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 2018_register executive 2018-12-18 article Notices D09002ee1c7e3cce1 D09002ee1c7e3cfdc 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 Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2019 rates for GDUFA II fees. 83 FR 35649 https://www.govinfo.gov/app/details/FR-2018-07-27/2018-16067 2018-16067 fr27jy18-77 4164-01-P Docket No. FDA-2016-N-0007 https://www.govinfo.gov/app/details/FR-2018-07-27/2018-16067 https://www.govinfo.gov/content/pkg/FR-2018-07-27/html/2018-16067.htm https://www.govinfo.gov/content/pkg/FR-2018-07-27/pdf/2018-16067.pdf 5 p. 35649 35653 83 FR 35649 Generic Drug User Fee Rates for Fiscal Year 2019; Federal Register Vol. 83, Issue NOTICE 2018-16067 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-N-0007 4164-01-P 2018-16067 Notice.

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2019 rates for GDUFA II fees.

Melissa Hurley, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14202J, Silver Spring, MD 20993-0002, 240-402-4585. Generic Drug User Fee Rates for Fiscal Year 2019 , https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURA311SA0,CUUSA311SA0 https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp https://userfees.fda.gov/pay https://www.fda.gov/gdufa https://www.pay.gov/public/home Pay.gov Vol. 83, no. 145 Office of the Federal Register, National Archives and Records Administration 2018-07-27 continuing daily deposited born digital 872 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-07-27 P0b002ee19e2f2e62 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27jy18 https://www.govinfo.gov/app/details/FR-2018-07-27 https://www.govinfo.gov/content/pkg/FR-2018-07-27/pdf/FR-2018-07-27.pdf https://www.govinfo.gov/content/pkg/FR-2018-07-27/xml/FR-2018-07-27.xml fdlp 35537 36397 DGPO 2018-12-18 2024-06-01 FR-2018-07-27 machine generated eng FR FR-2018-07-27 83 145