Document ID: FDA-2016-F-0821-0001
Agency: fda
Document Type: Proposed Rule
Title: Milton W. Chu, M.D.; Filing of Color Additive Petition
Posted Date: 2016-03-22T04:00Z

[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Page 15173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06397]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 73 and 74

[Docket No. FDA-2016-F-0821]

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 
Sec.  73.3126 Titanium dioxide (21 CFR 73.3126) and Sec.  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.
[FR Doc. 2016-06397 Filed 3-21-16; 8:45 am]
BILLING CODE 4164-01-P