[Federal Register: February 2, 2005 (Volume 70, Number 21)]
[Notices]               
[Page 5484]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02fe05-103]                         

-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Antitrust Division

 
Notice Pursuant to the National Cooperative Research and 
Production Act of 1993--Foundation for the Accreditation of Cellular 
Therapy

    Notice is hereby given that, on September 15, 2004, pursuant to 
section 6(a) of the National Cooperative Research and Production Act of 
1993, 15 U.S.C. 4301 et seq. (``the Act''), Foundation for the 
Accreditation of Cellular Therapy (``FACT'') has filed written 
notification simultaneously with the Attorney General and the Federal 
Trade Commission disclosing (1) the name and principal place of 
business of the standards development organization and (2) the nature 
and scope of its standards development activities. The notifications 
were filed for the purpose of invoking the Act's provisions limiting 
the recovery of antitrust plaintiffs to actual damages under specified 
circumstances.
    Pursuant to section 6(b) of the Act, the name and principal place 
of business of the standards development organization is: Foundation 
for the Accreditation of Cellular Therapy, Omaha, NE. The nature and 
scope of FACT's standards development activities are: development of 
certain standards for medical facilities engaged in blood, bone marrow 
and cord blood transplantation in then treatment of human disease. 
FACT's standards apply to all sources of hematopoietic progenitor cells 
and all phases of collection, processing, and administration of these 
cells. The standards encompass, but are not limited to, cells isolated 
from bone marrow or peripheral blood and any variety of manipulations 
including removal or enrichment of various cell populations, expansion 
of hematopoietic cell populations, cryopreservation, and infusion. The 
Standards fall into the following categories: (1) Clinical Program 
Standards; (2) Hematopoietic Progenitor Cell Collection Standards; (3) 
Donor and Cell Collection Standards; and (4) Hematopoietic Progenitor 
Cell Processing Standards. FACT's standards have been made available to 
health institutions, health professionals, clinical laboratories, 
health facilities, and other interested members of the scientific and 
medical community and public. FACT's voluntary standards are designed 
to provide minimum quality and safety guidelines for facilities and 
professionals performing hematopoietic progenitor cell therapy or 
providing related services. FACT has established a voluntary 
accreditation program for medical facilities that seek FACT 
certification of compliance with these standards. The goal of FACT's 
accreditation program is to ensure that both the laboratory and 
clinical aspects of hematopoietic cell transplantion are conducted in 
accordance with the Fact standards.
    FACT has also developed cord blood bank standards. These standards 
were developed by consensus with representatives of NETCORD, individual 
members of ISCT, and other professionals active in cord blood banking. 
The cord blood bank standards fall into the following categories: (1) 
Cord Blood Bank Standards; (2) Cord Blood Donor and Collection 
Standards; (3) Cord Blood Processing Standards; and (4) Selection, 
Release and Shipping of Cord Blood Units. Such standards are designed 
to provide minimum guidelines for facilities and individuals performing 
cord blood collection, processing, testing, banking, selection and 
release or providing support services for such procedures.

Dorothy B. Fountain,
Deputy Director of Operations, Antitrust Division.
[FR Doc. 05-1965 Filed 2-1-05; 8:45 am]

BILLING CODE 4410-11-M