Document ID: FDA-2017-C-2902-0001
Agency: fda
Document Type: Proposed Rule
Title: Glo Eyes, LLC; Filing of Color Additive Petition
Posted Date: 2017-05-31T04:00Z

[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Proposed Rules]
[Pages 24912-24913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11165]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2017-C-2902]

Glo Eyes, LLC; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Glo Eyes, LLC, proposing 
that the color additive regulations be amended to provide for the safe 
use of D&C Yellow No. 8 as a color additive in contact lens solution.

DATES: The color additive petition was filed on April 18, 2017.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1075.

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 7C0311), submitted by 
Glo Eyes, LLC, 5501 Highway 199, suite 202, Fort Worth, TX 76114. The 
petition proposes to amend the color additive regulations in 21 CFR 
part 74, Listing of Color Additives Subject To Certification, to 
provide for the safe use of D&C Yellow

[[Page 24913]]

No. 8 (principally the disodium salt of fluorescein) as a color 
additive in contact lens solution.
    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: May 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11165 Filed 5-30-17; 8:45 am]
 BILLING CODE 4164-01-P