Submission for OMB Review; 30-Day Comment Request Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA), 71965-71966 [2019-28130]
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Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices
Dated: December 23, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–28151 Filed 12–27–19; 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 Meetings
khammond on DSKJM1Z7X2PROD with NOTICES
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 on
Aging Special Emphasis Panel; Exploratory
Alzheimer’s Disease Research Centers
Evaluation.
Date: January 31, 2020.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Maurizio Grimaldi, MD,
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, 301–496–9374,
grimaldim2@mail.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Marmoset
Model U34 Review.
Date: February 18, 2020.
Time: 12:00 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 (Telephone Conference
Call).
Contact Person: Birgit Neuhuber, 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, 301–480–1266, neuhuber@
ninds.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Microbiome
and Aging Meeting.
VerDate Sep<11>2014
20:00 Dec 27, 2019
Jkt 250001
Date: February 28, 2020.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Admiral Fell Inn, Conference Room,
Admiral Ballroom, 888 South Broadway,
Baltimore, MD 21231.
Contact Person: Greg Bissonette, 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, 301–402–1622, bissonettegb@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: December 20, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–28155 Filed 12–27–19; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
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
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel—BRAIN Initiative:
New Concepts and Early-Stage Research for
Large-Scale Recording and Modulation in the
Nervous System (R21).
Date: January 23, 2020.
Time: 12:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Eye Institute 6700B
Rockledge Drive Bethesda, MD 20818
(Virtual Meeting).
Contact Person: Brian Hoshaw, Ph.D.,
Acting Review Chief, National Eye Institute,
National Institutes of Health, Division of
Extramural Research, 6700 B Rockledge Dr.,
Ste. 3400, Rockville, MD 20892, (301) 451–
2020, hoshawb@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
PO 00000
Frm 00076
Fmt 4703
Dated: December 20, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–28152 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 Post-Award
Reporting Requirements Including
Research Performance Progress
Report Collection (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.
ADDRESSES: 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.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on April 12, 2019, Volume 84,
No. 71 pages 14958–14959 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
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
71965
E:\FR\FM\30DEN1.SGM
30DEN1
71966
Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices
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 (PRA) 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) Post-award Reporting
Requirements Revision, OMB 0925–
0002, Expiration Date 3/31/2020, Office
of the Director (OD), National Institutes
of Health (NIH). This collection
represents eliminating the Final
Progress Report form as the form has
been incorporated into the Final RPPR.
Competing applications in the future
may be updated to reflect related
Human Fetal Tissue (HFT) information.
Need and Use of Information
Collection: The RPPR is required to be
used by all NIH, Food and Drug
Administration, Centers for Disease
Control and Prevention, and Agency for
Healthcare Research and Quality
(AHRQ) grantees. Interim progress
reports are required to continue support
of a PHS grant for each budget year
within a competitive segment. The
phased transition to the RPPR required
the maintenance of dual reporting
processes for a period of time.
Continued use of the PHS Noncompeting Continuation Progress Report
(PHS 2590), exists for a small group of
grantees. This collection also includes
other PHS post-award reporting
requirements: PHS 416–7 NRSA
Termination Notice, PHS 2271
Statement of Appointment, 6031–1
NRSA Annual Payback Activities
Certification, HHS 568 Final Invention
Statement and Certification, iEdison,
and PHS 3734 Statement Relinquishing
Interests and Rights in a PHS Research
Grant. The PHS 416–7, 2271, and 6031–
1 are used by NRSA recipients to
activate, terminate, and provide for
payback of a NRSA. Closeout of an
award requires a Final Invention
Statement (HHS 568) and Final Progress
Report. iEdison allows grantees and
Federal agencies to meet statutory
requirements for reporting inventions
and patents. The PHS 3734 serves as the
official record of grantee relinquishment
of a PHS award when an award is
transferred from one grantee institution
to another. Pre-award reporting
requirements are simultaneously
consolidated under 0925–0001 and the
changes to the collection here are
related. 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 as well as continued
monitoring and update during the postaward reporting requirements will
facilitate NIH’s oversight of clinical
trials. In addition, some of the data
reported in the RPPR will ultimately be
accessible to investigators to update
certain sections of forms when
registering or reporting their trials with
ClinicalTrials.gov.
Frequency of response: Applicants
may submit applications for published
receipt dates. For NRSA awards,
fellowships are activated, and trainees
appointed.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
517,408.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Information collection forms
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Total annual
burden
hours
khammond on DSKJM1Z7X2PROD with NOTICES
Reporting
PHS 416–7 ................................................................................................................................................................................................
PHS 6031–1 ..............................................................................................................................................................................................
PHS 568 ....................................................................................................................................................................................................
iEdison .......................................................................................................................................................................................................
PHS 2271 ..................................................................................................................................................................................................
PHS 2590 ..................................................................................................................................................................................................
RPPR—Core Data .....................................................................................................................................................................................
Biosketch (Part of RPPR) ..........................................................................................................................................................................
Data Tables (Part of RPPR) ......................................................................................................................................................................
Trainee Diversity Report (Part of RPPR) ..................................................................................................................................................
PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) ...........................................
Publication Reporting ................................................................................................................................................................................
Final RPPR—Core Data ............................................................................................................................................................................
Data Tables (Part of Final RPPR) .............................................................................................................................................................
Trainee Diversity Report (Part of Final RPPR) .........................................................................................................................................
PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment) .............................................
PHS 374 ....................................................................................................................................................................................................
SBIR/STTR Phase II Final Progress Report .............................................................................................................................................
SBIR/STTR Life Cycle Certification ...........................................................................................................................................................
12,580
1,778
11,180
5,697
22,035
243
32,098
2,544
758
480
6,420
97,023
18,000
758
480
3,600
479
1,330
1,500
1
1
1
1
1
1
1
1
1
1
1
3
1
1
1
1
1
1
1
30/60
20/60
5/60
15/60
15/60
18
8
2
4
15/60
4
5/60
10
4
15/60
4
30/60
1
15/60
6,290
593
932
1,424
5,509
4,374
256,784
5,088
3,032
120
25,680
8,085
180,000
3,032
120
14,400
240
1,330
375
Total ....................................................................................................................................................................................................
........................
218,983
....................
517,408
Dated: December 20, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–28130 Filed 12–27–19; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
20:00 Dec 27, 2019
Jkt 250001
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71965-71966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28130]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Post-Award
Reporting Requirements Including Research Performance Progress Report
Collection (OD/OPERA)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
ADDRESSES: 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,
[email protected] 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: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on April 12, 2019, Volume
84, No. 71 pages 14958-14959 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
[[Page 71966]]
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 (PRA) 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) Post-award
Reporting Requirements Revision, OMB 0925-0002, Expiration Date 3/31/
2020, Office of the Director (OD), National Institutes of Health (NIH).
This collection represents eliminating the Final Progress Report form
as the form has been incorporated into the Final RPPR. Competing
applications in the future may be updated to reflect related Human
Fetal Tissue (HFT) information.
Need and Use of Information Collection: The RPPR is required to be
used by all NIH, Food and Drug Administration, Centers for Disease
Control and Prevention, and Agency for Healthcare Research and Quality
(AHRQ) grantees. Interim progress reports are required to continue
support of a PHS grant for each budget year within a competitive
segment. The phased transition to the RPPR required the maintenance of
dual reporting processes for a period of time. Continued use of the PHS
Non-competing Continuation Progress Report (PHS 2590), exists for a
small group of grantees. This collection also includes other PHS post-
award reporting requirements: PHS 416-7 NRSA Termination Notice, PHS
2271 Statement of Appointment, 6031-1 NRSA Annual Payback Activities
Certification, HHS 568 Final Invention Statement and Certification,
iEdison, and PHS 3734 Statement Relinquishing Interests and Rights in a
PHS Research Grant. The PHS 416-7, 2271, and 6031-1 are used by NRSA
recipients to activate, terminate, and provide for payback of a NRSA.
Closeout of an award requires a Final Invention Statement (HHS 568) and
Final Progress Report. iEdison allows grantees and Federal agencies to
meet statutory requirements for reporting inventions and patents. The
PHS 3734 serves as the official record of grantee relinquishment of a
PHS award when an award is transferred from one grantee institution to
another. Pre-award reporting requirements are simultaneously
consolidated under 0925-0001 and the changes to the collection here are
related. 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 as well as continued monitoring
and update during the post-award reporting requirements will facilitate
NIH's oversight of clinical trials. In addition, some of the data
reported in the RPPR will ultimately be accessible to investigators to
update certain sections of forms when registering or reporting their
trials with ClinicalTrials.gov.
Frequency of response: Applicants may submit applications for
published receipt dates. For NRSA awards, fellowships are activated,
and trainees appointed.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 517,408.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average Total
Number of responses burden per annual
Information collection forms respondents per response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Reporting
----------------------------------------------------------------------------------------------------------------
PHS 416-7................................................ 12,580 1 30/60 6,290
PHS 6031-1............................................... 1,778 1 20/60 593
PHS 568.................................................. 11,180 1 5/60 932
iEdison.................................................. 5,697 1 15/60 1,424
PHS 2271................................................. 22,035 1 15/60 5,509
PHS 2590................................................. 243 1 18 4,374
RPPR--Core Data.......................................... 32,098 1 8 256,784
Biosketch (Part of RPPR)................................. 2,544 1 2 5,088
Data Tables (Part of RPPR)............................... 758 1 4 3,032
Trainee Diversity Report (Part of RPPR).................. 480 1 15/60 120
PHS Human Subjects and Clinical Trial Information (Part 6,420 1 4 25,680
of RPPR, includes inclusion enrollment report)..........
Publication Reporting.................................... 97,023 3 5/60 8,085
Final RPPR--Core Data.................................... 18,000 1 10 180,000
Data Tables (Part of Final RPPR)......................... 758 1 4 3,032
Trainee Diversity Report (Part of Final RPPR)............ 480 1 15/60 120
PHS Human Subjects and Clinical Trial Information (Part 3,600 1 4 14,400
of Final RPPR, includes inclusion/enrollment)...........
PHS 374.................................................. 479 1 30/60 240
SBIR/STTR Phase II Final Progress Report................. 1,330 1 1 1,330
SBIR/STTR Life Cycle Certification....................... 1,500 1 15/60 375
------------------------------------------------------
Total................................................ .............. 218,983 ........... 517,408
----------------------------------------------------------------------------------------------------------------
Dated: December 20, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-28130 Filed 12-27-19; 8:45 am]
BILLING CODE 4140-01-P
