Wesley Jessen Corp.; Filing of Color Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that Wesley Jessen Corp. has filed a petition proposing that the color additive regulations be amended to provide for the safe use of mica in contact lenses.

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:

Under the Federal Food, Drug, and Cosmetic Act (sec. 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that a color additive petition (CAP 0C0271) has been filed by Wesley Jessen Corp., 333 East Howard Ave., Des Plaines, IL 60018. The petition proposes to amend the color additive regulations in 21 CFR part 73 subpart D—Medical Devices to provide for the safe use of mica in contact lenses.

The agency has determined under 21 CFR 25.32(l) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.