RFP HHS-BARDA-09-33

ADVANCED DEVELOPMENT OF THERAPEUTICS FOR TREATING NEUTROPENIA RESULTING FROM ACUTE EXPOSURE TO IONIZING RADIATION



Contracting Office Address:

Linda Luczak, Contracting Officer, ASPR, BARDA, 330 Independence Ave, S.W., Room G640, Washington, D.C. 20201, Phone: 202-260-0271; FAX 202-205-6061; e-mail: linda.luczak@hhs.gov



THIS IS A FORMAL SYNOPSIS OF PROPOSED CONTRACT ACTION NOTICE IN ACCORDANCE WITH FAR 5.2. The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA’s mission includes managing the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN).

As part of its CBRN medical countermeasure development and preparedness mission, BARDA contemplates a five year Cost Reimbursement, multiple award contract for the advanced development and manufacturing of therapeutics on the path to licensure or market approval (i.e., BLA or NDA, respectively) for the indication of treating neutropenia arising from acute exposure to ionizing radiation, (Acute Radiation Syndrome, ARS). This announcement will support ARS product development activities on the path to obtaining a New Drug Application (NDA) or a Biologic License Application (BLA), including:

• Manufacturing scale-up supporting consistent lot-to-lot manufacturing.

• Clinical trials, if feasible and ethical.

• Establishing appropriate animal models, as necessary.

• Animal studies leading to pivotal animal efficacy data required to support licensure under the U.S. Food and Drug Administration (FDA) “Animal Rule” (“Approval of Biological Products when Human Efficacy Studies are not Ethical or feasible" 21 CFR §601 Subpart H, as well as 21 CFR §314 Subpart I for New Drugs) .



NOTE: This solicitation does not acquire product for delivery to the Strategic National Stockpile.



In order to be considered eligible to submit a proposal under this solicitation, the Offeror(s) shall meet the following two mandatory criteria for eligibility:



1) The Offeror shall provide documentation that shows they have met with the appropriate review division at the FDA to consult on the appropriate path for approval of their proposed therapeutic for use in treating neutropenia caused by Acute Radiation Syndrome (ARS). Documentation should include, but is not limited to, a cover page, executive summary and a table of contents that demonstrates the Offeror’s intent to file an IND for ARS. FDA meeting minutes should also be included.

2) The product in question must be a) licensed or in clinical trials for any indication OR b) have an Investigative New Drug (Application) for ARS (IND; as per 21 CFR 312) filed with the Food and Drug Administration (FDA). The proposed product shall not be on clinical hold.



Offerors are required to maintain a relationship with the FDA and be on alert for Agency regulatory updates and changes to USG or HHS policies specific to their product development.



This requirement is to support product development which demonstrates both safety and efficacy of the product when administered 24 hours or more following exposure to a neutropenia-inducing exposure to ionizing radiation. To that end, non-clinical studies should be designed to show efficacy in abrogating neutropenia in appropriate animal models and that these models support approval or licensure under the FDA Animal Rule.

Additional details and requirements will be described in the RFP entitled “Advanced Development of Therapeutics for Treating Neutropenia Resulting from Acute Exposure to Ionizing Radiation”. The solicitation number RFP HHS-BARDA-09-33, is anticipated to be available electronically through FEDBIZOPPS on or about February 20, 2009. This solicitation is being issued as full and open competition; however, small and small disadvantaged businesses are highly encouraged to participate in this acquisition. Please note on your solicitation request your business size status. It is anticipated that the USG will award multiple contracts consisting of a base period and options as a result of this solicitation. Contracts resulting from this solicitation have an estimated award date of September 2009.



A draft RFP of the above referenced solicitation is anticipated to be released for industry comment on or about January 22, 2009. Industry comments are highly encouraged. Any written comments or questions on the draft RFP are due to the Contracting Office by COB on February 11, 2009.



Any responsible Offeror may submit a proposal for consideration by the USG. This solicitation notice does not commit the USG to the award of a contract. Only written mailed, faxed or emailed questions and comments will be accepted from potential offerors regarding this notice and the draft RFP. Collect calls will not be accepted.



Proposals submitted in response to the final RFP must be in accordance with the instructions stated in the solicitation. All correspondence should be identified with the following information: solicitation number RFP HHS-BARDA-09-33, name of company, name of requestor, mailing address, telephone number, fax number, and email address of Point of Contact (POC). Submit all correspondence to the Contracting Office address identified below.



Contracting Office Address:

Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response (OS/ASPR), Biomedical Advanced Research and Development Authority (BARDA), 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, UNITED STATES



Point of Contact(s):

Shane Kram, Contract Specialist, Phone 202-205-4705, Fax 202-205-6061, Email Anthony.kram@hhs.gov and,

Linda Luczak, Contracting Officer, Phone 202-260-0271, Fax 202-205-6061, Email linda.luczak@hhs.gov