[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1432-1433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-174]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0468]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: Herpes Simplex 
Virus Types 1 and 2 Serological Assays; 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availability of the draft guidance entitled ``Class II Special Controls 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: Herpes Simplex Virus Types 1 and 2 Serological 
Assays.'' This draft guidance document

[[Page 1433]]

describes a means by which herpes simplex virus types 1 and/or 2 (HSV 1 
and/or 2) serological assays 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 devices 
from class III into class II (special controls).

DATES: Submit written or electronic comments on this draft guidance by 
April 10, 2006.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Class II Special 
Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 
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 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    Submit written comments concerning this draft guidance to the 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

    FDA developed this draft guidance document as a special control to 
support the classification of in vitro diagnostic devices for the 
laboratory diagnosis of herpes simplex virus (HSV) infection into class 
II (special controls). HSV (types 1 and/or 2) serological assays are 
intended for testing specimens from individuals who have signs and 
symptoms of infection consistent with HSV 1 and/or 2; determining if an 
individual has been previously infected with HSV 1 and/or 2; or 
providing epidemiological information about these infections. The 
detection of these antibodies aids in the clinical diagnosis of an 
infection by HSV 1 and/or 2 in conjunction with other clinical 
laboratory findings.
    This draft guidance document identifies the classification 
regulation and product codes for HSV 1 and/or 2 serological 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 HSV 1 and/or 2 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 requirements of the applicable statute and 
regulations.

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Herpes 
Simplex Virus Types 1 and 2 Serological Assays'' 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 (1305) 
followed by the pound sign (). Follow the remaining voice 
prompts to complete your request.
    To receive ``Class II Special Controls Guidance Document: Herpes 
Simplex Virus Types 1 and 2 Serological Assays,'' you may either send a 
fax request to 301-443-8818 to receive a hard copy of the document, or 
send an e-mail request to [email protected] to receive a hard copy or an 
electronic copy. Please use the document number (1305) to identify the 
guidance you are requesting.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. 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 manufacturer's assistance, information 
on video conferencing and electronic submissions, 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 of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 807.87 have been approved under 
OMB Control No. 0910-0120; the collections of information in 21 CFR 
801.109 have been approved under OMB Control 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 
paper 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: December 21, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 06-174 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S