Document ID: FDA-2016-F-0821-0011
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date
Posted Date: 2017-01-23T05:00Z

[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Rules and Regulations]
[Pages 7648-7649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00534]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 73 and 74

[Docket No. FDA-2016-F-0821]

Listing of Color Additives Exempt From Certification; Titanium 
Dioxide and Listing of Color Additives Subject to Certification; 
[Phthalocyaninato (2-)] Copper; 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 December 2, 2016, for the final rule that appeared in 
the Federal Register of November 1, 2016, and that amended the color 
additive regulations to provide for the safe use of titanium dioxide 
and [phthalocyaninato (2-)] copper to color orientation marks for 
intraocular lenses (IOLs). We are taking this action to ensure clarity 
that the effective date in the final rule remains December 2, 2016.

DATES: Effective date of final rule published in the Federal Register 
of November 1, 2016 (81 FR 75689), confirmed: December 2, 2016.

FOR FURTHER INFORMATION CONTACT: Laura A. Dye, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740-3835, 240-402-1275.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 1, 2016 
(81 FR 75689), we amended the color additive regulations in Sec.  
73.3126 (21 CFR 73.3126) and Sec.  74.3045 (21 CFR 74.3045) to provide 
for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper 
to color orientation marks for IOLs.
    The preamble to the final rule stated that persons who would be 
adversely affected by one or more provisions in the final rule could 
file electronic or written objections (81 FR 75689 at 75691). We also 
stated that the effective date of the final rule would be on December 
2, 2016, unless a person properly files an objection or request for a 
hearing to review any provisions in the final rule (81 FR 75689). We 
explained that, to file an objection, a person must, among other 
things, specify with particularity the provision(s) of the regulation 
to which they object and the grounds for the objection (81 FR 75689 at 
75691). Within each objection, a person also must specifically state 
whether he/she requests a hearing. We received no objections or 
requests for a hearing on the final rule that met these requirements. 
We received five general comments, including one that disagreed with 
the rule, but the comments did not meet the requirements to be 
considered an objection under 21 CFR 12.22(a)(3). Therefore, we find 
that the effective date of the final rule that published in the Federal 
Register of November 1, 2016, should be confirmed.

List of Subjects

21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

[[Page 7649]]

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, and 
redelegated to the Director, Office of Food Additive Safety, we are 
giving notice that no objections or requests for a hearing were filed 
in response to the November 1, 2016, final rule. Accordingly, the 
amendments issued thereby became effective December 2, 2016.

    Dated: January 9, 2017.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2017-00534 Filed 1-19-17; 8:45 am]
 BILLING CODE 4164-01-P