Proposed Rule2024-21684
DSM Biomedical; Filing of Color Additive Petition
Primary source
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Published
September 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 184 (Monday, September 23, 2024)</title>
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[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Proposed Rules]
[Page 77467]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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.
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]
BILLING CODE 4164-01-P
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