FRN 30-Day 0990-0279

53883

Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
pharmaceuticals on the male
reproductive system. The guidance
discusses findings in nonclinical studies
that may increase the level of concern
for drug-related testicular toxicity. The
guidance provides a general approach
on how to weigh the relevance of
nonclinical findings, considering factors
that can confound the interpretation of
these findings. If a concerning
nonclinical signal is identified, the
guidance presents suggestions for
clinical monitoring when the product is
initially administered to humans.
If a reasonable basis for concern of
human testicular toxicity exists, a trial
with a primary objective of evaluating
drug-related testicular toxicity may be
warranted. The guidance provides
recommendations for the design of such
a trial, including study conduct,
endpoints, and presentation of results.
These are general recommendations for
defining the role of drugs in testicular
injury; however, the specific details of
an individual trial may vary depending
on the context of use of the drug
product.
This guidance finalizes the draft
guidance of the same name issued on
July 17, 2015 (80 FR 42501). Changes
made to the guidance took into
consideration written and verbal
comments received. In addition to
editorial changes primarily for
clarification, the major changes in the
guidance include revision of
information on nonclinical study design
(including species selection, chronic
study design, histopathology
assessment, sperm quality, and findings
that increase concern for impaired
fertility) and revision of information
that, to the extent possible, subjects
enrolled in the dedicated clinical safety
trial represent the intended population.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the evaluation of
testicular toxicity during drug
development. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR parts 50 and 56
(‘‘Protection of Human Subjects:
Informed Consent and Institutional
Review Boards’’) have been approved
under OMB control number 0910–0755.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23304 Filed 10–24–18; 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 November 26,
2018.
ADDRESSES: Submit your comments to
[email protected] or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0279
SUMMARY:

New-30D and project title for reference,
to [email protected], or call the
Reports Clearance Officer at 202–795–
7714.
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.

SUPPLEMENTARY INFORMATION:

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ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Number of
respondents

Form name

IRB Registration Update ..................................................................................

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Number of
responses per
respondent

5,650

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2

25OCN1

Average
burden per
response
(in hours)
30/60

Total burden
hours
5,650

53884

Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE—Continued
Number of
respondents

Form name

Average
burden per
response
(in hours)

Total burden
hours

IRB Registration Initial and Update .................................................................

350

2

45/60

525

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

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

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

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

6,175

Terry Clark,
Asst Paperwork Reduction Act Reports
Clearance Officer, Office of the Secretary.
[FR Doc. 2018–23282 Filed 10–24–18; 8:45 am]
BILLING CODE 4150–36–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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.

daltland on DSKBBV9HB2PROD with NOTICES

Number of
responses per
respondent

Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Cell Biology, Developmental
Biology, and Bioengineering.
Date: November 13–14, 2018.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Alexander Gubin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4196,
MSC 7812, Bethesda, MD 20892, 301–435–
2902, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–HD–
19–001 Safe and Effective Devices for Use in
Neonatal, Perinatal and Pediatric Care
Settings.
Date: November 15, 2018.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: JW Marriott New Orleans, 614 Canal
Street, New Orleans, LA 70130.
Contact Person: Clara M. Cheng, Ph.D.,
Scientific Review Officer, Center for

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Jkt 247001

Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170,
MSC 7892, Bethesda, MD 20892, 301–435–
1041, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Endocrinology, Metabolism,
Nutrition and Reproductive Sciences.
Date: November 15–16, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: JW Marriott New Orleans, 614 Canal
Street, New Orleans, LA 70130.
Contact Person: Clara M. Cheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170,
MSC 7892, Bethesda, MD 20892, 301–435–
1041, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Translational Research in Pediatric and
Obstetric Pharmacology and Therapeutics.
Date: November 16, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Discovery of Molecular Targets and
Therapeutics for Pregnancy-Related Diseases;
Drug Repurposing for Conditions Affecting
Neonates and Pregnant Women.
Date: November 16, 2018.
Time: 3:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Blood and Vascular Biology.
Date: November 19–20, 2018.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.

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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ai-Ping Zou, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9497, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Musculoskeletal, Oral, Skin, Rheumatology
and Rehab Sciences AREA (R15) Review.
Date: November 20, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bahia Resort Hotel, 998 West
Mission Bay Drive, San Diego, CA 92109.
Contact Person: Aftab A Ansari, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4108,
MSC 7814, Bethesda, MD 20892, 301–237–
9931, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 19, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–23267 Filed 10–24–18; 8:45 am]
BILLING CODE 4140–01–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

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25OCN1