
[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Rules and Regulations]
[Pages 25234-25235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10869]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2009-C-0543]


Listing of Color Additives Exempt From Certification; Reactive 
Blue 69

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the color 
additive regulations to provide for the safe use of disodium 1-amino-4-
[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-
9,10-dioxoanthracene-2-sulphonate (CAS Reg. No. 70209-99-3), also known 
as Reactive Blue 69, as a color additive in contact lenses. This action 
is in response to a petition filed by Sauflon Pharmaceuticals Ltd.

DATES: This rule is effective June 6, 2011. Submit either electronic or 
written objections and requests for a hearing by June 3, 2011. See 
section VII of this document for information on the filing of 
objections.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing, identified by Docket No. FDA-2009-C-0543, by 
any of the following methods:

Electronic Submissions

    Submit electronic objections in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2009-C-0543 for this rulemaking. All objections 
received will be posted without change to http://www.regulations.gov, 
including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.regulations.gov and insert the 
docket numbers, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Raphael A. Davy, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1272.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of November 18, 2009 
(74 FR 59560), FDA announced that a color additive petition (CAP 
8C0287) had been filed by Sauflon Pharmaceuticals Ltd., 49-53 York St., 
Twickenham, Middlesex, TW1 3LP, United Kingdom. The petition proposed 
to amend the color additive regulations in part 73 (21 CFR part 73), 
subpart D, Medical Devices, to provide for the safe use of disodium 1-
amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-
dihydro-9,10-dioxoanthracene-2-sulphonate (Reactive Blue 69) (CAS Reg. 
No. 70209-99-3, Colour Index No. 612037) as a color additive in contact 
lenses. The petition was filed under section 721 of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e).

II. Safety Evaluation

    Under section 721(b)(4) of the FD&C Act, a color additive may not 
be listed for a particular use unless a fair evaluation of the data and 
information available to FDA establishes that the color additive is 
safe for that use. FDA's color additive regulations at 21 CFR 70.3(i) 
define safe to mean that there is ``convincing evidence that 
establishes with reasonable certainty that no harm will result from the 
intended use of the color additive.''
    During its review of the safety of the use of Reactive Blue 69 
pigment in contact lenses, the Agency considered the exposure to the 
color additive from the petitioned use. Based on information submitted 
in the petition, the Agency notes that it is highly unlikely that 
Reactive Blue 69 will migrate out of the contact lens into the aqueous 
environment of the eye because the color additive is covalently 
incorporated (copolymerized) into the polymeric lens matrix. Therefore, 
the Agency concludes that the exposure to the color additive, including 
any impurities that may be present in it,

[[Page 25235]]

from the petitioned use would be negligible (Ref. 1).
    To establish that Reactive Blue 69 is safe for use in contact 
lenses, the petitioner submitted toxicity data from various studies. In 
a primary ocular irritation study in rabbits, there was no evidence of 
ocular irritation from saline and cottonseed oil extracts of the tinted 
lens material. The petitioner also conducted tests on lens extracts 
systemically injected into mice and cytotoxicity studies of lens 
extracts using L-959 mouse fibroblast cells. Neither study produced any 
evidence of toxicity (Ref. 2).

III. Conclusion

    Based on the data contained in the petition and other available 
relevant material, FDA concludes that the petitioned use of the color 
additive in contact lenses is safe and that the color additive will 
achieve its intended technical effect. FDA also concludes that there is 
no need for imposing a limitation on the amount of the color additive 
that may be present in the lens, beyond the limitation that only the 
amount necessary to accomplish the intended technical effect may be 
used. Therefore, the regulations in part 73 should be amended as set 
forth in this document. In addition, based upon the factors listed in 
21 CFR 71.20(b), the Agency concludes that certification of Reactive 
Blue 69 is not necessary for the protection of the public health.

IV. Inspection of Documents

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the 
documents that FDA considered and relied upon in reaching its decision 
to approve the petition will be made available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person (see FOR FURTHER INFORMATION CONTACT). As 
provided in Sec.  71.15, the Agency will delete from the documents any 
materials that are not available for public disclosure before making 
the documents available for inspection.

V. Environmental Impact

    The Agency has previously considered the environmental effect of 
this rule as announced in the notice of filing for CAP 8C0287 (74 FR 
59560, November 18, 2009). No new information or comments have been 
received that would affect the Agency's previous determination that 
there is no significant impact on the human environment and that an 
environmental impact statement is not required.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. Objections

    This rule is effective as shown in the DATES section of this 
document; except as to any provisions that may be stayed by the filing 
of proper objections. Any person who will be adversely affected by this 
regulation may file with the Division of Dockets Management (see 
ADDRESSES) either electronic or written objections. Each objection 
shall be separately numbered, and each numbered objection shall specify 
with particularity the provisions of the regulation to which objection 
is made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event that a hearing 
is held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. It is only necessary to send one set of 
documents. It is no longer necessary to send three copies of all 
documents. Identify documents with the docket number found in brackets 
in the heading of this document. Any objections received in response to 
the regulation may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish 
notice of the objections that the Agency has received or lack thereof 
in the Federal Register.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Memorandum from H. Lee, Division of Petition Review, 
Chemistry Review Team, FDA, to R. Davy, Division of Petition Review, 
Regulatory Group II, FDA, October 8, 2010.
    2. Memorandum from T. Thurmond, Division of Petition Review, 
Toxicology Review Group, FDA, to R. Davy, Division of Petition 
Review, Regulatory Group II, FDA, October 25, 2010.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 21 CFR part 73 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.


0
2. Add Sec.  73.3129 to subpart D to read as follows:


Sec.  73.3129  Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-
sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate.

    (a) Identity. The color additive is disodium 1-amino-4-[[4-[(2-
bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-
dioxoanthracene-2-sulphonate (Reactive Blue 69) (CAS Reg. No. 70209-99-
3, Colour Index No. 612037).
    (b) Uses and restrictions. (1) The substance listed in paragraph 
(a) of this section may be used as a color additive in contact lenses 
in amounts not to exceed the minimum reasonably required to accomplish 
the intended coloring effect.
    (2) Authorization and compliance with this use shall not be 
construed as waiving any of the requirements of sections 510(k), 515, 
and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to 
the contact lenses in which the additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements in Sec.  70.25 of this chapter.
    (d) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification 
requirements of section 721(c) of the Federal Food, Drug, and Cosmetic 
Act.

    Dated: April 21, 2011.
Susan M. Bernard,
Acting Director, Office of Regulations, Policy and Social Sciences, 
Center for Food Safety and Applied Nutrition.
[FR Doc. 2011-10869 Filed 5-3-11; 8:45 am]
BILLING CODE 4160-01-P


