2018-27234. Listing of Color Additives Subject to Certification; D&C Yellow No. 8; Confirmation of Effective Date

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; confirmation of effective date.

SUMMARY:

The Food and Drug Administration (FDA or we) is confirming the effective date of October 26, 2018, for the final rule that appeared in the Federal Register of September 25, 2018, and that amended the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.

DATES:

The effective date of final rule published in the Federal Register of September 25, 2018 (83 FR 48373) is confirmed: October 26, 2018.

ADDRESSES:

For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075.

SUPPLEMENTARY INFORMATION:

In the Federal Register of September 25, 2018 (83 FR 48373), we amended the color additive regulations to add § 74.3708, “D&C Yellow No. 8,” (21 CFR 74.3708) to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.

We gave interested persons until October 25, 2018, to file objections or requests for a hearing. We explained that, to file an objection, among other things, persons must specify with particularity the provision(s) to which they object. We also explained that if a person who properly submits an objection wants a hearing, he or she must specifically request a hearing and that failure to do so will constitute a waiver of the right to a hearing (83 FR 48373 at 48375).

We received seven comments regarding our decision to amend the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution. None of the comments, however, specified with particularity the provision(s) of the regulation to which they objected nor specifically requested a hearing. Therefore, we find that the effective date of the final rule that published in the Federal Register of September 25, 2018, should be confirmed.

List of Subjects in 21 CFR Part 74

• Color additives
• Cosmetics
• Drugs

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, we are giving notice that no objections or requests for a hearing were filed in response to the September 25, 2018, final rule. Accordingly, the amendments issued in the final rule became effective October 26, 2018.

Dated: December 11, 2018.

Leslie Kux,

Associate Commissioner for Policy.