CooperVision, Inc.; Withdrawal of Color Additive Petition

• Published date: 24 August 2020
• Citation: 85 FR 52081
• Record Number: 2020-17195
• Section: Proposed rules
• Court: Food And Drug Administration

Federal Register, Volume 85 Issue 164 (Monday, August 24, 2020)

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                DATES: The color additive petition was withdrawn on June 15, 2020.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