[Federal Register Volume 67, Number 88 (Tuesday, May 7, 2002)]
[Notices]
[Pages 30717-30718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11208]


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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 [email protected]. 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