[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Proposed Rules]
[Pages 19026-19027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06579]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2023-N-0437]


Filing of Color Additive Petition From Center for Science in the 
Public Interest, et al.; Request To Revoke Color Additive Listing for 
Use of FD&C Red No. 3 in Food and Ingested Drugs; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Petition for rulemaking; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the color additive petition for which we published a 
notice of filing in the Federal Register of February 17, 2023. In the 
notice, FDA requested comments on a filed color additive petition 
submitted by Center for Science in the Public Interest, et al., 
proposing that FDA repeal the color additive regulations providing for 
the use of FD&C Red No. 3 in foods (including dietary supplements) and 
in ingested drugs. We are taking this action in response to a request 
for an extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the color additive 
petition for which a notice of filing was published in the Federal 
Register of February 17, 2023 (88 FR 10245). Either electronic or 
written comments must be submitted by May 18, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time on May 18, 2023. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are received on or before that date.

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

[[Page 19027]]

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-N-0437 for ``Filing of Color Additive Petition from Center for 
Science in the Public Interest, et al.; Request to Revoke Color 
Additive Listing for Use of FD&C Red No. 3 in Food and Ingested 
Drugs.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Shayla West-Barnette, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1262.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 17, 2023 
(88 FR 10245), we published a notice of filing of a color additive 
petition with a 60-day comment period. We explained that, under section 
721(d)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 379e(d)(1)), we were giving notice that we had filed a color 
additive petition (CAP 3C0323), submitted by Center for Science in the 
Public Interest, Breast Cancer Prevention Partners, Center for 
Environmental Health, Center for Food Safety, Chef Ann Foundation, 
Children's Advocacy Institute, Consumer Federation of America, Consumer 
Reports, Defend Our Health, Environmental Defense Fund, Environmental 
Working Group, Feingold Association of the United States, Food & Water 
Watch, Healthy Babies Bright Futures, Life Time Foundation, Momsrising, 
Prevention Institute, Public Citizen, Public Health Institute, Public 
Interest Research Group, Real Food for Kids, Lisa Y. Lefferts, Linda S. 
Birnbaum, and Philip J. Landrigan, c/o Jensen Jose, 1250 I Street NW, 
Suite 500, Washington, DC 20005. The color additive petition proposes 
that we repeal the color additive regulations for FD&C Red No. 3 in 21 
CFR 74.303, which permits the use of FD&C Red No. 3 in foods (including 
dietary supplements), and 21 CFR 74.1303, which permits the use of FD&C 
Red No. 3 in ingested drugs.
    We have received a request for a 60-day extension of the comment 
period for the color additive petition The request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a thoughtful response to the color additive petition.
    FDA has considered the request and is extending the comment period 
for the color additive petition until May 18, 2023. We believe that a 
30-day extension allows adequate time for interested persons to submit 
comments without significantly delaying a response to this petition.
    We also clarify a statement in the notice of filing. In describing 
the petitioners' claim that the action they sought in their petition is 
categorically excluded under our environmental regulations at Sec.  
25.32 (21 CFR 25.32), we referred only to a categorical exclusion for 
food packaging (88 FR 10245 at 10246). The regulation we cited, Sec.  
25.32(m), categorically excludes an action to prohibit or otherwise 
restrict or reduce the use of a substance in food, food packaging, or 
cosmetics.

    Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06579 Filed 3-29-23; 8:45 am]
BILLING CODE 4164-01-P