This PDF is the current document as it appeared on Public Inspection on 03/03/2017 at 08:45 am.
Food and Drug Administration, HHS.
Notice of petition.
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.
The color additive petition was filed on January 27, 2017.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.Start Signature
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]
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