14302 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations

SUPPLEMENTARY INFORMATION: Merck

Research Laboratories, Division of

Merck & Co., Inc., P.O. Box 2000,

Rahway, NJ 07065, is sponsor of NADA

140–833, which provides for the use of

Ivomec Plus Injection (1 perecent

ivermectin and 10 percent clorsulon) for

cattle for the treatment and control of

gastrointestinal roundworm, lungworm,

grub, lice, and mange mites. The

supplement provides for control of

infections of Dictyocaulus viviparus and

Ostertagia ostertagi for 21 days after

treatment, and Haemonchus placei,

Trichostrongylus axei, Cooperia

punctata, C. oncophora, and

Oesophagostomum radiatum for 14

days after treatment. The supplement is

approved as of February 24, 1997, and

the regulations are amended in 21 CFR

522.1193(d)(2) 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)(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

February 24, 1997, because the

supplement contains substantial

evidence of 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 of the

supplement and conducted or

sponsored by the applicant. Exclusivity

applies only to the additional

indications.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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 522

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 522 is 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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 522.1193 is amended by

adding a new sentence to the end of

paragraph (d)(2) to read as follows:

§ 522.1193 Ivermectin and clorsulon

injection.

* * * * *

(d) * * *

(2) * * * It is also used to control

infections of D. viviparus and O.

ostertagi for 21 days after treatment, and

H. placei, T. axei, C. punctata, C.

oncophora, and O. radiatum for 14 days

after treatment.

* * * * *

Dated: March 17, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–7544 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs;

Oxytetracycline Hydrochloride

Injection

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

Boehringer Ingelheim Animal Health,

Inc. The supplemental NADA provides

for the subcutaneous use (in addition to

the approved intravenous and

intramuscular use) of 100 milligrams/

milliliter (mg/mL) of oxytetracycline

hydrochloride injection in cattle for the

treatment of diseases caused by

oxytetracycline susceptible organisms,

for a 2-day withdrawal period following

the subcutaneous use, and for a 13-day

withdrawal period following the

intramuscular and intravenous use.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION:

Boehringer Ingelheim Animal Health,

Inc., 2621 North Belt Hwy., St. Joseph,

MO 64502, is the sponsor of NADA 97–

452, formerly sponsored by Fermenta

Animal Health Co. The firm has filed a

supplement to NADA 97–452, which

provides for subcutaneous use of 100

mg/mL of oxytetracycline hydrochloride

injection in addition to the approved

intravenous and intramuscular use in

beef and nonlactating dairy cattle for the

treatment of pneumonia and shipping

fever associated with Pasteurella spp.,

Haemophilus spp., and Klebsiella spp.,

caused by organisms susceptible to

oxytetracycline. In cattle, a 2-day

withdrawal period is required following

subcutaneous use, and a 13-day

withdrawal period is required following

intramuscular and intravenous use. The

product is also approved for

intramuscular and intravenous use in

swine. The supplemental NADA is

approved as of February 21, 1997, and

the regulations are amended in 21 CFR

522.1662a(g)(3)(i)(c) 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.

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

approval for food-producing animals

qualifies for 3 years of marketing

exclusivity beginning February 21,

1997, 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 of the

supplement and conducted or

sponsored by the applicant.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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 522

Animal drugs.
Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations 14303

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 522 is 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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 522.1662a is amended by

revising paragraph (g)(3)(i)(c) to read as

follows:

§ 522.1662a Oxytetracycline hydrochloride

injection.

* * * * *

(g) * * *

(3) * * *

(i) * * *

(c) Limitations. Administer by

intramuscular, intravenous, or

subcutaneous injection. In severe forms

of the indicated diseases, administer 5

milligrams of oxytetracycline per pound

of body weight per day. Continue

treatment 24 to 48 hours following

remission of disease symptoms, not to

exceed a total of 4 consecutive days. If

no improvement is noted within 48

hours, consult a veterinarian. Do not

inject more than 10 milliliters per

injection site intramuscularly in adult

cattle; no more than 1 milliliter per site

in calves weighing 100 pounds or less.

Do not slaughter cattle for 13 days after

intramuscular or intravenous treatment,

or 2 days after subcutaneous treatment.

Exceeding the highest recommended

dosage or duration of treatment (not

more than 4 consecutive days) may

result in residues beyond the

withdrawal period. A withdrawal

period has not been established for use

of this product in preruminating calves.

Do not use in calves to be processed for

veal.

* * * * *

Dated: March 14, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–7542 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Chlortetracycline; Technical

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule, technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

new animal drug regulations that

provided for approval of five

supplemental new animal drug

applications (NADA’s) filed by

Hoffmann-LaRoche, Inc.; Pfizer, Inc.;

ALPHARMA, Inc.; ADM Animal Health

& Nutrition Div.; and PennField Oil Co.

to reflect conclusions of the National

Academy of Sciences/National Research

Council (NAS/NRC) review of the use of

chlortetracycline Type A articles to

make certain Type C medicated feeds,

and FDA’s conclusions based on that

review.

DATES: Effective March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 9, 1996 (61 FR

35949), FDA published a document

reflecting approval of the NAS/NRC

supplements for Hoffmann–LaRoche’s

NADA 48–761, Pfizer’s NADA’s 92–286

and 92–287, ALPHARMA’s NADA 46–

699, ADM Animal Health and Nutrition

Div.’s NADA 48–480, and PennField

Oil’s NADA 138–935. The July 9, 1996,

document failed to include certain

amendments to the regulation including

a warning against use of certain

medicated articles in duck eggs for

human food.

In addition, 21 CFR 558.128(c) is

redesignated as paragraph (d) and new

paragraph (c) is reserved for future use

to provide for more uniformity,

flexibility, and consistency in the

regulations.

List of Subjects in 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 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: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.128 [Amended]

2. Section 558.128 Chlortetracycline is

amended by redesignating paragraph (c)

as paragraph (d), by reserving new

paragraph (c), and by amending newly

redesignated paragraph (d) as follows:

a. In paragraph (d)(1)(vi), in the

‘‘Limitations’’ column in the second

entry by adding a second sentence to

read ‘‘Do not feed to ducks producing

eggs for human consumption.’’

b. In paragraph (d)(1)(xii), in the

‘‘Limitations’’ column in the first entry

by removing the word ‘‘excluding’’ in

the second phrase and adding in its

place the word ‘‘including’’, and in the

first and third entries by adding a new

first sentence to read ‘‘Feed

approximately 400 g/t, varying with

body weight and feed consumption to

provide 10 mg/lb per day.’’

c. In paragraph (d)(1)(xvii), in the

third column, in entry 1. by removing

the phrase ‘‘Cattle (under 700 lb)’’ and

adding in its place ‘‘Beef cattle’’.

Dated: March 13, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–7547 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Monensin

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

Elanco Animal Health, Division of Eli

Lilly and Co. The supplemental NADA

provides for use of a 90.7 grams per

pound (g/lb) (200 g/kilogram (kg))

monensin Type A medicated article for

making Type B and C medicated cattle

and goat feeds.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Russell G. Arnold, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1674.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, Division of Eli Lilly and

Co., Lilly Corporate Center,

Indianapolis, IN 46285, filed

supplemental NADA 95–735, which

provides for using a 90.7 g/lb (200 g/kg)

monensin Type A medicated article to

make monensin Type B and C

medicated cattle and goat feeds.

The supplemental NADA is approved

as of February 6, 1997, and the

regulations are amended in 21 CFR