[Federal Register Volume 69, Number 184 (Thursday, September 23, 2004)]
[Notices]
[Pages 57034-57035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21317]


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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://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 [email protected] 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://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

[[Page 57035]]

on the Division of Dockets Management Internet site at 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