[Federal Register: May 7, 2002 (Volume 67, Number 88)]
[Notices]
[Page 30717-30718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my02-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Comparability Studies for Human Plasma-Derived Therapeutics;
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, cosponsored with the Plasma Protein Therapeutics Association
(PPTA), entitled ``Comparability Studies for Human Plasma-Derived
Therapeutics.'' The workshop will discuss current guidance, critical
issues, and approaches for establishing the comparability of human
plasma derivatives in order to support changes in manufacturing
processes, equipment, or facilities.
Date and Time: The public workshop will be held on May 30, 2002,
from 8 a.m. to 5:30 p.m., and on May 31, 2002, from 9 a.m. to 12 noon.
Location: The workshop will be held at the Doubletree Hotel, 1750
Rockville Pike, Rockville, MD 20852.
Contact: HelmsBriscoe Resource One, 12530 Browns Ferry Rd.,
Herndon, VA
[[Page 30718]]
20170, 703-421-5826, FAX 703-444-1737.
Registration: Preregistration is recommended on or before May 29,
2002. Onsite registration will be done on a space-available basis on
both days of the workshop, beginning at 7:30 a.m. You may obtain
registration forms and information about registration fees from
HelmsBriscoe Resource One (see the Contact section of this document) or
from Joseph Wilczek, Project Manager, at wilczek@cber.fda.gov. Mail or
fax your registration information and registration fee to HelmsBriscoe
Resource One by May 29, 2002.
If you need special accommodations due to a disability, please
contact HelmsBriscoe Resource One at least 7 days in advance.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page. The public workshop transcript will also be available on the
Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.
SUPPLEMENTARY INFORMATION: FDA and PPTA are jointly cosponsoring a
public workshop on comparability studies for human plasma-derived
therapeutics. The workshop will discuss critical issues and approaches
for establishing the comparability of human plasma derivatives for
supporting changes in manufacturing processes, equipment, or
facilities. On May 30, 2002, the workshop will address the three levels
of comparability studies--physical/chemical characterization,
preclinical studies, and clinical evaluations as they are related to
manufacturing changes for a human plasma derivative, as well as
information on reporting manufacturing changes, comparability
protocols, and several case studies.
On May 31, 2002, the workshop will focus on issues related to
comparing fractionation intermediates, a topic specific to the plasma
derivative industry. FDA will present historical perspectives and
current guidance on cooperative manufacturing arrangements. Industry
will discuss the current status of the necessity for fractionation
intermediates from sources outside of the company and the criteria for
acceptance. The complexities involved in characterizing the source
material, intermediates, and the drug products will be discussed. The
public workshop agenda will be posted on the Internet at http://
www.fda.gov/cber/whatsnew.htm.
Dated: April 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-11208 Filed 5-6-02; 8:45 am]
BILLING CODE 4160-01-S