[Federal Register: November 22, 2000 (Volume 65, Number 226)]
[Notices]
[Page 70356-70357]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no00-70]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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