36864 Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 

at: https://www.fda.gov/industry/ 

electronic-submissions-gateway. 

9. Regulatory Submissions in Electronic and 

Paper Format for CBER-Regulated 

Products; available at: https://

www.fda.gov/about-fda/center-biologicsevaluation-and-research-cber/regulatorysubmissions-electronic-and-paperformat-cber-regulated-products. 

10. ‘‘The 510(k) Program: Evaluating 

Substantial Equivalence in Premarket 

Notifications [510(k)]: Guidance for 

Industry and Food and Drug 

Administration Staff,’’ dated July 28, 

2014; available at: https://www.fda.gov/ 

media/82395/download. 

Dated: June 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13210 Filed 6–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–1997] 

Food and Drug Administration 

Oversight of Food Covered by 

Systems Recognition Arrangements; 

Guidance for Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for FDA staff entitled ‘‘FDA 

Oversight of Food Covered by Systems 

Recognition Arrangements.’’ This 

guidance provides recommendations 

related to FDA’s regulatory oversight 

activities for food covered by a Systems 

Recognition Arrangement (SRA) and 

imported from countries whose food 

safety systems FDA has recognized in 

SRAs. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 21, 2022. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–D–1997 for ‘‘FDA Oversight of 

Food Covered by Systems Recognition 

Arrangements; Guidance for FDA Staff.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). Submit written requests 

for a single hard copy of the guidance 

entitled ‘‘FDA Oversight of Food 

Covered by Systems Recognition 

Arrangements’’ to the Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Building, Rm. 4148, Rockville, 

MD 20857. Send one self-addressed 

adhesive label to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Marla Hallacy, Office of Regulatory 

Affairs, Division of Operational Policy, 

Food and Drug Administration, 12420 

Parklawn Dr., Rockville, MD 20857, 

240–402–6674. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for FDA staff entitled ‘‘FDA 

Oversight of Food Covered by Systems 

Recognition Arrangements; Guidance 

for FDA Staff.’’ The guidance is part of 

FDA’s larger effort to take a risk-based 

approach to food safety to include 

ensuring the safety of imported food, 

consistent with the FDA Food Safety 

Modernization Act. The guidance covers 

FDA’s regulatory oversight activities for 

food covered by SRAs between FDA and 

its foreign regulatory counterparts. 

Currently, FDA has signed SRAs with 

food safety agencies in Australia, 

Canada, and New Zealand. 


jspears on DSK121TN23PROD with NOTICES1
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