3.0.0 3204 2023-01-11T13:22:05Z 2023-01-11T13:22:05Z House H HR 2011-10-14 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GUTHRIE:H.R. 3204.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3To regulate Commerce with foreign Nations and among theseveral States, and with the Indian Tribes[Page H6977]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-10-18T13:48:11Z Referred to 2011-10-14T13:00:42Z 2011-10-18 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-10-14 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-10-14 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-10-14 Introduced in House IntroReferral 1000 9 Library of Congress G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 N S000364 Rep. Shimkus, John [R-IL-19] JOHN SHIMKUS R IL M. 19 2011-10-14 True R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2011-10-14 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2011-10-14 True P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2011-10-14 True L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2011-10-14 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2011-10-24 False C001048 Rep. Culberson, John Abney [R-TX-7] JOHN CULBERSON R TX ABNEY 7 2011-10-24 False R000592 Rep. Rokita, Todd [R-IN-4] Todd Rokita R IN 4 2012-01-25 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Public participation and lobbying Health 00 2011-10-14 Introduced in House 2012-01-27T21:06:23Z 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 Display Title Guidance Accountability and Transparency Act of 2011 Official Title as Introduced 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 in House IH Short Titles as Introduced Guidance Accountability and Transparency Act of 2011 Introduced in House 2011-10-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3204ih/xml/BILLS-112hr3204ih.xml 2011-10-18 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.