4644 Federal Register / Vol. 62, No. 21 / Friday, January 31, 1997 / Rules and Regulations

(if at all), to determine the accuracy,

relevance, and completeness of some

information. This requirement would

inhibit the ability of trained

investigators to exercise professional

judgment in conducting a thorough

investigation. Moreover, fairness to

affected individuals is assured by the

due process they are accorded in any

trial or other proceeding resulting from

the TVA Police investigation.

(j) 5 U.S.C. 552a(e)(8) requires an

agency to make reasonable efforts to

serve notice on an individual when any

record on such individual is made

available under compulsory legal

process when such process becomes a

matter of public record. Compliance

with this provision could prematurely

reveal and compromise an ongoing

criminal investigation to the target of

the investigation and reveal techniques,

procedures, or evidence.

(k) 5 U.S.C. 552a(g) provides for civil

remedies if an agency fails to comply

with the requirements concerning

access to records under subsections (d)

(1) and (3) of the Act; maintenance of

records under subsection (e)(5) of the

Act; and any other provision of the Act,

or any rule promulgated thereunder, in

such a way as to have an adverse effect

on an individual. Allowing civil

lawsuits for alleged Privacy Act

violations by TVA Police would

compromise TVA Police investigations

by subjecting the sensitive and

confidential information in the TVA

Police Records to the possibility of

inappropriate disclosure under the

liberal civil discovery rules. That

discovery may reveal confidential

sources, the identity of informants, and

investigative procedures and

techniques, to the detriment of the

particular criminal investigation as well

as other investigations conducted by the

TVA Police.

The pendency of such a suit would

have a chilling effect on investigations,

given the possibility of discovery of the

contents of the investigative case file,

and a Privacy Act lawsuit could

therefore become a ready strategic

weapon used to impede TVA Police

investigations. Furthermore, since,

under the current regulations, the

system is exempt from many of the Act’s

requirements, it is unnecessary and

contradictory to provide for civil

remedies from violations of those

provisions in particular.

This final rule has been reviewed

under Executive Order No. 12291 and

has been determined not to be a ‘‘major

rule’’ since it will not have an annual

effect on the economy of $100 million

or more.

In addition, it has been determined

that this final rule will not have a

significant economic impact on a

substantial number of small entities.

List of Subjects in 18 CFR Part 1301

Administrative practice and

procedure, Freedom of Information,

Privacy Act, Sunshine Act.

For the reasons set forth in the

preamble, 18 CFR Ch. XIII, part 1301, is

amended as follows:

PART 1301—PROCEDURES

1. The authority citation for part 1301

continues to read as follows:

Authority: 16 U.S.C. 831–831dd, 5 U.S.C.

552.

§ 1301.24 [Amended]

2. Section 1301.24(e) is added to read

as follows:

* * * * *

(e) The TVA system TVA Police

Records is exempt from subsections

(c)(3), (d), (e)(1), (e)(4), (G), (H), and (I)

and (f) of 5 U.S.C. 552a (section 3 of the

Privacy Act) and corresponding sections

of these rules pursuant to 5 U.S.C.

552a(k)(2). The TVA system Police

Records is exempt from subsections

(c)(3), (d), (e)(1), (e)(2), (e)(3), (e)(4)(G),

(H), and (I), (e)(5), (e)(8), and (g)

pursuant to 5 U.S.C. 552a(j)(2). This

system is exempt because application of

these provisions might alert

investigation subjects to the existence or

scope of investigations, lead to

suppression, alteration, fabrication, or

destruction of evidence, disclose

investigative techniques or procedures,

reduce the cooperativeness or safety of

witnesses, or otherwise impair

investigations.

William S. Moore,

Senior Manager, Administrative Services.

[FR Doc. 97–2299 Filed 1–30–97; 8:45 am]

BILLING CODE 8120–08–U

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1311

[DEA Number 146I]

RIN 1117–AA38

Exemption From Import and Export

Requirements for Personal Medical

Use; Interpretation Regarding Effect of

State Law and Federal Laws

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Final rule; interpretation of

existing regulations.

SUMMARY: Current DEA regulations

provide an exemption from certain

provisions of the Controlled Substances

Import Export Act (CSIEA) regarding

personal use quantities of certain

controlled substances. DEA is amending

the language of the exemption to

incorporate an existing provision that

controlled substances for personal use

may be imported only to the extent that

such importation is authorized or

permitted under other Federal laws or

state law. Recent occurrences have

demonstrated that the exemption is

being improperly promoted and used as

a means to import controlled substances

for abuse purposes in violation of other

Federal laws and state law. This action

will prevent misinterpretation of the

circumstances under which the

exemption applies.

EFFECTIVE DATE: January 31, 1997.

FOR FURTHER INFORMATION CONTACT:

G. Thomas Gitchel, Chief, Liaison and

Policy Section, Office of Diversion

Control, Drug Enforcement

Administration, Washington, D.C.

20537, Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: The

CSIEA provides in 21 U.S.C. 956(a) that

the Attorney General may, by

regulation, exempt an individual who

has a controlled substance for personal

medical use from the import/export

requirements of 21 U.S.C. 952–955.

Pursuant to title 21, Code of Federal

Regulations (CFR), 1311.27, individuals

may enter or depart the United States

with a controlled substance in

Schedules II, III, IV, or V, that they have

lawfully obtained for personal medical

use, provided that the controlled

substance is in the original container in

which it was dispensed and the

appropriate declaration is made to the

United States (U.S.) Customs Service.

However, the exemption must be read

within the context of the existing

requirements of 21 CFR 1307.02, which

states that nothing in DEA’s regulations

can be construed as authorizing or

permitting any person to do any act that

is not authorized or permitted under

other Federal or state laws.

DEA, the U.S. Customs Service, and

independent sources have found that

the personal medical use exemption

found in 21 CFR 1311.27 is being

promoted and exploited as a means to

import controlled substances for

purposes of trafficking and abuse.

Especially troubling is the fact that

controlled substances that are not

approved for marketing or distribution

in the United States are being imported

in this manner for trafficking and abuse

purposes in amounts that represent a

danger to the public health and safety.
Federal Register / Vol. 62, No. 21 / Friday, January 31, 1997 / Rules and Regulations 4645

The Internet and the news media

contain numerous references to the

personal use exemption found in

Section 1311.27 as a means to import

drugs from Mexico that are not readily

available here in the United States. The

Internet messages provide advice on

how to use the exemption to obtain

drugs and get them through U.S.

Customs, including one message that

provides specific details on how to act

and what to say regarding the personal

use exemption when bringing the drugs

through U.S. Customs. These messages

are incorrect and misleading because

they do not acknowledge that the

exemption applies only to the extent

that the importation is allowed under

other Federal laws and state law.

DEA is concerned with, and will be

addressing in a separate rulemaking

action, the misuse of the personal use

exemption for the general purpose of

importing controlled substances for

abuse and trafficking purposes.

However, the present concern is the

misconception that Section 1311.27

permits the importation of controlled

substances regardless of prohibitions

that may be found in other Federal or

state laws. A case in point involves

flunitrazepam, which is manufactured

in certain foreign countries under

various brand names, including

Rohypnol. Rohypnol is not approved

under the Federal Food, Drug, and

Cosmetic Act (FDCA) for use in the

United States and the FDCA prohibits

the importation of the drug. Despite

this, large amounts of the drug were

being imported by individuals under the

personal medical use exemption.

DEA has received reports from law

enforcement authorities in numerous

states, including Alabama, Arkansas,

Georgia, Louisiana, Tennessee and

Indiana, regarding the trafficking in and

seizure of flunitrazepam (Rohypnol) that

had originally been imported from

Mexico. DEA itself has engaged in a

significant number of seizures of the

product throughout the country.

As part of its investigation of these

problems, DEA conducted a study of

U.S. Customs drug declaration records

at one border crossing point in Laredo,

Texas. During a three week period in

July of 1995, 1679 declarations for

prescription drugs were filed. Of these,

796, or 47.4%, included Rohypnol. A

total of 101,700 dosage units were

reported on 730 of the declarations; the

remaining 66 declarations did not

specify the number of dosage units. The

daily number of dosage units of

Rohypnol reported ranged from a low of

1680 to a high of 12,930, with an

average of 4843 dosage units reported

per day, or, on an annualized basis,

1,767,695 dosage units per year, at this

one checkpoint. Taking into

consideration the declarations that did

not specify the number of dosage units,

the annual figure could well exceed

1,900,000 dosage units per year. These

figures represent the number of dosage

units per year. These figures represent

the number of dosage units of Rohypnol

reported at just one of the many border

crossings between the United States and

Mexico. A separate study conducted by

another source of the top 15 drugs

declared over a randomly selected 84-

day period at this border crossing, found

that individuals declared a total of

338,760 dosage units of Rohypnol.

As noted earlier, flunitrazepam

(Rohypnol) is not approved for medical

use in the United States. Further, there

is no indication that the manufacturer of

Rohypnol or any other manufacturer of

a product containing flunitrazepam, the

medical community, or any public

interest groups are actively pursuing or

advocating the approval of the drug in

this country. There are other drugs

available that are widely recognized and

used in treating the conditions for

which flunitrazepam might be

considered. There is increasing

evidence of abuse and trafficking of

flunitrazepam into the United States.

There have been at least 2000 seizures

of the drug by law enforcement officials;

a growing number of reports in the

national media regarding its abuse;

reports of its use to facilitate sexual

assaults against unsuspecting victims;

and increasing inquiries from medical

personnel for information regarding the

drug, including its properties, actions,

and treatments.

In light of the exploitation of the

personal medical use exemption from

the requirements of the CSIE as a means

to import unapproved controlled

substances for abuse purposes and the

incorrect and misleading promotion of

the exemption as an easy means to

import drugs, DEA is incorporating into

21 CFR 1311.27 the existing language in

21 CFR 1307.02. This change makes

clear that the personal use exemption

applies only to those importations of

controlled substances that are

authorized or permitted under other

Federal laws or state law. Personal

medical use importations of controlled

substances that are not authorized or

permitted under other Federal laws or

state law are not exempt from the

requirements of the CSIE. Absent

satisfaction of the requirements of the

CSIE, such imports are subject to seizure

by U.S. authorities.

The Deputy Assistant Administrator

of the Office of Diversion Control, Drug

Enforcement Administration has

determined that because this rule

addresses existing regulatory

requirements and does not impose any

new requirements, general notice and

comment are unnecessary pursuant to 5

U.S.C. 553(b). This action emphasizes

DEA’s existing regulatory requirements

to ensure that individuals are not misled

by the language of the regulation into

believing that they may engage in

activities that are inconsistent with

other Federal laws or state law and to

address the incorrect and inappropriate

promotion and exploitation of the

personal medical use exemption as a

means to import otherwise unavailable

controlled substances for abuse

purposes.

The Deputy Assistant Administrator

for the Office of Diversion Control, Drug

Enforcement Administration certifies

that this action will have no significant

impact upon entities whose interests

must be considered under the

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

et seq. This action reiterates existing

regulatory requirements regarding the

personal medical use importation of

controlled substances.

The Office of Management and Budget

(OMB) has determined that this is a

significant regulatory action, therefore,

it has been reviewed by OMB pursuant

to the requirements of Executive Order

12866.

This action has been analyzed in

accordance with the principles and

criteria in E.O. 12612, and it has been

determined that the proposed rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

List of Subjects in 21 CFR Part 1311

Administrative practice and

procedure, Drug traffic control, Exports,

Imports.

For the reasons set out above, 21 CFR

Part 1311 is amended as follows:

PART 1311—[AMENDED]

1. The authority citation for part 1311

continues to read as follows:

Authority: 21 U.S.C. 952, 956, 957, 958,

unless otherwise noted.

2. Section 1311.27 is amended by

revising paragraph (b)(2) and adding a

new paragraph (c) to read as follows:

§ 1311.27 Exemptions for personal

medical use.

* * * * *

(b) * * *

(2) The trade or chemical name and

the symbol designating the schedule of

the controlled substance if it appears on

the container label, or, if such name

does not appear on the label, the name
4646 Federal Register / Vol. 62, No. 21 / Friday, January 31, 1997 / Rules and Regulations

1Alteration does not include razing

(Commissioner of the District of Columbia v.

Bennenson, D.C. Court of App. 1974, 329 A.2d 437).

Partial demolition, however, is viewed as an

alteration (The Committee to Preserve Rhodes

Tavern and the Natl. Processional Route v. Oliver

T. Carr Company, et. al., U.S. Court of App. for D.C.

Cir., 1979, 79–1457, Dept. Justice Brief for Fed.

Appellee).

and address of the pharmacy or

practitioner who dispensed the

substance and the prescription number,

if any; and

(c) The importation of the controlled

substance for personal medical use is

authorized or permitted under other

Federal laws and state law.

Dated: January 2, 1997.

Gene R. Haislip,

Deputy Assistant Administrator, Office of

Diversion Control.

[FR Doc. 97–2352 Filed 1–30–97; 8:45 am]

BILLING CODE 4410–09–M

COMMISSION OF FINE ARTS

45 CFR Parts 2101, 2102, and 2103

Procedures and Policies

AGENCY: The Commission of Fine Arts.

ACTION: Final rule.

SUMMARY: This document amends the

procedures and policies governing the

administration of the U.S. Commission

of Fine Arts. The current wording is

incomplete and has become obsolete or

incorrect in several of its parts. This

document serves to clarify the functions

and requirements of the agency in order

to address more efficiently the needs of

the Federal government and the public.

EFFECTIVE DATE: March 3, 1997.

FOR FURTHER INFORMATION CONTACT:

Charles H. Atherton, Secretary,

(202) 504–2200.

SUPPLEMENTARY INFORMATION: As

established by Congress in 1910, the

Commission of Fine Arts is a small

independent advisory body made up of

seven Presidentially appointed ‘‘well

qualified judges of the arts’’ whose

primary role is architectural review of

designs for buildings, parks, monuments

and memorials erected by the Federal or

District of Columbia governments in

Washington, D.C. In addition to

architectural review, the Commission

considers and advises on the designs for

coins, medals and U.S. memorials on

foreign soil. The Commission also

advises the District of Columbia

government on private building projects

within the Georgetown Historic District,

the Rock Creek Park perimeter and the

Monumental Core area. The

Commission advises Congress, the

President, Federal agencies, and the

District of Columbia government on the

general subjects of design, historic

preservation and on orderly planning on

matters within its jurisdiction.

The regulations revised in this rule

were last published in the Federal

Register on November 21, 1979 (44 FR

67050). Specific items this document

amends include providing the current

address and telephone number of the

agency, publishing formerly omitted

Public Laws for which the agency is

responsible (Heraldic services provided

by the Department of the Army, 10

U.S.C. 4594; Commemorative Works, 40

U.S.C. 1001), clarifying a series of

procedural functions, and in general

correcting ambiguous or grammatically

questionable phraseology. Therefore, as

these changes clarify established

procedures and are minor in nature, the

Commission determines that notice and

comment are unnecessary and that, in

accordance with 5 U.S.C. 553 (b)(B),

good cause to waive notice and

comment is established.

List of Subjects

45 CFR Part 2101

Organization and Functions

(Government agencies).

45 CFR Part 2102

Administrative practice and

procedure, Sunshine Act.

45 CFR Part 2103

Administrative practice and

procedure.

This document was prepared under

the direction of Charles H. Atherton,

Secretary, U.S. Commission of Fine

Arts, 441 F Street, N.W., Suite 312,

Washington, D.C., 20001.

Accordingly, for the reasons set forth

above, Parts 2101, 2102, and 2103 are

amended as set forth below.

Signed at Washington, D.C., this 24th day

of January, 1997.

Charles H. Atherton,

Secretary, U.S. Commission of Fine Arts.

CFA hereby revises 45 CFR Parts

2101, 2102 and 2103 to read as follows:

PART 2101—FUNCTIONS AND

ORGANIZATION

Subpart A—Functions and Responsibilities

of the Commission

Sec.

2101.1 Statutory and Executive Order

authority.

2101.2 Relationships of Commission’s

functions to responsibilities of other

government units.

Subpart B—General Organization

2101.10 The Commission.

2101.11 Secretary to the Commission.

2101.12 Georgetown Board of Architectural

Consultants.

Authority: Pub. L. 81–808, 64 Stat. 903; 10

U.S.C. 4594; 36 U.S.C. 124; 40 U.S.C. 72, 104,

106, 121, 1001; E.O. 1259 of October 25,

1910; E.O. 1862 of November 28, 1913; and

E.O. 3524 of July 28, 1921.

Subpart A—Functions and

Responsibilities of the Commission

§ 2101.1 Statutory and Executive Order

Authority.

The Commission of Fine Arts

(referred to as the ‘‘Commission’’)

functions pursuant to statutes of the

United States and Executive Orders of

Presidents, as follows:

(a) Public buildings, other structures,

and parklands. (1) For public buildings

to be erected in the District of Columbia

by the federal government and for other

structures to be so erected which affect

the appearance of the city, the

Commission comments and advises on

the plans and on the merits of the

designs before final approval or action;

(2) For statues, fountains and

monuments to be erected in the District

of Columbia under authority of the

federal government, the Commission

advises upon their location in public

squares, streets, and parks, and the

merits of their designs;

(3) For monuments to be erected at

any location pursuant to the American

Battle Monuments Act, the Commission

approves the designs before they are

accepted by the American Battle

Monuments Commission (See also

§ 2101.1 (g));

(4) For parks within the District of

Columbia, when plans of importance are

under consideration, the Commission

advises upon the merits of the designs;

and

(5) For the selection by the National

Capital Planning Commission of lands

suitable for development of the National

Capital park, parkway, and playground

system in the District of Columbia,

Maryland, and Virginia, the

Commission provides advice.

(b) Private buildings bordering certain

public areas in Washington, D.C.

(Shipstead-Luce Act). For buildings to

be erected or altered 1 in locations

which border the Capitol, the White

House, the intermediate portion of

Pennsylvania Avenue, the Mall Park

System, Lafayette Park, the Zoological

Park, Rock Creek Park or Parkway, or

Potomac Park or Parkway, or are

otherwise within areas defined by the

official plats prepared pursuant to Sec.

2 of the Shipstead-Luce Act, the

Commission reviews the plans as they

relate to height and appearance, color

and materials of the exteriors, and