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
Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations 14305

10 minutes, moving not less than 1

percent of the tank contents per minute

from the bottom of the tank to the top.

Recirculate daily as described even

when not used.

(ii) For liquid Type B feeds stored in

mechanical, air, or other agitation type

tank systems: Agitate immediately prior

to use for not less than 10 minutes,

creating a turbulence at the bottom of

the tank that is visible at the top. Agitate

daily as described even when not used.

(2) A positionally stable melengestrol

acetate liquid Type B feed will not be

subject to the requirements for mixing

directions prescribed in paragraphs

(c)(1) of this section provided it has a

pH of 4.0 to 8.0 and contains a

suspending agent(s) sufficient to

maintain a viscosity of not less than 300

centipoises per second for 3 months.

(d) * * *

(7) Amount. 0.5 milligram per head

per day.

(i) Indications for use. For

suppression of estrus (heat).

(ii) Limitation. Heifers intended for

breeding. Do not exceed 24 days of

feeding. Administer 0.5 to 2.0 pounds

per head per day of Type C feed

containing 0.25 to 1.0 milligram of

melengestrol acetate per pound to

provide 0.5 milligram of melengestrol

acetate per head per day. Melengestrol

acetate as provided by No. 000009 in

§ 510.600(c) of this chapter.

Dated: March 13, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–7545 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Salinomycin

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

Hoffmann-LaRoche, Inc. The

supplement provides for use of an

approved salinomycin Type A

medicated article to make Type C

roaster and replacement chicken feeds

used for prevention of certain forms of

coccidiosis.

EFFECTIVE DATE: May 27, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: HoffmannLaRoche, Inc., 340 Kingsland St.,

Nutley, NJ 07110–1199, filed

supplemental NADA 128–686 that

provides for use of a 30-gram-per-pound

salinomycin Type A article (as

salinomycin sodium) to make Type C

roaster and replacement (breeder and

layer) chicken feeds containing 40 to 60

grams per ton salinomycin sodium

activity for prevention of coccidiosis

caused by Eimeria tenella, E. necatrix,

E. acervulina, E. maxima, E. brunetti,

and E. mivati. This supplement is

approved as of February 3, 1997, and

the regulations are amended in 21 CFR

558.550 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

(the 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 3, 1997, because the

supplement 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 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.

This approval is for use of

salinomycin Type A medicated articles

to make Type C medicated feeds.

Salinomycin is a category I drug as

defined in 21 CFR 558.3(b)(1)(i). As

provided in 21 CFR 558.4(b), an

approved Form FDA 1900 is not

required for making a Type C medicated

feed as provided in the NADA. Under

section 512(m) of the act, as amended by

the Animal Drug Availability Act of

1996 (Pub. L. 104–250), medicated feed

applications have been replaced by feed

mill licensing.

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: Sec. 512, 701 of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b, 371).

2. Section 558.550 is amended by

redesignating paragraph (b)(3) as

paragraph (b)(4) and by adding new

paragraph (b) (3) to read as follows

§ 558.550 Salinomycin.

* * * * *

(b) * * *

(3) Roaster and replacement (breeder

and layer) chickens: It is used as

follows:

(i) Amount per ton. Salinomycin 40 to

60 grams.

(ii) Indications for use. For prevention

of coccidiosis caused by Eimeria tenella,

E. necatrix, E. acervulina, E. maxima, E.

brunetti, and E. mivati.

(iii) Limitations. Feed continuously as

sole ration. Do not feed to laying hens

producing eggs for human consumption.

Not approved for use with pellet

binders. May be fatal if accidentally fed

to horses or adult turkeys.

Dated: March 17, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–7543 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