Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67765

the publication of a notice in the

Federal Register of any such procedure

should such a situation arise.

Regulatory Flexibility Act

The Commissioner of the Immigration

and Naturalization Service, in

accordance with the Regulatory

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

reviewed this regulation and, by

approving it, certifies that the rule will

not have a significant economic impact

on a substantial number of small

entities. This regulation merely explains

the system which the Service currently

uses to track the number of H–1B

petition approved in a given fiscal year.

Unfunded Mandates Reform Act of

1995

This rule will not result in the

expenditure by State, local and tribal

governments, in the aggregate, or by the

private sector, of $100 million or more

in any one year, and it will not

significantly or uniquely affect small

governments. Therefore, no actions were

deemed necessary under the provisions

of the Unfunded Mandates Reform Act

of 1995.

Small Business Regulatory Enforcement

Fairness Act of 1996

This rule in not a major rule as

defined by section 804 of the Small

Business Regulatory Enforcement Act of

1996. This rule will not result in an

annual effect on the economy of $100

million or more; a major increase in

costs or prices; or significant adverse

effects on competition, employment,

investment, productivity, innovation, or

on the ability of United States-based

companies to compete with foreignbased companies in domestic and

export markets.

Executive Order 12866

This rule is considered by the

Department of Justice, Immigration and

Naturalization Service, to be a

‘‘significant regulatory action’’ under

Executive Order 12866, section 3(f),

Regulatory Planning and Review.

Accordingly, this regulation has been

submitted to the Office of Management

and Budget for review.

Executive Order 12612

The regulation proposed herein will

not have substantial direct effects on the

States, on the relationship between the

National Government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this rule does not

have sufficient Federalism implications

to warrant the preparation of a

Federalism Assessment.

Executive Order 12988—Civil Justice

Reform

This rule meets the applicable

standards set forth in sections 3(a) and

3(b)(2) of E.O. 12988.

List of Subjects in 8 CFR Part 214

Administrative practice and

procedure, Aliens, Employment,

Reporting and recordkeeping

requirements.

Accordingly, part 214 of chapter I of

title 8 of the Code of Federal Regulation

is proposed to be amended as follows:

PART 214—NONIMMIGRANT

GLASSES

1. The authority citation for part 214

continues to read as follows:

Authority: 8 U.S.C. 1101, 1103, 1182, 1184,

1186a, 1187, 1221, 1281, 1282; 8 CFR part 2.

2. Section 214.2 is amended by

revising paragraph (h)(8)(ii) to read as

follows:

§ 214.2 Special requirements for

admission, extension, and maintenance of

status.

* * * * *

(h) * * *

(8) * * *

(ii) Procedures. (A) Each alien issued

a visa or otherwise provided

nonimmigrant status under section

101(a)(15)(H)(i)(b) or (ii)(b) of the Act

shall be counted for purposes of the

numerical limit prescribed in section

214(g)(1) of the Act. Requests for

petition extension or an extension of the

alien’s stay, concurrent employment, or

sequential employment within the same

fiscal year shall not be counted against

the numerical limit. The spouse and

children of principal aliens classified as

H–4 nonimmigrant aliens shall not be

counted against the numerical limit.

(B) An alien will be counted against

the annual H–1B or H–2B numerical

limit only after an H–1B or H–2B

petition has been approved on his or her

behalf. An alien will be counted in the

order by which the H–1B or H–2B

petition has been approved on his or her

behalf. An alien on whose behalf an H–

1B or H–2B petition has been denied

will not be counted against the annual

numerical limit.

(C) When an approved petition is not

used because the beneficiary(ies) does

not obtain H–1B or H–2B classification,

the petitioner shall notify the Service

Center Director who approved the

petition that the petition was not used

as soon as the petitioner becomes aware

of the circumstance. The petition shall

be revoked pursuant to paragraph

(h)(11)(ii) of this section.

(D) If the total numbers available in a

fiscal year are used, the Service may

reject and return the petition and the

accompanying fee with a notice that

numbers are not available for the

nonimmigrant classification until the

next fiscal year. The Service, may, in its

discretion, adopt other mechanisms for

processing petitions filed after the

numerical limit has been reached in

order to prevent unnecessary hardship

to the public. The Service shall provide

notice of such new mechanisms through

publication in the Federal Register.

* * * * *

Dated: October 21, 1997.

Doris Meissner,

Commissioner, Immigration and

Naturalization Service.

[FR Doc. 97–33827 Filed 12–29–97; 8:45 am]

BILLING CODE 4410–10–M

DEPARTMENT OF THE TREASURY

Customs Service

19 CFR Parts 123 and 142

RIN 1515–AC16

Land Border Carrier Initiative Program

AGENCY: Customs Service, Treasury.

ACTION: Notice of proposed rulemaking.

SUMMARY: This document proposes to

amend the Customs Regulations to

provide for the Land Border Carrier

Initiative Program (LBCIP), a program

designed to prevent smugglers of illicit

drugs from utilizing commercial land

conveyances for their contraband. The

program provides for agreements

between carriers and Customs in which

the carrier agrees to increase its security

measures and cooperate more closely

with Customs and Customs agrees to

apply special administrative provisions

pertaining to penalty amounts and

expedited processing of penalty actions

if illegal drugs are found on a

conveyance belonging to the

participating carrier. Further, at certain

high-risk locations along the land

border, it is proposed to condition an

importer’s continued use of the Line

Release method of processing entries of

merchandise on the use of carriers/

drivers that participate in the LBCIP.

These proposed regulatory changes are

designed to improve Customs

enforcement of Federal drug laws along

the land border by enhancing its ability

to interdict illicit drug shipments

through additional trade movement

information provided by common
67766 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

carriers that voluntarily choose to

participate in the LBCIP.

DATES: Comments must be received on

or before March 2, 1998.

ADDRESSES: Written comments

(preferably in triplicate) may be

addressed to the Regulations Branch,

Office of Regulations and Rulings, U.S.

Customs Service, 1300 Pennsylvania

Avenue, N.W., Washington, D.C. 20229.

Comments submitted may be inspected

at the Regulations Branch, Office of

Regulations and Rulings, U.S. Customs

Service, 1300 Pennsylvania Avenue,

N.W., Suite 3000, Washington, D.C.

FOR FURTHER INFORMATION CONTACT: Jim

Kelly, Office of Field Operations, AntiSmuggling Division, (202) 927–0458.

SUPPLEMENTARY INFORMATION:

Background

I. Carrier Initiative Programs in General

In 1984, Customs began an air and sea

Carrier Initiative Program (CIP),

generally in response to Customs

awareness of a substantial increase in

the smuggling of marijuana and cocaine

in the South-Florida area, and

specifically as a result of a Customs

seizure of an aircraft operated by an

American-flag carrier. The carrier,

whose aircraft had been involved in

repeated drug violations, agreed to a

multi-point agreement implementing

stringent security measures as a

condition to release of the conveyance.

Developed under Customs remission

and mitigation of penalties authority

pursuant to section 618 of the Tariff Act

of 1930 (19 U.S.C. 1618), the CIP is

grounded in the execution of written

Carrier Initiative Agreements between

Customs and the common carrier,

whereby the carrier agrees to improve

cargo and conveyance security, and

Customs provides security and drug

awareness training.

Over the past ten years, the air and

sea CIP has proved to be a marked

success. Since that time, Customs has

come to view carriers as allies in the

war against drug smugglers, and

expanded the CIP to include Super

Carriers (see, 54 FR 14310, April 10,

1989). To date, over 2,300 air and sea

carriers have voluntarily signed such

Carrier Initiative Agreements with

Customs.

Because of the proven success of the

air and sea CIP, in 1995 Customs

decided to expand the CIP to land

border carriers to address the increased

drug smuggling threat. This new Land

Border Carrier Initiative Program

(LBCIP) is designed to deter smugglers

of illegal drugs from utilizing

commercial land conveyances for their

contraband. The exact locations along

the Southwest border where the LBCIP

will be implemented will be published

in the Federal Register.

In signing Carrier Initiative

Agreements with Customs, land and rail

carriers agree to increase the security

measures at their places of business and

on the conveyances used to transport

cargo. Further, carriers agree to

cooperate closely with Customs in

identifying and reporting suspected

smuggling conduct. In return for this

cooperation, Customs agrees to provide

training to carrier employees and

drivers in the areas of cargo and

personnel security, document review

techniques, drug awareness, and

conveyance search. Further, should

illegal drugs be found aboard a

conveyance belonging to a carrier that

has executed an agreement with

Customs, Customs agrees to apply

special administrative provisions

pertaining to penalty amounts and

expedited processing of penalties. Of

course, the degree of compliance with

the terms of the Agreement by the

carrier will be considered by Customs in

any seizure or penalty decision or

recommendation.

II. The Drug Interdiction Mandates of

the Anti-Drug Abuse Acts

In 1986, Congress enacted the AntiDrug Abuse Act of 1986 (Pub. L. 99–570,

100 Stat. 3207; 21 U.S.C. 801 note) (the

1986 Act) to, among other things,

strengthen Federal efforts to improve

the enforcement of Federal drug laws

and enhance the interdiction of illicit

drug shipments.

The 1986 Act amended Customs laws

relating to the assessment of monetary

penalties against persons in charge of

conveyances used as common carriers

and the seizure and forfeiture of

conveyances for the illegal importation

or transportation of drugs. Congress

subjected common carriers to increased

penalties and sanctions for at least two

reasons: (1) To encourage greater

vigilance on the part of those in charge

of conveyances used as common

carriers; and (2) to increase the

accountability and legal responsibility

of carriers to insure that drugs were not

carried on board their conveyances.

In particular, the 1986 Act amended

sections 584 and 594 of the Tariff Act

of 1930 (19 U.S.C. 1584 and 1594).

Section 584 was amended to increase

the penalty provisions which could be

assessed against owners, masters, or

persons in charge of conveyances

engaged as common carriers when

unmanifested drugs were discovered on

board vessels or in vehicles bound for

the United States. The penalties,

virtually unchanged since the 1930s,

were increased 2,000%, i.e., from $25

per ounce of marijuana to $500 per

ounce, and from $50 per ounce of

heroin or cocaine to $1,000 per ounce.

Further, the seizure and forfeiture

provisions of section 594 were greatly

expanded to include all common carrier

conveyances and operators where

prohibited merchandise was involved.

Section 594 was amended to require a

conveyance to be forfeited unless the

owner, operator, or person in charge

proves that he exercised the ‘‘highest

degree of care and diligence’’ where

violations involved prohibited

merchandise contained in unmanifested

packages or where the marks, numbers,

weights, or quantities disagreed with the

manifest, or where the merchandise was

concealed in or on the conveyance but

not in the cargo.

Although the Customs laws hold

common carriers to a high standard of

care, Customs has provided guidance

and training through the CIP to alleviate

the harsh consequences of those laws in

the face of a carrier’s diligent and good

faith effort to comply with them.

III. Customs Modernization, Trade

Facilitation, and the Line Release

Method of Merchandise Processing

Pursuant to section 448(b) of the

Tariff Act of 1930, as amended (19

U.S.C. 1448(b)), the Secretary of the

Treasury is authorized to provide by

regulation for the issuance of special

permits for delivery prior to formal

entry (‘‘immediate delivery’’). In the late

1980s, Customs established a new

automated system for the expedited

processing of repetitive, high volume

entries of merchandise (‘‘Line Release’’)

through the use of personal computers

and bar code technology (see, T.D. 92–

93). Regulations implementing the Line

Release processing method are

delineated at subpart D of Part 142

(§§ 142.41–142.52), Customs

Regulations (19 CFR Part 142, subpart

D).

Line Release facilitates the entry of

merchandise along the land borders of

the United States. However, at certain

high-risk locations Customs does not

wish to continue to offer line-release

processing unless it can be assured that

such will not compromise its various

law enforcement and drug interdiction

responsibilities. Balancing these

concerns, Customs proposes that at

certain high-risk land border locations,

continued importer use of Line Release

be conditioned on the imported

merchandise being carried by

participants in the LBCIP. The

additional information made available

to Customs by interfacing the
Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67767

merchandise-data of Line Release with

the cargo-driver-conveyance data of the

LBCIP will enhance Customs ability to

assess the threat of certain commercial

transactions more effectively. Only with

the continuing assistance of such

participatory land border carriers, as

shown by the success of the previous

CIPs, can Customs be assured that every

tool available to protect the United

States borders from illicit drug traffic is

employed before according the benefits

of expedited merchandise processing by

means of Line Release.

Proposed Amendments Concerning the

LBCIP and Line Release

In this document it is proposed to

provide for the new LBCIP in Part 123

of the Customs Regulations, which

pertains to Customs relations with

Canada and Mexico, by adding a new

Subpart H; the current subpart H which

contains miscellaneous provisions will

be redesignated as new subpart I. The

new subpart H of Part 123 will consist

of five sections (§§ 123.71—123.75).

Further, it is proposed to provide

Customs with the discretion, at certain

high-risk locations, to require for the use

of Line Release that imported

merchandise, which otherwise qualifies

for Line Release, be transported over the

border by carriers and drivers that

participate in the LBCIP. Accordingly,

two sections in subpart D (§§ 142.41 and

142.47) will be revised to reference that

carrier participation in the LBCIP may

be required by Customs for Line Release

transactions at particular locations. The

public will be informed of these

locations by publications in the Federal

Register. At this time Customs plans

that these locations will be limited to

those along the Southern border, where

the greatest drug threat to the United

States is located. This limited

implementation of the LBCIP is

designed to reduce the threat to public

safety presented by the drug problem in

that area.

It is noted that participation in either

the LBCIP or the Line Release program

does not alter the general authority of

Customs officials to conduct inspections

of participating carriers or their

merchandise.

Discussion of Proposed Changes to

Regulations

Proposed New Section 123.71

Proposed § 123.71, entitled

‘‘Description of program’’, describes, in

general terms, the responsibilities of

participants in the LBCIP, and cross

references subpart D, Part 142 of the

Customs Regulations, which provides

for expedited processing of repetitive

entries by means of Line Release, to

indicate that, at certain high-risk

locations (the locations to be published

in the Federal Register), Customs may

require for the use of Line Release that

imported merchandise, which otherwise

qualifies for Line Release, be

transported over the border by carriers

and drivers that participate in the

LBCIP.

Proposed New Section 123.72

Proposed § 123.72, entitled ‘‘Written

agreement requirement’’, explains the

mutual obligations of LBCIP carriers/

drivers and Customs. A carrier wishing

to participate in the LBCIP must agree

to assume certain security

responsibilities and a continuing

reporting obligation to Customs

regarding material changes to its

operations. These material changes

include changes to the structure and

relationships of the carrier’s business

enterprise and associations, the list of

drivers designated or conveyances

registered by the carrier within the

agreement to transport merchandise into

the United States, or any other

circumstance that affects the basis of the

carrier to participate in the LBCIP. In

return, Customs agrees to train carrier

personnel and designated drivers, and

to consider the application of special

administrative procedures when

assessing and mitigating drug-related

penalties should controlled substances

be found aboard a conveyance owned or

operated by a participating carrier.

Proposed New Section 123.73

Proposed § 123.73, entitled

‘‘Application to participate’’, provides

that the application is prepared by the

carrier, with pertinent information

provided by those drivers designated for

participation in the program, and

delineates the four items of information

needed by Customs to process a request

by carriers and their designated drivers

to participate in the program at specific

ports. The descriptive information

required pertains to (1) general business

identification and the condition of the

business site; (2) designated drivers; (3)

conveyance identification; and (4) an

affidavit of business character. The

driver and conveyance information

sought is to enable Customs to conduct

background checks and to aid Customs

officers at the border crossing in

visually identifying LBCIP-authorized

drivers and LBCIP-registered

conveyances. The affidavit of business

character requirement is designed to

provide sufficient business background

information for Customs to determine if

the applicant possesses the requisite

business integrity to be given access to

Line Release entry processing.

Accordingly, applicants will be required

to provide complete business histories

to Customs, i.e., account for business

name changes, reasons for relocations,

etc.

Proposed New Section 123.74

Proposed § 123.74, entitled ‘‘Notice of

selection; appeal of determination’’,

provides that Customs shall provide

written notice to carrier-applicants

concerning their participation in the

LBCIP. (Customs will provide written

notice to individual designated drivers

only in cases where they are not

selected to participate in the LBCIP.)

This section also lists the grounds for

nonselection and references the agency

appeal procedures, described at

proposed § 123.75, that carriers/drivers

must follow if they wish to appeal the

decision of nonselection.

Proposed New Section 123.75

Proposed § 123.75, entitled ‘‘Notice of

revocation; appeal of decision’’,

explains the circumstances under which

Customs may terminate a carrier’s or

driver’s participation in the LBCIP. This

section also describes the agency appeal

procedures carriers/drivers must follow

if they wish to challenge revocation of

their participation in the LBCIP.

Proposed Amendments to Sections

142.41 and 142.47

Section 142.41, which explains Line

Release in general terms, and § 142.47,

which concerns the voiding of Line

Release transactions, are being revised

to indicate that, at certain high-risk

locations (the locations to be published

in the Federal Register), Customs may

require for the use of Line Release that

imported merchandise, which otherwise

qualifies for Line Release, be

transported over the border by carriers

and drivers that participate in the

LBCIP.

Comments

Before adopting this proposed

regulation as a final rule, consideration

will be given to any written comments

timely submitted to Customs. Comments

submitted will be available for public

inspection in accordance with the

Freedom of Information Act (5 U.S.C.

552), § 1.4 of the Treasury Department

Regulations (31 CFR 1.4), and

§ 103.11(b) of the Customs Regulations

(19 CFR 103.11(b)), on regular business

days between the hours of 9 a.m. and

4:30 p.m. at the Regulations Branch,

Office of Regulations and Rulings, U.S.

Customs Service, 1300 Pennsylvania

Avenue, N.W., Suite 3000, Washington,

D.C.
67768 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

Inapplicability of the Regulatory

Flexibility Act, and Executive Order

12866

Pursuant to provisions of the

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

et seq.), it is certified that, if adopted,

the proposed amendments will not have

a significant economic impact on a

substantial number of small entities,

because the proposed amendments

concern a voluntary program that will

confer a benefit on the trade

community. Accordingly, the proposed

amendments are not subject to the

regulatory analysis or other

requirements of 5 U.S.C. 603 and 604.

This amendment does not meet the

criteria for a ‘‘significant regulatory

action’’ as specified in Executive Order

12866.

Paperwork Reduction Act

The collection of information

contained in this notice of proposed

rulemaking has been submitted to the

Office of Management and Budget

(OMB) for review in accordance with

the Paperwork Reduction Act of 1995

(44 U.S.C. 3507). Comments on the

collection of information should be sent

to the Office of Management and

Budget, Attention: Desk Officer for the

Department of the Treasury, Office of

Information and Regulatory Affairs,

Washington, D.C. 20503. A copy should

also be sent to Customs at the address

set forth previously.

Comments are invited on:

(a) Whether the collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information shall have practical utility;

(b) The accuracy of the agency’s

estimate of the information collection

burden;

(c) Ways to enhance the quality,

utility, and clarity of the information to

be collected;

(d) Ways to minimize the information

collection burden on respondents,

including through the use of automated

collection techniques or other forms of

information technology; and

(e) Estimates of capital or startup costs

and costs of operations, maintenance,

and purchase of services to provide

information.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless the collection of information

displays a valid control number.

The collection of information in these

proposed regulations is at § 123.73. The

information to be collected is necessary

to improve Customs ability to interdict

illicit drug shipments along the land

border in cooperation with common

carriers and their designated drivers

who participate in the LBCIP. The likely

respondents are individual drivers and

commercial carrier organizations that

engage in foreign commerce and trade

along the land border of the United

States.

Estimated total annual reporting and/

or recordkeeping burden: 500 hours.

Estimated average annual burden per

respondent/ recordkeeper: 1 hour.

Estimated number of respondents

and/or recordkeepers: 500.

Estimated annual frequency of

responses: 1.

Part 178 of the Customs Regulations

(19 CFR Part 178), which lists the

information collections contained in the

regulations and control numbers

assigned by OMB, would be amended

accordingly if this proposal is adopted.

Drafting Information: The principal

author of this document was Gregory R.

Vilders, Attorney, Regulations Branch.

However, personnel from other offices

participated in its development.

List of Subjects

19 CFR Part 123

Administrative practice and

procedure, Aliens, Canada, Common

carriers, Customs duties and inspection,

Forms, Imports, International

boundaries, Mexico, Motor carriers,

Railroads, Reporting and recordkeeping

requirements, Vehicles.

19 CFR Part 142

Bonds, Common carriers, Customs

duties and inspection, Entry of

merchandise, Forms, Reporting and

recordkeeping requirements.

Amendments to the Regulations

For the reasons stated above, it is

proposed to amend parts 123 and 142 of

the Customs Regulations (19 CFR parts

123 and 142), as set forth below:

PART 123—CUSTOMS RELATIONS

WITH CANADA AND MEXICO

1. The general authority citation for

part 123 continues to read as follows,

the specific authority citation for

§ 123.71 is removed, and specific

authority citations for §§ 123.71 through

123.75 and for § 123.81 are added, to

read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 20, Harmonized Tariff Schedule of the

United States (HTSUS)), 1431, 1433, 1624.

* * * * *

Sections 123.71–123.75 also issued under

19 U.S.C. 1618; Section 123.81 also issued

under 19 U.S.C. 1595.

2. Subpart H is redesignated as

subpart I and §§ 123.71 and 123.72 are

redesignated as §§ 123.81 and 123.82

therein, respectively, and a new subpart

H, consisting of §§ 123.71 through

123.75, is added to read as follows:

Subpart H—Land Border Carrier

Initiative Program

§ 123.71 Description of program.

The Land Border Carrier Initiative

Program (LBCIP) is a program designed

to enlist the voluntary cooperation of

commercial conveyance entities—and

their designated drivers—in Customs

effort to prevent the smuggling of

controlled substances into the United

States. Participation in the LBCIP

requires the land or rail commercial

carrier (e.g., trucks, buses, locomotives,

etc.) to enter into a written agreement

with Customs that describes the

responsibilities of participants in the

LBCIP. The agreement generally

provides that the carrier agrees to

enhance the security of its facilities and

the conveyances employed to transport

merchandise. The carrier also agrees to

cooperate closely with Customs in

identifying and reporting suspected

smuggling attempts. In exchange for this

cooperation, Customs agrees to provide

training to carrier personnel in the areas

of cargo and personnel security,

document review techniques, drug

awareness, and conveyance searches.

Customs also agrees that should a

controlled substance be found aboard a

conveyance owned or operated by a

participating carrier, special

administrative procedures relating to

the assessment and mitigation of drugrelated penalties will be followed; the

degree of compliance with the terms of

the agreement will be considered as an

additional positive mitigating factor in

any seizure or penalties decision or

recommendation. Lastly, at certain highrisk locations, for the use of Line

Release, imported merchandise, which

otherwise qualifies for Line Release

entry (see, subpart D of part 142 of this

chapter), must be transported over the

border by carriers and drivers that

participate in the LBCIP. The locations

where the use of Line Release will be

conditioned on participation in the

LBCIP will be published in the Federal

Register.

§ 123.72 Written agreement requirement.

Commercial carriers desiring to

participate in the LBCIP shall enter into

a written agreement with Customs

regarding the mutual obligations of

carrier/driver participants and Customs.

The terms and conditions in the written

agreement shall generally provide that

the carrier-applicant agrees:
Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules 67769

(a) To participate in Customs training

regarding cargo and personnel security,

document review techniques, drug

awareness, and conveyance searches;

(b) To establish (1) security systems at

the place of business for the safe storage

and handling of cargo intended to be

imported into the United States, and (2)

security procedures aimed at restricting

access to transporting conveyances and

preventing the unauthorized lading of

illegal drugs while the conveyance is

enroute to the United States;

(c) To conduct, to the extent allowed

by law, employment and criminal

history record checks on all personnel

designated to participate in the LBCIP

and to exercise responsible supervision

and control over those personnel;

(d) To ensure that only authorized

drivers and properly registered

conveyances are utilized in the

transportation of merchandise into the

United States, and to maintain current

lists of such drivers and conveyances for

Customs inspection upon request;

(e) To immediately report to the

appropriate port director any criminal

or dishonest conduct on the part of

drivers designated to participate in the

LBCIP, or attempt by others to impede,

influence, or coerce the carrier or

drivers into violating any United States

law, including Customs regulations,

especially those concerned with

trafficking in illegal drugs; and

(f) To notify the appropriate port

director in writing by mail within 5

days of any change in legal name,

business address, business principals,

ownership, drivers, or conveyances that

affects the basis for continued

participation in the LBCIP or any other

provision contained in the written

agreement.

§ 123.73 Application to participate.

To request participation in the LBCIP,

the carrier-applicant must submit an

application containing the information

requested in this section. The

application must be accompanied by

two copies of a LBCIP written agreement

(see § 123.72 of this part; upon request,

the local port director of Customs will

provide copies of an unsigned written

agreement) containing original

signatures of corporate officers or

owners of the common carrier. The

application shall be prepared by the

common carrier, be signed by corporate

officers or owners, and submitted to the

port director. If a submitted application

does not provide all of the information

specified in this section, the processing

of the application will either be delayed

or the application will be rejected. The

application information shall include

the following information:

(a) General business identification

and site condition information. The

name and address of the commercial

conveyance entity, the names of all

principals or corporate officers, the

name and telephone number of an

individual to be contacted for further

information, and a complete and

detailed description of the premises

where business operations are

conducted, to include all working/

storage areas and security features

employed;

(b) Designated driver information. A

listing of the drivers designated by the

carrier who will be transporting

merchandise into the U.S. The listing

shall set forth the name(s), address(es),

date of birth, nationality, driver’s

license number, and any other personal

identifying information regarding the

drivers listed, e.g., social security

number (if available), to enable Customs

to conduct background checks and to

aid Customs officers at the border

crossing point in identifying individual

LBCIP-authorized drivers;

(c) Conveyance identification

information. A listing of the

conveyances, e.g., trucks and

locomotives, that the carrier will utilize

to transport merchandise into the U.S.

The listing shall set forth the type and

make of conveyances, country of

registration and license number(s),

conveyance-specific identifying

markings, e.g., vehicle identification

numbers (VINs), and any other general

conveyance identifying information,

e.g., weight, color, recognizable

modifications, etc., to aid Customs

officers at the border crossing point in

identifying particular LBCIP-registered

conveyances; and

(d) Affidavit of business character. A

statement signed by the carrierapplicant which attests to each

principal’s or corporate officer’s past

and present business relations, e.g., a

list of past companies worked for and

positions held, which fully explains the

presence of any past or present crime

involving theft or smuggling or

investigations into such crimes, or other

dishonest conduct on the part of a

principal.

§ 123.74 Notice of selection; appeal of

determination.

The information provided pursuant to

paragraphs (b) through (d) of § 123.73

shall constitute the criteria used to

evaluate the competency of the carrierapplicant and its designated drivers to

participate in the LBCIP. Following

Customs evaluation of the information

provided, Customs shall determine the

carrier-applicant’s and its designated

drivers’ ability to participate in the

LBCIP. In cases of selection, Customs

will notify the common carrier in

writing and sign and return one of the

copies of the written agreement. In cases

of nonselection, the written notice of

nonselection shall clearly state the

reason(s) for denial and recite the

applicant’s/driver’s appeal rights under

paragraph (b) of this section.

(a) Grounds for nonselection. The port

director may deny a carrier’s

application, or a driver’s designation, to

participate in the LBCIP for any of the

following reasons:

(1) Evidence of any criminal or

dishonest conduct involving the carrier,

a corporate officer, designated drivers,

or other person the port director

determines is exercising substantial

ownership or control over the carrier

operation or corporate officer;

(2) Evidence of improper use of

designated conveyances;

(3) Evidence that the written

agreement was entered into by fraud or

misstatement of a material fact; or

(4) A determination is made that the

grant of LBCIP privileges would

endanger the revenue or security of the

Customs area.

(b) Appeal of determination. Carrierapplicants and designated drivers not

selected to participate in the LBCIP and

who wish to appeal the decision shall

either:

(1) Appeal the adverse determination

in accordance with the appeal

procedure set forth in § 123.75(c) of this

part; or

(2) Cure any deficiency in the first

application by submitting a new

application to the port director who

denied the previous application after

waiting 60 days from the date of

issuance of the first determination.

§ 123.75 Notice of revocation; appeal of

decision.

(a) Revocation. The port director may

immediately revoke a carrier’s

participation in the LBCIP and cancel

the written agreement, or a driver’s

authorization to participate in the

LBCIP, for any of the following

applicable reasons:

(1) The selection and written

agreement were obtained through fraud

or the misstatement of a material fact by

the carrier;

(2) The carrier, a corporate officer, any

designated driver, or other person the

port director determines is exercising

substantial ownership or control over

the carrier operation or corporate

officer, is indicted for, convicted of, or

has committed acts which would

constitute any felony or misdemeanor

under United States Federal or State

law. In the absence of an indictment,
67770 Federal Register / Vol. 62, No. 249 / Tuesday, December 30, 1997 / Proposed Rules

conviction, or other legal process, the

port director must have probable cause

to believe the proscribed acts occurred;

(3) The carrier-participant or a

designated driver allows an

unauthorized person or entity to use its

LBCIP certificate or other approved form

of identification;

(4) The carrier-participant or a

designated driver misuses authorized

conveyances;

(5) The carrier-participant or a

designated driver refuses or otherwise

fails to follow any proper order of a

Customs officer or any Customs order,

rule, or regulation relative to continued

participation in the LBCIP;

(6) The carrier-participant or a

designated driver fails to operate in

accordance with the terms of the written

agreement; or

(7) Continuation of LBCIP privileges

would endanger the revenue or security

of the Customs area in the judgment of

the port director.

(b) Notice. When a decision revoking

participation has been made, the port

director shall notify the carrierparticipant, and, where appropriate, the

individual designated driver(s), of the

decision in writing. The notice of

revocation shall clearly state the

reason(s) for revocation and recite the

applicant’s/driver’s appeal rights under

paragraph (c) of this section.

(c) Appeal. An LBCIP participant who

receives a notice of revocation and who

wishes to appeal the decision shall file

a written appeal with the Assistant

Commissioner, Office of Field

Operations, U.S. Customs Service,

Washington, D.C. 20229, within 10

calendar days of receipt of the notice.

The appeal shall be filed in duplicate

and shall set forth the participant’s

responses to the grounds specified by

the port director in the notice. Within

30 working days of receipt of the appeal,

the Assistant Commissioner, or his

designee, shall make a determination

regarding the appeal and notify the

applicant in writing.

PART 142—ENTRY PROCESS

1. The authority citation for part 142

continues to read as follows:

Authority: 19 U.S.C. 66, 1448, 1484, 1624.

2. Section 142.41 is amended by

adding a sentence at the end to read as

follows:

§ 142.41 Line release.

* * * * *

At certain high-risk locations along

the land borders of the United States

(the locations to be published in the

Federal Register), which are approved

by Customs for handling Line Release,

the use of Line Release may be denied

by Customs unless the imported

merchandise is transported by carriers

and drivers that participate in the Land

Border Carrier Initiative Program (see,

subpart H of part 123 of this chapter).

§ 142.47 [Amended]

3. In § 142.47, the first sentence of

paragraph (b) is amended by removing

the words ‘‘because of an examination’’

and adding, in their place, the words

‘‘for the following reasons: because of an

examination, because a carrier

transporting the Line Release

merchandise is not a participant in the

Land Border Carrier Initiative Program

(LBCIP), or because a driver or

conveyance is not authorized in

accordance with the LBCIP’’.

Samuel H. Banks,

Acting Commissioner of Customs.

Approved: August 7, 1997.

Dennis M. O’Connell,

Acting Deputy Assistant Secretary of the

Treasury.

[FR Doc. 97–33854 Filed 12–29–97; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 330, and 358

[Docket No. 96N–0420]

Over-The-Counter Human Drugs;

Proposed Labeling Requirements;

Notice of Availability of Study Data and

Reopening of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

comment period on specific data.

SUMMARY: The Food and Drug

Administration (FDA) is reopening to

February 13, 1998 the comment period

on specific data related to the February

27, 1997, proposed rule to establish a

standardized format for the labeling of

over-the-counter (OTC) drug products

(62 FR 9024). As part of that rulemaking

proceeding, the agency collected data

under a study entitled ‘‘Over-theCounter (OTC) Label Format Preference,

Study B.’’ (Study B). This document

announces the availability of the data

and frequency tabulations that

summarize the Study B data and

reopens the comment period for the

OTC rulemaking proceeding to allow an

opportunity for comment on Study B.

DATES: Submit written comments on

Study B by February 13, 1998.

ADDRESSES: Submit written comments

on the information collected in Study B

to the Dockets Management Branch

(HFA–305), ATTN: Study B, OTC Drug

Labeling Data Collection, Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Kathryn J. Aikin, Food and Drug

Administration, Division of Drug

Marketing, Advertising, and

Communications (HFD–40), 5600

Fishers Lane, Rockville, MD, 20857,

301–827–2828, Aikink@cder.fda.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 27, 1997

(62 FR 9024), FDA published a

proposed rule intended to enable

consumers to read and understand OTC

drug product labeling and to more

effectively apply the information in the

labeling to the safe and effective use of

such products. An important element of

FDA’s proposed rule is a standardized

labeling format for OTC drug products.

After issuing the proposed rule, FDA

published in the Federal Register a

notice under the Paperwork Reduction

Act of 1995 announcing the agency’s

intention to conduct four studies

relating to OTC drug products (62 FR

28482, May 23, 1997). The agency

intends at this time to use two of the

studies (‘‘Evaluation of Proposed Overthe-Counter (OTC) Label Formats, Study

A,’’ and ‘‘Over-the-Counter (OTC) Label

Format Preference, Study B’’ ) in

deliberations on developing a

standardized, easy to read and easy to

understand, labeling format for OTC

drug products (see 62 FR 9024). The

data and frequency tabulations for one

of these studies, Study B, are now

available.

In Study B, consumers were invited to

view examples and variations of current

OTC label designs. Respondents were

asked to indicate their preference for

various designs and to evaluate labeling

terminology and graphics to help the

agency understand how consumers

interpret various ways of

communicating drug safety and drug

effectiveness information. The agency is

now seeking comments on the data

developed under Study B, including the

opinions of the respondents on the

various labeling format elements used in

the Study. The comments on Study B

will be included in the agency’s

deliberations on developing a final,

standardized OTC labeling format

regulation.

After the results for Study A are

tabulated, the agency will publish a

notice in the Federal Register

announcing when the data and

tabulations are available for viewing.