Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Rules and Regulations 62241

BILLING CODE 4910–13–C

Issued in Fort Worth, Texas, on November

14, 1997.

Eric Bries,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–30603 Filed 11–20–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for an approved new

animal drug application (NADA) from

Schering-Plough Animal Health Corp. to

Sioux Biochemical, Inc.

EFFECTIVE DATE: November 21, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095

Morris Ave., Union, NJ 07083, has

informed FDA that it has transferred

ownership of, and all rights and

interests in NADA 9–505 (follicle

stimulating hormone) to Sioux

Biochemical, Inc., 204 Third St. NW.,

Sioux Center, IA 51250. Accordingly,

the agency is amending the regulations

in 21 CFR 522.1002 to reflect the

transfer of ownership. The agency is

also amending the regulations in 21 CFR

510.600(c)(1) and (c)(2) by

alphabetically adding a new listing for

Sioux Biochemical, Inc.

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: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 376e.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding a new entry for

‘‘Sioux Biochemical, Inc.’’ and in the

table in paragraph (c)(2) by numerically

adding a new entry for ‘‘063112’’ to read

as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250 ..... 063112

* * * * * * *

(2) * * *
62242 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Rules and Regulations

Drug labeler code Firm name and address

* * * * * * *

063112 ...................................................................................................... Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250

* * * * * * *

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: 21 U.S.C. 360b.

§ 522.1002 [Amended]

4. Section 522.1002 Follicle

stimulating hormone is amended in

paragraph (b)(2) by removing ‘‘000061’’

and adding in its place ‘‘063112’’.

Dated: November 6, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–30563 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Animal Drugs, Feeds, and Related

Products; Doramectin

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 Pfizer,

Inc. The supplemental NADA provides

for intramuscular use of doramectin in

swine for the treatment and control of

certain infections of nematode and

arthropod parasites.

EFFECTIVE DATE: November 21, 1997.

FOR FURTHER INFORMATION CONTACT:

Estella Z. Jones, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017–5755, is sponsor of NADA 141–

061, which provides for the

subcutaneous and intramuscular use of

Dectomax 1 percent injectable solution

(doramectin) for treatment and control

of certain gastrointestinal roundworms,

lungworms, eyeworms, grubs, lice, and

mange mites of cattle, and to control

infections and to protect cattle from

reinfection with Ostertagia ostertagi for

21 days, and Cooperia punctata and

Dictyocaulus viviparus for 28 days after

treatment. The firm filed a supplemental

NADA that provides for intramuscular

use of doramectin in swine for the

treatment and control of certain

infections of gastrointestinal

roundworms, lungworms, kidney

worms, sucking lice, and mange mites.

The supplemental NADA is approved as

of September 18, 1997, and the

regulations are amended in 21 CFR

522.770(d) to reflect the approval. The

basis of approval is discussed in the

freedom of information summary.

In addition, a tolerance for residues of

doramectin in edible swine tissues has

not been previously established. Section

556.225 (21 CFR 556.225) is amended to

provide for a tolerance for residues of

doramectin in swine tissues.

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 supplemental

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

supplemental approval for foodproducing animals qualifies for 3 years

of marketing exclusivity beginning

September 18, 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

supplemental application and

conducted or sponsored by the

applicant. Exclusivity applies only to

the added indication for the treatment

and control of gastrointestinal

roundworms, lungworms,

kidneyworms, sucking lice, and mange

mites in swine.

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 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 522 and 556 are 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: 21 U.S.C. 360b.

2. Section 522.770 is amended by

revising the heading of paragraph (d)

and redesignating paragraphs (d)(1),

(d)(2), and (d)(3) as paragraphs (d)(1)(i),

(d)(1)(ii), and (d)(1)(iii), respectively,

and by adding new paragraph (d)(2) to

read as follows:

§ 522.770 Doramectin.

* * * * *

(d) Conditions of use—(1) Cattle. (i)

Amount. * * *

* * * * *

(2) Swine. (i) Amount. 300

micrograms per kilogram (10 milligrams

per 75 pounds).

(ii) Indications for use. For treatment

and control of gastrointestinal

roundworms, lungworms, kidney

worms, sucking lice, and mange mites.