Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD), 18994-18995 [2021-07397]
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18994
Federal Register / Vol. 86, No. 68 / Monday, April 12, 2021 / Notices
Dated: April 4, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2021–07396 Filed 4–9–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Post-Award Reporting
Requirements Including Research
Performance Progress Report
Collection (OD)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health (NIH) will
publish periodic summaries of propose
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60-days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
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
ProjectClearanceBranch@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
SUMMARY:
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function 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) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: Public
Health Service (PHS) Post-award
Reporting Requirements Including
Research Performance Progress Report
(RPPR) Collection, Revision, OMB
0925–0002, 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 because 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. 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 is 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 multiyear 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
535,579.
khammond on DSKJM1Z7X2PROD with NOTICES
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
REPORTING
PHS 416–7 ......................................................................................................
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21:37 Apr 09, 2021
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1
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6,290
18995
Federal Register / Vol. 86, No. 68 / Monday, April 12, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Information collection forms
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Total
annual burden
hours
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 RPPR, includes
inclusion enrollment report) ..........................................................................
PHS 374 ..........................................................................................................
Final Progress Report ......................................................................................
SBIR/STTR Phase II Final Progress Report ...................................................
1,778
11,180
5,697
22,035
243
32,098
2,544
758
480
1
1
1
1
1
1
1
1
1
20/60
5/60
15/60
15/60
18
8
2
4
15/60
593
932
1,424
5,509
4,374
256,784
5,088
3,032
120
6,420
97,023
18,000
758
480
1
3
1
1
1
4
5/60
10
4
15/60
25,680
24,256
180,000
3,032
120
3,600
479
2,000
1,330
1
1
1
1
4
30/60
1
1
14,400
240
2,000
1,330
Reporting Burden Total ............................................................................
........................
........................
........................
535,204
RECORDKEEPING
SBIR/STTR Life Cycle Certification .................................................................
1,500
1
15/60
375
Grand Total ...............................................................................................
220,983
415,029
........................
535,579
Dated: April 4, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2021–07397 Filed 4–9–21; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2021–0190]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0018
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting an
extension of its approval for the
following collection of information:
1625–0018, Official Logbook; without
change. Our ICR describes the
information we seek to collect from the
public. Before submitting this ICR to
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
21:37 Apr 09, 2021
Public Participation and Request for
Comments
Comments must reach the Coast
Guard on or before June 11, 2021.
This notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. chapter 35, as amended. An
ICR is an application to OIRA seeking
the approval, extension, or renewal of a
Coast Guard collection of information
(Collection). The ICR contains
information describing the Collection’s
purpose, the Collection’s likely burden
on the affected public, an explanation of
the necessity of the Collection, and
other important information describing
the Collection. There is one ICR for each
Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) The practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology.
DATES:
You may submit comments
identified by Coast Guard docket
number [USCG–2021–0190] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
See the ‘‘Public participation and
request for comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from:
COMMANDANT (CG–6P), ATTN:
PAPERWORK REDUCTION ACT
MANAGER, U.S. COAST GUARD, 2703
MARTIN LUTHER KING JR. AVE SE,
STOP 7710, WASHINGTON, DC 20593–
7710.
ADDRESSES:
BILLING CODE 4140–01–P
VerDate Sep<11>2014
OIRA, the Coast Guard is inviting
comments as described below.
Jkt 253001
A.L.
Craig, Office of Privacy Management,
telephone 202–475–3528, or fax 202–
372–8405, for questions on these
documents.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
PO 00000
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]]>Agencies
[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18994-18995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07397]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Post-Award Reporting
Requirements Including Research Performance Progress Report Collection
(OD)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health (NIH) will
publish periodic summaries of propose projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, 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 [email protected].
Formal requests for additional plans and instruments must be requested
in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function 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) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Public Health Service (PHS) Post-award
Reporting Requirements Including Research Performance Progress Report
(RPPR) Collection, Revision, OMB 0925-0002, 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 because 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. 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 is 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 535,579.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Information collection forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
REPORTING
----------------------------------------------------------------------------------------------------------------
PHS 416-7....................................... 12,580 1 30/60 6,290
[[Page 18995]]
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 6,420 1 4 25,680
Information (Part of RPPR, includes inclusion
enrollment report).............................
Publication Reporting........................... 97,023 3 5/60 24,256
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 3,600 1 4 14,400
Information (Part of RPPR, includes inclusion
enrollment report).............................
PHS 374......................................... 479 1 30/60 240
Final Progress Report........................... 2,000 1 1 2,000
SBIR/STTR Phase II Final Progress Report........ 1,330 1 1 1,330
---------------------------------------------------------------
Reporting Burden Total...................... .............. .............. .............. 535,204
----------------------------------------------------------------------------------------------------------------
RECORDKEEPING
----------------------------------------------------------------------------------------------------------------
SBIR/STTR Life Cycle Certification.............. 1,500 1 15/60 375
---------------------------------------------------------------
Grand Total................................. 220,983 415,029 .............. 535,579
----------------------------------------------------------------------------------------------------------------
Dated: April 4, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-07397 Filed 4-9-21; 8:45 am]
BILLING CODE 4140-01-P
