14216 Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Rules and Regulations

(m) A claim for benefits under

§ 416.351 based on alleged

misinformation; and

* * * * *

Dated: March 7, 1995.

Neil J. Stillman,

Deputy Assistant Secretary for Information

Resources Management.

[FR Doc. 95–6502 Filed 3–15–95; 8:45 am]

BILLING CODE 4190–29–M

Food and Drug Administration

21 CFR Part 510

Animal Drugs, Feeds, and Related

Products; Change of Sponsor Name

and 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 name and address for

a new animal drug application (NADA)

from Zoecon Industries, Inc., to Sandoz

Agro, Inc.

EFFECTIVE DATE: March 16, 1995.

FOR FURTHER INFORMATION CONTACT:

Benjamin A. Puyot, Center for

Veterinary Medicine (HFV–130), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1646.

SUPPLEMENTARY INFORMATION: Due to a

merger with Zoecon Industries, Inc.,

12200 Denton Dr., Dallas, TX 75234,

and Sandoz Agro, Inc., 1300 East Touhy

Ave., Des Plaines, IL 60018, the firms

have requested that FDA publish a

notice of a change of sponsor name and

address for their new animal drug

application NADA 98–895, Starbar GX–

118 (N-(mercaptomethyl) phthalimide

S-(O,O dimethylphosphorodithioate)

emulsifiable liquid). Accordingly, the

agency is amending the regulations in

21 CFR 510.600(c)(1) and (c)(2) to reflect

the change of sponsor name and

address. The drug labeler code

‘‘011536’’ for Zoecon Industries, Inc., is

being retained for the new sponsor.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and record keeping

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 removing

the entry for ‘‘Zoecon Industries, Inc.,’’

and alphabetically adding a new entry

for ‘‘Sandoz Agro, Inc.,’’ and in the table

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

‘‘011536’’ 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

* * * * *

Sandoz Agro, Inc., 1300 East Touhy

Ave., Des Plaines, IL 60018 ......... 011536

* * * * *

(2) * * *

Drug

labeler

code

Firm name and address

* * * * *

011536 Sandoz Agro, Inc., 1300 East Touhy

Ave., Des Plaines, IL 60018

* * * * *

Dated: March 8, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–6528 Filed 3–15–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lincomycin Hydrochloride Soluble

Powder

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental new animal

drug application (NADA) filed by The

Upjohn Co. The NADA provides for the

use of lincomycin hydrochloride soluble

powder to make medicated swine and

broiler chicken drinking water. The

supplement provides for use of a packet

containing the equivalent of 32 grams

(g) of lincomycin in addition to the

currently approved packet containing

the equivalent of 16 g of lincomycin.

EFFECTIVE DATE: March 16, 1995.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–2701.

SUPPLEMENTARY INFORMATION: The

Upjohn Co., Kalamazoo, MI 49001, filed

a supplement to NADA 111–636 for

Lincomix (lincomycin hydrochloride)

soluble powder. The supplemental

NADA provides for the use of an 80-g

packet containing the equivalent of 32 g

of lincomycin in addition to the

approved 40-g packet containing the

equivalent of 16 g of lincomycin. Both

packets are used to make a swine

drinking water containing 250

milligrams (mg) of lincomycin per

gallon used for the treatment of swine

dysentery and broiler chicken drinking

water containing 64 mg of lincomycin

per gallon for the control of necrotic

enteritis.

This supplemental NADA is approved

as of February 9, 1995, and the

regulations in § 520.1263c(a) (21 CFR

520.126c(a)) are amended to reflect the

approval.

This is a manufacturing supplement

to an approved NADA. The approval

does not require a summary of safety,

effectiveness data, or information.

Therefore, a freedom of information

summary as provided in part 20 (21 CFR

part 20) and § 514.11(e)(2)(ii) (21 CFR

514.11(e)(2)(ii)) is not required.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval for food-producing animals

does not qualify for marketing

exclusivity because the supplemental

application does not contain new

clinical or field investigations (other

than bioequivalence or residue studies)

and new human food safety studies

(other than bioequivalence or residue

studies) essential to the approval and

conducted or sponsored by the

applicant.

The agency has determined under 21

CFR 25.24(d)(1)(iii) that this action is of

a type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under