[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Page 14413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6084]



Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Risk Mitigation Strategies To Address Potential Procoagulant 
Activity in Immune Globulin Intravenous Products; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


    The Food and Drug Administration (FDA), in cooperation with the 
National Heart, Lung, and Blood Institute, and the Plasma Protein 
Therapeutics Association, are jointly cosponsoring a public workshop on 
risk mitigation strategies to address procoagulant activity that may be 
present in some Immune Globulin Intravenous (IGIV) products. The 
purposes of the public workshop are to identify the most likely causes 
of IGIV-associated thrombotic events, to determine which procoagulant 
proteins may be causative, and to identify relevant, feasible tests 
that could be used to assess levels and/or activity of these proteins 
in IGIV products. The public workshop will feature presentations by 
national and international experts from government, academic 
institutions, and industry.
    Dates and Time: The public workshop will be held on May 17, 2011, 
from 8:30 a.m. to 5 p.m. and May 18, 2011, from 8 a.m. to 11:30 a.m.
    Location: The public workshop will be held at the Universities at 
Shady Grove Conference Center, Building II, Multipurpose Room, 9630 
Gudelsky Dr., Rockville, MD 20850. Please visit http://www.shadygrove.umd.edu/about/visit for directions, visitor parking, and 
public transportation information.
    Contact Person: Rhonda Dawson, 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 or fax your registration information (including 
name, title, firm name, address, telephone and fax numbers) to the 
contact person by April 26, 2011. There is no registration fee for the 
public workshop. Early registration is recommended because seating is 
limited. Registration on the day of the public workshop will be 
provided on a space available basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Rhonda Dawson at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The following topics will be discussed at 
the public workshop: (1) Epidemiology of thrombotic events in IGIV 
recipients; (2) pathophysiology of arterial and venous thrombosis in 
this context; (3) research to identify specific procoagulant proteins 
that can co-purify with IGIV; (4) partitioning of coagulation factors 
during IGIV purification; (5) the role of activated Coagulation Factor 
XIa in IGIV-associated thrombosis; (6) test methods for screening IGIV 
products; (7) ancillary animal models; and (8) standards development 
for thrombin generation tests. On the first day of the public workshop, 
the epidemiology and potential causes of historically observed IGIV-
associated thrombotic adverse events, as well as biochemical 
identification of procoagulant proteins that co-purify with IGIV will 
be discussed. In addition, methods and relevance of both broad and 
specific tests to screen IGIV products for procoagulant activity will 
be addressed, and limitations in test methodologies and validation 
needs will be identified. On the second day of the public workshop, 
preliminary results of IGIV product testing for procoagulant activity 
will be presented and discussed, followed by a summary of the meeting.
    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. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. A transcript of the public workshop will be available 
on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.

    Dated: March 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6084 Filed 3-15-11; 8:45 am]