3.0.0 6432 2023-11-13T20:31:11Z 2023-11-13T20:31:11Z House H HR 2008-07-08 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2008-07-09T18:30:05Z Markup by 2008-07-09T18:29:51Z Referred to 2008-07-08T18:29:09Z Reported by 2008-07-30T17:49:16Z Markup by 2008-07-16T18:51:20Z Referred to 2008-07-08T18:02:00Z H. Rept. 110-804 2008-08-14 Became Public Law No: 110-316. President E40000 2 House floor actions 2008-08-14 Became Public Law No: 110-316. BecameLaw 36000 9 Library of Congress 2008-08-14 Signed by President. President E30000 2 House floor actions 2008-08-14 Signed by President. BecameLaw 36000 9 Library of Congress 2008-08-06 Presented to President. Floor E20000 2 House floor actions 2008-08-06 Presented to President. President 28000 9 Library of Congress 2008-08-01 Cleared for White House. 2008-08-01 Senate Message on Senate action sent to the House. Floor 2008-08-01 Senate Passed Senate without amendment by Unanimous Consent. (consideration: CR S7984) Floor 2008-08-01 Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S7984) Floor 17000 9 Library of Congress 2008-07-31 Senate Received in the Senate, read twice. IntroReferral 2008-07-30 15:51:25 The title of the measure was amended. Agreed to without objection. Floor H38800 2 House floor actions 2008-07-30 15:51:21 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2008-07-30 15:51:15 On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7534-7539) Floor H37300 2 House floor actions 2008-07-30 15:51:15 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) Floor 8000 9 Library of Congress 2008-07-30 15:33:27 DEBATE - The House proceeded with forty minutes of debate on H.R. 6432. Floor H8D000 2 House floor actions 2008-07-30 15:33:25 Considered under suspension of the rules. (consideration: CR H7534-7541) Floor H30000 2 House floor actions 2008-07-30 15:33:08 Mr. Pallone moved to suspend the rules and pass the bill, as amended. Floor H30300 2 House floor actions 2008-07-30 Placed on the Union Calendar, Calendar No. 520. Calendars H12410 2 House floor actions U00520 2008-07-30 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-804. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2008-07-30 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-804. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2008-07-16 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by Voice Vote. Committee 2008-07-16 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2008-07-09 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee by Voice Vote . Committee 2008-07-09 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2008-07-08 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2008-07-08 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2008-07-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2008-07-08 Introduced in House IntroReferral 1000 9 Library of Congress P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 N D000355 Rep. Dingell, John D. [D-MI-15] JOHN DINGELL D MI D. 15 2008-07-08 True B000213 Rep. Barton, Joe [R-TX-6] JOE BARTON R TX L. 6 2008-07-08 True D000168 Rep. Deal, Nathan [R-GA-9] NATHAN DEAL R GA 9 2008-07-08 True T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 2008-07-08 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2008-07-10 False 2008-07-28T04:00:00Z H.R. 6432, Animal Drug User Fee Amendments of 2008 http://www.cbo.gov/publication/20116 <p>Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on July 16, 2008</p> 2008-07-28T04:00:00Z H.R. 6432, Animal Drug User Fee Amendments of 2008 https://www.cbo.gov/publication/20116 Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on July 16, 2008 Public Law 110-316 Health 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 Health 00 2008-07-08 Introduced in House 2008-08-15T20:26:47Z 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.

]]> 36 2008-07-30 Passed House amended 2008-08-15T20:50:17Z 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 "process for the review of animal drug applications" 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.

]]> 82 2008-08-01 Passed Senate without amendment 2008-08-15T20:50:39Z (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 "process for the review of animal drug applications" 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.

]]> 49 2008-08-14 Public Law 2008-08-20T13:46:34Z (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 "process for the review of animal drug applications" 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.

]]> 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. Short Titles as Introduced Animal Drug User Fee Amendments of 2008 Short Titles as Passed House for portions of this bill Animal Generic Drug User Fee Act of 2008 H House Short Titles as Passed House for portions of this bill Animal Drug User Fee Amendments of 2008 H House Short Titles as Passed Senate for portions of this bill Animal Generic Drug User Fee Act of 2008 S Senate Short Titles as Passed Senate for portions of this bill Animal Drug User Fee Amendments of 2008 S Senate Short Titles as Enacted for portions of this bill Animal Generic Drug User Fee Act of 2008 Short Titles as Enacted for portions of this bill Animal Drug User Fee Amendments of 2008 Display Title 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. Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, and for other purposes. Official Titles as Amended by House 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. H House Enrolled Bill 2008-08-01T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr6432enr/xml/BILLS-110hr6432enr.xml Received in Senate 2008-07-31T04:00:00Z Engrossed in House 2008-07-30T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr6432eh/xml/BILLS-110hr6432eh.xml Reported in House 2008-07-30T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr6432rh/xml/BILLS-110hr6432rh.xml Introduced in House 2008-07-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr6432ih/xml/BILLS-110hr6432ih.xml 2008-08-15T03:59:59Z Public Law 2008-08-14 Became Public Law No: 110-316. 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.