[Federal Register Volume 64, Number 184 (Thursday, September 23, 1999)]
[Notices]
[Page 51548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Workshop on Standards for Inactivation and Clearance of 
Infectious Agents in the Manufacture of Plasma Derivatives from 
Nonhuman Sources for Human Injectable Use; 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 ``Standards for Inactivation and Clearance of 
Infectious Agents in the Manufacture of Plasma Derivatives from 
Nonhuman Sources for Human Injectable Use.'' The purpose of the public 
workshop is to discuss whether infectious agent inactivation and 
clearance steps should become standard industry practice in the 
manufacture of human injectable products from nonhuman source plasma.
    Date and Time: The public workshop will be held on Monday, October 
25, 1999, from 9 a.m. to 3:30 p.m.
    Location: The public workshop will be held at the National 
Institutes of Health (NIH), NIH Clinical Center, Bldg. 10, Jack Masur 
Auditorium, 9000 Rockville Pike, Bethesda, MD.
    Contact:
    For information regarding the public workshop and registration: 
Therese Burke, Laurel Consulting Group, 1815 Fort Meyer Dr., suite 300, 
Arlington, VA 22209, 703-351-7676, FAX 703-528-0716, e-mail: 
[email protected].
    For information regarding this document: Nathaniel L. Geary, Center 
for Biologics Evaluation and Research (CBER) (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210, FAX 301-594-1944.
SUPPLEMENTARY INFORMATION:
    FDA is considering the requirement of inclusion of steps for the 
inactivation and clearance of infectious agents in the manufacture of 
products from nonhuman source plasma. This is an effort to level the 
regulatory requirements for all plasma derivatives regardless of their 
source and to continue to ensure high levels of safety for injectable 
blood products.
    Many plasma derivatives represent product lines that are of 
critical use to a limited number of patients. Some of these products 
are used chronically, some acutely. For those products that utilize 
human plasma as a raw material, standards have been set that require 
inactivation procedures to be included in the manufacturing process. 
The risk of plasma derivatives manufactured from nonhuman raw materials 
has been more difficult to define. With the development of gene 
therapy, somatic cell therapy, and xenotransplantation, concerns are 
growing regarding the effect of xenobiotics on patients. Concerns have 
also been expressed about the use of plasma derivatives manufactured 
from nonhuman source plasma.
    In an effort to address the needs of patients to have safe and 
effective blood products and to set realistic requirements for blood 
derivative manufacturers, FDA is sponsoring a public workshop to 
discuss these issues. Specifically, blood products manufactured from 
equine (horse), lapine (rabbit), ovine (sheep), caprine (goat), and 
porcine (pig) plasma and formulated into injectable products will be 
discussed.
    Registration: Mail or fax registration information (including name, 
title, firm name, address, telephone, and fax number) to Therese Burke 
(address above) by Friday, October 8, 1999. Onsite registration will be 
done on a space available basis on the day of the public workshop, 
beginning at 7:30 a.m. There is no registration fee for the public 
workshop. Space is limited, therefore, interested parties are 
encouraged to register early.
    If you need special accommodations due to a disability, please 
contact Therese Burke at least 7 days in advance.
    Transcripts: Transcripts of the meeting 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 meeting transcript will be available on CBER's website at 
``http://www.fda.gov/cber/minutes/workshop-min.htm''.

    Dated: September 16, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-24721 Filed 9-22-99; 8:45 am]
BILLING CODE 4160-01-F