[Federal Register Volume 62, Number 53 (Wednesday, March 19, 1997)]
[Rules and Regulations]
[Page 12951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 91C-0189]


Listing of Color Additives for Coloring Contact Lenses; 1,4-
Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester 
copolymers; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of November 5, 1996, for the final rule that amended the 
color additive regulations to provide for the safe use of the colored 
reaction products formed by copolymerizing 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester either 
with glyceryl methacrylate/methyl methacrylate/ethylene glycol 
dimethacrylate monomers or with N,N-dimethyl acrylamide/methyl 
methacrylate/ethylene glycol dimethacrylate monomers to form contact 
lenses.

DATES: Effective date confirmed: November 5, 1996.

FOR FURTHER INFORMATION CONTACT: Helen R. Thorsheim, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3092.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 3, 1996 
(61 FR 51584), FDA amended 21 CFR part 73 to provide for the safe use 
of the colored reaction products formed by copolymerizing 1,4-bis[(2-
hydroxyethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester either 
with glyceryl methacrylate/methyl methacrylate/ethylene glycol 
dimethacrylate monomers or with N,N-dimethyl acrylamide/methyl 
methacrylate/ethylene glycol dimethacrylate monomers to form contact 
lenses.
    FDA gave interested persons until November 4, 1996, to file 
objections or requests for a hearing. The agency received no objections 
or requests for a hearing on the final rule. Therefore, FDA finds that 
the final rule published in the Federal Register of October 3, 1996, 
should be confirmed.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act (secs. 
201, 401, 402, 403, 409, 501, 502, 505, 601, 602, 701, 721 (21 U.S.C. 
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e)) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 
5.10), notice is given that no objections or requests for a hearing 
were filed in response to the October 3, 1996, final rule. Accordingly, 
the amendments promulgated thereby became effective November 5, 1996.

    Dated: March 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-6849 Filed 3-18-97; 8:45 am]
BILLING CODE 4160-01-F