H.R. 3204: Guidance Accountability and Transparency Act of 2011

112th Congress · introduced 2011-10-14 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

Where it came from: introduced 2011-10-14 · official record
Who proposed it: Rep. Guthrie, Brett [R-KY-2] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Guidance Accountability and Transparency Act of 2011

Plain 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.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

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What does this mean? (plain words)

Official text

Guidance Accountability and Transparency Act of 2011

Source: Congressional Research Service summary (Introduced in House)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Guthrie, Brett [R-KY-2] · 8 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Marsha Blackburn (R-TN), Robert E. Latta (R-OH)

Sponsor's campaign money: Rep. Guthrie, Brett [R-KY-2] reported raising $6.0 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (4)

Federal Register: The official daily publication of the U.S. government for agency rules, proposed rules, public notices and presidential documents.
Public comment: A chance for anyone to tell a government agency what they think about a proposed rule or plan before it is final. Agencies must consider the comments they receive.
Rulemaking: The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.
Statute: A written law passed by a legislature. A statute can be changed by a later law; changing a constitution needs an amendment.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112hr3204.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/hr>

Record fed-us-cong112-hr3204 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112