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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. 2004D-0385]

# 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                        The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Class II Special Controls Guidance Document:   Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus.”  This draft guidance document describes a means by which in vitro diagnostic devices for the laboratory diagnosis of Hepatitis A Virus may comply with the requirement of special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).                    

      ( print 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Submit written or electronic comments on this draft guidance by December 29, 2004.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                        Submit written requests for single copies on a 3.5” diskette of the draft guidance document entitled “Class II Special Controls Guidance Document:   Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus” to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                        Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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