[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Page 41080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17783]
[[Page 41080]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1896]
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of the proposal period.
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SUMMARY: 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.
DATES: 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).
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: [email protected], 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.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 29, 2018 (83 FR 30751), FDA
announced the availability of a notice for industry entitled ``Quality
Metrics Site Visit Program for Center for Drug Evaluation and Research
and Center for Biologics Evaluation and Research Staff.'' Interested
persons were originally given until August 28, 2018, to submit a
proposal to the Quality Metrics Site Visit Program per the notice. The
Agency believes that extending the proposal period for an additional
120 days from the date of publication of this notice will allow
adequate time for interested persons to submit proposals for FDA's
consideration. The Site Visit Program is to provide experiential and
firsthand learning opportunities to FDA staff involved in the
development of the FDA Quality Metrics Program and to provide
stakeholders with an opportunity to explain the advantages and
challenges associated with implementing and managing a robust Quality
Metrics Program. The program and information to be included in the
proposal are explained more fully in the original notice.
II. Electronic Access
Persons with access to the internet may obtain the information
about the FDA Quality Metrics for Drug Manufacturing Program, including
this Quality Metric Site Visit Program, at https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm526869.htm.
Dated: August 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17783 Filed 8-16-18; 8:45 am]
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