[Federal Register Volume 64, Number 221 (Wednesday, November 17, 1999)]
[Rules and Regulations]
[Pages 62582-62583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29917]
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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.
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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
