THIS IS A FORMAL SYNOPSIS OF PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. The Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) is seeking to acquire medical countermeasures (MCM) that will support an effective public health emergency response to a radiological or nuclear event. The United States Government (USG) intends to award one or more contracts to the responsible Offeror(s) whose proposal(s) is responsive to the solicitation. The award will be a five year Firm Fixed Price contract for MCMs that can specifically treat the neutropenia component of Acute Radiation Syndrome. Neutropenia is defined as the depression of neutrophils which occurs as a component of the hematologic pathologies arising following sufficient exposure to ionizing radiation (h-ARS). It is the goal of the RFP to obtain advanced development products, i.e., at a development level, as classified by the Food and Drug Administration (FDA), which are in no less than Phase 2 of the Investigational New Drug (IND) stage as well as those products which already have approved therapeutic indications. Prior to the submission of the proposal, the offeror must have met with the appropriate review division at the FDA to consult on the appropriate path for approval of their respective therapeutic for use in pathologies known to be associated with, or as components of, Acute Radiation Syndrome (ARS). It is the goal of BARDA to place in the Strategic National Stockpile (SNS) a Final Drug Product (FDP) which may be used for therapy of neutropenia in human subjects associated with whole body acute exposure to ionizing radiation exceeding 2 Gy.



The desired product that will be acquired with this contract must be able to support a public health emergency. The current post-event capabilities of the USG medical emergency personnel to organize, respond, triage, and begin treating patients victimized by a radiological or nuclear event is estimated at no less than 24 hours. Thus an obligation of this acquisition is to acquire products that have demonstrated efficacy in treating neutropenia (i.e., increase in the peripheral blood neutrophil counts) in appropriate animal models (FDA Animal Efficacy Rule, was established in 2002; see: Federal Register 67: 37988-37998, May 31, 2002; 21 CFR 601.90 for biologics, and, 21 CFR 313.600-650 for drugs; (with possible human subject studies, if applicable), when administered at a minimum of 24 hours, and preferably greater than 48 hours, following acute exposure to ionizing radiation, and with no pre-exposure prophylaxis. Other requirements: (1) delivery of 100,000 treatment courses for neutropenia; (2) Long-term storage temperature in the range of 2-8 degrees C; (3) A defined therapeutic regimen and dosing schedule for treatment of radiation-induced neutropenia; (4) Treatment of neutropenia arising from ARS with the FDP must result in a 30% increase in survival from lethal exposure to ionizing radiation relative to controls (i.e.,LD50, the dose of ionizing radiation which results in 50% lethality in untreated irradiated subjects), plus an increase in neutrophil count. (5) have an acceptable safety profile; (6) have a minimum expiry period of 36 months with 30 months remaining when delivered to the SNS; (7) support a CDC-held IND for contingency use or CDC-held pre-Emergency Use Authorization (EUA) submission; (8) prior to the end of the contract the therapeutic must be approved or licensed (NDA or BLA) for use as a therapy for neutropenia in adults (age: 18-64 years) exposed to ionizing radiation, (9) The USG reserves an option for safety studies in normal geriatric and pediatric populations; and (10) The USG reserves the right to exercise options to procure up to an additional 100,000 treatment courses. It is imperative that the Offerors to this RFP seek guidance from the FDA prior to submission of their proposals so the proposal may be aligned with current FDA policy, practices and guidance.



Additional details and requirements will be described in the Acute Radiation Syndrome solicitation, RFP HHS-BARDA-08-10 which will be made available electronically through FEDBIZOPPS on or about March 14, 2008. Any responsible offeror may submit a proposal to be considered by the USG. This notice does not commit the USG to the award of a contract. Only written or email requests will be accepted directly from the requestor for this solicitation. No collect calls will be accepted. No facsimile transmissions will be accepted. All responses should be identified with the respective solicitation number RFP HHS-BARDA-08-10, name of company, name of requestor, mailing address, telephone number, fax number, and email address of Point of Contact (POC), should be submitted to the Contracting Office address identified in this notice. The contract award resulting from this solicitation will have an estimated award date of September 2008.



BARDA Points of Contact: Jeannett W. Jackman, Contract Specialist, Phone 202.205.1625, Email: jeannett.jackman@hhs.gov, or Linda D. Luczak, Contracting Officer, Phone: 202.260.0271, Email: linda.luczak@hhs.gov