3.0.0 6433 2022-02-03T05:19:34Z 2022-05-20T16:27:20Z House H HR 2008-07-08 110 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2008-07-09T18:30:44Z Markup by 2008-07-09T18:30:34Z Referred to 2008-07-08T18:31:17Z Reported by 2008-07-30T17:49:42Z Markup by 2008-07-16T18:52:53Z Referred to 2008-07-08T18:01:40Z H. Rept. 110-805 2008-07-30 Placed on the Union Calendar, Calendar No. 521. Calendars H12410 2 House floor actions U00521 2008-07-30 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-805. 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. 110-805. 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. 6433, Animal Generic Drug User Fee Act of 2008 http://www.cbo.gov/publication/20117 <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. 6433, Animal Generic Drug User Fee Act of 2008 https://www.cbo.gov/publication/20117 Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on July 16, 2008 Health Administrative fees Administrative procedure Animals Appropriations Authorization Commerce Congress Congressional reporting requirements Department of Health and Human Services Drug approvals Drug industry Economics and Public Finance Electronic government information Food and Drug Administration (FDA) Generic drugs Government Operations and Politics Government publicity Law Pharmaceutical research Science, Technology, Communications Sunset legislation Veterinary medicine Health 00 2008-07-08 Introduced in House 2008-07-23T18:03:10Z Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to collect: (1) an application fee from persons who submit an abbreviated application for a generic new animal drug on or after July 1, 2008; (2) an annual product fee from applicants named in an abbreviated application or supplemental abbreviated application for a generic new animal drug product that has been submitted for listing for commercial distribution who have such an application pending before the Secretary after September 1, 2008; and (3) an annual sponsor fee from generic new animal drug sponsors who have such an application or an investigational submission pending after such date.

Sets forth the total revenues to be collected from each of such fees in each of FY2009-FY2013. Provides for revenue adjustments based on application review workloads. Requires the Secretary to establish such fees before each fiscal year based on such revenue amounts and adjustments and total review costs.

Deems such an application or investigational submission to be incomplete until all such fees have been paid. Authorizes the Secretary to waive or reduce such fees where the drug is intended solely to provide for a minor use or minor species indication.

Conditions fee assessment and obligation on appropriation funding levels.

Requires the Secretary to report annually on: (1) the Food and Drug Administration's (FDA's) progress in expediting the development process and the review of abbreviated applications and investigational submissions for generic new animal drugs; and (2) implementation of the fee authority and FDA's use of the fees.

Sets forth consultation requirements regarding the process for the review of such abbreviated applications for the five years after FY2013.

]]> 17 2008-07-30 Reported to House with amendment(s) 2008-08-15T21:00:08Z Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services 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.

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.

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

]]> Animal Generic Drug User Fee Act of 2008 Short Titles as Introduced Animal Generic Drug User Fee Act of 2008 Short Titles as Reported to House Animal Generic Drug User Fee Act of 2008 H House Display Title Animal Generic Drug User Fee Act of 2008 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs. Reported in House 2008-07-30T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr6433rh/xml/BILLS-110hr6433rh.xml Introduced in House 2008-07-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr6433ih/xml/BILLS-110hr6433ih.xml 2008-07-30 Placed on the Union Calendar, Calendar No. 521. 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.