[Federal Register Volume 63, Number 129 (Tuesday, July 7, 1998)]
[Notices]
[Pages 36699-36700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Team Biologics; Workshop for Manufacturers of Licensed In Vitro 
Diagnostics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER) and the Office of Regulatory Affairs 
(ORA) is announcing the following workshop for the biologics industry: 
Team Biologics: Workshop for Manufacturers of Licensed In Vitro 
Diagnostics. The topics to be discussed include information for 
manufacturers of licensed in vitro diagnostics on team biologics, good 
manufacturing practices, and compliance and enforcement issues. 
Questions submitted by industry prior to the workshop will be addressed 
by FDA staff.

    Date and Time: The workshop will be held on Friday, August 7, 1998, 
8 a.m. to 5 p.m.

    Location: The workshop will be held at the Hyatt Regency Bethesda, 
One Bethesda Metro, Bethesda, MD 20814, 301-657-6406.

    Contact: Kathy A. Eberhart, Food and Drug Administration, Center 
for Biologics Evaluation and Research (HFM-49), 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX 301-827-3079, 
e-mail ``[email protected]''.
    Registration: Fax registration information (including name, title, 
firm name, address, telephone, and fax number) and questions to the 
contact person by Friday, July 24, 1998. There is no registration fee 
for the workshop. Space is limited, therefore interested parties are 
encouraged to register early.
    If you need special accommodations due to a disability, please 
contact Kathy A. Eberhart at least 7 days in advance.
Supplementary Information: FDA has established a framework for a 
partnership between ORA and CBER called Team Biologics. This 
partnership will use the diverse skills and knowledge of both ORA and 
CBER staffs to focus resources on inspectional and compliance issues in 
the biologics area.

[[Page 36700]]

 The goal of Team Biologics is to ensure the quality and safety of 
biological products and quickly resolve inconsistencies and bring 
products into compliance. It is designed to promote uniformity between 
CBER and the field and among FDA field components associated with 
inspections, policy implementation, and current good manufacturing 
practice interpretation.
    In April 1998, the responsibility for inspecting manufacturers of 
licensed in vitro diagnostics was transferred to Team Biologics 
investigators. The purpose of this workshop is to provide an overview 
of the Team Biologics concept to this segment of regulated industry, 
share the agency's experience with Team Biologics' inspections of 
manufacturers of licensed in vitro diagnostics to date, and provide 
manufacturers with an overview of FDA's expectations under this 
program.
    The agenda and any other relevant information will be available 
electronically via the Internet at ``http://www.fda.gov/cber/
scireg.htm''.
    Transcripts: Transcripts of the workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 15 working days after the workshop at a cost of 10 cents 
per page. FDA will videotape the workshop and copies of the tapes will 
also be made available through the Freedom of Information Office.

    Dated: June 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-17878 Filed 7-6-98; 8:45 am]
BILLING CODE 4160-01-F