Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / Proposed Rules 29365

accessed at http://www.fda.gov/cdrh/

gmp/gmp.html.

Send registration information

(including name, title, firm name,

address, telephone, and fax number),

and written material and requests to

make oral presentations, to the contact

person by June 11, 1998. No telephone

requests will be accepted. You will be

notified by fax to tell whether your

presentation will be included and your

time limitation. If you cannot be

reached by fax, please note that in your

request.

Due to space limitations, interested

parties are encouraged to register early.

Depending on the number of requests,

registration may be limited to one

representative per firm or organization.

If special accommodations are needed

due to a disability, please contact

Timothy R. Wells, at least 7 days in

advance.

Dated: May 19, 1998.

Linda S. Kahan,

Acting Deputy Director for Regulations Policy,

Center for Devices and Radiological Health.

[FR Doc. 98–14049 Filed 5–28–98; 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–144–FOR]

Indiana Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; public comment

period and opportunity for public

hearing.

SUMMARY: OSM is announcing receipt of

a proposed amendment to the Indiana

regulatory program (hereinafter the

‘‘Indiana program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). The proposed

amendment consists of revisions to and

additions of statutes pertaining to

definitions, permit conditions, and

permit revisions. The amendment is

intended to revise the Indiana program

to improve operational efficiency.

This document sets forth the times

and locations that the Indiana program

and proposed amendment to that

program are available for public

inspection, the comment period during

which interested persons may submit

written comments on the proposed

amendment, and the procedures that

will be followed regarding the public

hearing, if one is requested.

DATES: Written comments must be

received by 4:00 p.m., e.s.t., June 29,

1998. If requested, a public hearing on

the proposed amendment will be held

on June 23, 1998. Requests to speak at

the hearing must be received by 4:00

p.m., e.s.t. on June 15, 1998.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to Andrew

R. Gilmore, Director, Indianapolis Field

Office, at the address listed below

Copies of the Indiana program, the

proposed amendment, a listing of any

scheduled public hearings, and all

written comments received in response

to this document will be available for

public review at the addresses listed

below during normal business hours,

Monday through Friday, excluding

holidays. Each requester may receive

one free copy of the proposed

amendment by contacting OSM’s

Indianapolis Field Office.

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, IN

46204, Telephone: (317) 226–6700.

Indiana Department of Natural

Resources, 402 West Washington Street,

Room C256, Indianapolis, Indiana

46204, Telephone: (317) 232–1547.

FOR FURTHER INFORMATION CONTACT:

Andrew R. Gilmore, Director,

Indianapolis Field Office, Telephone:

(317) 226–6700.

SUPPLEMENTARY INFORMATION:

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, 194.15, and 194.15.

II. Description of the Proposed

Amendment

By letter dated May 14, 1998

(Administrative Record No. IND–1606),

Indiana submitted a proposed

amendment to its program pursuant to

SMCRA. Indiana submitted the

proposed amendment at its own

initiative. The amendment pertains to

revisions of and additions to the Indiana

Code (IC) made by House Enrolled Act

(HEA) No. 1074. HEA No. 1074 was

passed through the Indiana Legislature

and signed by the Governor of Indiana

on March 12, 1998. Only those portions

of HEA No. 1074 that pertain to Articles

14–8 and 14–34 are being considered in

this document. The full text of the

proposed program amendment

submitted by Indiana is available for

public inspection at the locations listed

above under ADDRESSES. A discussion of

the proposed amendment is presented

below.

1. IC 14–8–2–117.3, Definition for

‘‘Governmental Entity’’

Indiana proposes the following

definition: ‘‘Governmental entity, for the

purposes of IC 14–22–10–2 and IC 14–

22–10.2.5, has the meaning set forth in

IC 14–22–10–2(a).’’

2. IC 14–34–4–18, Permit Conditions

Indiana identified the existing

provision as subsection (a) and added

the following new provision at

subsection (b):

The director may issue a permit subject to

the condition that the permittee obtain or

maintain in force other licenses or permits

required for the surface coal mining and

reclamation operation. However, the

imposition of a condition under this

subsection does not authorize or require the

director to administer or enforce the

requirements of any federal law or of any

state law other than this article.

3. IC 14–34–5–7, Permit Revisions

The existing provisions in subsections

(a) and (b) were removed and the

following new provisions were added:

(a) A change in mining or reclamation

operations from the approved mining and

reclamation plans that would adversely affect

the permittee’s compliance with this article

is a permit revision subject to review and

approval as provided in this section and

sections 8 through 8.4 of this chapter.

(b) A permit revision is either: (1) A

significant revision subject to sections 8 and

8.1 of this chapter; (2) a nonsignificant

revision subject to sections 8.2 and 8.3 of this

chapter; or (3) a minor field revision subject

to section 8.4 of this chapter.

(c) Permit revisions may be approved by:

(1) The director; or (2) the director’s

designated representative.

(d) A permit revision may not be approved

unless the permittee demonstrates and the

director or the director’s designated

representative finds the following:

(1) That reclamation as required by this

article and by the rules adopted by the

commission under IC 14–34–2–1 can be

accomplished.

(2) That applicable requirements of IC 14–

34–4–7 that are pertinent to the permit

revision are met.

(3) That the permit revision complies with

all applicable requirements of this article and

the rules adopted by the commission under

IC 14–34–2–1.
29366 Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / Proposed Rules

4. IC 14–34–5–8, Permit Revisions

Indiana proposes to remove the

language ‘‘as defined in the rules

adopted under section 6 of this chapter’’

and to add the language ‘‘or minor field

revisions’’ after the phrase ‘‘based only

on nonsignificant revisions.’’

5. IC 14–34–5–8.1, Significant Permit

Revisions

Indiana proposes to add a new section

that defines significant permit revisions.

A proposed revision of a permit is

significant if any of eight conditions

exists. The conditions include: adverse

impacts affecting cultural resources,

blasting operations, water supply,

handling of toxic forming or acid

forming materials, and fish and wildlife;

the addition of a coal processing facility

or a permanent support facility; the

changes will cause a new or an updated

probable hydrologic consequences

determination or cumulative hydrologic

impact analysis; or a postmining land

use will be changed to a residential land

use, a commercial or industrial land

use, a recreational land use, or

developed water resources.

6. IC 14–34–5–8.2, Nonsignificant

Permit Revisions

Indiana proposes to add a new section

that defines nonsignificant permit

revisions. A proposed revision of a

permit is nonsignificant if any of five

conditions exist. The conditions

include: (1) For surface mines, changes

in the direction of mining or location of

mining equipment; (2) substitution of

mining equipment designed for the

same purpose; (3) for underground

mines, any change in the direction or

location of mining within the permit

area or shadow area in response to

unanticipated events; (4) a postmining

land use other than a change described

in section 8.1; or (5) any other change

in the mining or reclamation plan that

will not have a significant effect on

achievement of final reclamation plans,

on subsidence control plans, and on the

surrounding area, that does not involve

significant delay in achieving final

reclamation or significant change in the

land use, or that is necessitated by

unanticipated and unusually adverse

weather conditions, other acts of God,

strikes, or other cause beyond the

reasonable control of the permittee.

7. IC–14–34–5–8.3, Nonsignificant

Permit Revisions

Indiana proposes to require that a

nonsignificant revision in a mining or

reclamation plan must be reviewed and

approved in writing by the director

before it may be implemented.

8. IC 14–34–5–8.4, Minor Field Revisions

Indiana’s proposed new section adds

provisions for approval of minor field

revisions by an inspector in the field.

Subsection (a) defines minor field

revisions as those that do not require

technical review or design analysis and

are capable of being evaluated in the

field by the director’s designated

delegate for compliance with section

14–34–5–7(d). Subsection (b) allows a

minor field revision to be approved by

a field inspector in an inspection report

or on a form signed in the field.

Subsection (c) provides examples of the

types of minor field revisions allowed,

including soil stockpile location and

configuration, as-built pond

certifications, minor transportation

facility changes, pond depth, shape, and

orientation, an area for temporary

drainage control or temporary water

storage, equipment changes, explosive

storage areas, minor mine management

or support facility locations, adding

United States Natural Resources

Conservation Service conservation

practices, methods of erosion protection

on diversions, temporary cessation of

mining, and minor diversion location

changes.

9. IC 14–34–5–8.5, Permit Area

Extensions

Indiana’s proposed statute provides

that an extension of the area covered by

a permit, except for an incidental

boundary revision, must be made by

applying for a new permit.

10. IC–14–34–5–8.6, Incidental

Boundary Revisions

This proposed statute addresses the

requirements for incidental boundary

revisions. Subsection (a) provides that

five conditions must apply before an

extension is considered an incidental

boundary revision: (1) The extension

may not constitute a significant revision

to the method of conduct of mining or

reclamation operations; (2) the

extension must be required for the

orderly and continuous mining and

reclamation operation; (3) the extension

must adjoin the permit or shadow area

acreage; (4) the extended area must be

mined and reclaimed in conformity

with the approved permit plans; and (5)

the area of the extension may not exceed

the lesser of 10 percent of the area

originally covered by the permit or 20

acres.

Subsection (b) requires that the

aggregate of all incidental boundary

revisions of a permit may not exceed the

area originally covered by the permit by

more than 15 percent, unless the

director finds that all other provisions of

this section are met and the interests of

the public are not adversely affected.

Subsection (c) provides that the

aggregate of all incidental boundary

revisions of a permit that involve coal

removal may not exceed the area

originally covered by the permit by

more than 10 percent.

Subsection (d) specifies the

application requirements for incidental

boundary revisions, including size of

the area, pre- and post-mining land

uses, maps, proof of the permittee’s

legal right to enter and conduct surface

coal mining and reclamation operations

on the area, necessary plans, and a

statement pertaining to areas unsuitable

for mining.

Subsection (e) provides that an

application for an incidental boundary

revision may not be approved unless the

applicant demonstrates and the director

finds that reclamation of the area can be

accomplished and that the application

complies with all requirements of

Article 34.

Subsection (f) requires the director to

approve or deny an incidental boundary

revision of a permit within 30 days,

unless the director finds that more than

30 days are needed to adequately review

the application and make the findings

required by subsection (e).

Subsection (g) specifies that section

14–34–5–8.6 does not alter the

requirements for the submission of fees

and bonds.

III. Public Comment Procedures

In accordance with the provisions of

30 CFR 732.17(h), OSM is seeking

comments on whether the proposed

amendment satisfies the applicable

program approval criteria of 30 CFR

732.15. If the amendment is deemed

adequate, it will become part of the

Indiana program.

Written Comments

Written comments should be specific,

pertain only to the issues proposed in

this rulemaking, and include

explanations in support of the

commenter’s recommendations.

Comments received after the time

indicated under DATES or at locations

other than the Indianapolis Field Office

will not necessarily be considered in the

final rulemaking or included in the

Administrative Record.

Public Hearing

Persons wishing to speak at the public

hearing should contact the person listed

under FOR FURTHER INFORMATION

CONTACT by 4:00 p.m., e.s.t. on June 15,

1998. The location and time of the

hearing will be arranged with those

persons requesting the hearing. Any
Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 / Proposed Rules 29367

disabled individual who has need for a

special accommodation to attend a

public hearing should contact the

individual listed under FOR FURTHER

INFORMATION CONTACT. If no one requests

an opportunity to speak at the public

hearing, the hearing will not be held.

Filing of a written statement at the

time of the hearing is requested as it

will greatly assist the transcriber.

Submission of written statements in

advance of the hearing will allow OSM

officials to prepare adequate responses

and appropriate questions.

The public hearing will continue on

the specified date until all persons

scheduled to speak have been heard.

Persons in the audience who have not

been scheduled to speak, and who wish

to do so, will be heard following those

who have been scheduled. The hearing

will end after all persons scheduled to

speak and persons present in the

audience who wish to speak have been

heard.

Public Meeting

If only one person requests an

opportunity to speak at a hearing, a

public meeting, rather than a public

hearing, may be held. Persons wishing

to meet with OSM representatives to

discuss the proposed amendment may

request a meeting by contacting the

person listed under FOR FURTHER

INFORMATION CONTACT. All such meetings

will be open to the public and, if

possible, notices of meetings will be

posted at the location listed under

ADDRESSES. A written summary of each

meeting will be made a part of the

Administrative Record.

IV. 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 3 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 counterpart 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

counterpart Federal regulations.

Unfunded Mandates

OSM has determined and certifies

pursuant to the Unfunded Mandates

Reform Act (2 U.S.C. 1502 et seq.) that

this rule will not impose a cost of $100

million or more in any given year on

local, state, or tribal governments or

private entities.

List of Subjects in 30 CFR Part 914

Intergovernmental relations, Surface

mining, Underground mining.

Dated: May 22, 1998.

Brent Wahlquist,

Regional Director, Mid-Continent Regional

Coordinating Center.

[FR Doc. 98–14272 Filed 5–28–98; 8:45 am]

BILLING CODE 4310–05–M

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

RIN 1018–AE83

50 CFR Part 17

Endangered and Threatened Wildlife

and Plants; Notice of Public Hearings

and Reopening of Comment Period on

Proposed Reclassification From

Endangered to Threatened Status for

the Mariana Fruit Bat From Guam, and

Proposed Threatened Status for the

Mariana Fruit Bat From the

Commonwealth of the Northern

Mariana Islands

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Proposed rule; notice of public

hearing and reopening of comment

period.

SUMMARY: The Fish and Wildlife Service

(Service), pursuant to the Endangered

Species Act of 1973, as amended (Act),

provides notice of two public hearings

on the proposed reclassification from

endangered to threatened status for the

Mariana fruit bat from Guam, and on

proposed threatened status for the

Mariana fruit bat from the

Commonwealth of the Northern Mariana

Islands. In addition, the Service has

reopened the comment period. All

parties are invited to submit comments

on this proposal.

DATES: The comment period now closes

on July 10, 1998. There will be two

public hearings, one each on the islands

of Saipan and Rota. The public hearing

on Saipan will be held from 7:30 p.m.

to 9:00 p.m. on Wednesday, June 24,

1998. The public hearing on Rota will

be held from 7:30 p.m. to 9:00 p.m. on

Thursday, June 25, 1998. Prior to each

of the public hearings, the Service will

be available from 5:00 to 6:30 p.m. to

provide information and to answer

questions.

ADDRESSES: On Saipan, the public

hearing will be held at the Pacific

Gardenia Hotel, Chalan Kanoa Beach

Road. On Rota, the public hearing will

be held at the Rota Resort and Country

Club. Written comments and materials

concerning this proposal may be

submitted at the hearings or sent

directly to Mr. Brooks Harper, Field