40824 Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 /Rules and Regulations

uplands of Womens Bay and is

generally located in Section 21,

Township 28 South, Range 20 West,

Seward Meridian according to the USGS

1:63360 scale quadrangle maps of

Kodiak (C–2 and D–2) Alaska. The

Kodiak State Airport site includes the

developed and undeveloped lands and

is generally located within Section 15,

Township 28 South, Range 20 West,

Seward Meridian according to the USGS

1:63360 scale quadrangle map of Kodiak

(D–2) Alaska.

Inapplicability of Public Notice and

Comment and Delayed Effective Date

Because this document relates to

agency organization and management

and merely corrects the geographical

description of a port, the establishment

of which was directed by Congress, it is

not subject to the notice and public

procedure requirements of 5 U.S.C. 553.

For the same reasons, pursuant to 5

U.S.C. 553(d)(3), a delayed effective date

is not required.

Regulatory Flexibility Act

Because this document is not subject

to the notice and public procedure

requirements of 5 U.S.C. 553, it is not

subject to the provisions of the

Regulatory Flexibility Act (5 U.S.C. 601

et seq.).

Executive Order 12866

Agency organization matters such as

this are exempt from consideration

under Executive Order 12866.

List of Subjects in Part 101

Customs duties and inspection,

Customs ports of entry, Exports, Foreign

trade, Harbors, Imports, Reporting and

recordkeeping requirements, Shipments,

Vessels.

Amendments to the Regulations

For the reasons set forth in the

preamble, Part 101 of the Customs

Regulations is amended as follows:

PART 101–GENERAL PROVISIONS

1. The general authority citation for

part 101 and the specific authority

citation for §§ 101.3 and 101.4 continue

to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 2, 66,

1202 (General Note 20, Harmonized Tariff

Schedule of the United States), 1623, 1624.

* * * * *

Sections 101.3 and 101.4 also issued under

19 U.S.C. 1 and 58b;

* * * * *

§ 101.3 [Amended]

2. Section 101.3(b)(1) is amended by

removing the reference ‘‘T.D. 98–24’’ in

the ‘‘Limits of port’’ column adjacent to

the entry for ‘‘Kodiak’’ in the ‘‘Ports of

entry’’ column under Alaska and adding

in its place the reference ‘‘T.D. 98–65.’’

Dated: June 10, 1998.

Samuel H. Banks,

Acting Commissioner of Customs.

John P. Simpson,

Deputy Assistant Secretary of the Treasury.

[FR Doc. 98–20455 Filed 7–30–98; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Bacitracin Methylene

Disalicylate

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

Alpharma Inc. The supplemental NADA

provides for using approved bacitracin

methylene disalicylate (BMD) Type A

medicated articles to make a Type C

medicated feed for replacement

chickens.

EFFECTIVE DATE: July 31, 1998.

FOR FURTHER INFORMATION CONTACT:

William T. Flynn, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1652.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, filed supplemental

NADA 46–592 that provides for using

approved BMD (10, 25, 30, 40, 50, 60,

or 75 grams (g) per pound BMD) Type

A medicated articles to make Type C

medicated replacement chicken feed. A

Type C feed containing 50 g per ton (/

t) BMD is fed continuously as an aid in

the prevention of necrotic enteritis

caused or complicated by Clostridium

spp. or other organisms susceptible to

BMD. A Type C feed containing 100 to

200 g/t BMD is fed for 5 to 7 days, or

as long as clinical signs persist, as an

aid in the control of necrotic enteritis

caused or complicated by Clostridium

spp. or other organisms susceptible to

BMD. The supplemental NADA is

approved as of June 22, 1998, and the

regulations in 21 CFR 558.76(d)(1) are

amended in the table in items (vi) and

(ix) to add new entries to reflect the

approval. The basis for 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 the 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.

FDA has determined under 21 CFR

25.33(a)(1) that these actions are of a

type that do 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 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: 21 U.S.C. 360b, 371.

2. Section 558.76 is amended in

paragraph (d)(1) in the table in items (vi)

and (ix) by adding new entries to read

as follows:

§ 558.76 Bacitracin methylene disalicylate.

* * * * *

(d) * * *

(1) * * *
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