Milton W. Chu, M.D.; Filing of Color Additive Petition

---
identifier: "/us/fr/2016-06397"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Milton W. Chu, M.D.; Filing of Color Additive Petition"
title_number: 0
title_name: "Federal Register"
section_number: "2016-06397"
section_name: "Milton W. Chu, M.D.; Filing of Color Additive Petition"
positive_law: false
currency: "2016-03-22"
last_updated: "2016-03-22"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2016-06397"
document_type: "proposed_rule"
publication_date: "2016-03-22"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 73"
  - "21 CFR Part 74"
fr_citation: "81 FR 15173"
fr_volume: 81
docket_ids:
  - "Docket No. FDA-2016-F-0821"
fr_action: "Notice of petition."
---


#  Milton W. Chu, M.D.; 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 Milton W. Chu, M.D., proposing that the color additive regulations be amended to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as orientation marks for intraocular lenses.

**DATES:**

The color additive petition was filed on February 19, 2016.

**FOR FURTHER INFORMATION CONTACT:**

Laura Dye, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1275.

**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 6C0305), submitted by Milton W. Chu, M.D., 5800 Santa Rosa Rd., Suite 111, Camarillo, CA 93012. The petition proposes to amend the color additive regulations in § 73.3126 *Titanium dioxide* (21 CFR 73.3126) and § 74.3045 *[Phthalocyaninato (2-)] copper* (21 CFR 74.3045) to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as orientation marks for intraocular lenses.

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: March 17, 2016.

Dennis M. Keefe,

Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.