Animal Drug User Fee Act of 2003

Bill: 108-s-313
Sponsor: Sen. Ensign, John [R-NV]
Introduced: 2003-02-05 in the Senate
Policy area: Health
Subjects: Administrative fees
Administrative procedure
Agriculture and Food
Animals
Appropriations
Collection of accounts
Commerce
Congress
Congressional reporting requirements
Department of Health and Human Services
Drug approvals
Drug industry
Economics and Public Finance
Feeds
Government Operations and Politics
Government paperwork
Indexing (Economic policy)
Law
Performance measurement
Pharmaceutical research
Science, Technology, Communications
Small business
User charges
Veterinary medicine

Summary:
action_date: 2003-02-05
text: Animal Drug User Fee Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to assess and collect fees for an animal drug or a supplemental animal drug application (if it requires safety or effectiveness data). Requires payment upon submission or the application will be considered incomplete and not accepted. Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.
Assesses annual fees on animal drug products, establishments, and sponsors.
Establishes a fee schedule for FY 2004 through 2007, including total fee revenues for animal drug products, establishments, and sponsors. Adjusts fees to reflect inflation, review workload, and operating reserves of carryover user fees (in the final year).
Directs the Secretary to establish before each fiscal year, based on the fee schedule revenue amounts and the adjustments, the following: (1) animal drug application and supplement fees; (2) animal drug sponsor fees; (3) animal drug establishment fees; and (4) animal drug product fees. Reduces or waives fees: (1) in excess of administrative costs; (2) that present a significant barrier to innovation; (3) if an animal drug application or supplemental animal drug application is intended solely for use of an animal drug in specified types of feed; (4) if an animal drug application or supplemental animal drug application is intended solely to provide for minor uses or use in minor species; or (5) for first applications by a small business.
Makes fees available for obligation only to the extent provided in advance in appropriations Acts. Offsets any excess fees against subsequent appropriations.
action_date: 2003-05-21
text: Animal Drug User Fee Act of 2003 - (Sec. 3) Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to assess and collect fees for an animal drug application, defined as a request for approval of a new animal drug (not including generic drugs). Directs the Secretary to also assess fees for a supplemental animal drug application, defined as a request for a change in an approved animal drug application or in an approved generic animal drug application (if it requires safety or effectiveness data). Requires payment upon submission or the application will be considered incomplete and not accepted. Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.
Assesses annual fees on animal drug products, establishments, and sponsors. Declares that only one such fee per category must be paid each year.
Establishes a fee schedule for FY 2004 through 2007, including total fee revenues for animal drug products, establishments, and sponsors. Adjusts fees to reflect inflation, review workload, and operating reserves of carryover user fees (in the final year).
Directs the Secretary to establish before each fiscal year, based on the fee schedule revenue amounts and the adjustments, the following: (1) animal drug application and supplement fees; (2) animal drug sponsor fees; (3) animal drug establishment fees; and (4) animal drug product fees. Reduces or waives fees: (1) in excess of administrative costs; (2) that present a significant barrier to innovation; (3) if an animal drug application or supplemental animal drug application is intended solely for use of an animal drug in specified types of feed; (4) if an animal drug application or supplemental animal drug application is intended solely to provide for minor uses or use in minor species; or (5) for first applications by a small business.
Makes fees available for obligation only to the extent provided in advance in appropriations Acts. Authorizes appropriations. Offsets any excess fees against subsequent appropriations.
(Sec. 4) Establishes public accountability and reporting requirements.
(Sec. 5) Sets a sunset of October 1, 2007, for the provisions of this Act not pertaining to public accountability and reports and a sunset of 120 days after such date for such accountability and reporting provisions.
action_date: 2003-06-03
text: Animal Drug User Fee Act of 2003 - (Sec. 3) Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to assess and collect fees for an animal drug application, defined as a request for approval of a new animal drug (not including generic drugs). Directs the Secretary to also assess fees for a supplemental animal drug application, defined as a request for a change in an approved animal drug application or in an approved generic animal drug application (if it requires safety or effectiveness data). Requires payment upon submission or the application will be considered incomplete and not accepted. Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.
Assesses annual fees on animal drug products, establishments, and sponsors. Declares that only one such fee per category must be paid each year.
Establishes a fee schedule for FY 2004 through 2008, including total fee revenues for animal drug products, establishments, and sponsors. Adjusts fees to reflect inflation, review workload, and operating reserves of carryover user fees (in the final year).
Directs the Secretary to establish before each fiscal year, based on the fee schedule revenue amounts and the adjustments, the following: (1) animal drug application fees and supplemental animal drug application fees (for applications in which safety or effectiveness data are required); (2) animal drug sponsor fees; (3) animal drug establishment fees; and (4) animal drug product fees. Reduces or waives fees: (1) in excess of administrative costs; (2) that present a significant barrier to innovation; (3) if an animal drug application or supplemental animal drug application is intended solely for use of an animal drug in specified types of feed; (4) if an animal drug application or supplemental animal drug application is intended solely to provide for minor uses or use in minor species; or (5) for first applications by a small business.
Makes fees available for obligation only to the extent provided in advance in appropriations Acts. Authorizes appropriations. Offsets any excess fees against subsequent appropriations.
(Sec. 4) Establishes public accountability and reporting requirements.
(Sec. 5) Sets a sunset of October 1, 2008, for the provisions of this Act not pertaining to public accountability and reports and a sunset of 120 days after such date for such accountability and reporting provisions.
action_date: 2003-11-04
text: 
Animal Drug User Fee Act of 2003 - (Sec. 3) Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to assess and collect fees for an animal drug application, defined as a request for approval of a new animal drug (not including generic drugs). Directs the Secretary to also assess fees for a supplemental animal drug application, defined as a request for a change in an approved animal drug application or in an approved generic animal drug application (if it requires safety or effectiveness data). Requires payment upon submission or the application will be considered incomplete and not accepted. Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.
 
Assesses annual fees on animal drug products, establishments, and sponsors. Declares that only one such fee per category must be paid each year.
 
Establishes a fee schedule for FY 2004 through 2008, including total fee revenues for animal drug products, establishments, and sponsors. Adjusts fees to reflect inflation, review workload, and operating reserves of carryover user fees (in the final year).
 
Directs the Secretary to establish before each fiscal year, based on the fee schedule revenue amounts and the adjustments, the following: (1) animal drug application fees and supplemental animal drug application fees (for applications in which safety or effectiveness data are required); (2) animal drug sponsor fees; (3) animal drug establishment fees; and (4) animal drug product fees. Reduces or waives fees: (1) in excess of administrative costs; (2) that present a significant barrier to innovation; (3) if an animal drug application or supplemental animal drug application is intended solely for use of an animal drug in specified types of feed; (4) if an animal drug application or supplemental animal drug application is intended solely to provide for minor uses or use in minor species; or (5) for first applications by a small business.
 
Makes fees available for obligation only to the extent provided in advance in appropriations Acts.
 
 Authorizes appropriations. Offsets any excess fees against subsequent appropriations.
 
(Sec. 4) Establishes public accountability and reporting requirements.
 
(Sec. 5) Establishes a sunset date of October 1, 2008, for the provisions of this Act not pertaining to public accountability and reports and a sunset date of 120 days after such date for such accountability and reporting provisions. 

action_date: 2003-11-18
text: 

(This measure has not been amended since it was passed by the House on November 4, 2003. The summary of that version is repeated here.)

 
Animal Drug User Fee Act of 2003 - (Sec. 3) Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to assess and collect fees for an animal drug application, defined as a request for approval of a new animal drug (not including generic drugs). Directs the Secretary to also assess fees for a supplemental animal drug application, defined as a request for a change in an approved animal drug application or in an approved generic animal drug application (if it requires safety or effectiveness data). Requires payment upon submission or the application will be considered incomplete and not accepted. Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.
 
Assesses annual fees on animal drug products, establishments, and sponsors. Declares that only one such fee per category must be paid each year.
 
Establishes a fee schedule for FY 2004 through 2008, including total fee revenues for animal drug products, establishments, and sponsors. Adjusts fees to reflect inflation, review workload, and operating reserves of carryover user fees (in the final year).
 
Directs the Secretary to establish before each fiscal year, based on the fee schedule revenue amounts and the adjustments, the following: (1) animal drug application fees and supplemental animal drug application fees (for applications in which safety or effectiveness data are required); (2) animal drug sponsor fees; (3) animal drug establishment fees; and (4) animal drug product fees. Reduces or waives fees: (1) in excess of administrative costs; (2) that present a significant barrier to innovation; (3) if an animal drug application or supplemental animal drug application is intended solely for use of an animal drug in specified types of feed; (4) if an animal drug application or supplemental animal drug application is intended solely to provide for minor uses or use in minor species; or (5) for first applications by a small business.
 
Makes fees available for obligation only to the extent provided in advance in appropriations Acts.
 
Authorizes appropriations. Offsets any excess fees against subsequent appropriations.
 
(Sec. 4) Establishes public accountability and reporting requirements.
 
(Sec. 5) Establishes a sunset date of October 1, 2008, for the provisions of this Act not pertaining to public accountability and reports and a sunset date of 120 days after such date for such accountability and reporting provisions. 


Legislative actions:
action_date: 2003-11-18
text: Became Public Law No: 108-130.
action_date: 2003-11-18
text: Became Public Law No: 108-130.
action_date: 2003-11-18
text: Signed by President.
action_date: 2003-11-18
text: Signed by President.
action_date: 2003-11-12
text: Presented to President.
action_date: 2003-11-12
text: Presented to President.
action_date: 2003-11-10
text: Message on Senate action sent to the House.
action_date: 2003-11-07
text: Senate agreed to House amendment by Unanimous Consent. (consideration: CR S14279-14282; text as Senate agreed to House amendment: CR S14279-14282)
action_date: 2003-11-07
text: Resolving differences -- Senate actions: Senate agreed to House amendment by Unanimous Consent.(consideration: CR S14279-14282; text as Senate agreed to House amendment: CR S14279-14282)
action_date: 2003-11-05
text: Message on House action received in Senate and at desk: House amendment to Senate bill.
action_date: 2003-11-04
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2003-11-04
text: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H10293-10296)
action_date: 2003-11-04
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H10293-10296)
action_date: 2003-11-04
text: DEBATE - The House proceeded with forty minutes of debate on S. 313.
action_date: 2003-11-04
text: Considered under suspension of the rules. (consideration: CR H10293-10297)
action_date: 2003-11-04
text: Mr. Upton moved to suspend the rules and pass the bill, as amended.
action_date: 2003-06-11
text: Referred to the Subcommittee on Health.
action_date: 2003-06-04
text: Referred to the House Committee on Energy and Commerce.
action_date: 2003-06-04
text: Received in the House.
action_date: 2003-06-04
text: Message on Senate action sent to the House.
action_date: 2003-06-03
text: Passed Senate with an amendment by Unanimous Consent.
action_date: 2003-06-03
text: Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
action_date: 2003-06-03
text: Measure laid before Senate by unanimous consent. (consideration: CR S7266)
action_date: 2003-06-03
text: Senate vitiated previous passage.
action_date: 2003-05-23
text: Passed Senate with amendments by Unanimous Consent. (consideration:  CR S7165-7171; text as passed Senate:  CR H7168-7171; text of measure as reported in Senate:  CR S7165-7168)
action_date: 2003-05-23
text: Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.(consideration:  CR S7165-7171; text as passed Senate:  CR H7168-7171; text of measure as reported in Senate:  CR S7165-7168)
action_date: 2003-05-21
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 104.
action_date: 2003-05-21
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with amendments. With written report No. 108-51.
action_date: 2003-05-21
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with amendments. With written report No. 108-51.
action_date: 2003-02-12
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2003-02-05
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2003-02-05
text: Introduced in Senate

Enacted as: number: 108-130