[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Notices]
[Page 71793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33122]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Microbiology Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA).
    Name of Committee: Microbiology Devices Panel of the Medical 
Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 20, 2000, 9:45 
a.m. to 6:30 p.m., and January 21, 2000, 8 a.m. to 4:30 p.m.
    Location: Corporate Bldg., conference rm. 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact: Freddie M. Poole, Center for Devices and Radiological 
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 301-594-2096, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12517. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On January 20, 2000, the committee will discuss, make 
recommendations, and vote on six premarket approval applications 
(PMA's) for in vitro diagnostic qualitative devices to detect hepatitis 
B serological markers in human sera or plasma. The following hepatitis 
B serological marker assays, when used appropriately in combination, 
are indicated as an aid in the diagnosis and monitoring of disease and 
therapy in acute and chronic hepatitis B virus infection (HBV) in both 
low and high risk adult populations:
    1. Hepatitis B surface antigen (HBsAg) (HBsAg assay may be used 
alone as an indicator of HBV infection when performing prenatal 
testing);
    2. Antibodies to hepatitis B surface antigen (anti-HBs) (anti-HBs 
assay may be used alone to determine the immune status of HBV vaccine 
recipients);
    3. Hepatitis B e antigen (HBeAg);
    4. Antibodies to hepatitis B e antigen (anti-HBe);
    5. Hepatitis B core antigen (anti-HBc); and
    6. Immunoglobulin M antibodies to hepatitis B core antigen (IgM 
anti-HBc).
    These tests are not intended for blood donor screening.
    Also, on January 20, 2000, the committee will discuss and make 
recommendations on issues concerning the use of characterized hepatitis 
panels in assessing the performance of in vitro diagnostic devices for 
the determination of hepatitis infection as an alternative to 
conducting intensive prospective clinical trials.
    The following draft questions are proposed for discussion and may 
be subject to changes prior to the committee meeting:
    1. Will the use of characterized hepatitis panels provide assurance 
of the safety and effectiveness of the assay in various populations?
    2. What criteria should be used to include specimens in these 
panels?
    3. Will panels be sufficient to support claims for the diagnosis of 
HBV infection or immunity for all indicated populations?
    4. Who should control panel distribution and evaluation, e.g., 
device manufacturers, FDA, or an independent third party?
    FDA will consider these recommendations in the future development 
of review criteria for in vitro diagnostic devices, for the detection 
of hepatitis antigen or antibodies to hepatitis antigen, as valid 
scientific evidence to determine whether there is reasonable assurance 
that these devices are safe and effective.
    On January 21, 2000, the committee will discuss, make 
recommendations, and vote on a PMA for an in vitro diagnostic 
qualitative device for the detection of antibody to hepatitis C virus 
in human serum or plasma. This device is not intended for use in blood 
or plasma donor screening.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by January 12, 
2000. On January 20, 2000, oral presentations from the public will be 
scheduled between approximately 12 noon and 12:30 p.m., 3 p.m. and 3:30 
p.m., and 5:30 p.m. and 6 p.m. On January 21, 2000, oral presentations 
from the public will be scheduled between approximately 11:30 a.m. and 
12:15 p.m., and 3:30 p.m. and 4 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before January 12, 2000, 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 13, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-33122 Filed 12-21-99; 8:45 am]
BILLING CODE 4160-01-F