Notice2021-14789
Food and Drug Administration Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for Food and Drug Administration Staff; Availability
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Published
July 12, 2021
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff entitled "FDA Oversight of Food Products Covered by Systems Recognition Arrangements." This draft guidance provides recommendations related to the FDA's regulatory oversight activities for food products imported from countries whose food safety systems the FDA has recognized in Systems Recognition Arrangements (SRAs).
Full Text
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<title>Federal Register, Volume 86 Issue 130 (Monday, July 12, 2021)</title>
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[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36559-36560]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14789]
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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 Products Covered
by Systems Recognition Arrangements; Draft Guidance for Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for FDA staff entitled ``FDA
Oversight of Food Products Covered by Systems Recognition
Arrangements.'' This draft guidance provides recommendations related to
the FDA's regulatory oversight activities for food products imported
from countries whose food safety systems the FDA has recognized in
Systems Recognition Arrangements (SRAs).
DATES: Submit either electronic or written comments on the draft
guidance by September 10, 2021 to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final
version of the guidance.
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
[[Page 36560]]
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 Products Covered by Systems
Recognition Arrangements; Draft 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 draft
guidance entitled ``FDA Oversight of Food Products 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 draft 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 draft guidance for FDA
staff entitled ``FDA Oversight of Food Products Covered by Systems
Recognition Arrangements; Draft Guidance for FDA Staff.'' The draft
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 products covered
by SRAs between FDA and its foreign regulatory counterparts. Currently,
the FDA has signed SRAs with food safety agencies in Australia, Canada,
and New Zealand.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the topic of
Systems Recognition Arrangement 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
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft 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: July 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14789 Filed 7-9-21; 8:45 am]
BILLING CODE 4164-01-P
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