Document ID: FDA-2019-C-1782-0001
Agency: fda
Document Type: Proposed Rule
Title: CooperVision, Inc.; Filing of Color Additive Petition
Posted Date: 2019-05-08T04:00Z

[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Proposed Rules]
[Page 20060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09411]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2019-C-1782]

CooperVision, Inc.; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by CooperVision, Inc., 
proposing that the color additive regulations be amended to provide for 
the safe use of disperse orange 3 methacrylamide to color contact 
lenses. The color additive is intended to be copolymerized with various 
monomers to produce colored contact lens materials.

DATES: The color additive petition was filed on March 28, 2019.

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 document 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: Under section 721(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice 
that we have filed a color additive petition (CAP 9C0315), submitted by 
CooperVision, Inc., 5870 Stoneridge Dr., Suite 1, Pleasanton, CA 94588. 
The petition proposes to amend the color additive regulations in 21 CFR 
part 73, Listing of Color Additives Exempt from Certification, to 
provide for the safe use of disperse orange 3 methacrylamide (CAS Reg. 
No. 58142-15-7; CAS name 2-propenamide, 2-methyl-N-[4-[2-(4-
nitrophenyl)diazenyl]phenyl]-) to color contact lenses. The color 
additive is intended to be copolymerized with various monomers to 
produce colored contact lens materials.
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(l) because disperse orange 3 methacrylamide 
is intended for use in contact lenses. In addition, the petitioner has 
stated that, to their knowledge, no extraordinary circumstances exist. 
If FDA determines a categorical exclusion applies, neither an 
environmental assessment nor an environmental impact statement is 
required. If FDA determines a categorical exclusion does not apply, we 
will request an environmental assessment and make it available for 
public inspection.

    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09411 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P