30-day Notice

Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Secretary Notice of
Meeting

khammond on DSKJM1Z7X2PROD with NOTICES

Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Task Force on Research
Specific to Pregnant Women and
Lactating Women.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Task Force on
Research Specific to Pregnant Women and
Lactating Women.
Date: February 3, 2020.
Time: 8:30 a.m. to 4:45 p.m.
Agenda: The Task Force is charged with
providing advice and guidance to the
Secretary of HHS, regarding Federal activities
related to identifying and addressing gaps in
knowledge and research regarding safe and
effective therapies for pregnant women and
lactating women, including the development
of such therapies and the collaboration on
and coordination of such activities.
8:00 a.m. Registration
8:30 a.m.–4:45 p.m. Open Session
Place: NICHD Offices, Multipurpose Room
1425/1427 (1st Floor), 6710B Rockledge
Drive, Bethesda, MD 20892.
Contact Person: Lisa Kaeser, Executive
Secretary, Office of Legislation and Public
Policy, Eunice Kennedy Shriver, National
Institute of Child Health and Human
Development, Bethesda, MD 20892, (301)
496–0536, kaeserl@mail.nih.gov.
Public comments are welcome either by
filing written comments in advance and/or
providing oral comments at the meeting.
Written comments to be included at the
meeting should be sent to Lisa Kaeser by 5:00
p.m. on Friday, January 24, 2020. Brief oral
comments from the public may occur during
the discussion periods following each of the
four working group presentations.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto NIH federal property. Visitors will be
asked to show one form of identification (for
example, a government-issued photo ID,
driver’s license, or passport) and to state the
purpose of their visit.
Details and additional information about
this meeting, prior meetings, and the Task
Force’s 2018 Report and Recommendations
can be found at the NICHD website for the
Task Force on Research Specific to Pregnant
Women and Lactating Women (PRGLAC):
https://www.nichd.nih.gov/about/advisory/
PRGLAC/Pages/index.aspx Presentations

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made during the meeting and any written
comments will be formatted to be posted on
the PRGLAC website for the record.
Registration Link: http://tiny.cc/
PRGLAC0220.
Please note: This meeting will be available
through NIH Videocast. If you are planning
on watching the videocast remotely, please
select this option on the registration form.
Dated: December 23, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–28156 Filed 12–27–19; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request PHS Applications
and Pre-Award Reporting
Requirements (OD/OPERA)
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

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/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
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, Project Clearance Branch, Office
of Policy for Extramural Research
Administration, NIH, Rockledge 1
Building, Room 803–C, 6705 Rockledge
Drive, Bethesda, MD 20892–7974, or
call non-toll-free number (301) 435–
0941, or email your request, including
your address to:
projectclearancebranch@mail.nih.gov.
ADDRESSES:

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This
proposed information collection was
previously published in the Federal
Register on April 12, 2019, Volume 84,
No.212 pages 14956–14957 and allowed
60 days for public comment. One public
comment was received. The purpose of
this notice is to allow an additional 30
days for public comment. The Office of
the Director, NIH, 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.

SUPPLEMENTARY INFORMATION:

In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the 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 3/31/2020. Form numbers: PHS
398, PHS416–1, 416–5, and PHS 6031.
This collection represents a
consolidation of PHS applications and
pre-award reporting requirements into a
revised data collection under the PRA.
This collection includes the proposed
use of a new PHS Human Subjects and
Clinical Trial Information form.
Need and Use of Information
Collection: NIH has received approval to
require applicants and recipients to
address Human Fetal Tissue
requirements within the SF–424 R&R
and the Research Performance Progress
Report due to Congressional ((Sections
498A and 498B of the PHS Act (42
U.S.C. 289g–1 and 289g–2)) and
Department of Health and Human
Services (45 CFR 46.204 and 46.206)
mandates regarding human fetal tissue
research. Applicants and recipients will
be required to comply with Federal and
state laws concerning the acquisition of
human fetal tissue (including cell lines)
obtained from elective abortions as well
as include a description of the proposed
characteristics of the human fetal cells/
tissue outlining the procurement budget
details, and how the applicants/
recipients will document the processes
for how they will use the human fetal
tissues and cells. Additionally, this
revision will clarify information
regarding an institutional commitment
to ensuring that proper policies,
procedures, and oversight are in place to

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Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices

prevent discriminatory harassment and
other discriminatory practices.
This collection also continues to
include 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 (NRSA) 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), PHS 416–1, 416–
5, and PHS 6031 are currently approved
under 0925–0001. All forms expire 10/

31/2018. Post-award reporting
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. The Venture Capital
Operating Companies (VCOC)
Certification and the Small Business

Innovation Research and Small Business
Technology Transfer (SBIR/STTR)
Funding Agreement Certifications are
used by small business applicants.
Oversight systems and tools are critical
for the NIH to ensure participant safety,
data integrity, and accountability of the
use of public funds. The 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 about proposed
clinical trials in the PHS applications
and pre-award reporting requirements
will facilitate the NIH’s oversight of
clinical trials as well as assist in
understanding where needs in the NIH
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
2,150,389.

ESTIMATED ANNUALIZED BURDEN HOURS

PHS 398—Paper ...........................................................................................................................................
PHS 398/424—Electronic:
PHS Assignment Request Form ............................................................................................................
PHS 398 Cover Page Supplement ........................................................................................................
PHS 398 Modular Budget ......................................................................................................................
PHS 398 Training Budget ......................................................................................................................
PHS 398 Training Subaward Budget Attachment(s) Form ...................................................................
PHS 398 Research Plan ........................................................................................................................
PHS 398 Research Training Program Plan ..........................................................................................
Data Tables ............................................................................................................................................
PHS 398 Career Development Award Supplemental Form ..................................................................
PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) ................
Biosketch (424 Electronic) .....................................................................................................................
PHS Fellowship—Electronic:
PHS Fellowship Supplemental Form (includes F reference letters) .....................................................
PHS Assignment Request Form ............................................................................................................
PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) ................
Biosketch (Fellowship) ...........................................................................................................................
416–1 .....................................................................................................................................................
PHS 416–5 .............................................................................................................................................
PHS 6031 ...............................................................................................................................................
VCOC Certification .................................................................................................................................
SBIR/STTR Funding Agreement Certification .......................................................................................
Total ................................................................................................................................................

khammond on DSKJM1Z7X2PROD with NOTICES

Number of
responses
per
respondent

Number of
respondents

Information collection forms

1

35

148,645

37,120
74,239
56,693
1,122
561
70,866
1,122
1,515
2,251
54,838
80,946

1
1
1
1
1
1
1
1
1
1
1

30/60
1
1
2
90/60
10
10
4
10
14
2

18,560
74,239
56,693
2,244
842
708,660
11,220
6,060
22,510
767,732
161,892

6,707
3,354
5,030
6,707
29
6,707
6,217
6
1,500

1
1
1
1
1
1
1
1
1

12.5
30/60
14
2
10
5/60
5/60
5/60
15/60

83,838
1,677
70,420
13,414
290
559
518
1
375

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

421,777

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

2,150,389

[FR Doc. 2019–28129 Filed 12–27–19; 8:45 am]
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Total annual
burden
hours

4,247

Dated: December 19, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.

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Average
burden per
response
(in hours)

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