[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 filed in 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. 99-29917 Filed 11-16-99; 8:45 am]
BILLING CODE 4160-01-F