[Federal Register Volume 60, Number 119 (Wednesday, June 21, 1995)]
[Rules and Regulations]
[Page 32264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15083]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 93C-0380]


Listing of Color Additives for Coloring Contact Lenses; 1,4-
Bis[4-(2-Methacryloxyethyl)Phenylamino] Anthraquinone 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 March 30, 1995, of the final rule published in the 
Federal Register of February 27, 1995 (60 FR 10495), that amended the 
color additive regulations to provide for the safe use of the colored 
reaction product formed by copolymerizing 1,4-bis[4-(2-
methacryloxyethyl)phenylamino]
 anthraquinone with 3-[tris(trimethylsiloxy)silyl]propyl vinyl 
carbamate (CAS Reg. No. 134072-99-4) and N-vinyl pyrrolidone to form 
contact lenses.

DATES: Effective date confirmed: March 30, 1995.

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 February 27, 1995 
(60 FR 10495), FDA amended 21 CFR 73.3106 of the color additive 
regulations to provide for the safe use of 1,4-bis[4-(2-
methacryloxyethyl)phenylamino] anthraquinone copolymerized with N-vinyl 
pyrrolidone and 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate to 
form contact lenses.
    FDA gave interested persons until March 29, 1995, 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 February 27, 1995, 
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 February 27, 1995, final rule. 
Accordingly, the amendments promulgated thereby became effective March 
30, 1995.

    Dated: June 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-15083 Filed 6-20-95; 8:45 am]
BILLING CODE 4160-01-F