Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Proposed Rules 38765

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 341 be amended as follows:

PART 341—COLD, COUGH, ALLERGY,

BRONCHODILATOR, AND

ANTIASTHMATIC DRUG PRODUCTS

FOR OVER–THE–COUNTER HUMAN

USE

1. The authority citation for 21 CFR

part 341 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 353,

355, 360, 371.

2. Section 341.74 is amended by

adding paragraphs (c)(5)(iii), (c)(5)(iv),

and (c)(5)(v), and revising paragraphs

(d)(2)(i), (d)(2)(ii), (d)(2)(iv), and

(d)(2)(v) to read as follows:

§ 341.74 Labeling of antitussive drug

products.

* * * * *

(c) * * *

(5) * * *

(iii) For any product containing

camphor or menthol in a suitable

ointment vehicle or for steam inhalation

use.—(A) The labeling should contain

an appropriate flammability signal

word, e.g., ‘‘extremely flammable,’’

‘‘flammable,’’ ‘‘combustible,’’ consistent

with 16 CFR 1500.3(b)(10).

(B) ‘‘Keep away from fire or flame.’’

(iv) For any product formulated in a

volatile vehicle. ‘‘Cap container tightly

and store at room temperature away

from heat.’’

(v) For any product with labeling that

contains warnings, the following

information shall appear after the

subheader ‘‘Do Not Use’’.—(A) ‘‘Near an

open flame.’’

(B) ‘‘By adding to hot water.’’

(C) ‘‘In a microwave oven.’’

(D) ‘‘In a container in which water is

being heated, except when adding to

cold water in only a hot steam

vaporizer.’’

(d) * * *

(2) * * *

(i) For products containing camphor

identified in § 341.14(b)(1) in a suitable

ointment vehicle. The product contains

4.7 to 5.3 percent camphor. Adults and

children 2 to under 12 years of age: Rub

on the throat and chest in a thick layer.

Cover with a warm, dry cloth if desired.

However, clothing should be loose

about throat and chest to help vapors

reach the nose and mouth. Use up to

three times daily or as directed by a

doctor. Children under 2 years of age:

Consult a doctor. ‘‘See important

warnings about not using near a flame,

in hot water, or in a microwave oven.

Improper use may cause the mixture to

splatter and cause burns.’’ (Last two

sentences to be highlighted in bold type

or contrasting color.)

(ii) For products containing menthol

identified in § 341.14(b)(2) in a suitable

ointment vehicle. The product contains

2.6 to 2.8 percent menthol. Adults and

children 2 to under 12 years of age: Rub

on the throat and chest in a thick layer.

Cover with a warm, dry cloth if desired.

However, clothing should be loose

about throat and chest to help vapors

reach the nose and mouth. Use up to

three times daily or as directed by a

doctor. Children under 2 years of age:

Consult a doctor. ‘‘See important

warnings about not using near a flame,

in hot water, or in a microwave oven.

Improper use may cause the mixture to

splatter and cause burns.’’ (Last two

sentences to be highlighted in bold type

or contrasting color.)

* * * * *

(iv) For products containing camphor

identified in § 341.14(b)(1) for steam

inhalation use. The product contains 6.2

percent camphor. Adults and children 2

to under 12 years of age: Add 1

tablespoonful of solution, for each quart

of water, or add 11⁄2 teaspoonsful of

solution, for each pint of water, directly

to cold water in only a hot steam

vaporizer. Breathe in the medicated

vapors. Use up to three times daily or

as directed by a doctor. Children under

2 years of age: Consult a doctor. ‘‘See

important warnings about not using

near a flame, in hot water, or in a

microwave oven. Improper use may

cause the mixture to splatter and cause

burns.’’ (Last two sentences to be

highlighted in bold type or contrasting

color.)

(v) For products containing menthol

identified in § 341.14(b)(2) for steam

inhalation use. The product contains 3.2

percent menthol. Adults and children 2

to under 12 years of age: Add 1

tablespoonful of solution, for each quart

of water, or add 11⁄2 teaspoonsful of

solution, for each pint of water, directly

to cold water in only a hot steam

vaporizer. Breathe in the medicated

vapors. Use up to three times daily or

as directed by a doctor. Children under

2 years of age: Consult a doctor. ‘‘See

important warnings about not using

near a flame, in hot water, or in a

microwave oven. Improper use may

cause the mixture to splatter and cause

burns.’’ (Last two sentences to be

highlighted in bold type or contrasting

color.)

Dated: July 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19239 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

28 CFR Part 23

[OJP (BJA)–1177]

RIN 1121–ZB14

Criminal Intelligence Sharing Systems;

Policy Clarification

AGENCY: Bureau of Justice Assistance

(BJA), Office of Justice Programs (OJP),

Justice.

ACTION: Proposed clarification of policy.

SUMMARY: The current policy governing

the entry of identifying information into

criminal intelligence sharing systems

requires clarification. This policy

clarification is to make clear that the

entry of individuals, entities and

organizations, and locations that do not

otherwise meet the requirements of

reasonable suspicion is appropriate

when it is done solely for the purposes

of criminal identification or is germane

to the criminal subject’s criminal

activity. Further, the definition of

‘‘criminal intelligence system’’ is

clarified. While this clarification is not

a rulemaking for the purposes of the

Administrative Procedure Act, 5 U.S.C.

553, BJA is of the opinion that this

clarification is significant enough to

warrant public comment.

DATES: Public comment is due by

September 18, 1998. Comments may be

faxed to (202) 307–1419, e-mailed to

‘‘fisheral@ojp.usdoj.gov,’’ or mailed to

the Office of the General Counsel, 810

7th Street NW, Washington, DC, 20531.

FOR FURTHER INFORMATION CONTACT: Paul

Kendall, General Counsel, Office of

Justice Programs, 810 7th Street NW,

Washington, DC 20531, (202) 307–6235.

SUPPLEMENTARY INFORMATION: The

operation of criminal intelligence

information systems is governed by 28

CFR Part 23. This regulation was written

to both protect the privacy rights of

individuals and to encourage and

expedite the exchange of criminal

intelligence information between and

among law enforcement agencies of

different jurisdictions. Frequent

interpretations of the regulation, in the

form of policy guidance and

correspondence, have been the primary

method of ensuring that advances in

technology did not hamper its

effectiveness.
38766 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Proposed Rules

Use of Identifying Information

28 CFR 23.3(b)(3) states that criminal

intelligence information that can be put

into a criminal intelligence sharing

system is ‘‘information relevant to the

identification of and the criminal

activity engaged in by an individual

who or organization which is reasonably

suspected of involvement in criminal

activity, and * * * [m]eets criminal

intelligence system submission

criteria.’’ Further, 28 CFR 23.20(a) states

that a system shall only collect

information on an individual if ‘‘there is

reasonable suspicion that the individual

is involved in criminal conduct or

activity and the information is relevant

to that criminal conduct or activity.’’ 28

CFR 23.20(b) extends that limitation to

collecting information on groups and

corporate entities.

In an effort to protect individuals and

organizations from the possible taint of

having their names in intelligence

systems (as defined at 28 CFR

§ 23.3(b)(1)), the Office of Justice

Programs has previously interpreted this

section to allow information to be

placed in a system only if that

information independently meets the

requirements of the regulation.

Information that might be vital to

identifying potential criminals, such as

favored locations and companions, or

names of family members, has been

excluded from the systems. This policy

has hampered the effectiveness of many

criminal intelligence sharing systems.

Given the swiftly changing nature of

modern technology and the expansion

of the size and complexity of criminal

organizations, the Bureau of Justice

Assistance (BJA) has determined that it

is necessary to clarify this element of 28

CFR Part 23. Many criminal intelligence

databases are now employing

‘‘Comment’’ or ‘‘Modus Operandi’’

fields whose value would be greatly

enhanced by the ability to store more

detailed and wide-ranging identifying

information. This may include names

and limited data about people and

organizations that are not suspected of

any criminal activity or involvement,

but merely aid in the identification and

investigation of a criminal suspect who

independently satisfies the reasonable

suspicion standard.

Therefore, BJA issues the following

clarification to the rules applying to the

use of identifying information.

Information that is relevant to the

identification of a criminal suspect or to

the criminal activity in which the

suspect is engaged may be placed in a

criminal intelligence database, provided

that (1) appropriate disclaimers

accompany the information noting that

is strictly identifying information,

carrying no criminal connotations; (2)

the identifying information may not be

used as an independent basis to target

a subject for investigation or to establish

reasonable suspicion of involvement in

criminal activity; and (3) the individual

who is the criminal suspect identified

by this information otherwise meets all

requirements of 28 CFR Part 23. This

information may be a searchable field in

the intelligence system.

For example: A person reasonably

suspected of being a drug dealer is

known to conduct his criminal activities

at the fictional ‘‘Northwest Market.’’ An

agency may wish to note this

information in a criminal intelligence

database, as it may be important to

future identification of the suspect.

Under the previous interpretation of the

regulation, the entry of ‘‘Northwest

Market’’ would not be permitted,

because there was no reasonable

suspicion that the ‘‘Northwest Market’’

was a criminal organization. Given the

current clarification of the regulation,

this will be permissible, provided that

the information regarding the

‘‘Northwest Market’’ was clearly noted

to be non-criminal in nature. For

example, the data field that ‘‘Northwest

Market’’ was entered in could be

marked ‘‘Non-Criminal Identifying

Information,’’ or the words ‘‘Northwest

Market’’ could be followed by a

parenthetical comment such as ‘‘This

organization has been entered into the

system for identification purposes

only—it is not suspected of any criminal

activity or involvement.’’ ‘‘Northwest

Market’’ could not become the target of

an investigation solely on the basis of

the information provided in the

comment field on the suspected drug

dealer. Independent information would

have to be obtained as a basis for the

opening of an investigative file or the

submission of intelligence information,

based on reasonable suspicion, on

‘‘Northwest Market.’’ Further, the fact

that other individuals frequent

‘‘Northwest Market’’ would not provide

a reasonable suspicion determination

for those other individuals.

The Definition of a ‘‘Criminal

Intelligence System’’

The definition of a ‘‘criminal

intelligence system’’ is given in 28 CFR

23.3(b)(1) as the ‘‘arrangements,

equipment, facilities, and procedures

used for the receipt, storage, interagency

exchange or dissemination, and analysis

of criminal intelligence information . . .

.’’ Given the fact that cross-database

searching techniques are now commonplace, and given the fact that multiple

databases may be contained on the same

computer system, BJA has determined

that this definition needs clarification,

specifically to differentiate between

criminal intelligence systems and nonintelligence systems.

The comments to the 1993 revision of

28 CFR Part 23 noted that ‘‘[t]he term

‘intelligence system’ is redefined to

clarify the fact that historical telephone

toll files, analytical information, and

work products that are not either

retained, stored, or exchanged and

criminal history record information or

identification (fingerprint) systems are

excluded from the definition, and hence

are not covered by the regulation

* * *.’’ 58 FR 48448–48449 (Sept. 16,

1993.) The comments further noted that

materials that ‘‘may assist an agency to

produce investigative or other

information for an intelligence system

* * *’’ do not necessarily fall under the

regulation. Id.

The above rationale for the exclusion

of non-intelligence information sources

from the definition of ‘‘criminal

intelligence system,’’ suggests now that,

given the availability of more modern

non-intelligence information sources

such as the Internet, newspapers, motor

vehicle administration records, and

other public record information on-line,

such sources shall not be considered

part of criminal intelligence systems,

and shall not be covered by this

regulation, even if criminal intelligence

systems access such sources during

searches on criminal suspects.

Therefore, criminal intelligence systems

may conduct searches across the

spectrum of non-intelligence systems

without those systems being brought

under 28 CFR Part 23. There is also no

limitation on such non-intelligence

information being stored on the same

computer system as criminal

intelligence information, provided that

sufficient precautions are in place to

separate the two types of information

and to make it clear to operators and

users of the information that two

different types of information are being

accessed. Such precautions should be

consistent with the above clarification

of the rule governing the use of

identifying information. This could be

accomplished, for example, through the

use of multiple windows, differing

colors of data or clear labeling of the

nature of information displayed.

Additional guidelines will be issued

to provide details of the above

clarifications as needed.

Richard H. Ward, III,

Director, Bureau of Justice Assistance.

[FR Doc. 98–19092 Filed 7–17–98; 8:45 am]

BILLING CODE 4410–18–P