THIS IS A FORMAL SYNOPSIS OF A PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. THIS IS A SMALL BUSINESS SET-ASIDE IN ACCORDANCE WITH FAR 19.5. 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 medical emergency response. The United States Government (USG) contemplates award of a five year Firm Fixed Price type contract for MCMs that can specifically provide treatment courses for symptomatic individuals exposed to smallpox. It is the goal of the forthcoming 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 the clinical study phase of the Investigational New Drug (IND) process 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, a Smallpox antiviral drug. It is the goal of BARDA to place a Smallpox Antiviral drug in the Strategic National Stockpile (SNS) as a Final Drug Product (FDP) which can be used for the treatment of individuals who are symptomatic.



The desired product that will be acquired with this contract must be able to support a public health medical emergency. Thus an obligation of this acquisition is to acquire a FDP that can support the potential use of the antiviral drug product during a declared emergency under an Emergency Use Authorization (EUA). Other requirements: (1) for achieving approval, have demonstrated efficacy in a variola challenge in the appropriate animal models (see FDA Draft Guidance for Industry, “Smallpox (Variola) Infection: Developing Drugs for Treatment and Prevention”); (2) delivery of 1,700,000 treatment courses of FDP of smallpox antiviral drug to the SNS; (3) Be in unit-of-use dosing or other approved packaging that requires no more than three doses per day for up to 21 days; (4) have a minimum expiry period of 36 months of stability and a target of 32 months remaining when delivered to the SNS; (5) have approval for symptomatic adults (18-64 years of age); (6) for achieving additional approved label and extended expiry dating, the USG reserves an option for the following concept plans to (a) support approval of an IV formulation for severely ill in; (b) to support liquid formulation for pediatric and geriatric populations; and (c) to manufacture and control antiviral drug production on a large scale to deliver up to an additional 12 million course. It is imperative that the Offeror(s) 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 Smallpox Antiviral solicitation, RFP-BARDA-09-35 which will be made available electronically through FEDBIZOPPS on or about February 24, 2009. 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-BARDA-09-35, 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 2009.