[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