3.0.0 3932 2023-01-11T13:17:49Z 2023-01-11T13:17:49Z House H HR 2009-10-27 111 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2009-10-28T18:59:54Z Referred to 2009-10-27T14:30:41Z 2009-10-28 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2009-10-27 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2009-10-27 Introduced in House IntroReferral Intro-H 9 Library of Congress 2009-10-27 Introduced in House IntroReferral 1000 9 Library of Congress B000213 Rep. Barton, Joe [R-TX-6] JOE BARTON R TX L. 6 N S000364 Rep. Shimkus, John [R-IL-19] JOHN SHIMKUS R IL M. 19 2009-10-27 True B001228 Rep. Bono Mack, Mary [R-CA-45] MARY BONO MACK R CA 45 2009-10-27 True T000459 Rep. Terry, Lee [R-NE-2] LEE TERRY R NE 2 2009-10-27 True S001155 Rep. Sullivan, John [R-OK-1] John Sullivan R OK 1 2009-10-27 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2009-10-27 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2009-10-27 True W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2009-10-27 True Health Drug safety, medical device, and laboratory regulation Health 00 2009-10-27 Introduced in House 2010-01-08T22:18:44Z Strengthening of FDA Integrity Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices.

Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product.

Requires the Secretary of Health and Human Services (HHS), in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available.

Requires the Secretary to annually report to Congress on the implementation of debarment provisions.

]]> Strengthening of FDA Integrity Act of 2009 Display Title Strengthening of FDA Integrity Act of 2009 Official Title as Introduced To expand the authority of the Secretary of Health and Human Services to impose debarments in order to ensure the integrity of drug, biological product, and device regulation, and for other purposes. Introduced in House IH Short Titles as Introduced Strengthening of FDA Integrity Act of 2009 Introduced in House 2009-10-27T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr3932ih/xml/BILLS-111hr3932ih.xml 2009-10-28 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.