---
kind: "section"
citation: "42 U.S.C. § 247d–6a"
title: "42"
title_heading: "The Public Health and Welfare"
number: "247d–6a"
heading: "Authority for use of certain procedures regarding qualified countermeasure research and development activities"
release: "119-102"
url: "https://uscodex.org/usc/42/247d-6a"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter II — General Powers and Duties"
  - "Part B — Federal-State Cooperation"
---

# §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 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.

## Source credit

(July 1, 1944, ch. 373, title III, § 319F–1, as added Pub. L. 108–276, § 2(a), July 21, 2004, 118 Stat. 835; amended Pub. L. 109–417, title IV, § 403(a), Dec. 19, 2006, 120 Stat. 2874; Pub. L. 113–5, title IV, § 402(g)(1), Mar. 13, 2013, 127 Stat. 195; Pub. L. 116–22, title VII, § 705(a)(1), June 24, 2019, 133 Stat. 964.)

## Notes

### Editorial Notes

### References in Text

The Project BioShield Act of 2004, referred to in subsec. (b)(1)(D), is Pub. L. 108–276, July 21, 2004, 118 Stat. 835. For complete classification of this Act to the Code, see Short Title of 2004 Amendments note set out under section 201 of this title and Tables.

The Federal Tort Claims Act, referred to in subsec. (d)(2), is title IV of act Aug. 2, 1946, ch. 753, 60 Stat. 842, which was classified principally to chapter 20 (§§ 921, 922, 931–934, 941–946) of former Title 28, Judicial Code and Judiciary. Title IV of act Aug. 2, 1946, was substantially repealed and reenacted as sections 1346(b) and 2671 et seq. of Title 28, Judiciary and Judicial Procedure, by act June 25, 1948, ch. 646, 62 Stat. 992, the first section of which enacted Title 28. The Federal Tort Claims Act is also commonly used to refer to chapter 171 of Title 28, Judiciary and Judicial Procedure. For complete classification of title IV to the Code, see Tables. For distribution of former sections of Title 28 into the revised Title 28, see Table at the beginning of Title 28.

### Codification

In subsec. (b)(1)(A), “section 134 of title 41” substituted for “section 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11))” and “section 3101(b)(1)(A) of title 41” substituted for “section 302A(a) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 252a(a))” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

In subsec. (b)(1)(A)(i), “section 3305(a)(1) of title 41” substituted for “section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A))” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

In subsec. (b)(1)(A)(ii), “section 3101(b)(1)(B) of title 41” substituted for “section 302A(b) of such Act (41 U.S.C. 252a(b))” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

In subsec. (b)(1)(B)(ii), “Section 8703(a) of title 41” substituted for “Subsections (a) and (b) of section 7 of the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b))” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

In subsec. (b)(1)(B)(iii), “Section 4706 of title 41” substituted for “Section 304C of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254d)” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

In subsec. (b)(1)(B)(v), “Section 3901 of title 41” substituted for “Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 254(a))” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

In subsec. (b)(2)(A), “section 3304(a)(1) of title 41” substituted for “section 303(c)(1) of title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(1))” and “such section 3304(a)(1)” substituted for “such section 303(c)(1)” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

In subsec. (b)(2)(C), “such section 3304(a)(1)” substituted for “such section 303(c)(1)” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

In subsec. (b)(3)(A), “subsections (a), (d), and (e) of section 1902 of title 41” substituted for “subsections (c), (d), and (f) of section 32 of the Office of Federal Procurement Policy Act (41 U.S.C. 428)” on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

### Amendments

2019—Subsec. (a)(1), (5). Pub. L. 116–22 substituted “section 247d–6(e) of this title” for “section 247d–6(h) of this title”.

2013—Subsec. (a)(2)(A). Pub. L. 113–5 struck out “to” before dash at end of introductory provisions, inserted “to” before “diagnose” in cls. (i) and (ii), and added cl. (iii).

2006—Subsec. (a)(2). Pub. L. 109–417 added par. (2) and struck out heading and text of former par. (2). Text read as follows: “For purposes of this section, the term ‘qualified countermeasure’ means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21) that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to—

“(A) treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or

“(B) treat, identify, or prevent harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in subparagraph (A).”

### Statutory Notes and Related Subsidiaries

### Rule of Construction

Pub. L. 108–276, § 2(e), July 21, 2004, 118 Stat. 842, provided that: “Nothing in this section [enacting this section and amending sections 247d–6, 287a–2, and 300aa–6 of this title] has any legal effect on sections 302(2), 302(4), 304(a), or 304(b) of the Homeland Security Act of 2002 [6 U.S.C. 182(2), (4), 184(a), (b)].”

### Collaboration and Coordination

Pub. L. 109–417, title IV, § 405, Dec. 19, 2006, 120 Stat. 2875, as amended by Pub. L. 113–5, § 402(e)(1), Mar. 13, 2013, 127 Stat. 195; Pub. L. 116–22, title VII, § 701(e)(1)(A), (B), June 24, 2019, 133 Stat. 961, which authorized the Secretary of Health and Human Services, in coordination with the Attorney General and the Secretary of Homeland Security, to conduct meetings with persons engaged in the development of a security countermeasure, a qualified countermeasure, or a qualified pandemic or epidemic product, in such a manner to ensure that no national security, confidential commercial, or proprietary information is disclosed outside the meeting, and exempted from antitrust laws conduct pursuant to a written agreement executed at such a meeting approved by the Attorney General and the Chairman of the Federal Trade Commission, was redesignated as section 319L–1 of act July 1, 1944, ch. 373, known as the Public Health Service Act, by Pub. L. 116–22, title VII, § 701(e)(1)(C), (D), June 24, 2019, 133 Stat. 961, and editorially reclassified as section 247d–7f of this title.

### Outreach

Pub. L. 108–276, § 6, July 21, 2004, 118 Stat. 862, provided that: “The Secretary of Health and Human Services shall develop outreach measures to ensure to the extent practicable that diverse institutions, including Historically Black Colleges and Universities and those serving large proportions of Black or African Americans, American Indians, Appalachian Americans, Alaska Natives, Asians, Native Hawaiians, other Pacific Islanders, Hispanics or Latinos, or other underrepresented populations, are meaningfully aware of available research and development grants, contracts, cooperative agreements, and procurements conducted under sections 2 and 3 of this Act [enacting this section and section 320 of Title 6, Domestic Security, amending sections 247d–6, 247d–6b, 287a–2, and 300aa–6 of this title and sections 312 and 313 of Title 6, renumbering section 300hh–12 of this title as section 247d–6b of this title, and enacting provisions set out as notes under this section and section 247d–6b of this title].”

### Recommendation for Export Controls on Certain Biomedical Countermeasures

Pub. L. 108–276, § 7, July 21, 2004, 118 Stat. 863, provided that: “Upon the award of any grant, contract, or cooperative agreement under section 2 or 3 of this Act [enacting this section and section 320 of Title 6, Domestic Security, amending sections 247d–6, 247d–6b, 287a–2, and 300aa–6 of this title and sections 312 and 313 of Title 6, renumbering section 300hh–12 of this title as section 247d–6b of this title, and enacting provisions set out as notes under this section and section 247d–6b of this title] for the research, development, or procurement of a qualified countermeasure or a security countermeasure (as those terms are defined in this Act [see Short Title of 2004 Amendments note set out under section 201 of this title]), the Secretary of Health and Human Services shall, in consultation with the heads of other appropriate Federal agencies, determine whether the countermeasure involved in such grant, contract, or cooperative agreement is subject to existing export-related controls and, if not, may make a recommendation to the appropriate Federal agency or agencies that such countermeasure should be included on the list of controlled items subject to such controls.”

### Ensuring Coordination, Cooperation and the Elimination of Unnecessary Duplication in Programs Designed To Protect the Homeland From Biological, Chemical, Radiological, and Nuclear Agents

Pub. L. 108–276, § 8, July 21, 2004, 118 Stat. 863, provided that: Ensuring Coordination of Programs.—The Secretary of Health and Human Services, the Secretary of Homeland Security, and the Secretary of Defense shall ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs to identify potential domestic threats from biological, chemical, radiological or nuclear agents, detect domestic incidents involving such agents, analyze such incidents, and develop necessary countermeasures. The aforementioned Secretaries shall further ensure that information and technology possessed by the Departments relevant to these activities are shared with the other Departments. Designation of Agency Coordination Officer.—The Secretary of Health and Human Services, the Secretary of Homeland Security, and the Secretary of Defense shall each designate an officer or employee of their respective Departments who shall coordinate, through regular meetings and communications, with the other aforementioned Departments such programs and activities carried out by their Departments.”