[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Proposed Rules]
[Page 77467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2024-C-4339]


DSM Biomedical; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by DSM Biomedical, proposing 
that the color additive regulations be amended to provide for the safe 
use of phthalocyanine green to color surgical sutures made of ultra-
high molecular weight polyethylene (UHMWPE) for use in general surgery, 
at a concentration of no more than 0.5 percent by weight of the suture.

DATES: The color additive petition was filed on August 15, 2024.

ADDRESSES: For access to the docket to read background documents or 
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.

FOR FURTHER INFORMATION CONTACT: Stephen DiFranco, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2710.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), we are giving notice 
that we have filed a color additive petition (CAP 4C0335), submitted by 
DSM Biomedical, 735 Pennsylvania Dr., Exton, PA 19341. The petition 
proposes to amend the color additive regulations in 21 CFR part 74, 
``Listing of Color Additives Subject to Certification,'' to provide for 
the safe use of phthalocyanine green to color surgical sutures made of 
UHMWPE for use in general surgery, at a concentration of no more than 
0.5 percent by weight of the suture.
    The petitioner claims that this action is categorically excluded 
under 21 CFR 25.32(l) because the substance is used in sutures. If FDA 
determines a categorical exclusion applies, neither an environmental 
assessment nor an environmental impact statement is required. If FDA 
determines a categorical exclusion does not apply, we will request an 
environmental assessment and make it available for public inspection.

    Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21684 Filed 9-20-24; 8:45 am]
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