[Federal Register Volume 87, Number 118 (Tuesday, June 21, 2022)]
[Notices]
[Pages 36864-36865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13211]


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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.

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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.

[[Page 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/regulatory-information/search-fda-guidance-documents 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