Color additives: Aluminum Lake on alumina for coloring bone cement,

[Federal Register: November 17, 1999 (Volume 64, Number 221)]

[Rules and Regulations]

[Page 62582-62583]

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

[DOCID:fr17no99-7]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 92C-0348]

Listing of Color Additives for Coloring Bone Cement; FD&C Blue No. 2-Aluminum Lake on Alumina; 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 October 5, 1999 (64 FR 48288), for the final rule that appeared in the Federal Register of September 3, 1999, and that amended the color additive regulations to provide for the safe use of FD&C Blue No. 2-Aluminum Lake on alumina to color bone cement. The agency also transferred the listing for the use of FD&C Blue No. 2 in sutures to reflect that sutures in which this color additive is used are devices, not drugs.

DATES: Effective date confirmed: October 5, 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 September 3, 1999 (64 FR 48288), FDA amended the color additive regulations to provide for the safe use of FD&C Blue No. 2-Aluminum Lake on alumina to color bone cement. To reflect that sutures in which this color additive is used are devices, not drugs, the agency also transferred the listing for the use of FD&C Blue No. 2

[[Page 62583]]

in sutures from Sec. 74.1102 FD&C Blue No. 2 (21 CFR 74.1102) under subpart B--Drugs to new Sec. 74.3102 FD&C Blue No. 2 (21 CFR 74.3102) under subpart D--Medical Devices and made nonsubstantive amendments to Sec. 74.1102.

FDA gave interested persons until October 4, 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 September 3, 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 September 3, 1999, final rule. Accordingly, the amendments issued thereby became effective October 5, 1999.

Dated: November 9, 1999. William K. Hubbard, Senior Associate Commissioner for Policy, Planning, and Legislation.

[FR Doc. 99-29917Filed11-16-99; 8:45 am]

BILLING CODE 4160-01-F