For purposes of this section:
The term "advisory committee" means an advisory committee under chapter 10 of title 5 that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.
The term "financial interest" means a financial interest under section 208(a) of title 18.
The Secretary shall-
The recruitment activities under paragraph (1) may include-
In carrying out this subsection, the Secretary shall seek to ensure that the Secretary has access to the most current expert advice.
Notwithstanding section 13109(a)(2) of title 5, the following shall apply:
As soon as practicable, but (except as provided in paragraph (2)) not later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18 or a written certification as referred to in section 208(b)(3) of such title, applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 or section 552a of title 5 (popularly known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet Web site of the Food and Drug Administration-
In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18 or a written certification as referred to in section 208(b)(3) of such title applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 or 552a of title 5) on the Internet Web site of the Food and Drug Administration, the information described in subparagraphs (A) and (B) of paragraph (1) as soon as practicable after the Secretary makes such determination or certification, but in no case later than the date of such meeting.
The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c) (other than information exempted from disclosure under section 552 of title 5 and section 552a of title 5).
Not later than February 1 of each year, the Secretary 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 and Commerce of the House of Representatives, a report that describes-
Not later than 30 days after submitting any report under paragraph (1) to the committees specified in such paragraph, the Secretary shall make each such report available to the public.
Not less than once every 5 years, the Secretary shall-
The Secretary shall issue guidance that describes how the Secretary reviews the financial interests and involvement of advisory committee members that are disclosed under subsection (c) but that the Secretary determines not to meet the definition of a disqualifying interest under section 208 of title 18 for the purposes of participating in a particular matter.
21 U.S.C. § 379d-1
EDITORIAL NOTES
REFERENCES IN TEXTThe Privacy Act of 1974, referred to in subsec. (c)(3)(A), is Pub. L. 93-579, Dec. 31, 1974, 88 Stat. 1896, which enacted section 552a of Title 5, Government Organization and Employees, and provisions set out as notes under section 552a of Title 5. For complete classification of this Act to the Code, see Short Title of 1974 Amendment note set out under section 552a of Title 5 and Tables.
PRIOR PROVISIONSA prior section 712 of act June 25, 1938, was renumbered section 711 by Pub. L. 102-571 and is classified to section 379d of this title.
AMENDMENTS2022-Subsec. (a)(1). Pub. L. 117-286, §4(a)(159), substituted "chapter 10 of title 5" for "the Federal Advisory Committee Act".Subsec. (c). Pub. L. 117-286, §4(c)(29), substituted "section 13109(a)(2) of title 5," for "section 107(a)(2) of the Ethics in Government Act of 1978,". 2016-Subsec. (e)(1)(B). Pub. L. 114-255 substituted "service as members" for "services as members". 2012-Subsecs. (b), (c). Pub. L. 112-144, §1142(a)(1), added subsecs. (b) and (c) and struck out former subsecs. (b) and (c) which related to appointments to advisory committees and disclosures, prohibitions on participation, and waivers.Subsec. (d). Pub. L. 112-144, §1142(a)(2), substituted "subsection (c)" for "subsection (c)(3)". Subsec. (e). Pub. L. 112-144, §1142(a)(3), amended subsec. (e) generally. Prior to amendment, subsec. (e) related to annual report. Subsec. (f). Pub. L. 112-144, §1142(a)(4), substituted "shall-" for "shall review guidance of the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory committees and update such guidance as necessary." and added pars. (1) and (2). Subsec. (g). Pub. L. 112-144, §1142(a)(5), added subsec. (g).
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2012 AMENDMENT Pub. L. 112-144, title XI, §1142(b), July 9, 2012, 126 Stat. 1130, provided that: "The amendments made by subsection (a) [amending this section] apply beginning on October 1, 2012."
EFFECTIVE DATESection effective Oct. 1, 2007, see section 701(c) of Pub. L. 110-85 set out as an Effective Date of 2007 Amendment note under section 355 of this title.