[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
                                                 ---------------------------------------------------------------
        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