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