Document ID: FDA-2018-N-1896-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2018-08-17T04:00Z

[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]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
 BILLING CODE 4164-01-P