Document ID: FDA-2019-C-1782-0002
Agency: fda
Document Type: Proposed Rule
Title: CooperVision, Inc.; Withdrawal of Color Additive Petition
Posted Date: 2020-08-24T04:00Z

[Federal Register Volume 85, Number 164 (Monday, August 24, 2020)]
[Proposed Rules]
[Page 52081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2019-C-1782]

CooperVision, Inc.; Withdrawal of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; withdrawal of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
withdrawal, without prejudice to a future filing, of a color additive 
petition (CAP 9C0315) proposing that the color additive regulations be 
amended to provide for the safe use of disperse orange 3 methacrylamide 
as a color additive in contact lenses.

DATES: The color additive petition was withdrawn on June 15, 2020.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this document into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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: In the Federal Register of May 8, 2019 (84 
FR 20060), we announced that we had filed a color additive petition 
(CAP 9C0315), submitted by CooperVision, 5870 Stoneridge Dr., Suite 1, 
Pleasanton, CA 94588. The petition proposed 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 disperse orange 3 
methacrylamide (CAS Reg. 58142-15-7; CAS name 2-propenamide, 2-methyl-
N-[4-[2-(4-nitrophenyl)diazenyl]phenyl]-) as a color additive in 
silicone-based hydrogel contact lenses. The color additive was intended 
to copolymerize with various monomers in the contact lens formulation 
to produce colored contact lenses. Through this notice, we are 
announcing that CooperVision has withdrawn the petition without 
prejudice to a future filing (21 CFR 71.6(c)(2)).

    Dated: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17195 Filed 8-21-20; 8:45 am]
BILLING CODE 4164-01-P