Attachment C OMB FRN 60 and 30 day

ATTACHMENT C 
60‐ and 30‐Day Federal Register Notices 

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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This draft guidance describes how the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 This draft
guidance also describes how FDA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This draft guidance revises the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 This draft
guidance updates the November 2014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This draft guidance is being issued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The draft guidance, when finalized, will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This draft guidance refers to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]
BILLING CODE 4164–01–P

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
Sherrette.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 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]
BILLING CODE 4150–34–P

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, copeka@mail.nih.gov.
(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,
erin.gray@nih.gov.
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,
millerda@mail.nih.gov.
(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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development for rare diseases, this draft
guidance expands on the topic of
natural history studies specifically.
There are approximately 7,000
recognized rare diseases. Individually,
rare diseases affect a small number of
people, but collectively rare diseases
affect about 1 in 10 people in the United
States. Most rare diseases have no
approved therapies and thus present a
significant unmet public health need.
Although knowledge of a disease’s
natural history can benefit drug
development for many disorders and
conditions, natural history information
is usually not available or is incomplete
for most rare diseases; therefore, natural
history information is particularly
needed for these diseases.
This draft guidance describes the
potential uses of a natural history study
in all phases of drug development and
in the postmarketing period, the
strengths and weaknesses of various
types of natural history studies that
might be conducted to support drug
development, data elements and
research plans, and a practical
framework for the conduct of a natural
history study. The draft guidance also
discusses patient confidentiality and
data protection issues in natural history
studies and the potential nature of
interactions with FDA related to these
studies.
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 ‘‘Rare Diseases: Natural History
Studies for 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 parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively. The collections of
information in 21 CFR parts 50 and 56
(Protection of Human Subjects:
Informed Consent; Institutional Review
Boards) have been approved under OMB
control number 0910–0755.

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III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/default.htm, or https://
www.regulations.gov.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05655 Filed 3–22–19; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–New]

Agency Information Collection
Request; 30-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 April 24, 2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0937-Fertility Knowledge Survey-30D
and project title for reference.
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.
Title of the Collection: Fertility
Knowledge Survey.
SUMMARY:

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Type of Collection: New.
Abstract: The Office of the Assistant
Secretary for Health/Office of
Population Affairs (OPA) is requesting a
three-year approval by the Office of
Management and Budget of a new
information collection. We are seeking
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 20-minute 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. Respondents will
be members of the general public, and
consist of English-speaking females and
males, aged 15 to 29 years, who are able
to get pregnant or to biologically father
a child, respectively. The survey will
produce evidence and findings that are
expected to be generalizable to the
population of individuals in the United
States with these characteristics.
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 web survey (Fertility Knowledge
Survey) will be self-administered once
by each respondent using a personal
computer, tablet, or smart phone. A web
survey has numerous methodological
advantages, including increased
accuracy in measurement of key
variables of interest, and reduced
burden on study participants. 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

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no costs to respondents other than their
time.

ANNUALIZED BURDEN HOUR TABLE
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

Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2019–05595 Filed 3–22–19; 8:45 am]
BILLING CODE 4150–48–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0010]

Agency Information Collection
Activities: Certificate of Registration
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 60-day notice and request for
comments; Extension of an existing
collection of information.
AGENCY:

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FOR FURTHER INFORMATION CONTACT:

Requests for additional PRA information
should be directed to Seth Renkema,
Chief, Economic Impact Analysis
Branch, U.S. Customs and Border
Protection, Office of Trade, Regulations
and Rulings, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177,
Telephone number 202–325–0056 or via
email CBP_PRA@cbp.dhs.gov. Please
note that the contact information
provided here is solely for questions
regarding this notice. Individuals
seeking information about other CBP
programs should contact the CBP
National Customer Service Center at
877–227–5511, (TTY) 1–800–877–8339,
or CBP website at https://www.cbp.gov/.
CBP
invites the general public and other
Federal agencies to comment on the
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). This process is conducted in
accordance with 5 CFR 1320.8. Written
comments and suggestions from the
public and affected agencies should
address one or more of the following
four points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
suggestions to enhance the quality,
utility, and clarity of the information to
be collected; and (4) suggestions to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses. The
comments that are submitted will be
summarized and included in the request
for approval. All comments will become
a matter of public record.

SUPPLEMENTARY INFORMATION:

The Department of Homeland
Security, U.S. Customs and Border
Protection will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
DATES: Comments are encouraged and
must be submitted (no later than May
24, 2019) to be assured of consideration.
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice must include
the OMB Control Number 1651–0010 in
the subject line and the agency name.
To avoid duplicate submissions, please
use only one of the following methods
to submit comments:
(1) Email. Submit comments to: CBP_
PRA@cbp.dhs.gov.
(2) Mail. Submit written comments to
CBP Paperwork Reduction Act Officer,
U.S. Customs and Border Protection,
Office of Trade, Regulations and
Rulings, Economic Impact Analysis
Branch, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177.
SUMMARY:

Number of
respondents

Number of
responses per
respondents

Forms
(if necessary)

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Total burden
hours

Overview of This Information
Collection
Title: Certificate of Registration.
OMB Number: 1651–0010.
Form Number: CBP Forms 4455 and
4457.
Abstract: Travelers who do not have
proof of prior possession in the United
States of foreign made articles and who
do not want to be assessed duty on these
items can register them prior to
departing on travel. In order to register
these articles, the traveler completes
CBP Form 4457, Certificate of
Registration for Personal Effects Taken
Abroad, and presents it at the port at the
time of export. This form must be signed
in the presence of a CBP official after
verification of the description of the
articles is completed. CBP Form 4457 is
accessible at: http://www.cbp.gov/
newsroom/publications/
forms?title=4457&=Apply.
CBP Form 4455, Certificate of
Registration, is used primarily for the
registration, examination, and
supervised lading of commercial
shipments of articles exported for
repair, alteration, or processing, which
will subsequently be returned to the
United States either duty free or at a
reduced duty rate. CBP Form 4455 is
accessible at: http://www.cbp.gov/
newsroom/publications/
forms?title=4455&=Apply.
CBP Forms 4455 and 4457 are
provided for by 19 CFR 10.8, 10.9,
10.68, 148.1, 148.8, 148.32 and 148.37.
Action: CBP proposes to extend the
expiration date of this information
collection with no change to the burden
hours or to the information collected on
CBP Forms 4455 and 4457.
Type of Review: Extension (without
change).
Affected Public: Businesses.
CBP Form 4455
Estimated Number of Respondents:
60,000.
Estimated Number of Annual
Responses per Respondent: 1.
Estimated Number of Total Annual
Responses: 60,000.
Estimated Time per Response: 10
minutes.

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