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, 41080 [2018-17783]

Download as PDF 41080 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 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. Notice; extension of the proposal period. ACTION: 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. SUMMARY: 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: 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. SUPPLEMENTARY INFORMATION: DATES: amozie on DSK3GDR082PROD with NOTICES1 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 VerDate Sep<11>2014 17:17 Aug 16, 2018 Jkt 244001 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/development approvalprocess/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 DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–0279] Agency Information Collection Activities; Proposed Collection; Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before October 16, 2018. ADDRESSES: Submit your comments to Sherette.Funn@hhs.gov or by calling (202) 795–7714. SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0990–New–60D and project title for reference, to Sherrette.funn@hhs.gov, or call the Reports Clearance Officer. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. SUPPLEMENTARY INFORMATION: Information Collection Request Title: 0990–0279—Extension Institutional Review Board Registration Form Abstract: Assistant Secretary for Health, Office for Human Research Protections is requesting an extension on a currently approved information collection by the Office of Management and Budget, on the Protection of Human Subjects, on the Institutional Review Board (IRB) Form. The purpose of the IRB Registration Form is to provide a simplified procedure for institutions engaged in research conducted or supported by HHS to satisfy the (1) HHS regulations for the protection of human subjects at 45 CFR 46.103((b), 45 CFR 46.107, and 45 CFR 46, subpart E, Registration of Institutional Review Boards; and, the Food and Drug Administration (FDA) regulations for institutional review boards at 21 CFR 56.106. Likely Respondents: Institutions or organizations operating IRBs that review human subjects research conducted or supported by HHS, or, in the case of FDA’s requirements, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products. E:\FR\FM\17AUN1.SGM 17AUN1

Agencies

[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.

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

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

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