Attachment E: 60-Day FRN

44130

Federal Register / Vol. 87, No. 141 / Monday, July 25, 2022 / Notices

the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Operational Policy, Office of
Regulatory Affairs, Food and Drug
Administration, Element Building,
12420 Parklawn Dr., Rockville, MD
20852. Send one self-addressed
adhesive label to assist the office in
processing your requests. The draft
guidance may also be obtained by email
by emailing ORA at orapolicystaffs@
fda.hhs.gov. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Christopher Henderson, Office of
Regulatory Affairs, Food and Drug
Administration, Element Building,
12420 Parklawn Dr., Rockville, MD
20857, Christopher.Henderson@
fda.hhs.gov, 240–402–8186; or Ben
Firschein, Office of Regulatory Affairs,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Silver
Spring, MD 20993–0002,
[email protected], 240–402–
8186.
SUPPLEMENTARY INFORMATION:

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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Conducting Remote Regulatory
Assessments—Questions and Answers.’’
FDA is issuing the draft guidance to
describe the Agency’s current thinking
regarding its use of RRAs in order to
help increase industry’s understanding
of RRAs, thereby facilitating FDA’s
process for conducting remote
assessments. RRAs include requests for
records and other information for FDA
review and interactive evaluations of an
FDA-regulated establishment or product
with the use of, for example,
livestreaming video. RRAs can be either
voluntary or mandated. FDA has used
RRAs to conduct oversight, mitigate
risk, meet critical public health needs,
and help maximize compliance with

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applicable FDA requirements, for all
types of FDA-regulated products.
For example, during the Coronavirus
Disease 2019 (COVID–19) pandemic,
FDA has used RRAs to inform approval
and licensing decisions, verify
corrective actions for establishments
with an acceptable compliance status,
and gain compliance insight into
establishments that FDA has been
unable to inspect. This experience has
identified significant benefits of using
RRAs to FDA, regulated industry, and
the public. For these and other reasons,
FDA is issuing this draft guidance to
describe its intention to, when
appropriate, continue to use RRAs
outside of the COVID–19 public health
emergency and for all FDA-regulated
product types.
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 ‘‘Conducting Remote Regulatory
Assessments.’’ 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.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://
www.regulations.gov.
Dated: July 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–15812 Filed 7–22–22; 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

SUMMARY:

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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 September 23,
2022.
ADDRESSES: Submit your comments to
[email protected] or by calling
(202) 264–0041.
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 A. Funn, email:
[email protected], or call (202)
264–0041 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.
Title of the Collection: Teen
Pregnancy Prevention Fiscal Year 2020/
2021 Tier 1 and Tier 2 Implementation
Study.
Type of Collection: New collection.
OMB No. 0990–NEW–Office of
Population Affairs.
Abstract: The Office of Population
Affairs (OPA), U.S. Department of
Health and Human Services (HHS) is
requesting 2 years of approval by OMB
on a new collection. The Teen
Pregnancy Prevention (TPP) Tier 1 and
Tier 2 Implementation Study will
document how 75 grantees funded in
2020 and 2021 are implementing their
grant strategies to reduce rates of teen
pregnancy and sexually transmitted
infections in their selected communities
or priority areas. OPA anticipates that
grantees will employ diverse strategies
working with partner organizations
within communities to implement their
teen pregnancy prevention projects. To
document approaches and experiences
of each grantee, a lead staff member in
each grantee organization and up to one
other staff member will be interviewed
during an in-person or virtual site visit.
Up to two staff members from key
grantee partner organizations will be
interviewed for 31 of the 62 Tier 1
grantees and all 13 Tier 2 grantees.

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44131

Federal Register / Vol. 87, No. 141 / Monday, July 25, 2022 / Notices
Type of Respondent: Interview
participants will include up to 124 Tier
1 grantee staff members, 62 Tier 1
grantee partner organization staff

members, 26 Tier 2 grantee staff
members and 26 Tier 2 grantee partner
organization staff members.
Frequency: One time.

Affected Parties: Public and private
businesses.

ANNUALIZED BURDEN HOUR TABLE

Tier 1 Grantee Interview Guide ........

124

1

2

248

62
26

1
1

1
2

62
52

Tier 2 Partner Interview Guide .........

Tier 1 grantee director and other
staff.
Tier 1 grantee partner staff ..............
Tier 2 grantee director and other
staff.
Tier 2 grantee partner staff ..............

26

1

1

26

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

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

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

1

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

388

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–15792 Filed 7–22–22; 8:45 am]
BILLING CODE 4150–34–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; 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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Average
burden per
response

Respondents
(if necessary)

Tier 1 Partner Interview Guide .........
Tier 2 Grantee Interview Guide ........

Name of Committee: National Cancer
Institute Special Emphasis Panel NCI
Informatics Technologies for Cancer
Research.
Date: September 8–9, 2022.
Time: 10 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W236, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Shuli Xia, Ph.D., Scientific
Review Officer, Research Technology and
Contract Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W236, Rockville, Maryland 20852,
240–276–5460, [email protected].

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Number of
respondents

Number of
responses per
respondents

Forms
(if necessary)

Name of Committee: National Cancer
Institute Special Emphasis Panel IMAT
Biospecimen Research.
Date: September 16, 2022.
Time: 10 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W236, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Shuli Xia, Ph.D., Scientific
Review Officer, Research Technology and
Contract Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W236, Rockville, Maryland 20852,
240–276–5256, [email protected].
Name of Committee: National Cancer
Institute Special Emphasis Panel Transition
Career Development Award (K22) and
Institutional Training and Education (T32,
R25).
Date: September 22, 2022.
Time: 10 a.m. to 7 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W234, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Adriana Stoica, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W234, Rockville, Maryland 20850,
240–276–6368, [email protected].
Name of Committee: National Cancer
Institute Special Emphasis Panel Innovative
Molecular and Cellular Analysis
Technologies.
Date: October 5, 2022.
Time: 10 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W246, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Jun Fang, Ph.D., Scientific
Review Officer, Research Technology and
Contract Review Branch, Division of
Extramural Activities, National Cancer

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Total burden
hours

Institute, NIH, 9609 Medical Center Drive,
Room 7W246, Rockville, Maryland 20850,
240–276–5460, [email protected].
Name of Committee: National Cancer
Institute Special Emphasis Panel NCI
Program Project (P01) SEP–D.
Date: October 6–7, 2022.
Time: 9:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W248, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Anita T. Tandle, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W248,
Rockville, Maryland 20850, 240–276–5007,
[email protected].
Name of Committee: National Cancer
Institute Special Emphasis Panel NCI SPORE
(P50) Review I.
Date: October 18–19, 2022.
Time: 9 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W634, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Michael E. Lindquist,
Ph.D., Scientific Review Officer, Research
Programs Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W634, Rockville, Maryland 20850,
240–276–5735, [email protected].
Name of Committee: National Cancer
Institute Special Emphasis Panel NCI SPORE
(P50) Review II.
Date: October 19–20, 2022.
Time: 9 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W618, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Mukesh Kumar, Ph.D.,
Scientific Review Officer, Research Program
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,

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