Independent Testing & Evaluation Capabilities

Type of Notice: This is a Request for Information (RFI) notice issued for market research and planning purposes, as defined in FAR 10, and does not constitute a solicitation or firm Government requirement. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Any information submitted will not be returned, and no payment will be made by the Government for such information. Information provided herein is subject to change and in no way binds the Government to solicit for proposals or award contracts. It is the respondent's responsibility to monitor FedBizOpps at http://www.fbo.gov for the release of any subsequent information. While the submission of questions regarding this notice is permitted, responses will not be provided, as any questions received will be used solely to develop more information with respect to this subject. Background and Mission: The Chemical and Biological Technologies Department (J9CB) is part of the Defense Threat Reduction Agency (DTRA) within the Research and Development Directorate (J9) and functions as the Joint Science and Technology Office (JSTO) for the Chemical and Biological Defense Program (CBDP) under the Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense [(ASD(NCB)]. In order to accomplish its mission of safeguarding the United States and its allies from warfare agents that can harm or kill, J9CB funds numerous Research, Development, Test and Evaluation (RDT&E) efforts that accelerate chemical and biological defense technologies through readiness levels for transition to Joint Program Managers (JPM). Successful transition of operationally valuable technologies requires producing valid laboratory performance data that directly correlates with field performance. Validation of a test methodology or model development is realized through demonstrating accuracy, precision, repeatability/reproducibility, intermediate precision, specificity, detection limit, quantitation limit, statistical relevance, range, scientific relevance and predictive capacity. These qualities are essential because they verify the suitability of the analytical procedure and allow for standardization; particularly when the statistical analysis is highly complex. A current lack of correlation between warfare agent and simulant behavior and lack of predictive capacity of models is further complicated by the continual emergence of new threat agents and the dearth of reference data and correlates. And the continuing advent of more sophisticated technology demands reexamination and revalidation. Development and validation of methodologies and models will provide good predictive value that will provide operationally relevant and reliable data, which may even obviate the need for whole system or live agent testing under some conditions. Methodology and model development encompasses development or improvement/ modification of design, standards, specifications, networks, materials, methods, solutions, models, applications, systems, tools, surveys, configurations, agents, formulas, practices, processes or other technologies. Purpose and Objectives: This is a survey of the chemical and biological defense community to determine the existing infrastructure and personnel resources capable of performing testing, analysis and the development of methodology, assays, and models for chemical and biological warfare agents (to include non-traditional agents) for the purpose of accelerating the technology readiness level of technologies and medical interventions relating to homeland defense and security or military operations. To avoid an inherent conflict of interest, it will be essential that the entities performing testing and analysis are independent from the entities developing the materials (medical or non-medical) for review. The following is a list of representative tasks that demonstrates the capabilities being sought: 1.) Characterize and predict biological and chemical simulant and threat agent behavior in terms performance, response, defeat, removal, uptake and/or interactions with whole body, equipment, terrain, metallics, cloth, plastics, coatings, filters, etc. 2.) Elucidate statistical, quantifiable agent-to-simulant correlation methods for liquid or solid chemical and biological agents, NTAs, PBAs, aerosol CWA and TIM's and dusty agents 3.)Time-dependent areal dose/distribution/deposition characterization of disseminated (aerosol and mist) agents and/or simulants over whole body, equipment, terrain, metallics, cloth, plastics, and filters in variety of environments (wind, dry, humid, wet, dusty), to include particle size distribution, particle concentration, chemical and biological composition. 4.) Methodology to validate performance of CBRNE detection equipment across threat agents (response time, clear-down or recovery time, accuracy, and repeatability) 5.) Permeation and penetration testing of material swatches utilizing Aerosol Vapor Liquid Assessment Group (AVLAG) and/or Low Volatility Agent Permeation (LVAP) methods under a range of environmental conditions against multiple threat compounds in multiple states of matter (liquid, solid, and/or vapor) to elucidate how interactions among variables affect protection and hazard levels 6.) Evaluate the effect on the protective performance of individual protection equipment (IPE) and collective protection equipment (COLPRO) following exposure to threat materials and/or simulants, decontaminants (the latter in accordance with TOP 8-2-501A and other pertinent guidance) 7.) Correlation of results from confined space and/or model-size testing to operational environments and full-scale (e.g., coupon testing in a lab to warfighter suit in the field) 8.) Develop component and whole-system performance prediction models of protective materials in response to live chemical or biological agents (e.g., quantifiable correlation between simulant leakage through protective material/filters and that of either chemical or biological agents); 9.) Improve test methodology for determining chemical agent resistance of novel materials 10.) Modeling to allow integration of toxicity data into valid estimates 11.) FDA qualified animal model development, characterization and testing for chemical and biological threat toxicology with good predictive value that facilitate studying mechanisms of toxicity and development of prophylactic and therapeutic interventions 12.) In-silico bio-simulation modeling that simulates physiological and pathophysiological processes and capture the complex dynamics of interacting molecules, cells, tissues and organs outside of the organism. 13.) Characterize host response to single pathogen or toxicant and correlate disease across pathogens or toxicants 14.) Elucidation of impact of preparation and handling of simulant and agent pre-testing Facility Qualifications Sought: 1.) Able to receive, store, secure, use and produce Biological Select Agents and toxins (surety materials) at a Biosafety Level 3 (BSL-3), substances listed under the Chemicals of the Chemical Weapons Convention (surety materials), NTAs and/or PBAs: a.) In order to handle CWA, BWA or NTA substances in the US, a laboratory must operate under a bailment agreement with the US Army. Outside the US, a laboratory must operate as a Schedule 1/2 Facility under a Privileges and Immunities Agreement with the Organisation for the Prohibition of Chemical Weapons, allowing the facility to produce, possess and store agent. b.) In order to synthesize, store or conduct testing with PBA's considered Controlled Substances Schedule I-V in the United States, facilities must be registered with the Drug Enforcement Agency, IAW Controlled Substances Act (CSA), 21 USC 801-890, and the DEA regulations, Title 21, Code of Federal Regulations (CFR), Parts 1300 to 1316. c.) Operate under Good Manufacturing Practices (GMP) and hold regulatory permission for synthesis of NTA, PBA, and various chemical and biological compounds at greater than 100 compounds of chemicals related to chemical and biological threat materials. d.) In compliance with Army Regulation 50-1 (AR50-1)/Biological Personnel Reliability Program (BPRP) and AR50-6/Chemical Surety and be registered with the Center for Disease Control (CDC) Select Agent Program and the Animal and Plant Health Inspection Service (APHIS) Agricultural Select Agent program with authorization to accept, possess, use, and transfer select agents and toxins IWA 42CFR Part 72, 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331. e.) Registered, on-site Biosafety Lab-1 (BSL-1) up to BSL-3, minimum. BSL-4, preferably, when conducting work with BWA f.) Meets Guidebook of Performance Standards for Operations of an RDT&E Chemical Agent Laboratory and certified under ISO/IEC/EN 17025 or a higher standard, when conducting work with CWA. 2.) All facilities shall hold active quality program certification (such as ISO 9000 or ISO 17025), Operate under Good Laboratory Practices (GLP) [specifically 21 CFR Part 58 (21 CFR 11 Electronic Records) Federal Food, Drug, and Cosmetic Act- FDA GLPs; 40 CFR Part 160 EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) - EPA GLPs; and 40 CFR Part 792 EPA Toxic Substances Control Act (TSCA) - EPA GLPs. 3.) Minimum facility classification of SECRET and staff members in possession of SECRET clearance 4.) Infrastructure to support immediate mission requirements (e.g., maintenance and storage of all CWA, BWA, TIC, TIM, NTA and PBA contaminated equipment, storage, and security of existing neat chemical stocks). 5.) On-site laboratory outfitted with (or unrestricted access to) standard equipment to conduct basic research on agents [e.g., gas/liquid chromatography, mass and/or imaging spectrometers; Raman light detector; infrared Fourier transform spectrometers; liquid scintillation counters, radio thin-layer chromatography, and radioisotope detectors; Light Detection and Ranging (LIDAR) unit; nuclear magnetic resonance (NMR); etc.] 6.) Automated storage and processing of data to support development, population, implementation and maintenance of unclassified and classified databases of CBRNE agents, properties, and performance 7.) Registered, on-site Animal Biosafety Lab-2 and -3 and on-site animal and life sciences facilities animal care staff certified by American Association for Laboratory Animal Science (AALAS) certified and laboratories certified by Association for Assessment and Accreditation of Laboratory Animal Care (MC) International, when conducting work with animals 8.) Relevant animal models immediately available to include, but not limited to, mouse, rat, rabbit, hamsters, ferret, pigs, bats and non-human primates (New World and Old World). 9.) Expanded processing capability that extends beyond 1-2 subjects per trial and ability to provide more controlled range of variables Response Instructions: Respondents having the capability to meet the objectives herein themselves or in conjunction with teaming partners/subcontractors are invited to respond to this RFI. Each response shall outline the comprehensive team (i.e., respondent and any teaming partners/subcontractors) and document how the team satisfies the specific representative tasks and facility qualifications outlined in the Capabilities Sought section above. All teaming partner or subcontractor information must be included within the respondent's singular submission and organized logically to communicate each team member's capabilities. Respondents also shall include a section that presents an anticipated orgainzational conflict of interest strategy for mitigating or avoiding the potential conflict of interest in testing and analysis work (i.e., an independent testing/analysis performer could not also perform as a product developer in the same space). For all RFI responses, an additional, non-proprietary cover page is also requested identifying the respondent's company name, technical and business points of contact, DUNS, CAGE, and size standard under the 541714 and 541715 NAICS codes. Responses (not including the cover page) shall be no more than five (5) pages in length (Microsoft Word/Adobe PDF, single-spaced, 12-point, Times New Roman font). All responses must be UNCLASSIFIED. Responses shall be submitted to Catherine.L.Keaty.civ@mail.mil, with a copy to Brian.D.Nuckols.civ@mail.mil no later than the date/time specified in this notice.