Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations 41189

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: Novartis

Animal Health US, Inc., P.O. Box 18300,

Greensboro, NC 27419–8300, filed

supplemental NADA 140–915 that

provides for veterinary prescription use

of 2.3- and 5.75-milligram (mg)

SAFEHEARTTM (milbemycin oxime)

tablets in dogs and puppies 4 weeks of

age or older and 2 pounds (lb) body

weight or greater for the prevention of

heartworm disease caused by Dirofilaria

immitis at a minimum dosage of 0.1 mg

milbemycin oxime/kilogram (kg) of

body weight (0.05 mg/lb). The

supplement is approved as of June 4,

1998. FDA is amending the regulations

in 21 CFR 520.1445(c) 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, 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 beginning June

4, 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 milbemycin oxime tablets at 0.1

mg/kg for prevention of canine

heartworm disease.

The agency 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 520.1445 is amended by

removing and reserving paragraph (c)

and by revising paragraph (d) to read as

follows:

§ 520.1445 Milbemycin oxime tablets.

* * * * *

(c) [Reserved]

(d) Conditions of use—(1) Dogs and

puppies—(i) Amount. For hookworm,

roundworm, and whipworm, use 0.23

milligram per pound of body weight (0.5

milligram per kilogram). For heartworm,

use 0.05 milligram per pound of body

weight (0.1 milligram per kilogram).

(ii) Indications for use. For prevention

of heartworm disease caused by

Dirofilaria immitis, control of

hookworm infections caused by

Ancylostoma caninum, and removal and

control of adult roundworm infections

caused by Toxocara canis and

Toxascaris leonina and whipworm

infections caused by Trichuris vulpis in

dogs and in puppies 4 weeks of age or

greater and 2 pounds of body weight or

greater.

(iii) Limitations. Do not use in

puppies less than 4 weeks of age and

less than 2 pounds of body weight.

Administer once a month. First dose

given within 1 month after first

exposure to mosquitoes and continue

regular use until at least 1 month after

end of mosquito season. Federal law

restricts this drug to use by or on the

order of a licensed veterinarian.

(2) Cats and kittens—(i) Amount. 0.91

milligram per pound of body weight (2.0

milligrams per kilogram).

(ii) Indications for use. For prevention

of heartworm disease caused by

Dirofilaria immitis and the removal of

adult Toxocara cati (roundworm) and

Ancylostoma tubaeforme (hookworm)

infections in cats 6 weeks of age or

greater and 1.5 pounds body weight or

greater.

(iii) Limitations. Do not use in kittens

less than 6 weeks of age or 1.5 pounds

body weight. Administer once a month.

Federal law restricts this drug to use by

or on the order of a licensed

veterinarian.

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–20533 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 520

Oral Dosage Form New Animal Drugs;

Milbemycin Oxime/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 supplemental new animal

drug application (NADA) filed by

Novartis Animal Health US, Inc. The

supplemental NADA provides for use of

a milbemycin oxime/lufenuron flavored

tablet formulation for dogs not less than

4 weeks of age and not less than 11

pounds of body weight for prevention of

heartworm disease, for prevention and

control of flea populations, for control

of hookworm, and for removal and

control of roundworms and whipworms.

EFFECTIVE DATE: August 3, 1998.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: Novartis

Animal Health US, Inc., P.O. Box 18300,

Greensboro, NC 27419–8300, filed

supplemental NADA 141–084 that

provides for veterinary prescription use

of SentinelTM (milbemycin oxime/

lufenuron) flavor tablets (5.75 and 115

milligrams (mg), 11.5 and 230 mg, and

23 and 460 mg) for dogs not less than

4 weeks of age and not less than 11

pounds of body weight. The tablets are

used for the prevention of heartworm

disease, for prevention and control of

flea populations, for control of adult

hookworm, and removal and control of

adult roundworm and whipworm

infections when used at a minimum

dosage of 0.5 milligram/kilogram of

body weight (mg/kg) milbemycin with a

minimum of 10 mg/kg lufenuron. The

supplement is approved as of June 17,

1998. To reflect the approval, FDA is

redesignating 21 CFR 520.1446(c) as

paragraph (d), reserving paragraph (c),

and revising newly redesignated

paragraph (d). 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
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,