PATH is the only private company currently able to conduct D-Antigen testing. PATH's labs have extensive experience with D-Antigen testing. D-Antigen testing is a unique and critical technology for assessing the potency of IP Vaccine without use of human trials. Reagents needed for D-Antigen testing are in very limited supply (i.e., not widely available, not easily produced, not easy to standardize by new producers). A robust assessment of the effect of freezing on IPV is needed as soon as possible to accommodate urgent programmatic recommendations and changes in polio immunization practices. Global IPV supplies are limited and the results of this study will greatly improve the efficient use and management of IPV stocks. D-Antigen testing is an accepted standard for evaluating IPV immunogenicity regardless of IPV manufacturer. The use of other than full and open competition for this acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulations, Subpart 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. This notice of intent is not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a Capability Statement demonstrating their abilities to meet this requirement. All responses will be considered. All Capability Statements shall be received by the closing date of this synopsis and shall be submitted in writing. Responses may be sent via email to
[email protected]. No solicitation will be issued. No telephone inquiries will be accepted.
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