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. 

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: 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: 

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/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 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: 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. 

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. 

SUPPLEMENTARY INFORMATION: 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. 

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. 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41081 

ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

IRB Registration 0990–0279 ........................................................................... 5,650 2 1 11,300 

350 2 1.5 525 

Total .......................................................................................................... ........................ ........................ ........................ 11,825 

Terry Clark, 

Asst. Information Collection Clearance 

Officer. 

[FR Doc. 2018–17748 Filed 8–16–18; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Neurological Sciences 

Training Initial Review Group; NST–1 

Subcommittee. 

Date: September 17–18, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Kinzie Hotel, 20 West Kinzie Street, 

Chicago, IL 60654. 

Contact Person: William C. Benzing, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd., SUITE 3204, 

MSC 9529, Bethesda, MD 20892–9529, (301) 

496–0660, benzingw@mail.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Ruth L. Kirschstein National 

Research Service Award (NRSA) Institutional 

Research Training Grant (T32) Program. 

Date: November 14–15, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Crystal City, 2399 Jefferson 

Davis Hwy., Arlington, VA 22202. 

Contact Person: Elizabeth A. Webber, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20892– 

9529, (301) 496–1917, webbere@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: August 13, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–17780 Filed 8–16–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Request for Information To Solicit 

Feedback on the Brain Research 

Through Advancing Innovative 

Neurotechnologies (BRAIN) Initiative 

AGENCY: National Institutes for Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The purpose of this Request 

for Information (RFI) is to solicit input 

on how best to accomplish the 

ambitious vision for the Brain Research 

through Advancing Innovative 

Neurotechnologies (BRAIN) Initiative®

set forth in BRAIN 2025: A Scientific 

Vision. NIH is soliciting input from all 

interested stakeholders, including 

members of the scientific community, 

trainees, academic institutions, the 

private sector, health professionals, 

professional societies, advocacy groups, 

and patient communities, as well as 

other interested members of the public. 

DATES: The Request for Information is 

open for public comment. To assure 

consideration, your responded must be 

received by November 15, 2018, 11:59 

p.m. 

ADDRESSES: Responses to this RFI must 

be submitted electronically using the 

web-based form at https://

www.braininitiative.nih.gov/rfi.aspx. 

FOR FURTHER INFORMATION CONTACT: 

Please direct all inquiries to Samantha 

White, Ph.D., National Institute of 

Neurological Disorders and Stroke, 301– 

496–1675; BRAINFeedback@nih.gov 

with ‘‘BRAIN RFI’’ in the subject line. 

SUPPLEMENTARY INFORMATION: 

Background 

The BRAIN Initiative aims to develop 

new tools and technologies to 

understand and manipulate networks of 

cells in the brain. BRAIN 2025: A 

Scientific Vision serves as the strategic 

plan for the BRAIN Initiative at NIH and 

outlines an overarching vision, seven 

high level scientific priorities, and many 

specific goals. Designed to be achieved 

over at least a decade, the first five years 

of BRAIN 2025 emphasizes 

development of tools and technology, 

and the next five years shifts emphasis 

to using these tools to make 

fundamental discoveries about how 

brain circuits work and what goes 

wrong in disease. 

The BRAIN Initiative is well 

underway (see http://

www.braininitiative.nih.gov), and we are 

now approaching the midpoint. At this 

time, NIH is seeking feedback on the 

BRAIN Initiative’s progress and on 

opportunities moving forward given the 

current state of the science. NIH has 

established a new BRAIN Initiative 

Advisory Committee of the NIH Director 

(ACD) Working Group that will provide 

scientific guidance to the ACD on how 

best to continue to accelerate the 

ambitious vision for the BRAIN 

Initiative. 

The ACD–WG will use the responses 

to this RFI, along with information 

gathered through a series of public 

workshops, to help inform their 

discussions of the BRAIN Initiative’s 

progress and potential updates to the 

plan moving forward. 

Information Requested 

Anyone wishing to submit a response 

is asked to include: 

• Ideas for new tools and 

technologies that have the potential to 

transform brain circuit research. 

• Suggestions for fundamental 

questions about brain circuit function in 


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