In this section-
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-
Not later than 1 year after March 13, 2013, the Secretary 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) when human efficacy studies are not ethical or feasible.
The Secretary may extend the deadline for providing final guidance under paragraph (1) by not more than 6 months upon submission by the Secretary of a report on the status of such guidance to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.
To facilitate the timely development of animal models and support the development, stockpiling, licensure, approval, and clearance of countermeasures, the Secretary shall, not later than 180 days after March 13, 2013, establish a procedure by which a sponsor 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 application or investigational device exemption, may request and receive-
To facilitate the development and selection of animal models that could translate to pediatric studies, any meeting conducted under paragraph (1) shall include discussion of animal models for pediatric populations, as appropriate.
When evaluating an application or submission for approval, licensure, or clearance of a countermeasure, the Secretary 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 for which the countermeasure under review is intended.
When practicable and appropriate, teams of Food and Drug Administration personnel reviewing applications or submissions described under paragraph (1) shall include a reviewer with sufficient training or experience with countermeasures pursuant to the protocols established under subsection (b)(3)(D).
In this subsection, the term "eligible countermeasure" means-
The Secretary, in consultation with the Assistant Secretary 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.
The Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including-
A sponsor or applicant of an eligible countermeasure may initiate the process described under paragraph (2) upon submission of a written request to the Secretary. Such request shall include a proposed regulatory management plan.
A sponsor or applicant may submit a written request under subparagraph (A) after the eligible countermeasure has an investigational new drug or investigational device exemption in effect.
The Secretary shall direct the Food and Drug Administration, upon submission of a written request by a sponsor or applicant under subparagraph (A), to work with the sponsor or applicant to agree on a regulatory management plan within a reasonable time not to exceed 90 days. If the Secretary determines that no plan can be agreed upon, the Secretary shall provide to the sponsor or applicant, in writing, the scientific or regulatory rationale why such agreement cannot be reached.
The content of a regulatory management plan agreed to by the Secretary and a sponsor or applicant shall include-
The developmental milestones described in paragraph (5)(A) and the performance targets and goals described in paragraph (5)(B) shall include-
The Secretary shall establish regulatory management plans for all security countermeasures for which a request is submitted under paragraph (4)(A).
The Secretary 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, shall prioritize which eligible countermeasures may receive regulatory management plans.
Not later than 180 days after March 13, 2013, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food and Drug Administration a report that details the countermeasure development and review activities of the Food and Drug Administration, including-
The Secretary may, at the request of the sponsor 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, 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.
The actions to expedite the development and review of a countermeasure under paragraph (1) may include the following:
Nothing in this subsection shall be construed to require the Secretary to grant, or take any other action related to, a request of a sponsor to expedite the development and review of a countermeasure for approval, licensure, clearance, or authorization under paragraph (1).
For purposes of conducting evaluations regarding whether an in vitro diagnostic product (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 meets the criteria for issuance of such authorization, the Secretary may, as appropriate, consult with persons with appropriate expertise with respect to such evaluations or enter into cooperative agreements or contracts with such persons under which such persons conduct such evaluations and make such recommendations, including, as appropriate, evaluations and recommendations regarding the scope of authorization and conditions of authorization.
In evaluating and making recommendations to the Secretary regarding the validity, accuracy, and reliability of in vitro diagnostic products, as described in paragraph (1), a person shall consider and document whether the relevant criteria under subsection (c)(2) of section 360bbb-3 of this title for issuance of authorization under such section are met with respect to the in vitro diagnostic product.
Recommendations made by a person under this subsection shall be submitted to the Secretary in writing, and shall include the reasons for such recommendation and other information that may be requested by the Secretary.
Nothing in this subsection shall be construed to require the Secretary to consult with, or enter into cooperative agreements or contracts with, persons as described in paragraph (1) for purposes of authorizing an in vitro diagnostic product or otherwise affecting the emergency use authorization authorities under this section or section 360bbb-3 of this title.
21 U.S.C. § 360bbb-4
EDITORIAL NOTES
AMENDMENTS2022-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, §30913091,, 130 Stat. 1149, provided that:"(a) 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."(b) 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."(c) 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-"(1) 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"(2) could be used in a public health emergency."(d) 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."