DSM Biomedical; Filing of Color Additive Petition

---
identifier: "/us/fr/2017-04188"
source: "fr"
legal_status: "authoritative_unofficial"
title: "DSM Biomedical; Filing of Color Additive Petition"
title_number: 0
title_name: "Federal Register"
section_number: "2017-04188"
section_name: "DSM Biomedical; Filing of Color Additive Petition"
positive_law: false
currency: "2017-03-06"
last_updated: "2017-03-06"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2017-04188"
document_type: "proposed_rule"
publication_date: "2017-03-06"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 73"
fr_citation: "82 FR 12531"
fr_volume: 82
docket_ids:
  - "Docket No. FDA-2017-C-0935"
fr_action: "Notice of petition."
---


#  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.