[Federal Register Volume 69, Number 152 (Monday, August 9, 2004)]
[Notices]
[Page 48250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18075]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Development of Plasma Standards; 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 ``Development of Plasma Standards.'' A major 
objective of the workshop is to assist FDA in the development of plasma 
standards that will address concerns encountered over the years with 
the preparation, storage, shipment, and use of plasma for both 
transfusion and the manufacture of blood products such as Factor VIII 
and Immune Globulin Intravenous.
    Date and Time: The 2-day public workshop will be held on August 31, 
2004, from 8:40 a.m. to 4:45 p.m., and on September 1, 2004, from 9 
a.m. to 12:15 p.m.
    Location: The public workshop will be held at the National 
Institutes of Health (NIH), Lister Hill Center, Bldg. 38A, 8800 
Rockville Pike, Bethesda, MD 20894.
    The NIH campus is accessible via the Washington, DC Metro Transit 
System, Red Line, at the Medical Center Station. The Lister Hill Center 
is a short walk from the metro station, or you may take a shuttle bus 
that runs from the metro station to the various buildings on the 
campus. Because of security measures, visitors' parking is extremely 
limited and use of private vehicles may cause significant delays in 
entering the campus. Additionally, you will be required to show a photo 
ID upon entry to the campus and the Lister Hill Center.
    Contact Person: Joseph Wilczek, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, 
e-mail: [email protected].
    Registration: Mail, fax, or e-mail the registration information 
(including name, title, firm name, address, telephone, and fax number) 
to Joseph Wilczek (see Contact Person) by August 17, 2004. Registration 
at the site will be done on a space available basis on the days of the 
workshop, beginning at 7:30 a.m. Because seating is limited, we 
recommend early registration. There is no registration fee for the 
workshop. If you need special accommodations due to a disability, 
please contact Joseph Wilczek at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA is sponsoring a 2-day public workshop on 
plasma standards. A major objective of the workshop is to gather 
information on current industry practices that are in place for the 
manufacture of plasma, including information on the following issues 
and topics:
     What are appropriate freezing and storage temperatures for 
the components?
     What is the appropriate time to freezing?
     Should freezing and storage conditions be dependent on the 
final product?
     What should the recovered plasma component be called?
     What should be the expiration dating period for recovered 
plasma?
     Should recovered plasma be distinguished from Source 
Plasma? If so, how?
    Following the workshop, FDA intends to develop standards for the 
preparation, labeling, storage, and shipping of non-cellular blood 
components for transfusion and for further manufacture to ensure the 
safety, purity, and potency of the products.
    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 public workshop at a cost of 10 
cents per page. In addition, the transcript will be placed on FDA's 
Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: August 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18075 Filed 8-6-04; 8:45 am]
BILLING CODE 4160-01-S