[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
