SOLICITATION NOTICE
R -- Technical, Scientific, and Research Support Services
- Notice Date
- 2/24/2006
- Notice Type
- Solicitation Notice
- 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
- Point of Contact
- Terrie Nestor, Contract Specialist, Phone 301-402-6790, Fax 301-480-0689,
- E-Mail Address
-
tnestor@niaid.nih.gov
- Small Business Set-Aside
- Partial Small Business
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for 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 541990) Clinical Material Development; Task 2-(NAICS 541990) Regulatory Monitoring and Oversight; Task 3-(NAICS 541710) Laboratory Animal Medicine Support and Task 4-(NAICS 541990) Support to the NIAID VITAL Laboratory. 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. Offerors must 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. Offerors must have extensive experience providing similar services in an international arena and expertise at handling large and complex INDs. Offerors must also 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 by the VRC, 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. For Task 4, 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. Tasks will be evaluated independently of one another and multiple awards may result. Tasks 1, 2, and 4 are being solicited on an unrestricted basis. Task 3, will be solicited as a 100% small business set aside. A CPFF/IDIQ type contract for one year with the option for four additional years beginning on August 1, 2006 is anticipated. The solicitation will be available for download from www.fedbizopps.gov on or about March 15, 2006. Please submit any questions in writing to tnestor@niaid.nih.gov. If you are interested in Task 3, please see numbered note 1. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (24-FEB-2006). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 27-SEP-2006, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/AMOB/NIAID-VRC-06-36/listing.html)
- Place of Performance
- Address: TBD
- Record
- SN01156623-F 20060929/060927223326 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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