3.0.0 622 2023-03-22T18:49:22Z 2023-03-22T18:49:22Z Senate S S 2013-03-20 113 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported original measure 2013-03-20T21:12:57Z Animal Drug User Fee Amendments of 2013 113 1407 HR 2013-08-02 Placed on the Union Calendar, Calendar No. 135. Related bill CRS Animal Generic Drug User Fee Amendments of 2013 113 1408 HR 2013-04-12 Referred to the Subcommittee on Health. Related bill CRS 2013-06-13 Became Public Law No: 113-14. President E40000 2 House floor actions 2013-06-13 Became Public Law No: 113-14. BecameLaw 36000 9 Library of Congress 2013-06-13 Signed by President. President E30000 2 House floor actions 2013-06-13 Signed by President. BecameLaw 36000 9 Library of Congress 2013-06-06 Presented to President. Floor E20000 2 House floor actions 2013-06-06 Presented to President. President 28000 9 Library of Congress 2013-06-03 19:04:27 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2013-06-03 19:04:26 On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 390 - 12 (Roll no. 185). (text: CR H2984-2991) Floor H37300 2 House floor actions 185 https://clerk.house.gov/evs/2013/roll185.xml House 113 2013-06-03T23:04:26Z 1 2013-06-03 19:04:26 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 390 - 12 (Roll no. 185).(text: CR H2984-2991) Floor 8000 9 Library of Congress 185 https://clerk.house.gov/evs/2013/roll185.xml House 113 2013-06-03T23:04:26Z 1 2013-06-03 18:56:25 Considered as unfinished business. (consideration: CR H3001) Floor H30000 2 House floor actions 2013-06-03 16:54:05 At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed. Floor H37220 2 House floor actions 2013-06-03 16:35:07 DEBATE - The House proceeded with forty minutes of debate on S. 622. Floor H8D000 2 House floor actions 2013-06-03 16:35:05 Considered under suspension of the rules. (consideration: CR H2984-2993) Floor H30000 2 House floor actions 2013-06-03 16:34:55 Mr. Latta moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2013-05-09 12:59:58 Held at the desk. Floor H15000 2 House floor actions 2013-05-09 Senate Message on Senate action sent to the House. Floor 2013-05-09 10:17:34 Received in the House. Floor H14000 2 House floor actions 2013-05-08 Senate Passed Senate without amendment by Unanimous Consent. (consideration: CR S3275-3282; text as passed Senate: CR S3275-3282) Floor 2013-05-08 Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S3275-3282; text as passed Senate: CR S3275-3282) Floor 17000 9 Library of Congress 2013-03-20 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 31. Calendars 2013-03-20 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Original measure reported to Senate by Senator Harkin. Without written report. Committee 2013-03-20 Committee on Health, Education, Labor, and Pensions. Original measure reported to Senate by Senator Harkin. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2013-03-20 Introduced in Senate IntroReferral 10000 9 Library of Congress H000206 Sen. Harkin, Tom [D-IA] THOMAS HARKIN D IA RICHARD N Public Law 113-14 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 2013-03-20 Introduced in Senate 2013-06-03T18:08:13Z Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 - 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 year 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.

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

Animal Generic Drug User Fee Amendments of 2013 - 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.

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.

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

]]> 80 2013-03-20 Reported to Senate without amendment 2013-07-01T14:29:32Z (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 - Title I: Fees Relating to Animal Drugs - 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 annual FDA reports to report to Congress on progress in 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: Fees Relating to Generic Animal Drugs - 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.

]]> 82 2013-05-08 Passed Senate without amendment 2013-07-01T14:28:25Z (This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)

Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 - Title I: Fees Relating to Animal Drugs - 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: Fees Relating to Generic Animal Drugs - 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.

]]> 81 2013-06-03 Passed House without amendment 2013-07-01T14:30:44Z (This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)

Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 - Title I: Fees Relating to Animal Drugs - 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: Fees Relating to Generic Animal Drugs - 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.

]]> 49 2013-06-13 Public Law 2013-07-01T14:25:07Z (This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)

Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 - Title I: Fees Relating to Animal Drugs - 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: Fees Relating to Generic Animal Drugs - 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 and Animal Generic Drug User Fee Reauthorization Act of 2013 Display Title Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 Short Titles as Passed Senate for portions of this bill Animal Drug User Fee Amendments of 2013 S Senate Short Titles as Passed Senate for portions of this bill Animal Generic Drug User Fee Amendments of 2013 S Senate Short Titles as Enacted for portions of this bill Animal Generic Drug User Fee Amendments of 2013 Short Titles as Enacted for portions of this bill Animal Drug User Fee Amendments of 2013 Short Titles as Passed House for portions of this bill Animal Drug User Fee Amendments of 2013 H House Short Titles as Introduced for portions of this bill Animal Generic Drug User Fee Amendments of 2013 Short Titles as Reported to Senate for portions of this bill Animal Generic Drug User Fee Amendments of 2013 S Senate Short Titles as Reported to Senate for portions of this bill Animal Drug User Fee Amendments of 2013 S Senate Short Titles as Passed House for portions of this bill Animal Generic Drug User Fee Amendments of 2013 H House Short Titles as Introduced Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 Official Title as Introduced An original bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs. Short Titles as Reported to Senate Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 S Senate Short Titles as Passed House Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 H House Short Titles as Passed Senate Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 S Senate Short Titles as Enacted Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 Short Titles as Introduced for portions of this bill Animal Drug User Fee Amendments of 2013 Enrolled Bill https://www.govinfo.gov/content/pkg/BILLS-113s622enr/xml/BILLS-113s622enr.xml Engrossed in Senate 2013-05-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s622es/xml/BILLS-113s622es.xml Placed on Calendar Senate 2013-03-20T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s622pcs/xml/BILLS-113s622pcs.xml 2013-06-14T03:59:59Z https://www.govinfo.gov/content/pkg/PLAW-113publ14/uslm/PLAW-113publ14.xml Public Law 2013-06-13 Became Public Law No: 113-14. 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.