Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations 10495

CPSA and subpart G of part 1101 of title

16 of the CFR.

§ 1117.8 Effect of reports on liability.

A report by a manufacturer,

distributor, retailer, or importer under

this part shall not be interpreted, for any

purpose, as an admission of liability or

of the truth of the information contained

in the report.

§ 1117.9 Prohibited acts and sanctions.

(a) Whoever knowingly and willfully

falsifies or conceals a material fact in a

report submitted under this part is

subject to criminal penalties under 18

U.S.C. 1001.

(b) A failure to report to the

Commission in a timely fashion as

required by this part is a prohibited act

under section 19(a)(3) of the CPSA, 15

U.S.C. 2068(a)(3).

(c) A subject firm that knowingly fails

to report is subject to civil penalties

under section 20 of the CPSA, 15 U.S.C.

2069. ‘‘Knowing’’ means the having of

actual knowledge or the presumed

having of knowledge deemed to be

possessed by a reasonable person who

acts in the circumstances, including

knowledge obtainable upon the exercise

of due care to ascertain the truth of

representations. Section 20(d) of the

CPSA, 15 U.S.C. 2069(d).

(d) Any person who knowingly and

willfully violates section 19 of this Act

after having received notice of

noncompliance from the Commission

may be subject to criminal penalties

under section 21 of the CPSA, 15 U.S.C.

2070.

Dated: February 17, 1995.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 95–4483 Filed 2–24–95; 8:45 am]

BILLING CODE 6355–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 93C–0380]

Listing of Color Additives for Coloring

Contact Lenses; 1,4-Bis[4-(2-

Methacryloxyethyl)

Phenylamino]Anthraquinone

Copolymers

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 the colored reaction

product formed by copolymerizing 1,4-

bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone with 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate (CAS Reg. No. 134072–99–4)

and N-vinyl pyrrolidone to form contact

lenses. This action is in response to a

petition filed by Bausch & Lomb, Inc.

DATES: Effective on March 30, 1995,

except as to any provisions that may be

stayed by the filing of proper objections;

written objections and requests for a

hearing by March 29, 1995.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Helen R. Thorsheim, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3092.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal

Register of November 3, 1993 (58 FR

58699), FDA announced that a color

additive petition (CAP 3C0242) had

been filed by Bausch & Lomb, Inc., 1400

North Goodman St., Rochester, NY

14692–0450. The petition proposed that

the color additive regulations be

amended in § 73.3106 1,4-Bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone

copolymers (21 CFR 73.3106) to provide

for the safe use of 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone

copolymerized with N-vinyl

pyrrolidone and

3[tris(trimethylsiloxy)silyl] propyl vinyl

carbamate to form contact lenses. The

filing notice erroneously indicated that

the petition was filed under section

409(b)(5) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

348(b)(5)). The correct section of the act

is 721(d)(1) (21 U.S.C. 379e(d)(1)).

II. Applicability of the Act

With the passage of the Medical

Device Amendments of 1976 (Pub. L.

94–295), Congress mandated the listing

of color additives for use in medical

devices when the color additive in the

device comes in direct contact with the

body for a significant period of time (21

U.S.C. 379e(a)). The use of the reaction

product of 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone

copolymerized with 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate and N-vinyl pyrrolidone as a

color additive in manufacturing contact

lenses is subject to this listing

requirement. The color additive is

formed into contact lenses in such a

way that at least some of the color

additive will come in contact with the

eye when the lenses are worn. In

addition, the lenses are intended to be

placed on the eye for several hours a

day, each day, for 1 year or more. Thus,

the color additive will be in direct

contact with the body for a significant

period of time. Consequently, the use of

the color additive currently before the

agency is subject to the statutory listing

requirement.

III. Identity

The color additive, when used to

color contact lenses, is produced by

copolymerizing the dye 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone (CAS Reg.

No. 121888–69–5) with 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate (CAS Reg. No. 134072–99–4)

and N-vinyl pyrrolidone monomers. The

dye 1,4-bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone covalently

bonds through two methacrylate groups

to the polymer matrix during

polymerization. The resulting

copolymeric product is formed into a

contact lens.

IV. Safety Evaluation

The agency believes that because 1,4-

bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone has a

significantly lower molecular weight

than the N-vinyl pyrrolidone/3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate/1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone copolymer,

it would be more readily absorbed into

the body than the copolymeric color

additive and would thus be expected to

show a greater toxic effect. Therefore,

the safety evaluation of the subject color

additive focused primarily on 1,4-bis[4-

(2-methacryloxyethyl)

phenylamino]anthraquinone.

FDA concludes, from the data

submitted in the petition and from other

relevant information, that the maximum

daily exposure to 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone from this

petitioned use in contact lenses would

be no greater than 0.08 micrograms per

person per day (μg/p/d). The agencycalculated upper limit was based on two

factors. First, the maximum use level

anticipated by the petitioner is 300 parts

per million (ppm) of the lens material or

15 μg of 1,4-bis[4-(2-methacryloxyethyl)
10496 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations

phenylamino]anthraquinone per lens

(Ref. 1). Second, the agency made two

worst-case assumptions: (1) The user

will replace lenses tinted with 1,4-bis[4-

(2-methacryloxyethyl)

phenylamino]anthraquinone at the

maximum use level once each year with

a new pair of identical lenses; and (2)

one hundred percent of 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone will

migrate from the lenses into the eyes

over the 1-year period. Because these

assumptions are worst-case estimates,

exposure to 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone from its

use in coloring N-vinyl pyrrolidone/3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate contact lenses is likely to be

far less than 0.08 μg/p/d (Ref. 1).

To establish the safety of 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone for

coloring N-vinyl pyrrolidone/3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate contact lenses, the petitioner

conducted toxicity studies with 1,4-

bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone, colored

lenses, and colored lens extracts. The

studies included five in vitro

cytotoxicity studies, three by the agar

overlay method (with 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone and lens)

and two by the direct-contact method

(with 1,4-bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone and lens

extract). The maximum noncytotoxic

concentration for 1,4-bis[4-(2-

methacryloxyethyl) phenylamino]

anthraquinone was determined to be

1,810 μg/milliliter (mL) by the directcontact method using mouse fibroblast

cells. Both the lenses and lens extracts

were found to be noncytotoxic to mouse

fibroblast cells. A 21-day ocular

irritation study with contact lenses in

rabbits and a guinea pig maximization

(Kligman) study with lens extracts were

also conducted. These studies

demonstrated no evidence of ocular

irritation or an allergic response in the

test animals.

To relate the 1,810 μg/mL no-effect

level, established in the direct-contact

cytotoxicity study for the dye, to the

0.08 μg/p/d exposure from wearing the

colored lenses, the agency calculated

the maximum concentration level of 1,4-

bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone in each eye

that would result from the use of the

contact lens. The agency estimated that

the daily exposure to 1,4-bis[4-(2-

methacryloxyethyl) phenylamino]

anthraquinone in each eye would be

0.04 μg and that this would be diluted

by the average daily tear film of 1.2 mL

produced in each eye. This

concentration is equal to a maximum

daily concentration in the tear flow of

the eye of 0.04 μg dye/mL. This

concentration represents a more than a

45,000 fold safety factor for this

proposed use of 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone.

Based upon the available toxicity

data, the small amount of 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone used to

form the color additive in the contact

lenses, and the agency’s exposure

calculation for 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone, FDA finds

that the reaction product formed by

copolymerizing 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone with Nvinyl pyrrolidone and 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate is safe for use as a color

additive in contact lenses. FDA further

concludes that the safety margin is

sufficiently large that no limitation is

required beyond the usual limitation

that the reactants may be used in

amounts not to exceed the minimum

reasonably required to accomplish the

intended technical effect. Batch

certification is not required to ensure

safety.

V. Conclusions

Based on data contained in the

petition and other relevant material,

FDA concludes that there is a

reasonable certainty that no harm will

result from the petitioned use of the

reaction product formed by

copolymerizing 1,4-bis[4-(2-

methacryloxyethyl)

phenylamino]anthraquinone with Nvinyl pyrrolidone and 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate to form colored contact

lenses, and that the color additive is safe

and suitable for its intended use.

VI. Inspection of Documents

In accordance with § 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 are available for inspection at

the Center for Food Safety and Applied

Nutrition (address above) by

appointment with the information

contact person listed above. As

provided in § 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.

VII. Environmental Impact

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

VIII. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before March 29, 1995, file

with the Dockets Management Branch

(address above) written objections

thereto. 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. Three copies of all documents

shall be submitted and shall be

identified 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 Dockets Management Branch

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.

IX. Reference

The following reference has been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Memorandum from the Chemistry

Review Branch to the Indirect Additives

Branch, ‘‘CAP 3C0242 (MATS# 741)–Bausch

& Lomb. Reactive Blue 246 for coloring

contact lenses, copolymerized with N-vinyl

pyrrolidinone and 3-

[tris(trimethylsiloxy)silyl]propyl vinyl
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Rules and Regulations 10497

carbamate. Submission dated 9–10–93,’’

dated February 22, 1994.

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, 21 CFR part 73 is

amended as follows:

PART 73—LISTING OF COLOR

ADDITIVES EXEMPT FROM

CERTIFICATION

1. The authority citation for 21 CFR

part 73 continues to read as follows:

Authority: Secs. 201, 401, 402, 403, 409,

501, 502, 505, 601, 602, 701, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,

361, 362, 371, 379e).

2. Section 73.3106 is amended by

revising paragraph (a) to read as follows:

§ 73.3106 1,4-Bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone copolymers.

(a) Identity. The color additive is 1,4-

bis[4-(2-methacryloxyethyl)

phenylamino]anthraquinone (CAS Reg.

No. 121888–69–5), copolymerized with

hydroxyethyl methacrylate monomer, or

a blend of hydroxyethyl methacrylate

and N-vinyl pyrrolidone monomers, or

a blend of 3-

[tris(trimethylsiloxy)silyl]propyl vinyl

carbamate (CAS Reg. No. 134072–99–4)

and N-vinyl pyrrolidone monomers to

form the contact lens material.

* * * * *

Dated: February 17, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–4767 Filed 2–24–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

Bureau of Consular Affairs

22 CFR Part 41

[Public Notice 2171]

Visas: Documentation of

Nonimmigrants Under the Immigration

and Nationality Act, as Amended

AGENCY: Bureau of Consular Affairs,

DOS.

ACTION: Final rule.

SUMMARY: Legislation over the last

several years has created several new

nonimmigrant visa categories. This rule

provides a new table of nonimmigrant

visa symbols at § 41.12 which reflects

these changes. Minor editorial changes

have also been made throughout.

EFFECTIVE DATE: This rule takes effect on

February 27, 1995.

ADDRESSES: Chief, Legislation and

Regulation Division, Visa Office,

Washington, D.C. 20522–1013.

FOR FURTHER INFORMATION CONTACT:

Stephen K. Fischel, Chief, Legislation

and Regulations Division, 202–663–

1204.

SUPPLEMENTARY INFORMATION: The

passage of the Violent Crime Control

and Law Enforcement Act of 1994 and

the enactment of the North American

Free Trade Agreement Implementation

Act, which implemented the North

American Free Trade Agreement

(NAFTA), resulted in the creation of

new nonimmigrant visa categories. The

visa symbols for these nonimmigrant

categories, S–1 and S–2 and TN and TD,

are added to the list of nonimmigrant

visa symbols at § 41.12.

Aliens Supplying Critical Information

Relating to a Criminal Organization or

Enterprise

On September 13, 1994, the President

signed into law the Violent Crime

Control and Law Enforcement Act of

1994 (Pub. L. 103–322). Section 130001

of this Act amends the Immigration and

Nationality Act (INA)( by adding a new

subparagraph (S) at INA 101(a)(15), thus

establishing a new nonimmigrant (S)

classification (‘‘S–1’’ and ‘‘S–2’’) for

these aliens and their dependents.

NAFTA Professionals

In December 1993, the United States

concluded the North American Free

Trade Agreement (NAFTA) with Canada

and Mexico. The North American Free

Trade Agreement Implementation Act

(Pub. L. 103–182) implementing the

NAFTA agreement was signed by the

President on December 8, 1993 and took

effect January 1, 1994. Section 341 of

the Implementation Act provided for

certain professionals entering the

United States under this agreement to be

treated as if classified as nonimmigrants

under INA 101(a)(15). The symbols TN

and TD have been designated for these

professionals and their dependents.

Final Rule

This rule adds the S–1 and S–2 and

TN and TD symbols to the list of

nonimmigrant symbols at 22 CFR 41.12.

This rule is not expected to have a

significant impact on a substantial

number of small entities under the

criteria of the Regulatory Flexibility Act.

This rule imposes no reporting or

record-keeping action from the public

requiring the approval of the Office of

Management and Budget under the

Paperwork Reduction Act requirements.

This rule has been reviewed as required

by E.O. 12778 and certified to be in

compliance therewith. This rule is

exempted from E.O. 12866 but has been

reviewed to ensure consistency

therewith.

List of Subjects in 22 CFR Part 41

Classification of nonimmigrants,

Classification symbols, Visas.

Accordingly, part 41 to 22 of the Code

of Federal Regulations is amended to

read as indicated below:

PART 41—[AMENDED]

1. The authority citation for Part 41 is

revised to read as follows:

Authority: 8 U.S.C. 1101 and 1104; 19

U.S.C. 3401.

2. Section 41.12 is revised to read as

follows:

§ 41.12 Classification symbols.

A visa issued to a nonimmigrant alien

within one of the classes described in

this section shall bear an appropriate

visa symbol to show the classification of

the alien. The symbol shall be inserted

in the space provided in the visa stamp.

The following visa symbols shall be

used:

NONIMMIGRANTS

Symbol Class Section of law

A–1 .............. Ambassador, Public Minister, Career Diplomat or Consular Officer, or Immediate Family ....................... 101(a)(15)(A)(i).

A–2 .............. Other Foreign Government Official or Employee, or Immediate Family ..................................................... 101(a)(15)(A)(ii).

A–3 .............. Attendant, Servant, or Personal Employee of A–1 or A–2, or Immediate Family ...................................... 101(a)(15)(A)(iii).

B–1 .............. Temporary Visitor for Business ................................................................................................................... 101(a)(15)(B).