[Federal Register: October 30, 2003 (Volume 68, Number 210)]
[Notices]               
[Page 61813-61814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30oc03-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0451]

 
Guidance for Industry and FDA Staff: Class II Special Controls 
Guidance Document: West Nile Virus Serological Assay; 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 entitled ``Class II Special Controls 
Guidance Document: Serological Reagents for the Laboratory Diagnosis of 
West Nile Virus.'' This guidance document describes a means by which 
West Nile virus serological reagents 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 to classify West Nile 
Virus IgM Capture Elisa assay into class II (special controls). This 
guidance document is immediately in effect as the special control for 
West Nile virus serological reagents, but it remains subject to comment 
in accordance with the agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on this guidance at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
on a 3.5'' diskette of the guidance document entitled ``Class II 
Special Controls Guidance Document: Serological Reagents for the 
Laboratory Diagnosis of West Nile 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 two self-addressed adhesive 
labels 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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, 301-594-2096

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying the West Nile Virus IgM Capture Elisa Assay 
into class II (special controls) under section 513(f)(2) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This 
guidance document will serve as the special control for West Nile virus 
serological reagents. Section 513(f)(2) of the act provides that any 
person who submits a premarket notification under section 510(k) of the 
act (21 U.S.C. 360(k)) for a device that has not previously been 
classified may, within 30 days after receiving an order classifying the 
device in class III under section 513(f)(1) of the act, request FDA to 
classify the device under the criteria set forth in section 513(a)(1) 
of the act. FDA shall, within 60 days of receiving such a request, 
classify the device by written order. This classification shall be the 
initial classification of the device. Within 30 days after the issuance 
of an order classifying the device, FDA must publish a notice in the 
Federal Register announcing such classification. Because of the 
timeframes established by section 513(f)(2) of the act, FDA has 
determined, under Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)), that it is 
not feasible to allow for public participation before issuing this 
guidance as a final guidance document. Therefore, FDA is issuing this 
guidance document as a level 1 guidance document that is immediately in 
effect. FDA will consider any comments we receive in response to this 
notice to determine whether to amend the guidance document.

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 West Nile virus 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: 
Serological Reagents for the Laboratory Diagnosis of West Nile Virus'' 
by fax machine, call the CDRH Facts-On-Demand system at

[[Page 61814]]

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 1206 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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available on the Dockets Management Branch 
Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    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 USC 3501-3520). 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 Control Number 0910-0120). The labeling provisions addressed in 
the guidance have been approved by OMB under the PRA 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. 
Two copies of mailed comments are to be submitted, 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. 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: October 8, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27293 Filed 10-29-03; 8:45 am]

BILLING CODE 4160-01-S