Submission for OMB Review; 30-Day Comment Request Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA), 9572-9573 [2017-02471]
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Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Mental Health;
Amended Notice of Meeting
Submission for OMB Review; 30-Day
Comment Request Post-Award
Reporting Requirements Including
Research Performance Progress
Report Collection (OD/OPERA)
Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
February 03, 2017, 10:00 a.m. to
February 03, 2017, 03:00 p.m., National
Institutes of Health, Neuroscience
Center, 6001 Executive Boulevard,
Rockville, MD, 20852 which was
published in the Federal Register on
January 18, 2017, 82 FR 5588.
This meeting notice is amended to
change the meeting time to 10:30 a.m.–
1:00 p.m. The meeting is closed to the
public.
Dated: February 1, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–02429 Filed 2–6–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel, March
02, 2017, 12:00 p.m. to March 02, 2017,
04:00 p.m., National Cancer Institute
Shady Grove, 9609 Medical Center
Drive, 7W538, Rockville, MD, 20850
which was published in the Federal
Register on January 27, 2017, 82 FR
8620.
The meeting notice is amended to
change the date of the meeting to March
8, 2017 from 12:00 p.m. to 4:00 p.m. The
meeting is closed to the public.
Dated: February 1, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
Lhorne on DSK30JT082PROD with NOTICES
BILLING CODE 4140–01–P
VerDate Sep<11>2014
14:31 Feb 06, 2017
Jkt 241001
ACTION:
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. This proposed
information collection was previously
published in the Federal Register on
November 2, 2016, Volume 81, No. 212,
pages 76371–76372 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.
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 3505, 6705 Rockledge
Drive, Bethesda, MD 20892–7974, or
call non-toll-free number (301) 435–
0941, or Email your request, including
your address to: trialsinfo@od.nih.gov.
SUPPLEMENTARY INFORMATION: The Office
of the Director, National Institutes of
Health (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.
In compliance with Section
3507(a)(1)(D) of the Paperwork
ADDRESSES:
National Institutes of Health
[FR Doc. 2017–02431 Filed 2–6–17; 8:45 am]
National Institutes of Health.
Notice.
AGENCY:
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
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 10/31/2018. Form numbers: PHS
2590, PHS 416–7, PHS 2271, PHS 3734,
PHS 6031–1, and HHS 568. This
collection represents a consolidation of
post-award reporting requirements
under the PRA, including the Research
Performance Progress Report (RPPR).
This collection includes the proposed
additional reporting requirements for
clinical trials.
Need and Use of Information
Collection: The RPPR is now required to
be used by all NIH, Food and Drug
Administration, Centers for Disease
Control and Prevention, and Agency for
Healthcare Research and Quality
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, Final
Progress Report instructions, 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. Using 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. The Small Business
Innovation Research and Small Business
Technology Transfer (SBIR/STTR) Life
Cycle Certifications are completed by
small business grantees once certain
milestones are reached during the
project period. Pre-award reporting
requirements are simultaneously
consolidated under 0925–0001 and the
changes to the collection here are
related. Clinical trials are complex and
E:\FR\FM\07FEN1.SGM
07FEN1
9573
Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices
challenging research activities.
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 in the PHS
applications and pre-award reporting
requirements as well as continued
monitoring and update during the postaward reporting requirements will
facilitate the 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.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
519,408.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Information collection forms
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 3734 .................................................................................................
Final Progress Report ..............................................................................
SBIR/STTR Phase II Final Progress Report ............................................
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
12,580
1,778
11,180
5,697
22,035
243
32,098
2,544
758
480
1
1
1
1
1
1
1
1
1
1
30/60
20/60
5/60
15/60
15/60
18
8
2
4
15/60
6,290
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
8,085
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 .....................................................................
Recordkeeping:
SBIR/STTR Life Cycle Certification ..........................................................
........................
........................
........................
499,033
1,500
1
15/60
375
Grand Total ................................................................................
........................
........................
........................
519,408
Dated: February 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017–02471 Filed 2–6–17; 8:45 am]
This meeting notice is amended to
change the meeting time to 1:00 p.m.–
5:00 p.m. The meeting is closed to the
public.
Dated: February 1, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–02430 Filed 2–6–17; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
Lhorne on DSK30JT082PROD with NOTICES
National Institute of Mental Health;
Amended Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
February 03, 2017, 10:00 a.m. to
February 03, 2017, 03:00 p.m., National
Institutes of Health, Neuroscience
Center, 6001 Executive Boulevard,
Rockville, MD, 20852 which was
published in the Federal Register on
January 18, 2017, 82FR5588.
National Institutes of Health
VerDate Sep<11>2014
14:31 Feb 06, 2017
Jkt 241001
National Institutes of Health,
HHS.
ACTION:
PO 00000
Notice.
Frm 00015
Fmt 4703
Sfmt 4703
Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
DATES:
Submission for OMB Review; 30-Day
Comment Request PHS Applications
and Pre-Award Reporting
Requirements (OD/OPERA)
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. This proposed
information collection was previously
published in the Federal Register on
November 2, 2016, Volume 81, No. 212,
pages 76368–76370 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.
SUMMARY:
Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
ADDRESSES:
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Notices]
[Pages 9572-9573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02471]
-----------------------------------------------------------------------
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.
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. This proposed information
collection was previously published in the Federal Register on November
2, 2016, Volume 81, No. 212, pages 76371-76372 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.
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 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974,
or call non-toll-free number (301) 435-0941, or Email your request,
including your address to: trialsinfo@od.nih.gov.
SUPPLEMENTARY INFORMATION: The Office of the Director, National
Institutes of Health (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.
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 10/31/2018. Form numbers:
PHS 2590, PHS 416-7, PHS 2271, PHS 3734, PHS 6031-1, and HHS 568. This
collection represents a consolidation of post-award reporting
requirements under the PRA, including the Research Performance Progress
Report (RPPR). This collection includes the proposed additional
reporting requirements for clinical trials.
Need and Use of Information Collection: The RPPR is now required to
be used by all NIH, Food and Drug Administration, Centers for Disease
Control and Prevention, and Agency for Healthcare Research and Quality
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,
Final Progress Report instructions, 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. Using 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. The Small Business Innovation Research and Small Business
Technology Transfer (SBIR/STTR) Life Cycle Certifications are completed
by small business grantees once certain milestones are reached during
the project period. Pre-award reporting requirements are simultaneously
consolidated under 0925-0001 and the changes to the collection here are
related. Clinical trials are complex and
[[Page 9573]]
challenging research activities. 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 in the PHS applications and pre-award reporting
requirements as well as continued monitoring and update during the
post-award reporting requirements will facilitate the 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.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 519,408.
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
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 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 480 1 15/60 120
RPPR)......................................
PHS Human Subjects and Clinical Trial 3,600 1 4 14,400
Information (Part of Final RPPR, includes
inclusion/enrollment)......................
PHS 3734.................................... 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.................. .............. .............. .............. 499,033
Recordkeeping:
SBIR/STTR Life Cycle Certification.......... 1,500 1 15/60 375
---------------------------------------------------------------
Grand Total......................... .............. .............. .............. 519,408
----------------------------------------------------------------------------------------------------------------
Dated: February 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017-02471 Filed 2-6-17; 8:45 am]
BILLING CODE 4140-01-P
