Request for Proposals (RFP) Announcement: "Development of Medical Countermeasures to Mitigate and/or Treat Radiation-Induced Lung Injury after a Radiological/Nuclear Incident" BAA-NIAID-DAIT-NIHAI2014001

Notice Number: NOT-AI-14-050

Key Dates
Release Date: April 16, 2014

Related Announcements
None

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Allergy, Immunology and Transplantation has been charged by the DHHS with developing products for the mitigation and/or treatment of radiation injuries resulting from a nuclear and radiological attacks to the stage where products are eligible for advanced product development by the Biomedical Advanced Research and Development Authority (BARDA) or acquisition under the Project BioShield Act of 2004.

The National Institute of Allergy and Infectious Diseases intends to solicit proposals for contracts entitled "Development of Medical Countermeasures to Mitigate and/or Treat Radiation-Induced Lung Injury after a Radiological/Nuclear Incident " to advance the development of candidate medical countermeasures (MCMs) to reduce mortality and/or major morbidities (e.g. pneumonitis, fibrosis) associated with exposure of the lungs to radiation from a radiological or nuclear incident. NIAID anticipates that research and development studies supported by this BAA will advance candidate MCMs toward eventual FDA approval or licensure to mitigate/treat radiation-induced pulmonary injury and thereby improve survival. For this Broad Agency Announcement, it is anticipated that candidate MCMs will enter the evaluation and development pathway at various stages, from early research to post marketing (for drugs or biologics that are already licensed or approved for other indications), so the offeror is expected to provide a Statement of Work based on the stage of the candidate and the work that needs to be performed to advance the MCM.

The proposals will be evaluated on the extant, underlying data supporting the amelioration of radiation-induced lung damage and reduction of mortality and/or major morbidities (e.g. pneumonitis, fibrosis) by the compound proposed for study, and the comprehensiveness, soundness, adequacy and suitability of the proposed scientific approach and methodology used to support the advancement of the candidate MCM for the mitigation or treatment of the Delayed Effects of Acute Radiation Exposure (DEARE) towards FDA approval or licensure under the FDA Animal Rule. The evaluation will also be based on the adequacy of the scientific and technical personnel, facilities, equipment, (Good Laboratory Practice [GLP], etc.) and project management. Approaches proposed for study should already have positive efficacy data in an animal model, which demonstrates improved survival or a reduction in major morbidity when the compound is administered 24 hours or later after radiation exposure. Proposals will be evaluated based on the following technical evaluation criteria: (1) Technical Plan, (2) Scientific and Technical Personnel, (3) Project Management, and (4) Facilities, Equipment and Other Resources.

It is anticipated that 2-4 cost reimbursement; completion type contracts will be awarded for a 3-year period of performance beginning on or about 06/01/2015.

The NIAID estimates that the annual total cost (direct and indirect costs combined) will be $1-2 million per contract award per year; however, it is anticipated that the total cost for the award(s) may vary depending upon the scope of the project and the technical objectives of the award(s). The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The period of performance proposed by an offeror should not exceed 3 years.

All responsible sources may submit a proposal, which shall be considered by the Agency. This BAA will be available electronically on/about 04/14/2014, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."

Inquiries

Please direct all inquiries to:

Emily Dubbaneh
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-3682
Telephone: 301-496-0612
Email:  emily.dubbaneh@nih.gov

 

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