Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 34891 

Contact Person: Joseph D. Mosca, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5158, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

2344, moscajos@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; HEAL 

Initiative: Secondary Analysis and 

Integration of Existing Data Related to Acute 

and Chronic Pain Development or 

Management in Humans. 

Date: July 21, 2022. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Linda MacArthur, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4187, 

Bethesda, MD 20892, 301–537–9986, 

macarthurlh@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: June 2, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–12303 Filed 6–7–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; PHS Applications and PreAward Reporting Requirements (OD) 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 

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, 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 

ProjectClearanceBranch@mail.nih.gov. 

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. 

Proposed Collection Title: Public 

Health Service (PHS) Applications and 

Pre-Award Reporting Requirements, 

Revision, OMB 0925–0001, Expiration 

Date 9/30/2024, Office of the Director 

(OD), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: Starting in January 2023, 

NIH will require applicants and 

recipients to submit and address Data 

Management and Sharing Plans within 

the SF424 Research and Related (R&R) 

application and the Research 

Performance Progress Report (RPPR) in 

accordance with the final NIH Policy for 

Data Management and Sharing (DMS 

Policy) to promote the management and 

sharing of scientific data generated from 

NIH-funded or conducted research. The 

application and progress report forms 

will be updated to align with this 

requirement. This collection also 

continues to include 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 2/28/2023. Post-award reporting 

requirements are simultaneously 

consolidated under 0925–0002 and 

include the RPPR. The PHS 398 and SF 

424 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 


khammond on DSKJM1Z7X2PROD with NOTICES
34892 Federal Register / Vol. 87, No. 110 / Wednesday, June 8, 2022 / Notices 

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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Information collection forms Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

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) Form ............................. 561 1 90/60 842 

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 Supplemental Form ............................ 2,251 1 10 22,510 

PHS Human Subjects and Clinical Trial Information ....................................... 54,838 1 13 712,894 

Biosketch (424 Electronic) ............................................................................... 80,946 1 2 161,892 

PHS Fellowship—Electronic ............................................................................ ........................ ........................ ........................ ........................

PHS Fellowship Supplemental Form (includes F reference letters) ............... 6,707 1 12.5 83,838 

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 ........................ 2,023,454 

Dated: June 1, 2022. 

Tara A. Schwetz, 

Acting Principal Deputy Director, National 

Institutes of Health. 

[FR Doc. 2022–12278 Filed 6–7–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group; NHLBI SingleSite and Pilot Clinical Trials Study Section. 

Date: June 22–23, 2022. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6705 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: YingYing Li-Smerin, MD, 

Ph.D., Scientific Review Officer, Office of 

Scientific Review/DERA, National Heart, 

Lung, and Blood Institute, 6705 Rockledge 

Drive, Room 207–P, Bethesda, MD 20892– 

7924, 301–827–7942, lismerin@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: June 3, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–12338 Filed 6–7–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request: Request Human Embryonic 

Stem Cell Line To Be Approved for Use 

in NIH Funded Research (Office of the 

Director) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

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) 

Office of the Director 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, 


khammond on DSKJM1Z7X2PROD with NOTICES