Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Rules and Regulations 17637

51364) is herein finalized without

change.

The contents of records required for

regulated transactions are stated in 21

CFR 1310.06. Specifically, 21 CFR

1310.06(a)(5) provides that each record

shall include the type of identification

used by the purchaser and any unique

number on that identification. It is the

responsibility of the regulated person

who engages in a regulated transaction

to identify the other party to the

transaction and verify the existence and

apparent validity of a business entity

ordering a listed chemical in

compliance with 21 CFR 1310.07. If the

assignment of a company customer

identification number is based upon

meeting all requirements as specified in

21 CFR 1310.07, and this customer

identification number can be crossreferenced with the type of

identification used to verify the

existence and apparent validity of the

purchaser and any unique number on

that identification, then a customer

identification number will be deemed

adequate to meet the requirements of 21

CFR 1310.06(a)(5).

Further, 21 CFR 1310.06(b) states that

normal business records shall be

considered adequate if they contain the

information listed in 21 CFR 1310.06(a)

and are readily retrievable from other

business records of the regulated

person. Thus, if these records are

readily retrievable and meet all the

requirements of 21 CFR 1310.06(a) then

these records shall be deemed adequate.

However, it is the responsibility of each

regulated person to ensure that all

requirements of 21 CFR 1310.06 are

adequately met if relying on normal

business records to satisfy the

recordkeeping requirements of 21 CFR

1310.03.

The products in question are

prescription products which are already

subject to strict Federal and state

controls. This final rule modifies 21

CFR 1310.06(b) to reflect that for

purposes of this section, prescription

and hospital records kept in the normal

course of medical treatment shall be

adequate to meet recordkeeping

requirements.

This rule has been drafted and

reviewed in accordance with Executive

Order 12866, Section 1(b), Principles of

Regulation. The Deputy Administrator

has determined that this rule is not a

significant regulatory action under

Executive Order 12866 Section 3(f),

Regulatory Planning and Review. This

action allows relief from regulatory

requirements by permitting the use of

normal business records for these

prescription products rather than

requiring the creation of separate

records of transactions. Accordingly,

this rule has not been reviewed by the

Office of Management and Budget.

The Deputy Administrator in

accordance with the Regulatory

Flexibility Act (5 U.S.C. 605(b)), has

reviewed this regulation and by

approving it certifies that this regulation

will not have a significant economic

impact on a substantial number of small

entities.

This action has been analyzed in

accordance with the principles and

criteria in Executive Order 12612, and it

has been determined that the rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

List of Subjects in 21 CFR Part 1310

Drug traffic control, Reporting and

recordkeeping requirements.

PART 1310—RECORDS AND

REPORTS OF LISTED CHEMICALS

AND CERTAIN MACHINES

Accordingly, the interim rule

amending 21 CFR part 1310 which was

published at 59 FR 51364 on October

11, 1994, is adopted as a final rule

without change.

Dated: March 20, 1995.

Stephen H. Greene,

Deputy Administrator, Drug Enforcement

Administration.

[FR Doc. 95–8592 Filed 4–6–95; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 914

[IN–121; Amendment 94–7]

Indiana 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 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 the Indiana Surface Coal

Mining rules pertaining to the

backfilling and grading of surface coal

mining and reclamation operations. The

amendment is intended to provide

additional safeguards and clarify

ambiguities.

EFFECTIVE DATE: April 7, 1995.

FOR FURTHER INFORMATION CONTACT:

Roger W. Calhoun, Director,

Indianapolis Field Office, OSM, MintonCapehart Federal Building, Room 301,

Indianapolis, Indiana 46204. Telephone:

(317) 232–1547.

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 29, 1982, Federal Register (47

FR 32071). Subsequent actions

concerning 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 January 31, 1995,

(Administrative Record No. IND–1420)

Indiana submitted a proposed

amendment to its program pursuant to

SMCRA at its own initiative. Indiana

proposed to revise 310 IAC 12–5–54.1—

Surface Mining: Backfilling and

Grading, Timing Limitations.

OSM announced receipt of the

proposed amendment in the February

17, 1995, Federal Register (60 FR 9313),

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

March 20, 1995.

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, or revised cross-references and

paragraph notations to reflect

organizational changes resulting from

this amendment.

310 IAC 12–5–54.1—Surface Mining:

Backfilling and Grading, Timing

Limitations

Indiana is revising subsection (a) to

make several nonsubstantive wording

changes. At subsection (a)(1), Indiana is

requiring that backfilling and grading in
17638 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Rules and Regulations

mining operations that involve spoil

ridges be accomplished in 180 days of

deposition, provided that no more than

four spoil ridges remain at any one time.

The current regulations specify that no

more than an average of four spoil

ridges by length remain.

Indiana is revising subsection (b) to

make two nonsubstantive wording

changes and to correct a cross-reference.

Indiana is revising subsection (c) to

make two nonsubstantive wording

changes and to delete the requirement

that requests for an extension of the

timing limitation for more than one year

be approved by the Natural Resources

Commission.

The corresponding Federal

regulations at 30 CFR 816.101 were

suspended effective August 31, 1992 (57

FR 33875). Therefore, States may adopt

backfilling and grading time and

distance standards which result in

contemporaneous mining and

reclamation as required by 30 CFR

816.100. The Director finds the

proposed revisions at 310 IAC 12–5–

54.1 no less effective than the Federal

requirements for contemporaneous

reclamation at 30 CFR 816.100 and

817.100.

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 public 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 interests in the Indiana

program. No comments 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 Indiana

proposed to make in this amendment

pertain to air or water quality standards.

Therefore, OSM did not request EPA’s

concurrence.

V. Director’s Decision

Based on the above finding, the

Director approves the proposed

amendment as submitted by Indiana on

January 31, 1995.

The Federal regulations at 30 CFR

part 914, codifying decisions concerning

the Indiana 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.

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 12778

The Department of the Interior has

conducted the reviews required by

section 2 of Executive Order 12778

(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.

List of Subjects in 30 CFR 914

Intergovernmental relations, Surface

mining, Underground mining.

Dated: March 30, 1995.

David G. Simpson,

Acting Assistant Director, Eastern Support

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 914—INDIANA

1. The authority citation for part 914

continues to read as follows:

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

2. Section 914.15 is amended by

adding paragraph (hhh) to read as

follows:

§ 914.15 Approval of regulatory program

amendments.

* * * * *

(hhh) The following amendment

(Program Amendment Number 94–7) as

submitted to OSM on January 31, 1995

is approved effective April 7, 1995: 310

IAC 12–5–54.1 concerning timing

limitations for backfilling and grading of

surface coal mining and reclamation

operations.

[FR Doc. 95–8583 Filed 4–6–95; 8:45 am]

BILLING CODE 4310–05–M