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2018-02-09
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Generic Drug User Fees; Public Meeting; Request for Comments
Notices
D09002ee1bdc101ef
D09002ee1bdc102a6
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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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA), which authorizes FDA to collect fees and use them for the review of certain generic human drug applications and associated Type II active pharmaceutical ingredient (API) drug master files (DMFs), and for conducting associated inspections for fiscal years (FYs) 2018 through 2022. The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to present the recommendations to the relevant Congressional committees, publish the recommendations for the reauthorized program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
81 FR 66035
https://www.govinfo.gov/app/details/FR-2016-09-26/2016-23111
2016-23111
fr26se16-78
4164-01-P
Docket No. FDA-2012-N-0882
https://www.govinfo.gov/app/details/FR-2016-09-26/2016-23111
https://www.govinfo.gov/content/pkg/FR-2016-09-26/html/2016-23111.htm
https://www.govinfo.gov/content/pkg/FR-2016-09-26/pdf/2016-23111.pdf
5 p.
66035
66039
81 FR 66035
Generic Drug User Fees; Public Meeting; Request for Comments; Federal Register Vol. 81, Issue
NOTICE
2016-23111
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-11-07
2016-10-21
Docket No. FDA-2012-N-0882
4164-01-P
2016-23111
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA), which authorizes FDA to collect fees and use them for the review of certain generic human drug applications and associated Type II active pharmaceutical ingredient (API) drug master files (DMFs), and for conducting associated inspections for fiscal years (FYs) 2018 through 2022. The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to present the recommendations to the relevant Congressional committees, publish the recommendations for the reauthorized program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
The public meeting will be held on October 21, 2016, from 9 a.m. to 5 p.m. Submit electronic or written comments to the public docket by November 7, 2016.
Derek Griffing, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993, 240-402- 6980, email: GenericDrugPolicy@fda.hhs.gov.
Meetings:
Generic Drug User Fees
,
GenericDrugPolicy@fda.hhs.gov
http://www.fda.gov
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM407849.pdf
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
www.fda.gov/gdufa
Federal Register
Vol. 81, no. 186
Office of the Federal Register, National Archives and Records Administration
2016-09-26
continuing
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338 p.
Table of Contents:
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GS 4.107:
AE 2.106:
KF70.A2
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https://www.govinfo.gov/content/pkg/FR-2016-09-26/xml/FR-2016-09-26.xml
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