http://www.washingtonwatch.com/bills info@washingtonwatch.com http://www.pjdoland.com/chai/?v=0.1 http://www.washingtonwatch.com/bills/history/110_HR_6433.html?rev=29657 <p>H.R. 6433 would amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.</p> <h2 id="toc0"> Detailed Summary </h2> <p>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.</p> <p>Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.</p> <p>Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.</p> <p>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.</p> <p>Authorizes appropriations for FY2009-FY2013.</p> <p>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.</p> <p>Sets forth the process for developing recommendations to present to Congress for the review of abbreviated applications for generic new animal drugs after FY2013.</p> <p>Terminates the authority to assess and use generic new animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc1"> Status of the Legislation </h2> <p>Latest Major Action: 7/30/2008: Placed on the Union Calendar, Calendar No. 521.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc2"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc3"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 29657@http://www.washingtonwatch.com Fri, 15 Aug 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6433.html?rev=28701 <p>H.R. 6433 would amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.</p> <h2 id="toc4"> Detailed Summary </h2> <p>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.</p> <p>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.</p> <p>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.</p> <p>Conditions fee assessment and obligation on appropriation funding levels.</p> <p>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.</p> <p>Sets forth consultation requirements regarding the process for the review of such abbreviated applications for the five years after FY2013.</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc5"> Status of the Legislation </h2> <p>Latest Major Action: 7/30/2008: Placed on the Union Calendar, Calendar No. 521.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc6"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc7"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 28701@http://www.washingtonwatch.com Thu, 31 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_HR_6433.html 7/30/2008: Placed on the Union Calendar, Calendar No. 521. 38413@http://www.washingtonwatch.com Wed, 30 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6433.html?rev=27915 <p>H.R. 6433 would amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.</p> <h2 id="toc8"> Detailed Summary </h2> <p>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.</p> <p>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.</p> <p>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.</p> <p>Conditions fee assessment and obligation on appropriation funding levels.</p> <p>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.</p> <p>Sets forth consultation requirements regarding the process for the review of such abbreviated applications for the five years after FY2013.</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc9"> Status of the Legislation </h2> <p>Latest Major Action: 7/16/2008: House committee/subcommittee actions. Status: Ordered to be Reported (Amended) by Voice Vote.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc10"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc11"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 27915@http://www.washingtonwatch.com Wed, 23 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6433.html?rev=27687 <p>H.R. 6433 would amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.</p> <h2 id="toc12"> Detailed Summary </h2> <p>(Log in to edit the wiki and be the first to provide a detailed summary of the bill!)</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc13"> Status of the Legislation </h2> <p>Latest Major Action: 7/16/2008: House committee/subcommittee actions. Status: Ordered to be Reported (Amended) by Voice Vote.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc14"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc15"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 27687@http://www.washingtonwatch.com Fri, 18 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_HR_6433.html 7/16/2008: House committee/subcommittee actions. Status: Ordered to be Reported (Amended) by Voice Vote. 37806@http://www.washingtonwatch.com Wed, 16 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6433.html?rev=27144 <p>H.R. 6433 would amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.</p> <h2 id="toc16"> Detailed Summary </h2> <p>(Log in to edit the wiki and be the first to provide a detailed summary of the bill!)</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc17"> Status of the Legislation </h2> <p>Latest Major Action: 7/9/2008: House committee/subcommittee actions. Status: Forwarded by Subcommittee to Full Committee by Voice Vote .</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc18"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc19"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 27144@http://www.washingtonwatch.com Fri, 11 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6433.html?rev=26981 <p>H.R. 6433 would amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.</p> <h2 id="toc20"> Detailed Summary </h2> <p>(Log in to edit the wiki and be the first to provide a detailed summary of the bill!)</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc21"> Status of the Legislation </h2> <p>(Log in to edit the wiki and be the first to update the status of the bill!)</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc22"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc23"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 26981@http://www.washingtonwatch.com Wed, 09 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/history/110_HR_6433.html?rev=26982 <p>H.R. 6433 would amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.</p> <h2 id="toc24"> Detailed Summary </h2> <p>(Log in to edit the wiki and be the first to provide a detailed summary of the bill!)</p> <!--Leave in the 'summary' tags if you want the latest summary from the Congressional Research Service automatically to replace the text between the tags once it becomes available. --> <h2 id="toc25"> Status of the Legislation </h2> <p>Latest Major Action: 7/8/2008: Referred to House committee. Status: Referred to the House Committee on Energy and Commerce.</p> <!-- Leave in the 'status' tags if you want the latest reported status from THOMAS automatically to replace the text between the tags once it becomes available. --> <h2 id="toc26"> Points in Favor </h2> <p>(Log in to edit the wiki and be the first to show why the bill should pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> <h2 id="toc27"> Points Against </h2> <p>(Log in to edit the wiki and be the first to show why the bill should not pass!)<br /> <!-- First editor: Go ahead and take out the sentence in parentheses, and this notice! --> </p> 26982@http://www.washingtonwatch.com Wed, 09 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_HR_6433.html 7/9/2008: House committee/subcommittee actions. Status: Forwarded by Subcommittee to Full Committee by Voice Vote . 37497@http://www.washingtonwatch.com Wed, 09 Jul 2008 00:00:00 EDT http://www.washingtonwatch.com/bills/show/110_HR_6433.html 7/8/2008: Referred to House committee. Status: Referred to the House Committee on Energy and Commerce. 37402@http://www.washingtonwatch.com Tue, 08 Jul 2008 00:00:00 EDT