[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Rules and Regulations]
[Pages 48373-48375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20767]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2017-C-2902]


Listing of Color Additives Subject to Certification; D&C Yellow 
No. 8

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
color additive regulations to provide for the expanded safe use of D&C 
Yellow No. 8 as a color additive in contact lens solution. We are 
taking this action in response to a color additive petition submitted 
by Glo Eyes, LLC.

DATES: This rule is effective October 26, 2018. See section VIII for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing on the 
final rule by October 25, 2018.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. Electronic objections must be submitted on or before 
October 25, 2018. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
October 25, 2018. Objections received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your objection, that information will be 
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets 
Management Staff, FDA will post your objection, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-C-2902 for ``Listing of Color Additives Subject to 
Certification; D&C Yellow No. 8.'' Received objections, those filed in 
a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or with the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in our consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting

[[Page 48374]]

of comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    In a document published in the Federal Register of May 31, 2017 (82 
FR 24912), we announced that we filed a color additive petition (CAP 
7C0311) submitted by Glo Eyes, LLC (petitioner), 5501 Highway 199, 
suite 202, Fort Worth, TX 76114. The petition proposed to amend the 
color additive regulations in 21 CFR part 74, Listing of Color 
Additives Subject to Certification by expanding the permitted uses of 
D&C Yellow No. 8 (principally the disodium salt of fluorescein) to 
include use in coloring contact lens solution at a level not to exceed 
0.044 percent in the contact lens solution. Because the colored contact 
lens solution is intended for coloring disposable daily-wear hydrogel-
based soft (hydrophilic) contact lenses and because D&C Yellow No. 8 in 
these colored contact lenses will come into direct contact with the 
user's eyes for a significant amount of time, this color additive is 
subject to section 721 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 379e).

II. Background

    D&C Yellow No. 8 is currently approved under Sec.  74.1708 (21 CFR 
74.1708) for coloring externally applied drugs in amounts consistent 
with good manufacturing practice (GMP). D&C Yellow No. 8 is also 
approved under Sec.  74.2708 (21 CFR 74.2708) for coloring externally 
applied cosmetics in amounts consistent with GMP. The regulations for 
D&C Yellow No. 8 require that all batches of the color additive be 
certified in accordance with regulations in part 80.
    D&C Yellow No. 8 (CAS 518-47-8) is principally the disodium salt of 
fluorescein. In the subject petition, D&C Yellow No. 8 is proposed for 
use as a color additive in contact lens solution intended for soaking 
disposable daily-wear hydrogel-based soft (hydrophilic) contact lenses 
for up to 12 hours. The treated lenses are to be used one time and then 
discarded. The treated contact lenses, when exposed to ultraviolet 
light, fluoresce a yellow-green color for cosmetic purposes. The 
treated color contact lenses are expected to be used for limited, 
celebratory, and special occasions, and not every day. The maximum 
intended use level of D&C Yellow No. 8 in the contact lens solution is 
0.044 percent. The contact lens solution colored with D&C Yellow No. 8 
is intended for distribution by prescription only and for use in 
accordance with the directions supplied. Based on data and information 
provided in the petition on the identity, properties, manufacturing 
process, and composition of the color additive, we have determined that 
the color additive meets the specifications for D&C Yellow No. 8 in 
Sec.  74.1708 (Ref. 1).

III. Safety Evaluation

    Under section 721(b)(4) of the FD&C Act (21 U.S.C. 379e(b)(4)), a 
color additive may not be listed for a particular use unless the data 
and information available to FDA establish that the color additive is 
safe for that use. Our color additive regulations at Sec.  70.3(i) (21 
CFR 70.3(i)) define ``safe'' to mean that there is convincing evidence 
establishing with reasonable certainty that no harm will result from 
the intended use of the color additive.
    As part of our safety evaluation of the color additive, we 
considered the projected human exposure to D&C Yellow No. 8 and any 
impurities resulting from the petitioned use of the color additive. We 
also considered results from ocular irritation, skin sensitization, 
oral mucosal irritation, acute systemic toxicity, and cytotoxicity 
studies that tested extracts from contact lenses soaked in contact lens 
solution colored with D&C Yellow No. 8.

A. Exposure Estimate

    During our safety assessment of the use of D&C Yellow No. 8 in 
contact lens solution, we considered the estimated exposure to D&C 
Yellow No. 8 that would result from the petitioned use in amounts not 
to exceed 0.044 percent in contact lens solution. The petitioner 
determined that the theoretical maximum amount of D&C Yellow No. 8 that 
could be absorbed by, and potentially extracted from, a contact lens is 
17 micrograms per lens ([micro]g/lens). The petitioner considers 17 
[micro]g/lens or 34 [micro]g/person/day (p/d) (for two lenses) to be a 
conservative estimate of the exposure to the color additive under the 
proposed use conditions (Ref. 1). FDA agrees with the petitioner's 
estimate. We note that the estimated exposure (17 [micro]g/lens or 34 
[micro]g/p/d) represents a theoretical maximum amount of the color 
additive per use and is based on the worst-case assumption that all the 
water in the hydrogel-based soft contact lens is displaced by the 
colored contact lens solution. However, this exposure estimate is not 
an estimate of chronic daily exposure since the treated contact lenses 
are for occasional wear and not for everyday use. Furthermore, the 
actual exposure to D&C Yellow No. 8 from the petitioned use is expected 
to be lower than 17 [micro]g/lens or 34 [micro]g/p/d based on the 
amount of color additive extracted from the contact lenses soaked in 
the colored contact lens solution as indicated in the instructions for 
use (Ref. 1).

B. Safety of Petitioned Use of Color Additive

    To establish that D&C Yellow No. 8 is safe for use in a contact 
lens solution intended for soaking disposable daily-wear hydrogel-based 
soft (hydrophilic) contact lenses, the petitioner submitted toxicity 
studies including an ocular irritation test in rabbits, a Guinea pig 
maximization sensitization test, an oral mucosal irritation study in 
hamsters, an acute systemic toxicity test in mice, and a cytotoxicity 
test that tested extracts from representative contact lenses soaked in 
contact lens solution colored with D&C Yellow No. 8. The results of 
these studies indicate that the color additive is not an irritant to 
the skin, eyes or oral mucosa, is not a sensitizer, is not cytotoxic, 
and shows no systemic toxicity (Ref. 2). Therefore, we conclude that 
the available toxicology data are sufficient to support the safety of 
the proposed expanded safe use of D&C Yellow No. 8.

IV. Conclusion

    Based on the data and information in the petition and other 
available relevant information, we conclude that the petitioned use of 
D&C Yellow No. 8 for coloring contact lens solution intended for 
soaking disposable daily-wear hydrogel-based soft (hydrophilic) contact 
lenses is safe. We further conclude that this color additive will 
achieve its intended technical effect and is suitable for the 
petitioned use. Consequently, we are amending the color additive 
regulations in 21 CFR part 74 as set forth in this document. We also 
conclude that batch certification of

[[Page 48375]]

D&C Yellow No. 8 continues to be necessary to protect the public 
health.

V. Public Disclosure

    In accordance with Sec.  [thinsp]71.15(a) (21 CFR 71.15(a)), the 
petition and the documents that we considered and relied upon in 
reaching our decision to approve the petition will be made available 
for public disclosure (see ADDRESSES). As provided in Sec.  
[thinsp]71.15(b), we will delete from the documents any materials that 
are not available for public disclosure.

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as 
stated in the May 31, 2017, Federal Register notice of filing for CAP 
7C0311 (82 FR 24912). We stated that we had determined, under 21 CFR 
25.32(l), that this action ``is of a type that does not individually or 
cumulatively have a significant effect on the human environment'' such 
that neither an environmental assessment nor an environmental impact 
statement is required. We have not received any new information or 
comments that would affect our previous determination.

VII. 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.

VIII. Objections

    This rule is effective as shown in the DATES section, except as to 
any provisions that may be stayed by the filing of proper objections. 
If you will be adversely affected by one or more provisions of this 
regulation, you may file electronic objections to this docket at 
https://www.regulations.gov, or written objections with the Dockets 
Management Staff (see ADDRESSES). You must separately number each 
objection, and within each numbered objection you must specify with 
particularity the provision(s) to which you object, and the grounds for 
your objection. Within each numbered objection, you must specifically 
state whether you are requesting a hearing on the particular provision 
that you specify in that numbered objection. If you do not request a 
hearing for any particular objection, you waive the right to a hearing 
on that objection. If you request a hearing, your objection must 
include a detailed description and analysis of the specific factual 
information you intend to present in support of the objection in the 
event that a hearing is held. If you do not include such a description 
and analysis for any particular objection, you waive the right to a 
hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the Dockets Management Staff office between 9 a.m. and 4 p.m., 
Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we 
have received or lack thereof in the Federal Register.

IX. References

    The following references are on display with the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov.

1. Memorandum from H. Lee, Chemistry Review Team, Division of 
Petition Review, Office of Food Additive Safety (OFAS), CFSAN, FDA 
to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA, July 3, 
2018.
2. Memorandum from A. Khan, Toxicology Team, Division of Petition 
Review, OFAS, CFSAN, FDA to M. Harry, Division of Petition Review, 
OFAS, CFSAN, FDA, July 12, 2018.

List of Subjects in 21 CFR Part 74

    Color additives, Cosmetics, Drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of the Food and Drugs, 21 
CFR part 74 is amended as follows:

PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

0
1. The authority citation for part 74 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.  74.3708 to subpart D to read as follows:


Sec.  74.3708  D&C Yellow No. 8.

    (a) Identity and specifications. The color additive D&C Yellow No. 
8 shall conform in identity and specifications to the requirements of 
Sec.  74.1708(a)(1) and (b).
    (b) Uses and restrictions. (1) D&C Yellow No. 8 may be safely used 
for coloring contact lens solution for coloring disposable daily-wear 
hydrogel-based soft (hydrophilic) contact lenses at a level not to 
exceed 0.044 percent in the contact lens solution. Following excitation 
by ultraviolet light, the colored contact lenses fluoresce a yellow-
green color. The contact lens solution colored with D&C Yellow No. 8 is 
distributed by prescription only and used in accordance with the 
supplied directions for use. Contact lens solutions containing D&C 
Yellow No. 8 are intended for use only for coloring contact lenses that 
are worn for infrequent, celebratory occasions, and not for regular or 
daily use.
    (2) Authorization for 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 lens 
solution in which the color additive is used.
    (c) Labeling. The label of the color additive shall conform to the 
requirements of Sec.  70.25 of this chapter.
    (d) Certification. All batches of D&C Yellow No. 8 shall be 
certified in accordance with regulations in part 80 of this chapter.

    Dated: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20767 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P