Sole Source Justification and Approval: Regulatory Submission and Biostatistical Support Services for the US Army Medical Materiel Development Activity

The U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the U.S. Army Medical Materiel Development Activity (USAMMDA) intends to issue a Cost Plus Fixed Fee (CPFF), Sole Source, contract to PPD Development, LP, DUNS: 362574527, in accordance with statute 10 U.S.C 2304(c)(2) as implemented in Federal Acquisition Regulation (FAR) 6.302-2, Unusual and Compelling Urgency.

The USAMMDA Office of Regulated Activities (ORA) has a requirement to obtain electronic Common Technical Documents (eCTD) submission support. The Contractor will be required to assemble and publish submissions and documents that meet the requirements for publishing and work with ORA and/or regulatory agency software programs including but not limited to LiveLink, Liquent Insight Publisher (eCTD), and FDA Electronic Submission Gateway (ESG), and eSubmitter (eCOPY). The publishing submissions are for 80 open Food and Drug Administration (FDA) Applications which include Investigational New Drugs, Drug Master Files and Orphan Drug Applications with approximately 70 ongoing clinical trial efforts; of the 70 ongoing clinical trial efforts, approximately 35 of those are actively enrolling, while the other ~35 are either in study start up or close out phases. The services will also include developing statistical models using clinical and biological data that will inform clinical trial design (e.g., overall design schema, sample size calculations, screening, randomization, inclusion/exclusion criteria, etc.) in support of the Neurotrauma and Psychological Health Program Management Office.

The required period of performance is five (5) months (1 May 2018 - 30 September 2018) plus a one (1) month option period (1 October 2018 - 31 October 2018).

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES and a written solicitation will not be issued. This announcement constitutes the only notice by the government; however any interested concern that believes it can meet the requirement must respond in writing in the form of a capability statement. Responses must include supporting evidence that is clear and concise which articulates the ability to comply with the requirement outlined above.

A request for documentation will not be considered an affirmative response. A determination by the Government not to compete this procurement on a full and open competitive basis will be made based on the responses received. Determination is solely within the discretion of the Government. If no written responses are received by the date listed below, the proposed contract modification will be awarded without further remark.

Interested concerns must identify their capability in writing via email to Ms. Dana Kavitski at dana.kavitski.civ@mail.mil. no later than 4:00 pm ET, April 30, 2018. All questions and responses concerning this notice shall be emailed to Ms. Dana Kavitski at dana.kavitski.civ@mail.mil.