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 2012_register executive 2012-10-25 article Notices D09002ee1c7fc4454 D09002ee1c7fc44ad 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 rate for the Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master File (DMF) fees related to the Generic Drug User Fee Program for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), as further amended by the FDA User Fee Correction Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY. This document establishes FY 2013 rates for an ANDA ($51,520), PAS ($25,760), and DMF ($21,340). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013. 77 FR 65198 https://www.govinfo.gov/app/details/FR-2012-10-25/2012-26256 2012-26256 fr25oc12-57 4160-01-P Docket No. FDA-2012-N-0007 https://www.govinfo.gov/app/details/FR-2012-10-25/2012-26256 https://www.govinfo.gov/content/pkg/FR-2012-10-25/html/2012-26256.htm https://www.govinfo.gov/content/pkg/FR-2012-10-25/pdf/2012-26256.pdf 2 p. 65198 65199 77 FR 65198 Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013; Federal Register Vol. 77, Issue NOTICE 2012-26256 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-N-0007 4160-01-P 2012-26256 Notice.

The Food and Drug Administration (FDA) is announcing the rate for the Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master File (DMF) fees related to the Generic Drug User Fee Program for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), as further amended by the FDA User Fee Correction Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY. This document establishes FY 2013 rates for an ANDA ($51,520), PAS ($25,760), and DMF ($21,340). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.

David Miller, Office of Financial Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr., PI50, rm. 210J, Rockville, MD 20850, 301-796-7103. Generic Drug User Fee: Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013 , http://www.fda.gov/gdufa Pay.gov Vol. 77, no. 207 Office of the Federal Register, National Archives and Records Administration 2012-10-25 continuing daily deposited born digital 163 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-10-25 P0b002ee1836cf6d2 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr25oc12 https://www.govinfo.gov/app/details/FR-2012-10-25 https://www.govinfo.gov/content/pkg/FR-2012-10-25/pdf/FR-2012-10-25.pdf https://www.govinfo.gov/content/pkg/FR-2012-10-25/xml/FR-2012-10-25.xml fdlp 65097 65249 DGPO 2012-10-25 2024-06-03 FR-2012-10-25 machine generated eng FR FR-2012-10-25 77 207