[Federal Register Volume 65, Number 226 (Wednesday, November 22, 2000)]
[Notices]
[Pages 70356-70357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29842]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1566]


Guidance for Industry and FDA Reviewers: Class II Special Control 
Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) 
Antibody (ASCA) Premarket Notifications; 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 document entitled ``Guidance for Industry 
and FDA Reviewers: Class II Special Control Guidance Document for Anti-
Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket 
Notifications.'' Elsewhere in this issue of the Federal Register, FDA 
is issuing a final rule classifying ASCA devices into class II. FDA is 
issuing this guidance to provide a means by which ASCA devices may 
comply with the requirements of class II special controls.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the guidance document entitled ``Guidance for Industry and FDA 
Reviewers: Class II Special Control Guidance Document for Anti-
Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket 
Notifications'' to the Division of Small Manufacturers 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. Submit written comments 
concerning this guidance to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Comments should be identified with the

[[Page 70357]]

docket number found in brackets in the heading of this document. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Deborah M. Moore, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1293.

SUPPLEMENTARY INFORMATION:

I. Background

    ASCA is a test system intended to measure S. cerevisiae antibodies 
in human serum or plasma as an aid in the diagnosis of Crohn's disease. 
The guidance sets forth the risk associated with this generic type of 
device, and lists recommendations for submission of a premarket 
notification. Designation of this guidance as a special control means 
that manufacturers of ASCA devices who comply with either the 
recommendations of this guidance or some alternate means that provide 
equivalent assurance of safety and effectiveness will be able to market 
their device after they have submitted a premarket notification 
(510(k)) and received a finding of substantial equivalence for their 
device. The guidance focuses on the following issues: Labeling, design 
controls, and clinical information. FDA believes that this special 
control, when combined with the general controls of the act, will 
provide reasonable assurance of the safety and effectiveness for this 
type of device.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the submission of premarket notifications for ASCA test systems. 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 applicable statute, regulations, or 
both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (65 FR 56468, September 19, 
2000). This guidance document is issued as a Level 2 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive ``Guidance for Industry and FDA Reviewers: 
Class II Special Control Guidance Document for Anti-Saccharomyces 
cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications'' 
via your fax machine, call the CDRH Facts-on-Demand system at 800-899-
0381 or 301-827-0111 from a touchtone telephone. At the first voice 
prompt press 1 to access DSMA Facts, at second voice prompt press 2, 
and then enter the document number (1183) followed by the pound sign 
(#). Then follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so 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 access to the Internet. Updated 
on a regular basis, the CDRH home page includes ``Guidance for Industry 
and FDA Reviewers: Class II Special Control Guidance Document for Anti-
Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket 
Notifications,'' device safety alerts, Federal Register reprints, 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.

IV. Comments

    Interested persons may, at any time, submit written comments 
regarding the guidance to the Dockets Management Branch (address 
above). Such comments will be considered when determining whether to 
amend the current guidance. Two copies of any 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 document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 9, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-29842 Filed 11-21-00; 8:45 am]
BILLING CODE 4160-01-F