[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Rules and Regulations]
[Pages 83024-83026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26095]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 130 and 131

[Docket No. FDA-2023-D-4722]


Milk and Cream Products and Yogurt Products; Final Rule To Revoke 
the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the 
Standard for Yogurt; 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 or we) is announcing the 
availability of a guidance for industry entitled ``Milk and Cream 
Products and Yogurt Products; Final Rule To Revoke the Standards for 
Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt--
Small Entity Compliance Guide.'' The small entity compliance guide 
(SECG) is intended to explain the actions a small entity must take to 
comply with FDA's regulations after recent changes made by our 2021 
final rule titled ``Milk and Cream Products and Yogurt Products; Final 
Rule To Revoke the Standards for Lowfat Yogurt

[[Page 83025]]

and Nonfat Yogurt and To Amend the Standard for Yogurt,'' 2022 final 
rule titled ``International Dairy Foods Association and Chobani, Inc.: 
Response to the Objections and Requests for a Public Hearing on the 
Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt 
and To Amend the Standard for Yogurt,'' and 2023 final order titled 
``International Dairy Foods Association: Response to the Objections and 
Requests for a Public Hearing on the Final Rule To Revoke the Standards 
for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for 
Yogurt.''

DATES: The announcement of the guidance is published in the Federal 
Register on November 28, 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-4722 for ``Milk and Cream Products and Yogurt Products; 
Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt 
and To Amend the Standard for Yogurt; 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.'' We will review 
this copy, including the claimed confidential information, in our 
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 Nutrition and Food Labeling, Product Evaluation and Labeling Branch, 
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: Vivien Yan Peng, Office of Nutrition 
and Food Labeling (HFS-820), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2371; or Jessica Ritsick, Office of Regulations and 
Policy (HFS-024), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Milk and Cream Products and Yogurt Products; Final Rule To 
Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend 
the Standard for Yogurt; Small Entity Compliance Guide.''
    In the Federal Register of June 11, 2021 (86 FR 31117), we issued a 
final rule titled ``Milk and Cream Products and Yogurt Products; Final 
Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To 
Amend the Standard for Yogurt'' (2021 final rule). The 2021 final rule 
amended title 21 of the Code of Federal Regulations at parts 130 and 
131 (21 CFR parts 130 and 131) by revoking the standards of identity 
for lowfat yogurt and nonfat yogurt and amending the standard of 
identity for yogurt in numerous respects. In brief, we revoked the 
standards for lowfat yogurt and nonfat yogurt. Consequently, lowfat 
yogurt and nonfat yogurt became covered under the general definition 
and standard of identity in 21 CFR 130.10, which sets out requirements 
for foods that deviate from other standardized foods due to compliance 
with a nutrient content claim. The 2021 final rule also amended the 
standard of identity for yogurt by making certain technical changes, 
established functional classes of safe and suitable ingredients, 
replaced the list of nutritive sweeteners with the term ``nutritive 
carbohydrate sweeteners,'' and permitted and required certain 
statements about cultures under certain conditions.

[[Page 83026]]

    The International Dairy Foods Association (IDFA) and Chobani, Inc., 
timely filed objections and requested a hearing with respect to several 
provisions in the 2021 final rule. In the Federal Register of March 23, 
2022 (87 FR 16394), we issued a notice providing clarification on which 
provisions of the final rule were stayed and which requirements of the 
previous final rule that we issued in 1981 (46 FR 9924) were in effect 
pending final action. We completed our evaluation of the objections, 
and, on December 15, 2022, we published a final rule denying requests 
for a hearing with respect to all but one of the objections, providing 
modifications to certain provisions in the 2021 final rule, and 
announcing that the stay of effectiveness of provisions for which 
hearings were denied was lifted (87 FR 76559) (2022 final rule). The 
2022 final rule did not address IDFA's objections and request for a 
hearing on the acidity requirement of yogurt, and we instead addressed 
this in a proposed order sent to IDFA and posted to the docket for 
public review.
    We did not receive any response to the proposed order, and on April 
14, 2023, we published a final order, ``International Dairy Foods 
Association: Response to the Objections and Requests for a Public 
Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and 
Nonfat Yogurt and Amend the Standard for Yogurt'' (88 FR 22907) (2023 
final order). The 2023 final order modified the acidity requirement in 
21 CFR 131.200(a) of the 2021 final rule.
    Manufacturers must begin complying with the rule for products 
labeled on or after January 1, 2024.
    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 would 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 this SECG consistent with our good guidance 
practices regulation (21 CFR 10.115). 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

    This 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 SECG at https://www.fda.gov/FoodGuidances, 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: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26095 Filed 11-27-23; 8:45 am]
BILLING CODE 4164-01-P