US Congress House Bill 3204 (Prior Session Legislation)

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Spectrum: Partisan Bill (Republican 9-0)
Status: Introduced on October 14 2011 - 25% progression, died in committee
Action: 2011-10-18 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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.

Guidance Accountability and Transparency Act of 2011

Rep. Brett Guthrie [R-KY]	Sen. Marsha Blackburn [R-TN]	Rep. Michael Burgess [R-TX]	Rep. John Culberson [R-TX]
Rep. Robert Latta [R-OH]	Rep. Erik Paulsen [R-MN]	Rep. Mike J. Rogers [R-MI]	Rep. Todd Rokita [R-IN]
Rep. John Shimkus [R-IL]

Date	Chamber	Action
2011-10-18	House	Referred to the Subcommittee on Health.
2011-10-14	House	Referred to the House Committee on Energy and Commerce.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/3204/all-info
Text	https://www.congress.gov/112/bills/hr3204/BILLS-112hr3204ih.pdf