MODIFICATION
R -- Technical, Scientific, and Research Support Services
- Notice Date
- 4/7/2005
- Notice Type
- Modification
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, MD, 20817
- ZIP Code
- 20817
- Solicitation Number
- NIAID-VRC-05-41
- Response Due
- 4/18/2005
- Description
- *****The attached synopsis is hereby cancelled.*****The National Institute of Allergy and Infectious Diseases (NIAID) is seeking sources that can provide comprehensive technical, scientific, analytical and research support to facilitate the Vaccine Research Center (VRC) research efforts necessary for accomplishing programmatic goals. The requirement will include the following tasks: Task 1- (NAICS 561210) Support for the Vaccine Research Center Vaccine Production Program and the Vaccine Pilot Plant (VPP); Task 2- (NAICS 541690) Support for the Vaccine Research Center Research Laboratories; Task 3- (NAICS 541990) Clinical Material Development; Task 4- (NAICS 541990) Clinical Trial Support; Task 5- (NAICS 541990) Regulatory Monitoring and Oversight; Task 6- (NAICS 541710) Laboratory Animal Medicine Support; and Task 7- (NAICS 561210) Support for NIAID Immune Analysis Services. For Task 1 the contractor shall support all aspects of cGMP production, including, Warehousing; Maintenance; Quality Control; Preparation of manufacturing documents for IND and related submissions; Production, testing, release and regulatory filing preparation of Phase I/II vaccine products; Development of manufacturing processes that are suitable for eventual manufacture of material for Phase III and licensed vaccine production, including Process Qualification, Assay Development, and Process Validation; Manufacture of Phase I/II clinical lots of candidate vaccines utilizing appropriate cGMP standards; Development of manufacturing processes through staffing in the various VRC production laboratories; Establishment of Quality Systems to support manufacturing of candidate vaccines by additional VRC contractors; Participate in the conceptual design of vaccine manufacturing processes as projects are transferred from basic research labs to VRC production labs; and Develop and transfer technology to industrial partners for production of Phase III lots and delivery of vaccine to market. For Task 2, the contractor shall support, as needed, the basic clinical research and advanced clinical development components of the VRC to translate basic findings into clinically relevant vaccine products. For Task 3, contractor shall support, as needed, clinical material development activities for clinical research and advanced clinical development of VRC HIV and non-HIV candidate vaccines. For Task 4 contractor will support, as needed, activities relating to clinical trials of VRC HIV and non-HIV vaccines. This shall include: clinical research and recruitment support, epidemiologic analysis support, Medical Officer support, field laboratory support, and clinical site monitoring at VRC supported study sites as described in the FDA guidelines. For Task 5, contractor will be responsible, as needed, for data and document collection and compilation for regulatory filing (pre-IND, IND, DMF) with the U.S. Food and Drug Administration (FDA); technical review and report preparation; implementing and maintaining computer information systems; and providing administrative coordination and general logistical support for regulatory activities. For Task 6, contractor shall provide all necessary facilities, labor, supplies, and equipment to house and maintain research animals and to provide technical research support services as required pertinent to Laboratory Animal Medicine Support. For Task 7, contractor shall provide technical, scientific, and administrative support for NIAID Immune Analysis Services. Tasks will be evaluated independently of one another and multiple awards may result. Any potential contractors should respond with a capability statement by April 18, 2005 at 2:00pm EDT. Capability statements must specify which tasks the contractor is capable of performing and information must be provided to support the contractor?s ability to perform the tasks. Capability statements must also reference similar work that has been performed by the contractor and the dollar value of that work. Potential offerors must indicate business size in their capability statement. This is a market survey, not a request for proposals. All questions must be directed in writing to tnestor@niaid.nih.gov.
- Place of Performance
- Address: TBD
- Record
- SN00784193-W 20050409/050407211913 (fbodaily.com)
- Source
-
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