Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 36865 

On July 12, 2021, FDA made available 

the draft guidance entitled ‘‘FDA 

Oversight of Food Products Covered by 

Systems Recognition Arrangements; 

Draft Guidance for Food and Drug 

Administration Staff’’ in the Federal 

Register (86 FR 36559). The comment 

period closed on September 10, 2021. 

FDA received no comments on the draft 

guidance. The Agency made minor 

editorial changes to the guidance to 

improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the topic of SRA 

implementation. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternate approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information regarding the Foreign 

Supplier Verification Program have 

been approved under OMB control 

number 0910–0752, the collections of 

information regarding the Hazard 

Analysis and Critical Control Point 

Procedures for the Safe and Sanitary 

Processing and Importing of Juice have 

been approved under OMB control 

number 0910–0466, and the collections 

of information regarding the Hazard 

Analysis and Critical Control Point 

Procedures for the Safe and Sanitary 

Processing and Importing of Fish and 

Fishery Products have been approved 

under OMB control number 0910–0354. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://

www.regulations.gov. 

Dated: June 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13211 Filed 6–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Minority Health 

and Health Disparities; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: National Institute on 

Minority Health and Health Disparities 

Special Emphasis Panel; NIH Support for 

Conferences and Scientific Meetings (R13). 

Date: July 8, 2022. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Gateway Plaza, 7201 Wisconsin Ave., 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Ivan K. Navarro, Ph.D., 

Scientific Review Officer, Office of 

Extramural Research Administration, 

National Institute on Minority Health and 

Health Disparities, National Institutes of 

Health, Gateway Building, 7201 Wisconsin 

Avenue, Bethesda, MD 20892, 301–827– 

2061, ivan.navarro@nih.gov. 

Name of Committee: National Institute on 

Minority Health and Health Disparities 

Special Emphasis Panel; Rapid Acceleration 

of Diagnostics Tribal Data Repository (RADx 

TDR) (U24). 

Date: July 12, 2022. 

Time: 2:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Gateway Plaza, 7201 Wisconsin Ave., 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Maryline Laude-Sharp, 

Ph.D., Scientific Review Officer, Office of 

Extramural Research Administration, 

National Institute on Minority Health and 

Health Disparities, National Institutes of 

Health, Gateway Building, 7201 Wisconsin 

Avenue, Ste. 525, MSC. 9206, Bethesda, MD 

20892, 301–451–9536, mlaudesharp@

mail.nih.gov. 

Name of Committee: National Institute on 

Minority Health and Health Disparities 

Special Emphasis Panel; Research Centers in 

Minority Institutions Clinical Research 

Network for Health Equity (RCMI–CRNHE). 

Date: July 27, 2022. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Gateway Plaza, 7201 Wisconsin Ave., 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Xinli Nan, M.D., Ph.D., 

Scientific Review Officer, Office of 

Extramural Research Activities, National 

Institute on Minority Health and Health 

Disparities, National Institutes of Health, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892, 301–594–7784, 

Xinli.Nan@nih.gov. 

Name of Committee: National Institute on 

Minority Health and Health Disparities 

Special Emphasis Panel; Misinformation 

among Populations that Experience Health 

Disparities (R01—Clinical Trials Optional). 

Date: July 28, 2022. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Gateway Plaza, 7201 Wisconsin Ave., 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Karen Nieves-Lugo, 

M.P.H., Ph.D., Scientific Review Officer, 

Office of Extramural Research Activities, 

National Institute on Minority Health and 

Health Disparities, National Institutes of 

Health, Gateway Building, 7201 Wisconsin 

Avenue, Bethesda, MD 20892, (301) 480– 

4727, karen.nieveslugo@nih.gov. 

Dated: June 14, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–13147 Filed 6–17–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request: NIH Extramural Harassment 

Web Form (Office of the Director, 

Office of Extramural Research) 

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 (OD) Office of 

Extramural Research (OER) 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. 


jspears on DSK121TN23PROD with NOTICES1
36866 Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 

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: Dr. Patricia Valdez, Chief 

Extramural Research Integrity Officer, 

Office of Extramural Research, National 

Institutes of Health, 6705 Rockledge Dr., 

Room 811–G MSC 7963, Bethesda, 

Maryland 20892 or call non-toll-free 

number (301) 451–2160 or email your 

request, including your address to: 

patricia.valdez@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 

to address 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: NIH 

Extramural Harassment Web Form, 

0925–NEW, exp., date, XX/XX/XXXX, 

National Institutes of Health (NIH) 

Office of the Director (OD), Office of 

Extramural Research (OER). 

Need and Use of Information 

Collection: The purpose of this web 

form is to assist extramural institutions 

with complying with Section 239 of the 

Consolidated Appropriations Act, 2022 

(Pub. L. 117–103), Division H, Title II, 

which requires that ‘‘institutions that 

receive funds through a grant or 

cooperative agreement during fiscal year 

2022 and in future years to notify the 

Director when individuals identified as 

a principal investigator or as key 

personnel in an NIH notice of award are 

removed from their position or are 

otherwise disciplined due to concerns 

about harassment, bullying, retaliation, 

or hostile working conditions.’’ The 

Harassment Web Form will be used as 

a secure and confidential portal by 

which recipient institutions notify NIH 

when individuals identified as a 

Program Director/Principal Investigator 

(PD/PI) or other Senior/Key personnel 

in an NIH notice of award are removed 

from their position or are otherwise 

disciplined by the recipient institution 

due to concerns about harassment, 

bullying, retaliation, or hostile working 

conditions, as specified in NOT–OD– 

22–129. Notification must be provided 

by the Authorized Organization 

Representative within 30 days of the 

removal or disciplinary action and must 

be submitted to NIH through the 

Harassment Web Form. All required 

notifications must include, at a 

minimum, the name of the Authorized 

Organization Representative submitting 

the notification, the name of the 

individual of concern, a description of 

the concerns, the action(s) taken, and 

any anticipated impact on the NIHfunded award(s). 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

60. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

Private Sector (grant recipients) ...................................................................... 140 1 15/60 35 

Individuals (general public not in administrative role) ..................................... 100 1 15/60 25 

Total .......................................................................................................... ........................ 240 ........................ 60 

Dated: June 10, 2022. 

Tara A. Schwetz, 

Acting Principal Deputy Director, National 

Institutes of Health. 

[FR Doc. 2022–13142 Filed 6–17–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel. 

The meetings 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: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel; Career Development 

(Ks) and Conference Support (R13) Review. 

Date: July 19, 2022. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Democracy II, 6707 Democracy Blvd., 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Ruixia Zhou, Ph.D., 

Scientific Review Officer, National Institute 

of Biomedical Imaging and Bioengineering, 

National Institutes of Health, 6707 

Democracy Blvd., Bethesda, MD 20892, (301) 

496–4773, zhour@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, National Institute of 

Biomedical Imaging and Bioengineering, 

National Institutes of Health, HHS) 

Dated: June 15, 2022. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–13238 Filed 6–17–22; 8:45 am] 

BILLING CODE 4140–01–P 


jspears on DSK121TN23PROD with NOTICES1