Document ID: FDA-2017-C-0935-0001
Agency: fda
Document Type: Proposed Rule
Title: DSM Biomedical; Filing of Color Additive Petition
Posted Date: 2017-03-06T05:00Z

[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Proposed Rules]
[Page 12531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04188]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-0935]

DSM Biomedical; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice 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 high purity carbon black for coloring ultra-high molecular 
weight polyethylene sutures for use in general surgery.

DATES: The color additive petition was filed on January 27, 2017.

FOR FURTHER INFORMATION CONTACT: Joseph M. Thomas, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 301-796-9465.

SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice 
that we have filed a color additive petition (CAP 7C0310), submitted by 
DSM Biomedical, 735 Pennsylvania Dr., Exton, PA 19341. The petition 
proposes to amend the color additive regulations in 21 CFR part 73, 
Listing of Color Additives Exempt From Certification, to provide for 
the safe use of high purity carbon black for coloring ultra-high 
molecular weight polyethylene sutures for use in general surgery.
    We have determined under 21 CFR 25.32(l) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: February 28, 2017.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2017-04188 Filed 3-3-17; 8:45 am]
 BILLING CODE 4164-01-P