Notices. Notice of petition
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/register/2017/03/06/2017-04188A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4910-13-P 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. 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]
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