[Federal Register Volume 64, Number 84 (Monday, May 3, 1999)]
[Notices]
[Pages 23652-23653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10982]


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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.

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     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