Rule2022-22706
Laboratory Accreditation for Analyses of Foods; Small Entity Compliance Guide; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 20, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Laboratory Accreditation for Analyses of Foods: What You Need to Know About the FDA Regulation: Guidance for Industry--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "Laboratory Accreditation for Analyses of Foods."
Full Text
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<title>Federal Register, Volume 87 Issue 202 (Thursday, October 20, 2022)</title>
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[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Rules and Regulations]
[Pages 63686-63687]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22706]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2022-D-1126]
Laboratory Accreditation for Analyses of Foods; Small Entity
Compliance Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for industry entitled
``Laboratory Accreditation for Analyses of Foods: What You Need to Know
About the FDA Regulation: Guidance for Industry--Small Entity
Compliance Guide.'' The small entity compliance guide (SECG) is
intended to help small entities comply with the final rule entitled
``Laboratory Accreditation for Analyses of Foods.''
DATES: The announcement of the guidance is published in the Federal
Register on October 20, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2022-D-1126 for ``Laboratory Accreditation for Analyses of Foods:
What You Need to Know About the FDA Regulation: Guidance for Industry--
Small Entity Compliance Guide.'' 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
[[Page 63687]]
``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 single copies of the SECG to the Office
of Strategic Planning and Operational Policy, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element
Building, Rockville, MD 20857. Send two self-addressed adhesive labels
to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT: Stacie Hammack, Food and Feed
Laboratory Operations, Office of Regulatory Affairs, Food and Drug
Administration, 60 8th Street NE, Atlanta, GA 30309, 301-796-5817.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 3, 2021 (86 FR 68728), we
issued a final rule establishing a program for the testing of food in
certain circumstances by accredited laboratories, as required under the
Federal Food, Drug, and Cosmetic Act (the final rule). Establishing
this program will help FDA improve the safety of the U.S. food supply
and protect U.S. consumers by helping to ensure that certain food
testing of importance to public health is conducted subject to
appropriate oversight and in accordance with appropriate model
standards to produce reliable and valid test results. The final rule,
which is codified at 21 CFR part 1, subpart R (21 CFR 1.1101 through
1.1201), became effective February 1, 2022.
We examined the economic implications of the final rule as required
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined
that the final rule will have a significant economic impact on a
substantial number of small entities. In compliance with section 212 of
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to
explain the actions that a small entity must take to comply with the
rule.
We are issuing the SECG consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The SECG represents the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative 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 in 21 CFR part 1, subpart R have been approved under OMB
control number 0910-0898.
III. Electronic Access
Persons with access to the internet may obtain the SECG at <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry">https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry</a>, <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>. Use the FDA
website listed in the previous sentence to find the most current
version of the guidance.
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22706 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on October 20, 2022.
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