[Federal Register Volume 66, Number 182 (Wednesday, September 19, 2001)]
[Notices]
[Page 48264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23264]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


PDA/FDA Viral Clearance Forum; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Parenteral Drug Association (PDA)/FDA Viral 
Clearance Forum.'' The topic to be discussed is viral clearance for 
biologics.
    Date and Time: The public workshop will be held on October 1, 2001, 
from 8 a.m. to 4:30 p.m., October 2, 2001, from 8:30 a.m. to 4:30 p.m., 
and October 3, 2001, from 8:30 a.m. to 3 p.m.
    Location: The public workshop will be held at the Hyatt Regency 
Bethesda, One Bethesda Metro Center, Bethesda, MD.
    Contact:
    For information regarding this notice: Nathaniel L. Geary, Center 
for Biologics Evaluation and Research (CBER) (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6210, 
FAX 301-594-1944, e-mail: [email protected].
    For information regarding the public workshop: Melanie Whelan, 
Center for Biologics Evaluation and Research (HFM-43), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3841, 
FAX 301-827-3843, e-mail: [email protected], or Leslie Zeck, PDA, 
Inc., 7500 Old Georgetown Rd., suite 620, Bethesda, MD 20814, 301-986-
0293, FAX 301-986-0296, e-mail: [email protected].
    If you need special accommodations due to a disability, please 
contact Leslie Zeck (address above) at least 7 days in advance.
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, and fax number), and 
registration fee to PDA, Inc., P.O. Box 79465, Baltimore, MD 21279-3465 
by Monday, September 24, 2001. You may also register with PDA, Inc., by 
phone at 301-986-0293 or fax at 301-986-0296 with your credit card.
    The registration fee will be used to offset the expenses of hosting 
the conference, including meals, refreshments, meeting rooms, and 
materials. You may obtain registration forms from PDA, Inc., (address 
above) or from the FDA Internet at http://www.fda.gov/cber/meetings.htm.

SUPPLEMENTARY INFORMATION: The public workshop is being cosponsored by 
FDA, CBER, and PDA, Inc. The goals of the public workshop are to 
discuss: (1) Current and new viral removal technologies; (2) issues 
related to the reuse of chromatographic columns with an emphasis on 
viral clearance requirements; (3) current opinions on the need to 
standardize quality attributes of viral preparations used as controls 
in spiking and infectivity assays; (4) current methods used to 
standardize or validate traditional infectivity assays; (5) 
implementation and acceptability of polymerase chain reaction (PCR), 
PCR enhanced reverse transcriptase, and real-time PCR-based viral 
assays, standardization and validation of these new assays, and (6) the 
potential of and issues related to bracket/matrix studies defining 
generic virus inactivation conditions. FDA expects that participation 
in this workshop will provide manufacturers a regulatory perspective on 
viral clearance and facilitate product development and approval.

    Dated: September 10, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-23264 Filed 9-18-01; 8:45 am]
BILLING CODE 4160-01-S