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 2014_register executive 2014-10-06 article Notices D09002ee1c7f8f599 D09002ee1c7f8f651 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 rates for prescription drug user fees for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products. This notice establishes the fee rates for FY 2015. 79 FR 44807 https://www.govinfo.gov/app/details/FR-2014-08-01/2014-18113 2014-18113 fr01au14-93 4164-01-P Docket No. FDA-2014-N-0007 https://www.govinfo.gov/app/details/FR-2014-08-01/2014-18113 https://www.govinfo.gov/content/pkg/FR-2014-08-01/html/2014-18113.htm https://www.govinfo.gov/content/pkg/FR-2014-08-01/pdf/2014-18113.pdf 5 p. 44807 44811 79 FR 44807 Prescription Drug User Fee Rates for Fiscal Year 2015; Federal Register Vol. 79, Issue NOTICE 2014-18113 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-N-0007 4164-01-P 2014-18113 Notice.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products. This notice establishes the fee rates for FY 2015.

Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE-14202F, Silver Spring, MD 20993-0002, 301-796-7223. Prescription Drug User Fee Rates for Fiscal Year 2015 , http://data.bls.gov/cgi-bin/surveymost?cu Pay.gov Vol. 79, no. 148 Office of the Federal Register, National Archives and Records Administration 2014-08-01 continuing daily deposited born digital 460 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-08-01 P0b002ee189d80da5 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr01au14 https://www.govinfo.gov/app/details/FR-2014-08-01 https://www.govinfo.gov/content/pkg/FR-2014-08-01/pdf/FR-2014-08-01.pdf https://www.govinfo.gov/content/pkg/FR-2014-08-01/xml/FR-2014-08-01.xml fdlp 44635 45083 DGPO 2014-10-06 2024-06-02 FR-2014-08-01 machine generated eng FR FR-2014-08-01 79 148