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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 160 (August 17, 2018)

Page Range		41080-41080
FR Document		2018-17783

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.

Federal Register, Volume 83 Issue 160 (Friday, August 17, 2018)

[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Page 41080]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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

41080 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices

DEPARTMENT OF HEALTH AND until August 28, 2018, to submit a FOR FURTHER INFORMATION CONTACT:
HUMAN SERVICES proposal to the Quality Metrics Site When submitting comments or
Visit Program per the notice. The requesting information, please include
Food and Drug Administration Agency believes that extending the the document identifier 0990–New–60D
proposal period for an additional 120 and project title for reference, to
[Docket No. FDA–2018–N–1896]
days from the date of publication of this Sherrette.funn@hhs.gov, or call the
Quality Metrics Site Visit Program for notice will allow adequate time for Reports Clearance Officer.
Center for Drug Evaluation and interested persons to submit proposals
SUPPLEMENTARY INFORMATION: Interested
Research and Center for Biologics for FDA’s consideration. The Site Visit
persons are invited to send comments
Evaluation and Research Staff; Program is to provide experiential and
regarding this burden estimate or any
Information Available to Industry; firsthand learning opportunities to FDA
other aspect of this collection of
Extension of the Proposal Period staff involved in the development of the
information, including any of the
FDA Quality Metrics Program and to
following subjects: (1) The necessity and
AGENCY: Food and Drug Administration, provide stakeholders with an
utility of the proposed information
HHS. opportunity to explain the advantages
collection for the proper performance of
ACTION:Notice; extension of the and challenges associated with
the agency’s functions; (2) the accuracy
proposal period. implementing and managing a robust
of the estimated burden; (3) ways to
Quality Metrics Program. The program
enhance the quality, utility, and clarity
SUMMARY: The Food and Drug and information to be included in the
of the information to be collected; and
Administration (FDA, Agency, or we) is proposal are explained more fully in the
(4) the use of automated collection
extending the proposal period for the original notice.
techniques or other forms of information
‘‘Quality Metrics Site Visit Program for
II. Electronic Access technology to minimize the information
Center for Drug Evaluation and Research
collection burden.
and Center for Biologics Evaluation and Persons with access to the internet
Research Staff,’’ published in the may obtain the information about the Information Collection Request Title:
Federal Register of June 29, 2018. FDA FDA Quality Metrics for Drug 0990–0279—Extension Institutional
is extending the proposal period to Manufacturing Program, including this Review Board Registration Form
allow interested persons additional time Quality Metric Site Visit Program, at
to submit an electronic or written https://www.fda.gov/drugs/development Abstract: Assistant Secretary for
proposal. approvalprocess/manufacturing/ Health, Office for Human Research
ucm526869.htm. Protections is requesting an extension
DATES: FDA is extending the proposal on a currently approved information
period on the notice published June 29, Dated: August 10, 2018.
collection by the Office of Management
2018 (83 FR 30751). Submit either an Leslie Kux, and Budget, on the Protection of Human
electronic or written proposal by Associate Commissioner for Policy. Subjects, on the Institutional Review
December 17, 2018 directly to Tara [FR Doc. 2018–17783 Filed 8–16–18; 8:45 am] Board (IRB) Form. The purpose of the
Gooen Bizjak or Stephen Ripley (see FOR BILLING CODE 4164–01–P IRB Registration Form is to provide a
FURTHER INFORMATION CONTACT). simplified procedure for institutions
FOR FURTHER INFORMATION CONTACT: Tara engaged in research conducted or
Gooen Bizjak, Center for Drug DEPARTMENT OF HEALTH AND supported by HHS to satisfy the (1) HHS
Evaluation and Research, Food and HUMAN SERVICES regulations for the protection of human
Drug Administration, 10903 New [Document Identifier: OS–0990–0279]
subjects at 45 CFR 46.103((b), 45 CFR
Hampshire Ave., Bldg. 51, Rm. 2109, 46.107, and 45 CFR 46, subpart E,
Silver Spring, MD 20993–0002, 301– Agency Information Collection Registration of Institutional Review
796–3257, email: Tara.Gooen@ Activities; Proposed Collection; Public Boards; and, the Food and Drug
fda.hhs.gov, or Stephen Ripley, Center Comment Request Administration (FDA) regulations for
for Biologics Evaluation and Research, institutional review boards at 21 CFR
Food and Drug Administration, 10903 AGENCY: Office of the Secretary, HHS. 56.106.
New Hampshire Ave., Bldg. 71, Rm. ACTION: Notice. Likely Respondents: Institutions or
7301, Silver Spring, MD 20993–0002, organizations operating IRBs that review
240–402–7911. SUMMARY: In compliance with the
human subjects research conducted or
requirement of the Paperwork
SUPPLEMENTARY INFORMATION: supported by HHS, or, in the case of
Reduction Act of 1995, the Office of the
FDA’s requirements, each IRB in the
I. Background Secretary (OS), Department of Health
United States that reviews clinical
and Human Services, is publishing the
In the Federal Register of June 29, investigations regulated by FDA under
following summary of a proposed
2018 (83 FR 30751), FDA announced the sections 505(i) or 520(g) of the Federal
collection for public comment.
availability of a notice for industry Food, Drug and Cosmetic Act; and each
entitled ‘‘Quality Metrics Site Visit DATES: Comments on the ICR must be IRB in the United States that reviews
Program for Center for Drug Evaluation received on or before October 16, 2018. clinical investigations that are intended
and Research and Center for Biologics ADDRESSES: Submit your comments to to support applications for research or
amozie on DSK3GDR082PROD with NOTICES1

Evaluation and Research Staff.’’ Sherette.Funn@hhs.gov or by calling marketing permits for FDA-regulated
Interested persons were originally given (202) 795–7714. products.

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Document Created: 2018-08-17 03:24:50
Document Modified: 2018-08-17 03:24:50

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; extension of the proposal period.
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).
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.
FR Citation		83 FR 41080

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 160 (August 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration