SPECIAL NOTICE
A -- Development, Testing and Evaluation of a Live Attenuated Tularemia Vaccine Candidate
- Notice Date
- 7/15/2004
- Notice Type
- Special Notice
- 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 Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- Reference-Number-HHSN266200400002C
- Response Due
- 8/30/2004
- Archive Date
- 9/14/2004
- Point of Contact
- Elizabeth Osinski, Contract Specialist, Phone 301-402-6289, Fax 301-402-0972, - Jacqueline Holden, Senior Contracting Officer, Phone 301-496-7119, Fax 301-402-0972,
- E-Mail Address
-
eo43m@nih.gov, jh55b@nih.gov
- Description
- The Division of Microbiology and Infectious Diseases, (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to negotiate, under the authority of 41 U.S.C. 253(c)(1) and FAR 6.302-1, a modification to its current contract with DynPort Vaccine Company (DVC) for additional current Good Manufacturing Practice (cGMP) of a clinical grade Tularemia vaccine candidate. In October of 2003, NIAID entered into a collaborative research agreement with the US Department of Defense to complete ongoing preclinical and product testing of this vaccine and file an Investigational New Drug, (IND), with the goal of conducting a phase 1 clinical trial. As part of this interagency collaboration, NIAID awarded a non-competitive contract to DVC as the developer of the manufacturing process. Work currently includes preclinical testing and support for compilation of an Investigational New Drug (IND) submission. This modification will provide for continued development of the vaccine candidate. Tasks include manufacture of an additional cGMP clinical lot and its release and stability testing, suitable to support the use of this product in continuing clinical investigations. Inherent duplication of cost to the government and the difficulty in developing a new product make competition unfeasible for this project. See Numbered Note 22. No collect calls will be accepted.
- Record
- SN00623902-W 20040717/040716103314 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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