Clinical Studies Monitoring Service (CSMS) National Center for Complementary and Integrative Health (NCCIH)

The contract type considered appropriate for this acquisition is Cost-plus-fixed-fee (CPFF). Circumstances do not allow the agency to define its requirements sufficiently to allow for a Fixed-Price type contract for The Clinical Studies Monitoring Service (CSMS) National Center for Complementary and Integrative Health (NCCIH). Uncertainties involved in contract performance do not permit costs to be estimated with sufficient accuracy to use any type of Fixed-Price contract, the requirement includes an unspecified number of site monitoring visits which includes Pre and Post preparation reporting that is not reasonably measurable. In addition to the unmeasurable labor hour or man power involved in the site visits and reporting, travel cost and fee are also included in this contract. Travel cost is based on an uncertain and consistently changing economy and in the unprecedented environment of COVID-19, it will be difficult to anticipate how all costs will be affected. A CPFF completion type contract is necessary for this acquisition. Completion shall be used by stating a definite goal or target and specifying an end product (up to 50 site visits per year, along with other required services such as training). This form of contract normally requires the contractor to complete and deliver the specific end product, in this case, site visits with Pre and Post reporting, within the estimated cost, as a condition for payment of the entire fixed fee. However, in the event the work cannot be completed within the estimated cost, the Government may require more effort without increase in fee provided the Government increases the estimated cost. The legacy contracts for this project have been successfully awarded and managed as CPFF with options. The contractors have managed to stay within budget and the contract has met the Government’s needs.