United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2011_register executive 2011-08-30 article Notices D09002ee1c7ff6233 D09002ee1c7ff62c7 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2012. 76 FR 53910 https://www.govinfo.gov/app/details/FR-2011-08-30/2011-22062 2011-22062 fr30au11-68 4160-01-P Docket No. FDA-2011-N-0594 https://www.govinfo.gov/app/details/FR-2011-08-30/2011-22062 https://www.govinfo.gov/content/pkg/FR-2011-08-30/html/2011-22062.htm https://www.govinfo.gov/content/pkg/FR-2011-08-30/pdf/2011-22062.pdf 3 p. 53910 53912 76 FR 53910 Fee for Using a Priority Review Voucher in Fiscal Year 2012; Federal Register Vol. 76, Issue NOTICE 2011-22062 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2011-N-0594 4160-01-P 2011-22062 Notice.

The Food and Drug Administration (FDA) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2012.

David Miller, Office of Financial Management (HFA-100), Food and Drug Administration, 1350 Picard Dr., Rockville, MD 20850, 301-796-7103. Fee for Using a Priority Review Voucher in Fiscal Year 2012 , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf Vol. 76, no. 168 Office of the Federal Register, National Archives and Records Administration 2011-08-30 continuing daily deposited born digital 272 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-08-30 P0b002ee180de442f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr30au11 https://www.govinfo.gov/app/details/FR-2011-08-30 https://www.govinfo.gov/content/pkg/FR-2011-08-30/pdf/FR-2011-08-30.pdf https://www.govinfo.gov/content/pkg/FR-2011-08-30/xml/FR-2011-08-30.xml fdlp 53811 54070 DGPO 2011-08-30 2024-06-04 FR-2011-08-30 machine generated eng FR FR-2011-08-30 76 168