Animal Models of Infectious Diseases
Added: Sep 12, 2008 2:22 pm
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 NIAIDs Division of Microbiology and Infectious Diseases (DMID) has a requirement to provide and develop animal models in order to advance our understanding of infectious diseases as well as advance the development of therapeutics and vaccines for infectious diseases.
NIAIDs role in developing medical products to counter emerging, re-emerging and other infectious diseases, as well as agents of bioterrorism, is part of a larger national strategy, involving multiple governmental agencies. As such, NIAID supports integrated efforts in basic and applied research, product development, and technology development based on national priorities for medical products. Since 2001, NIAID has established a comprehensive infrastructure with extensive resources that support all levels of biodefense research. With this solid framework of research and product development resources for biodefense in place, NIAID is now transitioning this infrastructure to provide the flexibility required to meet the challenges of emerging, re-emerging and other infectious diseases in addition to biodefense.
The use of animal models helps advance our understanding of infectious diseases as well as the development of therapeutics and vaccines. For example, animal models are used to evaluate product candidates; provide data in support of Investigational New Drug (IND) applications; guide the selection of human dose levels and the design of clinical studies/trials; and provide pivotal efficacy data for products to be licensed under FDAs Animal Efficacy Rule (21 CFR 314.610 and 601.91), when clinical trials are not ethical or feasible. In addition, for emerging and rare diseases, understanding the disease in animals may provide relevant information when little can be learned directly from humans. Therefore, DMID is committed to developing and providing animal models to benefit the research community and public health.
For the most part, animal model services are currently provided through multiple, specialized programs. DMID now seeks to adopt an integrated approach to the provision of services by creating unified, comprehensive, coordinated programs. This strategy is being employed to: advance science by promoting cross-fertilization across and within disciplines and approaches; serve the research community more conveniently; achieve efficient use of resources through economy of scale and avoidance of duplication; and provide the flexibility needed to respond to changing priorities. Accordingly, DMID is establishing the Animals Models of Infectious Diseases program, utilizing the Indefinite Delivery, Indefinite Quantity (IDIQ) contract mechanism.
Under IDIQ contracts, base contract awards are made to multiple offerors that successfully propose a general approach to the technical requirements of the solicitation, providing a guaranteed minimum award. Task orders for specific tasks requiring specialized expertise are solicited and funded within the program Contractor pool. DMID is replacing multiple pathogen or class specific solicitations with one broad IDIQ solicitation for multiple contracts to cover all areas of current and potential future interests. Animal models currently covered by existing pathogen-specific contracts will not be re-competed separately upon completion; however, they could be awarded as task orders under this program, upon expiration of those contracts.
DMID is also establishing the Microbiology and Infectious Diseases Biological Research Resources (MID-BRR) program, which will serve as a central repository for microbiology and infectious disease researchers. The Animal Models of Infectious Diseases program will ensure a supply for the MID-BRR of pathogens that must be grown in animals and reagents integral to research on these organisms.
The Technical Requirements will be assembled into the following sections:
o General Statement of Work, which specifies the basic technical requirements for all contracts.
o Part Statements of Work, which specify additional technical requirements for contracts awarded to support each of four specific Parts:
Part A Small Animal Models
Part B GLP Small Animal Models
Part C Non-Human Primate Models (+/- GLP)
Part D Nontraditional Animal Models (+/- GLP)
Offerors may propose in response to one or more Part(s) of their choosing, and are not expected to respond to all Parts. Offerors are also not expected to be responsible for all pathogens of interest or within scope for these contracts. Offerors responding to multiple Parts must provide separate Technical and Business Proposals for each Part. Proposals for each Part will be reviewed independently.
For the purposes of this contract:
 Small animals (Parts A and B) are defined as traditional small laboratory animal species, such as mice, rats, guinea pigs, hamsters, ferrets, chinchillas, and rabbits.
 Non-human primates (Part C) include various species, such as macaques, including Chinese and Indian rhesus macaques (Macaca mulatta), cynomyologous macaques (Macaca fascicularis), and pig-tailed macaques (Macaca nemestrina), etc. Excluded are baboons and chimpanzees.
 Nontraditional animals (Part D) are defined as specialty laboratory animal species not covered in Small Animal or Non-Human Primate Models (Parts A C), which may have requirements not met in typical biomedical laboratory animal facilities, such as armadillos, woodchucks, snails, other invertebrates, and goats, swine, horses, cattle, etc.
 Products to be evaluated in these animal models are broadly defined to include vaccines and other prevention strategies (e.g. microbicides), therapeutics targeting the host or the pathogen, including immunotherapeutics, and diagnostics. Products will be provided to the Contractor by the Project Officer or a third party after Project Officer approval.
 Pathogens of interest must be pathogens of human concern and not only of animal concern; however surrogate human pathogen/animal combinations may be used for diseases where human pathogens cannot be studied in animal models.
 Pathogens are defined as bacteria, viruses, parasites, fungi, toxins, and other agents such as prions, including NIAID Category A, B and C Priority Pathogens (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm).
 Reagents are defined as biochemical, genomic, molecular, cellular, and immunologic materials integral to research on these pathogens.
The following factors will be considered when evaluating proposals:
Technical Capability: adequacy and appropriateness of the general technical approach to animal model studies, to include conduct of product efficacy studies, animal model development, and supportive measurements (immunological, pharmacological, clinical, pathological, etc.); technical approach to pathogen production and characterization, including overall understanding of the pathogen and its behavior in animal models. In addition, capability to comply with Good Laboratory Practices (21 CFR Part 58) will be evaluated for Part B, Part C and Part D.
Personnel and Project Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity; adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources.
Facilities, Equipment and other Resources: availability of adequate, accredited animal facilities, with biocontainment appropriate for the pathogens proposed; availability of equipment necessary for the proposed animal studies; and adequacy of institutional biosafety program.
It is anticipated that multiple cost reimbursement, completion type contracts will be awarded for a seven-year period of performance beginning on or about
January 4, 2010.
Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about September 29, 2008, 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. See Government-Wide Numbered Note 26.
NIH-NIAID-DMID-AI2008041 Department of Health and Human Services National Institutes of Health
9/12/08, 2:22 PM