        - (IV) **Authority to limit competition—** In conducting a procurement under this subparagraph, the [Secretary](/usc/42/201.md?p=c) may not use the authority provided for under [subclause (I)](#c-7-B-iii-I) to conduct a procurement on a basis other than full and open competition unless the [Secretary](/usc/42/201.md?p=c) determines that the mission of the BioShield [Program](/usc/42/274l–1.md?p=4) under the [Project](/usc/42/11360.md?p=20) BioShield Act of 2004 would be seriously impaired without such a limitation.
      - (iv) **Procedures other than full and open competition—**
        - (I) **In general—** In using the authority provided in [section 3304(a)(1) of title 41](/usc/41/3304.md?p=a-1) to use procedures other than competitive procedures in the case of a procurement under this subsection, the phrase “available from only one responsible source” in such [section 3304(a)(1)](/usc/41/3304.md?p=a-1) shall be deemed to mean “available from only one responsible source or only from a limited number of responsible sources”.
        - (II) **Relation to other authorities—** The authority under [subclause (I)](#c-7-B-iv-I) is in addition to any other authority to use procedures other than competitive procedures.
        - (III) **Applicable government-wide regulations—** The [Secretary](/usc/42/201.md?p=c) shall implement this clause in accordance with government-wide [regulations](/usc/42/201.md?p=d) implementing such section 3304(a)(1) (including requirements that offers be solicited from as many potential sources as is practicable under the circumstances, that required notices be published, and that submitted offers be considered), as such [regulations](/usc/42/201.md?p=d) apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or [services](/usc/42/201.md?p=a) needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or [services](/usc/42/201.md?p=a) will satisfy the needs of the agency.
      - (v) **Premium provision in multiple award contracts—**
        - (I) **In general—** If, under this subsection, the [Secretary](/usc/42/201.md?p=c) enters into contracts with more than one vendor to procure a [security countermeasure](#c-1-B), such [Secretary](/usc/42/201.md?p=c) may, notwithstanding any other provision of law, include in each of such contracts a provision that—
          - (aa) identifies an increment of the total quantity of [security countermeasure](#c-1-B) required, whether by percentage or by numbers of [units](/usc/42/1395w–114b.md?p=g-2); and
          - (bb) promises to pay one or more specified premiums based on the priority of such vendors’ production and delivery of the increment identified under [item (aa)](#c-7-B-v-I-aa), in accordance with the terms and conditions of the contract.
        - (II) **Determination of Government’s requirement not reviewable—** If the [Secretary](/usc/42/201.md?p=c) includes in each of a set of contracts a provision as described in [subclause (I)](#c-7-B-v-I), such [Secretary](/usc/42/201.md?p=c)’s determination of the total quantity of [security countermeasure](#c-1-B) required, and any amendment of such determination, is committed to agency discretion.
      - (vi) **Extension of closing date for receipt of proposals not reviewable—** A decision by the [Secretary](/usc/42/201.md?p=c) to extend the closing date for receipt of proposals for a procurement under this subsection is committed to agency discretion.
      - (vii) **Limiting competition to sources responding to request for information—** In conducting a procurement under this subsection, the [Secretary](/usc/42/201.md?p=c) may exclude a source that has not responded to a request for information under [section 3306(a)(1)(B) of title 41](/usc/41/3306.md?p=a-1-B) if such request has given notice that the [Secretary](/usc/42/201.md?p=c) may so exclude such a source.
      - (viii) **Flexibility—** In carrying out this section, the [Secretary](/usc/42/201.md?p=c) may, consistent with the applicable provisions of this section, enter into contracts and other [agreements](/usc/42/1320b–8.md?p=a-3-A) that are in the best interest of the Government in meeting identified [security countermeasure](#c-1-B) needs, including with respect to reimbursement of the cost of [advanced research and development](#h-1) as a reasonable, allowable, and allocable direct cost of the contract involved.
  - (8) **Interagency cooperation—**
    - (A) **In general—** In carrying out activities under this section, the Homeland Security [Secretary](/usc/42/201.md?p=c) and the [Secretary](/usc/42/201.md?p=c) are authorized, subject to [subparagraph (B)](#c-8-B), to enter into interagency [agreements](/usc/42/1320b–8.md?p=a-3-A) and other collaborative undertakings with other agencies of the [United States](/usc/42/403.md?p=k) Government. Such [agreements](/usc/42/1320b–8.md?p=a-3-A) may allow other executive agencies to order qualified and [security countermeasures](#c-1-B) under procurement contracts or other [agreements](/usc/42/1320b–8.md?p=a-3-A) established by the [Secretary](/usc/42/201.md?p=c). Such ordering process (including transfers of appropriated [funds](/usc/42/12854.md?p=3) between an agency and the Department of Health and Human [Services](/usc/42/201.md?p=a) as reimbursements for such orders for countermeasures) may be conducted under the authority of [section 1535 of title 31](/usc/31/1535.md), except that all such orders shall be processed under the terms established under this subsection for the procurement of countermeasures.
    - (B) **Limitation—** An [agreement](/usc/42/1320b–8.md?p=a-3-A) or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section to the Homeland Security [Secretary](/usc/42/201.md?p=c) or to the [Secretary](/usc/42/201.md?p=c).
- (d) **Disclosures—** No [Federal agency](/usc/42/300j–6.md?p=d-2) may disclose under [section 552 of title 5](/usc/5/552.md) any information identifying the location at which materials in the stockpile described in [subsection (a)](#a) are stored, or other information regarding the contents or deployment capability of the stockpile that could compromise national security.
- (e) **Definition—** For purposes of [subsection (a)](#a), the term “stockpile” includes—
  - (1) a physical accumulation (at one or more locations) of the supplies described in [subsection (a)](#a); or
  - (2) a contractual [agreement](/usc/42/1320b–8.md?p=a-3-A) between the [Secretary](/usc/42/201.md?p=c) and a vendor or vendors under which such vendor or vendors agree to provide to such [Secretary](/usc/42/201.md?p=c) supplies described in [subsection (a)](#a).
- (f) **Authorization of appropriations—**
  - (1) **Strategic National Stockpile—** For the purpose of carrying out [subsection (a)](#a), there are authorized to be appropriated $610,000,000 for each of fiscal years 2019 through 2021, and $750,000,000 for each of fiscal years 2022 and 2023, to remain available until expended. Such [authorization](/usc/42/4370m.md?p=3) is in addition to amounts in the [special reserve fund](#h-2) referred to in [subsection (h)](#h).
  - (2) **Smallpox vaccine development—** For the purpose of carrying out [subsection (b)](#b), there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006.
- (g) **Special reserve fund—**
  - (1) **Authorization of appropriations—** In addition to amounts appropriated to the [special reserve fund](#h-2) prior to March 13, 2013, there is authorized to be appropriated, for the procurement of [security countermeasures](/usc/42/247d–6d.md?p=i-9) under [subsection (c)](#c) and for carrying out [section 247d–7e of this title](/usc/42/247d–7e.md) (relating to the Biomedical [Advanced Research and Development](#h-1) Authority), $7,100,000,000 for the period of fiscal years 2019 through 2028, to remain available until expended.
  - (2) **Use of special reserve fund for advanced research and development—** The [Secretary](/usc/42/201.md?p=c) may utilize not more than 50 percent of the amounts authorized to be appropriated under [paragraph (1)](#g-1) to carry out [section 247d–7e of this title](/usc/42/247d–7e.md) (related to the Biomedical [Advanced Research and Development](#h-1) Authority). Amounts authorized to be appropriated under this subsection to carry out [section 247d–7e of this title](/usc/42/247d–7e.md) are in addition to amounts otherwise authorized to be appropriated to carry out such section.
  - (3) **Restrictions on use of funds—** Amounts in the [special reserve fund](#h-2) shall not be used to pay costs other than payments made by the [Secretary](/usc/42/201.md?p=c) to a vendor for advanced development (under [section 247d–7e of this title](/usc/42/247d–7e.md)) or for procurement of a [security countermeasure](/usc/42/247d–6d.md?p=i-9) under [subsection (c)(7)](#c-7).
  - (4) **Report on security countermeasure procurement—** Not later than March 1 of each year in which the [Secretary](/usc/42/201.md?p=c) determines that the amount of [funds](/usc/42/12854.md?p=3) available for procurement of [security countermeasures](/usc/42/247d–6d.md?p=i-9) is less than $1,500,000,000, the [Secretary](/usc/42/201.md?p=c) shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) of the House of [Representatives](/usc/42/3058f.md?p=5) a report detailing the amount of such [funds](/usc/42/12854.md?p=3) available for procurement and the impact such amount of funding will have—
    - (A) in meeting the [security countermeasure](/usc/42/247d–6d.md?p=i-9) needs identified under this section; and
    - (B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to [section 300hh–10(d) of this title](/usc/42/300hh–10.md?p=d)).
  - (5) **Clarification on contracting authority—** The [Secretary](/usc/42/201.md?p=c), acting through the [Director](/usc/42/5061.md?p=1) of the Biomedical [Advanced Research and Development](#h-1) Authority, shall carry out the [programs](/usc/42/274l–1.md?p=4) funded by the [special reserve fund](#h-2) (for the procurement of [security countermeasures](/usc/42/247d–6d.md?p=i-9) under [subsection (c)](#c) and for carrying out [section 247d–7e of this title](/usc/42/247d–7e.md)), including the execution of procurement contracts, grants, and cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) pursuant to this section and [section 247d–7e of this title](/usc/42/247d–7e.md).
- (h) **Definitions—** In this section:
  - (1) The term “advanced research and development” has the meaning given such term in [section 247d–7e(a) of this title](/usc/42/247d–7e.md?p=a).
  - (2) The term “special reserve fund” means the “Biodefense Countermeasures” appropriations account, any appropriation made available pursuant to [section 321j(a) of title 6](/usc/6/321j.md?p=a), and any appropriation made available pursuant to [subsection (g)(1)](#g-1).
- (i) **Pilot program to support State medical stockpiles—**
  - (1) **In general—** The [Secretary](/usc/42/201.md?p=c), in consultation with the Assistant [Secretary](/usc/42/201.md?p=c) for Preparedness and Response and the [Director](/usc/42/5061.md?p=1) of the Centers for Disease Control and Prevention, shall award grants or cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) to not fewer than 5 [States](/usc/42/300gg–91.md?p=d-14), or consortia of [States](/usc/42/300gg–91.md?p=d-14), with consideration given to distribution among the geographical regions of the [United States](/usc/42/403.md?p=k), to establish, expand, or maintain a stockpile of appropriate [drugs](/usc/42/282.md?p=j-1-A-vii), vaccines and other [biological products](/usc/42/287a.md?p=a-1), medical devices, and other medical supplies determined by the [State](/usc/42/300gg–91.md?p=d-14) to be necessary to respond to a public health emergency declared by the [Governor](/usc/42/6372.md?p=1) of a [State](/usc/42/300gg–91.md?p=d-14) or by the [Secretary](/usc/42/201.md?p=c) under [section 247d of this title](/usc/42/247d.md), or a [major disaster](/usc/42/5302.md?p=a-25) or emergency declared by the President under section [5170](/usc/42/5170.md) or [5191](/usc/42/5191.md), respectively, of this title, in order to support the preparedness goals described in paragraphs (2) through (6) and (8) of [section 300hh–1(b) of this title](/usc/42/300hh–1.md?p=b). A [recipient](/usc/42/2996a.md?p=6) of such an award may not use award [funds](/usc/42/12854.md?p=3) to support the stockpiling of [security countermeasures](/usc/42/247d–6d.md?p=i-9) (as defined in [subsection (c)(1)](#c-1),[^3] unless the [eligible entity](/usc/42/256a.md?p=l-1) provides justification for maintaining such countermeasures and the [Secretary](/usc/42/201.md?p=c) determines such justification is appropriate and applicable.
  - (2) **Requirements—**
    - (A) **Application—** To be eligible to receive an award under [paragraph (1)](#i-1), an entity shall prepare, in consultation with appropriate health care entities and health officials within the jurisdiction of such [State](/usc/42/300gg–91.md?p=d-14) or [States](/usc/42/300gg–91.md?p=d-14), and submit to the [Secretary](/usc/42/201.md?p=c) an application that contains such information as the [Secretary](/usc/42/201.md?p=c) may require, including—
      - (i) a plan for such stockpile, consistent with [paragraph (4)](#i-4), including—
        - (I) a description of the activities such entity will carry out under the [agreement](/usc/42/1320b–8.md?p=a-3-A);
        - (II) an assurance that such entity will use [funds](/usc/42/12854.md?p=3) under such award in alignment with the requirements of [chapter 83](/usc/41/chstIV-ch83.md) of title 41 (commonly referred to as the “Buy American Act”); and
        - (III) an outline of proposed expenses; and
      - (ii) a description of how such entity will coordinate with relevant entities in receipt of an award under section [247d–3a](/usc/42/247d–3a.md) or [247d–3b](/usc/42/247d–3b.md) of this title pursuant to [paragraph (4)](#i-4), including through promoting alignment between the stockpile plan established pursuant to [clause (i)](#i-2-A-i) and applicable plans that are established by such entity pursuant to section [247d–3a](/usc/42/247d–3a.md) or [247d–3b](/usc/42/247d–3b.md) of this title.
    - (B) **Matching funds—**
      - (i) Subject to [clause (ii)](#i-2-B-ii), the [Secretary](/usc/42/201.md?p=c) may not make an award under this subsection unless the applicant agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection, to make available non-Federal contributions toward such costs in an amount equal to—
        - (I) for each of fiscal years 2023 and 2024, not less than $1 for each $20 of Federal [funds](/usc/42/12854.md?p=3) provided in the award; and
        - (II) for fiscal year 2025 and each fiscal year thereafter, not less than $1 for each $10 of Federal [funds](/usc/42/12854.md?p=3) provided in the award.
      - (ii) **Waiver.—** The [Secretary](/usc/42/201.md?p=c) may, upon the request of a [State](/usc/42/300gg–91.md?p=d-14), waive the requirement under [clause (i)](#i-2-B-i), in whole or in part, if the [Secretary](/usc/42/201.md?p=c) determines that extraordinary economic conditions in the [State](/usc/42/300gg–91.md?p=d-14) in the fiscal year involved or in the previous fiscal year justify the waiver. A waiver provided by the [Secretary](/usc/42/201.md?p=c) under this subparagraph shall apply only to the fiscal year involved.
    - (C) **Administrative expenses—** Not more than 10 percent of amounts received by an entity pursuant to an award under this subsection may be used for administrative expenses.
  - (3) **Lead entity—** An entity in receipt of an award under [paragraph (1)](#i-1) may designate a lead entity, which may be a public or [private entity](/usc/42/12181.md?p=6), as appropriate, to manage the stockpile at the direction of the [State](/usc/42/300gg–91.md?p=d-14) or [consortium](/usc/42/16282.md?p=d-4) of [States](/usc/42/300gg–91.md?p=d-14).
  - (4) **Use of funds—** An entity in receipt of an award under [paragraph (1)](#i-1) shall use such [funds](/usc/42/12854.md?p=3) to—
    - (A) purchase, store, and maintain a stockpile of appropriate [drugs](/usc/42/282.md?p=j-1-A-vii), vaccines and other [biological products](/usc/42/287a.md?p=a-1), medical devices, and other medical supplies to be used during a public health emergency, [major disaster](/usc/42/5302.md?p=a-25), or emergency described in [paragraph (1)](#i-1), in such numbers, types, and amounts as the entity determines necessary, consistent with such entity’s stockpile plan established pursuant to [paragraph (2)(A)(i)](#i-2-A-i);
    - (B) deploy the stockpile as required by the entity to respond to an actual or potential public health emergency, [major disaster](/usc/42/5302.md?p=a-25), or other emergency described in [paragraph (1)](#i-1);
    - (C) replenish and make necessary additions or [modifications](/usc/42/7501.md?p=4) to the contents of such stockpile, including to address potential depletion;
    - (D) in consultation with Federal, [State](/usc/42/300gg–91.md?p=d-14), and local officials, take into consideration the availability, deployment, dispensing, and administration requirements of medical products within the stockpile;
    - (E) ensure that procedures are followed for [inventory](/usc/42/4370m.md?p=14) management and accounting, and for the physical security of the stockpile, as appropriate;
    - (F) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that, to the extent practicable, new technologies and medical products are considered;
    - (G) carry out exercises, drills, and other [training](/usc/42/285e–2.md?p=b-2) for purposes of stockpile deployment, dispensing, and administration of medical products, and for purposes of assessing the capability of such stockpile to address the medical supply needs of public health emergencies, [major disasters](/usc/42/5302.md?p=a-25), or other emergencies described in [paragraph (1)](#i-1) of varying types and scales, which may be conducted in accordance with requirements related to exercises, drills, and other [training](/usc/42/285e–2.md?p=b-2) for [recipients](/usc/42/2996a.md?p=6) of awards under section [247d–3a](/usc/42/247d–3a.md) or [247d–3b](/usc/42/247d–3b.md) of this title, as applicable; and
    - (H) carry out other activities related to the [State](/usc/42/300gg–91.md?p=d-14) strategic stockpile as the entity determines appropriate, to support [State](/usc/42/300gg–91.md?p=d-14) efforts to prepare for, and respond to, public health threats.
  - (5) **Supplement not supplant—** Awards under [paragraph (1)](#i-1) shall supplement, not supplant, the maintenance and use of the Strategic National Stockpile by the [Secretary](/usc/42/201.md?p=c) under [subsection (a)](#a).
  - (6) **Guidance for States—** Not later than 180 days after December 29, 2022, the [Secretary](/usc/42/201.md?p=c), in consultation with [States](/usc/42/300gg–91.md?p=d-14), health officials, and other relevant stakeholders, as appropriate, shall issue guidance, and update such guidance as appropriate, for [States](/usc/42/300gg–91.md?p=d-14) related to maintaining and replenishing a stockpile of medical products, which may include strategies and best [practices](/usc/42/17061.md?p=19) related to—
    - (A) types of medical products and medical supplies that are critical to respond to public health emergencies, and may be appropriate for inclusion in a stockpile by [States](/usc/42/300gg–91.md?p=d-14), with consideration of threats that require the large-scale and simultaneous deployment of stockpiles, including the stockpile maintained by the [Secretary](/usc/42/201.md?p=c) pursuant to [subsection (a)](#a), and long-term public health and medical response needs;
    - (B) appropriate management of the contents of a stockpile, including management by vendors of reserve amounts of medical products and supplies intended to be delivered to the ownership of the [State](/usc/42/300gg–91.md?p=d-14) and appropriate disposition of excess products, as applicable; and
    - (C) the procurement of medical products and medical supplies consistent with the requirements of [chapter 83](/usc/41/chstIV-ch83.md) of title 41 (commonly referred to as the “Buy American Act”).
  - (7) **Technical assistance—** The [Secretary](/usc/42/201.md?p=c) shall provide assistance to [States](/usc/42/300gg–91.md?p=d-14), including technical assistance, as appropriate, in establishing, maintaining, improving, and utilizing a medical stockpile, including appropriate [inventory](/usc/42/4370m.md?p=14) management and disposition of products.
  - (8) **Reporting—**
    - (A) **State reports—** Each entity receiving an award under [paragraph (1)](#i-1) shall update, as appropriate, the plan established pursuant to [paragraph (2)(A)(i)](#i-2-A-i) and submit to the [Secretary](/usc/42/201.md?p=c) an annual report on implementation of such plan, including any changes to the contents of the stockpile supported under such award. The [Secretary](/usc/42/201.md?p=c) shall use information obtained from such reports to inform the maintenance and management of the Strategic National Stockpile pursuant to [subsection (a)](#a).
    - (B) **Reports to Congress—** Not later than 1 year after the initial issuance of awards pursuant to [paragraph (1)](#i-1), and annually thereafter for the duration of the [program](/usc/42/274l–1.md?p=4) established under this subsection, the [Secretary](/usc/42/201.md?p=c) shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) and the Committee on Appropriations of the House of [Representatives](/usc/42/3058f.md?p=5) a report on such [program](/usc/42/274l–1.md?p=4), including—
      - (i) Federal and [State](/usc/42/300gg–91.md?p=d-14) expenditures to support stockpiles under such [program](/usc/42/274l–1.md?p=4);
      - (ii) activities conducted pursuant to [paragraph (4)](#i-4); and
      - (iii) any additional information from the [States](/usc/42/300gg–91.md?p=d-14) that the [Secretary](/usc/42/201.md?p=c) determines relevant.
  - (9) **Authorization of appropriations—** To carry out this subsection, there is authorized to be appropriated $3,500,000,000 for each of fiscal years 2023 and 2024, to remain available until expended.

# [§247d–6c. Repealed. Pub. L. 113–5, title II, § 205, Mar. 13, 2013, 127 Stat. 179 — repealed]



# §247d–6d. Targeted liability protections for pandemic and epidemic products and security countermeasures

- (a) **Liability protections—**
  - (1) **In general—** Subject to the other provisions of this section, a [covered person](#i-2) shall be immune from suit and liability under Federal and [State](/usc/42/300gg–91.md?p=d-14) law with respect to all [claims](/usc/42/1320a–7a.md?p=i-2) for [loss](#a-2-A) caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a [covered countermeasure](#i-1) if a [declaration](/usc/42/247d–6e.md?p=e-4) under [subsection (b)](#b) has been issued with respect to such countermeasure.
  - (2) **Scope of claims for loss—**
    - (A) **Loss—** For purposes of this section, the term “loss” means any type of loss, including—
      - (i) death;
      - (ii) physical, mental, or emotional injury, illness, disability, or condition;
      - (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
      - (iv) [loss](#a-2-A) of or damage to property, including business interruption [loss](#a-2-A).

      Each of [clauses (i) through (iv)](#a-2-A-i..a-2-A-iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.

    - (B) **Scope—** The immunity under [paragraph (1)](#a-1) applies to any [claim](/usc/42/1320a–7a.md?p=i-2) for [loss](#a-2-A) that has a causal relationship with the administration to or use by an individual of a [covered countermeasure](#i-1), including a causal relationship with the design, development, clinical testing or investigation, [manufacture](/usc/42/300aa–33.md?p=3), labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.
  - (3) **Certain conditions—** Subject to the other provisions of this section, immunity under [paragraph (1)](#a-1) with respect to a [covered countermeasure](#i-1) applies only if—
    - (A) the countermeasure was administered or used during the effective period of the [declaration](/usc/42/247d–6e.md?p=e-4) that was issued under [subsection (b)](#b) with respect to the countermeasure;
    - (B) the countermeasure was administered or used for the [category](/usc/42/1395w–4.md?p=j-1) or [categories](/usc/42/1395w–4.md?p=j-1) of diseases, health conditions, or threats to health specified in the [declaration](/usc/42/247d–6e.md?p=e-4); and
    - (C) in addition, in the case of a [covered person](#i-2) who is a [program planner](#i-6) or [qualified person](#i-8) with respect to the administration or use of the countermeasure, the countermeasure was administered to or used by an individual who—
      - (i) was in a population specified by the [declaration](/usc/42/247d–6e.md?p=e-4); and
      - (ii) was at the time of administration physically present in a [geographic area](/usc/42/11360.md?p=9) specified by the [declaration](/usc/42/247d–6e.md?p=e-4) or had a connection to such area specified in the [declaration](/usc/42/247d–6e.md?p=e-4).
  - (4) **Applicability of certain conditions—** With respect to immunity under [paragraph (1)](#a-1) and subject to the other provisions of this section:
    - (A) In the case of a [covered person](#i-2) who is a [manufacturer](#i-4) or [distributor](#i-3) of the [covered countermeasure](#i-1) involved, the immunity applies without regard to whether such countermeasure was administered to or used by an individual in accordance with the conditions described in [paragraph (3)(C)](#a-3-C).
    - (B) In the case of a [covered person](#i-2) who is a [program planner](#i-6) or [qualified person](#i-8) with respect to the administration or use of the [covered countermeasure](#i-1), the scope of immunity includes circumstances in which the countermeasure was administered to or used by an individual in circumstances in which the [covered person](#i-2) reasonably could have believed that the countermeasure was administered or used in accordance with the conditions described in [paragraph (3)(C)](#a-3-C).
  - (5) **Effect of distribution method—** The provisions of this section apply to a [covered countermeasure](#i-1) regardless of whether such countermeasure is obtained by donation, commercial sale, or any other means of distribution, except to the extent that, under [paragraph (2)(E)](#b-2-E) of subsection (b), the [declaration](/usc/42/247d–6e.md?p=e-4) under such subsection provides that [subsection (a)](#a) applies only to [covered countermeasures](#i-1) obtained through a particular means of distribution.
  - (6) **Rebuttable presumption—** For purposes of [paragraph (1)](#a-1), there shall be a rebuttable presumption that any administration or use, during the effective period of the [emergency declaration](/usc/42/1397h.md?p=c-2) by the [Secretary](/usc/42/201.md?p=c) under [subsection (b)](#b), of a [covered countermeasure](#i-1) shall have been for the [category](/usc/42/1395w–4.md?p=j-1) or [categories](/usc/42/1395w–4.md?p=j-1) of diseases, health conditions, or threats to health with respect to which such [declaration](/usc/42/247d–6e.md?p=e-4) was issued.
- (b) **Declaration by Secretary—**
  - (1) **Authority to issue declaration—** Subject to [paragraph (2)](#b-2), if the [Secretary](/usc/42/201.md?p=c) makes a determination that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency, the [Secretary](/usc/42/201.md?p=c) may make a [declaration](/usc/42/247d–6e.md?p=e-4), through publication in the Federal Register, recommending, under conditions as the [Secretary](/usc/42/201.md?p=c) may specify, the [manufacture](/usc/42/300aa–33.md?p=3), testing, development, distribution, administration, or use of one or more [covered countermeasures](#i-1), and stating that [subsection (a)](#a) is in effect with respect to the activities so recommended.
  - (2) **Contents—** In issuing a [declaration](/usc/42/247d–6e.md?p=e-4) under [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c) shall identify, for each [covered countermeasure](#i-1) specified in the [declaration](/usc/42/247d–6e.md?p=e-4)—
    - (A) the [category](/usc/42/1395w–4.md?p=j-1) or [categories](/usc/42/1395w–4.md?p=j-1) of diseases, health conditions, or threats to health for which the [Secretary](/usc/42/201.md?p=c) recommends the administration or use of the countermeasure;
    - (B) the period or periods during which, including as [modified](/usc/42/7501.md?p=4) by [paragraph (3)](#b-3), [subsection (a)](#a) is in effect, which period or periods may be designated by dates, or by milestones or other description of events, including factors specified in [paragraph (6)](#b-6);
    - (C) the population or populations of individuals for which [subsection (a)](#a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation to all individuals);
    - (D) the [geographic area](/usc/42/11360.md?p=9) or areas for which [subsection (a)](#a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation), including, with respect to individuals in the populations identified under [subparagraph (C)](#b-2-C), a specification, as determined appropriate by the [Secretary](/usc/42/201.md?p=c), of whether the [declaration](/usc/42/247d–6e.md?p=e-4) applies only to individuals physically present in such areas or whether in addition the [declaration](/usc/42/247d–6e.md?p=e-4) applies to individuals who have a connection to such areas, which connection is described in the [declaration](/usc/42/247d–6e.md?p=e-4); and
    - (E) whether [subsection (a)](#a) is effective only to a particular means of distribution as provided in [subsection (a)(5)](#a-5) for obtaining the countermeasure, and if so, the particular means to which such subsection is effective.
  - (3) **Effective period of declaration—**
    - (A) **Flexibility of period—** The [Secretary](/usc/42/201.md?p=c) may, in describing periods under [paragraph (2)(B)](#b-2-B), have different periods for different [covered persons](#i-2) to address different logistical, practical or other differences in responsibilities.
    - (B) **Additional time to be specified—** In each [declaration](/usc/42/247d–6e.md?p=e-4) under [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c), after consulting, to the extent the [Secretary](/usc/42/201.md?p=c) deems appropriate, with the [manufacturer](#i-4) of the [covered countermeasure](#i-1), shall also specify a date that is after the ending date specified under [paragraph (2)(B)](#b-2-B) and that allows what the [Secretary](/usc/42/201.md?p=c) determines is—
      - (i) a reasonable period for the [manufacturer](#i-4) to arrange for disposition of the [covered countermeasure](#i-1), including the return of such product to the [manufacturer](#i-4); and
      - (ii) a reasonable period for [covered persons](#i-2) to take such other actions as may be appropriate to limit administration or use of the [covered countermeasure](#i-1).
    - (C) **Additional period for certain strategic national stockpile countermeasures—** With respect to a [covered countermeasure](#i-1) that is in the stockpile under [section 247d–6b of this title](/usc/42/247d–6b.md), if such countermeasure was the subject of a [declaration](/usc/42/247d–6e.md?p=e-4) under [paragraph (1)](#b-1) at the time that it was obtained for the stockpile, the effective period of such [declaration](/usc/42/247d–6e.md?p=e-4) shall include a period when the countermeasure is administered or used pursuant to a distribution or [release](/usc/42/9601.md?p=22) from the stockpile.
  - (4) **Amendments to declaration—** The [Secretary](/usc/42/201.md?p=c) may through publication in the Federal Register amend any portion of a [declaration](/usc/42/247d–6e.md?p=e-4) under [paragraph (1)](#b-1). Such an amendment shall not retroactively limit the applicability of [subsection (a)](#a) with respect to the administration or use of the [covered countermeasure](#i-1) involved.
  - (5) **Certain disclosures—** In publishing a [declaration](/usc/42/247d–6e.md?p=e-4) under [paragraph (1)](#b-1) in the Federal Register, the [Secretary](/usc/42/201.md?p=c) is not required to disclose any matter described in [section 552(b) of title 5](/usc/5/552.md?p=b).
  - (6) **Factors to be considered—** In deciding whether and under what circumstances or conditions to issue a [declaration](/usc/42/247d–6e.md?p=e-4) under [paragraph (1)](#b-1) with respect to a [covered countermeasure](#i-1), the [Secretary](/usc/42/201.md?p=c) shall consider the desirability of encouraging the design, development, clinical testing or investigation, [manufacture](/usc/42/300aa–33.md?p=3), labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of such countermeasure.
  - (7) **Judicial review—** No court of the [United States](/usc/42/403.md?p=k), or of any [State](/usc/42/300gg–91.md?p=d-14), shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the [Secretary](/usc/42/201.md?p=c) under this subsection.
  - (8) **Preemption of State law—** During the effective period of a [declaration](/usc/42/247d–6e.md?p=e-4) under [subsection (b)](#b), or at any time with respect to conduct undertaken in accordance with such [declaration](/usc/42/247d–6e.md?p=e-4), no [State](/usc/42/300gg–91.md?p=d-14) or political subdivision of a [State](/usc/42/300gg–91.md?p=d-14) may establish, enforce, or continue in effect with respect to a [covered countermeasure](#i-1) any provision of law or legal requirement that—
    - (A) is different from, or is in conflict with, any requirement applicable under this section; and
    - (B) relates to the design, development, clinical testing or investigation, formulation, [manufacture](/usc/42/300aa–33.md?p=3), distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by [qualified persons](#i-8) of the [covered countermeasure](#i-1), or to any matter included in a requirement applicable to the [covered countermeasure](#i-1) under this section or any other provision of this chapter, or under the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.].
  - (9) **Report to Congress—** Within 30 days after making a [declaration](/usc/42/247d–6e.md?p=e-4) under [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c) shall submit to the appropriate committees of the Congress a report that provides an explanation of the reasons for issuing the [declaration](/usc/42/247d–6e.md?p=e-4) and the reasons underlying the determinations of the [Secretary](/usc/42/201.md?p=c) with respect to [paragraph (2)](#b-2). Within 30 days after making an amendment under [paragraph (4)](#b-4), the [Secretary](/usc/42/201.md?p=c) shall submit to such committees a report that provides the reasons underlying the determination of the [Secretary](/usc/42/201.md?p=c) to make the amendment.
- (c) **Definition of willful misconduct—**
  - (1) **Definition—**
    - (A) **In general—** Except as the meaning of such term is further restricted pursuant to [paragraph (2)](#c-2), the term “willful misconduct” shall, for purposes of [subsection (d)](#d), denote an act or omission that is taken—
      - (i) intentionally to achieve a wrongful purpose;
      - (ii) knowingly without legal or factual justification; and
      - (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
    - (B) **Rule of construction—** The criterion stated in [subparagraph (A)](#c-1-A) shall be construed as establishing a [standard](/usc/42/1320d.md?p=7) for liability that is more stringent than a [standard](/usc/42/1320d.md?p=7) of negligence in any form or recklessness.
  - (2) **Authority to promulgate regulatory definition—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c), in consultation with the [Attorney General](/usc/42/14902.md?p=6), shall promulgate [regulations](/usc/42/201.md?p=d), which may be promulgated through interim final rules, that further restrict the scope of actions or omissions by a [covered person](#i-2) that may qualify as “willful misconduct” for purposes of [subsection (d)](#d).
    - (B) **Factors to be considered—** In promulgating the [regulations](/usc/42/201.md?p=d) under this paragraph, the [Secretary](/usc/42/201.md?p=c), in consultation with the [Attorney General](/usc/42/14902.md?p=6), shall consider the need to define the scope of permissible civil actions under [subsection (d)](#d) in a way that will not adversely affect the public health.
    - (C) **Temporal scope of regulations—** The [regulations](/usc/42/201.md?p=d) under this paragraph may specify the temporal effect that they shall be given for purposes of [subsection (d)](#d).
    - (D) **Initial rulemaking—** Within 180 days after December 30, 2005, the [Secretary](/usc/42/201.md?p=c), in consultation with the [Attorney General](/usc/42/14902.md?p=6), shall commence and complete an initial rulemaking process under this paragraph.
  - (3) **Proof of willful misconduct—** In an action under [subsection (d)](#d), the plaintiff shall have the burden of proving by clear and convincing evidence willful misconduct by each [covered person](#i-2) sued and that such willful misconduct caused death or [serious physical injury](#i-10).
  - (4) **Defense for acts or omissions taken pursuant to Secretary’s declaration—** Notwithstanding any other provision of law, a [program planner](#i-6) or [qualified person](#i-8) shall not have engaged in “willful misconduct” as a matter of law where such [program planner](#i-6) or [qualified person](#i-8) acted consistent with applicable directions, guidelines, or recommendations by the [Secretary](/usc/42/201.md?p=c) regarding the administration or use of a [covered countermeasure](#i-1) that is specified in the [declaration](/usc/42/247d–6e.md?p=e-4) under [subsection (b)](#b), provided either the [Secretary](/usc/42/201.md?p=c), or a [State](/usc/42/300gg–91.md?p=d-14) or local health authority, was provided with notice of information regarding [serious physical injury](#i-10) or death from the administration or use of a [covered countermeasure](#i-1) that is material to the plaintiff’s alleged [loss](#a-2-A) within 7 days of the actual discovery of such information by such [program planner](#i-6) or [qualified person](#i-8).
  - (5) **Exclusion for regulated activity of manufacturer or distributor—**
    - (A) **In general—** If an act or omission by a [manufacturer](#i-4) or [distributor](#i-3) with respect to a [covered countermeasure](#i-1), which act or omission is alleged under [subsection (e)(3)(A)](#e-3-A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], such act or omission shall not constitute “willful misconduct” for purposes of [subsection (d)](#d) if—
      - (i) neither the [Secretary](/usc/42/201.md?p=c) nor the [Attorney General](/usc/42/14902.md?p=6) has initiated an [enforcement action](#c-5-B-i) with respect to such act or omission; or
      - (ii) such an [enforcement action](#c-5-B-i) has been initiated and the action has been terminated or [finally](#c-5-B-iii) resolved without a [covered remedy](#c-5-B-ii).

      Any action or proceeding under [subsection (d)](#d) shall be stayed during the pendency of such an [enforcement action](#c-5-B-i).

    - (B) **Definitions—** For purposes of this paragraph, the following terms have the following meanings:
      - (i) **Enforcement action—** The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section [505(i)](/usc/42/505.md) or 520(g) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 355(i)](/usc/21/355.md?p=i), 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an [employee](/usc/42/300gg–91.md?p=d-5) or agent of the [manufacturer](#i-4), a revocation, based on willful misconduct, of an [authorization](/usc/42/4370m.md?p=3) under section 564 of such Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md)], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [[21 U.S.C. 351](/usc/21/351.md) et seq.] or of a licensure under [section 262 of this title](/usc/42/262.md).
      - (ii) **Covered remedy—** The term “covered remedy” means an outcome—
        - (I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section [505(i)](/usc/42/505.md) or 520(g) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 355(i)](/usc/21/355.md?p=i), 360j(g)], a debarment, an investigator disqualification, a revocation of an [authorization](/usc/42/4370m.md?p=3) under section 564 of such Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md)], or a suspension or withdrawal of an approval or clearance under [chapter 5](/usc/42/ch5.md)[^1] of such Act or of a licensure under [section 262 of this title](/usc/42/262.md); and
        - (II) that results from a [final](#c-5-B-iii) determination by a court or from a [final](#c-5-B-iii) agency action.
      - (iii) **Final—** The terms “final” and “finally”—
        - (I) with respect to a court determination, or to a [final](#c-5-B-iii) resolution of an [enforcement action](#c-5-B-i) that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and
        - (II) with respect to an agency action, or to a [final](#c-5-B-iii) resolution of an [enforcement action](#c-5-B-i) that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a [final](#c-5-B-iii) court determination or a voluntary or stipulated dismissal.
    - (C) **Rules of construction—**
      - (i) **In general—** Nothing in this paragraph shall be construed—
        - (I) to affect the interpretation of any provision of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], of this chapter, or of any other applicable statute or regulation; or
        - (II) to impair, delay, alter, or affect the authority, including the enforcement discretion, of the [United States](/usc/42/403.md?p=k), of the [Secretary](/usc/42/201.md?p=c), of the [Attorney General](/usc/42/14902.md?p=6), or of any other official with respect to any administrative or court proceeding under this chapter, under the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], under [title 18](/usc/18.md), or under any other applicable statute or regulation.
      - (ii) **Mandatory recalls—** A mandatory recall called for in the [declaration](/usc/42/247d–6e.md?p=e-4) is not a Food and [Drug](/usc/42/282.md?p=j-1-A-vii) Administration [enforcement action](#c-5-B-i).
- (d) **Exception to immunity of covered persons—**
  - (1) **In general—** Subject to [subsection (f)](#f), the sole exception to the immunity from suit and liability of [covered persons](#i-2) set forth in [subsection (a)](#a) shall be for an exclusive Federal [cause](/usc/42/9908.md?p=c-2) of action against a [covered person](#i-2) for death or [serious physical injury](#i-10) proximately caused by [willful misconduct](#c-1-A), as defined pursuant to [subsection (c)](#c), by such [covered person](#i-2). For purposes of [section 2679(b)(2)(B) of title 28](/usc/28/2679.md?p=b-2-B), such a [cause](/usc/42/9908.md?p=c-2) of action is not an action brought for [violation](/usc/42/2000e–16a.md?p=c) of a statute of the [United States](/usc/42/403.md?p=k) under which an action against an individual is otherwise authorized.
  - (2) **Persons who can sue—** An action under this subsection may be brought for wrongful death or [serious physical injury](#i-10) by any [person](#i-5) who suffers such injury or by any [representative](/usc/42/3058f.md?p=5) of such a [person](#i-5).
- (e) **Procedures for suit—**
  - (1) **Exclusive Federal jurisdiction—** Any action under [subsection (d)](#d) shall be filed and maintained only in the [United States](/usc/42/403.md?p=k) District Court for the District of Columbia.
  - (2) **Governing law—** The substantive law for decision in an action under [subsection (d)](#d) shall be derived from the law, including choice of law principles, of the [State](/usc/42/300gg–91.md?p=d-14) in which the alleged willful misconduct occurred, unless such law is inconsistent with or preempted by Federal law, including provisions of this section.
  - (3) **Pleading with particularity—** In an action under [subsection (d)](#d), the complaint shall plead with particularity each element of the plaintiff’s [claim](/usc/42/1320a–7a.md?p=i-2), including—
    - (A) each act or omission, by each [covered person](#i-2) sued, that is alleged to constitute willful misconduct relating to the [covered countermeasure](#i-1) administered to or used by the [person](#i-5) on whose behalf the complaint was filed;
    - (B) facts supporting the allegation that such alleged willful misconduct proximately caused the injury claimed; and
    - (C) facts supporting the allegation that the [person](#i-5) on whose behalf the complaint was filed suffered death or [serious physical injury](#i-10).
  - (4) **Verification, certification, and medical records—**
    - (A) **In general—** In an action under [subsection (d)](#d), the plaintiff shall verify the complaint in the manner stated in [subparagraph (B)](#e-4-B) and shall file with the complaint the materials described in [subparagraph (C)](#e-4-C). A complaint that does not substantially comply with subparagraphs [(B)](#e-4-B) and [(C)](#e-4-C) shall not be accepted for filing and shall not stop the running of the statute of limitations.
    - (B) **Verification requirement—**
      - (i) **In general—** The complaint shall include a verification, made by affidavit of the plaintiff under oath, stating that the pleading is true to the knowledge of the deponent, except as to matters specifically identified as being alleged on information and belief, and that as to those matters the plaintiff believes it to be true.
      - (ii) **Identification of matters alleged upon information and belief—** Any matter that is not specifically identified as being alleged upon the information and belief of the plaintiff, shall be regarded for all purposes, including a criminal prosecution, as having been made upon the knowledge of the plaintiff.
    - (C) **Materials required—** In an action under [subsection (d)](#d), the plaintiff shall file with the complaint—
      - (i) an affidavit, by a [physician](/usc/42/1320a–7h.md?p=e-11) who did not treat the [person](#i-5) on whose behalf the complaint was filed, certifying, and explaining the basis for such [physician](/usc/42/1320a–7h.md?p=e-11)’s belief, that such [person](#i-5) suffered the [serious physical injury](#i-10) or death alleged in the complaint and that such injury or death was proximately caused by the administration or use of a [covered countermeasure](#i-1); and
      - (ii) certified medical records documenting such injury or death and such proximate causal connection.
  - (5) **Three-judge court—** Any action under [subsection (d)](#d) shall be assigned initially to a [panel](/usc/42/10362.md?p=16) of three judges. Such [panel](/usc/42/10362.md?p=16) shall have jurisdiction over such action for purposes of considering motions to dismiss, motions for summary judgment, and matters related thereto. If such [panel](/usc/42/10362.md?p=16) has denied such motions, or if the time for filing such motions has expired, such [panel](/usc/42/10362.md?p=16) shall refer the action to the chief judge for assignment for further proceedings, including any trial. [Section 1253 of title 28](/usc/28/1253.md) and [paragraph (3)](#b-3) of subsection (b) of [section 2284 of title 28](/usc/28/2284.md) shall not apply to actions under [subsection (d)](#d).
  - (6) **Civil discovery—**
    - (A) **Timing—** In an action under [subsection (d)](#d), no discovery shall be allowed—
      - (i) before each [covered person](#i-2) sued has had a reasonable opportunity to file a motion to dismiss;
      - (ii) in the event such a motion is filed, before the court has ruled on such motion; and
      - (iii) in the event a [covered person](#i-2) files an interlocutory appeal from the denial of such a motion, before the court of appeals has ruled on such appeal.
    - (B) **Standard—** Notwithstanding any other provision of law, the court in an action under [subsection (d)](#d) shall permit discovery only with respect to matters directly related to material issues contested in such action, and the court shall compel a response to a discovery request (including a request for admission, an interrogatory, a request for production of documents, or any other form of discovery request) under Rule 37, Federal Rules of Civil Procedure, only if the court finds that the requesting party needs the information sought to prove or defend as to a material issue contested in such action and that the likely benefits of a response to such request equal or exceed the burden or cost for the responding party of providing such response.
  - (7) **Reduction in award of damages for collateral source benefits—**
    - (A) **In general—** In an action under [subsection (d)](#d), the amount of an award of [damages](/usc/42/9601.md?p=6) that would otherwise be made to a plaintiff shall be reduced by the amount of [collateral source benefits](#e-7-C) to such plaintiff.
    - (B) **Provider of collateral source benefits not to have lien or subrogation—** No provider of [collateral source benefits](#e-7-C) shall recover any amount against the plaintiff or receive any lien or credit against the plaintiff’s recovery or be equitably or legally subrogated to the right of the plaintiff in an action under [subsection (d)](#d).
    - (C) **Collateral source benefit defined—** For purposes of this paragraph, the term “collateral source benefit” means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any [service](/usc/42/201.md?p=a), product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as a result of the injury or wrongful death, pursuant to—
      - (i) any [State](/usc/42/300gg–91.md?p=d-14) or Federal health, sickness, [income](/usc/42/292s.md?p=c-4)-disability, accident, or workers’ compensation law;
      - (ii) any health, sickness, [income](/usc/42/292s.md?p=c-4)-disability, or accident insurance that provides health benefits or [income](/usc/42/292s.md?p=c-4)-disability coverage;
      - (iii) any contract or [agreement](/usc/42/1320b–8.md?p=a-3-A) of any group, organization, partnership, or [corporation](/usc/42/2296b–7.md?p=1) to provide, pay for, or reimburse the cost of medical, [hospital](/usc/42/1395dd.md?p=e-5), dental, or [income](/usc/42/292s.md?p=c-4) disability benefits; or
      - (iv) any other publicly or privately funded [program](/usc/42/274l–1.md?p=4).
  - (8) **Noneconomic damages—** In an action under [subsection (d)](#d), any noneconomic damages may be awarded only in an amount directly proportional to the percentage of responsibility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term “noneconomic damages” means [damages](/usc/42/9601.md?p=6) for [losses](#a-2-A) for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, [loss](#a-2-A) of enjoyment of life, [loss](#a-2-A) of society and companionship, [loss](#a-2-A) of [consortium](/usc/42/16282.md?p=d-4), hedonic [damages](/usc/42/9601.md?p=6), injury to reputation, and any other nonpecuniary [losses](#a-2-A).
  - (9) **Rule 11 sanctions—** Whenever a district court of the [United States](/usc/42/403.md?p=k) determines that there has been a [violation](/usc/42/2000e–16a.md?p=c) of [Rule 11](/usc/28a/civil-11.md) of the Federal Rules of Civil Procedure in an action under [subsection (d)](#d), the court shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are responsible for the [violation](/usc/42/2000e–16a.md?p=c), an appropriate sanction, which may include an order to pay the other party or parties for the reasonable expenses incurred as a direct result of the filing of the pleading, motion, or other paper that is the subject of the [violation](/usc/42/2000e–16a.md?p=c), including a reasonable attorney’s fee. Such sanction shall be sufficient to deter repetition of such conduct or comparable conduct by others similarly situated, and to compensate the party or parties injured by such conduct.
  - (10) **Interlocutory appeal—** The [United States](/usc/42/403.md?p=k) Court of Appeals for the District of Columbia Circuit shall have jurisdiction of an interlocutory appeal by a [covered person](#i-2) taken within 30 days of an order denying a motion to dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by [subsection (a)](#a) or based on an assertion of the exclusion under [subsection (c)(5)](#c-5).
- (f) **Actions by and against the United States—** Nothing in this section shall be construed to abrogate or limit any right, remedy, or authority that the [United States](/usc/42/403.md?p=k) or any agency thereof may possess under any other provision of law or to waive sovereign immunity or to abrogate or limit any defense or protection available to the [United States](/usc/42/403.md?p=k) or its agencies, instrumentalities, officers, or [employees](/usc/42/300gg–91.md?p=d-5) under any other law, including any provision of [chapter 171](/usc/28/chptVI-ch171.md) of title 28 (relating to tort [claims](/usc/42/1320a–7a.md?p=i-2) procedure).
- (g) **Severability—** If any provision of this section, or the application of such provision to any [person](#i-5) or circumstance, is held to be unconstitutional, the remainder of this section and the application of such remainder to any [person](#i-5) or circumstance shall not be affected thereby.
- (h) **Rule of construction concerning National Vaccine Injury Compensation Program—** Nothing in this section, or any amendment made by the Public Readiness and Emergency Preparedness Act, shall be construed to affect the National Vaccine Injury Compensation [Program](/usc/42/274l–1.md?p=4) under subchapter XIX of this chapter.
- (i) **Definitions—** In this section:
  - (1) **Covered countermeasure—** The term “covered countermeasure” means—
    - (A) a [qualified pandemic or epidemic product](#i-7) (as defined in [paragraph (7)](#i-7));
    - (B) a [security countermeasure](#i-9) (as defined in [section 247d–6b(c)(1)(B) of this title](/usc/42/247d–6b.md?p=c-1-B));
    - (C) a [drug](/usc/42/282.md?p=j-1-A-vii) (as such term is defined in [section 201(g)(1)](/usc/42/201.md) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act ([21 U.S.C. 321(g)(1)](/usc/21/321.md?p=g-1)), [biological product](/usc/42/287a.md?p=a-1) (as such term is defined by [section 262(i) of this title](/usc/42/262.md?p=i)), or device (as such term is defined by [section 201(h)](/usc/42/201.md?p=h) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii) and Cosmetic Act ([21 U.S.C. 321(h)](/usc/21/321.md?p=h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md), 360bbb–3a, 360bbb–3b]; or
    - (D) a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under [part 84 of title 42, Code of Federal Regulations](/cfr/42/part84.md) (or any successor [regulations](/usc/42/201.md?p=d)), and that the [Secretary](/usc/42/201.md?p=c) determines to be a priority for use during a public health emergency declared under [section 247d of this title](/usc/42/247d.md).
  - (2) **Covered person—** The term “covered person”, when used with respect to the administration or use of a [covered countermeasure](#i-1), means—
    - (A) the [United States](/usc/42/403.md?p=k); or
    - (B) a [person](#i-5) or entity that is—
      - (i) a [manufacturer](#i-4) of such countermeasure;
      - (ii) a [distributor](#i-3) of such countermeasure;
      - (iii) a [program planner](#i-6) of such countermeasure;
      - (iv) a [qualified person](#i-8) who prescribed, administered, or dispensed such countermeasure; or
      - (v) an official, agent, or [employee](/usc/42/300gg–91.md?p=d-5) of a [person](#i-5) or entity described in clause [(i)](#i-2-B-i), [(ii)](#i-2-B-ii), [(iii)](#i-2-B-iii), or [(iv)](#i-2-B-iv).
  - (3) **Distributor—** The term “distributor” means a [person](#i-5) or entity engaged in the distribution of [drugs](/usc/42/282.md?p=j-1-A-vii), biologics, or devices, including but not limited to [manufacturers](#i-4); repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, and wholesale [drug](/usc/42/282.md?p=j-1-A-vii) warehouses; independent wholesale [drug](/usc/42/282.md?p=j-1-A-vii) traders; and retail pharmacies.
  - (4) **Manufacturer—** The term “manufacturer” includes—
    - (A) a contractor or subcontractor of a [manufacturer](#i-4);
    - (B) a [supplier](/usc/42/1395cc–4.md?p=a-2-I) or licenser of any product, intellectual property, [service](/usc/42/201.md?p=a), research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a [covered countermeasure](#i-1); and
    - (C) any or all of the [parents](/usc/42/1396a.md?p=k-3), subsidiaries, affiliates, successors, and assigns of a [manufacturer](#i-4).
  - (5) **Person—** The term “person” includes an individual, partnership, [corporation](/usc/42/2296b–7.md?p=1), association, entity, or public or [private corporation](/usc/42/2297h.md?p=7), including a Federal, [State](/usc/42/300gg–91.md?p=d-14), or [local government](/usc/42/8401a.md) agency or department.
  - (6) **Program planner—** The term “program planner” means a [State](/usc/42/300gg–91.md?p=d-14) or [local government](/usc/42/8401a.md), including an [Indian tribe](/usc/42/300f.md?p=14), a [person](#i-5) employed by the [State](/usc/42/300gg–91.md?p=d-14) or [local government](/usc/42/8401a.md), or other [person](#i-5) who supervised or administered a [program](/usc/42/274l–1.md?p=4) with respect to the administration, dispensing, distribution, provision, or use of a [security countermeasure](#i-9) or a [qualified pandemic or epidemic product](#i-7), including a [person](#i-5) who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a [facility](/usc/42/11049.md?p=4) to administer or use a [covered countermeasure](#i-1) in accordance with a [declaration](/usc/42/247d–6e.md?p=e-4) under [subsection (b)](#b).
  - (7) **Qualified pandemic or epidemic product—** The term “qualified pandemic or epidemic product” means a [drug](/usc/42/282.md?p=j-1-A-vii) (as such term is defined in [section 201(g)(1)](/usc/42/201.md) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act ([21 U.S.C. 321(g)(1)](/usc/21/321.md?p=g-1)),[^2] [biological product](/usc/42/287a.md?p=a-1) (as such term is defined by [section 262(i) of this title](/usc/42/262.md?p=i)), or device (as such term is defined by [section 201(h)](/usc/42/201.md?p=h) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii) and Cosmetic Act ([21 U.S.C. 321(h)](/usc/21/321.md?p=h))[^2] that is—
    - (A)
      - (i) a product manufactured, used, designed, developed, [modified](/usc/42/7501.md?p=4), licensed, or procured—
        - (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or
        - (II) to limit the harm such pandemic or epidemic might otherwise [cause](/usc/42/9908.md?p=c-2);
      - (ii) a product manufactured, used, designed, developed, [modified](/usc/42/7501.md?p=4), licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in [clause (i)](#i-7-A-i); or
      - (iii) a product or technology intended to enhance the use or effect of a [drug](/usc/42/282.md?p=j-1-A-vii), [biological product](/usc/42/287a.md?p=a-1), or device described in clause [(i)](#i-7-A-i) or [(ii)](#i-7-A-ii); and
    - (B)
      - (i) approved or cleared under chapter V of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 351](/usc/21/351.md) et seq.] or licensed under [section 262 of this title](/usc/42/262.md);
      - (ii) the object of research for possible use as described by [subparagraph (A)](#i-7-A) and is the subject of an exemption under section [505(i)](/usc/42/505.md) or 520(g) of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 355(i)](/usc/21/355.md?p=i), 360j(g)]; or
      - (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, [Drug](/usc/42/282.md?p=j-1-A-vii), and Cosmetic Act [[21 U.S.C. 360bbb–3](/usc/21/360bbb–3.md), 360bbb–3a, 360bbb–3b].
  - (8) **Qualified person—** The term “qualified person”, when used with respect to the administration or use of a [covered countermeasure](#i-1), means—
    - (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the [State](/usc/42/300gg–91.md?p=d-14) in which the countermeasure was prescribed, administered, or dispensed; or
    - (B) a [person](#i-5) within a [category](/usc/42/1395w–4.md?p=j-1) of [persons](#i-5) so identified in a [declaration](/usc/42/247d–6e.md?p=e-4) by the [Secretary](/usc/42/201.md?p=c) under [subsection (b)](#b).
  - (9) **Security countermeasure—** The term “security countermeasure” has the meaning given such term in [section 247d–6b(c)(1)(B) of this title](/usc/42/247d–6b.md?p=c-1-B).
  - (10) **Serious physical injury—** The term “serious physical injury” means an injury that—
    - (A) is life threatening;
    - (B) results in permanent impairment of a body function or permanent damage to a body structure; or
    - (C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

# §247d–6e. Covered countermeasure process

- (a) **Establishment of Fund—** Upon the issuance by the [Secretary](/usc/42/201.md?p=c) of a [declaration](#e-4) under [section 247d–6d(b) of this title](/usc/42/247d–6d.md?p=b), there is hereby established in the Treasury an emergency [fund](/usc/42/12854.md?p=3) designated as the “[Covered Countermeasure](/usc/42/239.md?p=a-1) Process [Fund](/usc/42/12854.md?p=3)” for purposes of providing timely, uniform, and adequate compensation to [eligible individuals](#e-5) for [covered injuries](#e-3) directly caused by the administration or use of a [covered countermeasure](/usc/42/239.md?p=a-1) pursuant to such [declaration](#e-4), which [Fund](/usc/42/12854.md?p=3) shall consist of such amounts designated as emergency appropriations under [section 402](/usc/42/402.md) of H. Con. Res. 95 of the 109th Congress, this emergency designation shall remain in effect through October 1, 2006.
- (b) **Payment of compensation—**
  - (1) **In general—** If the [Secretary](/usc/42/201.md?p=c) issues a [declaration](#e-4) under [247d–6d(b)](/usc/42/247d–6d.md?p=b) of this title, the [Secretary](/usc/42/201.md?p=c) shall, after amounts have by law been provided for the [Fund](/usc/42/12854.md?p=3) under [subsection (a)](#a), provide compensation to an [eligible individual](#e-5) for a [covered injury](#e-3) directly caused by the administration or use of a [covered countermeasure](/usc/42/239.md?p=a-1) pursuant to such [declaration](#e-4).
  - (2) **Elements of compensation—** The compensation that shall be provided pursuant to [paragraph (1)](#b-1) shall have the same elements, and be in the same amount, as is prescribed by sections [239c](/usc/42/239c.md), [239d](/usc/42/239d.md), and [239e](/usc/42/239e.md) of this title in the case of certain individuals injured as a result of administration of certain countermeasures against smallpox, except that [section 239e(a)(2)(B) of this title](/usc/42/239e.md?p=a-2-B) shall not apply.
  - (3) **Rule of construction—** Neither reasonable and necessary medical benefits nor lifetime total benefits for lost employment [income](/usc/42/292s.md?p=c-4) due to permanent and total disability shall be limited by [section 239e of this title](/usc/42/239e.md).
  - (4) **Determination of eligibility and compensation—** Except as provided in this section, the procedures for determining, and for reviewing a determination of, whether an individual is an [eligible individual](#e-5), whether such individual has sustained a [covered injury](#e-3), whether compensation may be available under this section, and the amount of such compensation shall be those stated in [section 239a of this title](/usc/42/239a.md) (other than in [subsection (d)(2)](/usc/42/239a.md?p=d-2) of such section), in [regulations](/usc/42/201.md?p=d) issued pursuant to that section, and in such additional or alternate [regulations](/usc/42/201.md?p=d) as the [Secretary](/usc/42/201.md?p=c) may promulgate for purposes of this section. In making determinations under this section, other than those described in [paragraph (5)(A)](#b-5-A) as to the direct causation of a [covered injury](#e-3), the [Secretary](/usc/42/201.md?p=c) may only make such determination based on compelling, reliable, valid, medical and scientific evidence.
  - (5) **Covered countermeasure injury table—**
    - (A) **In general—** The [Secretary](/usc/42/201.md?p=c) shall by regulation establish a table identifying [covered injuries](#e-3) that shall be presumed to be directly caused by the administration or use of a [covered countermeasure](/usc/42/239.md?p=a-1) and the time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in order for such presumption to apply. The [Secretary](/usc/42/201.md?p=c) may only identify such [covered injuries](#e-3), for purpose of inclusion on the table, where the [Secretary](/usc/42/201.md?p=c) determines, based on compelling, reliable, valid, medical and scientific evidence that administration or use of the [covered countermeasure](/usc/42/239.md?p=a-1) directly caused such [covered injury](#e-3).
    - (B) **Amendments—** The provisions of [section 239b of this title](/usc/42/239b.md) (other than a provision of [subsection (a)(2)](/usc/42/239b.md?p=a-2) of such section that relates to accidental vaccinia inoculation) shall apply to the table established under this section.
    - (C) **Judicial review—** No court of the [United States](/usc/42/403.md?p=k), or of any [State](/usc/42/300gg–91.md?p=d-14), shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the [Secretary](/usc/42/201.md?p=c) under this paragraph.
  - (6) **Meanings of terms—** In applying sections [239a](/usc/42/239a.md), [239b](/usc/42/239b.md), [239c](/usc/42/239c.md), [239d](/usc/42/239d.md), and [239e](/usc/42/239e.md) of this title for purposes of this section—
    - (A) the terms “vaccine” and “smallpox vaccine” shall be deemed to mean a [covered countermeasure](/usc/42/239.md?p=a-1);
    - (B) the terms “smallpox vaccine injury table” and “table established under [section 239b of this title](/usc/42/239b.md)” shall be deemed to refer to the table established under [paragraph (4)](#b-4); and
    - (C) other terms used in those sections shall have the meanings given to such terms by this section.
- (c) **Voluntary program—** The [Secretary](/usc/42/201.md?p=c) shall ensure that a [State](/usc/42/300gg–91.md?p=d-14), local, or Department of Health and Human [Services](/usc/42/201.md?p=a) plan to administer or use a [covered countermeasure](/usc/42/239.md?p=a-1) is consistent with any [declaration](#e-4) under [247d–6d](/usc/42/247d–6d.md) of this title and any applicable guidelines of the Centers for Disease Control and Prevention and that potential [participants](/usc/42/300gg–91.md?p=d-11) are educated with respect to contraindications, the voluntary nature of the [program](/usc/42/274l–1.md?p=4), and the availability of potential benefits and compensation under this part.
- (d) **Exhaustion; exclusivity; election—**
  - (1) **Exhaustion—** Subject to [paragraph (5)](#d-5), a [covered individual](#e-2) may not bring a civil action under [section 247d–6d(d) of this title](/usc/42/247d–6d.md?p=d) against a covered [person](/usc/42/1320a–7k.md?p=d-4-C-i) (as such term is defined in [section 247d–6d(i)(2) of this title](/usc/42/247d–6d.md?p=i-2)) unless such individual has exhausted such remedies as are available under [subsection (a)](#a), except that if amounts have not by law been provided for the [Fund](/usc/42/12854.md?p=3) under [subsection (a)](#a), or if the [Secretary](/usc/42/201.md?p=c) fails to make a final determination on a request for benefits or compensation filed in accordance with the requirements of this section within 240 days after such request was filed, the individual may seek any remedy that may be available under [section 247d–6d(d) of this title](/usc/42/247d–6d.md?p=d).
  - (2) **Tolling of statute of limitations—** The time limit for filing a civil action under [section 247d–6d(d) of this title](/usc/42/247d–6d.md?p=d) for an injury or death shall be tolled during the pendency of a [claim](/usc/42/1320a–7a.md?p=i-2) for compensation under [subsection (a)](#a).
  - (3) **Rule of construction—** This section shall not be construed as superseding or otherwise affecting the application of a requirement, under [chapter 171](/usc/28/chptVI-ch171.md) of title 28, to exhaust administrative remedies.
  - (4) **Exclusivity—** The remedy provided by [subsection (a)](#a) shall be exclusive of any other civil action or proceeding for any [claim](/usc/42/1320a–7a.md?p=i-2) or suit this section encompasses, except for a proceeding under [section 247d–6d of this title](/usc/42/247d–6d.md).
  - (5) **Election—** If under [subsection (a)](#a) the [Secretary](/usc/42/201.md?p=c) determines that a [covered individual](#e-2) qualifies for compensation, the individual has an election to accept the compensation or to bring an action under [section 247d–6d(d) of this title](/usc/42/247d–6d.md?p=d). If such individual elects to accept the compensation, the individual may not bring such an action.
- (e) **Definitions—** For purposes of this section, the following terms shall have the following meanings:
  - (1) **Covered countermeasure—** The term “[covered countermeasure](/usc/42/239.md?p=a-1)” has the meaning given such term in [section 247d–6d of this title](/usc/42/247d–6d.md).
  - (2) **Covered individual—** The term “covered individual”, with respect to administration or use of a [covered countermeasure](/usc/42/239.md?p=a-1) pursuant to a [declaration](#e-4), means an individual—
    - (A) who is in a population specified in such [declaration](#e-4), and with respect to whom the administration or use of the [covered countermeasure](/usc/42/239.md?p=a-1) satisfies the other specifications of such [declaration](#e-4); or
    - (B) who uses the [covered countermeasure](/usc/42/239.md?p=a-1), or to whom the [covered countermeasure](/usc/42/239.md?p=a-1) is administered, in a good faith belief that the individual is in the [category](/usc/42/1395w–4.md?p=j-1) described by [subparagraph (A)](#e-2-A).
  - (3) **Covered injury—** The term “covered injury” means serious physical injury or death.
  - (4) **Declaration—** The term “declaration” means a declaration under [section 247d–6d(b) of this title](/usc/42/247d–6d.md?p=b).
  - (5) **Eligible individual—** The term “eligible individual” means an individual who is determined, in accordance with [subsection (b)](#b), to be a [covered individual](#e-2) who sustains a [covered injury](#e-3).

# §247d–6f. Provision of medical countermeasures to Indian programs and facilities


In the event that the [Secretary](/usc/42/201.md?p=c) deploys the contents of the Strategic National Stockpile under [section 247d–6b(a) of this title](/usc/42/247d–6b.md?p=a), or otherwise distributes medical countermeasures to [States](/usc/42/300gg–91.md?p=d-14) to respond to a public health emergency declared by the [Secretary](/usc/42/201.md?p=c) under [section 247d of this title](/usc/42/247d.md), the [Secretary](/usc/42/201.md?p=c) shall, in consultation with the applicable [States](/usc/42/300gg–91.md?p=d-14), make such contents or countermeasures directly available to [Indian Tribes](/usc/42/300f.md?p=14) and [Tribal organizations](/usc/42/629a.md?p=a-6) (as such terms are defined in [section 5304 of title 25](/usc/25/5304.md)), which may include through health [programs](/usc/42/274l–1.md?p=4) or [facilities](/usc/42/11049.md?p=4) operated by the [Indian](/usc/42/6862.md?p=6) Health [Service](/usc/42/201.md?p=a), that are affected by such public health emergency.


# [§247d–7. Repealed. Pub. L. 117–328, div. FF, title II, § 2231(b), Dec. 29, 2022, 136 Stat. 5753 — repealed]



# §247d–7a. Grants regarding training and education of certain health professionals

- (a) **In general—** The [Secretary](/usc/42/201.md?p=c) may make awards of grants and cooperative [agreements](/usc/42/1320b–8.md?p=a-3-A) to appropriate public and nonprofit private health or educational entities, including health professions [schools](/usc/42/6372.md?p=1) and [programs](/usc/42/274l–1.md?p=4) as defined in [section 295p of this title](/usc/42/295p.md), for the purpose of providing low-interest loans, partial scholarships, partial [fellowships](/usc/42/1862n–1.md?p=i-3), revolving loan [funds](/usc/42/12854.md?p=3), or other [cost-sharing](/usc/42/18022.md?p=c-3-A) forms of assistance for the education and [training](/usc/42/285e–2.md?p=b-2) of individuals in any [category](/usc/42/1395w–4.md?p=j-1) of health professions for which there is a shortage that the [Secretary](/usc/42/201.md?p=c) determines should be alleviated in order to prepare for or respond effectively to bioterrorism and other public health emergencies.
- (b) **Authority regarding non-Federal contributions—** The [Secretary](/usc/42/201.md?p=c) may require as a condition of an award under [subsection (a)](#a) that a grantee under such subsection provide non-Federal contributions toward the purpose described in such subsection.
- (c) **Authorization of appropriations—** For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.

# §247d–7b. Emergency system for advance registration of volunteer health professional

- (a) **In general—** Not later than 12 months after December 19, 2006, the [Secretary](/usc/42/201.md?p=c) shall link existing [State](/usc/42/300gg–91.md?p=d-14) verification systems to maintain a [single](/usc/42/2304.md?p=m) national interoperable network of systems, each system being maintained by a [State](/usc/42/300gg–91.md?p=d-14) or group of [States](/usc/42/300gg–91.md?p=d-14), for the purpose of verifying the credentials and licenses of health care professionals who volunteer to provide health [services](/usc/42/201.md?p=a) during a public health emergency. Such health care professionals may include members of the National [Disaster](/usc/42/5204.md?p=2) Medical System, members of the Medical Reserve [Corps](/usc/42/12626.md?p=3), and individual health care professionals.
- (b) **Requirements—** The interoperable network of systems established under [subsection (a)](#a) (referred to in this section as the “verification network”) shall include—
  - (1) with respect to each volunteer health professional included in the verification network—
    - (A) information necessary for the rapid identification of, and communication with, such professionals; and
    - (B) the credentials, certifications, licenses, and relevant [training](/usc/42/285e–2.md?p=b-2) of such individuals; and
  - (2) the name of each member of the Medical Reserve [Corps](/usc/42/12626.md?p=3), the National [Disaster](/usc/42/5204.md?p=2) Medical System, and any other relevant federally-sponsored or administered [programs](/usc/42/274l–1.md?p=4) determined necessary by the [Secretary](/usc/42/201.md?p=c).
- (c) **Other assistance—** The [Secretary](/usc/42/201.md?p=c) may make grants and provide technical assistance to [States](/usc/42/300gg–91.md?p=d-14) and other public or nonprofit [private entities](/usc/42/12181.md?p=6) for activities relating to the verification network developed under [subsection (a)](#a).
- (d) **Accessibility—** The [Secretary](/usc/42/201.md?p=c) shall ensure that the verification network is electronically accessible by [State](/usc/42/300gg–91.md?p=d-14), local, and tribal health departments and can be linked with the identification cards under [section 300hh–15 of this title](/usc/42/300hh–15.md).
- (e) **Confidentiality—** The [Secretary](/usc/42/201.md?p=c) shall establish and require the application of and compliance with measures to ensure the effective security of, integrity of, and access to the data included in the verification network.
- (f) **Coordination—** The [Secretary](/usc/42/201.md?p=c) shall coordinate with the [Secretary](/usc/42/201.md?p=c) of Veterans Affairs and the [Secretary](/usc/42/201.md?p=c) of Homeland Security to assess the feasibility of integrating the verification network under this section with the VetPro system of the Department of Veterans Affairs and the National Emergency Responder Credentialing System of the Department of Homeland Security. The [Secretary](/usc/42/201.md?p=c) shall, if feasible, integrate the verification network under this section with such VetPro system and the National Emergency Responder Credentialing System.
- (g) **Updating of information—** The [States](/usc/42/300gg–91.md?p=d-14) that are [participants](/usc/42/300gg–91.md?p=d-11) in the verification network shall, on at least a quarterly basis, work with the [Director](/usc/42/5061.md?p=1) to provide for the updating of the information contained in the verification network.
- (h) **Clarification—** Inclusion of a health professional in the verification network shall not constitute appointment of such individual as a Federal [employee](/usc/42/300gg–91.md?p=d-5) for any purpose, either under [section 300hh–11(c) of this title](/usc/42/300hh–11.md?p=c) or otherwise. Such appointment may only be made under section [300hh–11](/usc/42/300hh–11.md) or [300hh–15](/usc/42/300hh–15.md) of this title.
- (i) **Health care provider licenses—** The [Secretary](/usc/42/201.md?p=c) shall encourage [States](/usc/42/300gg–91.md?p=d-14) to establish and implement mechanisms to waive the application of licensing requirements applicable to health professionals, who are seeking to provide medical [services](/usc/42/201.md?p=a) (within their scope of practice), during a national, [State](/usc/42/300gg–91.md?p=d-14), local, or tribal public health emergency upon verification that such health professionals are licensed and in good standing in another [State](/usc/42/300gg–91.md?p=d-14) and have not been disciplined by any [State](/usc/42/300gg–91.md?p=d-14) health licensing or disciplinary [board](/usc/42/10261.md?p=2). In order to inform the development of such mechanisms by [States](/usc/42/300gg–91.md?p=d-14), the [Secretary](/usc/42/201.md?p=c) shall make available information and material provided by [States](/usc/42/300gg–91.md?p=d-14) that have developed mechanisms to waive the application of licensing requirements to applicable health professionals seeking to provide medical [services](/usc/42/201.md?p=a) during a public health emergency. Such information shall be made publicly available in a manner that does not compromise national security.
- (j) **Rule of construction—** This section may not be construed as authorizing the [Secretary](/usc/42/201.md?p=c) to issue requirements regarding the provision by the [States](/usc/42/300gg–91.md?p=d-14) of credentials, licenses, accreditations, or [hospital](/usc/42/1395dd.md?p=e-5) privileges.
- (k) **Authorization of appropriations—** For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2019 through 2023.