3.0.0 1407 2023-01-11T13:24:20Z 2023-01-11T13:24:20Z House H HR 2013-04-09 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. SHIMKUS:H.R. 1407.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3: To regulate Commerce withforeign Nations, and among the several States, and with theIndian Tribes.[Page H1858]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Discharged from 2013-05-14T15:01:23Z Referred to 2013-04-12T20:02:56Z Reported by 2013-08-02T16:52:11Z Markup by 2013-05-15T15:12:08Z Referred to 2013-04-09T18:01:50Z H. Rept. 113-188 Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 113 622 S 2013-06-13 Became Public Law No: 113-14. Related bill CRS 2013-08-02 Placed on the Union Calendar, Calendar No. 135. Calendars H12410 2 House floor actions U00135 2013-08-02 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-188. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2013-08-02 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 113-188. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2013-05-15 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported by Voice Vote. Committee 2013-05-15 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2013-05-14 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2013-05-14 hsif00 Energy and Commerce Committee 1 House committee actions Subcommittee on Health Discharged. Committee 2013-04-12 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-04-09 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-04-09 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-04-09 Introduced in House IntroReferral 1000 9 Library of Congress S000364 Rep. Shimkus, John [R-IL-15] JOHN SHIMKUS R IL M. 15 N G000562 Rep. Gardner, Cory [R-CO-4] Cory Gardner R CO 4 2013-04-09 True U000031 Rep. Upton, Fred [R-MI-6] FRED UPTON R MI 6 2013-04-09 True P000373 Rep. Pitts, Joseph R. [R-PA-16] JOSEPH PITTS R PA R. 16 2013-04-09 True W000215 Rep. Waxman, Henry A. [D-CA-33] HENRY WAXMAN D CA A. 33 2013-04-09 True P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2013-04-09 True B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2013-04-09 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2013-04-09 True K000378 Rep. Kinzinger, Adam [R-IL-16] Adam Kinzinger R IL 16 2013-04-09 True Health Animal and plant health Department of Health and Human Services Drug safety, medical device, and laboratory regulation Executive agency funding and structure Food and Drug Administration (FDA) User charges and fees Veterinary medicine and animal diseases Health 00 2013-04-09 Introduced in House 2013-06-21T16:37:32Z Animal Drug User Fee Amendments of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect animal drug user fees, specifically new animal drug application or supplemental animal drug application fees, animal drug product fees, animal drug establishment fees, and animal drug sponsor fees.

Revises the due date for annual user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the amount of revenue such fees can generate. Specifies percentages of the total revenue that shall be derived from each type of user fee.

Requires the Secretary of Health and Human Services (HHS) to adjust the total revenue amounts for FY2015 and subsequent fiscal years for inflation.

Authorizes the Secretary to accept payment of user fees prior to their due date.

Requires the total fees collected for FY2016-FY2018 to be increased by the cumulative amount, if any, by which the amount of user fees collected and appropriated for prior fiscal year falls below the cumulative amount of fees authorized.

Extends requirements for the FDA to report to Congress on achieving goals related to animal drug development and review processes and implementation of authority to collect animal drug user fees.

Terminates the authority to collect user fees October 1, 2018.

]]> 17 2013-08-02 Reported to House with amendment(s) 2013-08-15T16:31:15Z Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2013 - (Sec. 103) Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect animal drug user fees, specifically new animal drug application or supplemental animal drug application fees, animal drug product fees, animal drug establishment fees, and animal drug sponsor fees.

Revises the due date for annual user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the amount of revenue such fees can generate. Specifies percentages of the total revenue that shall be derived from each type of user fee.

Requires the Secretary of Health and Human Services (HHS) to adjust the total revenue amounts for FY2015 and subsequent fiscal years for inflation.

Authorizes the Secretary to accept payment of user fees prior to their due date.

Requires the total fees collected for FY2016-FY2018 to be increased by the cumulative amount, if any, by which the amount of user fees collected and appropriated for prior fiscal year falls below the cumulative amount of fees authorized.

(Sec. 104) Extends requirements for the FDA to report to Congress on achieving goals related to animal drug development and review processes and implementation of authority to collect animal drug user fees.

(Sec. 107) Terminates the authority to collect user fees October 1, 2018.

Title II: Animal Generic Drug User Fee Amendments - Animal Generic Drug User Fee Amendments of 2013 - (Sec. 202) Extends for FY2014-FY2018 the authority of the FDA to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees.

Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved.

Revises the due date for annual generic animal drug user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the total amount of revenue each type of generic user fee shall generate.

Authorizes the Secretary to accept payment of user fees prior to their due date.

(Sec. 203) Extends requirements for the FDA to report to Congress on achieving goals related to the generic animal drug development and review process and the implementation of the authority to collect generic animal drug fees.

(Sec. 206) Terminates the authority to collect generic animal drug user fees October 1, 2018.

]]> Animal Drug User Fee Amendments of 2013 Display Title Animal Drug User Fee Amendments of 2013 Short Titles as Introduced Animal Drug User Fee Amendments of 2013 Short Titles as Reported to House for portions of this bill Animal Generic Drug User Fee Amendments of 2013 H House Short Titles as Reported to House for portions of this bill Animal Drug User Fee Amendments of 2013 H House Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs. Reported in House 2013-08-02T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr1407rh/xml/BILLS-113hr1407rh.xml Introduced in House 2013-04-09T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr1407ih/xml/BILLS-113hr1407ih.xml 2013-08-02 Placed on the Union Calendar, Calendar No. 135. 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.