Color additives: D&C Violet No. 2 for coloring meniscal tacks,

[Federal Register: October 28, 1999 (Volume 64, Number 208)]

[Rules and Regulations]

[Page 57974]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28oc99-4]

[[Page 57974]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 98C-0158]

Listing of Color Additives For Coloring Meniscal Tacks; D&C Violet No. 2; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of July 20, 1999, for the final rule that appeared in the Federal Register of June 18, 1999 (64 FR 32803), and that amended the color additive regulations to provide for the safe use of D&C Violet No. 2 to color absorbable meniscal tacks made from poly(L-lactic acid).

DATES: Effective date confirmed: July 20, 1999.

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 June 18, 1999 (64 FR 32803), 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 to color absorbable meniscal tacks made from poly(L-lactic acid). FDA gave interested persons until July 19, 1999, 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 June 18, 1999, should be confirmed.

List of Subjects in 21 CFR Part 74

Color additives, Cosmetics, Drugs, Foods, Medical devices. 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 filedin response to the June 18, 1999, final rule. Accordingly, the amendments issued thereby became effective July 20, 1999.

Dated: October 21, 1999. William K. Hubbard, Senior Associate Commissioner for Policy, Planning, and Legislation

[FR Doc. 99-28108Filed10-27-99; 8:45 am]

BILLING CODE 4160-01-F