Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Rules and Regulations 6723

IV. 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.

V. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before March 17, 1997, 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.

VI. References

The following references have 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 dated November 1, 1989,

from the Food and Color Additives Review

Section (HFF–415) to Indirect Additives

Branch (HFF–335) concerning ‘‘FAP

9B4158—Ciba-Geigy Corp. Submission dated

7–7–89. Irgazin Yellow 3RLTN as a colorant

in polymeric food packaging.’’

2. Kokoski, C. J., ‘‘Regulatory Food

Additive Toxicology,’’ in Chemical Safety

Regulation and Compliance, edited by F.

Homburger and J. K. Marquis, S. Karger, New

York, NY, pp. 24–33, 1985.

3. Memorandum dated May 23, 1995, from

the Chemistry Review Branch (HFS–247) to

Indirect Additives Branch (HFS–216).

4. Norback, D. H., and R. H. Weltman.,

‘‘Polychlorinated Biphenyl Induction of

Hepatocellular Carcinoma in the SpragueDawley Rat,’’ Environmental Health

Perspectives, 60:97–105, 1985.

5. Gaylor, D. W., and R. L. Kodell., ‘‘Linear

Interpolation Algorithm for Low Dose Risk

Assessment of Toxic Substances,’’ Journal of

Environmental Pathology and Toxicology,

4:305–312, 1980.

6. Memorandum, Report of the

Quantitative Risk Assessment Committee,

August 18, 1995.

7. Memorandum dated October 11, 1996,

from the Quantitative Risk Assessment

Committee (HFS–16) to Indirect Additives

Branch (HFS–216) concerning ‘‘Clarification

of QRAC Memorandum of August 18, 1995,

re FAPs 9B4158 and 3B4349.’’

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 178.3297 is amended in the

table in paragraph (e) by alphabetically

adding a new entry under the headings

‘‘Substances’’ and ‘‘Limitations’’ to read

as follows:

§ 178.3297 Colorants for polymers.

* * * * *

(e) * * *

Substances Limitations

* * * * * * *

2,3,4,5-Tetrachloro-6-cyanobenzoic acid, methyl ester reaction products

with p-phenylenediamine and sodium methoxide (CAS Reg. No.

106276–80–6)

For use only at levels not to exceed 1 percent by weight of polymers.

The finished articles are to contact food only under conditions of use

B through H, described in Table 2, of § 176.170(c) of this chapter.

* * * * * * *

Dated: February 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–3661 Filed 2–12–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 510 and 520

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for a new animal drug

application (NADA) from Biocraft

Laboratories, Inc., to Teva

Pharmaceuticals USA.

EFFECTIVE DATE: February 13, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Biocraft

Laboratories, Inc., 92 Route 46,

Elmwood Park, NJ 07407, has informed

FDA that it has transferred ownership

of, and all rights and interests in NADA

131–806 for furosemide tablets or

boluses to Teva Pharmaceuticals USA,

650 Cathill Rd., Sellersville, PA 18960.

Accordingly, the agency is amending

the regulations in 21 CFR 510.600(c)(1)

and (c)(2) by alphabetically adding a

new listing for Teva Pharmaceuticals

USA. The agency is also amending 21

CFR 520.1010a to reflect the transfer of

ownership.
6724 Federal Register / Vol. 62, No. 30 / Thursday, February 13, 1997 / Rules and Regulations

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 510 and 520 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

512, 701, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e).

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding a new entry for

‘‘Teva Pharmaceuticals USA’’ and in the

table in paragraph (c)(2) by numerically

adding a new entry for ‘‘000093’’ to read

as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Teva Pharmaceuticals USA, 650 Cathill Rd., Sellersville, PA 18960 ...... 000093

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

000093 ...................................................................................................... Teva Pharmaceuticals USA, 650 Cathill Rd., Sellersville, PA 18960

* * * * * * *

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 520.1010a [Amended]

4. Section 520.1010a Furosemide

tablets or boluses is amended in

paragraph (b) by removing the number

‘‘000332’’ and adding in its place

‘‘000093’’.

Dated: February 4, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–3662 Filed 2–12–97; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[TN–155–1–7178; TN–MEM–149–3–9701;

FRL–5669–3]

Approval and Promulgation of

Implementation Plans; State of

Tennessee and Memphis-Shelby

County, Tennessee

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving revisions to

the Tennessee State Implementation

Plan (SIP) to allow the State to issue

Federally enforceable state operating

permits (FESOP). EPA is also approving

revisions to the Memphis-Shelby

County portion of the Tennessee SIP to

allow the County to issue Federally

enforceable local operating permits

(FELOP). EPA is also approving the

State’s FESOP program and the County’s

FELOP program pursuant to section 112

of the Clean Air Act as amended in 1990

(CAA or ‘‘the Act’’) so that both

permitting agencies may issue Federally

enforceable state operating permits

containing limits for hazardous air

pollutants (HAP).

DATES: This final rule is effective April

14, 1997 unless adverse or critical

comments are received by March 17,

1997. If the effective date is delayed,

timely notice will be published in the

Federal Register.

ADDRESSES: Written comments should

be addressed to Gracy R. Danois at the

EPA Regional Office listed below.

Copies of the documents used in

developing this action are available for

public inspection during normal

business hours at the locations listed

below. Interested persons wanting to

examine these documents, contained in

files TN155 and TN149–3, should make

an appointment with the appropriate

office at least 24 hours before the

visiting day:

Air and Radiation Docket and

Information Center (Air Docket 6102),

U.S. Environmental Protection

Agency, 401 M Street, SW,

Washington, DC 20460.

U.S. Environmental Protection Agency,

Region 4, Air and Radiation

Technology Branch, Atlanta Federal