3.0.0 1734 2023-01-11T13:21:58Z 2023-01-11T13:21:58Z Senate S S 2011-10-19 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2011-10-19T16:21:00Z Generating Antibiotic Incentives Now Act of 2011 112 2182 HR 2011-06-16 Referred to the Subcommittee on Health. Identical bill CRS 2011-10-19 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2011-10-19 Introduced in Senate IntroReferral 10000 9 Library of Congress B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT N C001071 Sen. Corker, Bob [R-TN] Bob Corker R TN 2011-10-19 True B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2011-10-19 True H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT 2011-10-19 True C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA 2011-10-19 True A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN 2011-10-19 True C001088 Sen. Coons, Christopher A. [D-DE] Christopher Coons D DE A. 2011-10-19 True R000307 Sen. Roberts, Pat [R-KS] PAT ROBERTS R KS 2011-10-31 False K000148 Sen. Kerry, John F. [D-MA] JOHN KERRY D MA FORBES 2012-02-09 False C000286 Sen. Chambliss, Saxby [R-GA] SAXBY CHAMBLISS R GA 2012-02-17 False I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA 2012-02-17 False T000464 Sen. Tester, Jon [D-MT] Jon Tester D MT 2012-04-19 False B001265 Sen. Begich, Mark [D-AK] Mark Begich D AK 2012-04-23 False C000174 Sen. Carper, Thomas R. [D-DE] Thomas Carper D DE R. 2012-05-07 False A000368 Sen. Ayotte, Kelly [R-NH] Kelly Ayotte R NH 2012-05-22 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government studies and investigations Infectious and parasitic diseases Intellectual property Medical research Medical tests and diagnostic methods Prescription drugs Research and development Health 00 2011-10-19 Introduced in Senate 2012-02-17T16:21:26Z Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug application for which an extension is in effect or has expired; or (2) a subsequent application for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or a modification to the structure of the product that does not result in a change in safety or effectiveness.

Extends such period of exclusivity an additional six months for a sponsor or manufacturer of a qualified infectious disease product that identifies a companion diagnostic test.

Requires the Secretary to give priority review to any drug determined to be a qualified infectious disease product.

Includes qualified infectious disease products as fast track products for which the Secretary shall facilitate development and expedite review.

Directs the Comptroller General to study the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products.

Requires the Secretary to: (1) review Food and Drug Administration (FDA) guidelines for clinical trials of antibiotic drugs; and (2) revise such guidelines, as appropriate, to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug.

]]> Generating Antibiotic Incentives Now Act of 2011 Display Title Generating Antibiotic Incentives Now Act of 2011 Official Title as Introduced A bill to provide incentives for the development of qualified infectious disease products. Introduced in Senate IS Short Titles as Introduced Generating Antibiotic Incentives Now Act of 2011 Introduced in Senate 2011-10-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s1734is/xml/BILLS-112s1734is.xml 2011-10-19 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.