
[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Rules and Regulations]
[Pages 59503-59504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2009-C-0543]


Listing of Color Additives Exempt From Certification; Reactive 
Blue 69; 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 June 6, 2011, for the final rule that appeared in the 
Federal Register of May 4, 2011 (76 FR 25234). The final rule amended 
the color additive regulations to provide for the safe use of disodium 
1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-
9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (CAS Reg. No. 70209-99-
3), also known as Reactive Blue 69, as a color additive in contact 
lenses.

DATES: The effective date confirmed: June 6, 2011.

FOR FURTHER INFORMATION CONTACT: Raphael A. Davy, Center for Food 
Safety

[[Page 59504]]

and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1272.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 4, 2011 (76 
FR 25234), FDA amended the color additive regulations to add 21 CFR 
73.3129 to provide for the safe use of disodium 1-amino-4-[[4-[(2-
bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-
dioxoanthracene-2-sulphonate (CAS Reg. No. 70209-99-3), also known as 
Reactive Blue 69, as a color additive in contact lenses.
    FDA gave interested persons until June 3, 2011, 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 May 4, 2011, should be confirmed.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, 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, and 
redelegated to the Director, Office of Food Additive Safety, notice is 
given that no objections or requests for a hearing were filed in 
response to the May 4, 2011, final rule. Accordingly, the amendments 
issued thereby became effective June 6, 2011.

    Dated: September 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24795 Filed 9-26-11; 8:45 am]
BILLING CODE 4160-01-P


