Quiero saber acerca de...

43560

Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices
PRAMain. Find this particular information collection by selecting Currently under 30-day ReviewOpen 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 301435
0941 or Email your request, including your address to ProjectClearance Branch@mail.nih.gov. 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 1899218993 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 3507a1D 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 PreAward Reporting Requirements, Revision, OMB 09250001, 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 4161
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 4165 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 09250001. All forms expire 2/28/2023. Post-award reporting
lotter on DSK11XQN23PROD with NOTICES1

Information collection forms PHS
PHS
PHS
PHS
PHS
PHS
PHS
PHS
PHS

Number of respondents
398Paper
398/424Electronic
Assignment Request Form
398 Cover Page Supplement
398 Modular Budget
398 Training Budget
398 Training Subaward Budget Attachments Form
398 Research Plan
398 Research Training Program Plan

VerDate Sep<11>2014

17:26 Aug 06, 2021

Jkt 253001

PO 00000

Frm 00043

Fmt 4703

Sfmt 4703

requirements are simultaneously consolidated under 09250002 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 4161 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 4165 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 NIHs 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.
Number of responses per respondent
4,247
37,120
74,239
56,693
1,122
561
70,866
1,122

E:FRFM09AUN1.SGM

Average burden per response in hours 1
1 1
1 1
1 1
1

09AUN1

35
30/60
1 1
2 90/60
10
10

Total annual burden hours
148,645
18,560
74,239
56,693
2,244
842
708,660
11,220