To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes.

Bill: 110-hr-6432
Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6]
Introduced: 2008-07-08 in the House
Policy area: Health
Subjects: Administrative fees
Administrative remedies
Agriculture and Food
Animals
Antibiotics
Civil Rights and Liberties, Minority Issues
Clinical trials
Commerce
Congress
Congressional reporting requirements
Data banks
Drug approvals
Drug resistance in microorganisms
Drugs
Economics and Public Finance
Food safety
Generic drugs
Government Operations and Politics
Government publicity
Law
Livestock
Meat
Right of petition
Science, Technology, Communications
User charges
Veterinary medicine

Summary:
action_date: 2008-07-08
text: 
Animal Drug User Fee Amendments of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess a partial fee for a new drug application for a drug that combines active ingredients that have been approved separately.

Sets forth the amount of revenue that animal drug fees are to generate for FY2009-FY2013.

Reauthorizes appropriations for animal drug fees for FY2009-FY2013.

Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the animal drug development process and the review of animal drug applications; and (2) the implementation of the authority for and use of animal drug fees.

Sets forth a process for the Secretary to develop recommendations for the process of review of animal drug applications after FY2013.

Specifies the reporting period and due date for periodic drug experience reports on antibiotic new animal drugs.

Terminates the authority to assess and use animal drug fees on October 1, 2013.

action_date: 2008-07-30
text: 

Title I: Animal Drug User Fee Amendments
 - Animal Drug User Fee Amendments of 2008 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act to revise definitions, including defining the &quot;process for the review of animal drug applications&quot; to include the review of advertising and labeling prior to an approval of an animal drug application or supplemental animal application after the animal drug has been approved.

(Sec. 103) Requires the Secretary of Health and Human Services to assess 50% of the standard fee for a new animal drug application for a drug that combines active ingredients that have been approved separately.

Sets forth the amount of revenue that animal drug application fees, supplemental and other animal drug application fees, product fees, establishment fees, and sponsor fees are to generate for FY2009-FY2013.

(Sec. 104) Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the animal drug development process and the review of animal drug applications; and (2) implementation of the authority for and use of animal drug fees.

Sets forth a process for the Secretary to develop recommendations for the process of review of animal drug applications after FY2013.

(Sec. 105) Requires the sponsor of any new animal drug that contains an antimicrobial active ingredient to annually report to the Secretary on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Authorizes the Secretary to share such information with the Antimicrobial Resistance Task Force.

(Sec. 108) Terminates the authority to collect and assess animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.

Title II: Animal Generic Drug User Fee
 - Animal Generic Drug User Fee Act of 2008 - (Sec. 202) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.

Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.

Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.

Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.

Authorizes appropriations for FY2009-FY2013.

(Sec. 203) Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the generic new animal drug development process and the review of abbreviated applications for such drugs; and (2) the implementation of the authority for and use of generic new animal drug fees.

Sets forth the process for developing recommendations to present to Congress for the review of abbreviated applications for generic new animal drugs after FY2013.

(Sec. 204) Terminates the authority to assess and use generic new animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.

Title III: Technical Corrections to FDAAA
 - (Sec. 301) Amends the Federal Food, Drug, and Cosmetic Act to require that consideration of a citizen petition or a petition for a stay of agency action on a new drug application be separate and apart from review and approval of any such application.

(Sec. 302) Amends the Public Health Service Act to make technical corrections to provisions related to the clinical trials data bank. 

action_date: 2008-08-01
text: 

(This measure has not been amended since it was passed by the House on July 30, 2008. The summary of that version is repeated here.)

Title I: Animal Drug User Fee Amendments
 - Animal Drug User Fee Amendments of 2008 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act to revise definitions, including defining the &quot;process for the review of animal drug applications&quot; to include the review of advertising and labeling prior to an approval of an animal drug application or supplemental animal application after the animal drug has been approved.

(Sec. 103) Requires the Secretary of Health and Human Services to assess 50% of the standard fee for a new animal drug application for a drug that combines active ingredients that have been approved separately.

Sets forth the amount of revenue that animal drug application fees, supplemental and other animal drug application fees, product fees, establishment fees, and sponsor fees are to generate for FY2009-FY2013.

(Sec. 104) Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the animal drug development process and the review of animal drug applications; and (2) implementation of the authority for and use of animal drug fees.

Sets forth a process for the Secretary to develop recommendations for the process of review of animal drug applications after FY2013.

(Sec. 105) Requires the sponsor of any new animal drug that contains an antimicrobial active ingredient to annually report to the Secretary on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Authorizes the Secretary to share such information with the Antimicrobial Resistance Task Force.

(Sec. 108) Terminates the authority to collect and assess animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.

Title II: Animal Generic Drug User Fee
 - Animal Generic Drug User Fee Act of 2008 - (Sec. 202) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.

Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.

Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.

Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.

Authorizes appropriations for FY2009-FY2013.

(Sec. 203) Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the generic new animal drug development process and the review of abbreviated applications for such drugs; and (2) the implementation of the authority for and use of generic new animal drug fees.

Sets forth the process for developing recommendations to present to Congress for the review of abbreviated applications for generic new animal drugs after FY2013.

(Sec. 204) Terminates the authority to assess and use generic new animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.

Title III: Technical Corrections to FDAAA
 - (Sec. 301) Amends the Federal Food, Drug, and Cosmetic Act to require that consideration of a citizen petition or a petition for a stay of agency action on a new drug application be separate and apart from review and approval of any such application.

(Sec. 302) Amends the Public Health Service Act to make technical corrections to provisions related to the clinical trials data bank.

action_date: 2008-08-14
text: 

(This measure has not been amended since it was passed by the House on July 30, 2008. The summary of that version is repeated here.)

 

Title I: Animal Drug User Fee Amendments
 - Animal Drug User Fee Amendments of 2008 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act to revise definitions, including defining the &quot;process for the review of animal drug applications&quot; to include the review of advertising and labeling prior to an approval of an animal drug application or supplemental animal application after the animal drug has been approved.

(Sec. 103) Requires the Secretary of Health and Human Services to assess 50% of the standard fee for a new animal drug application for a drug that combines active ingredients that have been approved separately.

Sets forth the amount of revenue that animal drug application fees, supplemental and other animal drug application fees, product fees, establishment fees, and sponsor fees are to generate for FY2009-FY2013.

(Sec. 104) Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the animal drug development process and the review of animal drug applications; and (2) implementation of the authority for and use of animal drug fees.

Sets forth a process for the Secretary to develop recommendations for the process of review of animal drug applications after FY2013.

(Sec. 105) Requires the sponsor of any new animal drug that contains an antimicrobial active ingredient to annually report to the Secretary on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Authorizes the Secretary to share such information with the Antimicrobial Resistance Task Force.

(Sec. 108) Terminates the authority to collect and assess animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.

Title II: Animal Generic Drug User Fee
 - Animal Generic Drug User Fee Act of 2008 - (Sec. 202) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.

Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.

Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.

Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.

Authorizes appropriations for FY2009-FY2013.

(Sec. 203) Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the generic new animal drug development process and the review of abbreviated applications for such drugs; and (2) the implementation of the authority for and use of generic new animal drug fees.

Sets forth the process for developing recommendations to present to Congress for the review of abbreviated applications for generic new animal drugs after FY2013.

(Sec. 204) Terminates the authority to assess and use generic new animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.

Title III: Technical Corrections to FDAAA
 - (Sec. 301) Amends the Federal Food, Drug, and Cosmetic Act to require that consideration of a citizen petition or a petition for a stay of agency action on a new drug application be separate and apart from review and approval of any such application.

(Sec. 302) Amends the Public Health Service Act to make technical corrections to provisions related to the clinical trials data bank.


Legislative actions:
action_date: 2008-08-14
text: Became Public Law No: 110-316.
action_date: 2008-08-14
text: Became Public Law No: 110-316.
action_date: 2008-08-14
text: Signed by President.
action_date: 2008-08-14
text: Signed by President.
action_date: 2008-08-06
text: Presented to President.
action_date: 2008-08-06
text: Presented to President.
action_date: 2008-08-01
text: Cleared for White House.
action_date: 2008-08-01
text: Message on Senate action sent to the House.
action_date: 2008-08-01
text: Passed Senate without amendment by Unanimous Consent. (consideration: CR S7984)
action_date: 2008-08-01
text: Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7984)
action_date: 2008-07-31
text: Received in the Senate, read twice.
action_date: 2008-07-30
text: The title of the measure was amended. Agreed to without objection.
action_date: 2008-07-30
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2008-07-30
text: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7534-7539)
action_date: 2008-07-30
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 H7534-7539)
action_date: 2008-07-30
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 6432.
action_date: 2008-07-30
text: Considered under suspension of the rules. (consideration: CR H7534-7541)
action_date: 2008-07-30
text: Mr. Pallone moved to suspend the rules and pass the bill, as amended.
action_date: 2008-07-30
text: Placed on the Union Calendar, Calendar No. 520.
action_date: 2008-07-30
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-804.
action_date: 2008-07-30
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-804.
action_date: 2008-07-16
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2008-07-16
text: Committee Consideration and Mark-up Session Held.
action_date: 2008-07-09
text: Forwarded by Subcommittee to Full Committee by Voice Vote .
action_date: 2008-07-09
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2008-07-08
text: Referred to the Subcommittee on Health.
action_date: 2008-07-08
text: Referred to the House Committee on Energy and Commerce.
action_date: 2008-07-08
text: Introduced in House
action_date: 2008-07-08
text: Introduced in House

Enacted as: number: 110-316