38762 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Proposed Rules

Proposed Rule

Accordingly, as set forth in the

preamble, the Federal Crop Insurance

Corporation, proposes to amend 7 CFR

part 457 as follows:

PART 457—COMMON CROP

INSURANCE REGULATIONS;

REGULATIONS FOR THE 1998 AND

SUBSEQUENT CONTRACT YEARS

1. The authority citation for 7 CFR

part 457 continues to read as follows:

Authority: 7 U.S.C. 1506(l), 1506(p).

2. In § 457.128 revise section 10(b)(7)

to read as follows:

§ 457.128 Guaranteed Production Plan of

Fresh Market Tomato Crop Insurance

Provisions.

10. Insurance Period.

* * * * *

(b) * * *

(7) October 15 of the crop year in

Delaware, Maryland, New Jersey, North

Carolina, and Virginia; October 31 of the

crop year in California; November 10 of

the crop year in Florida, Georgia, and

South Carolina; and September 20 of the

crop year in all other states.

Signed in Washington, DC, on July 13,

1998.

Kenneth D. Ackerman,

Manager, Federal Crop Insurance

Corporation.

[FR Doc. 98–19245 Filed 7–17–98; 8:45 am]

BILLING CODE 3410–08–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 341

[Docket No. 76N–052T]

RIN 0910–AA01

Cold, Cough, Allergy, Bronchodilator,

and Antiasthmatic Drug Products for

Over-the-Counter Human Use;

Proposed Amendment of Final

Monograph for OTC Antitussive Drug

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a notice

of proposed rulemaking that would

amend the final monograph for over-thecounter (OTC) antitussive drug products

(drug products that relieve cough) to

revise the labeling warnings and

directions for topical/inhalant products

containing the active ingredients

camphor and/or menthol. New

information indicates that use of these

drug products near an open flame, in

hot water, or in a microwave oven can

cause the products to catch on fire and

cause serious burns to the user.

Therefore, the agency is proposing

warnings and directions for safer use of

these drug products by informing

consumers not to expose the products to

flame, hot water, or a microwave oven.

This proposal is part of the ongoing

review of OTC drug products conducted

by FDA.

DATES: Submit written comments by

October 19, 1998; written comments on

the agency’s economic impact

determination by October 19, 1998. FDA

is proposing that any final rule that may

issue based on this proposal become

effective 12 months after its date of

publication in the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Elizabeth A. Ryland, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

9, 1976 (41 FR 38312 at 38343), the

Advisory Review Panel on OTC Cold,

Cough, Allergy, Bronchodilator, and

Antiasthmatic Drug Products (the Panel)

recommended that the single

ingredients camphor and menthol for

topical/inhalant antitussive use be

classified in Category III (available data

are insufficient to classify as safe and

effective, and further testing is

required). The Panel based its

recommendations on a lack of

effectiveness data, but determined that

these products are safe (41 FR 38312 at

38344 and 38349 to 38352). The Panel

was not aware of and did not discuss

any information concerning possible

safety hazards occurring when these

products are placed near a flame, into

containers of hot water, or in a

microwave oven. The Panel

recommended the following directions

for topical/inhalant use for camphor and

menthol:

* * * 1 tablespoonful of solution per quart

of water is added directly to the water in a

hot steam vaporizer, bowl, or washbasin; or

2 teaspoonfuls of solution per pint of water

are added to an open container of boiling

water. Breathe in vapors during the period of

medicated steam generation. May be repeated

3 times daily.

In the final monograph for OTC

antitussive drug products (52 FR 30042

at 30045 to 30046, August 12, 1987), the

agency provided the following

directions in § 341.74(d)(2)(i) and

(d)(2)(ii) (21 CFR 341.74(d)(2)(i) and

(d)(2)(ii)) for products containing the

single ingredient camphor or menthol

for ointment vehicle use based on

additional clinical studies that

supported effectiveness:

* * * Adults and children 2 to under 12

years of age: Rub on the throat and chest as

a thick layer. The area of application may be

covered with a warm, dry cloth if desired.

However, clothing should be left loose about

the throat and chest to help the vapors rise

to reach the nose and mouth. Applications

may be repeated up to three times daily or

as directed by a doctor. Children under 2

years of age: consult a doctor.

For products containing the single

ingredient camphor or menthol for

steam inhalation use, the agency

provided the following directions in

§ 341.74(d)(2)(iv) and (d)(2)(v), based on

additional clinical studies that

supported effectiveness:

* * * Adults and children 2 to under 12

years of age: Add 1 tablespoonful of solution,

for each quart of water, directly to the water

in a hot steam vaporizer, bowl, or wash

basin; or add 11⁄2 teaspoonsful of solution, for

each pint of water, to an open container of

boiling water. Breathe in the medicated

vapors. May be repeated up to three times

daily or as directed by a doctor. Children

under 2 years of age: consult a doctor.

When the final monograph was

published, the agency was not aware of

safety problems occurring when

products containing camphor and/or

menthol are added to hot water. Since

that time, the agency has received new

information (Refs. 1, 2, and 3) that

indicates that the current warnings and

directions may not be adequate and that

safety concerns (e.g., burns caused by

flashing) could arise if these products

are heated near an open flame, in a

container of hot water, or in a

microwave oven. From 1983 to mid1997, 34 fire-related events from usage

of antitussive drug products containing

camphor and menthol were reported

(Refs. 2 and 3). Twenty-one fire-related

events concerned a combination of

camphor and menthol in an ointment

vehicle. This product when added to

hot water in a container on the stove, or

when added to water and heated in a

microwave oven, caused flashing and

severe burns. One of the 21 events

involved adding the product to hot

water in a vaporizer. An additional 11

events concerned heating products that

were combinations of camphor and

menthol in an alcohol-based solution.

These products, like the products in the

ointment vehicles, also caused flashing

and burns when placed in hot water or
Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Proposed Rules 38763

heated in a microwave oven. For

example, a product flashed from the top

of its container when it was opened

close to the gas stove where water had

been heated, but the gas flame had been

extinguished. In still another fire-related

event (the 33d event), the alcohol-based

solution product was poured over lava

rocks in a sauna. The product ignited,

caught the consumer’s bathrobe on fire,

and caused burns over 65 percent of her

body. The last reported fire-related

event involved the ointment product

and the alcohol-based product added to

water and heated together resulting in

flashing and burns. No fire-related

events were reported when these

products were added to cold water in a

hot steam vaporizer and then heated.

In all 34 reported events, flashing

occurred; in 5 events, the flashing

caused first and second degree burns to

the face, eyes, chest, shoulders, arms,

and/or hands. In some instances, these

burns may have caused permanent

scarring or reduced vision. Some

consumers treated themselves at home

and others went to a physician’s office,

a clinic, a medical center, or an

emergency room for treatment. One case

required hospitalization.

References

(1) Food and Drug Administration Drug

Product Reporting System, dated May 31,

1995, in OTC Vol. 04TFMA, Docket No. 76N–

052T, Dockets Management Branch.

(2) MEDWATCH: Adverse Event Reports

dated 1983 to 1995 in OTC Vol. 04TFMA,

Docket No. 76N–052T, Dockets Management

Branch.

(3) MEDWATCH: Adverse Event Reports

dated 1995 to 1997 in OTC Vol. 04TFMA,

Docket No. 76N–052T, Dockets Management

Branch.

II. The Agency’s Tentative Conclusions

and Proposal

The agency tentatively concludes that

the case reports raise safety concerns

that could be alleviated by providing

consumers with additional warnings

and directions for topical/inhalant OTC

antitussive drug products that contain

camphor and/or menthol. The agency

also notes that the labeling on one

manufacturer’s currently marketed

products (containing camphor and

menthol) (Ref. 3) is similar to the

labeling proposed in this document. The

agency believes that consumers need to

be informed not to expose these

products to flame or a microwave oven,

not to place the products in any

container in which water is being

heated, and to add to cool water when

using a hot steam vaporizer.

Accordingly, the agency is proposing to

amend the final monograph for OTC

antitussive drug products to expand the

warnings against possible flammability

or combustibility and a precaution to

keep them away from fire or flame.

Labeling may also tell consumers to

close caps tightly and store containers at

room temperature away from heat.

The following information shall

appear on any labeling that contains

warnings and shall appear after the

subheader ‘‘Do Not Use:’’ ‘‘near an open

flame’’, ‘‘by adding to hot water’’, ‘‘in a

microwave oven’’, or ‘‘in a container in

which water is being heated, except

when adding to cold water in only a hot

steam vaporizer’’.

Additionally, the agency is proposing

to amend the final monograph for OTC

antitussive drug products to shorten and

simplify the directions in

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

(d)(2)(v) for products containing

camphor or menthol for topical/

inhalation use. Further, the agency is

proposing to add the following

statements at the end of the directions:

‘‘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 boldface type or

contrasting color.)

The agency is also proposing to add

an additional revision to the directions

in § 341.74(d)(2)(iv) and (d)(2)(v) for

products containing camphor or

menthol for steam inhalation. The

proposed revised directions inform

users to add the solution directly to cold

water in only a hot steam vaporizer. All

suggestions to use the product in any

other container have been deleted. This

part of the proposed revised directions

reads as follows:

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.

The agency is inviting comment on

the specific wording of these warnings

and directions, and the best way to

convey this information to persons

using these drug products.

III. Effective Date

The agency is proposing that these

new warnings and directions become

effective 12 months after the date of

publication of a final rule in the Federal

Register. The agency believes that the

12-month effective date is needed

because this period of implementation

would allow many manufacturers to

coordinate this change with routinely

scheduled label printing and/or

revisions as well as the new OTC drug

product labeling format proposed in the

Federal Register of February 27, 1997

(62 FR 9024). The agency encourages

manufacturers of OTC antitussive drug

products to voluntarily implement this

labeling as of the date of publication of

this proposal because of the potential

for safety problems. Manufacturers,

however, should be aware of the

possibility that FDA may change the

wording of the warnings and/or

directions as a result of comments filed

in response to this proposal. Because

FDA is encouraging that the proposed

warnings and directions be used on a

voluntary basis at this time, the agency

advises that manufacturers will be given

ample time after publication of a final

rule to use up any labeling implemented

in conformance with this proposal.

IV. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612). Executive Order

12866 directs agencies to assess all costs

and benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). Under the

Regulatory Flexibility Act, if a rule has

a significant economic impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

economic impact of a rule on small

entities.

Title II of the Unfunded Mandates

Reform Act (2 U.S.C. 1501 et seq.)

requires that agencies prepare a written

statement and economic analysis before

proposing any rule that may result in

the expenditure in any 1 year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million (adjusted annually for

inflation).

The agency believes that this

proposed rule is consistent with the

principles set out in the Executive Order

and in these two statutes. The purpose

of this proposed rule is to revise and

improve the labeling (add additional

warning and direction statements) for

topical/inhalant products that contain

camphor, menthol, or both ingredients.

This revised labeling addresses the

flammability of these products when

used near an open flame, in hot water,

or in a microwave oven, and is intended

to provide consumers additional

information to help ensure safer use of

these products. Potential benefits

include reduction in the number of flash
38764 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Proposed Rules

fires and serious burns when consumers

use these products.

This proposed rule would amend the

final monograph for OTC antitussive

drug products and would require some

relabeling for topical/inhalant products

that contain camphor, menthol, or both

ingredients. The agency’s Drug Listing

System identifies approximately 30

manufacturers and 79 marketers of over

100 stock keeping units (SKU)

(individual products, packages, and

sizes) of topical/inhalant antitussive

drug products containing camphor,

menthol, or both ingredients. There may

be a few additional marketers and

products that are not identified in the

sources FDA reviewed.

The agency estimates that relabeling

costs of the type that would be required

by this proposal generally average about

$2,000 to $3,000 per SKU. Assuming

that there are about 110 affected OTC

SKU’s in the marketplace, total one-time

costs of relabeling would be $220,000 to

$330,000. The agency believes that

actual costs would be lower for several

reasons. First, most of the label changes

will be made by private label

manufacturers that tend to use relatively

simple and less expensive labeling.

Second, the agency is proposing a 12-

month implementation period that

would allow many manufacturers to

coordinate this change with routinely

scheduled label printing and/or

revisions. Similarly, labeling changes

for these products would not be

required until the monograph

amendment is issued and becomes

effective. Thus, manufacturers would

have time to use up existing labeling

stocks and the relabeling costs would be

mitigated. Third, manufacturers may be

able to implement the new labeling

required by this proposal at the same

time that they implement the new

labeling format proposed for OTC drug

products (62 FR 9024). Thus, the

relabeling costs resulting from two

different but related final rules may be

individually reduced by implementing

both required changes at the same time.

The agency considered but rejected a

shorter implementation period. While

the agency would like to have this new

labeling in place as soon as possible, it

considers a period less than 12 months

difficult for some manufacturers to

implement all of the labeling that would

be required by this proposal.

The proposed rule would not require

any new reporting and recordkeeping

activities. Therefore, no additional

professional skills are needed. There are

no other Federal rules that duplicate,

overlap, or conflict with the proposed

rule. The agency does not believe that

there are any significant alternatives to

the proposed rule that would reduce the

economic impact of the rule on small

entities and would still adequately

provide for the safe and effective OTC

use of antitussive topical/inhalant drug

products that contain camphor,

menthol, or both ingredients. For

example, the agency considered a longer

implementation period but concluded

that the marginal reduction in costs

associated with an implementation

period greater than 12 months could not

be justified in light of the additional

injuries that would likely occur. The

agency also considered but rejected

more permissive warning language but

concluded that such language would not

adequately reduce the number of

adverse events and accidents.

Based on current information, the

agency does not believe that this

proposed rule will have a significant

economic impact on a substantial

number of small entities, using the U.S.

Small Business Administration

designations for this industry (750

employees). As discussed above, FDA is

aware of only 30 manufacturers affected

by this rule, most of which are assumed

to be small for the purposes of this

analysis. In addition, the agency

believes that any other unidentified

manufacturer of these products is also

likely to be a small entity. From

information available to the agency, it

appears that only one small entity

manufactures more than three SKU’s of

these products. Based on the limited

number of SKU’s each manufacturer has

to relabel, the cost for each

manufacturer except one should be

minimal.

The analysis shows that this proposed

rule is not economically significant

under Executive Order 12866 and that

the agency has made an effort to reduce

the burden to small entities. In addition,

this economic analysis, together with

other relevant sections of this

document, serves as the agency’s initial

regulatory flexibility analysis, as

required under the Regulatory

Flexibility Act. Finally, this analysis

shows that the Unfunded Mandates Act

does not apply to the proposed

amendment because it would not result

in an expenditure in any 1 year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million.

The agency invites public comment

regarding any substantial or significant

economic impact that this rulemaking

would have on manufacturers of OTC

antitussive topical/inhalant drug

products that contain camphor,

menthol, or both ingredients. Comments

regarding the impact of this rulemaking

on such manufacturers should be

accompanied by appropriate

documentation. The agency is providing

a period of 90 days from the date of

publication of this proposed rulemaking

in the Federal Register for comments to

be developed and submitted. The

agency will evaluate any comments and

supporting data that are received and

will reassess the economic impact of

this rulemaking in the preamble to the

final rule.

In the Federal Register of February

27, 1997 (62 FR 9024), FDA proposed to

establish a standardized format for the

labeling of OTC drug products. When

the agency finalizes the February 27,

1997, labeling rule, the agency will also

amend the final version of this proposed

rule, as needed, to conform to the final

labeling rule.

V. Paperwork Reduction Act of 1995

FDA tentatively concludes that the

labeling requirements proposed in this

document are not subject to review by

the Office of Management and Budget

because they do not constitute a

‘‘collection of information’’ under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq). Rather, the

proposed labeling requirements are a

‘‘public disclosure of information

originally supplied by the Federal

Government to the recipient for the

purpose of disclosure to the public’’ (5

CFR 1320.3(c)(2)).

VI. Environmental Impact

The agency has determined under 21

CFR 25.24(c)(6) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VII. Request for Comment

Interested persons may, on or before

October 19, 1998, submit written

comments to the Dockets Management

Branch (address above). Written

comments on the agency’s economic

impact determination may be submitted

on or before October 19, 1998. Three

copies of all comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document and may be accompanied by

a supporting memorandum or brief.

Received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects in 21 CFR Part 341

Labeling, Over-the-counter drugs.
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.