[Federal Register Volume 60, Number 93 (Monday, May 15, 1995)]
[Notices]
[Pages 25920-25921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11828]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

International Scientific Conference on Viral Safety and 
Evaluation of Viral Clearance From Biopharmaceutical Products; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER), is announcing a meeting to discuss 
viral safety of biopharmaceutical products. FDA is cosponsoring the 
meeting with the National Institute of Allergy and Infectious Diseases 
(NIAID), the U.S. Department of Agriculture (USDA), the National 
Vaccine Program Office (NVPO), and the International Association of 
Biological Standardization (IABS). The meeting is intended to provide 
an exchange of information related to the viral safety of biological 
products, including information relevant to an International Conference 
on Harmonization (ICH) guideline on viral testing and validation that 
is presently under development.

DATES: The public meeting will be held on June 14 and 15, l995, from 
8:30 a.m. to 5 p.m., and on June 16, 1995, from 8:30 a.m. to 3:30 p.m. 
Participants may pick up their information packages and badges for 
admission to the sessions beginning at approximately 7:30 a.m. each 
morning.

ADDRESSES: The public meeting will be held at the National Institutes 
of Health, Bldg. 45, Main Auditorium of the Natcher Conference Center, 
9000 Rockville Pike, Bethesda, MD. There is no registration fee for 
this meeting. Space is limited, and all interested parties are 
encouraged to register early (see the contact person listed below).

FOR FURTHER INFORMATION CONTACT:
    For information regarding registration, housing, and other 
arrangements: Tammy Lowry, KRA Corp., 1010 Wayne [[Page 25921]] Ave., 
suite 850, Silver Spring, MD 20910, 301-495-1591, FAX 301-495-9410.
    For other information: William Freas, Scientific Advisors and 
Consultants Staff (HFM-21), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, FAX 301-827-
0294.

SUPPLEMENTARY INFORMATION: The purpose of this meeting is to present 
and discuss the available scientific evidence and experience relating 
to: Characterization of cell substrates for the presence of viruses, 
evaluation of virus removal and inactivation, and other issues relating 
to viral characterization. The symposium will discuss in detail topics 
related to the viral safety of biological products, including topics 
relevant to an ICH international guideline on viral testing and 
validation that is presently under development.
    Plenary sessions will be held on the mornings of June 14, 15, and 
16, 1995. Concurrent technical breakout sessions will be held on the 
afternoons of June 14 and 15, l995.

    Dated: May 9, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-11828 Filed 5-12-95; 8:45 am]
BILLING CODE 4160-01-F