Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 /Rules and Regulations 40825

Bacitracin methylene disalicylate in grams per tonCombination in grams per

ton Indications for use Limitations Sponsor

* * * * * * *

(vi) * * *.

............................................... ............................................... Replacement chickens; as an

aid in the prevention of necrotic enteritis caused or

complicated by Clostridium

spp. or other organisms

susceptible to bacitracin.

Feed continuously as sole

ration..

046573

* * * * * * *

(ix) * * *.

............................................... ............................................... Replacement chickens; as an

aid in the control of necrotic enteritis caused or complicated by Clostridium

spp. or other organisms

susceptible to bacitracin.

Feed continuously as sole

ration. Start at first clinical

signs of disease, vary dosage based on severity of

infection, administer continuously for 5 to 7 days or

as long as clinical signs

persist, then reduce medication to prevention level

(50 g/t).

046573

* * * * * * *

* * * * *

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–20466 Filed 7–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N–0171]

Medical Devices; Humanitarian Use of

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule; withdrawal.

SUMMARY: The Food and Drug

Administration (FDA) published, in the

Federal Register of April 17, 1998 (63

FR 19185), a direct final rule to

implement the amendments to the

humanitarian use devices provision of

the Federal Food, Drug, and Cosmetic

Act (the act), as amended by the Food

and Drug Administration Modernization

Act of 1997 (FDAMA). The comment

period closed July 1, 1998. FDA is

withdrawing the direct final rule

because the agency received significant

adverse comment.

DATES: The direct final rule published at

63 FR 19185, April 17, 1998, is

withdrawn effective July 31, 1998.

FOR FURTHER INFORMATION CONTACT:

Joanne R. Less, Center for Devices and

Radiological Health (HFZ–403), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20857,

301–594–1190.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, the direct final rule

published on April 17, 1998, at 63 FR

19185 is withdrawn.

Dated: July 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20594 Filed 7–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 917

[KY–217–FOR]

Kentucky Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: OSM is approving a proposed

amendment to the Kentucky regulatory

program (hereinafter referred to as the

‘‘Kentucky program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). Kentucky requested the

removal of 30 CFR 917.17(a) which

disapproved Kentucky’s proposed

revision to its staffing and budget levels

(49 FR 50718, December 31, 1984). The

amendment is intended to revise the

Kentucky program to be consistent with

the Federal regulations and SMCRA.

EFFECTIVE DATE: July 31, 1998.

FOR FURTHER INFORMATION CONTACT:

William J, Kovacic, Director, Lexington

Field Office, 2675 Regency Road,

Lexington, Kentucky 40502. Telephone:

(606) 233–2494.

SUPPLEMENTARY INFORMATION:

I. Background on the Kentucky 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 Kentucky

Program

On May 18, 1982, the Secretary of the

Interior conditionally approved the

Kentucky program. Background

information on the Kentucky program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the May 18, 1982 Federal Register (47

FR 21404). Subsequent actions

concerning conditions of approval and

program amendments can be found at