Document ID: FDA-2017-C-0935-0008
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Subject to Certification; D&C Black No. 4;
Confirmation of Effective Date
Posted Date: 2018-09-18T04:00Z

[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Rules and Regulations]
[Page 47069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20288]

[[Page 47069]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2017-C-0935]

Listing of Color Additives Subject to Certification; D&C Black 
No. 4; 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 July 10, 2018, for the final rule that appeared in 
the Federal Register of June 7, 2018, and that amended the color 
additive regulations to provide for the safe use of D&C Black No. 4 for 
coloring ultra-high molecular weight polyethylene (UHMWPE) non-
absorbable sutures for use in general surgery.

DATES: Effective date of final rule published in the Federal Register 
of June 7, 2018 (83 FR 26356) confirmed: July 10, 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: Joseph M. Thomas, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740-3835, 301-796-9465.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 7, 2018 (83 
FR 26356), we amended the color additive regulations to add Sec.  
74.3054, ``D&C Black No. 4,'' (21 CFR 74.3054) to provide for the safe 
use of D&C Black No. 4 for coloring UHMWPE non-absorbable sutures for 
use in general surgery.
    We gave interested persons until July 9, 2018, to file objections 
or requests for a hearing. We received no objections or requests for a 
hearing on the final rule. Therefore, we find that the effective date 
of the final rule that published in the Federal Register of June 7, 
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 June 7, 2018, final rule. Accordingly, the 
amendments issued in the final rule became effective July 10, 2018.

    Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20288 Filed 9-17-18; 8:45 am]
 BILLING CODE 4164-01-P