3.0.0 621 2023-01-11T13:27:55Z 2023-01-11T13:27:55Z Senate S 2015-03-02 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2015-03-02T22:50:21Z 2015-03-02 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1218-1219) IntroReferral 2015-03-02 Introduced in Senate IntroReferral 10000 9 Library of Congress F000062 Sen. Feinstein, Dianne [D-CA] Dianne Feinstein D CA N C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2015-03-02 True G000555 Sen. Gillibrand, Kirsten E. [D-NY] Kirsten Gillibrand D NY E. 2015-03-02 True W000817 Sen. Warren, Elizabeth [D-MA] Elizabeth Warren D MA A. 2015-03-02 True R000122 Sen. Reed, Jack [D-RI] John Reed D RI F. 2015-05-04 False B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2015-05-05 False B001288 Sen. Booker, Cory A. [D-NJ] Cory Booker D NJ 2015-07-15 False M001176 Sen. Merkley, Jeff [D-OR] Jeff Merkley D OR 2015-07-29 False Health Drug safety, medical device, and laboratory regulation Food supply, safety, and labeling Health information and medical records Health personnel Health promotion and preventive care Livestock Meat Veterinary medicine and animal diseases Health 00 2015-03-02 Introduced in Senate 2015-06-30T23:21:34Z Preventing Antibiotic Resistance Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refuse a new animal drug application if the drug is a medically important antimicrobial (used to treat humans) and the applicant fails to demonstrate that the drug meets specified criteria for use in animals, including that: (1) the drug is effective, (2) the drug is targeted to animals at risk of developing a specific bacterial disease, (3) the drug has a defined duration of therapy, and (4) there is reasonable certainty of no harm to human health from microbial resistance to the drug.

Sponsors of certain medically important antimicrobials already approved for use in food-producing animals must submit evidence to the FDA that demonstrates that their drug meets the criteria described above for approved indications. The FDA must withdraw approval for any indication for which the FDA determines there is insufficient evidence that the drug meets the criteria.

This bill expresses the sense of the Senate that a veterinarian-client-patient relationship should ensure that medically important antimicrobials are used in food-producing animals in a manner consistent with best practices.]]> Preventing Antibiotic Resistance Act of 2015 Display Title Preventing Antibiotic Resistance Act of 2015 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and effectiveness of medically important antimicrobials approved for use in the prevention and control of animal diseases, in order to minimize the development of antibiotic-resistant bacteria. Introduced in Senate IS Short Titles as Introduced Preventing Antibiotic Resistance Act of 2015 Introduced in Senate 2015-03-02T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s621is/xml/BILLS-114s621is.xml 2015-03-02 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1218-1219) 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.