191 
of an advisory committee may vote with respect to 
any matter considered by the advisory committee if 
such member (or an immediate family member of 
such member) has a financial interest that could be 
affected by the advice given to the Secretary with re-
spect to such matter, excluding interests exempted 
in regulations issued by the Director of the Office of 
Government Ethics as too remote or inconsequential 
to affect the integrity of the services of the Govern-
ment officers or employees to which such regulations 
apply. 
‘‘(3) WAIVER.—The Secretary may grant a 
waiver of the prohibition in paragraph (2) if such 
waiver is necessary to afford the advisory committee 
essential expertise. 
‘‘(4) LIMITATIONS.— 
‘‘(A) ONE WAIVER PER COMMITTEE MEET-
ING.—Notwithstanding any other provision of 
this section, with respect to each advisory com-
mittee, the Secretary shall not grant more than 
1 waiver under paragraph (3) per committee 
meeting. 
‘‘(B) SCIENTIFIC
WORK.—The Secretary 
may not grant a waiver under paragraph (3) 
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192 
for a member of an advisory committee when 
the member’s own scientific work is involved. 
‘‘(5) 
DISCLOSURE
OF
WAIVER.—Notwith-
standing section 107(a)(2) of the Ethics in Govern-
ment Act (5 U.S.C. App.), the following shall apply: 
‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As 
soon as practicable, but in no case later than 
15 days prior to a meeting of an advisory com-
mittee to which a written determination as re-
ferred to in section 208(b)(1) of title 18, United 
States Code, a written certification as referred 
to in section 208(b)(3) of title 18, United 
States Code, or a waiver as referred to in para-
graph (3) applies, the Secretary shall disclose 
(other than information exempted from disclo-
sure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States 
Code (popularly known as the Freedom of In-
formation Act and the Privacy Act of 1974, re-
spectively)) on the Internet website of the Food 
and Drug Administration— 
‘‘(i) the type, nature, and magnitude 
of the financial interests of the advisory 
committee member to which such deter-
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193 
mination, certification, or waiver applies; 
and 
‘‘(ii) the reasons of the Secretary for 
such determination, certification, or waiv-
er. 
‘‘(B) LESS THAN 30 DAYS IN ADVANCE.— 
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, United States Code, a 
written certification as referred to in section 
208(b)(3) of title 18, United States Code, or a 
waiver as referred to in paragraph (3) applies, 
the Secretary shall disclose (other than infor-
mation exempted from disclosure under section 
552 of title 5, United States Code, and section 
552a of title 5, United States Code) on the 
Internet website of the Food and Drug Admin-
istration, the information described in clauses 
(i) and (ii) of subparagraph (A) as soon as 
practicable after the Secretary makes such de-
termination, certification, or waiver, but in no 
case later than the date of such meeting. 
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194 
‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 
that the public record and transcript of each meeting of 
an advisory committee includes the disclosure required 
under subsection (c)(5) (other than information exempted 
from disclosure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States Code). 
‘‘(e) ANNUAL REPORT.—Not later than February 1 
of each year, the Secretary shall submit to the Committee 
on Appropriations and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate, and the Com-
mittee on Appropriations and the Committee on Energy 
and Commerce of the House of Representatives a report 
that describes— 
‘‘(1) with respect to the fiscal year that ended 
on September 30 of the previous year, the number 
of vacancies on each advisory committee, the number 
of nominees received for each committee, and the 
number of such nominees willing to serve; 
‘‘(2) with respect to such year, the aggregate 
number of disclosures required under subsection 
(c)(5) for each meeting of each advisory committee 
and the percentage of individuals to whom such dis-
closures did not apply who served on such committee 
for each such meeting; 
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