8372 Federal Register / Vol. 62, No. 37 / Tuesday, February 25, 1997 / Rules and Regulations

that the implant is not for use in bull

calves intended for reproduction. The

basis for approval is discussed in the

freedom of information summary.

In addition, due to enactment of the

Generic Animal Drug and Patent Term

Restoration Act of 1988, the paragraph

concerning National Academy of

Science/National Research Council

status is outdated. At this time, 21 CFR

522.1940 is amended by removing

paragraph (d)(2)(iv).

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 qualifies for 3 years of

marketing exclusivity beginning January

22, 1997, because the application

contains substantial evidence of the

effectiveness of the drug 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 and conducted or

sponsored by the applicant.

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 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).

§ 522.1940 [Amended]

2. Section 522.1940 Progesterone and

estradiol benzoate in combination is

amended in paragraph (d)(1)(iii) by

removing the phrases ‘‘For 000033:’’ and

‘‘For 021641: Do not use in calves

intended for reproduction.’’ and by

removing paragraph (d)(2)(iv).

Dated: February 10, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–4517 Filed 2–24–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 529

Certain Other Dosage Form New

Animal Drugs; Salicylic Acid;

Technical Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations concerning the

use of salicylic acid to correct a certain

typographical error. This action is being

taken to clarify and improve the

accuracy of the regulations.

EFFECTIVE DATE: February 25, 1997.

FOR FURTHER INFORMATION CONTACT:

David L. Gordon, Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1737.

SUPPLEMENTARY INFORMATION: FDA has

found an error concerning the amount of

salicylic acid per dose. In 21 CFR

529.2090(a)(1) that error has been

incorporated into the agency’s animal

drug regulations. FDA is correcting this

error. The approved concentration is

0.55 grain of salicylic acid per dose, not

0.55 gram of salicylic acid.

List of Subjects in 21 CFR Part 529

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 529 is amended as follows:

PART 529—CERTAIN OTHER DOSAGE

FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 529 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

§ 529.2090 [Amended]

2. Section 529.2090 Salicylic acid is

amended in paragraph (a)(1) by

removing the word ‘‘gram’’ and by

adding in its place the word ‘‘grain’’.

Dated: January 31, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–4516 Filed 2–24–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Melengestrol Acetate,

Monensin, and Tylosin

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

Pharmacia & Upjohn Co. The

supplement provides for the use of

separately approved Type A medicated

articles containing melengestrol acetate

(dry form only), monensin, and tylosin

to manufacture certain combination

drug, dry, meal Type B medicated feeds

for use in making Type C medicated

feeds. The 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: February 25, 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, 7000 Portage Rd., Kalamazoo,

MI 49001–0199, filed supplemental

NADA 138–792, which provides for

combining separately approved

melengestrol acetate (MGA) (dry form

only), monensin sodium, and tylosin

phosphate Type A medicated articles to

manufacture dry, meal Type B

medicated feeds used to make 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 supplement is approved

as of December 17, 1996, and 21 CFR

558.342 is amended in paragraph

(c)(5)(iii)(C) to reflect the approval.

Approval of this supplement which

provides for use of a different physical
Federal Register / Vol. 62, No. 37 / Tuesday, February 25, 1997 / Rules and Regulations 8373

form of Type B feed did not require

reevaluation of the safety or

effectiveness data supporting the NADA

or the submission of any new data.

Therefore, a freedom of information

summary is not required.

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 does not qualify for marketing

exclusivity because the supplement

does not contain 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)(ii) 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: Secs. 512, 701 of the Federal

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

360b, 371).

§ 558.342 [Amended]

2. Section 558.342 Melengestrol

acetate is amended in paragraph

(c)(5)(ii)(C) by removing the word

‘‘pelleted’’.

Dated: January 31, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–4514 Filed 2–24–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Bambermycins

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

Hoechst-Roussel Agri-Vet Co. The

supplement provides for using liquid

bambermycins Type B medicated feeds

to make Type C medicated feeds for

cattle fed in confinement for slaughter

for increased rate of weight gain and

improved feed efficiency.

EFFECTIVE DATE: February 25, 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: HoechstRoussel Agri-Vet Co., Route 202–206,

P.O. Box 2500, Somerville, NJ 08876–

1258, filed supplemental NADA 141–

034 that provides for using 10-gram per

pound (g/lb) Flavomycin

(bambermycins) Type A medicated

articles to make 40 to 800 g/ton liquid

Type B medicated feeds, the liquid Type

B feeds used to make dry Type C

medicated feeds. The Type C feeds

containing 1 to 4 g/ton bambermycins

are for cattle fed in confinement for

slaughter to provide 10 to 20 milligrams

bambermycins per head per day for

increased rate of weight gain and

improved feed efficiency. The

regulations are amended in § 558.95 (21

CFR 558.95) by adding new paragraph

(a)(5), by redesignating paragraph (b) as

paragraph (d), and by revising newly

redesignated paragraph (d)(4)(i)(b) to

reflect the approval.

Furthermore, use of liquid Type B

feeds to make Type C feeds requires

publication of specifications and

expiration information. New § 558.95(b)

is established to reflect the Type B feed

specifications and expiration

information. In the interest of issuing

uniform regulations in the future, new

§ 558.95(c) is also established at this

time and reserved for future use.

Approval of this supplement did not

require submission of additional safety

or efficacy data. A freedom of

information (FOI) summary as in 21

CFR part 20 and 514.11(e)(2)(ii) is not

required. An FOI summary submitted to

support approval of the original

application may be seen in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857, from 9 a.m. to 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

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 558.95 is amended by

adding new paragraph (a)(5), by

redesignating paragraph (b) as paragraph

(d), by adding new paragraph (b), by

adding and reserving paragraph (c), and

by adding a new fourth sentence to

newly redesignated paragraph

(d)(4)(i)(b), to read as follows:

§ 558.95 Bambermycins.

(a) * * *

(5) 10 grams of activity per pound to

012799 in § 510.600(c) of this chapter to

make 40 to 800 gram/ton Type B feeds

for use as in paragraph (d)(4)(i) of this

section.

(b) Special considerations. (1)

Bambermycins liquid Type B feeds may

be manufactured from dry

bambermycins Type A articles. The

liquid Type B feeds must have a pH of

3.8 to 7.5, moisture content of 30 to 45

percent.

(2) The expiration date for the liquid

Type B feed is 8 weeks after date of

manufacture. The expiration date for the

dry Type C feed made from the liquid

Type B feed is 1 week after date of

manufacture.

(c) [Reserved]

(d) * * *

(4) * * *

(i) * * *