[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Notices]
[Pages 58448-58449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22010]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0385]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Hepatitis A Serological 
Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Hepatitis A Serological Assays for the Clinical 
Laboratory Diagnosis of Hepatitis A Virus.'' This draft guidance 
document describes a means by which in vitro diagnostic devices for the 
laboratory diagnosis of Hepatitis A Virus may comply with the 
requirement of special controls for class II devices. Elsewhere in this 
issue of the Federal Register, FDA is publishing a proposed rule to 
reclassify these device types from class III into class II (special 
controls).

[[Page 58449]]


DATES: Submit written or electronic comments on this draft guidance by 
December 29, 2004.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Class II Special 
Controls Guidance Document: Hepatitis A Serological Assays for the 
Clinical Laboratory Diagnosis of Hepatitis A Virus'' to the Division of 
Small Manufacturers, International, and Consumer Assistance (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this draft guidance to the 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. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and 
Radiological Health (HFZ- 440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2096.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft document was developed as a special control to support 
the classification of in vitro diagnostic devices for the laboratory 
diagnosis of Hepatitis A Virus (HAV) into class II (special controls). 
Hepatitis A Virus Tests, Product Code LOL, are devices that detect 
immunoglobulins M, (IgM), immunoglobulin G (IgG), and total antibodies 
(IgM and IgG) reactive to HAV. The detection of HAV-specific antibodies 
in human serum or plasma is laboratory evidence of HAV infection, with 
the presence of IgM type antibodies differentiating an acute infection 
from past infection.
    This draft guidance document identifies the classification 
regulation and product code for HAV-specific IgM, IgG, and total 
antibody assays. In addition, other sections of this guidance document 
list the risks to health identified by FDA and describe measures that, 
if followed by manufacturers and combined with the general controls, 
will generally address the risks associated with these assays and lead 
to a timely premarket notification (510(k)) review and clearance. This 
document supplements other FDA documents regarding the specific content 
of a premarket notification submission.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on Class II 
special controls for in vitro diagnostic devices for the laboratory 
diagnosis of Hepatitis A Virus. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Hepatitis 
A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis 
A Virus'' by fax machine, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter 
the system. At the second voice prompt, press 1 to order a document. 
Enter the document number 1536 followed by the pound sign (). 
Follow the remaining voice prompts to complete your request.

IV. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520) (the PRA). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB No. 0910-0120). The labeling provisions addressed in the 
guidance have been approved by OMB under OMB No. 0910-0485.

V. Comments

    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. Comments received may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 21, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-22010 Filed 9-29-04; 8:45 am]
BILLING CODE 4160-01-S