Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD), 14956-14958 [2019-07324]
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14956
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
Time: 8:30 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton Washington DC
Bethesda North, 940 Rose Avenue, North
Bethesda, MD 20852.
Contact Person: Laurent Taupenot, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4183,
MSC 7850, Bethesda, MD 20892, 301–435–
1203, taupenol@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Virology—B Study Section.
Date: June 10–11, 2019.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Mayflower Hotel, 1127
Connecticut Avenue NW, Washington, DC
20036.
Contact Person: John C. Pugh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1206,
MSC 7808, Bethesda, MD 20892, (301) 435–
2398, pughjohn@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Gene and Drug Delivery Systems
Study Section.
Date: June 12–13, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: Leslie S. Itsara, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, leslie.itsara@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: April 9, 2019.
Sylva L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–07341 Filed 4–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSK30RV082PROD with NOTICES
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
VerDate Sep<11>2014
18:18 Apr 11, 2019
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the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–1: NCI
Clinical and Translational R21 and Omnibus
R03.
Date: June 3, 2019.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W248, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Anita T. Tandle, Ph.D.
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W248,
Bethesda, MD 20892–9750, 240–276–5007,
tandlea@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Moonshot:
Inherited Cancer Syndromes.
Date: June 6, 2019.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W106, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Reed A. Graves,, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W106, Bethesda, MD 20892–
9750, 240–276–6384, gravesr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS
Dated: April 8, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–07248 Filed 4–11–19; 8:45 am]
BILLING CODE 4140–01–P
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Frm 00046
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Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; PHS Applications and PreAward Reporting Requirements (OD)
AGENCY:
National Institutes of Health,
HHS
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for 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.
SUMMARY:
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, Chief,
Project Clearance Branch (PCB), Office
of Policy for Extramural Research
Administration (OPERA), 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.
FOR FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12APN1.SGM
12APN1
14957
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
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 3/31/2020, Office of the Director
(OD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: Starting in January 2020,
NIH will require applicants and
recipients to address Human Fetal
Tissue requirements within the SF–424
R&R and the Research Performance
Progress Report (RPPR) due to
Congressional ((Sections 498A and 498B
of the PHS Act (42 U.S.C. 289g–1 and
289g–2)) and Department of Health and
Human Services (45 CFR 46.204 and
46.206) mandates regarding human fetal
tissue research. Applicants and
recipients will be required to comply
with Federal and state laws concerning
the acquisition of human fetal tissue
(including cell lines) as well as include
a concise description of the proposed
characteristics of the human fetal cells/
tissue outlining the procurement budget
details, and how the applicants/
recipients will document the processes
for how they will use the human fetal
tissues and cells. Additionally, this
revision will clarify information
regarding an institutional commitment
to ensuring that proper policies,
procedures, and oversight are in place to
prevent discriminatory harassment and
other discriminatory practices. This
collection also continues to includes
PHS applications and pre-award
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. 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 will facilitate NIH’s
development of data systems to
facilitate oversight of clinical trials as
well as understand where gaps in the
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.
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 are currently
approved under 0925–0001. All forms
expire 3/31/2020. 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
jbell on DSK30RV082PROD 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 ..............................................................
PHS Human Subjects and Clinical Trial Information (includes inclusion
enrollment report) ..................................................................................
Biosketch (Fellowship) ..............................................................................
416–1 ........................................................................................................
PHS 416–5 ...............................................................................................
PHS 6031 .................................................................................................
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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
5,030
6,707
29
6,707
6,217
1
1
1
1
1
14
2
10
5/60
5/60
70,420
13,414
290
559
518
E:\FR\FM\12APN1.SGM
12APN1
14958
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Information collection forms
Average
burden
per response
(in hours)
Total annual
burden hours
VCOC Certification ...................................................................................
SBIR/STTR Funding Agreement Certification ..........................................
6
1,500
1
1
5/60
15/60
1
375
Total Annual Burden Hours ...............................................................
421,777
421,777
........................
2,150,389
Dated: April 5, 2019.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2019–07324 Filed 4–11–19; 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, for 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.
SUMMARY:
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.
FOR FURTHER INFORMATION CONTACT:
jbell on DSK30RV082PROD with NOTICES
Number of
responses per
respondent
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
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 Revision, OMB
0925–0002, Expiration Date 3/31/2020,
Office of the Director (OD), National
Institutes of Health (NIH).
Need and Use of Information
Collection: Starting in January 2020,
NIH will require applicants and
recipients to address Human Fetal
Tissue requirements within the SF–424
R&R and the Research Performance
Progress Report (RPPR) due to
Congressional ((Sections 498A and 498B
of the PHS Act (42 U.S.C. 289g–1 and
289g–2)) and Department of Health and
Human Services (45 CFR 46.204 and
46.206) mandates regarding human fetal
tissue research. Applicants and
recipients will be required to comply
with Federal and state laws concerning
the acquisition of human fetal tissue
(including cell lines) as well as include
a concise description of the proposed
characteristics of the human fetal cells/
tissue outlining the procurement budget
details, and how the applicants/
recipients will document the processes
for how they will use the human fetal
tissues and cells. Additionally, this
revision will clarify information
regarding an institutional commitment
to ensuring that proper policies,
procedures, and oversight are in place to
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
prevent discriminatory harassment and
other discriminatory practices. 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 National
Research Service Award (NRSA)
Termination Notice, PHS 2271
Statement of Appointment, 6031–1
NRSA Annual Payback Activities
Certification, HHS 568 Final Invention
Statement and Certification, iEdison,
and PHS 3734 Statement Relinquishing
Interests and Rights in a PHS Research
Grant. The PHS 416–7, 2271, and 6031–
1 are used by NRSA recipients to
activate, terminate, and provide for
payback of a NRSA. Closeout of an
award requires a Final Invention
Statement (HHS 568) and Final Progress
Report. iEdison allows grantees and
Federal agencies to meet statutory
requirements for reporting inventions
and patents. The PHS 3734 serves as the
official record of grantee relinquishment
of a PHS award when an award is
transferred from one grantee institution
to another. Pre-award reporting
requirements are simultaneously
consolidated under 0925–0001 and the
changes to the collection here are
related. Clinical trials are complex and
challenging research activities.
Oversight systems and tools are critical
for NIH to ensure participant safety,
data integrity, and accountability of the
use of public funds. NIH has been
engaged in a multi-year effort to
examine how clinical trials are
supported and the level of oversight
needed. The collection of more
structured information in the PHS
applications and pre-award reporting
E:\FR\FM\12APN1.SGM
12APN1
Agencies
[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Notices]
[Pages 14956-14958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07324]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; PHS Applications and
Pre-Award Reporting Requirements (OD)
AGENCY: National Institutes of Health, HHS
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, for 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, Chief, Project Clearance Branch (PCB), Office of Policy for
Extramural Research Administration (OPERA), 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
[[Page 14957]]
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 3/31/2020, Office of the Director (OD), National
Institutes of Health (NIH).
Need and Use of Information Collection: Starting in January 2020,
NIH will require applicants and recipients to address Human Fetal
Tissue requirements within the SF-424 R&R and the Research Performance
Progress Report (RPPR) due to Congressional ((Sections 498A and 498B of
the PHS Act (42 U.S.C. 289g-1 and 289g-2)) and Department of Health and
Human Services (45 CFR 46.204 and 46.206) mandates regarding human
fetal tissue research. Applicants and recipients will be required to
comply with Federal and state laws concerning the acquisition of human
fetal tissue (including cell lines) as well as include a concise
description of the proposed characteristics of the human fetal cells/
tissue outlining the procurement budget details, and how the
applicants/recipients will document the processes for how they will use
the human fetal tissues and cells. Additionally, this revision will
clarify information regarding an institutional commitment to ensuring
that proper policies, procedures, and oversight are in place to prevent
discriminatory harassment and other discriminatory practices. This
collection also continues to 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 are currently
approved under 0925-0001. All forms expire 3/31/2020. 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. 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 will facilitate NIH's development
of data systems to facilitate oversight of clinical trials as well as
understand where gaps in the 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
----------------------------------------------------------------------------------------------------------------
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 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
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
[[Page 14958]]
VCOC Certification.......................... 6 1 5/60 1
SBIR/STTR Funding Agreement Certification... 1,500 1 15/60 375
---------------------------------------------------------------
Total Annual Burden Hours............... 421,777 421,777 .............. 2,150,389
----------------------------------------------------------------------------------------------------------------
Dated: April 5, 2019.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2019-07324 Filed 4-11-19; 8:45 am]
BILLING CODE 4140-01-P