3.0.0 6331 2023-01-11T13:21:30Z 2023-01-11T13:21:30Z House H HR 2010-09-29 111 hsif00 Energy and Commerce Committee House Standing Referred to 2010-09-29T14:19:50Z 2010-09-29 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2010-09-29 Introduced in House IntroReferral Intro-H 9 Library of Congress 2010-09-29 Introduced in House IntroReferral 1000 9 Library of Congress G000550 Rep. Gingrey, Phil [R-GA-11] Phil Gingrey R GA 11 N G000410 Rep. Green, Gene [D-TX-29] GENE GREEN D TX 29 2010-09-29 True W000413 Rep. Whitfield, Ed [R-KY-1] EDWARD WHITFIELD R KY 1 2010-09-29 True R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2010-09-29 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2010-09-29 True Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Infectious and parasitic diseases Intellectual property Medical research Medical tests and diagnostic methods Prescription drugs Health 00 2010-09-29 Introduced in House 2011-01-26T14:55:36Z Generating Antibiotic Incentives Now Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) extend for five years the exclusivity period for the first licensure of a qualified infectious disease product; (2) grant priority review to an application for approval or licensure of a qualified infectious disease product (i.e., review and action on such application not later than six months after receipt); and (3) deem a qualified infectious disease product as a fast track product, for review and approval purposes.  Defines "qualified infectious disease product" as an antibiotic drug, or a diagnostic test including a point-of-care diagnostic test, for treating, detecting, preventing, or identifying a qualifying pathogen. 

Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to review the guidelines of the Food and Drug Administration (FDA) for the conduct of clinical trials for antibiotic drugs and revise such guidelines to reflect developments in medical information and technology.  Allows the sponsor of a drug intended to be used to treat, detect, prevent, or identify a qualifying pathogen, as defined by this Act, to request that the Secretary provide written recommendations for nonclinical and clinical investigations before such drug may be approved for use or licensed.

]]> Generating Antibiotic Incentives Now Act of 2010 Display Title Generating Antibiotic Incentives Now Act of 2010 Official Title as Introduced To provide incentives for the development of qualified infectious disease products. Introduced in House IH Short Titles as Introduced Generating Antibiotic Incentives Now Act of 2010 Introduced in House 2010-09-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr6331ih/xml/BILLS-111hr6331ih.xml 2010-09-29 Referred to the House Committee on Energy and Commerce. 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.