Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Proposed Rules 58371

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 170

[Docket No. 2001N–0234]

Food Additives: Food Contact 

Substance Notification System; 

Withdrawal

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Advance notice of proposed 

rulemaking; withdrawal.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of our advance notice of 

proposed rulemaking (ANPRM) 

published in the Federal Register of 

May 21, 2002 (67 FR 35764). The 

ANPRM requested input on whether the 

agency should establish regulations 

permitting the licensing of the rights to 

manufacture and market a food contact 

substance (FCS) for a use that is the 

subject of an effective food contact 

notification (FCN). FDA is withdrawing 

the ANPRM based upon comments 

indicating that such a regulation would 

not be necessary.

DATES: The advance notice of proposed 

rulemaking is withdrawn September 30, 

2004.

FOR FURTHER INFORMATION CONTACT:

Kenneth McAdams, Center for Food 

Safety and Applied Nutrition (HFS–

275), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 202–418–3392, e-mail: 

kenneth.mcadams@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 21, 2002 (67 FR 

35764), FDA published an ANPRM 

requesting input on whether the agency 

should establish regulations permitting 

the licensing of the rights to 

manufacture and market an FCS for a 

use that is the subject of an effective 

FCN. We received five comments on the 

ANPRM. Three of the comments, from 

individuals, concerned unrelated issues 

and did not address the ANPRM. The 

other two comments, from the American 

Plastics Council and the Society of the 

Plastics Industry, stated that a 

procedure to transfer or license the 

rights to an FCN is not needed because 

of the speed and efficiency of the 

current FCN system. Both comments 

also stated that if regulations for such a 

procedure are issued, they should be 

kept simple, requiring only notification 

that the transfer has occurred.

After careful consideration of these 

comments, FDA has concluded that a 

procedural regulation for transferring or 

licensing the rights to an FCN is not 

needed. Therefore, FDA is withdrawing 

our ANPRM.

Dated: September 17, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22013 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. 2003P–0564]

Microbiology Devices; Reclassification 

of Hepatitis A Virus (HAV) Serological 

Assays (IgM Antibody, IgG Antibody 

and Total Antibodies (IgM and IgG))

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

reclassify hepatitis A virus (HAV) 

serological assays from Class III 

(premarket approval) to class II (special 

controls). These devices are used for 

testing specimens from individuals who 

have signs and symptoms consistent 

with acute hepatitis A or for 

determining if an individual has been 

previously infected with HAV. The 

detection of these antibodies aids in the 

clinical laboratory diagnosis of an acute 

or past infection by HAV in conjunction 

with other clinical laboratory findings. 

FDA is proposing this action after 

reviewing a reclassification petition 

submitted by Beckman Coulter, Inc. The 

agency is taking this action under the 

Federal Food, Drug, and Cosmetic Act 

(the act), as amended by the Medical 

Device Amendments of 1976 (the 1976 

amendments), the Safe Medical Devices 

Act of 1990 (the SMDA), and the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA). Elsewhere in this 

issue of the Federal Register, FDA is 

announcing the availability of a class II 

special controls draft guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Hepatitis A Serological 

Assays for the Clinical Laboratory 

Diagnosis of Hepatitis A Virus.’’

DATES: Submit written or electronic 

comments by December 29, 2004. See 

section VIII of this document for the 

proposed effective date of a final rule 

based on this proposed rule.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Sally Hojvat, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 301–594–

2096.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

The act, as amended by the 1976 

amendments (Public Law 94–295), the 

SMDA (Public Law 101–629), and 

FDAMA (Public Law 105–115), 

established a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the act (21 U.S.C. 360c) established 

three categories (classes) of devices, 

depending on the regulatory controls 

needed to provide reasonable assurance 

of their safety and effectiveness. The 

three categories of devices are class I 

(general controls), class II (special 

controls), and class III (premarket 

approval).

Under section 513 of the act, devices 

that were in commercial distribution 

before May 28, 1976 (the date of 

enactment of the 1976 amendments), 

generally referred to as preamendments 

devices, are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures.

Devices that were not in commercial 

distribution prior to May 28, 1976, 

generally referred to as postamendments 

devices, are classified automatically by 

statute (section 513(f) of the act) into 

class III without any FDA rulemaking 

process. Those devices generally remain 

in class III until the device is 

reclassified into class I or II, or FDA 

issues an order finding the device to be 

substantially equivalent, under section 

513(i) of the act, to a legally marketed 

device. The agency determines whether 

new devices are substantially equivalent 

to previously offered devices by means 

of premarket notification procedures in 

section 510(k) of the act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807).

A preamendments device that has 

been classified into class III may be 

marketed, by means of premarket 

notification procedures, without 

58372 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Proposed Rules 

submission of a premarket approval 

application (PMA) until FDA issues a 

final regulation under section 515(b) of 

the act (21 U.S.C. 360e(b)) requiring 

premarket approval.

Section 513(f)(3) allows FDA to 

initiate reclassification of a 

postamendments device classified into 

class III under section 513(f)(1) of the 

act, or the manufacturer or importer of 

a device to petition the Secretary of the 

Department of Health and Human 

Services for the issuance of an order 

classifying the device in class I or class 

II. FDA’s regulations in § 860.134 (21 

CFR 860.134) set forth the procedures 

for the filing and review of a petition for 

reclassification of such class III devices. 

To change the classification of the 

device, it is necessary that the proposed 

new classification have sufficient 

regulatory controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use.

II. Regulatory History of the Device

HAV serological assays are used for 

testing specimens from individuals who 

have signs and symptoms consistent 

with acute hepatitis A or for 

determining if an individual has been 

previously infected with HAV. The 

detection of these antibodies aids in the 

clinical laboratory diagnosis of an acute 

or past infection by HAV in conjunction 

with other clinical laboratory findings. 

These devices are postamendments 

devices classified into class III under 

section 513(f)(1) of the act and must be 

the subject of an approved PMA under 

section 515 of the act before being 

placed into commercial distribution, 

unless they are reclassified under 

section 513(f)(3) of the act.

In accordance with section 513(f)(3) of 

the act and § 860.134, Beckman Coulter, 

Inc., submitted a petition on October 1, 

2003, requesting reclassification of HAV 

antibody assays from class III to class II.

III. Device Description

Hepatitis A virus serological assays 

are devices that consist of antigens and 

antisera for the detection of hepatitis A 

virus-specific immunoglobulin M (IgM), 

immunoglobulin G (IgG), or total 

antibodies (IgM and IgG), in human 

serum or plasma (Refs. 1 and 2). These 

devices are used for testing specimens 

from individuals who have signs and 

symptoms consistent with acute 

hepatitis or for determining if an 

individual has been previously infected 

with hepatitis A virus. The detection of 

these antibodies aids in the clinical 

laboratory diagnosis of an acute or past 

infection by the hepatitis A virus in 

conjunction with other clinical 

laboratory findings. The presence of IgM 

type antibodies differentiates an acute 

infection from past infection. These 

devices are not intended for screening 

blood or solid or soft tissue donors.

Currently marketed HAV serological 

assays typically are used on automated 

laboratory analyzers, providing 

reportable results within 45 minutes. 

FDA has also approved assays based on 

manual enzyme-linked immunosorbent 

assay (ELISA) and radioimmunoassay 

methods. Regardless of method, these 

assays typically rely on specific binding 

of antibodies to HAV and to fixed HAV 

antigen, which is then detected by a 

labeled secondary (anti-IgM or anti-IgG) 

antibody. HAV specific IgM may also be 

detected by the binding of human IgM 

to anti-human IgM bound to a solid 

matrix. Labeled HAV antigen is then 

added and if specific anti-HAV has been 

captured the antigen will bind. Serum 

and plasma are the common matrices for 

currently marketed assays for HAV 

antibodies, as antibodies reside 

physiologically in the liquid portion of 

the blood, and are therefore reliably 

detected there or in plasma. Currently, 

World Health Organization (WHO) 

material standards are available for 

standardization of anti-HAV assays 

(Refs. 3 and 4).

IV. Proposed Reclassification

The agency is proposing to reclassify 

HAV serological assays from class III to 

class II and has developed a guidance 

document which, when final, will serve 

as the special control. Elsewhere in this 

issue of the Federal Register, FDA is 

announcing the availability of this draft 

guidance for comment in accordance 

with FDA’s good guidance practices 

(GGPs) regulation (21 CFR 10.115). We 

have determined that there is adequate 

valid scientific evidence in the public 

domain to support this reclassification 

action and, therefore, it was 

unnecessary to refer the petition to a 

classification panel for its review and 

recommendation.

V. Risks to Health

There are no known direct risks to an 

individual’s health associated with the 

device. However, failure of HAV 

serological assays to perform as 

indicated or an error in interpretation of 

results may lead to improper patient 

management. There are no clinical 

features that distinguish HAV infection 

from infection by other etiologic agents 

of hepatitis such as the hepatitis B virus 

or hepatitis C virus. HAV serological 

assays are used to aid in this distinction. 

Therefore, false test results could 

contribute to misdiagnosis and 

improper patient management.

A false negative measurement with 

failure to detect HAV-specific IgM 

would misdiagnose an active HAV 

infection. False negative HAV 

serological assay results may place 

individuals infected with preexisting 

liver disease at risk for not receiving 

appropriate therapy. It has been shown 

that HAV infection in individuals with 

preexisting liver disease, e.g., HCV 

infection, has been associated with an 

increased rate of fulminant hepatitis and 

mortality (Refs. 5 to 7). The 

administration of HAV-specific 

hyperimmune globulin may help to 

prevent or improve the clinical 

manifestations of disease if given within 

2 weeks of infection as prophylaxis, 

although it is generally not helpful in 

the acute phase of HAV infection (Ref. 

8). In healthy individuals, HAV 

infections are generally self-limiting 

without serious consequences, with no 

chronic or persistent hepatitis (Ref. 9). 

The failure to detect HAV-specific total 

or IgG antibodies would result in 

misdiagnosis of past infection and may 

cause individuals to erroneously receive 

vaccination for HAV. It is believed that 

this would be of minimal risk because 

there is currently no contraindication 

for an individual immune to HAV 

receiving HAV vaccination.

A false positive measurement can 

result in incorrect diagnosis of active or 

past HAV infection. If HAV-specific 

total antibodies are detected 

erroneously, an individual may not 

receive the vaccine for HAV, and could 

continue to be at risk for HAV infection. 

A false positive anti-HAV IgM result 

also has public health considerations 

because the majority of state health 

departments are required to followup 

reported acute HAV infections. This 

would place an undue burden on state 

health department resources.

VI. Special Controls

In addition to general controls, FDA 

believes that the draft guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Hepatitis A Serological 

Assays for the Clinical Laboratory 

Diagnosis of Hepatitis A Virus’’ is an 

adequate special control to address the 

risk to health described above. 

Following the effective date of this final 

classification rule, any firm submitting 

a 510(k) premarket notification for 

Hepatitis A Virus (HAV) serological 

assays will need to address the issues 

covered in the special controls 

guidance. However, the firm need only 

show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurance of safety and effectiveness.

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Proposed Rules 58373

The class II special controls guidance 

provides information on how to meet 

premarket (510(k)) submission 

requirements for the assays in sections 

that discuss performance characteristics 

and labeling. The performance 

characteristics section describes studies 

integral to demonstration of appropriate 

performance and control against assays 

that may fail to perform to current 

standards. The labeling section 

addresses factors such as directions for 

use, quality control and precautions for 

use and interpretation. FDA tentatively 

believes that complying with the act and 

regulations and following the special 

controls guidance document will 

provide reasonable assurance of safety 

and effectiveness of these devices and 

adequately address the risk to health 

identified in section V of this document.

VII. FDA’s Tentative Findings

The efficacy of diagnosis of HAV by 

HAV antibody detection has been wellestablished over the past 25 years. HAV 

antibody detection plays a key role in 

diagnosis of HAV infection, because 

there are no other approved clinical or 

laboratory methods that are specific for 

HAV infection. Technological 

improvements have increased the 

reliability and clinical sensitivity and 

specificity of performance of these 

devices. A technologically improved 

enzyme-linked immunosorbent assay 

(ELISA) format, new detection 

methodology, and the advent of 

monoclonal antibody technology have 

enhanced the sensitivity and specificity 

of the assays without introducing 

confounding issues (Ref. 10).

FDA has considered issues that could 

potentially complicate use or 

interpretation of HAV antibody assay 

results. There do not appear to be 

notable concerns for use and 

interpretation of HAV antibody assays 

because most assays are now automated, 

HAV infection is primarily self-limiting, 

and there are no specific treatment 

measures for HAV infection. In 

addition, a WHO material reference for 

HAV antibodies is available and assays 

from different manufacturers should be 

expected to report similarly due to 

standardization to this material (Refs. 3 

and 4) . Because HAV antibody assays 

are currently the only approved specific 

diagnostic for HAV infection, the 

guidance recommends that assay results 

only be interpreted in the context of 

other laboratory findings and the total 

clinical status of the patient.

The FDAMA added section 510(m) to 

the act (21 U.S.C. 360(m)). Section 

510(m) of the act provides that a class 

II device may be exempted from the 

premarket notification requirements 

under section 510(k) of the act (21 

U.S.C. 360(k)), if the agency determines 

that premarket notification is not 

necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. For this type of device, 

FDA has determined that premarket 

notification is necessary to provide 

reasonable assurance of safety and 

effectiveness and, therefore, the device 

is not exempt from the premarket 

notification requirements. FDA review 

of performance characteristics will 

provide reasonable assurance that 

acceptable levels of performance for 

both safety and effectiveness are 

addressed before marketing clearance. 

Thus, persons who intend to market this 

device must submit to FDA a premarket 

notification submission containing 

information on HAV antibody detection 

assays before marketing the device.

VIII. Effective Date

FDA proposes that any final 

regulation that may issue based on this 

proposal become effective 30 days after 

its date of publication in the Federal 

Register.

IX. Environmental Impact

The agency has determined that under 

21 CFR 25.34(b) that this reclassification 

action is of a type that does not 

individually or cumulatively have a 

significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required.

X. Analysis of Impacts

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866, the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The agency 

believes that this proposed rule is not a 

significant regulatory action as defined 

by the Executive order.

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because reclassification of the 

device from class III to class II will 

relieve manufacturers of the cost of 

complying with the premarket approval 

requirements of section 515 of the act 

and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the agency certifies 

that the proposed rule will not have a 

significant economic impact on a 

substantial number of small entities.

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $110 

million. FDA does not expect this 

proposed rule to result in any 1-year 

expenditure that would meet or exceed 

this amount.

XI. Paperwork Reduction Act of 1995

FDA tentatively concludes that this 

proposed rule contains no new 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required.

XII. Request for Comments and 

Proposed Dates

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

XIII. References

The following references have been 

placed on display in the Division of 

Dockets Management (address above) 

and may be seen by interested persons 

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

through Friday.

1. Lemon, S.M., and N. Binn, ‘‘Serum 

Neutralizing Antibody Response to 

Hepatitis A Virus,’’ Journal of Infectious 

Diseases, 14:1033–1039, 1983.

2. Lemon, S.M., ‘‘Type A Viral 

Hepatitis: Epidemiology, Diagnosis, and 

Prevention,’’ Clinical Chemistry, 

43:1494–1499, 1997.

3. WHO International Standard for 

anti-HAV Immunoglobulin; 2nd 

International Standard 1998, WHO/BS/

98.1878, 98.1878. Add. 1 (Cited in WHO 

International Biological Reference 

58374 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Proposed Rules 

Preparations (Version 2001 Catalog, 

page 3 of 34 at: http://www9.who.int/

vaccines/Biologicals/KAlph.pdf)).

4. Ferguson, M., et al., ‘‘Hepatitis A 

Immunoglobulin: an International 

Collaborative Study to Establish the 

Second International Standard,’’

Biologicals, 28:233–240, 2000.

5. Devalle, S., V.S. de Paula, J.M. de 

Oliveira, et. al., ‘‘Hepatitis A virus 

infection in hepatitis C Brazilian 

patients,’’ Journal of Infectious Diseases, 

August, 47(2):125–128, 2003.

6. Koff, R.S., ‘‘Risks associated with 

hepatitis A and hepatitis B in patients 

with hepatitis C,’’ Journal of Clinical 

Gastroenerology, July, 33(1):20–26, 

2001.

7. Vento, S., ‘‘Fulminant hepatitis 

associated with hepatitis A virus 

superinfection in patients with chronic 

hepatitis C,’’ Journal of Viral Hepatitis, 

May; 7 Suppl 1:7–8, 2000.

8. Stapleton, J.T., ‘‘Host immune 

response to hepatitis A virus,’’ Journal 

of Infectious Diseases, 171(S1):S9–S14, 

1995.

9. Hollinger, F.B. and S.U. Emerson, 

‘‘Hepatitis A Virus,’’ in D.M. Knipe et 

al., eds. Fields Virology, 4th ed. 

Lippincott Williams and Wilkins, 

Philadelphia, 799–840, 2001.

10. Brown, E.A., and J.T. Stapleton, 

‘‘Hepatitis A Virus’’ in P.R. Murray et 

al., eds., Manual of Clinical 

Microbiology, 8th ed., ASM Press, 

Washington, DC, 1452–1463, 2003.

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 

proposed to be 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 866.3310 is added to subpart 

D to read as follows:

§ 866.3310 Hepatitis A Virus (HAV) 

serological assays.

(a) Identification. Hepatitis A virus 

serological assays are devices that 

consist of antigens and antisera for the 

detection of hepatitis A virus-specific 

IgM, IgG, or total antibodies (IgM and 

IgG), in human serum or plasma. These 

devices are used for testing specimens 

from individuals who have signs and 

symptoms consistent with acute 

hepatitis or for determining if an 

individual has been previously infected 

with hepatitis A virus. The detection of 

these antibodies aids in the clinical 

laboratory diagnosis of an acute or past 

infection by hepatitis A virus in 

conjunction with other clinical 

laboratory findings. These devices are 

not intended for screening blood or 

solid or soft tissue donors.

(b) Classification. Class II (special 

controls). The special control is ‘‘Class 

II Special Controls Guidance Document: 

Hepatitis A Serological Assays for the 

Clinical Laboratory Diagnosis of 

Hepatitis A Virus.’’ See § 866.1(e) for the 

availability of this guidance document.

Dated: September 21, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–22009 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

31 CFR Part 103 

RIN 1506–AA65 

Financial Crimes Enforcement 

Network; Amendment to the Bank 

Secrecy Act Regulations—Imposition 

of Special Measure Against First 

Merchant Bank OSH Ltd, Including Its 

Subsidiaries, FMB Finance Ltd, First 

Merchant International Inc, First 

Merchant Finance Ltd, and First 

Merchant Trust Ltd, as a Financial 

Institution of Primary Money 

Laundering Concern

AGENCY: Financial Crimes Enforcement 

Network (FinCEN), Treasury.

ACTION: Proposed rule; reopening of 

comment period. 

SUMMARY: On August 24, 2004, FinCEN 

requested public comment on a 

proposed rulemaking to impose a 

special measure against First Merchant 

Bank OSH Ltd as a financial institution 

of primary money laundering concern, 

pursuant to the authority contained in 

31 U.S.C. 5318A of the Bank Secrecy 

Act. FinCEN is extending the comment 

period on the proposal until November 

1, 2004. This action will allow 

interested persons additional time to 

analyze the issues and prepare their 

comments.

DATES: Written comments on the notice 

of proposed rulemaking (69 FR 51979) 

must be submitted on or before 

November 1, 2004.

ADDRESSES: You may submit comments, 

identified by RIN 1506–AA65, by any of 

the following methods: 

• Federal e-rulemaking portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: 

regcomments@fincen.treas.gov. Include 

RIN 1506–AA65 in the subject line of 

the message. 

• Mail: FinCEN, P.O. Box 39, Vienna, 

VA 22183. Include RIN 1506–AA65 in 

the body of the text. 

Instructions: It is preferable for 

comments to be submitted by electronic 

mail because paper mail in the 

Washington, DC, area may be delayed. 

Please submit comments by one method 

only. All submissions received must 

include the agency name and the 

Regulatory Information Number (RIN) 

for this proposed rulemaking. All 

comments received will be posted 

without change to http://

www.fincen.gov, including any personal 

information provided. Comments may 

be inspected at FinCEN between 10 a.m. 

and 4 p.m., in the FinCEN reading room 

in Washington, DC. Persons wishing to 

inspect the comments submitted must 

request an appointment by telephoning 

(202) 354–6400 (not a toll-free number).

FOR FURTHER INFORMATION CONTACT:

Office of Regulatory Programs, FinCEN, 

at (202) 354–6400 or Office of Chief 

Counsel, FinCEN, at (703) 905–3590 

(not toll-free numbers).

SUPPLEMENTARY INFORMATION: On August 

24, 2004, FinCEN requested comment 

on a proposal to impose the special 

measure authorized by 31 U.S.C. 

5318A(b)(5) against First Merchant Bank 

OSH Ltd, including its subsidiaries, 

FMB Finance Ltd, First Merchant 

International Inc, First Merchant 

Finance Ltd, and First Merchant Trust 

Ltd. That special measure authorizes the 

prohibition of the opening or 

maintaining of correspondent or 

payable-through accounts by any 

domestic financial institution or 

domestic financial agency for, or on 

behalf of, a foreign financial institution 

found to be of primary money 

laundering concern. 

The proposal was published for a 30-

day comment period, which closed 

September 23, 2004. In order to ensure 

that as many interested parties as 

possible have time to comment on the 

proposal, the comment period is being 

extended to November 1, 2004.

Dated: September 23, 2004. 

William J. Fox, 

Director, Financial Crimes Enforcement 

Network.

[FR Doc. 04–21879 Filed 9–29–04; 8:45 am] 

BILLING CODE 4810–02–P