Federal Register / Vol. 61, No. 3 / Thursday, January 4, 1996 / Rules and Regulations 259

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 removing

the entry for ‘‘American Cyanamid Co.’’

and by adding in its place a new entry

for ‘‘American Cyanamid, Division of

America Home Products,’’ and in the

table in paragraph (c)(2) in the entry for

‘‘010042’’ by revising the sponsor name

and address 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

* * * * * * *

American Cyanamid, Division of American Home Products, P.O.

Box 1339, Fort Dodge, IA 50501 ..................................................... 010042

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

010042 American Cyanamid, Division of American Home Products, P.O.

Box 1339, Fort Dodge, IA 50501.

* * * * * * *

Dated: December 22, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–122 Filed 1–3–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 510

New Animal Drugs; Change of Sponsor

Address

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 address for

TRINADA, Inc.

EFFECTIVE DATE: January 4, 1996.

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:

TRINADA, Inc., P.O. Box 129,

Lewisburg, OH 45338, has informed

FDA that it has changed its address to

One Executive Dr., P.O. Box 1399, Fort

Lee, NJ 07024. Accordingly, the agency

is amending the regulations in 21 CFR

510.600(c)(1) and (c)(2) to reflect the

change of sponsor address.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 part 510 is 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 revising the

sponsor address for ‘‘TRINADA, Inc.,’’

and in the table in paragraph (c)(2) in

the entry for ‘‘058690’’ by revising the

sponsor address 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

* * * * * * *

TRINADA, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024 .... 058690

* * * * * * *
260 Federal Register / Vol. 61, No. 3 / Thursday, January 4, 1996 / Rules and Regulations

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

058690 TRINADA, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024.

* * * * * * *

Dated: December 22, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–121 Filed 1–3–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

New Animal Drugs 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 Fort Dodge

Laboratories to Wildlife Laboratories,

Inc.

EFFECTIVE DATE: January 4, 1996.

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: Fort

Dodge Laboratories, Fort Dodge, IA

50501, has informed FDA that it has

transferred ownership of, and all rights

and interests in approved NADA 47–870

(Etorphine hydrochloride injection) to

Wildlife Laboratories, Inc., 1401 Duff

Dr., suite 600, Fort Collins, CO 80524.

This NADA was originally owned by

American Cyanamid Co. and transferred

to Fort Dodge Laboratories but was

inadvertently not codified in the

regulations. Accordingly, FDA is

amending the regulations in 21 CFR

522.883 to reflect the change of sponsor.

List of Subjects in 21 CFR Part 522

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 part 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

§ 522.883 [Amended]

2. Section 522.883 Etorphine

hydrochloride injection is amended in

paragraph (c) by removing ‘‘010042’’

and adding in its place ‘‘053923’’.

Dated: December 22, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–123 Filed 1–3–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1, 301, and 602

[TD 8651]

RIN 1545–AS05

Automatic Extension of Time for Filing

Individual Income Tax Returns

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Temporary regulations.

SUMMARY: This document contains

temporary regulations that reflect new

simpler procedures for an individual to

obtain an automatic extension of time to

file an individual income tax return.

The text of the temporary regulations

also serves as the text of the cross

reference notice of proposed rulemaking

on this subject in the Proposed Rules

section of this issue of the Federal

Register.

DATES: These regulations are effective

January 4, 1996.

For dates of applicability, see

§ 1.6081–4T and § 301.6651–1T.

FOR FURTHER INFORMATION CONTACT:

Margaret A. Owens, (202) 622–6232 (not

a toll-free number).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

These regulations are being issued

without prior notice and public

procedure pursuant to the

Administrative Procedure Act (5 U.S.C.

553). For this reason, the collection of

information contained in these

regulations has been reviewed and,

pending receipt and evaluation of

public comments, approved by the

Office of Management and Budget under

control number 1545–1479. Responses

to this collection of information are

required to obtain a benefit (an

automatic 4-month extension of time to

file an individual income tax return).

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless the collection of information

displays a valid control number.

For further information concerning

the collection of information, and where

to submit comments on the collection of

information and the accuracy of the

estimated burden, and suggestions for

reducing this burden, please refer to the

preamble to the cross-referencing notice

of proposed rulemaking published in

the Proposed Rules section of this issue

of the Federal Register.

Books or records relating to a

collection of information must be

retained as long as their contents may

become material in the administration

of any internal revenue law. Generally,

tax returns and tax return information

are confidential, as required by 26

U.S.C. 6103.

Background

This document amends the Income

Tax Regulations (26 CFR Part 1) under

section 6081 of the Internal Revenue

Code of 1986 to implement Notice 93–

22 (1993–1 C.B. 305). Notice 93–22,

released April 7, 1993, grants relief to

individuals who want an automatic 4-

month extension of time to file an

individual income tax return but who

are unable to pay by the due date for the

return the tax properly estimated to be

due. The notice allows these individuals

to obtain an automatic 4-month

extension of time to file their individual