---
kind: "section"
citation: "21 U.S.C. § 360bbb–4"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–4"
heading: "Countermeasure development, review, and technical assistance"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-4"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–4. Countermeasure development, review, and technical assistance

- (a) **Definitions—** In this section—
  - (1) the term “countermeasure” means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic [product](/usc/21/360eee.md?p=13);
  - (2) the term “qualified countermeasure” has the meaning given such term in [section 247d–6a of title 42](/usc/42/247d–6a.md);
  - (3) the term “security countermeasure” has the meaning given such term in [section 247d–6b of title 42](/usc/42/247d–6b.md); and
  - (4) the term “qualified pandemic or epidemic [product](/usc/21/360eee.md?p=13)” means a [product](/usc/21/360eee.md?p=13) that meets the definition given such term in [section 247d–6d of title 42](/usc/42/247d–6d.md) and—
    - (A) that has been identified by the [Department](/usc/21/321.md?p=c) of Health and Human Services or the [Department](/usc/21/321.md?p=c) of Defense as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including pandemic influenza; or
    - (B) is included under this paragraph pursuant to a determination by the [Secretary](/usc/21/321.md?p=d).
- (b) **General duties—** In order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic [products](/usc/21/360eee.md?p=13), the [Secretary](/usc/21/321.md?p=d), in consultation with the Assistant [Secretary](/usc/21/321.md?p=d) for Preparedness and Response, shall—
  - (1) ensure the appropriate involvement of [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration personnel in interagency activities related to countermeasure advanced research and development, consistent with sections [247d–6](/usc/42/247d–6.md), [247d–6a](/usc/42/247d–6a.md), [247d–6b](/usc/42/247d–6b.md), [247d–6d](/usc/42/247d–6d.md), [247d–7e](/usc/42/247d–7e.md), and [300hh–10](/usc/42/300hh–10.md) of title 42;
  - (2) ensure the appropriate involvement and consultation of [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration personnel in any flexible manufacturing activities carried out under [section 247d–7e of title 42](/usc/42/247d–7e.md), including with respect to meeting regulatory requirements set forth in this chapter;
  - (3) promote countermeasure expertise within the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration by—
    - (A) ensuring that [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration personnel involved in reviewing countermeasures for approval, licensure, or clearance are informed by the Assistant [Secretary](/usc/21/321.md?p=d) for Preparedness and Response on the material threat assessment conducted under [section 247d–6b of title 42](/usc/42/247d–6b.md) for the agent or agents for which the countermeasure under review is intended;
    - (B) training [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration personnel regarding review of countermeasures for approval, licensure, or clearance;
    - (C) holding public meetings at least twice annually to encourage the exchange of scientific ideas; and
    - (D) establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures;
  - (4) maintain teams, composed of [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration personnel with expertise on countermeasures, including specific countermeasures, populations with special clinical needs (including children and pregnant women that may use countermeasures, as applicable and appropriate), classes or groups of countermeasures, or other countermeasure-related technologies and capabilities, that shall—
    - (A) consult with countermeasure experts, including countermeasure [sponsors](/usc/21/360fff.md?p=8) and applicants, to identify and help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops or public meetings; and
    - (B) improve and advance the science relating to the development of new tools, standards, and approaches to assessing and evaluating countermeasures—
      - (i) in order to inform the process for countermeasure approval, clearance, and licensure; and
      - (ii) with respect to the development of countermeasures for populations with special clinical needs, including children and pregnant women, in order to meet the needs of such populations, as necessary and appropriate; and
  - (5) establish within the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration a team of experts on manufacturing and regulatory activities (including compliance with current Good Manufacturing Practice) to provide both off-site and on-site technical assistance to the [manufacturers](/usc/21/360hh.md?p=3) of qualified countermeasures (as defined in [section 247d–6a of title 42](/usc/42/247d–6a.md)), security countermeasures (as defined in [section 247d–6b of title 42](/usc/42/247d–6b.md)), or vaccines, at the request of such a [manufacturer](/usc/21/360hh.md?p=3) and at the discretion of the [Secretary](/usc/21/321.md?p=d), if the [Secretary](/usc/21/321.md?p=d) determines that a shortage or potential shortage may occur in the United States in the supply of such vaccines or countermeasures and that the provision of such assistance would be beneficial in helping alleviate or avert such shortage.
- (c) **Final guidance on development of animal models—**
  - (1) **In general—** Not later than 1 year after March 13, 2013, the [Secretary](/usc/21/321.md?p=d) shall provide final guidance to industry regarding the development of animal models to support approval, clearance, or licensure of countermeasures referred to in [subsection (a)](#a) when human efficacy studies are not ethical or feasible.
  - (2) **Authority to extend deadline—** The [Secretary](/usc/21/321.md?p=d) may extend the deadline for providing final guidance under [paragraph (1)](#c-1) by not more than 6 months upon submission by the [Secretary](/usc/21/321.md?p=d) of a report on the status of such guidance to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.
- (d) **Development and animal modeling procedures—**
  - (1) **Availability of animal model meetings—** To facilitate the timely development of animal models and support the development, stockpiling, licensure, approval, and clearance of countermeasures, the [Secretary](/usc/21/321.md?p=d) shall, not later than 180 days after March 13, 2013, establish a procedure by which a [sponsor](/usc/21/360fff.md?p=8) or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational [new drug](/usc/21/321.md?p=p) application or investigational [device](/usc/21/321.md?p=h-1) exemption, may request and receive—
    - (A) a meeting to discuss proposed animal model development activities; and
    - (B) a meeting prior to initiating pivotal animal studies.
  - (2) **Pediatric models—** To facilitate the development and selection of animal models that could translate to pediatric studies, any meeting conducted under [paragraph (1)](#d-1) shall include discussion of animal models for pediatric populations, as appropriate.
- (e) **Review and approval of countermeasures—**
  - (1) **Material threat—** When evaluating an application or submission for approval, licensure, or clearance of a countermeasure, the [Secretary](/usc/21/321.md?p=d) shall take into account the material threat posed by the chemical, biological, radiological, or nuclear agent or agents identified under [section 247d–6b of title 42](/usc/42/247d–6b.md) for which the countermeasure under review is intended.
  - (2) **Review expertise—** When practicable and appropriate, teams of [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration personnel reviewing applications or submissions described under [paragraph (1)](#e-1) shall include a reviewer with sufficient training or experience with countermeasures pursuant to the protocols established under [subsection (b)(3)(D)](#b-3-D).
- (f) **Regulatory management plan—**
  - (1) **Definition—** In this subsection, the term “eligible countermeasure” means—
    - (A) a security countermeasure with respect to which the [Secretary](/usc/21/321.md?p=d) has entered into a procurement contract under [section 247d–6b(c) of title 42](/usc/42/247d–6b.md?p=c); or
    - (B) a countermeasure with respect to which the Biomedical Advanced Research and Development Authority has provided funding under [section 247d–7e of title 42](/usc/42/247d–7e.md) for advanced research and development.
  - (2) **Regulatory management plan process—** The [Secretary](/usc/21/321.md?p=d), in consultation with the Assistant [Secretary](/usc/21/321.md?p=d) for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority, shall establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans in accordance with this subsection.
  - (3) **Publication—** The [Secretary](/usc/21/321.md?p=d) shall make available on the internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration information regarding regulatory management plans, including—
    - (A) the process by which an applicant may submit a request for a regulatory management plan;
    - (B) the timeframe by which the [Secretary](/usc/21/321.md?p=d) is required to respond to such request;
    - (C) the information required for the submission of such request;
    - (D) a description of the types of development milestones and performance targets that could be discussed and included in such plans; and
    - (E) contact information for beginning the regulatory management plan process.
  - (4) **Submission of request and proposed plan by sponsor or applicant—**
    - (A) **In general—** A [sponsor](/usc/21/360fff.md?p=8) or applicant of an eligible countermeasure may initiate the process described under [paragraph (2)](#f-2) upon submission of a written request to the [Secretary](/usc/21/321.md?p=d). Such request shall include a proposed regulatory management plan.
    - (B) **Timing of submission—** A [sponsor](/usc/21/360fff.md?p=8) or applicant may submit a written request under [subparagraph (A)](#f-4-A) after the eligible countermeasure has an investigational [new drug](/usc/21/321.md?p=p) or investigational [device](/usc/21/321.md?p=h-1) exemption in effect.
    - (C) **Response by Secretary—** The [Secretary](/usc/21/321.md?p=d) shall direct the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, upon submission of a written request by a [sponsor](/usc/21/360fff.md?p=8) or applicant under [subparagraph (A)](#f-4-A), to work with the [sponsor](/usc/21/360fff.md?p=8) or applicant to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the [Secretary](/usc/21/321.md?p=d) determines that no plan can be agreed upon, the [Secretary](/usc/21/321.md?p=d) shall provide to the [sponsor](/usc/21/360fff.md?p=8) or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached.
  - (5) **Plan—** The content of a regulatory management plan agreed to by the [Secretary](/usc/21/321.md?p=d) and a [sponsor](/usc/21/360fff.md?p=8) or applicant shall include—
    - (A) an agreement between the [Secretary](/usc/21/321.md?p=d) and the [sponsor](/usc/21/360fff.md?p=8) or applicant regarding developmental milestones that will trigger responses by the [Secretary](/usc/21/321.md?p=d) as described in [subparagraph (B)](#f-5-B);
    - (B) performance targets and goals for timely and appropriate responses by the [Secretary](/usc/21/321.md?p=d) to the triggers described under [subparagraph (A)](#f-5-A), including meetings between the [Secretary](/usc/21/321.md?p=d) and the [sponsor](/usc/21/360fff.md?p=8) or applicant, written feedback, decisions by the [Secretary](/usc/21/321.md?p=d), and other activities carried out as part of the development and review process; and
    - (C) an agreement on how the plan shall be modified, if needed.
  - (6) **Milestones and performance targets—** The developmental milestones described in [paragraph (5)(A)](#f-5-A) and the performance targets and goals described in [paragraph (5)(B)](#f-5-B) shall include—
    - (A) feedback from the [Secretary](/usc/21/321.md?p=d) regarding the data required to support the approval, clearance, or licensure of the eligible countermeasure involved;
    - (B) feedback from the [Secretary](/usc/21/321.md?p=d) regarding the data necessary to inform any authorization under [section 360bbb–3 of this title](/usc/21/360bbb–3.md);
    - (C) feedback from the [Secretary](/usc/21/321.md?p=d) regarding the data necessary to support the positioning and delivery of the eligible countermeasure, including to the Strategic National Stockpile;
    - (D) feedback from the [Secretary](/usc/21/321.md?p=d) regarding the data necessary to support the submission of protocols for review under [section 355(b)(5)(B) of this title](/usc/21/355.md?p=b-5-B);
    - (E) feedback from the [Secretary](/usc/21/321.md?p=d) regarding any gaps in scientific knowledge that will need resolution prior to approval, licensure, or clearance of the eligible countermeasure and plans for conducting the necessary scientific research;
    - (F) identification of the population for which the countermeasure [sponsor](/usc/21/360fff.md?p=8) or applicant seeks approval, licensure, or clearance and the population for which desired [labeling](/usc/21/321.md?p=m) would not be appropriate, if known; and
    - (G) as necessary and appropriate, and to the extent practicable, a plan for demonstrating safety and effectiveness in pediatric populations, and for developing pediatric dosing, formulation, and administration with respect to the eligible countermeasure, provided that such plan would not delay authorization under [section 360bbb–3 of this title](/usc/21/360bbb–3.md), approval, licensure, or clearance for adults.
  - (7) **Prioritization—**
    - (A) **Plans for security countermeasures—** The [Secretary](/usc/21/321.md?p=d) shall establish regulatory management plans for all security countermeasures for which a request is submitted under [paragraph (4)(A)](#f-4-A).
    - (B) **Plans for other eligible countermeasures—** The [Secretary](/usc/21/321.md?p=d) shall determine whether resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures. If resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures, and if resources are not available to establish regulatory management plans for all eligible countermeasures for which requests have been submitted, the Director of the Biomedical Advanced Research and Development Authority, in consultation with the [Commissioner](/usc/21/321.md?p=ee), shall prioritize which eligible countermeasures may receive regulatory management plans.
- (g) **Annual report—** Not later than 180 days after March 13, 2013, and annually thereafter, the [Secretary](/usc/21/321.md?p=d) shall make publicly available on the Web site of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration a report that details the countermeasure development and review activities of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, including—
  - (1) with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures—
    - (A) the identification of the priorities of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and the progress made on such priorities; and
    - (B) the identification of scientific gaps that impede the development, approval, licensure, or clearance of countermeasures for populations with special clinical needs, including children and pregnant women, and the progress made on resolving these challenges;
  - (2) with respect to countermeasures for which a regulatory management plan has been agreed upon under [subsection (f)](#f), the extent to which the performance targets and goals set forth in [subsection (f)(4)(B)](#f-4-B) and the regulatory management plan have been met, including, for each such countermeasure—
    - (A) whether the regulatory management plan was completed within the required timeframe, and the length of time taken to complete such plan;
    - (B) whether the [Secretary](/usc/21/321.md?p=d) adhered to the timely and appropriate response times set forth in such plan; and
    - (C) explanations for any failure to meet such performance targets and goals;
  - (3) the number of regulatory teams established pursuant to [subsection (b)(4)](#b-4), the number of [products](/usc/21/360eee.md?p=13), classes of [products](/usc/21/360eee.md?p=13), or technologies assigned to each such team, and the number of, type of, and any progress made as a result of consultations carried out under [subsection (b)(4)(A)](#b-4-A);
  - (4) an estimate of resources obligated to countermeasure development and regulatory assessment, including—
    - (A) Center-specific objectives and accomplishments; and
    - (B) the number of full-time equivalent employees of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration who directly support the review of countermeasures;
  - (5) the number of countermeasure applications and submissions submitted, the number of countermeasures approved, [licensed](/usc/21/360eee.md?p=9), or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to [section 360bbb–3 of this title](/usc/21/360bbb–3.md);
  - (6) the number of written requests for a regulatory management plan submitted under [subsection (f)(3)(A)](#f-3-A), the number of regulatory management plans developed, and the number of such plans developed for security countermeasures; and
  - (7) the number, type, and frequency of meetings between the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and—
    - (A) [sponsors](/usc/21/360fff.md?p=8) of a countermeasure as defined in [subsection (a)](#a); or
    - (B) another agency engaged in development or management of portfolios for such countermeasures, including the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the National Institutes of Health, and the appropriate agencies of the [Department](/usc/21/321.md?p=c) of Defense.
- (h) **Accelerating countermeasure development and review during an emergency—**
  - (1) **Acceleration of countermeasure development and review—** The [Secretary](/usc/21/321.md?p=d) may, at the request of the [sponsor](/usc/21/360fff.md?p=8) of a countermeasure, during a domestic, military, or public health emergency or material threat described in [section 360bbb–3a(a)(1)(C) of this title](/usc/21/360bbb–3a.md?p=a-1-C), expedite the development and review of countermeasures that are intended to address such domestic, military, or public health emergency or material threat for approval, licensure, clearance, or authorization under this title or [section 262 of title 42](/usc/42/262.md).
  - (2) **Actions—** The actions to expedite the development and review of a countermeasure under [paragraph (1)](#h-1) may include the following:
    - (A) Expedited review of submissions made by [sponsors](/usc/21/360fff.md?p=8) of countermeasures to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, including rolling submissions of countermeasure applications and other submissions.
    - (B) Expedited and increased engagement with [sponsors](/usc/21/360fff.md?p=8) regarding countermeasure development and manufacturing, including—
      - (i) holding meetings with the [sponsor](/usc/21/360fff.md?p=8) and the review team and providing timely advice to, and interactive communication with, the [sponsor](/usc/21/360fff.md?p=8) regarding the development of the countermeasure to ensure that the development program to gather the nonclinical and clinical data necessary for approval, licensure, clearance, or authorization is as efficient as practicable;
      - (ii) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;
      - (iii) assigning a cross-disciplinary project lead for the review team to facilitate;
      - (iv) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; and
      - (v) streamlining the review of approved, [licensed](/usc/21/360eee.md?p=9), cleared, or [authorized](/usc/21/360eee.md?p=2) countermeasures to treat or prevent new or emerging threats, including the review of any changes to such countermeasures.
    - (C) Expedited issuance of guidance documents and publication of other regulatory information regarding countermeasure development and manufacturing.
    - (D) Other steps to expedite the development and review of a countermeasure application submitted for approval, licensure, clearance, or authorization, as the [Secretary](/usc/21/321.md?p=d) determines appropriate.
  - (3) **Limitation of effect—** Nothing in this subsection shall be construed to require the [Secretary](/usc/21/321.md?p=d) to grant, or take any other action related to, a request of a [sponsor](/usc/21/360fff.md?p=8) to expedite the development and review of a countermeasure for approval, licensure, clearance, or authorization under [paragraph (1)](#h-1).
- (i) **Third party evaluation of tests used during an emergency—**
  - (1) **In general—** For purposes of conducting evaluations regarding whether an in vitro diagnostic [product](/usc/21/360eee.md?p=13) (as defined in section 809.3 of title 21, Code of Federal Regulations (or any successor regulations)) for which a request for emergency use authorization is submitted under [section 360bbb–3 of this title](/usc/21/360bbb–3.md) meets the criteria for issuance of such authorization, the [Secretary](/usc/21/321.md?p=d) may, as appropriate, consult with [persons](/usc/21/321.md?p=e) with appropriate expertise with respect to such evaluations or enter into cooperative agreements or contracts with such [persons](/usc/21/321.md?p=e) under which such [persons](/usc/21/321.md?p=e) conduct such evaluations and make such recommendations, including, as appropriate, evaluations and recommendations regarding the scope of authorization and conditions of authorization.
  - (2) **Requirements regarding evaluations and recommendations—**
    - (A) **In general—** In evaluating and making recommendations to the [Secretary](/usc/21/321.md?p=d) regarding the validity, accuracy, and reliability of in vitro diagnostic [products](/usc/21/360eee.md?p=13), as described in [paragraph (1)](#i-1), a [person](/usc/21/321.md?p=e) shall consider and document whether the relevant criteria under subsection (c)(2) of [section 360bbb–3 of this title](/usc/21/360bbb–3.md) for issuance of authorization under such section are met with respect to the in vitro diagnostic [product](/usc/21/360eee.md?p=13).
    - (B) **Written recommendations—** Recommendations made by a [person](/usc/21/321.md?p=e) under this subsection shall be submitted to the [Secretary](/usc/21/321.md?p=d) in writing, and shall include the reasons for such recommendation and other information that may be requested by the [Secretary](/usc/21/321.md?p=d).
  - (3) **Rule of construction—** Nothing in this subsection shall be construed to require the [Secretary](/usc/21/321.md?p=d) to consult with, or enter into cooperative agreements or contracts with, [persons](/usc/21/321.md?p=e) as described in [paragraph (1)](#i-1) for purposes of authorizing an in vitro diagnostic [product](/usc/21/360eee.md?p=13) or otherwise affecting the emergency use authorization authorities under this section or [section 360bbb–3 of this title](/usc/21/360bbb–3.md).

## Source credit

(June 25, 1938, ch. 675, § 565, as added Pub. L. 109–417, title IV, § 404, Dec. 19, 2006, 120 Stat. 2875; amended Pub. L. 113–5, title III, §§ 303–306, Mar. 13, 2013, 127 Stat. 185–190; Pub. L. 116–22, title V, § 503, June 24, 2019, 133 Stat. 951; Pub. L. 117–328, div. FF, title II, §§ 2501, 2502(a), Dec. 29, 2022, 136 Stat. 5796, 5797.)

## Notes

### Editorial Notes

### Amendments

2022—Subsec. (h). Pub. L. 117–328, § 2501, added subsec. (h).

Subsec. (i). Pub. L. 117–328, § 2502(a), added subsec. (i).

2019—Subsec. (f)(3) to (5). Pub. L. 116–22, § 503(1), (2), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively. Former par. (5) redesignated (6).

Subsec. (f)(6). Pub. L. 116–22, § 503(1), (3), redesignated par. (5) as (6) and, in introductory provisions, substituted “paragraph (5)(A)” for “paragraph (4)(A)” and “paragraph (5)(B)” for “paragraph (4)(B)”. Former par. (6) redesignated (7).

Subsec. (f)(7). Pub. L. 116–22, § 503(1), redesignated par. (6) as (7).

Subsec. (f)(7)(A). Pub. L. 116–22, § 503(4), substituted “paragraph (4)(A)” for “paragraph (3)(A)”.

2013—Pub. L. 113–5, § 304(1), substituted “Countermeasure development, review, and technical assistance” for “Technical assistance” in section catchline.

Pub. L. 113–5, § 303, designated existing provisions as subsec. (b) and inserted heading.

Subsec. (a). Pub. L. 113–5, § 303, added subsec. (a).

Subsec. (b). Pub. L. 113–5, § 304(2), reenacted heading without change, substituted “In order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, shall—” for “The Secretary, in consultation with the Commissioner of Food and Drugs, shall”, added pars. (1) to (4), and designated remainder of existing provisions as par. (5).

Subsecs. (c) to (e). Pub. L. 113–5, § 304(3), added subsecs. (c) to (e).

Subsec. (f). Pub. L. 113–5, § 305, added subsec. (f).

Subsec. (g). Pub. L. 113–5, § 306, added subsec. (g).

### Statutory Notes and Related Subsidiaries

### Guidance

Pub. L. 117–328, div. FF, title II, § 2502(b), Dec. 29, 2022, 136 Stat. 5798, provided that: “Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall issue draft guidance on consultations with persons under subsection (i) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as added by subsection (a), including considerations concerning conflicts of interest, compensation arrangements, and information sharing. Not later than 1 year after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.”

### Predictable Review Timelines of Vaccines by the Advisory Committee on Immunization Practices

Pub. L. 114–255, div. A, title III, § 3091, Dec. 13, 2016, 130 Stat. 1149, provided that: Consideration of New Vaccines.—Upon the licensure of any vaccine or any new indication for a vaccine, the Advisory Committee on Immunization Practices (in this section referred to as the ‘Advisory Committee’) shall, as appropriate, consider the use of the vaccine at its next regularly scheduled meeting. Additional Information.—If the Advisory Committee does not make a recommendation with respect to the use of a vaccine at the Advisory Committee’s first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine, the Advisory Committee shall provide an update on the status of such committee’s review. Consideration for Breakthrough Therapies and for Potential Use During Public Health Emergency.—The Advisory Committee shall make recommendations with respect to the use of certain vaccines in a timely manner, as appropriate, including vaccines that— are designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) and licensed under section 351 of the Public Health Service Act (42 U.S.C. 262); or could be used in a public health emergency. Definition.—In this section, the terms ‘Advisory Committee on Immunization Practices’ and ‘Advisory Committee’ mean the Advisory Committee on Immunization Practices established by the Secretary pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Disease Control and Prevention.”