SOURCES SOUGHT
A -- Development of Animal Models and Assays for Plague Vaccines
- Notice Date
- 6/20/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- RFP-NIH-NIAID-DMID-07-06
- Response Due
- 7/5/2006
- Archive Date
- 7/20/2006
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITY STATEMENTS RECEIVED FROM THIS SOURCES SOUGHT NOTICE, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. The National Institute of Allergy and Infectious Diseases (NIAID) of the 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 diseases. The NIAID, Division of Microbiology and Infectious Diseases (DMID), supports a comprehensive extramural research program focused on the prevention and control of diseases caused by virtually all infectious agents (with the exception of the Human Immunodeficiency Virus). This includes basic research, such as studies of microbial biology and physiology; applied research, including the development of vaccines, therapeutics and medical diagnostics; as well as clinical studies to evaluate experimental drugs and vaccines. The NIAID is seeking capability statements from sources that are capable of the development, optimization, qualification, and validation via Good Laboratory Practices (GLP) (21 CFR Part 58) and Good Manufacturing Practices (GMP) (21 CFR Part 211) of product-neutral immunological assays, potency assays, and animal efficacy models for the evaluation and assessment of plague vaccine candidates based on F1 and V antigens. These immunoassays and animal models will be developed in a manner that will support licensure of a plague vaccine under the FDA ?Animal Rule,? (21 CFR Part 601.90-95). NIAID anticipates that a minimum of two species of reproducible animal efficacy models will be developed and characterized for both the pneumonic and bubonic forms of plague, one of which will be a small animal model and the other a NHP model. Innate and adaptive immune responses will be analyzed and from these, correlates of protection will be identified. The development and subsequent validation of immunoassays associated with the correlates of protection includes the identification and provision for adequate amounts of standardized reagents. NIAID will require that potency assays be developed, characterized, and validated. Once validated, these immunoassays, potency assays, and animal models will provide important tools for researchers and manufacturers, and therefore, reagents, methods, and procedures must be transferable. This effort will become a crucial part of a joint Government Agency effort to develop and license a plague vaccine for both military and civilian needs. Potential sources must demonstrate and document the following in their capability statements: 1. relevant experience in conducting studies using Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as well as conducting validation studies; 2. capacity and adequacy of biocontainment facilities; 3. certification or recent application for Select Agent Approval or the ability to successfully meet the certification requirements; 4. capacity and adequacy of facilities for care and housing of animals, and; 5. relevant experience and expertise of personnel and adequacy of relevant training. Interested organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Written capability statements should be received by the NIAID Contracting Officer by July 5, 2006. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. Any proprietary information should be so marked. See Government-wide numbered note 25.
- Record
- SN01073618-W 20060622/060620220323 (fbodaily.com)
- Source
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