Federal Register / Vol. 63, No. 142 / Friday, July 24, 1998 /Rules and Regulations 39727

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Pyrantel Pamoate Suspension

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 an abbreviated new animal

drug application (ANADA) filed by

Phoenix Scientific, Inc. The ANADA

provides for oral use pyrantel pamoate

suspension as an anthelmintic to treat

horses and ponies.

EFFECTIVE DATE: July 24, 1998.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Phoenix

Scientific, Inc., 3915 South 48th St.

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–246 that

provides for oral use of 50 milligrams

per milliliter (mg/mL) pyrantel pamoate

suspension in horses and ponies for

removal and control of mature

infections of large strongyles (Strongylus

vulgaris, S. edentatus, S. equinus),

pinworms (Oxyuris equi), large

roundworms (Parascaris equorum), and

small strongyles.

Approval of ANADA 200–246 for

Phoenix Scientific, Inc.’s pyrantel

pamoate suspension is as a generic copy

of NADA 91–739 for Pfizer, Inc.’s

Strongid T (pyrantel pamoate)

suspension. The ANADA is approved as

of June 18, 1998, and the regulations are

amended in 21 CFR 520.2043(a)(2) 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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33(a) 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 520

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Section 520.2043 is amended by

revising paragraph (a)(2) to read as

follows:

§ 520.2043 Pyrantel pamoate suspension.

(a) * * *

(2) Sponsors. See Nos. 000069 and

059130 in § 510.600(c) of this chapter.

* * * * *

Dated: July 15, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19713 Filed 7–23–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 914

[SPATS No. IN–130–FOR; State Program

Amendment No. 95–8]

Indiana Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: OSM is approving an

amendment to the Indiana regulatory

program (hereinafter referred to as the

‘‘Indiana program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). Indiana proposed

revisions to its rules pertaining to

permit application requirements for

reclamation plans, public availability of

information, and stream buffer zones.

The amendment is intended to revise

the Indiana program to be consistent

with the corresponding Federal

regulations.

EFFECTIVE DATE: July 24, 1998.

FOR FURTHER INFORMATION CONTACT:

Andrew R. Gilmore, Director,

Indianapolis Field Office, Office of

Surface Mining Reclamation and

Enforcement, Minton-Capehart Federal

Building, 575 North Pennsylvania

Street, Room 301, Indianapolis, Indiana

46204–1521. Telephone: (317) 226–

6700. Internet: agilmore@osmre.gov.

SUPPLEMENTARY INFORMATION:

I. Background on the Indiana Program

II. Submission of the Proposed Amendment

III. Director’s Findings

IV. Summary and Disposition of Comments

V. Director’s Decision

VI. Procedural Determinations

I. Background on the Indiana Program

On July 29, 1982, the Secretary of the

Interior conditionally approved the

Indiana program. Background

information on the Indiana program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the July 26, 1982, Federal Register (47

FR 32107). Subsequent actions

concerning the conditions of approval

and program amendments can be found

at 30 CFR 914.10, 914.15, and 914.16.

II. Submission of the Proposed

Amendment

By letter dated March 6, 1998

(Administrative Record No. IND–1596),

Indiana submitted a proposed

amendment to its program pursuant to

SMCRA. Indiana submitted the

amendment at its own initiative.

OSM announced receipt of the

amendment in the April 6, 1998 Federal

Register (63 FR 16723), and in the same

document opened the public comment

period and provided an opportunity for

a public hearing or meeting on the

adequacy of the amendment. The public

comment period closed on May 6, 1998.

Because no one requested a public

hearing or meeting, none was held.

During its review of the amendment,

OSM identified concerns relating to

technical errors at 310 IAC 12–3–80(a),

reclamation plan requirements; 310 IAC

12–5–32(a)(1), water quality standards;

and 310 IAC 12–5–32(a)(2),

requirements for stream channel

diversions. OSM notified Indiana of

these concerns by letter dated April 20,

1998 (Administrative Record No. IND–

1603).

By electronic mail dated May 15, 1998

(Administrative Record No. IND–1608),

Indiana responded to OSM’s concerns

by stating that the editorial errors at 310

IAC 12–3–80(a), 12–5–32(a)(1), and 12–

5–32(a)(2) would be corrected. Because

no substantive revisions were made to

the amendment, OSM did not reopen

the public comment period.