60-day FRN

ATTACHMENT  
Federal Register Notice 
Vol. 83, No. 192, Wednesday, October 3, 2018 

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Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices

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Service Act (42 U.S.C. 262(k), referred to
in this document as a 351(k)
application).
This draft guidance describes how the
Agency determines if: (1) The
provisions of section 505(q) of the FD&C
Act addressing the treatment of citizen
petitions and petitions for stay of
Agency action (collectively, petitions)
apply to a particular petition and (2) a
petition would delay approval of a
pending ANDA, 505(b)(2) application,
or 351(k) application. This draft
guidance also describes how FDA
implements the provisions of section
505(q) requiring that: (1) A petition
include a certification and (2)
supplemental information or comments
to a petition include a verification. It
also addresses the relationship between
the review of petitions and pending
ANDAs, 505(b)(2) applications, and
351(k) applications for which the
Agency has not yet made a decision on
approvability.
This draft guidance revises the
guidance for industry entitled ‘‘Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act’’
issued in November 2014. This draft
guidance updates the November 2014
guidance to account for recent
regulatory changes to add § 10.31 (21
CFR 10.31) to FDA’s regulations and
modify 21 CFR 10.30 and 10.35. The
revision also describes a change in
FDA’s current thinking on what
constitutes a 505(q) petition. In
addition, FDA is revising this guidance
to describe some of the considerations
FDA will take into account in
determining whether a petition is
submitted with the primary purpose of
delaying the approval of an application
under section 505(q)(1)(E) of the FD&C
Act.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on citizen petitions and petitions for
stay of action subject to section 505(q)
of the FD&C Act. 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 draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under

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the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
10.20, 10.30, and 10.35 have been
approved under OMB control number
0910–0191; the collections of
information in § 10.31 have been
approved under OMB control number
0910–0679; and the collections of
information in 21 CFR 314.54, 314.94,
and 314.102 have been approved under
OMB control number 0910–0001. The
certification and verification statements
required under § 10.31(c) and (d) are
‘‘public disclosure[s] of information
originally supplied by the Federal
government to the recipient for the
purpose of disclosure to the public
. . .’’ (5 CFR 1320.3(c)(2)) and therefore
not subject to OMB review under the
PRA.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
http://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21532 Filed 10–2–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–New]

Agency Information Collection
Request. 60-Day 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 December 3, 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–New–60D
and project title for reference, to
[email protected], or call 202–
795–7714, the Reports Clearance
Officer.
SUMMARY:

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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.
Title of the Collection: Fertility
Knowledge Survey.
Type of Collection: OMB No. 0990–
NEW—Office of the Assistant Secretary
for Health (OASH).
Abstract: The Office of the Assistant
Secretary for Health/Office of
Population Affairs (OPA) is seeking an
approval by the Office of Management
and Budget on a new information
collection. We seek to collect
information to increase understanding
of (1) adolescent and young adult
knowledge of human (female and male)
fertility and (2) how this knowledge is
related to behaviors and intentions
involving childbearing. We propose to
collect this information through a 20minute web survey (Fertility Knowledge
Survey) of 2,100 females and 1,900
males, aged 15 to 29 years, using an
online panel that is based on a
probability-based sample of the U.S.
population. The survey will produce
evidence and findings that are expected
to be generalizable to the population of
English-speaking females and males
aged 15 to 29 years in the United States.
Possessing accurate knowledge about
human fertility is important information
that enables reproductive-aged women
and men to make informed decisions
and plans about reproduction and
empowers them to seek appropriate and
timely health services (e.g., family
planning, related preventive healthcare,
or infertility assessment) to achieve
those plans. OPA requires high-quality
information on the fertility knowledge
and related behaviors of U.S.
adolescents and young adults to inform
Title X policies and strategies that aim
to close knowledge gaps, enhance
reproductive life planning, and increase
access to appropriate and evidenceinformed care.
The Fertility Knowledge Survey will
be administered once to each
respondent. Respondents will include
English-speaking females and males,
aged 15 to 29 years, who are able to get
pregnant or father a child, respectively.
This study will rely on a web survey to

SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices
be self-administered at home on
personal computers, tablets, or phones.
A web survey has numerous
methodological advantages, including
increased accuracy in measurement of
key variables of interest, and reduced
burden on study participants.
Respondents in this study will be

members of the general public. This
collection will not involve small
business or small entities.
The estimated annualized hour
burden of responding to this
information collection is 1,333 hours, or
a weighted average of 20 minutes (.33
hours) per respondent. The hour-burden

estimate includes the time spent by a
respondent to read the email invitation,
review the online consent or assent
(minor), and complete the survey.
Participation is voluntary and there are
no costs to respondents other than their
time. OMB approval is requested for
three years.

ANNUALIZED BURDEN HOUR TABLE
Number of
respondents

Average
burden per
response

Respondents
(if necessary)

Fertility Knowledge Survey ...............

General Public, aged 15 to 29 years

4,000

1

20/60

1,333

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

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

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

4,000

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

1,333

Dated: September 27, 2018.
Terry Clark,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.

Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)

[FR Doc. 2018–21520 Filed 10–2–18; 8:45 am]
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Dated: September 27, 2018.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2018–21501 Filed 10–2–18; 8:45 am]
BILLING CODE 4140–01–P

National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting 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
respondents

Forms
(if necessary)

Name of Committee: Heart, Lung, and
Blood Initial Review Group; Clinical Trials
Review Committee.
Date: October 25–26, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Keary A. Cope, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7190, Bethesda, MD 20892–7924, 301–827–
7912, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and

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National Institutes of Health
National Institute of Mental Health;
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: National Institute of
Mental Health Special Emphasis Panel;
Jointly Sponsored Predoctoral Training
Program in the Neurosciences (T32).
Date: October 23, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin Georgetown, 2350 M
Street NW, Washington, DC 20037.
Contact Person: Erin E. Gray, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of

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Total burden
hours

Mental Health, National Institutes of Health,
6001 Executive Boulevard, NSC 6152B,
Bethesda, MD 20892, 301–402–8152,
[email protected].
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
NIMH Pathway to Independence Awards
(K99/R00).
Date: October 24, 2018.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: David W. Miller, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–9734,
[email protected].
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: September 27, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–21504 Filed 10–2–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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

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