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8/14/2008--Public Law. (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.<br/>(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.<br/>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.<br/>(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.<br/>Sets forth a process for the Secretary to develop recommendations for the process of review of animal drug applications after FY2013.<br/>(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.<br/>(Sec. 108) Terminates the authority to collect and assess animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.<br/>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.<br/>Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.<br/>Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.<br/>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.<br/>Authorizes appropriations for FY2009-FY2013.<br/>(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.<br/>Sets forth the process for developing recommendations to present to Congress for the review of abbreviated applications for generic new animal drugs after FY2013.<br/>(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.<br/>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.<br/>(Sec. 302) Amends the Public Health Service Act to make technical corrections to provisions related to the clinical trials data bank.<br/>

1218686400 2008-08-14 Fri Nov 07 07:12:48 -0600 2008 amended by house 51511 'act':9,44 'fee':18,25 'new':29 '2007':46 'anim':15,30 'drug':6,16,31,41 'food':5,39 'make':33 'user':17 'amend':2,43 'feder':4 'relat':26 'revis':11 'cosmet':8 'extend':13 'purpos':50 'certain':34 'correct':36 'generic':28 'program':19,23 'technic':35 'administr':42 'establish':21 62565 false official passed house 51511 'fee':4 '2008':7 'anim':1 'drug':2 'user':3 'amend':5 62672 false short passed house 51511 'act':6 'fee':5 '2008':8 'anim':1 'drug':3 'user':4 'generic':2 62673 false short passed senate 51511 'fee':4 '2008':7 'anim':1 'drug':2 'user':3 'amend':5 62674 false short passed senate 51511 'act':6 'fee':5 '2008':8 'anim':1 'drug':3 'user':4 'generic':2 62675 false short introduced 51511 'act':9 'fee':18 'anim':15 'drug':6,16 'food':5 'user':17 'amend':2 'feder':4 'revis':11 'cosmet':8 'extend':13 'purpos':23 'program':19 61954 false official introduced 51511 'fee':4 '2008':7 'anim':1 'drug':2 'user':3 'amend':5 62091 false short enacted 51511 'fee':4 '2008':7 'anim':1 'drug':2 'user':3 'amend':5 62859 false short enacted 51511 'act':6 'fee':5 '2008':8 'anim':1 'drug':3 'user':4 'generic':2 62860 false short signed 51511 1218686400 Thu Aug 14 00:00:00 -0500 2008 168955 Signed by President. P000034 1951-10-30 4019 237 Cannon House Office Building http://www.house.gov/pallone/contact.shtml 6 202-225-9665 Frank 'd':4 '-6':6 'nj':5 'rep':1 'frank':2,7,9 'pallon':3,8,10 M 400308 Pallone Frank_Jr.Pallone J. Rep. Frank Pallone [D, NJ-6] 2306 N00000781 6812 Democrat 202-225-4671 Catholic NJ Frank Pallone 3.41666666666667 http://www.house.gov/pallone/ B000213 1949-09-15 6292 2109 Rayburn House Office Building http://joebarton.house.gov/ContactJoe.aspx?Type=Email 6 202-225-3052 Joe 'r':4 '-6':6 'tx':5 'joe':2,7,9 'rep':1 'barton':3,8,10 M 400018 Barton Joe_Barton Linus Rep. Joe Barton [R, TX-6] 3183 N00005656 7058 Republican 202-225-2002 Methodist TX Joe Barton 5.5 http://joebarton.house.gov/ D000168 1942-08-25 2614 2133 Rayburn House Office Building http://www.house.gov/deal/contact/default.shtml 9 202-225-8272 Nathan 'r':4 '-9':6 'ga':5 'rep':1 'deal':3,8,10 'nathan':2,7,9 M 400099 Deal Nathan_Deal Rep. Nathan Deal [R, GA-9] 1074 N00002610 6535 Republican 202-225-5211 Baptist GA Nathan Deal 6.4 http://www.house.gov/deal/ D000197 1957-07-29 3777 1527 Longworth House Office Building http://www.house.gov/formdegette/zip_auth.htm 1 202-225-5657 Diana 'd':4 '-1':6 'co':5 'rep':1 'diana':2,7,9 'degett':3,8,10 F 400101 DeGette Diana_DeGette L. Rep. Diana DeGette [D, CO-1] 1963 N00006134 7870 Democrat 202-225-4431 Presbyterian CO Diana DeGette 3.27777777777778 http://www.house.gov/degette/index.shtml ddegette D000355 1926-07-08 8549 2328 Rayburn House Office Building https://forms.house.gov/wyr/welcome.shtml 15 202-226-0371 John 'd':4 'mi':5 '-15':6 'rep':1 'john':2,7,9 'dingel':3,8,10 M 400110 Dingell John_D._Dingell D. Rep. John Dingell [D, MI-15] 5317 N00001783 12612 Democrat 202-225-4071 Roman Catholic MI John Dingell 2.79411764705882 http://www.house.gov/dingell/ T000326 1934-07-21 2091 2232 Rayburn House Office Building http://www.house.gov/towns/contact_form_zipcheck.shtml 10 202-225-1018 Edolphus 'd':4 'ed':9 'ny':5 '-10':6 'rep':1 'town':3,8,11 'edolphus':2,7,10 M 400409 Towns Edolphus_Towns Rep. Edolphus Towns [D, NY-10] 689 Ed N00001082 6547 Democrat 202-225-5936 Baptist NY Ed Edolphus Towns 1.125 http://www.house.gov/towns/ enacted 51511 1218686400 Thu Aug 14 00:00:00 -0500 2008 168956 Became Public Law No: 110-316. signed 51511 1218686400 Thu Aug 14 00:00:00 -0500 2008 168955 Signed by President. topresident 51511 1217995200 Wed Aug 06 00:00:00 -0500 2008 168930 Presented to President. action 51511 1217563200 Fri Aug 01 00:00:00 -0500 2008 168701 Message on Senate action sent to the House. topresident 51511 1217563200 Fri Aug 01 00:00:00 -0500 2008 168914 Cleared for White House. vote 51511 1217563200 Fri Aug 01 00:00:00 -0500 2008 by Unanimous Consent 168700 pass Passed Senate without amendment by Unanimous Consent. vote2 s action 51511 1217476800 Thu Jul 31 00:00:00 -0500 2008 168699 Received in the Senate, read twice. action 51511 1217476800 Thu Jul 31 00:00:00 -0500 2008 168389 Received in the Senate. vote 51511 1217443860 Wed Jul 30 15:51:00 -0500 2008 by voice vote 168387 pass On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. vote h action 51511 1217443860 Wed Jul 30 15:51:00 -0500 2008 168388 The title of the measure was amended. Agreed to without objection. action 51511 1217442780 Wed Jul 30 15:33:00 -0500 2008 168386 DEBATE - The House proceeded with forty minutes of debate on H.R. 6432. action 51511 1217442780 Wed Jul 30 15:33:00 -0500 2008 168384 Mr. Pallone moved to suspend the rules and pass the bill, as amended. action 51511 1217442780 Wed Jul 30 15:33:00 -0500 2008 168385 Considered under suspension of the rules. calendar 51511 1217436540 Wed Jul 30 13:49:00 -0500 2008 168383 Placed on the Union Calendar, Calendar No. 520. action 51511 1217436540 Wed Jul 30 13:49:00 -0500 2008 168382 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-804. calendar 51511 1216180800 Wed Jul 16 00:00:00 -0500 2008 168381 Ordered to be Reported (Amended) by Voice Vote. action 51511 1216180800 Wed Jul 16 00:00:00 -0500 2008 168380 Committee Consideration and Mark-up Session Held. action 51511 1215576000 Wed Jul 09 00:00:00 -0500 2008 166240 Subcommittee Consideration and Mark-up Session Held. action 51511 1215576000 Wed Jul 09 00:00:00 -0500 2008 166241 Forwarded by Subcommittee to Full Committee by Voice Vote . action 51511 1215489600 Tue Jul 08 00:00:00 -0500 2008 165456 Referred to the House Committee on Energy and Commerce. action 51511 1215489600 Tue Jul 08 00:00:00 -0500 2008 166239 Referred to the Subcommittee on Health. introduced 51511 1215489600 Tue Jul 08 00:00:00 -0500 2008 165455