Animal Drug and Animal Generic Drug User Fee Amendments of 2023

3.0.0 1418 2026-01-09T22:39:20Z 2026-01-09T22:39:20Z House H HR 2023-03-07 118 https://www.congress.gov/bill/118th-congress/house-bill/1418 <pre>[Congressional Record Volume 169, Number 43 (Tuesday, March 7, 2023)][House]From the Congressional Record Online through the Government Publishing Office [<a href="https://www.gpo.gov">www.gpo.gov</a>]By Mr. PENCE:H.R. 1418.Congress has the power to enact this legislation pursuantto the following:Article 1 Section 8 Clause 3 of the U.S. ConstitutionThe single subject of this legislation is:To amend the Federal Food, Drug, and Cosmetic Act toreauthorize user fee programs relating to new animal drugsand generic new animal drugs.[Page H1152]</pre> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2023-05-17T20:40:30Z Markup by 2023-05-17T20:40:04Z Referred to 2023-03-17T18:24:56Z Reported By 2023-06-09T15:09:13Z Markup By 2023-05-24T17:59:42Z Referred To 2023-03-07T17:01:50Z H. Rept. 118-104 Animal Drug and Animal Generic Drug User Fee Amendments of 2023 118 1844 S 2023-07-26 Placed on Senate Legislative Calendar under General Orders. Calendar No. 174. Related bill CRS Continuing Appropriations Act, 2024 and Other Extensions Act 118 5860 HR 2023-09-30 Became Public Law No: 118-15. Related bill CRS 2023-09-20 Senate Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210. Calendars 2023-07-18 Senate Received in the Senate. IntroReferral 2023-07-17 16:50:41 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2023-07-17 16:50:39 On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623) Floor H37300 2 House floor actions 2023-07-17 16:50:39 Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623) Floor 8000 9 Library of Congress 2023-07-17 16:40:25 DEBATE - The House proceeded with forty minutes of debate on H.R. 1418. Floor H8D000 2 House floor actions 2023-07-17 16:40:24 Considered under suspension of the rules. (consideration: CR H3620-3624) Floor H30000 2 House floor actions 2023-07-17 16:40:11 Mr. Bilirakis moved to suspend the rules and pass the bill, as amended. Floor H30300 2 House floor actions 2023-06-09 Placed on the Union Calendar, Calendar No. 80. Calendars H12410 2 House floor actions U00080 2023-06-09 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2023-06-09 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2023-05-24 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0. Committee 2023-05-24 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2023-05-17 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 . Committee 2023-05-17 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2023-03-17 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-03-07 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-03-07 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-03-07 Introduced in House IntroReferral 1000 9 Library of Congress P000615 Rep. Pence, Greg [R-IN-6] Greg Pence R IN 6 N S001216 Rep. Schrier, Kim [D-WA-8] Kim Schrier D WA 8 2023-03-07 True L000590 Rep. Lee, Susie [D-NV-3] Susie Lee D NV 3 2023-06-06 False Health Research and development 2023-05-26T15:15:20Z User charges and fees 2023-05-26T15:15:20Z Veterinary medicine and animal diseases 2023-05-26T15:15:20Z Health 2023-03-29T17:18:42Z

00 2023-03-07 Introduced in House 2023-07-19T16:57:39Z Animal Drug User Fee Amendments of 2023 This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. The bill also provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly. Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.

07 2023-06-09 Reported to House 2023-09-20T20:00:24Z Animal Drug and Animal Generic Drug User Fee Amendments of 2023 This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. The bill also (1) provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly; (2) authorizes the FDA to remove species from the definition of major species (currently horses, dogs, cats, cattle, pigs, chickens, and turkeys); and (3) provides statutory authority for FDA to report on its progress supporting antimicrobial stewardship in veterinary settings (i.e., supporting responsible use of antimicrobial drugs for animals to slow the development of drug-resistant bacteria). Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.

53 2023-07-17 Passed House 2023-09-22T18:26:54Z Animal Drug and Animal Generic Drug User Fee Amendments of 2023 This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. The bill also (1) provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly; (2) authorizes the FDA to remove species from the definition of major species (currently horses, dogs, cats, cattle, pigs, chickens, and turkeys); and (3) provides statutory authority for the FDA to report on its progress supporting antimicrobial stewardship in veterinary settings (i.e., supporting responsible use of antimicrobial drugs for animals to slow the development of drug-resistant bacteria). Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.

Animal Drug and Animal Generic Drug User Fee Amendments of 2023 Display Title 45 Animal Drug and Animal Generic Drug User Fee Amendments of 2023 2024-07-24T15:18:17Z Short Title(s) from PCS (Placed on Senate Calendar) bill text 152 Animal Drug and Animal Generic Drug User Fee Amendments of 2023 2024-07-24T15:14:32Z S Senate Placed on Calendar Senate PCS Short Titles for portions of this bill from PCS (Placed on Senate Calendar) bill text 151 Animal Generic Drug User Fee Amendments of 2023 2024-07-24T15:14:32Z S Senate Placed on Calendar Senate PCS Short Titles for portions of this bill from PCS (Placed on Senate Calendar) bill text 151 Animal Drug User Fee Amendments of 2023 2024-07-24T15:14:32Z S Senate Placed on Calendar Senate PCS Short Title(s) as Introduced for portions of this bill 106 Animal Generic Drug User Fee Amendments of 2023 2024-05-24T13:41:47Z Introduced in House IH Short Title(s) as Introduced 101 Animal Drug User Fee Amendments of 2023 2024-05-24T13:41:47Z Introduced in House IH Short Title(s) as Introduced for portions of this bill 106 Animal Drug User Fee Amendments of 2023 2024-05-24T13:41:47Z Introduced in House IH Short Title(s) as Reported to House for portions of this bill 107 Animal Drug User Fee Amendments of 2023 2024-05-24T13:39:37Z H House Reported in House RH Short Title(s) as Reported to House for portions of this bill 107 Animal Generic Drug User Fee Amendments of 2023 2024-05-24T13:39:37Z H House Reported in House RH Short Title(s) as Reported to House 102 Animal Drug and Animal Generic Drug User Fee Amendments of 2023 2024-05-24T13:39:37Z H House Reported in House RH Short Title(s) as Passed House 104 Animal Drug and Animal Generic Drug User Fee Amendments of 2023 2024-05-24T13:38:34Z H House Engrossed in House EH Short Title(s) as Passed House for portions of this bill 109 Animal Drug User Fee Amendments of 2023 2024-05-24T13:38:34Z H House Engrossed in House EH Short Title(s) as Passed House for portions of this bill 109 Animal Generic Drug User Fee Amendments of 2023 2024-05-24T13:38:34Z H House Engrossed in House EH Official Title as Introduced 6 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs. 2024-03-18T20:58:14Z Introduced in House IH Placed on Calendar Senate 2023-09-20T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr1418pcs/xml/BILLS-118hr1418pcs.xml Engrossed in House 2023-07-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr1418eh/xml/BILLS-118hr1418eh.xml Reported in House 2023-06-09T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr1418rh/xml/BILLS-118hr1418rh.xml Introduced in House 2023-03-07T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr1418ih/xml/BILLS-118hr1418ih.xml 2023-09-20 Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210. 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.