[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43559-43561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; PHS 
Applications and Pre-Award Related Reporting (Office of the Director)

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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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.

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 recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/

[[Page 43560]]

PRAMain. Find this particular information collection by selecting 
``Currently under 30-day Review--Open for Public Comments'' or by using 
the search function.

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, 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: This proposed information collection was 
previously published in the Federal Register on April 12, 2021, pages 
18992-18993 (86 FR 18992) 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. The Office of the Director 
(OD), Office of Policy and Extramural Research Administration (OPERA), 
National Institutes of Health, 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 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.
    Proposed Collection: 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 2,023,454.

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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 Attachment(s)               561               1           90/60             842
 Form...........................................
PHS 398 Research Plan...........................          70,866               1              10         708,660
PHS 398 Research Training Program Plan..........           1,122               1              10          11,220

[[Page 43561]]

 
Data Tables.....................................           1,515               1               4           6,060
PHS 398 Career Development Award Supplemental              2,251               1              10          22,510
 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 Supplemental Form (includes F               6,707               1            12.5          83,838
 reference letters).............................
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.......................................  ..............         413,393  ..............       2,023,454
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    Dated: July 30, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-17031 Filed 8-6-21; 8:45 am]
BILLING CODE 4140-01-P