3.0.0 2182 2021-04-19T18:50:28Z 2021-04-19T18:50:28Z House H HR 2011-06-15 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GINGREY of Georgia:H.R. 2182.Congress has the power to enact this legislation pursuantto the following:The constitutional authority on which this legislation isbased is found in article I, section 8, clause 18 grantingCongress the power ``to make all Laws which shall benecessary and proper for carrying into Execution foregoingPowers, and all other Powers vested by this Constitution inthe Government of the United States, or in any Department orOfficer thereof.''[Page H4278]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-06-16T18:18:19Z Referred to 2011-06-15T14:00:22Z Generating Antibiotic Incentives Now Act of 2011 112 1734 S 2011-10-19 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS 2011-06-16 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-06-15 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-06-15 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-06-15 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 2011-06-15 True W000413 Rep. Whitfield, Ed [R-KY-1] EDWARD WHITFIELD R KY 1 2011-06-15 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2011-06-15 True R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2011-06-15 True E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2011-06-15 True S000364 Rep. Shimkus, John [R-IL-19] JOHN SHIMKUS R IL M. 19 2011-06-15 True B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 2011-07-06 False H001045 Rep. Harper, Gregg [R-MS-3] Gregg Harper R MS 3 2011-07-07 False B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2011-07-08 False L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2011-07-12 False M001134 Rep. Myrick, Sue Wilkins [R-NC-9] SUE MYRICK R NC WILKINS 9 2011-07-15 False S001155 Rep. Sullivan, John [R-OK-1] John Sullivan R OK 1 2011-07-20 False B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2011-07-21 False L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2011-07-26 False G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 2011-07-28 False B001227 Rep. Brady, Robert A. [D-PA-1] ROBERT BRADY D PA A. 1 2011-09-23 False M001169 Rep. Murphy, Christopher [D-CT-5] Christopher Murphy D CT S. 5 2011-10-03 False M000133 Rep. Markey, Edward J. [D-MA-7] Edward Markey D MA J. 7 2011-10-12 False K000375 Rep. Keating, William R. [D-MA-10] William Keating D MA R. 10 2011-10-13 False I000026 Rep. Inslee, Jay [D-WA-1] JAY INSLEE D WA 1 2011-10-25 False M001181 Rep. Meehan, Patrick [R-PA-7] Patrick Meehan R PA 7 2011-10-25 False C001083 Rep. Carney, John C., Jr. [D-DE-At Large] John Carney D DE C. 0 2011-10-25 False M001154 Rep. Miller, Brad [D-NC-13] Brad Miller D NC 13 2011-10-31 False B001149 Rep. Burton, Dan [R-IN-5] DAN BURTON R IN 5 2011-11-10 False B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2011-11-10 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2011-11-10 False M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2011-11-16 False C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2011-11-16 False B001274 Rep. Brooks, Mo [R-AL-5] Mo Brooks R AL 5 2011-11-30 False B001262 Rep. Broun, Paul C. [R-GA-10] Paul Broun R GA C. 10 2011-12-02 False M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2011-12-13 False H001047 Rep. Himes, James A. [D-CT-4] James Himes D CT A. 4 2011-12-15 False M001156 Rep. McHenry, Patrick T. [R-NC-10] Patrick McHenry R NC 10 2011-12-19 False W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2011-12-19 False T000465 Rep. Tsongas, Niki [D-MA-5] Niki Tsongas D MA 5 2012-02-02 False M001142 Rep. Matheson, Jim [D-UT-2] JIM MATHESON D UT 2 2012-02-07 False G000544 Rep. Gonzalez, Charles A. [D-TX-20] CHARLES GONZALEZ D TX A. 20 2012-02-15 False M001163 Rep. Matsui, Doris O. [D-CA-5] Doris Matsui D CA O. 5 2012-02-29 False L000111 Rep. Latham, Tom [R-IA-4] TOM LATHAM R IA 4 2012-03-05 False F000116 Rep. Filner, Bob [D-CA-51] BOB FILNER D CA 51 2012-04-17 False M001139 Rep. Miller, Gary G. [R-CA-42] GARY MILLER R CA 42 2012-04-17 False B001252 Rep. Barrow, John [D-GA-12] John Barrow D GA 12 2012-04-17 False K000378 Rep. Kinzinger, Adam [R-IL-11] Adam Kinzinger R IL 11 2012-04-24 False B001271 Rep. Benishek, Dan [R-MI-1] Dan Benishek R MI 1 2012-04-27 False R000573 Rep. Ross, Mike [D-AR-4] MIKE ROSS D AR 4 2012-05-07 False C000380 Del. Christensen, Donna M. [D-VI-At Large] DONNA CHRISTENSEN D VI M. 0 2012-05-08 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 2011-06-15 Introduced in House 2011-08-19T18:20:25Z 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 Short Titles as Introduced Generating Antibiotic Incentives Now Act of 2011 Display Title Generating Antibiotic Incentives Now Act of 2011 Official Title as Introduced To provide incentives for the development of qualified infectious disease products. Introduced in House 2011-06-15T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr2182ih/xml/BILLS-112hr2182ih.xml 2011-06-16 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.