Federal Register / Vol. 62, No. 205 / Thursday, October 23, 1997 / Rules and Regulations 55159

final rule that appeared in the Federal

Register of June 27, 1997 (62 FR 34631).

The document amended the animal

drug regulations to reflect approval of a

new animal drug application (NADA)

filed by Deprenyl Animal Health, Inc.

The NADA provides for oral use of

selegiline hydrochloride tables for dogs

for the control of clinical signs

associated with uncomplicated

pituitary-dependent

hyperadrenocorticism. The approved

use in dogs was inadvertently omitted

from the document. This document

corrects that error.

EFFECTIVE DATE: June 27, 1997.

FOR FURTHER INFORMATION CONTACT:

David L. Gordon, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1739.

In FR Doc. 97–16791, appearing on

page 34631 in the Federal Register of

Friday, June 27, 1997, the following

corrections are made:

1. On page 34631, in the first column,

in the heading ‘‘Tablet’’ is corrected to

read ‘‘Tablets’’.

§ 520.2098 [Corrected]

2. On page 34632, in the first column,

in § 520.2098 Selegiline hydrochloride

tablets, in paragraph (d), the heading

‘‘(d) Conditions of use—’’ is corrected to

read ‘‘(d) Conditions of use—Dogs—’’;

and in paragraph (d)(2), in the 4th line,

‘‘hyperadrenocorticism.’’ is corrected to

read ‘‘hyperadrenocorticism in dogs.’’

Dated: September 8, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–28017 Filed 10–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558

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 three new animal

drug applications (NADA’s) and three

abbreviated new animal drug

applications (ANADA’s) from WadeJones Co., Inc., and its manufacturing

subsidiary Arkansas Micro Specialties,

Inc., to Alpharma Inc. The agency is

also correcting a final rule that appeared

in the Federal Register of June 20, 1996

(61 FR 31398).

EFFECTIVE DATE: October 23, 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: WadeJones Co., Inc., 409 North Bloomington,

Lowell, AR 72745, and its

manufacturing subsidiary Arkansas

Micro Specialties, Inc., P.O. Box 308,

Highway 71 North, Lowell, AR 72745,

has informed FDA that it has transferred

ownership of, and all rights and

interests in, the following approved

NADA’s and ANADA’s to Alpharma

Inc., One Executive Dr., Fort Lee, NJ

07024.

NADA/ANADA Ingredient

065–140 Tetracycline Hcl Soluble Powder

140–443 Hygromycin B Type A Medicated Articles

140–578 Tetracycline Hcl Soluble Powder

200–122 Penicillin G Potassium Soluble Powder

200–130 Neomycin Sulfate Soluble Powder

200–233 Lincomycin Hcl Soluble Powder

The agency is amending parts 510,

520, and 558 (21 CFR parts 510, 520 and

558) to reflect the change of sponsor.

The agency is amending § 510.600(c)(1)

and (c)(2) to remove the sponsor name

for Wade-Jones Co., Inc., and Arkansas

Micro Specialties, Inc., because the firm

no longer is the holder of any approved

NADA’s.

The agency is also correcting a final

rule that appeared in the Federal

Register of June 20, 1996 (61 FR 31398).

This document amended the animal

drug regulations to reflect approval of a

supplemental NADA filed by The

Upjohn Co., and two supplemental

ANADA’s, one filed by Pfizer, Inc., and

the other filed by Rhone Merieux, Inc,

respectively. In § 520.1484(c)(3), the

drug labeler code (047864) for WadeJones Co., Inc., was inadvertently

omitted from the document. After that

document published, Wade-Jones Co.,

Inc., transferred ownership of and all

rights and interest to Alpharma Inc.

Accordingly, this document adds a drug

labeler code for Alpharma Inc. and,

thereby, corrects the error in the final

rule (61 FR 31398).

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 520

Animal drugs.

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, 520, 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: 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 entries for ‘‘Arkansas

Micro Specialties, Inc.’’and ‘‘WadeJones’’ and in the table in paragraph

(c)(2) by removing the entries ‘‘047863’’

and ‘‘047864’’.
55160 Federal Register / Vol. 62, No. 205 / Thursday, October 23, 1997 / Rules and Regulations

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 520.1484 [Amended]

4. Section 520.1484 Neomycin sulfate

soluble powder is amended in paragraph

(b) by removing ‘‘047864’’ and adding in

its place ‘‘046573’’ and in paragraph

(c)(3) by revising the words in the last

sentence ‘‘for sponsors 000009, 000069,

050604’’ to read as ‘‘for sponsors

000009, 000069, 046573, 050604’’.

§ 520.1696b [Amended]

5. Section 520.1696b Penicillin G

potassium in drinking water is amended

in paragraph (b) by removing ‘‘047864,

and’’ and adding in its place ‘‘046573,’’.

§ 520.2345d [Amended]

6. Section 520.2345d Tetracycline

hydrochloride soluble powder is

amended in paragraphs (a)(1), (d)(1)(iii),

and (d)(2)(iii) by removing ‘‘047864’’,

and adding in its place ‘‘046573’’ and in

paragraph (a)(4) by removing ‘‘047863’’

and adding in its place ‘‘046573’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

7. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.274 [Amended]

8. Section 558.274 Hygromycin B is

amended in paragraph (a)(8) by

removing ‘‘047863’’ and in the table in

paragraphs (c)(1)(i) and (c)(1)(ii), under

the ‘‘sponsor’’ column, by removing

‘‘047863’’ and numerically adding

‘‘046573’’.

Dated: September 9, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–28011 Filed 10–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 524, 556, and 558

Animal Drugs, Feeds, and Related

Products; Famphur

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to specify the

tolerance for residues of famphur in

cattle products. The residue tolerances

were originally issued in FDA’s

regulations under tolerances and

exemptions from tolerances for

pesticide chemicals in or on raw

agricultural commodities, and

subsequently moved to the

Environmental Protection Agency’s

(EPA’s) regulations for residues of

pesticides. Subsequent FDA new animal

drug approvals with the same

tolerances, instead of stating the

tolerances, cross-referenced EPA’s

regulations. This action is being taken

because EPA has removed the tolerance

from its regulations.

EFFECTIVE DATE: October 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: FDA has

several approved new animal drug

applications (NADA’s) providing for use

of various famphur products. Three

NADA’s sponsored by Mallinckrodt

Veterinary, Inc., Mundelein, IL 60060,

are:

NADA 34–266: Famix Famphur Type

A article (for Type C cattle feed).

NADA 34–697: Warbex Famphur

Cattle Pour-On/Bo-Anna Famphur

Cattle Insecticide.

NADA 139–858: Tramisol-X-Tra

(Famphur/Levamisole) Cattle

Anthelmintic and Ectoparasite Paste.

One NADA sponsored by PM

Resources, Inc., 13001 St. Charles Rock

Rd., Bridgeton, MO 63044, is:

NADA 43–215: Purina Grub-Kill

(Famphur).

Tolerances for residues of famphur

including its oxygen analog in or on the

raw agricultural commodities meat, fat,

and meat byproducts of cattle had been

established under 21 CFR 120.233 (33

FR 2935, February 14, 1968). Those

provisions were subsequently

transferred to EPA and redesignated as

40 CFR 180.233 (36 FR 424, January 13,

1971, interim rule; and 36 FR 22369 at

22564, November 25, 1971, final rule) at

0.1 part per million. FDA, in its

approvals of famphur as a new animal

drug, established the same tolerance for

residues of the drug. Instead of

specifying the tolerance in the

regulations reflecting the new animal

drug approvals, the regulations crossreferenced to 40 CFR 180.233. EPA has

revoked the tolerance for residues of

famphur in or on certain raw

agricultural commodities because the

pesticide no longer was covered by

EPA’s food use registrations (59 FR

17754, April 14, 1994, proposed rule;

and 60 FR 49798, September 27, 1995,

final rule). Because EPA has removed 40

CFR 180.233, FDA is amending its

regulations in 21 CFR 556.273 to

establish the tolerances for residues of

famphur including its oxygen analog.

In addition, the tolerance citations in

21 CFR 520.1242g(e), 524.900(e), and

558.254(c) are amended to replace the

cross-reference to 40 CFR 180.233 with

a reference to the residue tolerance

specified in 21 CFR part 556.

The agency has determined under 21

CFR 25.33(a)(1) 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

21 CFR Part 520

Animal drugs.

21 CFR Part 524

Animal drugs.

21 CFR Part 556

Animal drugs, Food, Residues.

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 520, 524, 556, and 558 are

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: 21 U.S.C. 360b.

§ 520.1242g [Amended]

2. Section 520.1242g Levamisole

resinate and famphur paste is amended

in paragraph (e) by removing ‘‘40 CFR

180.233 (under the chemical name)’’

and adding in its place ‘‘§ 556.273 of

this chapter.’’

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 524 continues to read as follows:

Authority: 21 U.S.C. 360b.