[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18992-18994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07396]
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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 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health (NIH) will
publish periodic summaries of propose 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 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 [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 collection techniques or other forms
of information technology.
[[Page 18993]]
Proposed Collection Title: Public Health Service (PHS) Applications
and Pre-Award Reporting Requirements, Revision, OMB 0925-0001,
Expiration Date 2/28/2023, Office of the Director (OD), National
Institutes of Health (NIH).
Need and Use of Information Collection: This collection is being
revised to omit the Inclusion Enrollment Report form, which is being
converted to a Common form to include the Department of Defense (DoD).
The Inclusion Enrollment Report is used for all applications involving
NIH-defined clinical research. This form is used to report both planned
and cumulative (or actual) enrollment, and describes the sex/gender,
race, and ethnicity of the study participants. Starting in January
2022, NIH will require will applicants and recipients to provide their
Unique Entity Identifier (UEI) instead of the Data Universal Number
System (DUNS) number. Also, the application forms will be updated to
align with the Grants.gov updated Country and State lists. NIH also
anticipates adding an optional field to the end of our forms and
applications to get a more accurate assessment of the time it takes our
applicants to complete the various forms and applications. 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 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 2/28/2023. 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 2,090,521.
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 13 712,894
Information................................
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 13 65,390
Information....................................
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............... .............. 421,777 .............. 2,090,521
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[[Page 18994]]
Dated: April 4, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-07396 Filed 4-9-21; 8:45 am]
BILLING CODE 4140-01-P