To insert provisions related to conflicts of interest among members of advisory panels of the Food and Drug Administration.
What it does: Adds Sec. 7___.(a) Subject to subsection (b), none of the funds made available in this Act may be used to-- on page 173, line 24Adds Sec. 7___.(a) Subject to subsection (b), none of the funds made available in this Act may be used to-- on page 173, line 24
Adds a sectionPrinted pageInserted: Sec. 7___.(a) Subject to subsection (b), none of the funds made available in this Act may be used to--
Inserted: (1) grant a waiver of a financial conflict of interest requirement pursuant to section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)(4)) for any voting member of an advisory committee or panel of the Food and Drug Administration; or
Inserted: (2) make a certification under section 208(b)(3) of title 18, United States Code, for any such voting member.
Inserted: (b) Subsection (a) shall not apply to a waiver or certification if--
Inserted: (1) not later than 15 days prior to a meeting of an advisory committee or panel to which such waiver or certification applies, the Secretary of Health and Human Services discloses on the Internet website of the Food and Drug Administration--
Inserted: (A) the nature of the conflict of interest at issue; and
Inserted: (B) the nature and basis of such waiver or certification (other than information exempted from disclosure under section 552 of title 5, United States Code (popularly known as the Freedom of Information Act)); or
Inserted: (2) in the case of a conflict of interest that becomes known to the Secretary less than 15 days prior to a meeting to which such waiver or certification applies, the Secretary shall make such public disclosure as soon as possible thereafter, but in no event later than the date of such meeting.
Inserted: (c) None of the funds made available in this Act may be used to make a new appointment to an advisory committee or panel of the Food and Drug Administration unless the Commissioner of Food and Drugs submits a confidential report to the Inspector General of the Department of Health and Human Services of the efforts made to identify qualified persons for such appointment with minimal or no potential conflicts of interest.
Original wording
On page 173, after line 24, insert the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
On page 173, after line 24, insert the following:
Sec. 7___.(a) Subject to subsection (b), none of the funds made available in this Act may be used to--
(1) grant a waiver of a financial conflict of interest requirement pursuant to section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)(4)) for any voting member of an advisory committee or panel of the Food and Drug Administration; or
(2) make a certification under section 208(b)(3) of title 18, United States Code, for any such voting member.
(b) Subsection (a) shall not apply to a waiver or certification if--
(1) not later than 15 days prior to a meeting of an advisory committee or panel to which such waiver or certification applies, the Secretary of Health and Human Services discloses on the Internet website of the Food and Drug Administration--
(A) the nature of the conflict of interest at issue; and
(B) the nature and basis of such waiver or certification (other than information exempted from disclosure under section 552 of title 5, United States Code (popularly known as the Freedom of Information Act)); or
(2) in the case of a conflict of interest that becomes known to the Secretary less than 15 days prior to a meeting to which such waiver or certification applies, the Secretary shall make such public disclosure as soon as possible thereafter, but in no event later than the date of such meeting.
(c) None of the funds made available in this Act may be used to make a new appointment to an advisory committee or panel of the Food and Drug Administration unless the Commissioner of Food and Drugs submits a confidential report to the Inspector General of the Department of Health and Human Services of the efforts made to identify qualified persons for such appointment with minimal or no potential conflicts of interest.
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Senate amendment submitted
September 20, 2005
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Senate amendment submitted
September 20, 2005
Senate amendment agreed to: Amendment SA 1749 agreed to in Senate by Voice Vote.
September 20, 2005
Senate amendment proposed (on the floor): Amendment SA 1749 proposed by Senator Durbin.
September 20, 2005
Amendment SA 1749 proposed by Senator Durbin. (consideration: CR S10216-10217; text: CR S10217) To insert provisions related to conflicts of interest among members of advisory panels of the Food and Drug Administration.
September 20, 2005
Amendment SA 1749 agreed to in Senate by Voice Vote.
September 20, 2005