[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]
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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.
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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
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Average
Number of Number of burden per Total annual
Information collection forms respondents responses per response (in burden hours
respondent hours)
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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
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Total Annual Burden Hours............... 421,777 421,777 .............. 2,150,389
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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