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