3.0.0 25 2023-01-11T20:05:49Z 2023-01-11T20:05:49Z Senate S S 2007-01-04 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-01-04T22:35:11Z 2007-01-04 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S65-66) IntroReferral 2007-01-04 Sponsor introductory remarks on measure. (CR S64-65) IntroReferral B00100 9 Library of Congress 2007-01-04 Introduced in Senate IntroReferral 10000 9 Library of Congress K000305 Sen. Kohl, Herb [D-WI] HERBERT KOHL D WI H. N L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2007-01-04 True Health Administrative procedure Administrative remedies Commerce Department of Health and Human Services Drug approvals Drug industry Fines (Penalties) Food and Drug Administration (FDA) Government Operations and Politics Governmental investigations Law Legal fees Marketing Health 00 2007-01-04 Introduced in Senate 2007-01-12T15:30:39Z Citizen Petition Fairness and Accuracy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require that any citizen petition or request for stay of action related to an abbreviated new drug application include a statement that to the petitioner's best knowledge and belief, the petition: (1) includes all information and views on which the petitioner relies; (2) is well grounded in fact and is warranted by law; (3) is not submitted for an improper purpose; and (4) does not contain a materially false, misleading, or fraudulent statement. Requires the Secretary of Health and Human Services to investigate any petition that does not comply with such requirements.

Allows the Secretary to impose penalties for knowingly and willfully submitting a petition for an improper purpose or that contains a materially false, misleading or fraudulent statement. Provides that such penalties may include: (1) imposition of a civil penalty; (2) suspension or revocation of the petitioner's authority to submit such a petition; and (3) dismissal of the petition. Requires the Secretary to refer such a violative petition to the Federal Trade Commission (FTC) for further action. Sets forth the factors that the Secretary shall consider in taking an enforcement action or determining the penalty.

Permits any person aggrieved by a petition that may contain violations to submit a request, with a certification of good faith, for the Secretary to initiate an investigation. Subjects such person to civil penalties for knowing and intentional submission of a violative request.

Requires the Secretary to take final agency action on such a petition within six months. Prohibits the Secretary from extending the review period for any reason.

]]> Citizen Petition Fairness and Accuracy Act of 2007 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to establish requirements for certain petitions submitted to the Food and Drug Administration, and for other purposes. Introduced in Senate IS Display Title Citizen Petition Fairness and Accuracy Act of 2007 Short Titles as Introduced Citizen Petition Fairness and Accuracy Act of 2007 Introduced in Senate 2007-01-04T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s25is/xml/BILLS-110s25is.xml 2007-01-04 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S65-66) 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.