30-day FRN

43559

Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Tawanda
Abdelmouti, Program Analyst, Office of
Policy for Extramural Research
Administration, 6705 Rockledge Drive,
Suite 805–C, Bethesda, Maryland 20892,
or call a non-toll-free number 301–435–
0978 or Email your request, including
your address to
[email protected].
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: This
proposed information collection was

previously published in the Federal
Register on April 22, 2021, page 21324
(86 FR 21234) and allowed 60 days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. Office of the
Director, Office of Extramural Research
(OER), National Institutes of Health,
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.

Proposed Collection: Inclusion
Enrollment Form Conversion to
Common Form—NEW, 0925–XXXX,
Expiration Date XX/XX/XXXX, Office of
the Director (OD), National Institutes of
Health (NIH).
Need and Use of Information
Collection: NIH’s Office of Extramural
Research (OER) Office of Policy and
Extramural Research Administration
(OPERA) is converting the Inclusion
Enrollment Report form to allow its use
by the Department of Defense (DoD).
The Inclusion Enrollment Report is used
for all applications involving NIHdefined clinical research. This form is
used to report both planned and
cumulative (or actual) enrollment, and
describes the sex/gender, race, and
ethnicity of the study participants.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
194,574.

ESTIMATED ANNUALIZED BURDEN HOURS
Information
collection forms

Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total annual
burden hours

Inclusion enrollment form ................................................................................

64,858

1

3

194,574

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

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

64,858

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

194,574

Dated: July 30, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2021–17037 Filed 8–6–21; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting

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Number of
respondents

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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

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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; AD Risk
Factors.
Date: September 8, 2021.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Nijaguna Prasad, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, 7201 Wisconsin Avenue,
Gateway Building, Suite 2W200, Bethesda,
MD 20892, 301–496–9667, nijaguna.prasad@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 4, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–16950 Filed 8–6–21; 8:45 am]
BILLING CODE 4140–01–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; PHS Applications
and Pre-Award Related Reporting
(Office of the Director)
National Institutes of Health,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:

Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/

ADDRESSES:

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09AUN1

43560

Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices

PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Ms. Mikia P.
Currie, Program Analyst, Office of
Policy for Extramural Research
Administration, 6705 Rockledge Drive,
Suite 350, Bethesda, Maryland 20892, or
call a non-toll-free number 301–435–
0941 or Email your request, including
your address to ProjectClearance
[email protected]. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on April 12, 2021, pages
18992–18993 (86 FR 18992) and
allowed 60 days for public comment. No
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The Office of the Director (OD), Office
of Policy and Extramural Research
Administration (OPERA), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Public Health
Service (PHS) Applications and PreAward Reporting Requirements,
Revision, OMB 0925–0001, Expiration
Date 2/28/2023, Office of the Director
(OD), National Institutes of Health
(NIH).

Need and Use of Information
Collection: This collection is being
revised to omit the Inclusion Enrollment
Report form, which is being converted
to a Common form to include the
Department of Defense (DoD). The
Inclusion Enrollment Report is used for
all applications involving NIH-defined
clinical research. This form is used to
report both planned and cumulative (or
actual) enrollment, and describes the
sex/gender, race, and ethnicity of the
study participants. Starting in January
2022, NIH will require will applicants
and recipients to provide their Unique
Entity Identifier (UEI) instead of the
Data Universal Number System (DUNS)
number. Also, the application forms
will be updated to align with the
Grants.gov updated Country and State
lists. NIH also anticipates adding an
optional field to the end of our forms
and applications to get a more accurate
assessment of the time it takes our
applicants to complete the various
forms and applications. This collection
also continues to includes PHS
applications and pre-award reporting
requirements: PHS 398 [paper] Public
Health Service Grant Application forms
and instructions; PHS 398 [electronic]
PHS Grant Application component
forms and agency specific instructions
used in combination with the SF424
(R&R); PHS Fellowship Supplemental
Form and agency specific instructions
used in combination with the SF424
(R&R) forms/instructions for
Fellowships [electronic]; PHS 416–1
Ruth L. Kirschstein National Research
Service Award Individual Fellowship
Application Instructions and Forms
used only for a change of sponsoring
institution application [paper];
Instructions for a Change of Sponsoring
Institution for NRSA Fellowships (F30,
F31, F32 and F33) and non-NRSA
Fellowships; PHS 416–5 Ruth L.
Kirschstein National Research Service
Award Individual Fellowship
Activation Notice; and PHS 6031
Payback Agreement. The PHS 398
(paper and electronic are currently
approved under 0925–0001. All forms
expire 2/28/2023. Post-award reporting

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Information
collection forms
PHS
PHS
PHS
PHS
PHS
PHS
PHS
PHS
PHS

Number of
respondents

398—Paper .............................................................................................
398/424—Electronic ................................................................................
Assignment Request Form ......................................................................
398 Cover Page Supplement ..................................................................
398 Modular Budget ................................................................................
398 Training Budget ................................................................................
398 Training Subaward Budget Attachment(s) Form .............................
398 Research Plan .................................................................................
398 Research Training Program Plan ....................................................

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requirements are simultaneously
consolidated under 0925–0002 and
include the Research Performance
Progress Report (RPPR). The PHS 398
and SF424 applications are used by
applicants to request Federal assistance
funds for traditional investigatorinitiated research projects and to request
access to databases and other PHS
resources. The PHS 416–1 is used only
for a change of sponsoring institution
application. PHS Fellowship
Supplemental Form and agency specific
instructions is used in combination with
the SF424 (R&R) forms/instructions for
Fellowships and is used by individuals
to apply for direct research training
support. Awards are made to individual
applicants for specified training
proposals in biomedical and behavioral
research, selected as a result of a
national competition. The PHS 416–5 is
used by individuals to indicate the start
of their NRSA awards. The PHS 6031
Payback Agreement is used by
individuals at the time of activation to
certify agreement to fulfill the payback
provisions. Clinical trials are complex
and challenging research activities.
Oversight systems and tools are critical
for NIH to ensure participant safety,
data integrity, and accountability of the
use of public funds. NIH has been
engaged in a multi-year effort to
examine how clinical trials are
supported and the level of oversight
needed. The collection of more
structured information in the PHS
applications and pre-award reporting
requirements will facilitate NIH’s
development of data systems to
facilitate oversight of clinical trials as
well as understand where gaps in the
research portfolio may exist. In
addition, some of the data collected here
will ultimately be accessible to
investigators to pre-populate certain
sections of forms when registering their
trials with ClinicalTrials.gov.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2,023,454.
Number of
responses
per
respondent

4,247
37,120
74,239
56,693
1,122
561
70,866
1,122

E:\FR\FM\09AUN1.SGM

Average
burden per
response
(in hours)
1
1
1
1
1
1
1
1

09AUN1

35
30/60
1
1
2
90/60
10
10

Total annual
burden hours

148,645
18,560
74,239
56,693
2,244
842
708,660
11,220

43561

Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices

Information
collection forms

Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total annual
burden hours

Data Tables .....................................................................................................
PHS 398 Career Development Award Supplemental Form ............................
PHS Human Subjects and Clinical Trial Information .......................................
Biosketch (424 Electronic) ...............................................................................
PHS Fellowship Supplemental Form (includes F reference letters) ...............
Biosketch (Fellowship) .....................................................................................
416–1 ...............................................................................................................
PHS 416–5 ......................................................................................................
PHS 6031 ........................................................................................................
VCOC Certification ..........................................................................................
SBIR/STTR Funding Agreement Certification .................................................

1,515
2,251
54,838
80,946
6,707
6,707
29
6,707
6,217
6
1,500

1
1
1
1
1
1
1
1
1
1
1

4
10
13
2
12.5
2
10
5/60
5/60
5/60
15/60

6,060
22,510
712,894
161,892
83,838
13,414
290
559
518
1
375

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

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

413,393

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

2,023,454

Dated: July 30, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2021–17031 Filed 8–6–21; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Meeting

lotter on DSK11XQN23PROD with NOTICES1

Number of
respondents

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory Child
Health and Human Development
Council.
The meeting will be held as a virtual
meeting and is open to the public.
Individuals who plan to view the virtual
meeting and need special assistance or
other reasonable accommodations to
view the meeting, should notify the
Contact Person listed below in advance
of the meeting. The open session will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (http://videocast.nih.gov/).
A portion of 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.
Name of Committee: National Advisory
Child Health and Human Development
Council.
Date: September 9–10, 2021.

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Open: September 9, 2021, 12:00 p.m. to
5:00 p.m.
Agenda: The agenda will include opening
remarks, administrative matters, NICHD
Director’s Report, and other business of the
Council.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C-Wing,
Conference Room 6, Bethesda, MD 20892
(Virtual Meeting).
Closed: September 10, 2021, 12:00 p.m. to
5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C-Wing,
Conference Room 6, Bethesda, MD 20894
(Virtual Meeting).
Contact Person: Ms. Lisa Neal, Committee
Management Officer, Committee
Management Branch, Eunice Kennedy
Shriver National Institute of Child Health
and Human Development, NIH, 6701B
Rockledge Drive, Room 2208, Bethesda, MD
20892, (301) 204–1830, [email protected].
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Individuals will be able to view the
meeting via NIH Videocast. Select the
following link for Videocast access
instructions: http://www.nichd.nih.gov/
about/advisory/nachhd/Pages/virtualmeeting.aspx.
Information is also available on the
Institute’s/Center’s home page: https://
www.nichd.nih.gov/about/advisory/council,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)

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Dated: August 4, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–16914 Filed 8–6–21; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Meeting of the Substance Abuse and
Mental Health Services
Administration’s National Advisory
Council
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:

Notice is hereby given of the
meeting on August 30, 2021 of the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
National Advisory Council (SAMHSA
NAC). The meeting is open to the public
and can only be accessed virtually.
Agenda with call-in information will be
posted on the SAMHSA website prior to
the meeting at: https://
www.samhsa.gov/about-us/advisorycouncils/meetings. The meeting will
include remarks and discussion with
the new Assistant Secretary for Mental
Health and Substance Use; updates on
SAMHSA priorities; follow up on topics
related to the previous SAMHSA NAC
meeting; new grant opportunities and
initiatives, and a council discussion on
clinical trends and emerging national
issues with SAMHSA NAC members.
DATES: August 30, 2021, 1:00 p.m. to
approximately 5:00 p.m. (EDT)/Open.
ADDRESSES: The meeting will be held
virtually.
SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Carlos Castillo, Committee Management

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