Sole Source Notice: Shelf Life Extension Program (SLEP) Digitization

Sole Source Award Notice: Data Federal Corporation

The FDA-DOD Shelf Life Extension Program (SLEP) for stockpiled human drugs is a key component of the U.S. military’s protection efforts against endemic and pandemic diseases, and the threats posed by chemical, biological, radiological or nuclear weapons. The FDA-DOD SLEP is a US Strategic National Stockpile that now supports the efforts of additional SNS stockpiles such as CDC, VA and the State Department to extend the shelf-life of their stockpiled products. It is the FDA/CDER goal to safeguard the public health. Therefore, the drug products stored/stockpiled must always be available for release during the time of emergency. The DOD stockpiled drugs are analyzed at various FDA field laboratories, and if the data meets the drug quality, the shelf life of the expired drugs are extended each time. The program was established in 1986 and the workflow is based on a paper to paper, site to site platform. The CDER SLEP coordinator has worked with FDA IT and CDER IT business units to design an electronic platform to support the growing requirements of the SLEP program. This electronic platform was created first to secure the nearly 100,000 FDA-DOD paper documents and as a result create a relational database that would provide electronic transfer of SLEP review documents from FDA ORA labs and lab data from FDA ORA labs to the CDER SLEP coordinator for review and approval of SLEP drug product extensions in the Strategic National Stockpiles. The FDA-DOD’s Shelf Life Extension Program saves the US government nearly a billion dollars a year. It is anticipated that the completion of the database, digitizing the paper documents to electronic files, thus creating an electronic workflow platform, will meet the government requirements to effectively administer the SLEP program.  

Estimated Value: $29,610.64.

A notice of intent is issued a sole source to Data Federal Corporation with authority of the FAR Part 12.603 (c)(2)(i), this is a combined synopsis/solicitation for commercial items prepared in accordance with additional information
included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued and If there are no responses have received in response to the posting.

In accordance with FAR Part 13.106-1(b), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action  deem only one source reasonably available. For the reasons stated above, Sermo, Inc. is the only  source considered in this procurement.