3.0.0 3742 2023-01-11T13:23:36Z 2023-01-11T13:23:36Z House H HR 2013-12-12 113 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-12-13T16:47:32Z Referred to 2013-12-12T15:04:30Z 2013-12-13 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-12-12 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-12-12 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-12-12 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 2013-12-12 True S000364 Rep. Shimkus, John [R-IL-15] JOHN SHIMKUS R IL M. 15 2013-12-12 True E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2013-12-12 True W000413 Rep. Whitfield, Ed [R-KY-1] EDWARD WHITFIELD R KY 1 2013-12-12 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2013-12-12 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2013-12-12 True E000179 Rep. Engel, Eliot L. [D-NY-16] ELIOT ENGEL D NY L. 16 2013-12-12 True G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 2013-12-12 True B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2013-12-12 True M001163 Rep. Matsui, Doris O. [D-CA-6] Doris Matsui D CA O. 6 2014-03-24 False E000291 Rep. Ellmers, Renee L. [R-NC-2] Renee Ellmers R NC L. 2 2014-03-24 False D000355 Rep. Dingell, John D. [D-MI-12] JOHN DINGELL D MI D. 12 2014-03-24 False L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2014-03-24 False M001142 Rep. Matheson, Jim [D-UT-4] JIM MATHESON D UT 4 2014-03-24 False C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2014-03-24 False Y000062 Rep. Yarmuth, John A. [D-KY-3] John Yarmuth D KY A. 3 2014-03-24 False O000168 Rep. Olson, Pete [R-TX-22] Pete Olson R TX 22 2014-03-24 False T000469 Rep. Tonko, Paul [D-NY-20] Paul Tonko D NY 20 2014-03-24 False L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2014-03-24 False P000602 Rep. Pompeo, Mike [R-KS-4] Mike Pompeo R KS 4 2014-03-24 False B001252 Rep. Barrow, John [D-GA-12] John Barrow D GA 12 2014-03-24 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2014-04-28 False L000570 Rep. Lujan, Ben Ray [D-NM-3] Ben Lujan D NM R. 3 2014-04-28 False B001257 Rep. Bilirakis, Gus M. [R-FL-12] Gus Bilirakis R FL M. 12 2014-05-08 False S001175 Rep. Speier, Jackie [D-CA-14] Jackie Speier D CA 14 2014-05-28 False S001170 Rep. Shea-Porter, Carol [D-NH-1] Carol Shea-Porter D NH 1 2014-05-28 False M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2014-07-09 False R000580 Rep. Roskam, Peter J. [R-IL-6] Peter Roskam R IL J. 6 2014-07-10 False M001157 Rep. McCaul, Michael T. [R-TX-10] Michael McCaul R TX T. 10 2014-07-15 False B000213 Rep. Barton, Joe [R-TX-6] JOE BARTON R TX L. 6 2014-07-17 False L000559 Rep. Langevin, James R. [D-RI-2] JAMES LANGEVIN D RI R. 2 2014-07-17 False M001166 Rep. McNerney, Jerry [D-CA-9] Jerry McNerney D CA 9 2014-07-22 False R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 2014-07-22 False B001289 Rep. Byrne, Bradley [R-AL-1] Bradley Byrne R AL 1 2014-07-22 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-9] WILLIAM PASCRELL D NJ J. 9 2014-07-29 False J000126 Rep. Johnson, Eddie Bernice [D-TX-30] EDDIE JOHNSON D TX BERNICE 30 2014-07-30 False H001055 Rep. Heck, Joseph J. [R-NV-3] Joseph Heck R NV J. 3 2014-09-08 False D000616 Rep. DesJarlais, Scott [R-TN-4] Scott DesJarlais R TN 4 2014-09-09 False E000288 Rep. Ellison, Keith [D-MN-5] Keith Ellison D MN 5 2014-09-11 False K000381 Rep. Kilmer, Derek [D-WA-6] Derek Kilmer D WA 6 2014-09-11 False C001062 Rep. Conaway, K. Michael [R-TX-11] K. Conaway R TX Michael 11 2014-09-15 False F000461 Rep. Flores, Bill [R-TX-17] Bill Flores R TX 17 2014-09-15 False T000472 Rep. Takano, Mark [D-CA-41] Mark Takano D CA 41 2014-09-16 False T000470 Rep. Tipton, Scott R. [R-CO-3] Scott Tipton R CO R. 3 2014-09-16 False S001189 Rep. Scott, Austin [R-GA-8] Austin Scott R GA 8 2014-09-16 False C001067 Rep. Clarke, Yvette D. [D-NY-9] Yvette Clarke D NY D. 9 2014-09-16 False J000295 Rep. Joyce, David P. [R-OH-14] David Joyce R OH P. 14 2014-09-16 False R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2014-11-12 False H001045 Rep. Harper, Gregg [R-MS-3] Gregg Harper R MS 3 2014-11-12 False R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2014-11-12 False C001090 Rep. Cartwright, Matt [D-PA-17] Matt Cartwright D PA 17 2014-11-19 False B001285 Rep. Brownley, Julia [D-CA-26] Julia Brownley D CA 26 2014-11-20 False Health Administrative law and regulatory procedures Administrative remedies Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health information and medical records Infectious and parasitic diseases Licensing and registrations Medical research Prescription drugs Health 00 2013-12-12 Introduced in House 2014-04-09T14:59:05Z Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.

Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.

Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.

Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.

]]> Antibiotic Development to Advance Patient Treatment Act of 2013 Display Title Antibiotic Development to Advance Patient Treatment Act of 2013 Official Title as Introduced To provide for approval of certain drugs and biological products indicated for use in a limited population of patients in order to address increases in bacterial and fungal resistance to drugs and biological products, and for other purposes. Introduced in House IH Short Titles as Introduced Antibiotic Development to Advance Patient Treatment Act of 2013 Introduced in House 2013-12-12T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr3742ih/xml/BILLS-113hr3742ih.xml 2013-12-13 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.