Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!

Proposed Rule

CooperVision, Inc.; Withdrawal of Color Additive Petition

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.


Notification; withdrawal of petition.


The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a color additive petition (CAP 9C0315) proposing that the color additive regulations be amended to provide for the safe use of disperse orange 3 methacrylamide as a color additive in contact lenses.


The color additive petition was withdrawn on June 15, 2020.


For access to the docket to read background documents or comments received, go to 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.

Start Further Info


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

End Further Info End Preamble Start Supplemental Information


In the Federal Register of May 8, 2019 (84 FR 20060), we announced that we had filed a color additive petition (CAP 9C0315), submitted by CooperVision, 5870 Stoneridge Dr., Suite 1, Pleasanton, CA 94588. The petition proposed 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. 58142-15-7; CAS name 2-propenamide, 2-methyl-N-[4-[2-(4-nitrophenyl)diazenyl]phenyl]-) as a color additive in silicone-based hydrogel contact lenses. The color additive was intended to copolymerize with various monomers in the contact lens formulation to produce colored contact lenses. Through this notice, we are announcing that CooperVision has withdrawn the petition without prejudice to a future filing (21 CFR 71.6(c)(2)).

Start Signature

Dated: July 31, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2020-17195 Filed 8-21-20; 8:45 am]