Federal Register / Vol. 60, No. 25 / Tuesday, February 7, 1995 / Rules and Regulations 7121

Food and Drug Administration

21 CFR Part 510

Animal Drugs, Feeds, and Related

Products; 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

Bioproducts, Inc.

EFFECTIVE DATE: February 7, 1995.

FOR FURTHER INFORMATION CONTACT:

Judith M. O’Haro, Center for Veterinary

Medicine (HFV–238), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1737.

SUPPLEMENTARY INFORMATION:

Bioproducts, Inc., has informed FDA of

a change of address from 8221

Brecksville Rd., Cleveland, OH 44141,

to 320 Springside Dr., suite 300,

Fairlawn, OH 44333–2435. Accordingly,

the agency is amending the regulations

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

reflect the new 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).

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) in the entry

for ‘‘Bioproducts, Inc.,’’ and in the table

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

‘‘051359’’ by removing ‘‘8221

Brecksville Rd., Cleveland, OH 44141’’

and adding in its place ‘‘320 Springside

Dr., suite 300, Fairlawn, OH 44333–

2435’’.

Dated: January 31, 1995.

George A. Mitchell,

Director, Office of Surveillance and

Compliance, Center for Veterinary Medicine.

[FR Doc. 95–2992 Filed 2–6–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Tylosin

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

Premiere Agri Technologies, Inc.,

providing for making a 20-gram-perpound (g/lb) tylosin Type A medicated

article in addition to existing approvals

for 40- and 100-g/lb Type A medicated

articles.

EFFECTIVE DATE: February 7, 1995

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1700.

SUPPLEMENTARY INFORMATION: Premiere

Agri Technologies, Inc. (Premiere), P.O.

Box 2508, Fort Wayne, IN 46801–2508,

filed a supplement to NADA 91–582

(formerly sponsored by Central Soya

Co., Inc.) that provides for making a new

20-g/lb tylosin Type A medicated article

used to make Type C medicated feeds

for cattle, chickens, and swine for use as

in § 558.625(f)(1)(i) through (f)(1)(vi) (21

CFR 558.625(f)(1)(i) through (f)(1)(vi)).

Premiere currently has approval for 40-

and 100-g/lb Type A medicated articles.

The supplemental NADA is approved

and the regulations are amended in

§ 558.625(b)(10) to reflect the approval.

Approval of this supplemental NADA

is an administrative action that did not

require the generation of new safety or

effectiveness data. Therefore, a freedom

of information summary is not required

for this action.

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 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

2. Section 558.625 is amended by

revising paragraph (b)(10) to read as

follows:

§ 558.625 Tylosin.

* * * * *

(b) * * *

(10) To 012286: 0.4, 0.8, and 1.6

grams per pound, paragraph (f)(1)(vi)(a)

of this section; 20, 40, and 100 grams

per pound, paragraphs (f)(1)(i) through

(f)(1)(vi) of this section.

* * * * *

Dated: January 11, 1995.

Andrew J. Beaulieau,

Deputy Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–2990 Filed 2–6–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD02–94–016]

RIN 2115–AE47

Drawbridge Operation Regulation; Red

River, AR

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is separating

the regulations governing drawbridges

on the Red River into two sections, one

for Louisiana and one for Arkansas.

Currently, the entire length of the Red

River in both Arkansas and Louisiana in

regulated in one CFR Section. The

completion of U.S. Army Corps of

Engineer projects at locks and dams 4

and 5 in December 1994 is expected to

result in an increase of commercial

traffic on the Red River in Louisiana,

necessitating a change in drawbridge

openings only for the portion of the

river flowing in Louisiana. This

amendment allows the drawbridge on

the Red River in Louisiana and

Arkansas to be regulated under separate

CFR sections but makes no substantive

changes to the regulations for