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.
Federal Register / Vol. 62, No. 205 / Thursday, October 23, 1997 / Rules and Regulations 55161

§ 524.900 [Amended]

4. Section 524.900 Famphur 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 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

5. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

6. Section 556.273 is added to subpart

B to read as follows:

§ 556.273 Famphur.

Tolerances are established for

residues of famphur including its

oxygen analog in or on meat, fat, or meat

byproducts of cattle at 0.1 part per

million.

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.

§ 558.254 [Amended]

8. Section 558.254 Famphur is

amended in paragraph (c) by removing

‘‘40 CFR 180.233’’ and adding in its

place ‘‘§ 556.273 of this chapter.’’

Dated: September 9, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–28016 Filed 10–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Miconazole Nitrate

Lotion and Spray

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 an abbreviated new animal

drug application (ANADA) filed by

Med-Pharmex, Inc. The ANADA

provides for use of miconazole nitrate

lotion and spray as topical antifungal

agents to treat certain infections of dogs

and cats.

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, 301–827–0209.

SUPPLEMENTARY INFORMATION: MedPharmex, Inc., 2727 Thompson Creek

Rd., Pomona, CA 91767, filed ANADA

200–196, which provides for use of

miconazole nitrate lotion 1 percent and

miconazole nitrate spray 1 percent as

antifungal agents for topical treatment of

infections in dogs and cats caused by

Microsporum canis, M. gypseum, and

Trichophyton mentagrophytes.

Med-Pharmex’s ANADA 200–196 is

approved as a generic copy of

Mallinckrodt Veterinary’s Conofite

miconazole nitrate 1 percent lotion and

spray, NADA 95–184. ANADA 200–196

is approved as of August 4, 1997, and

the regulations are amended in 21 CFR

524.1443(b) to reflect the approval. The

basis for 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.

The agency has determined under 21

CFR 25.33 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 524

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 524 is amended as follows:

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 524 continues to read as follows:

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

2. Section 524.1443 is amended by

revising paragraph (b) to read as follows:

§ 524.1443 Miconazole nitrate cream;

miconazole nitrate lotion; miconazole

nitrate spray.

* * * * *

(b) Sponsor. See No. 011716 in

§ 510.600(c) of this chapter for use of

cream, lotion, and spray; see No. 051259

in § 510.600(c) of this chapter for use of

lotion and spray.

* * * * *

Dated: September 10, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–28014 Filed 10–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Bacitracin Zinc

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 hybrid abbreviated new

animal drug application (ANADA) filed

by ALPHARMA, Inc. The hybrid

ANADA provides for the use of

bacitracin zinc Type A medicated

articles to make Type C medicated feeds

for cattle, broiler chickens, turkeys,

pheasants, growing quail, and growing

and finishing swine, for increased rate

of weight gain and improved feed

efficiency, and for laying chickens for

improved feed efficiency and increased

egg production.

EFFECTIVE DATE: October 15, 1997.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1638.

SUPPLEMENTARY INFORMATION:

ALPHARMA, Inc., One Executive Dr.,

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

sponsor of hybrid ANADA 200–223 that

provides for use of bacitracin zinc Type

A medicated articles (bacitracin zinc

equivalent to 50 grams (g) of bacitracin

per pound) to make Type C medicated

feeds for cattle when fed at 35 to 70

milligrams per head per day, for

growing broiler chickens, turkeys, and

pheasants fed at 4 to 50 g per ton (g/t),

for growing quail up to 5 weeks of age

fed at 5 to 20 g/t, for growing and

finishing swine fed at 10 to 50 g/t, for

increased rate of weight gain and

improved feed efficiency, and for laying

chickens fed at 10 to 25 g/t for improved