Request for Information; Clinical Data to Support Product Licensure Under the Animal Rule

The Defense Threat Reduction Agency (DTRA) is seeking studies to assess the clinical and immunological impact of select biothreat agents in humans for the purpose of validating animal models used for pre-clinical and pivotal animal efficacy evaluation of medical countermeasures seeking licensure under the Food and Drug Administration (FDA) Animal Rule (21 CFR 601.90-95 and 21 CFR 314.600-601) in support of the Transformational Medical Technologies Initiative (TMTI) program. The TMTI mission is to protect the Warfighter from potent known, naturally emerging and genetically engineered threats by providing a capability that includes rapid response and the development and FDA licensure of medical countermeasures. High priority organisms include hemorrhagic fever viruses and intracellular bacteria on the CDC Category A and B high priority pathogen list. Information Sought: TMTI currently supports the development of countermeasures against biothreat agents that warfighters may be exposed to, and the development of animal models to support FDA approval of these countermeasures under the Animal Rule. For animal models to effectively fulfill FDA Animal Rule requirements, it is crucial that they accurately reflect pathogenesis of human disease and are predictive of human response to countermeasures. However, there is an overall lack of understanding of disease in humans, and clinical and immunological data from human outbreaks, for many of these biothreats. As a consequence, this lack of knowledge of human disease could pose the most significant obstacle to the advancement and licensure of any candidate countermeasure. This RFI seeks study designs to collect and assess clinical data to determine the clinical and immunological impact of infection with select biothreat agents on the CDC Category A and B high priority pathogen list for the purpose of validating animal models used for pre-clinical and pivotal animal efficacy evaluation of medical countermeasures seeking licensure under the FDA Animal Rule. Responses should consider existing facilities and ongoing programs to collect clinical data from patients with suspected or proven endemic and epidemic disease; controls required to ensure that data collected to support the validation of animal models will be acceptable to the FDA; existing laboratory specimens from patients and matched control groups; regulations and policies governing transport and/or on-site analysis of clinical samples; the impact of basic interventions and supportive therapies on the clinical disease course; and requirements of oversight organizations such as Institutional Review Boards. Clinical data may include but not be limited to the evolution of symptoms, signs, and clinical course. Laboratory parameters to be studied may include but not be limited to clinical hematology, clinical chemistry, measurements of cytokine profiles and other host biomarkers, viral load, and imaging. Instructions to Responders: Sources having the capability and/or concept to meet these requirements are invited to respond to this RFI. Responses should be limited to five (5) pages for any given concept, not including cover page, cover letter and table of contents. Any proprietary concepts of information should be clearly identified as such. Submitted data and information will not be returned. Input on technical aspects of the responses may be solicited by DTRA from non-government consultants/experts who are bound by appropriate non-disclosure requirements. For all RFI responses, an additional, non proprietary cover page is also requested identifying your company name, technical point of contact, and contact information. This is a Sources Sought Synopsis/ Request for Information (RFI). There is no solicitation available at this time. Requests for Solicitation and inquiries related to same will not receive a response. This RFI is published for market research purposes only, and in no way obligates the Government to issue a solicitation or otherwise make a contract award. Any and all information submitted in response to this synopsis is strictly voluntary. The Government will not pay for any information submitted in response to this RFI. Only electronic submissions of information provided to the email address specified will be accepted. RFI responses should be sent to the following email address: contact@example.gov. All emails should include in the subject line the RFI number and the submitting organization's name. Responses should be submitted electronically not later than 5:00 p.m. EST on 01/15/2010.