[Federal Register: August 28, 1998 (Volume 63, Number 167)]
[Rules and Regulations]
[Page 45943-45944]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au98-12]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 95C-0399]


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 May 27, 1998, for the final rule that amended the
color additive regulations to provide for the safe use of D&C Violet
No. 2 as a color additive in glycolide/dioxanone/trimethylene carbonate
tripolymer absorbable sutures for general surgery.

DATES: Effective date confirmed: May 27, 1998.

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 April 23, 1998
(63 FR 20096), FDA amended the color additive regulations in
Sec. 74.3602 D&C Violet No. 2 (21 CFR 74.3602) to provide for the safe
use of D&C Violet No. 2 as a color additive in glycolide/dioxanone/

[[Page 45944]]

trimethylene carbonate tripolymer absorbable sutures for general
surgery.
    FDA gave interested persons until May 26, 1998, 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 April 23, 1998, should be confirmed.

List of Subjects in 21 CFR Part 74

    Color additives, Cosmetics, Drugs.
    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 April 23, 1998, final rule. Accordingly,
the amendments issued thereby became effective May 27, 1998.

    Dated: August 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23106 Filed 8-27-98; 8:45 am]
BILLING CODE 4160-01-F