60-Day FRN

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:

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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

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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]
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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
[email protected] or by calling
(202) 795–7714.
SUMMARY:

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FOR FURTHER INFORMATION CONTACT:

When submitting comments or
requesting information, please include
the document identifier 0990–New–60D
and project title for reference, to
[email protected], 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.

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41081

Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Average
burden per
response
(in hours)

Total burden
hours

IRB Registration 0990–0279 ...........................................................................

5,650
350

2
2

1
1.5

11,300
525

Total ..........................................................................................................

........................

........................

........................

11,825

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, [email protected].
(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)

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.

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Number of
responses per
respondent

Number of
respondents

Form name

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, [email protected].
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.

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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.

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.
SUMMARY:

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FOR FURTHER INFORMATION CONTACT:

Please direct all inquiries to Samantha
White, Ph.D., National Institute of
Neurological Disorders and Stroke, 301–
496–1675; [email protected]
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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