Broad Agency Announcement (BAA): Development of Medical Countermeasures to Enhance Platelet Regeneration and Survival Following Radiation Exposure from a Radiological/Nuclear Incident, BAA-NIAID-DAIT-NIH-AI-2013-166
Release Date: April 11, 2013
National Institute of Allergy and Infectious Diseases (NIAID)
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 (DAIT) has been charged by the DHHS with developing products for treatment of radiation exposures 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 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 Enhance Platelet Regeneration and Survival Following Radiation Exposure from a Radiological/Nuclear Incident" to advance the development of candidate medical countermeasures (MCMs) to enhance platelet regeneration and increase survival following radiation exposure. NIAID anticipates that research and development studies supported by this Broad Agency Announcement (BAA) will advance candidate MCMs toward eventual Food and Drug Administration (FDA) approval or licensure to mitigate/treat radiation-induced thrombocytopenia and thereby improve survival. For this BAA, 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.
Proposals will be evaluated on the underlying data supporting the amelioration of radiation-induced thrombocytopenia and improved survival, 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 acute radiation syndrome (ARS) 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), current Good Manufacturing Practices (cGMP) compliance and project management.
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 06/02/2014.
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.
For this solicitation, the NIAID requires proposals to be submitted in three methods: Paper, Disc (CD or DVD), and Online via the NIAID Electronic Contract Proposal Submission (eCPS). The content of the paper, 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."
To submit online using eCPS, offerors must have a valid NIH electronic Research Administration (eRA) Commons account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NIAID. The eRA Commons registration process may take up to 4 weeks. For more information, please see http://era.nih.gov/applicants/how-to_steps.cfm#register.
All responsible sources may submit a proposal, which shall be considered by the Agency. This BAA will be available electronically on 04/02/2013, 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.
Please direct all inquiries to:
Albert Nguyen
Contract Specialist
National Institute of Allergy and Infectious Diseases (NIAID)
6700-B Rockledge Drive
Room 3238, MSC 7612
Bethesda, MD 20892
(Express mail: Use Zip Code 20817-7612)
Phone: 301-496-0612
Email: nguyenal@niaid.nih.gov
and Human Services (HHS)
