41190 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

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

Friday.

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

supplemental approval for non-food

producing animals qualifies for 3 years

of marketing exclusivity for the new

formulation beginning June 17, 1998,

because the supplemental application

contains substantial evidence of

effectiveness of the drug involved or any

studies of animal safety required for the

approval of the supplement and

conducted or sponsored by the

applicant. The 3 years of marketing

exclusivity applies only to use of the

new milbemycin oxime/lufenuron

flavored tablets in three tablet sizes.

FDA has determined under 21 CFR

25.33(d)(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 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: 21 U.S.C. 360b.

2. Section 520.1446 is amended by

redesignating paragraph (c) as paragraph

(d), by reserving paragraph (c), and by

revising newly redesignated paragraph

(d), to read as follows:

§ 520.1446 Milbemycin oxime/lufenuron

tablets.

* * * * *

(c) [Reserved]

(d) Conditions of use— (1) Dogs— (i)

Amount. 0.5 milligrams of milbemycin

and 10 milligrams of lufenuron per

kilogram of body weight.

(ii) Indications for use. For use in

dogs and puppies for the prevention of

heartworm disease caused by Dirofilaria

immitis, for prevention and control of

flea populations, control of adult

Ancylostoma caninum (hookworm), and

removal and control of adult Toxocara

canis, Toxascaris leonina (roundworm),

and Trichuris vulpis (whipworm)

infections. Lufenuron controls flea

populations by preventing the

development of flea eggs and does not

kill adult fleas. Concurrent use of

insecticides may be necessary for

adequate control of adult fleas.

(iii) Limitations. Administer tablets

once a month, preferably on the same

date each time. All dogs in a household

should be treated to achieve maximum

efficacy. Do not use in dogs less than 4

weeks of age and less than 2 pounds

body weight. Federal law restricts this

drug to use by or on the order of a

licensed veterinarian.

(2) [Reserved]

Dated: July 14, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–20597 Filed 7–31–98 ; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Animal Drugs, Feeds, and Related

Products; Florfenicol Solution

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

Schering-Plough Animal Health. The

supplemental NADA provides for the

subcutaneous use of florfenicol

injectable solution in cattle for

treatment of bovine respiratory disease,

a new dosage, an additional slaughter

withdrawal time, and an additional

tolerance for residues in food.

EFFECTIVE DATE: August 3, 1998.

FOR FURTHER INFORMATION CONTACT:

William T. Flynn, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1652.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095

Morris Ave., Union, NJ 07083–1982, is

sponsor of NADA 141–063 that provides

for veterinary prescription use of

Nuflor Injectable Solution (florfenicol)

for intramuscular treatment of cattle for

bovine respiratory disease at 20

milligrams per kilogram of body weight,

with a second dose after 48 hours, and

a 28-day slaughter withdrawal time.

Schering-Plough filed a supplemental

NADA providing for a single

subcutaneous injection at 40 milligrams

per kilogram of body weight, and a 38-

day slaughter withdrawal time. The

supplemental NADA is approved as of

June 4, 1998, and the regulations are

amended by revising 21 CFR

522.955(d)(1)(i) and (d)(1)(iii) to reflect

the approval. The basis of approval is

discussed in the freedom of information

summary.

In addition, the regulation concerning

tolerances for residues of florfenicol in

food (21 CFR 556.283) is amended to

reflect an acceptable daily intake (ADI)

of residues of the drug in food and a

tolerance for residues in cattle muscle.

The ADI is the amount of total drug

residue that can be safely consumed

daily for a lifetime. Previously, FDA had

codified safe concentrations of animal

drugs, the ADI corrected for

consumption of various food products.

Few individuals understood the

relationship between safe

concentrations, a value representing

total drug residues, and tolerance, the

part of the drug residue in a given tissue

that is detected by an analytical method.

To avoid confusion between the

tolerance and safe concentration, FDA is

codifying ADI’s and removing safe

concentrations.

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 supplement may be

seen in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

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

Friday.

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

supplemental approval for foodproducing animals qualifies for 3 years

of marketing exclusivity beginning June

4, 1998, because the supplemental

application contains substantial

evidence of the effectiveness of the drug

involved, any studies of animal safety

or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval and

conducted or sponsored by the

applicant. Three years marketing

exclusivity is limited to subcutaneous

use of the drug in cattle as approved in

this supplement.

FDA 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,
Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations 41191

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects

21 CFR Part 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 522 and 556 are amended as

follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

2. Section 522.955 is amended by

revising paragraph (d)(1)(i) and the first

four sentences of paragraph (d)(1)(iii) to

read as follows:

§ 522.955 Florfenicol solution.

* * * * *

(d) * * *

(1) * * *

(i) Amount. For intramuscular

injection use 20 milligrams per kilogram

of body weight (3 milliliters per 100

pounds). A second dose should be given

48 hours later. Alternatively, a single

subcutaneous injection of 40 milligrams

per kilogram of body weight (6

milliliters per 100 pounds) may be used.

* * * * *

(iii) Limitations. For intramuscular or

subcutaneous use only. Do not inject

more than 10 milliliters at each site.

Injection should be given in the neck

only. Do not slaughter within 28 days of

last intramuscular treatment or within

38 days of subcutaneous treatment.

* * *

* * * * *

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

3. The authority citation for 21 CFR

part 556 continues to read as follows:

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

4. Section 556.283 is revised to read as

follows:

§ 556.283 Florfenicol.

(a) Acceptable daily intake (ADI). The

ADI for total residues of florfenicol is 10

micrograms per kilogram of body weight

per day.

(b) Cattle. A tolerance of 3.7 parts per

million (ppm) for florfenicol amine

(marker residue) in liver (target tissue)

is established. A tolerance of 0.3 ppm

for florfenicol amine in cattle muscle is

established.

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–20534 Filed 7–31–98; 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; Melengestrol Acetate and

Oxytetracycline

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 two original new animal

drug applications (NADA’s) filed by

Pharmacia & Upjohn Co. The NADA’s

provide for the use of separately

approved Type A medicated articles

containing melengestrol acetate (dry and

liquid form) and oxytetracycline (dry

form) to make dry combination drug

Type C medicated feeds. The Type C

medicated feeds are for heifers fed in

confinement for slaughter for increased

rate of weight gain, improved feed

efficiency, suppression of estrus, and

reduced incidence of liver abscesses.

EFFECTIVE DATE: August 3, 1998.

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: Pharmacia

& Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

original NADA’s 46–718 and 46–719

that provide for combining separately

approved melengestrol acetate (MGA)

(dry and liquid form) and

oxytetracycline (dry form) Type A

medicated articles to make dry Type C

medicated feeds for heifers fed in

confinement for slaughter for increased

rate of weight gain, improved feed

efficiency, suppression of estrus (heat),

and reduced incidence of liver

abscesses. The NADA’s are approved as

of May 6, 1998, and 21 CFR

558.342(d)(8) and 558.450(d)(3)(iii) are

added to reflect the approvals.

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.

FDA has determined under 21 CFR

25.33(a)(2) 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

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

2. Section 558.342 is amended by

adding paragraph (d)(8) to read as

follows:

§ 558.342 Melengestrol acetate.

* * * * *

(d) * * *

(8) Amount. Melengestrol acetate,

0.25 to 0.5 milligram per head per day,

plus oxytetracycline, 75 milligrams per

head per day.

(i) Indications for use. For increased

rate of weight gain, improved feed

efficiency, suppression of estrus (heat),

and reduction of liver condemnation

due to liver abscesses.

(ii) Limitations. Heifers fed in

confinement for slaughter. Add at the

rate of 0.5 to 2.0 pounds per head per

day a medicated feed (liquid or dry)

containing 0.125 to 1.0 milligram of

melengestrol acetate per pound to a feed

containing 6 to 10 grams of

oxytetracycline per ton; or add at the

rate of 0.5 to 2.0 pounds per head per

day a dry medicated feed containing

0.125 to 1.0 milligram of melengestrol

acetate plus 37.5 to 150 milligrams of

oxytetracycline per pound to provide

0.25 to 0.5 milligram of melengestrol

acetate and 75 milligrams of

oxytetracycline per head per day. Liquid

melengestrol acetate may not be mixed