Document ID: FDA-2017-C-2902-0013
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Subject to Certification; D&C Yellow No. 8;
Confirmation of Effective Date
Posted Date: 2018-12-17T05:00Z

[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Rules and Regulations]
[Page 64443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27234]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2017-C-2902]

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.

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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 
Sec.  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.

0
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.
[FR Doc. 2018-27234 Filed 12-14-18; 8:45 am]
 BILLING CODE 4164-01-P