[Federal Register: September 23, 2004 (Volume 69, Number 184)]
[Notices]
[Page 57034-57035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0371]
Guidance for Industry and Food and Drug Administration Staff:
Class II Special Controls Guidance Document: Serological Assays for the
Detection of Beta-Glucan; 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 Assays for the Detection of Beta-
Glucan.'' This class II special controls guidance document describes a
means by which beta-glucan serological assays used for the detection of
invasive fungal infection 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 reclassify beta-glucan
serological assays into class II (special controls). This guidance
document is immediately in effect as the special control for beta-
glucan serological assays, 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. 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 ``Class II Special Controls
Guidance Document: Serological Assays for the Detection of Beta-
Glucan'' 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 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: Freddie M. Poole, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2096, ext. 111.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule to reclassify beta-glucan serological assays 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)). FDA is taking this
action in response to a March 22, 2004, petition submitted by the
Associates of Cape Cod, Inc., that requested classification of the
beta-glucan serological assay under section 513(f)(2) of the act. This
guidance document will serve as the special control for the beta-glucan
serological assay devices. 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 that are received 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 GGPs
(Sec. 10.115). The guidance represents the agency's current thinking on
beta-glucan serological assays for the detection of invasive fungal
infection. 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 Assays for the Detection of Beta-Glucan'' 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
(1825) followed by the pound sign ([numsign]). Follow the remaining
voice prompts to complete your request.
To receive ``Class II Special Controls Guidance Document:
Serological Assays for the Detection of Beta-Glucan,'' 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 gwa@cdrh.fda.gov to receive a
hard copy or an electronic copy. Please use the document number (1825)
to identify the guidance you are requesting.
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
[[Page 57035]]
on the Division of Dockets Management 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 (44 U.S.C. 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 control number 0910-0120). The labeling provisions addressed in
the guidance have been approved by OMB 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. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: September 10, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-21317 Filed 9-22-04; 8:45 am]
BILLING CODE 4160-01-S