Identification, Referral and Follow-up of Patients who have HLTV-1 Associated Adult T-Cell Leukemia/Lymphoma (ATI)

ELECTRONIC RFP ANNOUNCEMENT. THIS RFP MAY BE ACCESSED THROUGH THE OFFICE OF ACQUISITIONS(OA) HOMEPAGE AT http://rcb.nci.nih.gov/rcb-internet INTERESTED OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS, IF ANY. The National Cancer Institute (NCI), Center for Cancer Research, (CCR), Metabolism Branch (MB) is soliciting proposals for a Contractor that shall identify and recruit between 20 and 80 new patients with HTLV-1 Associated Adult T-Cell Leukemia/Lymphoma (ATL) for inclusion in Phase I/II Clinical Trials at the NCI. The offeror shall identify patients who meet the criteria specified by the Clinical Trials Protocols that will be provided to them by the MB, NCI. Any potential contractor must demonstrate the ability to identify and provide follow up medical treatment and monitoring of patients diagnosed with HTLV-1 ATL. In addition, any Contractor must be able to assume follow-up monitoring of current patients being monitored in Jamaica. The Contractor shall provide the following: (1) identify members of this specific patient population; (2) interaction with the staff at the NCI, assist staff and patients with compliance of the clinical protocols for treatment of the patients at the National Institutes of Health (NIH) Clinical Center, in Bethesda, MD (USA), and then follow-up when the patients have returned to their home country; (3) perform patient diagnoses, pre-referral evaluations including laboratory data, post-referral evaluations, and provide blocks and slides of tissues to the NCI; (4) assist patients in obtaining VISAs, passports and other documentation required for travel to the Washington, D.C. area airports, and to the NCI from their home country; (5) interact with the NCI staff electronically concerning patient issues; 6) comply with the U.S. Food and Drug Administration (USDA) regulations concerning Investigational New Drugs, adhere to all required Institutional Review Board (IRB) regulations of the NCI, and comply with the ethical regulations of the NIH Clinical Center in Bethesda, MD (USA); and 7) adhere to any regulatory agency requirements in the Contractor=s geographic location.

The etiology of HTLV-1 ATL is such that the human populations who carry this disease exist primarily in the Caribbean basin, specific limited areas of Japan, and sub-Saharan Africa, thus limiting potential participants for NCI studies to these locations. This acquisition is a new project, however, it continues work that was part of prior NCI contracts N01-CP-40548 and N01-CP-21121.



RFP No. N01-RC-81009-16 will be issued, electronically, on or about January 4, 2008, after publication of this notice. Proposals will be due approximately 45 days after the issue date of the Requests for Proposal (RFP). One (1) four-year, cost-reimbursement contract award is anticipated. Collect calls will not be accepted.