Amendments2022—Subsec. (h). Puspan. L. 117–328, § 2501, added subsec. (h).
Subsec. (i). Puspan. L. 117–328, § 2502(a), added subsec. (i).
2019—Subsec. (f)(3) to (5). Puspan. 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). Puspan. 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). Puspan. L. 116–22, § 503(1), redesignated par. (6) as (7).
Subsec. (f)(7)(A). Puspan. L. 116–22, § 503(4), substituted “paragraph (4)(A)” for “paragraph (3)(A)”.
2013—Puspan. L. 113–5, § 304(1), substituted “Countermeasure development, review, and technical assistance” for “Technical assistance” in section catchline.
Puspan. L. 113–5, § 303, designated existing provisions as subsec. (span) and inserted span.
Subsec. (a). Puspan. L. 113–5, § 303, added subsec. (a).
Subsec. (span). Puspan. L. 113–5, § 304(2), reenacted span 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). Puspan. L. 113–5, § 304(3), added subsecs. (c) to (e).
Subsec. (f). Puspan. L. 113–5, § 305, added subsec. (f).
Subsec. (g). Puspan. L. 113–5, § 306, added subsec. (g).
GuidancePuspan. L. 117–328, div. FF, title II, § 2502(span), 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29, 2022], the Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall issue draft guidance on consultations with persons under subsection (i) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbspan–4), as added by subsection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 Not later than 1 year after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.”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 PracticesPuspan. L. 114–255, div. A, title III, § 3091, Dec. 13, 2016, 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.
“(span)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.”
