03-3668. Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; 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 November 26, 2002, for the final rule that appeared in the Federal Register of October 24, 2002 (67 FR 65311). The final rule amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in contact lenses.

DATES:

Effective date confirmed: November 26, 2002.

FOR FURTHER INFORMATION CONTACT:

Aydin Örstan, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3076.

SUPPLEMENTARY INFORMATION:

In the Federal Register of October 24, 2002 (67 FR 65311), FDA amended the color additive regulations to add § 73.3128 Mica-based pearlescent pigments (21 CFR 73.3128) to provide for the safe use of mica-based pearlescent pigments as color additives in contact lenses.

FDA gave interested persons until November 25, 2002, 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 October 24, 2002, 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 (21 CFR 5.10), notice is given that no objections or requests for a hearing were filed in response to the October 24, 2002, final rule. Accordingly, the amendments issued thereby became effective November 26, 2002.

Dated: Dated: February 7, 2002.

Margaret M. Dotzel,

Assistant Commissioner for Policy.