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HR 3204 112th Congress House

Guidance Accountability and Transparency Act of 2011

Official title: To amend the Federal Food, Drug, and Cosmetic Act to ensure public participation in the drafting and issuance of Level 1 guidance documents, and for other purposes.

Introduced: October 14, 2011 Introduced by: Guthrie, Brett Republican · Kentucky See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)
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Government information and archivesPublic participation and lobbying
This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 18, 2011
Referred to the Subcommittee on Health.
Oct 14, 2011
Referred to the House Committee on Energy and Commerce.
Oct 14, 2011
Introduced in House
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 Latest action October 18, 2011

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 3204: Guidance Accountability and Transparency Act of 2011. 112th Congress. Open America. https://openamerica.io/bill/112-HR-3204/
MLA
"H.R. 3204: Guidance Accountability and Transparency Act of 2011." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-3204/.
Bluebook (legal)
H.R. 3204, 112th Cong. (2026), https://openamerica.io/bill/112-HR-3204/.
Markdown link
[H.R. 3204: Guidance Accountability and Transparency Act of 2011](https://openamerica.io/bill/112-HR-3204/)
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