56936 Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 

potential competitors to enter the 

marketplace by lowering their costs. The 

agency, therefore, certifies that the final 

rule will not have a significant impact 

on a substantial number of small 

entities. In addition, this final rule will 

not impose costs of $100 million or 

more on either the private sector or 

State, local, and tribal governments in 

the aggregate and, therefore, a summary 

statement of analysis under section 

202(a) of the Unfunded Mandates 

Reform Act is not required.

IV. Federalism

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that 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. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required.

V. Paperwork Reduction Act of 1995

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required.

VI. Reference

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday.

1. Petition from Associates of Cape 

Cod dated March 22, 2004.

List of Subjects in 21 CFR Part 866

Biologics, Laboratories, Medical 

devices.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows:

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371.

■ 2. Section 866.3050 is added to subpart 

D to read as follows:

§ 866.3050 Beta-glucan serological 

assays.

(a) Identification. Beta-glucan 

serological assays are devices that 

consist of antigens or proteases used in 

serological assays. The device is 

intended for use for the presumptive 

diagnosis of fungal infection. The assay 

is indicated for use in patients with 

symptoms of, or medical conditions 

predisposing the patient to invasive 

fungal infection. The device can be used 

as an aid in the diagnosis of deep seated 

mycoses and fungemias.

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Serological Assays for the Detection of 

Beta-Glucan.’’ See § 866.1(e) for the 

availability of this guidance document.

Dated: September 10, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–21316 Filed 9–22–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Office of Foreign Assets Control 

31 CFR Part 592 

Rough Diamonds Control Regulations

AGENCY: Office of Foreign Assets 

Control, Treasury.

ACTION: Final rule.

SUMMARY: The Treasury Department’s 

Office of Foreign Assets Control is 

revising the Rough Diamonds Control 

Regulations previously issued as an 

interim final rule. The regulations carry 

out the purposes of Executive Order 

13312 of July 29, 2003, which 

implemented the Clean Diamond Trade 

Act and the Kimberley Process 

Certification Scheme for rough 

diamonds. Based on its experience and 

that of other involved agencies, OFAC is 

revising certain reporting and 

recordkeeping requirements of the 

regulations.

DATES: Effective Date: September 23, 

2004.

FOR FURTHER INFORMATION CONTACT:

OFAC’s Chief of Policy Planning and 

Program Management, tel.: (202) 622–

4855, or Chief Counsel, tel.: (202) 622–

2410.

SUPPLEMENTARY INFORMATION: 

Background 

On July 29, 2003, the President issued 

Executive Order 13312, to implement 

the Clean Diamond Trade Act (Pub. L. 

108–19) and the multilateral Kimberley 

Process Certification Scheme for rough 

diamonds (KPCS). The Clean Diamond 

Trade Act requires the President, subject 

to certain waiver authorities, to prohibit 

the importation into, and exportation 

from, the United States of any rough 

diamond not controlled through the 

KPCS. This means shipments of rough 

diamonds between the United States 

and non-Participants in the KPCS 

generally are prohibited, and shipments 

between the United States and 

Participants are permitted only if they 

are handled in accordance with the 

standards, practices, and procedures of 

the KPCS set out in these regulations. 

The Treasury Department’s Office of 

Foreign Assets Control (OFAC), acting 

pursuant to Executive Order 13312 and 

delegated authority, published the 

Rough Diamonds Control Regulations, 

31 CFR part 592 (the Regulations), as an 

interim final rule on August 4, 2003 (68 

FR 45777). The Regulations, which are 

described in detail in the preamble to 

the interim final rule, implement the 

Clean Diamond Trade Act and the 

KPCS. 

OFAC requested public comments on 

the Regulations. No public comments 

were received. However, based on its 

experience and that of other agencies 

that also participate in the 

implementation and administration of 

the Clean Diamond Trade Act and the 

KPCS, OFAC is revising the Regulations 

in four respects: (1) To specify that the 

ultimate consignee is responsible for 

retaining the original Kimberley Process 

Certificate accompanying an 

importation into the United States; (2) to 

require the ultimate consignee to report 

the receipt of a shipment of rough 

diamonds to the relevant foreign 

exporting authority within 15 calendar 

days of the date that the shipment 

arrived at a U.S. port of entry; (3) to 

advise persons engaged in the diamond 

trade of a pending requirement of U.S. 

Customs and Border Protection 

(Customs) that customs brokers, 

importers, and filers making entry of a 

shipment of rough diamonds either 

submit through Custom’s Automated 

Broker Interface (ABI) system the 

unique identifying number of the 

Kimberley Process Certificate 

accompanying the shipment or, for nonABI entries, indicate the certificate 

number on the Customs Form 7501 

Entry Summary at each entry line; and 

(4) to clarify the country-of-origin 

reporting requirements for shipments of 

Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 56937

parcels of mixed origin rough diamonds. 

OFAC is now issuing the Regulations as 

a final rule, incorporating these four 

revisions and the others described 

below.

Section 592.301 of the Regulations 

defines the term Controlled through the 

Kimberley Process Certification Scheme. 

OFAC is revising two subsections of this 

definition and adding a note to the 

section. First, § 592.301(a)(1) requires, 

among other things, that a shipment of 

rough diamonds imported into the 

United States be accompanied by a 

Kimberley Process Certificate validated 

by the relevant exporting authority. The 

certificate must be presented if 

demanded by Customs. Also, § 592.501 

of the Regulations requires a United 

States person importing rough 

diamonds into the United States to 

maintain full and accurate records of the 

transaction for at least five years after 

the date of the transaction. OFAC has 

been advised that persons engaged in 

the diamond trade are uncertain which 

person should maintain possession of 

the original Kimberley Process 

Certificate accompanying an 

importation into the United States. To 

eliminate this uncertainty and to 

facilitate OFAC’s and Customs’

enforcement efforts, OFAC is revising 

§ 592.301(a)(1) to specify that the 

ultimate consignee reported on the 

Customs Form 7501 Entry Summary or 

its electronic equivalent filed with 

Customs is responsible for retaining that 

certificate for a period of at least five 

years from the date of the importation. 

Second, § 592.301(a)(3) of the 

Regulations originally required the 

importer of record in the United States 

to confirm receipt of a shipment of 

rough diamonds to the relevant foreign 

exporting authority. OFAC is revising 

this subsection to specify which person 

involved in an importation is required 

now to report the receipt of a shipment 

in an effective and timely manner. As 

revised, § 592.301(a)(3) specifies that the 

ultimate consignee reported on the 

Customs Form 7501 Entry Summary or 

its electronic equivalent filed with 

Customs is the person responsible for 

reporting receipt of the shipment to the 

foreign exporting authority. Also, the 

revised § 592.301(a)(3) now requires that 

the ultimate consignee must report 

specified information about the 

shipment to the foreign exporting 

authority within 15 calendar days of the 

date that the shipment arrived at a U.S. 

port of entry. 

OFAC also is adding a note to 

§ 592.301 to reflect a pending Customs 

requirement that customs brokers, 

importers, and filers making entry of a 

shipment of rough diamonds either 

submit through Customs’ Automated 

Broker Interface (ABI) system the 

unique identifying number of the 

Kimberley Process Certificate 

accompanying the shipment or, for nonABI entries, indicate the certificate 

number on the Customs Form 7501 

Entry Summary at each entry line. This 

requirement will take effect on 

November 1, 2004. The submission of 

the Kimberley Process Certificate 

number will facilitate the Census 

Bureau’s compilation of statistical data 

relating to the importation of rough 

diamonds. 

Section 592.307 of the Regulations 

defines the term Kimberley Process 

Certificate to include a requirement that 

the certificate identify the country of 

origin for a shipment of one or more 

parcels of rough diamonds of unmixed 

(i.e., from the same) origin. The 

definition’s silence with respect to the 

treatment of a shipment that includes a 

parcel of mixed origin rough diamonds 

has prompted questions from importers 

as to whether the certificate may be 

used and how it should be completed, 

in such circumstances. A shipment 

including a parcel of mixed-origin rough 

diamonds is to be entered into the 

United States with the Kimberley 

Process Certificate validated by the 

relevant exporting authority, and the 

certificate need not indicate the 

countries of origin of the diamonds. 

With respect to such a shipment, 

however, OFAC is adding a note to 

§ 592.307(b) to state that the country-oforigin field must be filled in with 

asterisks. The note also advises that the 

shipment still must comply with all 

other country-of-origin reporting 

requirements imposed by law. 

OFAC is also revising the definition of 

Effective date in § 592.302 of the 

Regulations in light of the new reporting 

requirements imposed by 

§ 592.301(a)(3), as well as revising 

§ 592.801 to reflect the Office of 

Management and Budget’s (OMB) 

issuance of three control numbers 

authorizing the collections of 

information in the Regulations. Finally, 

OFAC is revising § 592.602 to reflect 

properly the basis upon which the 

Director of OFAC may decide to issue a 

prepenalty notice and to make other 

minor corrections.

Electronic and Facsimile Availability 

This file is available for download 

without charge in ASCII and Adobe 

Acrobat readable (*.PDF) formats at 

GPO Access. GPO Access supports 

HTTP, FTP, and Telnet at 

fedbbs.access.gpo.gov. It may also be 

accessed by modem dialup at (202) 512–

1387 followed by typing ‘‘/GO/FAC.’’

Paper copies of this document can be 

obtained by calling the Government 

Printing Office at (202) 512–1530. 

Additional information concerning the 

programs administered by OFAC is 

available for download from the Office’s 

Internet Home Page at: http://

www.treas.gov/ofac or via FTP at 

ofacftp.treas.gov. Facsimiles of 

information are available through the 

Office’s 24-hour fax-on-demand service: 

call (202) 622–0077 using a fax 

machine, a fax modem, or (within the 

United States) a touch-tone telephone. 

Executive Order 12866, Administrative 

Procedure Act, Regulatory Flexibility 

Act, and Paperwork Reduction Act 

Because the regulations involve a 

foreign affairs function, the provisions 

of Executive Order 12866 and the 

Administrative Procedure Act (5 U.S.C. 

553) requiring notice of proposed 

rulemaking, opportunity for public 

participation, and delay in effective date 

are inapplicable. Because no notice of 

proposed rulemaking is required for this 

rule, the Regulatory Flexibility Act (5 

U.S.C. 601–612) does not apply. 

With respect to section 3507 of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.), the collections of 

information in §§ 592.301(a)(1), 592.501, 

and 592.603 of the Regulations are made 

pursuant to OFAC’s Reporting, 

Procedures and Penalties Regulations 

(31 CFR part 501) and have been 

approved by OMB under control 

number 1505–0164. See 31 CFR 

501.901. The collection of information 

in § 592.301(a)(4) relating to the Census 

Bureau’s Foreign Trade Statistics 

Regulations (15 CFR part 30) has been 

approved by OMB under control 

number 0607–0152. See Automated 

Export System Mandatory Filing for 

Exports (Reexports) of Rough Diamonds, 

68 FR 59877 (Oct. 20, 2003). 

The collection of information in 

§ 592.301(a)(3) of the Regulations has 

been submitted to and approved by 

OMB pending public comment and has 

been assigned OMB control number 

1505–0198. Section 592.301(a)(3) 

specifies that the ultimate consignee 

identified on the Customs Form 7501 

Entry Summary filed with Customs is 

required to report specified information 

about the shipment of rough diamonds 

imported into the United States to the 

foreign exporting authority within 15 

calendar days of the date that the 

shipment arrived at a U.S. port of entry. 

This collection of information is needed 

to monitor the integrity of international 

rough diamond shipments, and the 

information collected will be used to 

further the compliance, enforcement, 

and civil penalty programs of OFAC, 

56938 Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 

U.S. Customs and Border Protection, 

and the Bureau of Immigration and 

Customs Enforcement. See sections 5(a) 

and 8 of the Clean Diamond Trade Act. 

With respect to all of the foregoing 

collections of 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 likely respondents and 

recordkeepers affected by the new 

collection of information in 

§ 592.301(a)(3) are business 

organizations and individuals engaged 

in the international diamond trade. The 

estimated annual number of 

respondents and recordkeepers is 250, 

and the estimated total annual number 

of responses is 3,000. 

The estimated total annual reporting 

and/or recordkeeping burden is 

estimated to be 500 hours. The 

estimated average annual burden per 

respondent/recordkeeper is 2 hours, 

based on an estimated annual frequency 

of 10 to 15 responses and an estimated 

time per response of 10 minutes. 

Comments are invited on: (a) Whether 

this collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information has practical 

utility; (b) the accuracy of the agency’s 

estimate of the burden of the collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques and other forms of 

information technology; and (e) 

estimated capital or start-up costs of 

operation, maintenance, and purchase 

of services to provide information.

Comments concerning the above 

information, the accuracy of these 

burden estimates, and suggestions for 

reducing this burden should be directed 

to OMB, Attention: Desk Officer for the 

Department of the Treasury, Office of 

Information and Regulatory Affairs, 

Washington, DC 20503, with a copy to 

Chief of Records, Attention: Request for 

Comments, Office of Foreign Assets 

Control, Department of the Treasury, 

1500 Pennsylvania Avenue, NW., 

Washington, DC 20220. Any such 

comments should be submitted not later 

than November 22, 2004. All comments 

on the collection of information in 

§ 592.301(a)(3) will be a matter of public 

record.

List of Subjects in 31 CFR Part 592 

Administrative practice and 

procedure, Foreign trade, Exports, 

Imports, Kimberley Process, Penalties, 

Reporting and recordkeeping 

requirements, Rough diamond.

■ For the reasons set forth in the 

preamble, 31 CFR chapter V, part 592 is 

revised to read as follows:

PART 592—ROUGH DIAMONDS 

CONTROL REGULATIONS

Subpart A—Relation of This Part to Other 

Laws and Regulations 

Sec. 

592.101 Relation of this part to other laws 

and regulations.

Subpart B—Prohibitions 

592.201 Prohibited importation and 

exportation of any rough diamond; 

permitted importation and exportation of 

any rough diamond. 

592.202 Evasions; attempts; conspiracies.

Subpart C—General Definitions 

592.301 Controlled through the Kimberley 

Process Certification Scheme. 

592.302 Effective date. 

592.303 Entity. 

592.304 Exporting authority. 

592.305 Importation into the United States. 

592.306 Importing authority. 

592.307 Kimberley Process Certificate. 

592.308 Participant. 

592.309 Person. 

592.310 Rough diamond. 

592.311 United States. 

592.312 United States person; U.S. person.

Subpart D—Interpretations 

592.401 Reference to amended sections. 

592.402 Effect of amendment. 

592.403 Transshipment or transit through 

the United States. 

592.404 Importation into or release from a 

bonded warehouse or foreign trade zone.

Subpart E—Records and Reports 

592.501 Records and reports.

Subpart F—Penalties 

592.601 Penalties. 

592.602 Prepenalty notice. 

592.603 Response to prepenalty notice; 

informal settlement. 

592.604 Penalty imposition or withdrawal. 

592.605 Administrative collection; referral 

to United States Department of Justice.

Subpart G—Procedures 

592.701 Procedures. 

592.702 Delegation by the Secretary of the 

Treasury.

Subpart H—Paperwork Reduction Act 

592.801 Paperwork Reduction Act notice.

Authority: 3 U.S.C. 301; 31 U.S.C. 321(b); 

Pub. L. 108–19, 117 Stat. 631 (19 U.S.C. 

3901–3913); E.O. 13312, 68 FR 45151 3 CFR, 

2003 Comp., p. 246.

Subpart A—Relation of This Part to 

Other Laws and Regulations

§ 592.101 Relation of this part to other 

laws and regulations. 

This part is separate from, and 

independent of, the other parts of this 

chapter, with the exception of part 501 

of this chapter, the recordkeeping and 

reporting requirements and procedures 

of which apply to this part. Actions 

taken pursuant to part 501 of this 

chapter with respect to the prohibitions 

contained in this part are considered 

actions taken pursuant to this part. 

Differing foreign policy and national 

security circumstances may result in 

differing interpretations of similar 

language among the parts of this 

chapter. No license or authorization 

contained in or issued pursuant to those 

other parts authorizes any transaction 

prohibited by this part. No license or 

authorization contained in or issued 

pursuant to any other provision of law 

or regulation authorizes any transaction 

prohibited by this part.

Subpart B—Prohibitions

§ 592.201 Prohibited importation and 

exportation of any rough diamond; 

permitted importation or exportation of any 

rough diamond. 

(a) Except to the extent provided in 

paragraph (b) of this section, and 

notwithstanding the existence of any 

rights or obligations conferred or 

imposed by any contract entered into or 

any license or permit granted prior to 

the effective date, the importation into, 

or exportation from, the United States 

on or after July 30, 2003, of any rough 

diamond, from whatever source, is 

prohibited, unless the rough diamond 

has been controlled through the 

Kimberley Process Certification Scheme. 

(b) The prohibitions in paragraph (a) 

of this section regarding the importation 

into, or exportation from, the United 

States of any rough diamond not 

controlled through the Kimberley 

Process Certification Scheme do not 

apply to an importation from, or 

exportation to, any country with respect 

to which the Secretary of State has 

granted a waiver pursuant to section 

4(b) of the Clean Diamond Trade Act 

(Pub. L. 108–19) and section 2(a)(i) of 

Executive Order 13312.

Note to § 592.201. An importation of any 

rough diamond from, or an exportation of 

any rough diamond to, a non-Participant is 

not controlled through the Kimberley Process 

Certification Scheme and thus is not 

permitted, except in the following 

circumstance. The Secretary of State may, 

pursuant to section 4(b) of the Clean 

Diamond Trade Act, waive the prohibitions 

contained in section 4(a) of that Act with 

Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 56939

respect to a particular country for periods of 

not more than one year each. The Secretary 

of State will publish a notice in the Federal 

Register identifying any country with respect 

to which a waiver applies and specifying the 

relevant time period during which the waiver 

will apply.

§ 592.202 Evasions; attempts; 

conspiracies. 

(a) Notwithstanding the existence of 

any rights or obligations conferred or 

imposed by any contract entered into or 

any license or permit granted prior to 

July 30, 2003, any transaction by a 

United States person anywhere, or any 

transaction that occurs in whole or in 

part within the United States, on or after 

the effective date that evades or avoids, 

or has the purpose of evading or 

avoiding, or attempts to violate, any of 

the prohibitions set forth in this part is 

prohibited.

(b) Notwithstanding the existence of 

any rights or obligations conferred or 

imposed by any contract entered into or 

any license or permit granted prior to 

July 30, 2003, any conspiracy formed to 

violate any of the prohibitions of this 

part is prohibited.

Subpart C—General Definitions

§ 592.301 Controlled through the 

Kimberley Process Certification Scheme. 

(a) Except as otherwise provided in 

paragraph (b) of this section, the term 

controlled through the Kimberley 

Process Certification Scheme refers to 

the following requirements that apply, 

as appropriate, to the importation into 

the United States from a Participant, or 

to the exportation from the United 

States to a Participant, of any shipment 

including any rough diamond: 

(1) Kimberley Process Certificate. A 

shipment of rough diamonds imported 

into, or exported from, the United States 

must be accompanied by an original 

Kimberley Process Certificate. The 

certificate must be presented in 

connection with an importation or 

exportation of rough diamonds if 

demanded by United States customs 

officials. Pursuant to 31 CFR §§ 501.601 

and 501.602, the person identified as 

the ultimate consignee (see Customs 

Directive 3550–079A) on the Customs 

Form 7501 Entry Summary or its 

electronic equivalent filed with U.S. 

Customs and Border Protection in 

connection with an importation of 

rough diamonds must retain the original 

Kimberley Process Certificate for a 

period of at least five years from the 

date of importation and must make such 

certificate available for examination 

upon demand. 

(2) Tamper-resistant container. A 

shipment of rough diamonds imported 

into, or exported, from the United States 

must be sealed in a tamper-resistant 

container; 

(3) Notification requirements for 

importations into the United States. The 

person identified as the ultimate 

consignee (see Customs Directive 3550–

079A) on the Customs Form 7501 Entry 

Summary or its electronic equivalent 

filed with U.S. Customs and Border 

Protection in connection with an 

importation of rough diamonds must 

report that person’s receipt of a 

shipment of rough diamonds to the 

relevant foreign exporting authority 

within 15 calendar days of the date that 

the shipment arrived at the U.S. port of 

entry. The report must refer to the 

relevant Kimberley Process Certificate 

by its unique identifying number; 

specify the number of parcels in the 

shipment; specify the total carat weight 

of the shipment; and identify the 

importer and exporter of the shipment. 

The report need not be in any particular 

form and may be submitted 

electronically or by mail or courier; and 

(4) Validation of Kimberley Process 

Certificate for exportations from the 

United States. With respect to the 

exportation of rough diamonds from the 

United States and regardless of the 

destination, the U.S. Census Bureau 

requires the filing of export information 

through the Automated Export System. 

Submission of export information 

through the Automated Export System 

must be done in advance and must be 

confirmed by the return of an Internal 

Transaction Number. The return to the 

filer of the Internal Transaction Number 

shall constitute the validation of the 

Kimberley Process Certificate for an 

exportation of rough diamonds from the 

United States to a Participant. The 

exporter is required to report the 

Internal Transaction Number on the 

Kimberley Process Certificate 

accompanying any exportation from the 

United States. The Internal Transaction 

Number is a unique confirmation 

number generated by the Automated 

Export System to the filer who provides 

in a timely manner the complete 

commodity shipment data when such 

data have been accepted by the system. 

(b) The Secretary of State, consistent 

with section 3(2)(B) of the Clean 

Diamond Trade Act (Pub. L. 108–19), 

may modify the requirements set forth 

in paragraph (a) of this section upon 

making a determination that a 

Participant has established an 

alternative system of control for rough 

diamonds that meets substantially the 

standards, practices, and procedures of 

the Kimberley Process Certification 

Scheme.

Note 1 to § 592.301. The Secretary of State 

will periodically publish in the Federal 

Register an up-to-date listing of all 

Participants and their importing and 

exporting authorities. Where appropriate, 

such listing also will describe any 

modification of the requirements set forth in 

paragraph (a) of this section.

Note 2 to § 592.301. Pursuant to 31 CFR 

§§ 501.601 and 501.602, the recordkeeping 

and reporting requirements imposed by 

§ 592.501 apply to all U.S. persons engaged 

in the importation into, or exportation from, 

the United States of any shipment of rough 

diamonds.

Note 3 to § 592.301. Effective November 1, 

2004, customs brokers, importers, and filers 

making entry of a shipment of rough 

diamonds must either submit through U.S. 

Customs’ Automated Broker Interface (ABI) 

system the unique identifying number of the 

Kimberley Process Certificate accompanying 

the shipment or, for non-ABI entries, indicate 

the certificate number on the Customs Form 

7501 Entry Summary at each entry line.

§ 592.302 Effective date. 

The term effective date refers to the 

effective date of the applicable 

prohibitions and directives contained in 

this part as follows: 

(a) With respect to all provisions of 

this part except for § 592.301(a)(3), 

12:01 a.m., eastern daylight time, July 

30, 2003; and 

(b) With respect to § 592.301(a)(3), 

September 23, 2004.

§ 592.303 Entity. 

The term entity means a partnership, 

association, trust, joint venture, 

corporation, or other organization.

§ 592.304 Exporting authority. 

(a) The term exporting authority

means one or more entities designated 

by a Participant from whose territory a 

shipment of rough diamonds is being 

exported as having the authority to 

validate the Kimberley Process 

Certificate. 

(b) The exporting authority for the 

United States is the U.S. Bureau of the 

Census.

Note to § 592.304. The Secretary of State 

will periodically publish in the Federal 

Register an up-to-date listing of the exporting 

authorities of all Participants.

§ 592.305 Importation into the United 

States. 

The term importation into the United 

States means the bringing of goods into 

the United States.

§ 592.306 Importing authority. 

(a) The term importing authority

means one or more entities designated 

by a Participant into whose territory a 

shipment of rough diamonds is being 

56940 Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 

imported as having the authority to 

enforce the laws and regulations of the 

Participant regulating imports, 

including the verification of the 

Kimberley Process Certificate 

accompanying the shipment. 

(b) The importing authorities for the 

United States are the U.S. Bureau of 

Customs and Border Protection or, in 

the case of a territory or possession of 

the United States with its own customs 

administration, analogous officials.

Note to § 592.306. The Secretary of State 

will periodically publish in the Federal 

Register an up-to-date listing of the 

importing authorities of all Participants.

§ 592.307 Kimberley Process Certificate. 

The term Kimberley Process 

Certificate means a tamper- and forgeryresistant document that bears the 

following information in any language, 

provided that an English translation is 

incorporated:

(a) The title ‘‘Kimberley Process 

Certificate’’ and the statement: ‘‘The 

rough diamonds in this shipment have 

been handled in accordance with the 

provisions of the Kimberley Process 

Certification Scheme for rough 

diamonds’’; 

(b) Country of origin for shipment of 

parcels of unmixed (i.e., from the same) 

origin;

Note to paragraph (b). A shipment 

including a parcel of mixed-origin rough 

diamonds is to be entered into the United 

States with the Kimberley Process Certificate 

accompanying the shipment, and the 

certificate need not indicate the countries of 

origin of the diamonds. With respect to such 

a shipment, the country-of-origin field on the 

certificate must be filled in with asterisks. 

The shipment must, however, still comply 

with all other country-of-origin reporting 

requirements imposed by statute or 

regulation.

(c) Unique numbering with the Alpha 

2 country code, according to ISO 3166–

1; 

(d) Date of issuance; 

(e) Date of expiry; 

(f) Name of issuing authority; 

(g) Identification of exporter and 

importer; 

(h) Carat weight/mass; 

(i) Value in U.S. dollars; 

(j) Number of parcels in the shipment; 

(k) Relevant Harmonized Commodity 

Description and Coding System; and 

(l) Validation by the exporting 

authority.

Note to paragraph (l). See § 592.301(a)(4) 

for procedures governing the validation of 

the Kimberley Process Certificate when 

exporting from the United States.

§ 592.308 Participant.

The term Participant means a state, 

customs territory, or regional economic 

integration organization identified by 

the Secretary of State as one for which 

rough diamonds are controlled through 

the Kimberley Process Certification 

Scheme.

Note to § 592.308. The Secretary of State 

will periodically publish in the Federal 

Register an up-to-date listing of all 

Participants.

§ 592.309 Person. 

The term person means an individual 

or entity.

§ 592.310 Rough diamond. 

The term rough diamond means any 

diamond that is unworked or simply 

sawn, cleaved, or bruted and classifiable 

under subheading 7102.10, 7102.21, or 

7102.31 of the Harmonized Tariff 

Schedule of the United States.

§ 592.311 United States. 

The term United States, when used in 

the geographic sense, means the several 

States, the District of Columbia, and any 

commonwealth, territory, or possession 

of the United States.

§ 592.312 United States person; U.S. 

person. 

The term United States person or U.S. 

person means any United States citizen; 

any alien admitted for permanent 

residence into the United States; any 

entity organized under the laws of the 

United States or any jurisdiction within 

the United States (including its foreign 

branches); or any person in the United 

States.

Subpart D—Interpretations

§ 592.401 Reference to amended sections. 

Except as otherwise specified, 

reference to any provision in this part or 

chapter or to any other regulation refers 

to the same as currently amended.

§ 592.402 Effect of amendment. 

Unless otherwise specifically 

provided, any amendment, 

modification, or revocation of any 

provision in or appendix to this part or 

chapter or of any order, regulation, 

ruling, or instruction issued by or under 

the direction of the Director of the 

Office of Foreign Assets Control does 

not affect any act done or omitted, or 

any civil or criminal suit or proceeding 

commenced or pending prior to such 

amendment, modification, or 

revocation. All penalties, forfeitures, 

and liabilities under any such order, 

regulation, ruling, or instruction 

continue and may be enforced as if such 

amendment, modification, or revocation 

had not been made.

§ 592.403 Transshipment or transit 

through the United States. 

The prohibitions in § 592.201 apply to 

the importation into, or exportation 

from, the United States, for 

transshipment or transit, of any rough 

diamond intended or destined for any 

country other than the United States, 

unless the shipment is sealed in a 

tamper-resistant container, 

accompanied by a Kimberley Process 

Certificate, and leaves the United States 

in the identical state in which it 

entered. The validation, recordkeeping, 

and reporting procedures applicable to 

importations and exportations do not 

apply in this case.

§ 592.404 Importation into or release from 

a bonded warehouse or foreign trade zone. 

The requirements of the Kimberley 

Process Certification Scheme apply to 

all imported shipments of a rough 

diamond, regardless of whether they are 

destined for entry into, or withdrawal 

from, a bonded warehouse or a foreign 

trade zone of the United States.

Subpart E—Records and Reports

§ 592.501 Records and reports. 

For provisions relating to required 

records and reports, see part 501, 

subpart C, of this chapter. 

Recordkeeping and reporting 

requirements imposed by part 501 of 

this chapter with respect to the 

prohibitions contained in this part are 

considered requirements arising 

pursuant to this part.

Subpart F—Penalties

§ 592.601 Penalties. 

(a) Attention is directed to section 8 

of the Clean Diamond Trade Act (the 

‘‘Act’’) (Pub. L. 108–19), which provides 

that: 

(1) A civil penalty not to exceed 

$10,000 per violation may be imposed 

on any person who violates, or attempts 

to violate, any order or regulation issued 

under the Act; 

(2) Whoever willfully violates, or 

willfully attempts to violate, any order 

or regulation issued under this Act 

shall, upon conviction, be fined not 

more than $50,000, or, if a natural 

person, may be imprisoned for not more 

than 10 years, or both; and any officer, 

director, or agent of any corporation 

who willfully participates in such 

violation may be punished by a like 

fine, imprisonment, or both; and 

(3) Those customs laws of the United 

States, both civil and criminal, 

including those laws relating to seizure 

Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 56941

and forfeiture, that apply to articles 

imported in violation of such laws shall 

apply with respect to any rough 

diamond imported in violation of the 

Act.

Note to paragraph (a). As reflected in 

paragraphs (a)(1) and (2) of this section, 

section 8(a) of the Clean Diamond Trade Act 

(Pub. L. 108–19) establishes penalties with 

respect to any violation of any regulation 

issued under the Act. OFAC prepenalty, 

penalty, and administrative collection 

procedures relating to such violations are set 

forth below in §§ 592.602 through 592.605. 

Section 8(c) of the Act also authorizes the 

U.S. Bureau of Customs and Border 

Protection and the U.S. Bureau of 

Immigration and Customs Enforcement, as 

appropriate, to enforce the penalty provisions 

set forth in paragraph (a) of this section and 

to enforce the laws and regulations governing 

exports of rough diamonds, including with 

respect to the validation of the Kimberley 

Process Certificate by the U.S. Bureau of the 

Census. The Office of Foreign Assets Control 

civil penalty procedures set forth below are 

separate from, and independent of, any 

penalty procedures that may be followed by 

the U.S. Bureau of Customs and Border 

Protection and the U.S. Bureau of 

Immigration and Customs Enforcement in 

their exercise of the authorities set forth in 

section 8(c) of the Clean Diamond Trade Act.

(b) The criminal penalties provided in 

the Act are subject to increase pursuant 

to 18 U.S.C. 3571. 

(c) Attention is also directed to 18 

U.S.C. 1001, which provides that 

whoever, in any matter within the 

jurisdiction of the executive, legislative, 

or judicial branch of the Government of 

the United States, knowingly and 

willfully falsifies, conceals, or covers up 

by any trick, scheme, or device, a 

material fact, or makes any materially 

false, fictitious, or fraudulent statement 

or representation or makes or uses any 

false writing or document knowing the 

same to contain any materially false, 

fictitious, or fraudulent statement or 

entry shall be fined under title 18, 

United States Code, or imprisoned not 

more than five years, or both. 

(d) Violations of this part may also be 

subject to relevant provisions of other 

applicable laws.

§ 592.602 Prepenalty notice. 

(a) When required. If the Director of 

the Office of Foreign Assets Control has 

reason to believe that there has occurred 

a violation of any provision of this part 

or a violation of the provisions of any 

regulation or order issued by or 

pursuant to the direction or 

authorization of the Secretary of the 

Treasury pursuant to this part or 

otherwise under the Clean Diamond 

Trade Act, and the Director determines 

that further civil proceedings are 

warranted, the Director shall notify the 

alleged violator of the agency’s intent to 

impose a monetary penalty by issuing a 

prepenalty notice. The prepenalty 

notice shall be in writing. The 

prepenalty notice may be issued 

whether or not another agency has taken 

any action with respect to the matter. 

(b) Contents of notice—(1) Facts of 

violation. The prepenalty notice shall 

describe the violation, specify the laws 

and regulations allegedly violated, and 

state the amount of the proposed 

monetary penalty. 

(2) Right to respond. The prepenalty 

notice also shall inform the respondent 

of the respondent’s right to make a 

written presentation within the 

applicable 30-day period set forth in 

§ 592.603 as to why a monetary penalty 

should not be imposed or why, if 

imposed, the monetary penalty should 

be in a lesser amount than proposed.

(c) Informal settlement prior to 

issuance of prepenalty notice. At any 

time prior to the issuance of a 

prepenalty notice, an alleged violator 

may request in writing that, for a period 

not to exceed sixty (60) days, the agency 

withhold issuance of the prepenalty 

notice for the exclusive purpose of 

effecting settlement of the agency’s 

potential civil monetary penalty claims. 

In the event the Director grants the 

request, under terms and conditions 

within his discretion, the Office of 

Foreign Assets Control will agree to 

withhold issuance of the prepenalty 

notice for a period not to exceed 60 days 

and will enter into settlement 

negotiations of the potential civil 

monetary penalty claim.

§ 592.603 Response to prepenalty notice; 

informal settlement. 

(a) Deadline for response. The 

respondent may submit a response to 

the prepenalty notice within the 

applicable 30-day period set forth in 

this paragraph. The Director of the 

Office of Foreign Assets Control may 

grant, at his discretion, an extension of 

time in which to submit a response to 

the prepenalty notice. The failure to 

submit a response within the applicable 

time period set forth in this paragraph 

shall be deemed to be a waiver of the 

right to respond. 

(1) Computation of time for response.

A response to the prepenalty notice 

must be postmarked or date-stamped by 

the U.S. Postal Service (or foreign postal 

service, if mailed abroad) or courier 

service provider (if transmitted to the 

Office of Foreign Assets Control by 

courier) on or before the 30th day after 

the postmark date on the envelope in 

which the prepenalty notice was 

mailed. If the respondent refused 

delivery or otherwise avoided receipt of 

the prepenalty notice, a response must 

be postmarked or date-stamped on or 

before the 30th day after the date on the 

stamped postal receipt maintained at 

the Office of Foreign Assets Control. If 

the prepenalty notice was personally 

delivered to the respondent by a nonU.S. Postal Service agent authorized by 

the Director, a response must be 

postmarked or date-stamped on or 

before the 30th day after the date of 

delivery. 

(2) Extensions of time for response. If 

a due date falls on a federal holiday or 

weekend, that due date is extended to 

include the following business day. Any 

other extensions of time will be granted, 

at the Director’s discretion, only upon 

the respondent’s specific request to the 

Office of Foreign Assets Control. 

(b) Form and method of response. The 

response must be submitted in writing 

and may be handwritten or typed. The 

response need not be in any particular 

form. A copy of the written response 

may be sent by facsimile, but the 

original also must be sent to the Office 

of Foreign Assets Control Civil Penalties 

Division by mail or courier and must be 

postmarked or date-stamped, in 

accordance with paragraph (a) of this 

section. 

(c) Contents of response. A written 

response must contain information 

sufficient to indicate that it is in 

response to the prepenalty notice and 

must include the Office of Foreign 

Assets Control identification number 

listed on the prepenalty notice. 

(1) A written response must include 

the respondent’s full name, address, 

telephone number, and facsimile 

number, if available, or those of the 

representative of the respondent.

(2) A written response should either 

admit or deny each specific violation 

alleged in the prepenalty notice and also 

state if the respondent has no 

knowledge of a particular violation. If 

the written response fails to address any 

specific violation alleged in the 

prepenalty notice, that alleged violation 

shall be deemed to be admitted. 

(3) A written response should include 

any information in defense, evidence in 

support of an asserted defense, or other 

factors that the respondent requests the 

Office of Foreign Assets Control to 

consider. Any defense or explanation 

previously made to the Office of Foreign 

Assets Control or any other agency must 

be repeated in the written response. Any 

defense not raised in the written 

response will be considered waived. 

The written response also should set 

forth the reasons why the respondent 

believes the penalty should not be 

imposed or why, if imposed, it should 

be in a lesser amount than proposed. 

56942 Federal Register / Vol. 69, No. 184 / Thursday, September 23, 2004 / Rules and Regulations 

(d) Failure to respond. Where the 

Office of Foreign Assets Control receives 

no response to a prepenalty notice 

within the applicable time period set 

forth in paragraph (a) of this section, a 

penalty notice generally will be issued, 

taking into account the mitigating and/

or aggravating factors present in the 

record. If there are no mitigating factors 

present in the record, or the record 

contains a preponderance of aggravating 

factors, the proposed prepenalty amount 

generally will be assessed as the final 

penalty. 

(e) Informal settlement. In addition to 

or as an alternative to a written response 

to a prepenalty notice, the respondent or 

respondent’s representative may contact 

the Office of Foreign Assets Control as 

advised in the prepenalty notice to 

propose the settlement of allegations 

contained in the prepenalty notice and 

related matters. However, the 

requirements set forth in paragraph (f) of 

this section as to oral communication by 

the representative must first be fulfilled. 

In the event of settlement at the 

prepenalty stage, the claim proposed in 

the prepenalty notice will be 

withdrawn, the respondent will not be 

required to take a written position on 

allegations contained in the prepenalty 

notice, and the Office of Foreign Assets 

Control will make no final 

determination as to whether a violation 

occurred. The amount accepted in 

settlement of allegations in a prepenalty 

notice may vary from the civil penalty 

that might finally be imposed in the 

event of a formal determination of 

violation. In the event no settlement is 

reached, the time limit specified in 

paragraph (a) of this section for written 

response to the prepenalty notice will 

remain in effect unless additional time 

is granted by the Office of Foreign 

Assets Control. 

(f) Representation. A representative of 

the respondent may act on behalf of the 

respondent, but any oral 

communication with the Office of 

Foreign Assets Control prior to a written 

submission regarding the specific 

allegations contained in the prepenalty 

notice must be preceded by a written 

letter of representation, unless the 

prepenalty notice was served upon the 

respondent in care of the representative.

§ 592.604 Penalty imposition or 

withdrawal. 

(a) No violation. If, after considering 

any response to the prepenalty notice 

and any relevant facts, the Director of 

the Office of Foreign Assets Control 

determines that there was no violation 

by the respondent named in the 

prepenalty notice, the Director shall 

notify the respondent in writing of that 

determination and of the cancellation of 

the proposed monetary penalty.

(b) Violation. (1) If, after considering 

any written response to the prepenalty 

notice, or default in the submission of 

a written response, and any relevant 

facts, the Director of the Office of 

Foreign Assets Control determines that 

there was a violation by the respondent 

named in the prepenalty notice, the 

Director is authorized to issue a written 

penalty notice to the respondent of the 

determination of the violation and the 

imposition of the monetary penalty. 

(2) The penalty notice shall inform 

the respondent that payment or 

arrangement for installment payment of 

the assessed penalty must be made 

within 30 days of the date of mailing of 

the penalty notice by the Office of 

Foreign Assets Control. 

(3) The penalty notice shall inform 

the respondent of the requirement to 

furnish the respondent’s taxpayer 

identification number pursuant to 31 

U.S.C. 7701 and that such number will 

be used for purposes of collecting and 

reporting on any delinquent penalty 

amount. 

(4) The issuance of the penalty notice 

finding a violation and imposing a 

monetary penalty shall constitute final 

agency action. The respondent has the 

right to seek judicial review of that final 

agency action in federal district court.

§ 592.605 Administrative collection; 

referral to United States Department of 

Justice. 

In the event that the respondent does 

not pay the penalty imposed pursuant to 

this part or make payment arrangements 

acceptable to the Director of the Office 

of Foreign Assets Control within 30 

days of the date of mailing of the 

penalty notice, the matter may be 

referred for administrative collection 

measures by the Department of the 

Treasury or to the United States 

Department of Justice for appropriate 

action to recover the penalty in a civil 

suit in a federal district court.

Subpart G—Procedures

§ 592.701 Procedures.

For procedures relating to rulemaking 

and requests for documents pursuant to 

the Freedom of Information and Privacy 

Acts (5 U.S.C. 552 and 552a), see part 

501, subpart E, of this chapter.

§ 592.702 Delegation by the Secretary of 

the Treasury. 

Any action that the Secretary of the 

Treasury is authorized to take pursuant 

to Executive Order 13312 (FR vol. 68, 

No. 147, July 31, 2003) and any further 

Executive orders relating to the Clean 

Diamond Trade Act (Pub. L. 108–19) 

may be taken by the Director of the 

Office of Foreign Assets Control or by 

any other person to whom the Secretary 

of the Treasury has delegated authority 

so to act.

Subpart H—Paperwork Reduction Act

§ 592.801 Paperwork Reduction Act notice. 

For approval by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3507) of the information 

collections relating to the recordkeeping 

and reporting requirements of 

§§ 592.301(a)(1), subpart C, § 592.501, 

subpart E, and 592.603, subpart F, see

§ 501.901 of this chapter. The 

information collection requirements in 

§§ 592.301(a)(3) and (a)(4), subpart C, 

have been approved by the OMB and 

assigned control numbers 1505–0198 

and 0607–0152, respectively. An agency 

may not conduct or sponsor, and a 

person is not required to respond to, a 

collection of information unless it 

displays a valid control number 

assigned by OMB.

Dated: August 20, 2004. 

R. Richard Newcomb, 

Director, Office of Foreign Assets Control.

Approved: September 2, 2004. 

Juan Zarate, 

Assistant Secretary (Terrorist Financing), 

Department of the Treasury.

[FR Doc. 04–21329 Filed 9–20–04; 10:11 am] 

BILLING CODE 4810–25–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[IA–191–1191; FRL–7812–5] 

Approval and Promulgation of Air 

Quality Implementation Plans; Iowa 

Update to Materials Incorporated by 

Reference

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule; notice of 

administrative change. 

SUMMARY: EPA is updating the materials 

submitted by Iowa that are incorporated 

by reference (IBR) into the state 

implementation plan (SIP). The 

regulations affected by this update have 

been previously submitted by the state 

agency and approved by EPA. This 

update affects the SIP materials that are 

available for public inspection at the 

Office of the Federal Register (OFR), 

Office of Air and Radiation Docket and 

Information Center, and the Regional 

Office.