The Centers for Disease Control and Prevention (CDC) intends to award, on a sole source basis, a contract to Quest Diagnostics Incorporated, 1901 Sulphur Spring Road, Baltimore, Md 21227. A contract shall be issued for a Progesterone Sub-Study. Serum specimens obtained from enrolled women will be assayed for serum progesterone levels. Results will be utilized in a sub-study to evaluate the effects of hormonal phase on the occurrence of local adverse events and immune response. Justification for other than full and open competition is considered due to the fact that Quest operates a national network of clinical testing laboratories. The Quest Baltimore laboratory already performed the progesterone evaluations on serum specimens obtained form women participants in the CDC's Anthrax Vaccination Program (AVP). The AVP study was a pilot observational study with sparse data for some vaccine doses. However, the CDC's human anthrax vaccine clinical trial sub-study will be better suited to evaluate the potential effect of hormonal status on the occurrence of adverse events following anthrax vaccine in women. Using the same clinical laboratory and thus the same laboratory method, will mean the results of serum progesterone levels obtained for both these studies will be readily comparable.
Note 22 applies herein. The statutory authority permitting other-than-full-and-open competition is 41 U.S.C., 253(c)(1): FAR 6.302-1. Only one responsible source and no other services will satisfy agency requirements. Interested persons may identify their interest and capability to respond to the requirement. This notice is not a request for competitive proposals. A determination by the Government not to compete this proposed contract will be based on responses to this notice and is solely within the discretion of the government. Information received will be considered solely for informational purposes. This procurement is not set-aside for small business. For contractual questions contact Maria Shamburger by email at [email protected].