"Best Pharmaceuticals tor Children Act (BPCA) - Data Coordinating Center (DCC)"

The Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to negotiate on a sole source basis, under the authority of 41 U.S.C. 253 (c) (1) and FAR 6.302-1(a) (2) (ii) and HHSAR 306.302-1 (a) (2) (ii), a 12-month bridge contract with the EMMES Corporation Inc. (EMMES), Rockville, MD, entitled "Best Pharmaceuticals tor Children Act (BPCA) - Data Coordinating Center (DCC)." The purpose of this procurement action under other than full and open competition is to execute a one (1) year bridge contract to sustain the DCC services supporting the BPCA pediatric clinical trials. It is critical that the services provided by the DCC not be interrupted as it is an integral part to the success of the BPCA pediatric clinical trials that it supports. A break in the services would result in unacceptable delays in fulfilling the Agency's requirements. This twelve month contract will allow the incumbent contractor, EMMES, to continue uninterrupted services in support of ongoing BPCA pediatric clinical trials until a new competitive contract can be awarded and the services transitioned to the new contractor. As the incumbent contractor, EMMES is currently providing data coordinating services in support of ongoing BPCA Phase 1-3 pediatric clinical trial activities. EMMES has developed and is currently implementing data entry protocols that allow for review of data quality, data analyses, and ultimately study reports that will be submitted to the FDA. Transitioning to a new contractor during such critical junctures as monitoring data, safety monitoring, tracking study progress, and submitting study data to FDA require a high level of coordination, effort and time; therefore, any delays could pose risk to the multiple clinical studies, data and patients. Specifically, interruption in these activities would result in unacceptable delays and unrecoverable losses in vital areas of the studies. In view of that, it is critical that the DCC services not be interrupted, as this operation is essential to the success of the BPCA pediatric clinical trials that its supports. There will not be a solicitation or Request for Proposals (RFP) issued. Any responses or inquiries to this notice must demonstrate clear and convincing evidence that competition will be advantageous to the Government. All information received from this notice shall be used for planning and market research purposes only. The determination to refrain from competing proposed contracts based on responses to this notice is solely within the discretion of the Government. The Government will not pay for the preparation of any information submitted or use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the evaluation of the information received. Interested parties may respond and provide a capability statement no later than 4:00 p.m. ET, April 5, 2016 via email to Elizabeth Osinski, Contracting Officer at elizabeth.osinski@nih.gov and Alice Pag'n, Contracting Officer at alice.pagan@nih.gov .