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

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. view all titles (2)

All Bill Titles

  • Official: 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. as introduced.
  • Short: Guidance Accountability and Transparency Act of 2011 as introduced.

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Introduced
 
House
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Senate
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President
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10/14/11
 
 
 
 
 
 
 

Official 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 interpre

Official 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.

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