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Notice

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

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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.

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Dorothy B. Fountain,

Deputy Director of Operations, Antitrust Division.

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[FR Doc. 05-1965 Filed 2-1-05; 8:45 am]

BILLING CODE 4410-11-M