[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