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2018-08-17
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Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry; Extension of the Proposal Period
Notices
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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, Agency, or we) is extending the proposal period for the ``Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff,'' published in the Federal Register of June 29, 2018. FDA is extending the proposal period to allow interested persons additional time to submit an electronic or written proposal.
83 FR 41080
https://www.govinfo.gov/app/details/FR-2018-08-17/2018-17783
2018-17783
fr17au18-67
4164-01-P
Docket No. FDA-2018-N-1896
https://www.govinfo.gov/app/details/FR-2018-08-17/2018-17783
https://www.govinfo.gov/content/pkg/FR-2018-08-17/html/2018-17783.htm
https://www.govinfo.gov/content/pkg/FR-2018-08-17/pdf/2018-17783.pdf
1 p.
41080
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83 FR 41080
Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry; Extension of the Proposal Period; Federal Register Vol. 83, Issue
NOTICE
2018-17783
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-12-17
Docket No. FDA-2018-N-1896
4164-01-P
2018-17783
Notice; extension of the proposal period.
The Food and Drug Administration (FDA, Agency, or we) is extending the proposal period for the ``Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff,'' published in the Federal Register of June 29, 2018. FDA is extending the proposal period to allow interested persons additional time to submit an electronic or written proposal.
FDA is extending the proposal period on the notice published June 29, 2018 (83 FR 30751). Submit either an electronic or written proposal by December 17, 2018 directly to Tara Gooen Bizjak or Stephen Ripley (see FOR FURTHER INFORMATION CONTACT).
Tara Gooen Bizjak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301- 796-3257, email: Tara.Gooen@fda.hhs.gov, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Information Available to Industry:
Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff
,
Tara.Gooen@fda.hhs.gov
https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm526869.htm
Federal Register
Vol. 83, no. 160
Office of the Federal Register, National Archives and Records Administration
2018-08-17
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https://www.govinfo.gov/app/details/FR-2018-08-17
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https://www.govinfo.gov/content/pkg/FR-2018-08-17/pdf/FR-2018-08-17.pdf
https://www.govinfo.gov/content/pkg/FR-2018-08-17/xml/FR-2018-08-17.xml
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