MODIFICATION
R -- Technical, Scientific, and Research Support Services
- Notice Date
- 11/28/2005
- 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-06-36
- Response Due
- 11/21/2005
- Description
- *****This notice is modified to include Task IV (NAICS 541990)-Support to the NIAID VITAL Laboratory. The contractor will provide the technical, scientific, and administrative support for the operation of the NIAID Vaccine Immune- T Cell and Antibody Laboratory (NVITAL). NVITAL shall be a state-of-the-art immunogenicity testing laboratory for the evaluation of samples from human clinical trials. The laboratory will be operated under strict regulatory control, such that the data may support licensure of vaccine products. Offerors must have experience developing or performing immunology assays under the highest level of regulatory control for advanced vaccine product development. Potential offerors should submit a capability statement demonstrating the ability to perform this task. Capability statements for this task must be submitted electronically to tnestor@niaid.nih.gov by December 13, 2005 at 2:00pm EST. Capability statements must also reference similar work that has been performed by the contractor and the dollar value of that work and must clearly reference offeror?s business size. At this time, we are requesting responses to Task IV only.******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. This synopsis replaces the requirement previously advertised under RFP # NIAID-VRC-05-41. The requirement will include the following tasks: Task 1-(NAICS 541990) Clinical Material Development; Task 2-(NAICS 541990) Regulatory Monitoring and Oversight; and Task 3-(NAICS 541710) Laboratory Animal Medicine Support. Potential offerors must provide a capability statement demonstrating the ability to perform these tasks. For Task 1, the contractor shall support, as needed, clinical material development activities for clinical research and advanced clinical development of VRC HIV and non-HIV candidate vaccines. Potential offerors must demonstrate, in addition to the ability to perform the task, that they hold an existing license for a commercial biologic product and/or have manufactured a licensed, commercial biologic product. For Task 2, the contractor will be responsible, as requested on a case-by-case basis, for data and document collection and compilation for regulatory filing (pre-IND, IND, DMF, BLA) with the U.S. Food and Drug Administration (FDA); technical review and report preparation; storage, distribution, and tracking of investigational products; storage of biological samples; and providing administrative coordination and general logistical support for regulatory activities. Due to the expansion of clinical trials on an international level, potential offerors must demonstrate, in addition to the ability to perform this task, that they have extensive experience providing similar services in an international arena. Potential offerors must also demonstrate expertise at handling large and complex INDs and that they have been involved in working with the product(s) from inception through commercialization and post marketing surveillance. For Task 3, contractor shall, as requested on a case-by-case basis, provide all necessary facilities, labor, supplies, and equipment to house and maintain research animals (mice, guinea pigs, and rabbits) and to provide technical research support services as required pertinent to Laboratory Animal Medicine Support. PLEASE READ THE FOLLOWING SECTION CAREFULLY.** Any potential offerors that previously submitted capability statements for the Laboratory Animal Medicine Support Task under RFP # NIAID-VRC-05-41 DO NOT need to re-submit a capability statement. This applies to the Laboratory Animal Medicine Support Task ONLY.** Tasks will be evaluated independently of one another and multiple awards may result. Capability statements must specify which tasks the company 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 clearly indicate business size in their capability statement. Any potential offerors must respond with a capability statement by November 21, 2005 at 2:00pm EST. Please submit any questions in writing to tnestor@niaid.nih.gov. Subsequent to the evaluation of the capability statements, another synopsis will be posted indicating when the release of an RFP is anticipated.
- Place of Performance
- Address: TBD
- Record
- SN00938177-W 20051130/051128211649 (fbodaily.com)
- Source
-
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