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
14304 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations

558.355(b)(7) and (b)(14) to reflect the

approval.

The supplemental approval is for a

higher concentration of Type A article

to make currently approved Type B and

C feeds, and it does not affect the basis

of approval of, or conditions of use in,

the currently approved application.

Therefore, no additional safety or

effectiveness data were required for this

approval, and a freedom of information

summary is not required. A summary of

the data and information submitted to

support the previously approved

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

does not qualify for marketing

exclusivity because the supplement

does not contain substantial evidence of

effectiveness of the drug involved, any

studies of animal safety, or 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)(iii) 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 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).

§ 558.355 [Amended]

2. Section 558.355 Monensin is

amended in paragraph (b)(7) by

removing the phrase ‘‘and 80’’ and

adding in its place ‘‘80, and 90.7’’ and

in paragraph (b)(14) by removing the

phrase ‘‘and 80’’ and adding in its place

‘‘, 80, and 90.7’’.

Dated: March 13, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–7546 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Melengestrol Acetate

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 supplemental new

animal drug applications (NADA’s) filed

by Pharmacia & Upjohn Co. The

supplemental NADA’s provide for the

use of dry and liquid melengestrol

acetate (MGA) Type A medicated

articles to manufacture certain Type B

and Type C medicated feeds for heifers

intended for breeding for suppression of

estrus (heat).

EFFECTIVE DATE: March 26, 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: Pharmacia

& Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

supplemental NADA’s 34–254 and 39–

402 providing for use of dry and liquid

MGA Type A medicated articles to

manufacture certain Type B and Type C

medicated feeds for heifers intended for

breeding for suppression of estrus

(heat). The supplements are approved as

of February 18, 1997, and the

regulations are amended in § 558.342

(21 CFR 558.342) by adding new

paragraph (d)(7) to reflect the approvals.

In addition, certain mixing directions

for liquid feeds are required for use of

MGA liquid Type A articles to

manufacture Type B medicated feeds.

Those directions had not been codified

previously in the MGA regulations. At

this time, the regulations are amended

to include those directions in new

§ 558.342(c) Special considerations and

existing paragraph (c) is redesignated as

paragraph (d).

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)), these

approvals qualify for 3 years of

marketing exclusivity beginning

February 18, 1997, because the

supplements contain substantial

evidence of effectiveness of the drugs

involved, 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

supplements and conducted or

sponsored by the applicant. Exclusivity

only applies to use in heifers intended

for breeding for suppression of estrus.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

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: Secs. 512, 701 of the Federal

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

360b, 371).

2. Section 558.342 is amended by

redesignating paragraph (c) as paragraph

(d) and by adding new paragraphs (c)

and (d)(7) to read as follows:

§ 558.342 Melengestrol acetate.

* * * * *

(c) Special considerations. (1) Type B

medicated feeds may be manufactured

from melengestrol acetate liquid Type A

articles or Type B medicated feeds

which have a pH of 4.0 to 8.0 and bear

appropriate mixing directions as

follows:

(i) For liquid Type B feeds stored in

recirculating tank systems: Recirculate

immediately prior to use for no less than