Notice2022-13211
Food and Drug Administration Oversight of Food Covered by Systems Recognition Arrangements; Guidance for Food and Drug Administration Staff; Availability
Primary source
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Published
June 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 118 (Tuesday, June 21, 2022)</title>
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[Federal Register Volume 87, Number 118 (Tuesday, June 21, 2022)]
[Notices]
[Pages 36864-36865]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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