83 FR 48373 - Listing of Color Additives Subject to Certification; D&C Yellow No. 8

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 186 (September 25, 2018)

Page Range		48373-48375
FR Document		2018-20767

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.

Federal Register, Volume 83 Issue 186 (Tuesday, September 25, 2018)

[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Rules and Regulations]
[Pages 48373-48375]
From the Federal Register Online [www.thefederalregister.org]
[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.thefederalregister.org/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

Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Rules and Regulations 48375

D&C Yellow No. 8 continues to be description and analysis for any lenses fluoresce a yellow-green color.
necessary to protect the public health. particular objection, you waive the right The contact lens solution colored with
to a hearing on the objection. D&C Yellow No. 8 is distributed by
V. Public Disclosure
Any objections received in response prescription only and used in
In accordance with § 71.15(a) (21 CFR to the regulation may be seen in the accordance with the supplied directions
71.15(a)), the petition and the Dockets Management Staff office for use. Contact lens solutions
documents that we considered and between 9 a.m. and 4 p.m., Monday containing D&C Yellow No. 8 are
relied upon in reaching our decision to through Friday, and will be posted to intended for use only for coloring
approve the petition will be made the docket at https:// contact lenses that are worn for
available for public disclosure (see www.regulations.gov. We will publish infrequent, celebratory occasions, and
ADDRESSES). As provided in § 71.15(b), notice of the objections that we have not for regular or daily use.
we will delete from the documents any received or lack thereof in the Federal (2) Authorization for this use shall not
materials that are not available for Register. be construed as waiving any of the
public disclosure. requirements of sections 510(k), 515,
IX. References
VI. Analysis of Environmental Impact and 520(g) of the Federal Food, Drug,
The following references are on and Cosmetic Act with respect to the
We previously considered the display with the Dockets Management contact lens solution in which the color
environmental effects of this rule, as Staff (see ADDRESSES) and are available additive is used.
stated in the May 31, 2017, Federal for viewing by interested persons (c) Labeling. The label of the color
Register notice of filing for CAP 7C0311 between 9 a.m. and 4 p.m., Monday additive shall conform to the
(82 FR 24912). We stated that we had through Friday; they are also available requirements of § 70.25 of this chapter.
determined, under 21 CFR 25.32(l), that electronically at https:// (d) Certification. All batches of D&C
this action ‘‘is of a type that does not www.regulations.gov. Yellow No. 8 shall be certified in
individually or cumulatively have a accordance with regulations in part 80
1. Memorandum from H. Lee, Chemistry
significant effect on the human of this chapter.
Review Team, Division of Petition
environment’’ such that neither an Review, Office of Food Additive Safety
environmental assessment nor an Dated: September 18, 2018.
(OFAS), CFSAN, FDA to M. Harry,
environmental impact statement is Division of Petition Review, OFAS, Leslie Kux,
required. We have not received any new CFSAN, FDA, July 3, 2018. Associate Commissioner for Policy.
information or comments that would 2. Memorandum from A. Khan, Toxicology [FR Doc. 2018–20767 Filed 9–24–18; 8:45 am]
affect our previous determination. Team, Division of Petition Review, BILLING CODE 4164–01–P
OFAS, CFSAN, FDA to M. Harry,
VII. Paperwork Reduction Act of 1995 Division of Petition Review, OFAS,
This final rule contains no collection CFSAN, FDA, July 12, 2018.
DEPARTMENT OF HOMELAND
of information. Therefore, clearance by List of Subjects in 21 CFR Part 74 SECURITY
the Office of Management and Budget
under the Paperwork Reduction Act of Color additives, Cosmetics, Drugs.
Coast Guard
1995 is not required. Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the 33 CFR Part 165
VIII. Objections authority delegated to the Commissioner
This rule is effective as shown in the of the Food and Drugs, 21 CFR part 74 [Docket Number USCG–2018–0619]
DATES section, except as to any is amended as follows: RIN 1625–AA00
provisions that may be stayed by the
filing of proper objections. If you will be PART 74—LISTING OF COLOR Safety Zone; Lower Mississippi River,
adversely affected by one or more ADDITIVES SUBJECT TO Mile Markers 94 to 95 Above Head of
provisions of this regulation, you may CERTIFICATION Passes, New Orleans, LA
file electronic objections to this docket
at https://www.regulations.gov, or ■ 1. The authority citation for part 74 AGENCY: Coast Guard, DHS.
written objections with the Dockets continues to read as follows: ACTION: Temporary final rule.
Management Staff (see ADDRESSES). You Authority: 21 U.S.C. 321, 341, 342, 343,
must separately number each objection, 348, 351, 352, 355, 361, 362, 371, 379e. SUMMARY: The Coast Guard is
and within each numbered objection establishing a temporary safety zone for
■ 2. Add § 74.3708 to subpart D to read certain navigable waters of the Lower
you must specify with particularity the as follows:
provision(s) to which you object, and Mississippi River. This action is
the grounds for your objection. Within § 74.3708 D&C Yellow No. 8. necessary to provide for the safety of
each numbered objection, you must (a) Identity and specifications. The persons, vessels, and the marine
specifically state whether you are color additive D&C Yellow No. 8 shall environment on these navigable waters
requesting a hearing on the particular conform in identity and specifications near New Orleans, LA, during a
provision that you specify in that to the requirements of § 74.1708(a)(1) fireworks display on October 6, 2018.
numbered objection. If you do not and (b). This regulation prohibits persons and
request a hearing for any particular (b) Uses and restrictions. (1) D&C vessels from being in the safety zone
objection, you waive the right to a Yellow No. 8 may be safely used for unless authorized by the Captain of the
hearing on that objection. If you request coloring contact lens solution for Port Sector New Orleans or a designated
daltland on DSKBBV9HB2PROD with RULES

a hearing, your objection must include coloring disposable daily-wear representative.
a detailed description and analysis of hydrogel-based soft (hydrophilic) DATES: This rule is effective from 9 p.m.
the specific factual information you contact lenses at a level not to exceed through 10 p.m. on October 6, 2018.
intend to present in support of the 0.044 percent in the contact lens ADDRESSES: To view documents
objection in the event that a hearing is solution. Following excitation by mentioned in this preamble as being
held. If you do not include such a ultraviolet light, the colored contact available in the docket, go to https://

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Document Created: 2018-09-25 00:22:29
Document Modified: 2018-09-25 00:22:29

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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.
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.
FR Citation		83 FR 48373
CFR Associated		Color Additives; Cosmetics and Drugs

83 FR 48373 - Listing of Color Additives Subject to Certification; D&C Yellow No. 8

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 186 (September 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration