[Federal Register: May 3, 1999 (Volume 64, Number 84)]
[Notices]
[Page 23652-23653]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my99-59]

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

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). At least one
portion of the meeting will be closed to the public.
    Name of Committee: The Microbiology Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on May 20, 1999, 9:45 a.m.
to 6:30 p.m., and May 21, 1999, 8:30 a.m. to 4:30 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
    Contact Person: 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 May 20, 1999, the committee will discuss and make
recommendations on a premarket notification submission for a
qualitative in vitro diagnostic assay intended for the detection of
human cytomegalovirus (CMV) deoxyribonucleic acid (DNA) in human
peripheral white blood cells and its labeling. The focus of the
discussion will be the appropriate use of signal amplification
terminology. The committee will also discuss, make recommendations, and
vote on a premarket approval application (PMA) supplement for an in
vitro diagnostic target-amplified nucleic acid probe test used for the
detection of Mycobacterium tuberculosis complex in sediments prepared
from sputum (induced or expectorated), bronchial specimens, or tracheal
aspirates. The device as modified is indicated for use of acid-fast
bacilli (AFB) smear negative and AFB smear positive respiratory
specimens for the diagnosis of active pulmonary tuberculosis disease.
On May 21, 1999, the committee will discuss, make recommendations, and
vote on a PMA for an in vitro diagnostic qualitative

[[Page 23653]]

device to detect immunoglobulin G (IgG) antibodies to parvovirus B19 as
a marker of previous infection in human serum and plasma. The IgG test
is indicated for use in all women where there is a suspicion of
exposure to parvovirus B19. The committee will also discuss, make
recommendations, and vote on a PMA for an in vitro diagnostic
qualitative device to detect IgM antibodies to parvovirus B19 in human
serum and plasma. The IgM test is indicated for use in conjunction with
the parvovirus B19 IgG enzyme immunoassay to determine immunological
status during the first trimester of pregnancy and for the testing of
pregnant women who have sonographic evidence of abnormal fetal
development, such as hydrops fetalis, or who had an adverse outcome,
such as fetal death or premature delivery with fetal abnormalities.
    Procedure: On May 20, 1999, from 9:45 a.m. to 6:30 p.m., and on May
21, 1999, from 9:30 a.m. to 4:30 p.m., the meeting is open to the
public. 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 May 10, 1999. On May
20, 1999, oral presentations from the public will be scheduled between
approximately 11:15 a.m. and 11:45 a.m. and between approximately 3:30
p.m. and 4 p.m. On May 21, 1999, oral presentations from the public
will be scheduled between approximately 10:15 a.m. and 10:45 a.m. and
between approximately 2 p.m. and 2:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before May 10, 1999, 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.
    Closed Committee Deliberation: On May 21, 1999, from 8:30 a.m. to
9:30 a.m., the meeting will be closed to the public to permit
discussion and review of trade secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)) relating to present and future agency
issues.
     Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 26, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-10982 Filed 4-30-99; 8:45 am]
BILLING CODE 4160-01-F