SPECIAL NOTICE
99 -- Request for Information (RFI)for the Joint Vaccine Acquisition Program (JVAP).
- Notice Date
- 9/6/2006
- Notice Type
- Special Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- USA-SNOTE-060906-003
- Archive Date
- 12/5/2006
- Description
- This is a Request for Information (RFI). The Joint Vaccine Acquisition Program (JVAP) is requesting information from organizations capable of developing metrics that will be used to assist in the selection of a single vaccine candidate from a pool o f potential candidates to meet Department of Defense (DoD)requirements and to obtain licensure by the Food and Drug Administration (FDA). The candidates are in late Phase 1, Phase 2 clinical trials. The metrics should have the collective capability to di stinguish qualitatively among biologic programs to determine which has best the requirements, and should continue through to a FDA licensure. Applicable metrics will be required to accompany each criterion quantitatively, for purposes of inclusion within a selection process. Respondents should also cite appropriate regulatory guidance documents, and provide best practices used to accomplish the comparative analysis. This RFI seeks to obtain industry concepts, best practices, capability, and market inform ation from potential vendors. This RFI is issued solely for information and planning purposes only and does not constitute a solicitation or issuance thereof. All information received in response to this RFI that is marked proprietary will be handled acc ordingly. Responses to this RFI will not be returned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. R esponses to this RFI shall include the following: 1) Name of organization; 2) point of contact; 3) corporate cabilities; 4) experience of the company and potential key personnel as it relates to relevent experience with development of metrics to assess pe rformance of biopharmaceuticals and relevant experience with the technical topics addressed above, as demonstrated by knowledge of FDA/Center for Biologics Evaluation and Research (CBER) licensing requirements under the Animal Rule. The page limitation fo r response to this RFI shall be no more than twenty (20) pages front only. The pages shall be numbered and singled spaced with a font size no less that 12 points, and margins no less than 1 inch. Responses shall be submitted electronically on or before 6 October 2006 no later than 4:00PM EST. All reponses shall be sent via email to Amos Lang, JVAP Vaccine Manager at amos.lang@det.amedd.army.mil and to Susan Dell, Contract Specialist at susan.dell@det.amedd.army.mil. Questions may also be addressed to th e above points of contact.
- Record
- SN01135384-W 20060908/060906230240 (fbodaily.com)
- Source
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