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2018-12-18
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Generic Drug User Fee Rates for Fiscal Year 2019
Notices
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D09002ee1bdb8af54
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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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
Federal Register
Vol. 83, no. 145
Office of the Federal Register, National Archives and Records Administration
2018-07-27
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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
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35537
36397
DGPO
2018-12-18
2023-04-28
FR-2018-07-27
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FR-2018-07-27
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145