[Federal Register Volume 65, Number 189 (Thursday, September 28, 2000)]
[Rules and Regulations]
[Pages 58221-58222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 99C-1455]


Listing of Color Additives for Coloring Sutures; D&C Violet No. 
2; 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 August 29, 2000 (65 FR 46342), for the final rule 
that appeared in the Federal Register of July 28, 2000, and that 
amended the color additive regulations to provide for the safe use of 
D&C Violet No. 2 as a color additive in absorbable sutures prepared 
from homopolymers of glycolide for general surgery. The agency also 
revised the nomenclature ``polyglactin 910 (glycolic-lactic acid 
polyester)'' to the generic nomenclature ``copolymers of 90 percent 
glycolide and 10 percent L-lactide.''

DATES: Effective date confirmed: August 29, 2000.

FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3089.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2000 (65 
FR 46342), FDA amended the color additive regulations in 21 CFR 74.3602 
D&C Violet No. 2 to provide for the safe use of D&C Violet No. 2 as a 
color additive in absorbable sutures prepared from homopolymers of 
glycolide for general surgery. The agency also revised the nomenclature 
``polyglactin 910 (glycolic-lactic acid polyester)'' to the generic 
nomenclature ``copolymers of 90 percent glycolide and 10 percent L-
lactide.''
    FDA gave interested persons until August 28, 2000, 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 effective date of the final rule that published in the Federal 
Register of July 28, 2000, should be confirmed.

List of Subjects in 21 CFR Part 74

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

[[Page 58222]]

    Therefore, under the Federal Food, Drug, and Cosmetic Act (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 July 28, 2000, final rule. Accordingly, 
the amendments issued thereby became effective August 29, 2000.

    Dated: September 21, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24877 Filed 9-27-00; 8:45 am]
BILLING CODE 4160-01-F