Broad Agency Announcement (BAA) for Medical Chemical Biological Radiological and Nuclear (CBRN) Countermeasure Developmental Studies The Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) is organized into five Joint Project Management Offices (JPMO), each responsible for specific commodity areas. General information on the JPEO-CBD and subordinate JPMOs can be obtained from the JPEO-CBD website at http://www.jpeocbd.osd.mil/. The medical CBRN countermeasures developed by the Joint Project Manager Medical Countermeasure Systems (JPM MCS) office, the subject of this BAA, directly support the current, near-term, and far-term challenges by providing the capability to prevent, diagnose and treat the effects of chemical, radiological and biological warfare agents. Mission areas and technical points of contact for the product management offices within the JPM MCS are shown in Section VIII of this BAA. This Broad Agency Announcement (BAA) is intended to solicit pre-proposals for JPM MCS for those parts of development not related to the development of a specific system or hardware procurement in accordance with (i) the Federal Acquisition Regulation (FAR) 35.016(a) and (ii) DoD Grant Regulations (DoDGARs) subject to section 2374 of Title 10 United State Code. The purpose of this BAA is to identify the best available science, and as such, there are no set-asides associated with any awards resulting from this BAA. Specific areas of interest are described in the quote mark Areas of Interest quote mark section of this BAA. As to any resultant procurement contracts, this BAA is issued under the provisions of the Competition in Contracting Act of 1984 (P.L. 98-369), as implemented in the FAR. This Announcement provides a general description of JPM MCS's project areas, including specific areas of interest, general information, evaluation and selection criteria, and proposal preparation instructions. All documentation and or Attachments that are required with the submission of a full proposal are described in the Mandatory Proposal Forms section of this announcement. Proposals are sought from all eligible sources, including educational institutions, nonprofit organizations, and private industry. Generally, this announcement is continuously open; preliminary proposals (preproposals) may be submitted and will be evaluated at any time throughout the year. The availability of funds may limit the ability of the U.S. Government to make awards in specific areas; nevertheless preproposals are sought under this BAA announcement for areas consistent with the mission areas identified in Section VIII of this announcement. JPM MCS is interested in proposals that are based on data from experiments using specific CBRN warfare agents, not surrogates, to demonstrate safety, efficacy or mode of action. (Please note that CBRN warfare agents will not be provided by the DoD for these efforts.) We are interested in studies on new and better ways to develop medical CBRN countermeasures more rapidly and with increased efficiency through enabling technologies, life cycle bioinformatics, and improved logistics tracking. We are not interested in proof-of-concept, advanced, applied or basic research proposals. We are interested in efforts directed toward the development of enabling technologies that speed up the advanced development process leading to FDA approval. All developmental efforts nominated to be considered by this BAA should be evaluated against the Quality Technology Readiness Levels (Q-TRL) (Attachment 1 to the BAA). Potential developmental efforts must be consistent with the minimum criteria at TRL level 4 for transition to advanced development. In particular, the scope of work proposed under this BAA must be limited to TRL 4 levels described at 4-M1, 4-D1 and 4-E1 for Medical Products and 4-DAM1, 4- DAS1, 4-DCS1 for Diagnostics: MEDICAL PRODUCTS: 4-M1: Demonstrate Capability to Produce the Technology in a Lab Environment. Prepare laboratory-scale non-GLP/non-cGMP quantities of BDS to further refine manufacturing process. Formulate an experimental drug product (EDP) for preliminary animal studies. Evaluate BDS and EDP for conformance to preliminary specifications. 4-D1: Conduct non-GLP safety studies to include early toxicity in animal models consistent with product's intended use (e.g. route of administration and dose range (small animals may be used). 4-E1: Expand on initial proof of concept studies to develop relevant animal model(s). Demonstrate relevance to threat being addressed. DIAGNOSTICS: 4-DAM1: Support assay architecture development, providing input on manufacturability of proposed product 4-DAS1: Continued animal studies, as required, to support assay development and assay design finalization. 4-DCS1: Continued pre-clinical studies, as required, to support assay development and diagnostic targets finalization. This announcement of the JPM MCS's current interests will be posted on the Federal Business Opportunity website (http://www.fedbizopps.gov), Natick Contracting Division http://www3.natick.army.mil/JPMMCSBAA.aspx. From time to time, this BAA may be amended with special announcements or calls for proposals. Additionally, the application process may be amended as other electronic application processes are implemented. All amendments to this BAA will be announced on the websites shown above. To facilitate communication on both scientific and administrative matters relating to this BAA, a single email address may be used for all communication with JPM MCS. Please send all technical and administrative questions and inquiries to
contact@example.gov. Potential applicants are encouraged to discuss their proposal ideas with the JPM MCS technical contacts listed in Section VIII. Missions and BAA Areas of Interest. Administrative questions concerning the preparation of preproposals or proposals should be addressed to: U.S. Army Contracting Command Natick Contracting Division/Grants Officer. They should be emailed to
contact@example.gov, or mailed to the following address: Joint Project Manager Medical Countermeasures ATTN: JPM MCS-BAA 14-01/ACC-APG-NCD 110 Thomas Johnson Drive Frederick, MD 21702
