[Federal Register Volume 88, Number 97 (Friday, May 19, 2023)]
[Rules and Regulations]
[Pages 32104-32105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2023-D-1336]


Requirements for Additional Traceability Records for Certain 
Foods: What You Need To Know About the Food and Drug Administration 
Regulation: Guidance for Industry; Small Entity Compliance Guide; 
Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (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 
``Requirements for Additional Traceability Records for Certain 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 ``Requirements for Additional Traceability Records for Certain 
Foods.''

DATES: The announcement of the guidance is published in the Federal 
Register on May 19, 2023.

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:
     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-2023-D-1336 for ``Requirements for Additional Traceability Records 
for Certain 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 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 single copies of the SECG to the Office 
of Analytics and Outreach, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740. 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: Katherine Vierk, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2122.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of November 21, 2022 (87 FR 70910), we 
issued a final rule establishing additional recordkeeping requirements 
for persons who manufacture, process, pack, or hold foods FDA has 
designated for inclusion on the Food Traceability List (the final 
rule). The requirements established in the final rule will help the 
Agency rapidly and effectively identify recipients of foods to prevent 
or mitigate foodborne illness outbreaks and address credible threats of 
serious adverse health consequences or death resulting from foods being 
adulterated or misbranded. The final rule, which is codified at 21 CFR 
part 1, subpart S (Sec. Sec.  1.1300 through 1.1465), became effective 
on January 20, 2023, but has a compliance date of January 20, 2026.
    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

[[Page 32105]]

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 S, have been approved under 
OMB control number 0910-0560.

III. Electronic Access

    Persons with access to the internet may obtain the SECG at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA 
website listed in the previous sentence to find the most current 
version of the guidance.

    Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10666 Filed 5-18-23; 8:45 am]
BILLING CODE 4164-01-P


