Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Rules and Regulations 21075

Dated: May 1, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–11516 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 510 and 522

Animal Drugs, Feeds, and Related

Products; Medetomidine

Hydrochloride Injection; Change of

Sponsor Name

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 new animal drug

application (NADA) filed by Orion

Corp. ORION–FARMOS. The NADA

provides for the use of medetomidine

hydrochloride injection in dogs for its

sedative and analgesic properties. The

regulations are also amended to reflect

a change of sponsor name.

EFFECTIVE DATE: May 9, 1996.

FOR FURTHER INFORMATION CONTACT:

Sandra K. Woods, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1616.

SUPPLEMENTARY INFORMATION: Orion

Corp. ORION–FARMOS, (formerly

Orion Corp. FARMOS), P.O. Box 425,

SF–20101 Turku, Finland, filed NADA

140–999, which provides for

intravenous or intramuscular use of

Domitor (medetomidine

hydrochloride) injection as a sedative

and analgesic in dogs over 12 weeks of

age to facilitate clinical examinations,

clinical procedures, minor surgical

procedures not requiring muscle

relaxation, and minor dental procedures

not requiring intubation. The drug

product is available by prescription. The

application is approved as of March 19,

1996, and the regulations are amended

in part 522 (21 CFR part 522) by adding

new § 522.1335 to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

Additionally, the firm has informed

FDA that it has changed its corporate

name from Orion Corp. FARMOS to

Orion Corp. ORION–FARMOS.

Accordingly, the agency is also

amending 21 CFR 510.600(c)(1) and

(c)(2) to reflect the change of sponsor

name.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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)(i) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(i)), this

approval qualifies for 5 years of

marketing exclusivity beginning March

19, 1996, because no active ingredient

(including any ester or salt of the active

ingredient) of the drug has been

approved in any other application under

section 512(b)(1) of the act.

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

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 parts 510 and 522 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

512, 701, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e).

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the sponsor name ‘‘Orion

Corp. FARMOS, Research and

Development, Pharmaceuticals,’’ and by

adding in its place ‘‘Orion Corp.

ORION–FARMOS’’, and in the table in

paragraph (c)(2) in the entry for

‘‘052483’’ by removing the sponsor

name ‘‘Orion Corp. FARMOS, Research

and Development, Pharmaceuticals,’’

and adding in its place ‘‘Orion Corp.

ORION–FARMOS’’.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

3. 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).

4. New § 522.1335 is added to read as

follows:

§ 522.1335 Medetomidine hydrochloride

injection.

(a) Specifications. Each milliliter of

sterile aqueous solution contains 1.0

milligram of medetomidine

hydrochloride.

(b) Sponsor. See 052483 in

§ 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount.

750 micrograms intravenously (IV) or

1,000 micrograms intramuscularly per

square meter of body surface. The IV

route is more efficacious for dental care.

(2) Indications for use. As a sedative

and analgesic in dogs over 12 weeks of

age to facilitate clinical examinations,

clinical procedures, minor surgical

procedures not requiring muscle

relaxation, and minor dental procedures

not requiring intubation. The

intravenous route of administration is

more efficacious for dental care.

(3) Limitations. Do not use in dogs

with cardiac disease, respiratory

disorders, liver or kidney diseases, dogs

in shock, dogs which are severly

debilitated, or dogs which are stressed

due to extreme heat, cold, or fatigue.

Allow agitated dogs to rest quietly

before administration. Do not repeat

dosing in dogs not responding

satisfactorily to treatment. Do not use in

breeding or pregnant animals. Federal

law restricts this drug to use by or on

the order of a licensed veterinarian.

Dated: April 15, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–11511 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Halofuginone Hydrobromide,

Bacitracin Methylene Disalicylate

AGENCY: Food and Drug Administration,

HHS.