Guidance Accountability and Transparency Act of 2011
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HR 3204 — Guidance Accountability and Transparency Act of 2011
Last action — Referred to the Subcommittee on Health.
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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✓In Committee
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Died in session
This bill died with 112th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.
Summary
Guidance Accountability and Transparency Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), when issuing guidance documents that set forth initial interpretations of a statute or regulation, set forth changes in interpretation or policy that are of more than a minor nature, include complex scientific issues, or cover highly controversial issues (Level 1 guidance documents), to: (1) publish notice in the Federal Register of the Secretary's intent to prepare such a document at least three months before issuance of a draft, and (2) meet with interested stakeholders and solicit public comment during preparation and before issuance of a draft. Includes within such guidance documents a notice to industry guidance letter, a notice to industry advisory letter, and any similar notice. Sets forth other procedures if the Secretary for good cause finds compliance with such requirements is impracticable, unnecessary, or contrary to the public interest. Requires the Secretary: (1) upon issuing a draft, to designate it as proposed or final; and (2) to issue a final draft within 12 months after issuing a proposed draft. Treats the proposed draft as null and void if the Secretary fails to finalize the draft within such time. Directs the Secretary to conduct a retrospective analysis of a final Level 1 guidance document not less than every five years to ensure it is not outmoded, ineffective, insufficient, or excessively burdensome and to modify or repeal the document accordingly.
Bill Text
We don't have the full text on file for this bill yet.
Read HR 3204 on the official United States source →Action History
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Referred to the Subcommittee on Health.
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Referred to the House Committee on Energy and Commerce.
Sponsors
- Brett Guthrie · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 0 co-sponsors · 546 not signed on
Sponsors (1)
Co-sponsors (0)
None.
Not signed on (546)
546 members have not signed on to this bill.
Show all 546 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Subjects
Frequently asked questions
- What does HR 3204 do?
- Guidance Accountability and Transparency Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), when issuing guidance documents that set forth initial interpretations of a statute or regulation, set forth changes in interpretation or policy that are of more than a minor nature, include complex scientific issues, or cover highly controversial issues (Level 1 guidance documents), to: (1) publish notice in the Federal Register of the Secretary's intent to prepare such a document at least three months before issuance of a draft, and (2) meet with interested stakeholders and solicit public comment during preparation and before issuance of a draft. Includes within such guidance documents a notice to industry guidance letter, a notice to industry advisory letter, and any similar notice. Sets forth other procedures if the Secretary for good cause finds compliance with such requirements is impracticable, unnecessary, or contrary to the public interest. Requires the Secretary: (1) upon issuing a draft, to designate it as proposed or final; and (2) to issue a final draft within 12 months after issuing a proposed draft. Treats the proposed draft as null and void if the Secretary fails to finalize the draft within such time. Directs the Secretary to conduct a retrospective analysis of a final Level 1 guidance document not less than every five years to ensure it is not outmoded, ineffective, insufficient, or excessively burdensome and to modify or repeal the document accordingly.
- Who sponsors HR 3204?
- HR 3204 is sponsored by Brett Guthrie (R).
- What is the current status of HR 3204?
- This bill died with 112th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
- Where can I track HR 3204?
- Track HR 3204 free on One Click Politics — get push/email alerts when it moves.
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