14306 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations

approval of a supplemental new animal

drug application (NADA) filed by

Elanco Animal Health, Division of Eli

Lilly and Co. The supplemental NADA

provides for use of monensin Type A

medicated articles to make a revised

formulation of a free-choice Type C

medicated feed for pastured cattle for

increased rate of weight gain.

EFFECTIVE DATE: March 26, 1997.

ADDRESSES: Data and information filed

to support previous approvals may be

seen in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Russell G. Arnold, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1674.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, Division of Eli Lilly and

Co., Lilly Corporate Center,

Indianapolis, IN 46285, is the sponsor of

NADA 95–735, which provides for use

of a monensin Type A medicated article

to make a monensin Type C medicated

feed/free-choice mineral granule

containing 1,620 grams monensin per

ton to be fed at 50 to 200 milligrams per

head per day free-choice to pasture

cattle (slaughter, stocker, feeder, and

dairy and beef replacement heifers) for

increased rate of weight gain.

Elanco Animal Health, Division of Eli

Lilly and Co. filed a supplemental

NADA that provides for a revised

formulation of the Type C medicated

feed/free-choice granule to properly

reflect the salt and mineral content of

the product. The supplemental NADA is

approved as of March 26, 1997, and the

regulations are amended in 21 CFR

558.355(f)(3)(x)(b) to reflect the

approval.

In addition, § 558.355(f)(3)(x)(b) is

amended in the table to correct some

editorial and typographical errors in the

entry for ‘‘Ground limestone (33%

calcium)’’ and in the entries for ‘‘6–01–

080’’ and ‘‘4–04–152,’’ respectively.

Approval of this supplement does not

require a freedom of information

summary because the approval concerns

a change in salt and mineral content of

the product. This change does not affect

the product’s safety or effectiveness.

Therefore, no additional data was

required for this approval. Data and

information filed to support previous

approvals may be seen in the Dockets

Management Branch (HFA–305)

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

The agency has determined under 21

CFR 25.24(d)(1)(iii) 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 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: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.355 [Amended]

2. Section 558.355 Monensin is

amended in the table in paragraph

(f)(3)(x)(b), in the first column, in the

entry for ‘‘Ground limestone (33%

calcium)’’ by adding the phrase ‘‘or

calcium carbonate (38% calcium)’’ and

in the third column in the first and third

entries by removing the numbers ‘‘6–

01–080’’ and ‘‘4–04–152’’ and adding in

their place the numbers ‘‘6–01–082’’

and ‘‘4–04–695’’, respectively.

Dated: March 13, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–7551 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Change of Scientific

Nomenclature

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 scientific nomenclature from

Corynebacterium to Actinomyces

(Corynebacterium). This change of

nomenclature is necessary due to the

scientific reclassification of the

organism.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1659.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, A Division of Eli Lilly

& Co., 2001 West Main St., P.O. Box

708, Greenfield, IN 46140, has informed

FDA that the scientific nomenclature for

the bacterial organism Corynebacterium

pyogenes has been changed to

Actinomyces (Corynebacterium)

pyogenes. This change of nomenclature

is necessary due to scientific

reclassification of the organism. The

organism causes liver abscesses in

cattle. Accordingly, the agency is

amending the regulations in 21 CFR

558.355(f)(3)(ii)(a) and (f)(3)(ix)(a) and

558.625(f)(1)(i)(b) to reflect this change.

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: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.355 [Amended]

2. Section 558.355 Monensin is

amended in paragraphs (f)(3)(ii)(a) and

(f)(3)(ix)(a) by removing the word

‘‘Corynebacterium’’ and adding in its

place the words ‘‘Actinomyces

(Corynebacterium)’’.

§ 558.625 [Amended]

3. Section 558.625 Tylosin is

amended in paragraph (f)(1)(i)(b) by

removing the word ‘‘Corynebacterius’’

and adding in its place the words

‘‘Actinomyces (Corynebacterium)’’.

Dated: March 13, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–7603 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 920

[MD–040–FOR]

Maryland Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.
Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations 14307

ACTION: Final rule; approval of

amendment.

SUMMARY: OSM is approving a proposed

amendment to the Maryland regulatory

program (hereinafter referred to as the

‘‘Maryland program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). Maryland proposed

revisions and additions to its statutes

pertaining to permit revocation,

reinstatement, and reissuance. The

amendment is intended to revise the

Maryland program to be consistent with

the corresponding Federal regulations

and SMCRA.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

George Rieger, Program Manager, OSM,

Appalachian Regional Coordinating

Center, 3 Parkway Center, Pittsburgh,

PA 15220. Telephone: (412) 937–2153.

SUPPLEMENTARY INFORMATION:

I. Background on the Maryland 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 Maryland

Program

On December 1, 1980, the Secretary of

the Interior conditionally approved the

Maryland program. Background

information on the Maryland program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the December 1, 1980, Federal Register

(45 FR 79449). Subsequent actions

concerning conditions of approval and

program amendments can be found at

30 CFR 920.12, 920.15, and 920.16.

II. Submission of the Proposed

Amendment

By letter dated August 5, 1996,

(Administrative Record No. MD–575.00)

Maryland submitted a proposed

amendment to its program pursuant to

SMCRA at its own initiative. House Bill

1124, enacted on May 14, 1996, revises

the provisions of Chapter 522 of the

Annotated Code of Maryland (Code) that

pertain to surface coal mining. By letter

dated November 26, 1996,

(Administrative Record No. MD–

575.03), Maryland clarified certain

provisions of the proposed amendment.

Because the information was

explanatory in nature and did not

constitute a major revision of the

original submission, OSM did not

reopen the comment period.

OSM announced receipt of the

proposed amendment in the August 28,

1996, Federal Register (61 FR 44258),

and in the same document opened the

public comment period and provided an

opportunity for a public hearing on the

adequacy of the proposed amendment.

The public comment period closed on

September 27, 1996.

III. Director’s Findings

Set forth below, pursuant to SMCRA

and the Federal regulations at 30 CFR

732.15 and 732.17, are the Director’s

findings concerning the proposed

amendment. Revisions not specifically

discussed below concern

nonsubstantive wording changes and

paragraph notations to reflect

organizational changes resulting from

this amendment.

Annotated Code of Maryland—Chapter

0522—Surface Coal Mining—Permit

Revocation—Reinstatement

At section 15–514(a)(4), Maryland

provides that if the Director revokes a

permit and forfeits a bond, the operator

of the permit forfeits: all rights and

claims to the permit, all materials

furnished with the permit application,

and any subsequent amendments to the

permit. The Director finds that the

proposed revisions are not inconsistent

with the general Federal requirements

for permits at 30 CFR Part 773.

At new section 15–514.1, Maryland

provides for the reinstatement and

reissuance of revoked permits. At

subsection (A), ‘‘permit’’ is defined to

include all areas approved in the mining

application. At subsection (B), a permit

that has been revoked may be reinstated

for the sole purpose of reissuing all or

part of the permit to another qualified

operator in accordance with subsection

(C). At subsection (C), in order to qualify

for a reissued permit, the operator shall:

provide proof of the right to mine; enter

into an agreement with the State to

assume the duties and responsibilities

of the permit and conduct mining

operations in accordance with

applicable requirements, regulations,

and permit conditions; file the required

performance bond; and provide any

other required information to reissue the

permit.

In its letter dated November 26, 1996,

Maryland stated that its procedures for

processing and reissuing a revoked

permit will track the procedures for the

transfer, sale, or assignment of permit

rights specified in the Code of Maryland

Administrative Regulations (COMAR) at

26.20.07.04. The applicant will be

required to: submit an application for

reissuance of a permit; comply with

public notice requirements; and post a

performance bond. Approval of the

permit will be in accordance with the

provisions of COMAR 26.20.07.04D.

The Director finds that the proposed

revisions, when read with the

corresponding regulations at COMAR

26.20.07.04, are not inconsistent with

the general Federal provisions for the

transfer, assignment, or sale of permits

at 30 CFR 774.17.

IV. Summary and Disposition of

Comments

Public Comments

The Director solicited public

comments and provided an opportunity

for a public hearing on the proposed

amendment. No comments were

received and because no one requested

an opportunity to speak at a public

hearing, no hearing was held.

Federal Agency Comments

Pursuant to 30 CFR 732.17(h)(11)(I),

the Director solicited comments on the

proposed amendment from various

Federal agencies with an actual or

potential interest in the Maryland

program. None were received.

Environmental Protection Agency (EPA)

Pursuant to 30 CFR 732.17(h)(11)(ii),

OSM is required to obtain the written

concurrence of the EPA with respect to

those provisions of the proposed

program amendment that relate to air or

water quality standards promulgated

under the authority of the Clean Water

Act (33 U.S.C. 1251 et seq.) or the Clean

Air Act (42 U.S.C. 7401 et seq.). None

of the revisions that Maryland proposed

to make in this amendment pertains to

air or water quality standards.

Therefore, OSM did not request EPA’s

concurrence.

The Federal regulations at 30 CFR

Part 920, codifying decisions concerning

the Maryland program, are being

amended to implement this decision.

This final rule is being made effective

immediately to expedite the State

program amendment process and to

encourage States to bring their programs

into conformity with the Federal

standards without undue delay.

Consistency of State and Federal

standards is required by SMCRA.

V. Director’s Decision

Based on the above findings, the

Director approves Maryland’s proposed

amendment as submitted on August 5,

1996, and supplemented with

additional explanatory information on

November 26, 1996.

The Federal regulations at 30 CFR

Part 920, codifying decisions concerning

the Maryland program, are being

amended to implement this decision.

This final rule is being made effective

immediately to expedite the State

program amendment process and to
14308 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations

encourage States to bring their programs

into conformity with the Federal

standards without undue delay.

Consistency of State and Federal

standards is required by SMCRA.

VI. Procedural Determinations

Executive Order 12866

This rule is exempted from review by

the Office of Management and Budget

(OMB) under Executive Order 12866

(Regulatory Planning and Review).

Executive Order 12988

The Department of the Interior has

conducted the reviews required by

section 2 of Executive Order 12988

(Civil Justice Reform) and has

determined that, to the extent allowed

by law, this rule meets the applicable

standards of subsections (a) and (b) of

that section. However, these standards

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and 30 CFR

730.11, 732.15, and 732.17(h)(10),

decisions on proposed State regulatory

programs and program amendments

submitted by the States must be based

solely on a determination of whether the

submittal is consistent with SMCRA and

its implementing Federal regulations

and whether the other requirements of

30 CFR Parts 730, 731, and 732 have

been met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA (30 U.S.C. 1292(d))

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The State submittal

which is the subject of this rule is based

upon corresponding Federal regulations

for which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions for the

corresponding Federal regulations.

Unfunded Mandates

This rule will not impose a cost of

$100 million or more in any given year

on any governmental entity or the

private sector.

List of Subjects in 30 Part CFR 920

Intergovernmental relations, Surface

mining, Underground mining.

Dated: March 5, 1997.

Allen D. Klein,

Regional Director, Appalachian Regional

Coordinating Center.

For the reasons set out in the

preamble, Title 30, chapter VII,

Subchapter T of the Code of Federal

Regulations is amended as set forth

below:

PART 920—MARYLAND

1. The authority citation for Part 920

continues to read as follows:

Authority: 30 U.S.C. 1201 et seq.

2. Section 920.15 is amended in the

table by adding a new entry in

chronological order by ‘‘Date of Final

Publication’’ to read as follows:

§ 920.15 Approval of Maryland regulatory

program amendments.

* * * * *

Original amendment submission date Date of final publication Citation/description

* * * * * * *

August 5, 1996 .......................................... March 26, 1997 ......................................... M.C.A. §§ 15–514(a)(4), 15–514.1.

[FR Doc. 97–7535 Filed 3–25–97; 8:45 am]

BILLING CODE 4310–05–M

30 CFR Part 935

[OH–236–FOR]

Ohio Abandoned Mine Land

Reclamation Plan

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: OSM is approving, with

certain exceptions, a proposed

amendment to the Ohio abandoned

mine land reclamation plan (hereinafter

referred to as the ‘‘Ohio plan’’) under

the Surface mining Control and

Reclamation Act of 1977 (SMCRA).

Ohio proposed revisions and additions

to its plan pertaining to acid mine

drainage set aside program, water

quality improvement, project eligibility,

and remining incentives. The

amendment is intended to revise the

Ohio plan to be consistent with SMCRA,

as amended.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

George Rieger, Field Branch Chief,

Appalachian Regional Coordinating

Center, OSM, 3 Parkway Center,

Pittsburgh, PA 15220, Telephone: (412)

937–2153.

SUPPLEMENTARY INFORMATION:

I. Background on the Ohio Plan

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 Ohio Plan

On August 10, 1982, the Secretary of

the Interior approved the Ohio plan.

Background information on the Ohio

plan, including the Secretary’s findings,

the disposition of comments, and the

approval of the plan can be found in the

April 15, 1994, Federal Register (59 FR

17930). Subsequent actions concerning

the conditions of approval and

amendments to the plan can be found at

30 CFR 935.25.

II. Submission of the Proposed

Amendment

By letter dated March 19, 1996,

(Administrative Record No. OH–2163)

Ohio submitted a proposed amendment

to its plan pursuant to SMCRA at its