Submission for OMB Review; 30-Day Comment Request PHS Applications and Pre-Award Reporting Requirements (OD/OPERA), 9573-9575 [2017-02472]
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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
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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
9574
Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices
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.
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, Suite 350, 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.
FOR FURTHER INFORMATION CONTACT:
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.
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) Applications and Preaward Reporting Requirements.
Revision, OMB 0925–0001, Expiration
Date 10/31/2018. 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
SUPPLEMENTARY INFORMATION:
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.
use of a new PHS Human Subjects and
Clinical Trial Information form.
Need and Use of Information
Collection: This collection 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 (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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Lhorne on DSK30JT082PROD with NOTICES
Information collection forms
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 ..............................................................
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Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
4,247
1
35
148,645
37,120
74,239
56,693
1,122
561
70,866
1,122
1,515
2,251
1
1
1
1
1
1
1
1
1
30/60
1
1
2
90/60
10
10
4
10
18,560
74,239
56,693
2,244
842
708,660
11,220
6,060
22,510
54,838
80,946
1
1
14
2
767,732
161,892
6,707
3,354
1
1
12.5
30/60
83,838
1,677
E:\FR\FM\07FEN1.SGM
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Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Information collection forms
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total annual
burden hours
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 ..........................................
5,030
6,707
29
6,707
6,217
6
1,500
1
1
1
1
1
1
1
14
2
10
5/60
5/60
5/60
15/60
70,420
13,414
290
559
518
1
375
Total Annual Burden Hours ...............................................................
........................
........................
........................
2,150,389
Dated: February 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017–02472 Filed 2–6–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: February 1, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
[FR Doc. 2017–02433 Filed 2–6–17; 8:45 am]
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.
Lhorne on DSK30JT082PROD with NOTICES
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel, NTU—Bench Testing
Therapeutic/Indication Pairing Strategies
(UH2/UH3).
Date: March 1–2, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
1066, 6701 Democracy Blvd., Bethesda, MD
20817 (Virtual Meeting).
Contact Person: Barbara J. Nelson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences (NCATS), National
Institutes of Health, 6701 Democracy Blvd.,
Democracy 1, Room 1080, Bethesda, MD
20892–4874, 301–435–0806, nelsonbj@
mail.nih.gov.
VerDate Sep<11>2014
14:31 Feb 06, 2017
Jkt 241001
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,
February 27, 2017, 08:00 a.m. to
February 28, 2017, 12:00 p.m., RitzCarlton Hotel, 1700 Tysons Boulevard,
McLean, VA, 22102 which was
published in the Federal Register on
January 27, 2017, 82 FR 8619.
The meeting notice is amended to
change the name of the meeting to NCI
R03/R21 SEP–4. The meeting is closed
to the public.
Dated: February 1, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–02432 Filed 2–6–17; 8:45 am]
BILLING CODE 4140–01–P
Frm 00017
Fmt 4703
Coast Guard
[Docket No. USCG–2017–0020]
Merchant Marine Personnel Advisory
Committee
Coast Guard, Department of
Homeland Security.
ACTION: Notice of Federal Advisory
Committee Meeting.
AGENCY:
The Merchant Marine
Personnel Advisory Committee and its
working groups will meet to discuss
various issues related to the training and
fitness of merchant marine personnel.
The meetings will be open to the public.
DATES: The Merchant Marine Personnel
Advisory Committee and its working
groups are scheduled to meet on
Wednesday, March 22, 2017, from 8
a.m. until 5:30 p.m., and the full
Committee is scheduled to meet on
Thursday, March 23, 2017, from 8 a.m.
until 5:30 p.m. Please note that these
meetings may adjourn early if the
Committee has completed its business.
ADDRESSES: The meetings will be held at
The U.S. Coast Guard Headquarters,
Room 6I10–01–C, 2703 Martin Luther
King Jr. Ave. SE., Stop 7509,
Washington, DC 20593–7509 (https://
www.uscg.mil/baseNCR/pages/visitor_
trans.asp).
Attendees at the U.S. Coast Guard
Headquarters who are U.S. citizens will
be required to pre-register no later than
5 p.m. on March 14, 2017, to be
admitted to the meeting. This preregistration should include your name,
telephone number, and company or
group with which you are affiliated.
Non-US citizens will be required to preregister no later than 5 p.m. on March
01, 2017, to be admitted to the meeting.
This pre-registration should include
name, country of citizenship, passport
and expiration date, or diplomatic
SUMMARY:
National Institutes of Health
PO 00000
DEPARTMENT OF HOMELAND
SECURITY
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]]>Agencies
[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Notices]
[Pages 9573-9575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02472]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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.
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
[[Page 9574]]
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, Suite 350, 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, 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) Applications and
Pre-award Reporting Requirements. Revision, OMB 0925-0001, Expiration
Date 10/31/2018. 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: This collection 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 (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 investigator-initiated 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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Information collection forms Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
PHS 398--Paper.................................. 4,247 1 35 148,645
PHS 398/424--Electronic:
PHS Assignment Request Form................. 37,120 1 30/60 18,560
PHS 398 Cover Page Supplement............... 74,239 1 1 74,239
PHS 398 Modular Budget...................... 56,693 1 1 56,693
PHS 398 Training Budget..................... 1,122 1 2 2,244
PHS 398 Training Subaward Budget 561 1 90/60 842
Attachment(s) Form.........................
PHS 398 Research Plan....................... 70,866 1 10 708,660
PHS 398 Research Training Program Plan...... 1,122 1 10 11,220
Data Tables................................. 1,515 1 4 6,060
PHS 398 Career Development Award 2,251 1 10 22,510
Supplemental Form..........................
PHS Human Subjects and Clinical Trial 54,838 1 14 767,732
Information (includes inclusion enrollment
report)....................................
Biosketch (424 Electronic).................. 80,946 1 2 161,892
PHS Fellowship--Electronic:
PHS Fellowship Supplemental Form (includes F 6,707 1 12.5 83,838
reference letters).........................
PHS Assignment Request Form................. 3,354 1 30/60 1,677
[[Page 9575]]
PHS Human Subjects and Clinical Trial 5,030 1 14 70,420
Information (includes inclusion enrollment
report)....................................
Biosketch (Fellowship)...................... 6,707 1 2 13,414
416-1....................................... 29 1 10 290
PHS 416-5................................... 6,707 1 5/60 559
PHS 6031.................................... 6,217 1 5/60 518
VCOC Certification.......................... 6 1 5/60 1
SBIR/STTR Funding Agreement Certification... 1,500 1 15/60 375
---------------------------------------------------------------
Total Annual Burden Hours............... .............. .............. .............. 2,150,389
----------------------------------------------------------------------------------------------------------------
Dated: February 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017-02472 Filed 2-6-17; 8:45 am]
BILLING CODE 4140-01-P
