17636 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Rules and Regulations

necessary to revise Regulation O in

order to eliminate a requirement that is

superseded by the CDR Act, and to

clarify that member banks may take

advantage of the recent amendment to

section 22(g) of the Federal Reserve Act.

The Board, for good cause, finds that

the notice and public comment

procedure normally required is

impractical, unnecessary, and contrary

to the public interest under 5 U.S.C.

553(b)(B). The Board further finds under

5 U.S.C. 553(d)(1) that the final rule is

a substantive rule that relieves a

restriction on lending and therefore is

making the final rule effective on April

7, 1995, without regard for the 30-day

period provided for in 5 U.S.C. 553(d).

Final Regulatory Flexibility Analysis

The Regulatory Flexibility Act (5

U.S.C. 601 et seq.) requires an agency to

publish a final regulatory flexibility

analysis at the time it promulgates a

final rule. One of the requirements of a

final regulatory flexibility analysis, a

succinct statement of the need for, and

objectives of, the final rule (5 U.S.C.

604(a)(1)), is contained in the

supplementary information above. For

the reasons stated above concerning the

need for public comment, the Board has

not sought public comment on the final

rule, and the Board has not considered

any alternatives to the final rule.

Paperwork Reduction Act

In accordance with the Paperwork

Reduction Act of 1980, 44 U.S.C. 3507,

and 5 CFR 1320.130, the Board, under

authority delegated by the Office of

Management and Budget, has reviewed

its amendments to Regulation O. The

Board has determined that its final rule

imposes no additional reporting or

recordkeeping requirements, and that

there are no relevant federal rules that

duplicate, overlap, or conflict with the

proposed rule. The final rule will apply

to all member banks, regardless of size.

The final rule should not have a

negative economic impact on small

institutions. Instead, the rule should

relieve the regulatory burden on all

member banks.

List of Subjects in 12 CFR Part 215

Credit, Federal Reserve System,

Penalties, Reporting and recordkeeping

requirements.

For the reasons set forth in the

preamble, the Board is amending 12

CFR Part 215, as set forth below:

PART 215—LOANS TO EXECUTIVE

OFFICERS, DIRECTORS, AND

PRINCIPAL SHAREHOLDERS OF

MEMBER BANKS (REGULATION O)

1. The authority citation for part 215

continues to read as follows:

Authority: 12 U.S.C. 248(i), 375a(10),

375b(9) and (10), 1817(k)(3) and

1972(2)(G)(ii); Pub. L. 102–242, 105 Stat.

2236.

2. In § 215.5, paragraph (c)(2)

introductory text is revised to read as

follows:

§ 215.5 Additional restrictions on loans to

executive officers of member banks.

* * * * *

(c) * * *

(2) In any amount to finance or

refinance the purchase, construction,

maintenance, or improvement of a

residence of the executive officer,

provided:

* * * * *

By order of the Board of Governors of the

Federal Reserve System, April 3, 1995.

William W. Wiles,

Secretary of the Board.

[FR Doc. 95–8578 Filed 4–6–95; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA No. 122F]

RIN 1117–AA25

Contents of Records and Reports

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Final rule.

SUMMARY: The interim rule published by

the Deputy Administrator of the Drug

Enforcement Administration (DEA) to

clarify what records shall be adequate to

satisfy recordkeeping requirements for

Listed Chemical transactions under

provisions of the Controlled Substances

Act (CSA) as amended by the Chemical

Diversion and Trafficking Act of 1988

(CDTA) and the Domestic Chemical

Diversion Control Act of 1993 (DCDCA)

is adopted without change. Specifically,

the amendment clarifies that for

prescription drug products, prescription

and hospital records shall be adequate

to satisfy recordkeeping requirements.

In addition, this final rule clarifies that

for the distribution of these products to

hospitals, pharmacies and other entities,

normal business records shall be

considered adequate if they meet the

requirements of 21 CFR 1310.06 (a) and

(b).

EFFECTIVE DATE: April 7, 1995.

FOR FURTHER INFORMATION CONTACT:

Howard McClain Jr., Chief, Drug and

Chemical Evaluation Section, Office of

Diversion Control, Drug Enforcement

Administration, Washington, DC 20537

Telephone (202) 307–7183.

SUPPLEMENTARY INFORMATION: On

October 11, 1994, the Acting

Administrator of the DEA published an

interim rule (59 FR 51364) which

clarified what records shall be adequate

to satisfy recordkeeping requirements

for listed chemical transactions under

provisions of the Controlled Substances

Act (CSA) as amended by the Chemical

Diversion and Trafficking Act of 1988

(CDTA) and the Domestic Chemical

Diversion Control Act of 1993 (DCDCA).

Specifically, this interim rule clarified

that for prescription drug products,

prescription and hospital records kept

in the normal course of medical

treatment are adequate to meet the

recordkeeping requirements for each

record required under 21 CFR 1310.03.

However, the interim notice stated that

reports as specified in 21 CFR 1310.05

and notification requirements as set

forth in 21 CFR 1313 must still be

satisfied for these products. Interested

parties had until November 10, 1994 to

submit comments and objections.

In response to the October 11, 1994

interim rule, one comment was

submitted by Abbott Laboratories. In

this comment Abbott requested that

records for the distribution of

prescription ephedrine injectable

products, which are kept in the normal

course of business, be considered

adequate to satisfy the recordkeeping

requirements, just as prescription and

hospital records kept in the normal

course of medical treatment shall be

considered adequate. Abbott further

stated that normal business records

contain (1) the name and address of

both parties to the transaction; (2) the

date of the regulated transaction; (3) the

name and quantity of the prescription

drug product; (4) the method of transfer;

and (5) an Abbott customer

identification number.

Upon review of Abbott’s comment,

DEA has determined that no further

amendment to the regulations are

required. Existing provisions of 21 CFR

1310.06 (which detail the sufficiency of

records kept in the normal course of

business) are broad enough to enable

businesses to meet the requirements

pertaining to injectable ephedrine

products without any new burden.

Therefore, the interim rule (59 FR
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