14300 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations

[FR Doc. 97–7676 Filed 3–25–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

New Animal Drugs; 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 from TRINADA, Inc.,

to ALPHARMA INC.

EFFECTIVE DATE: March 26, 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:

TRINADA, Inc. (a wholly owned

subsidiary of A. L. Pharma, Inc.), One

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

NJ 07024 has informed FDA that it has

transferred ownership of, and all rights

and interests in, approved NADA 91–

668 (Chlortetracycline, procaine

penicillin, and sulfamethazine) to

ALPHARMA INC., One Executive Dr.,

P.O. Box 1399, Fort Lee, NJ 07024.

Accordingly, the agency is amending

the regulations in 21 CFR 558.145 to

reflect the change of sponsor and also

amending the regulations in 21 CFR

510.600(c)(1) and (c)(2) by removing

TRINADA, Inc., because the firm is no

longer the sponsor of any approved

NADA’s.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 558

Animal drugs, animal feeds.

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 558 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).

§ 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) by

removing the entry ‘‘TRINADA, Inc.’’,

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

removing the entry ‘‘058690’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

3. 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).

§ 558.145 [Amended]

4. Section 558.145 Chlortetracycline,

procaine penicillin, and sulfamethazine

is amended in paragraph (a)(1) by

removing the number ‘‘058690’’ and

adding in its place ‘‘046573’’.

Dated: March 17, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–7548 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 510 and 558

Animal Drugs, Feeds, and Related

Products; Hygromycin B, Pyrantel

Tartrate, and Tylosin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to remove those

portions reflecting approval of the two

new animal drug applications (NADA’s)

held by Land O’Lakes, Inc., (one for use

of tylosin and one for tylosin/

sulfamethazine Type A medicated

articles), and three NADA’s held by

ADM Animal Health and Nutrition Div.

(one for use of pyrantel tartrate, one for

hygromycin B, and one for tylosin/

sulfamethazine Type A medicated

articles). In a notice published

elsewhere in this issue of the Federal

Register, FDA is withdrawing approval

of these NADA’s. The sponsors

requested the withdrawal of approval of

the NADA’s.

EFFECTIVE DATE: April 2, 1997.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: Land

O’Lakes, Inc., Agricultural Services,

2827 Eighth Avenue South, Fort Dodge,

IA 50501, is the sponsor of NADA’s 42–

489 tylosin (see 21 CFR 558.625(b)(53))

and 98–156 tylosin/sulfamethazine (see

§ 558.630(b)(3) (21 CFR 558.630(b)(3)).

ADM Animal Health and Nutrition Div.,

P.O. Box 2508, Fort Wayne, IN 46801–

2508, is the sponsor of NADA 118–874

pyrantel tartrate (see 21 CFR 558.485(a)

(4)) (formerly held by Henwood Feed

Additives, Inc.), NADA 127–825

hygromycin B (see 21 CFR 558.274(a)(4)

and (c)(1)(i) and (c)(1)(ii)), and NADA

127–826 tylosin/sulfamethazine (see

§ 558.630(b)(10)) (both formerly held by

Music City Supplement Co.). The

sponsors requested withdrawal of

approval of the NADA’s. The animal

drug regulations are amended to remove

those portions which reflect approval of

these NADA’s.

Also, with the withdrawal of approval

of these NADA’s, Land O’Lakes and

Music City Supplement Co. are no

longer sponsors of approved NADA’s.

Therefore, 21 CFR 510.600(c)(1) and

(c)(2) are amended to remove entries for

these firms.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 parts 510 and 558 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).

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

paragraph (c)(1) by removing the entries

for ‘‘Land O’Lakes, Inc.,’’ and ‘‘Music

City Supplement Co.’’, and in paragraph

(c)(2) by removing the entries for

‘‘017519’’ and ‘‘034500’’.
Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations 14301

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

3. 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).

§ 558.274 [Amended]

4. Section 558.274 Hygromycin B is

amended in paragraphs (a)(4) and

(c)(1)(i) and (c)(1)(ii) by removing the

number ‘‘017519,’’.

§ 558.485 [Amended]

5. Section 558.485 Pyrantel tartrate is

amended by removing and reserving

paragraph (a)(4).

§ 558.625 [Amended]

6. Section 558.625 Tylosin is

amended by removing and reserving

paragraph (b)(53).

§ 558.630 [Amended]

7. Section 558.630 Tylosin and

sulfamethazine is amended in

paragraph (b)(3) by removing the

number ‘‘,034500’’ and in paragraph

(b)(10) by removing the number

‘‘017519,’’.

Dated: March 13, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–7541 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lufenuron Tablets

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 new animal drug

application (NADA) filed by Ciba-Geigy

Animal Health Corp. The NADA

provides for oral administration of

lufenuron tablets to cats and kittens 6

weeks of age and older for the control

of flea populations.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Marcia K. Larkins, Center for Veterinary

Medicine (HFV–112), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–0614.

SUPPLEMENTARY INFORMATION: CibaGeigy Animal Health Corp., P.O. Box

18300, Greensboro, NC 27419–8300,

filed NADA 141–062, which provides

for oral administration of Program

(Lufenuron) Cat Flavor Tablets for cats

and kittens 6 weeks of age or older, for

the control of flea populations. The drug

is given orally, once a month, at a

minimum of 13.6 milligrams (mg) of

lufenuron per pound of body weight (30

mg/kilogram), in tablets containing 135

or 270 mg lufenuron each. Lufenuron

has no deleterious effect on adult fleas,

but it prevents most flea eggs from

hatching or maturing into adults. The

NADA is approved as of March 3, 1997,

and the regulations are amended in 21

CFR 520.1288(a) and (d) to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

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

Federal Food, Drug, and Cosmetic Act

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

approval qualifies for 3 years of

marketing exclusivity beginning March

3, 1997, because the NADA contains

substantial evidence of effectiveness of

the drug involved or any studies of

animal safety, required for 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

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. 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).

2. Section 520.1288 is amended by

revising paragraphs (a), (d) (1), and (d)

(3) to read as follows:

§ 520.1288 Lufenuron tablets.

(a) Specifications—(1) Dogs. Each

tablet contains either 45, 90, 204.9, or

409.8 milligrams (mg) lufenuron.

(2) Cats. Each regular tablet contains

either 90 or 204.9 mg lufenuron, each

flavor tablet contains 135 or 270 mg

lufenuron.

* * * * *

(d) Conditions of use in cats—(1)

Amount. Minimum of 13.6 mg

lufenuron per pound (lb) of body weight

(30 mg per kilogram). Recommended 90

mg regular tablet for cats up to 6 lb of

body weight, 204.9 mg regular tablet for

7 to 15 lb, 135 mg flavor tablet for up

to 10 lb, 270 mg flavor tablet for 11 to

20 lb. Cats over 15 lb (regular tablet) or

over 20 lb (flavor tablet) are provided

the appropriate combination of tablets.

* * * * *

(3) Limitations. For oral use in cats or

kittens 6 weeks of age or older, once a

month, directly or broken and mixed

with wet food. Administer in

conjunction with a full meal to ensure

adequate absorption. Treat all cats in the

household to ensure maximum benefits.

Because the drug has no affect on adult

fleas, the concurrent use of insecticides

that kill adults may be necessary

depending on the severity of the

infestation.

Dated: March 17, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–7549 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ivermectin

and Clorsulon

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 Merck

Research Laboratories, Division of

Merck & Co., Inc. The supplemental

NADA provides for persistent control of

gastrointestinal roundworms and

lungworms following use of ivermectin

and clorsulon injection for cattle.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.