[Federal Register Volume 71, Number 27 (Thursday, February 9, 2006)]
[Notices]
[Pages 6777-6778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1207]


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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 Virus 
Serological Assays; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance document entitled ``Guidance for Industry 
and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A 
Virus Serological Assays.'' The guidance document describes a means by 
which these in vitro diagnostic devices for the laboratory diagnosis of 
hepatitis A virus (HAV) may comply with the requirement of special 
controls for class II devices. Elsewhere in this issue of the Federal 
Register, FDA is publishing a final rule reclassifying these devices 
from class III (premarket approval) into class II (special controls). 
HAV serological assays are in vitro diagnostic devices used to test for 
specific antibodies to support the clinical laboratory diagnosis of 
HAV.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 
3.5 diskette of the guidance document entitled ``Guidance 
for Industry and FDA Staff: Class II Special Controls Guidance 
Document: Hepatitis A Virus Serological Assays'' 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

[[Page 6778]]

electronic access to the guidance document.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFZ-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, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0496.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 30, 2004 (69 FR 58371), FDA 
published a proposed rule to reclassify HAV serological assays from 
class III (premarket approval) into class II (special controls). FDA 
proposed this action after reviewing information contained in a 
reclassification petition submitted by Beckman Coulter Inc. In 
addition, FDA issued a draft class II special controls guidance 
document entitled ``Class II Special Controls Guidance Document: 
Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of 
Hepatitis A Virus'' to support the proposed reclassification. HAV 
serological assays are in vitro diagnostic devices that test for 
specific antibodies. In conjunction with other clinical laboratory 
findings, the detection of these HAV-specific antibodies aids in the 
clinical laboratory diagnosis of an acute or past infection by HAV. The 
comments FDA received were supportive of the proposed reclassification, 
but made some suggestions on the guidance's content. FDA considered the 
suggestions and made appropriate revisions. FDA is now identifying the 
guidance document entitled ``Guidance for Industry and FDA Staff: Class 
II Special Controls Guidance Document: Hepatitis A Virus Serological 
Assays'' as the guidance document that will serve as the special 
control for these devices.
    The guidance document provides a means by which HAV serological 
assays may comply with the requirement of special controls for class II 
devices. Following the effective date of the final reclassification 
rule, any firm submitting a premarket notification (510(k)) for HAV 
serological assays will need to address the issues covered in the 
special controls guidance document. However, the firm need only show 
that its device meets the recommendation of the guidance document or in 
some other way provides equivalent assurances of safety and 
effectiveness.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on HAV serological assays. 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 applicable statute and regulations.

III. Electronic Access

    To receive ``Guidance for Industry and FDA Staff: Class II Special 
Controls Guidance Document: Hepatitis A Virus Serological Assays'' by 
fax, 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.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. The Center for Devices and Radiological Health 
(CDRH) maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submission, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act

    This 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 (the PRA) (44 U.S.C. 3501-3520). 
The collection of information in part three of this guidance document 
has been submitted to OMB for review and was approved under OMB control 
number 0910-0120. The collection of information in part ten of this 
guidance document has been submitted to OMB for review and was approved 
under OMB control number 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 paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The guidance and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: February 1, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 06-1207 Filed 2-8-06; 8:45 am]
BILLING CODE 4160-01-S