Support Services for the CTEP Pharmaceutical Management Branch (PMB)

The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source, EDJ Associates, Inc., under the authority of FAR 6.302-1. Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive proposals. However, all proposals received will be considered by the Government. A determination by the Government not to continue with this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition. Background NCI awarded Contract Number HHSN261201700007C to EDJ Associates, Inc. as a cost plus fixed fee, completion type contract with a 12-month Base period of performance from May 1, 2017 through April 30, 2018 and four 12-month option periods for a total period of performance of five years. The contract will expire on April 30, 2022. The contract includes FAR clause 52.217-8 Option to Extend Services, thereby allowing the NCI to extend the contract for up to 6 months. However, the option to extend services was not evaluated at the time of award. The intent of this action is to evaluate the option and increase the value of the contract. This will enable NCI to exercise the Option to Extend Services as a bridge action in the event that there are any unforeseen delays to the recompetition of this requirement under RFP 75N91021R00030. The Pharmaceutical Management Branch (PMB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for the management and distribution of agents used on the majority of NCI sponsored treatment trials, as well as agent distribution support for select Division of Cancer Prevention (DCP) and non-NCI sponsored treatment trials. In accordance with being a regulatory sponsor of clinical trial research, the PMB is responsible for maintaining NCI registration and credentialing information for its investigators and associates, which allows them to participate in sponsored trials. Maintenance includes, but is not limited to, annual collection and storage of FDA Form 1572, Investigator Data Form, Financial Disclosure Form and Curriculum Vitae for all investigators and a subset of this data for registered associates. The PMB manages the Treatment Referral Center (TRC) for handling special CTEP clinical agent initiatives, referrals to high priority clinical trials and the coordination, authorization, and processing of all requests for Special Exception and Treatment Referral Center protocol agent use. The PMB is responsible for assuring that authorization and distribution of agents to only eligible NCI investigators. In order to accomplish this, the PMB pharmacists prepare agent forecasting, agent acquisitions, and perform inventory management of all IND agents distributed by CTEP for open-label and blinded clinical trials. The PMB staff coordinates distribution of NCI agents to investigators for non-human (preclinical) use. The PMB pharmacists also provide pharmaceutical reviews of all applicable CTEP trials. The contract provides support of PMB functions (http://ctep.cancer.gov/branches/pmb/default.htm), mainly in support of drug distribution (e.g., all processes surrounding agent management - order processing, transfers, local destruction, investigator brochure distribution, stock recovery notice distribution, etc.), investigator/associate registration processing and maintenance, curation of database containing NCI list of organizations associated with NCI trials, as well as helpdesks for managing the investigator, associate and organizations databases. Description The National Cancer Institute (NCI) is seeking to evaluate and exercise the Option to Extend Services as authorized by FAR clause 52.217-8 and extend the period of performance of the Contract Number HHSN261201700007C, Titled: - Support Services for Pharmaceutical Management Branch (PMB) by up to 6 months. The contract supports NCI's PMB function in support of drug distribution (e.g., all processes surrounding agent management - order processing, transfers, local destruction, investigator brochure distribution, stock recovery notice distribution, etc.), investigator/associate registration processing and maintenance, curation of database containing NCI list of organizations associated with NCI trials, as well as helpdesks for managing the investigator, associate and organizations databases. NCI intends to modify contract number HHSN261201700007C, with EDJ Associates, Inc. to allow for Option to Extend Services for up to six months in accordance with FAR Clause 52.217-8. NCI intends to use the Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. EDJ Associates, Inc. is the only responsible source, and no other supplies or services will satisfy agency requirements. EDJ Associates Inc. has been successfully performing the contract services since May 1, 2017. The requirement is currently undergoing a re-competition and the RFP 75N91021R00030 was published on sam.gov on August 9, 2022, with proposals dues on September 8, 2021. Due to unforeseen circumstances, there is a high likelihood that the contract award could be delayed beyond April 30, 2022. The continuation of this work is critical to maintaining patient treatment and safety on NCI sponsored clinical trials. Without continuation, patient safety would be jeopardized because investigational agent orders and person registrations would not be processed. These activities are also necessary to meet the regulatory requirements for maintenance of CTEP's Investigational New Drug applications with the FDA. Therefore, a disruption in service would put a stop to all ongoing NCI sponsored clinical trials and delay the start of new trials dependent on these services. No other source has been found that possess all the necessary elements to perform the services in a way that would satisfy the requirements on the current contract. Award to any other source would result in substantial delays in service delivery and duplication of cost to the Government that is not expected to be recovered through competition. This is not a request for proposals, Proposal abstracts, or quotations and does not commit the Government to any contractual agreement. The original award notice was posted to fbo.gov as Women Owned Small Business Set Aside under Solicitation Number N02CM71012-14 and Contract Number HHSN261201700007C. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Interested parties may contact the points of contact referenced in this posting.