Proposed Collection; 60-Day Comment Request; Public Health Service Applications and Pre-Award Reporting Requirements (Office of the Director), 76368-76370 [2016-26448]
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76368
Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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: Center for Scientific
Review Special Emphasis Panel; PAR–16–
121 Early-Stage Preclinical Validation of
Therapeutic Leads for Diseases of Interest to
the NIDDK (R01).
Date: November 17–18, 2016.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Antonello Pileggi, MD,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6166,
Bethesda, MD 20892–7892, (301) 402–6297,
pileggia@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–16–
121 Early-Stage Preclinical Validation of
Therapeutic Leads for Diseases of Interest to
the NIDDK (R01).
Date: November 17, 2016.
Time: 11:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Hui Chen, MD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, 301–435–1044,
chenhui@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Vasular and
Hematology: Molecular and Cellular
Hematology.
Date: November 30, 2016.
Time: 4:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4140,
MSC 7814, Bethesda, MD 20892, 301–435–
0952, espinozala@mail.nih.gov.
VerDate Sep<11>2014
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Risk, Prevention and Health
Behavior.
Date: December 1–2, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Claire E. Gutkin, MPH,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3106,
MSC 7808, Bethesda, MD 20892, 301–594–
3139, gutkincl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Digestive Diseases.
Date: December 1–2, 2016.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jianxin Hu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2156,
Bethesda, MD 20892, 301–827–4417,
jianxinh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Kidney and Urology.
Date: December 1, 2016.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Aiping Zhao, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm 2188, MSC
7818, Bethesda, MD 20892–7818, (301) 435–
0682, zhaoa2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA:
Immunology.
Date: December 1, 2016.
Time: 12:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Alok Mulky, Ph.D.,
Scientific Review Officer, Center for
Scientific Review (CSR), National Institutes
of Health (NIH), 6701 Rockledge Dr., Room
4203, Bethesda, MD 20817, (301) 435–3566,
alok.mulky@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR16–027:
Commercialization Readiness Pilot.
Date: December 2, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Marriott at Metro
Center, 775 12th Street NW., Washington, DC
20005.
PO 00000
Frm 00038
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Contact Person: Cristina Backman, Ph.D.,
Scientific Review Officer, ETTN IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5211,
MSC 7846, Bethesda, MD 20892, cbackman@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Mechanisms of Bacterial
Virulence and Pathogenesis.
Date: December 2, 2016.
Time: 10:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Gagan Pandya, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, RM 3200, MSC 7808,
Bethesda, MD 20892, 301–435–1167,
pandyaga@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 27, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–26451 Filed 11–1–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Public Health Service
Applications and Pre-Award Reporting
Requirements (Office of the Director)
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 proposed
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
SUMMARY:
E:\FR\FM\02NON1.SGM
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76369
Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices
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
trialsinfo@od.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
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
to address 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 minimizes
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) Applications and
Pre-Award Reporting Requirements,
Revision, OMB 0925–0001, Expiration
Date 10/31/2018. Form numbers: PHS
398, PHS 416–1, PHS 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:
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 National Research Service
Award (NRSA) awards. The PHS 6031
Payback Agreement is used by
individuals at the time of activation to
certify agreement to fulfill the payback
provisions. Clinical trials are complex
and 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 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.
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
850,756.
use of a new PHS clinical trial
application 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 Individual Fellowship
Application Instructions and Forms
used only for a change of sponsoring
institution application [paper];
Instructions for a Change of Sponsoring
Institution for the National Research
Service Award (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) are currently
approved under 0925–0001. All forms
expire 10/31/2018. Post-award reporting
requirements are simultaneously
consolidated under 0925–0002, and
include the Research Performance
Progress Report (RPPR). The PHS 398
and SF424 applications are used by
applicants to request federal assistance
funds for traditional investigatorinitiated research projects and to request
access to databases and other PHS
resources. The PHS 416–1 is used only
for a change of sponsoring institution
application. PHS Fellowship
Supplemental Form and agency specific
instructions is used in combination with
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
sradovich on DSK3GMQ082PROD with NOTICES
Information collection forms
PHS 398—Paper .............................................................................................
PHS 398/424—Electronic:
PHS Assignment Request Form ..............................................................
PHS 398 Cover Page Supplement ...........................................................
PHS Inclusion Enrollment Report .............................................................
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 Clinical Trial Protocol Form ..............................................................
Biosketch (424 Electronic) ........................................................................
PHS Fellowship—Electronic:
PHS Fellowship Supplemental Form (includes F reference letters) ........
VerDate Sep<11>2014
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Sfmt 4703
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
54,838
56,693
1,122
561
70,866
1,122
1,515
2,251
8,264
80,946
1
1
1
1
1
1
1
1
1
1
1
1
30/60
1
1
1
2
90/60
3
3
4
3
1
2
18,560
74,239
54,838
56,693
2,244
842
212,598
3,366
6,060
6,753
8,264
161,892
6,707
1
12.5
83,838
E:\FR\FM\02NON1.SGM
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76370
Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / 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 Assignment Request Form ..............................................................
PHS Inclusion Enrollment Report .............................................................
Biosketch (Fellowship) ..............................................................................
416–1 ........................................................................................................
PHS 416–5 ...............................................................................................
PHS 6031 .................................................................................................
VCOC Certification ...................................................................................
SBIR/STTR Funding Agreement Certification ..........................................
3,354
3,354
6,707
29
6,707
6,217
6
1,500
1
1
1
1
1
1
1
1
30/60
1
2
10
5/60
5/60
5/60
15/60
1,677
3,354
13,414
290
559
518
1
375
Total Annual Burden Hours ...............................................................
........................
420,101
........................
850,756
Dated: October 22, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–26448 Filed 11–1–16; 8:45 am]
BILLING CODE 4140–01–P
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: October 27, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–26386 Filed 11–1–16; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sradovich on DSK3GMQ082PROD with NOTICES
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.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: December 8, 2016.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD 20817,
(Virtual Meeting).
Contact Person: Priscah Mujuru, DRPH,
COHNS, Scientific Review Officer, Scientific
Review Branch, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Boulevard, Suite 5B01, Bethesda, MD 20892–
7510, 301–435–6908, mujurup@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
VerDate Sep<11>2014
17:18 Nov 01, 2016
Jkt 241001
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request, National Institutes
of Health Electronic Application
System for Certificates of
Confidentiality
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. This proposed
information collection was previously
published in the Federal Register on
August 18, 2016 (81 FR 55207–55208)
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
SUMMARY:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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: Dr. Ann Hardy,
NIH Extramural Human Research
Protections Officer and NIH
Coordinator, Certificates of
Confidentiality, 3701 Rockledge Dr. Rm.
3002, Bethesda, MD 20892, or call nontoll-free number (301) 435–2690 or
Email your request, including your
address to: hardyan@od.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Office of
Extramural Research (OER), 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 of 1995, the NIH has
submitted to the OMB a request for
review and approval of the information
collection listed below.
Proposed Collection: Certificate of
Confidentiality Electronic Application
System, 0925–0689, expiration date 01/
31/2017, OER, NIH.
Need and Use of Information
Collection: This application system
provides one electronic form to be used
by all research organizations that wish
to request a Certificate of Confidentiality
(CoC) from the NIH. As described in the
authorizing legislation (Section 301(d)
of the Public Health Service Act, 42
U.S.C. 241(d)), CoCs are issued by the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02NON1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76368-76370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26448]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Public Health
Service Applications and Pre-Award Reporting Requirements (Office of
the Director)
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 proposed 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
[[Page 76369]]
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 trialsinfo@od.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 to address 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 minimizes 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) Applications
and Pre-Award Reporting Requirements, Revision, OMB 0925-0001,
Expiration Date 10/31/2018. Form numbers: PHS 398, PHS 416-1, PHS 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 clinical trial application 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
Individual Fellowship Application Instructions and Forms used only for
a change of sponsoring institution application [paper]; Instructions
for a Change of Sponsoring Institution for the National Research
Service Award (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) 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
National Research Service Award (NRSA) awards. The PHS 6031 Payback
Agreement is used by individuals at the time of activation to certify
agreement to fulfill the payback provisions. Clinical trials are
complex and 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 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.
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 850,756.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total annual
Information collection forms respondents responses per response (in burden hours
respondent 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 Inclusion Enrollment Report............. 54,838 1 1 54,838
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 3 212,598
PHS 398 Research Training Program Plan...... 1,122 1 3 3,366
Data Tables................................. 1,515 1 4 6,060
PHS 398 Career Development Award 2,251 1 3 6,753
Supplemental Form..........................
PHS Clinical Trial Protocol Form............ 8,264 1 1 8,264
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).........................
[[Page 76370]]
PHS Assignment Request Form................. 3,354 1 30/60 1,677
PHS Inclusion Enrollment Report............. 3,354 1 1 3,354
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
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Total Annual Burden Hours............... .............. 420,101 .............. 850,756
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Dated: October 22, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-26448 Filed 11-1-16; 8:45 am]
BILLING CODE 4140-01-P
