Support Services for the CTEP Pharmaceutical Management Branch

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541611 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $16.5 million per annum. This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. The Capability Statements submitted in response to this notice should include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible business concern's name, point of contact, address, and DUNS number. Background 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, sub-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, NCI Biosketch, Financial Disclosure Form and Agent Shipment Form (if applicable) for all investigators and a subset of this data for other registered individuals. 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 Investigational New Drug (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 services are currently being performed by EDJ Associates, Inc. under contract number HHSN261201700007C. Previous contracts for this initiative include contract number HHSN261201200009C which was awarded to EDJ Associates, Inc. Purpose and Objective The Government is seeking a Contractor to provide logistical and administrative support of PMB functions, 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/sub-investigator/associate registration processing and maintenance, curation of a database [Enterprise Core Module (ECM)] containing an NCI list of organizations associated with NCI trials, as well as, helpdesks for managing the investigator, sub-investigator, associate and organizations databases. Project Requirements The Contractor shall be responsible for the work described below. 1. Providing and maintaining an off-site location for other personnel and file storage. Providing and maintaining an off-site location including all equipment necessary at that site for other personnel and file storage. Staffing the PMB office at NCI Shady Grove and off-site facility and be available to conduct all aspects of the Statement of Work during regular PMB business hours (8:30 AM - 5:00 PM, Eastern Time), Monday through Friday, except for official Federal Government holidays. 2. Agent Distribution Support Agent Inventory Management: Agent Inventory Management Activities include and are not limited to: monitoring agent usage, excessive use or low quantity inventory; scanning and maintenance of electronic files such as Investigator Brochures, Certificates of Analysis, Certificates of Conformance, GMP certificates, stability notifications, IND related document; Providing updates and summary from monthly meetings. Agent Order Processing: Agent Order Processing involves processing and authorizing Clinical Drug requests using the NCI Clinical Oncology Research Enterprise (CORE) systems. The Agent Orders include Standard orders, Blinded orders, TRC/Treatment Use/Special Exception Orders, Non-Human Use Orders, IND Orders as well as International Agent Requests. Agent Transfers: The contractor shall assist in the activities related to transfer of IND agents received from PMB between sites and protocols under a very specific set of circumstances. The contractor shall work with the requestor to verify that established criteria are met. Local Destruction of agents distributed by PMB: Requests for local destruction of agents shall be collected, reviewed, and processed based on an established list of agents approved for local destruction and PMB SOPs for local destruction. The contractor shall work with Government staff to review and process approval/denial notifications for requests. Site Communication / Document Management: Perform and maintain a record of electronic mailings required by the Government (PMB). 3. Person Registration and Credentialing Investigators and sub-investigators participating in NCI sponsored treatment trials are required to maintain an active registration with CTEP. The Contractor shall: Develop a method to review and quality assure/quality check the submitted profiles for newly registering and renewing persons in accordance with PMB standards Maintain a process for notifying registrants of issues. Maintain a help desk (email and phone) for assisting registrants Contact the registrant to assist in completing the NCI registration prior to the profile suspension (if possible) if issues with the submission have been identified Ensure/monitor proper notifications are sent to existing investigators regarding their upcoming renewal period. Review the FDA Investigator Disqualification page at least monthly or upon request from the COR. Additionally, the contractor shall maintain information in the Registration and Credential Repository Database and shall be responsible for maintaining records and their annual renewal in the Identity and Access Management (IAM) online system. The contractor shall develop and implement QA/QC processes to endure data integrity in the online systems and provide reports on the activities conducted. 4. Administrative Tasks The contractor shall be responsible for answering the PMB phone line, monitoring general PMB email boxes, scanning active and archival documents and providing quality assurance, provide word processing support, provide data entry, filing and photocopying support, and provide the Clinical Trial Monitoring Branch (CTMB) with agent distribution reports. 5. Quality Assurance (QA)/ Quality Control (QC) plan: The contractor shall be responsible for developing and implementing a written plan for QA/QC of activities conducted and maintaining current SOPs. 6. The Contractor shall work within the NCI databases and applications and providing technical advice concerning NCI CORE systems, and Person Registration, as needed. 7. The Contractor shall receive and process requests from our collaborating pharmaceutical partners for information relating to the Person registrations and Financial Disclosure Form submissions of our registered investigators and sub investigators for the purposes of regulatory submission to the FDA. 8. Electronic Archiving of Paper Files The Contractor shall: Have access to a high-speed scanner to convert the paper documents to an acceptable format for long term storage. Develop a plan for scanning, filing, QC'ing and naming the investigator files for storage within NCI systems. The plan shall include a description of the equipment and staff proposed to accomplish the task Scan and QC all registration documents and upon completion submit a final report to the COR. Anticipated Period of Performance It is anticipated that one cost reimbursement term (level-of-effort) contract will be awarded with one (1) base year plus four (4) option years for a total of five (5) years, beginning on or about May 1, 2022. Since the Government anticipates awarding a cost reimbursement contract for this requirement, in accordance with the requirements of FAR 16.301-3, the awardee will need to have an adequate accounting system prior to the award. It is also anticipated that the resultant contract may include options for Increased Capacity, Phase-In and Phase-Out Transitions. Capability Statement/Information Sought The Government encourages interested, qualified small business organizations to submit a tailored capability statement for this requirement which will be considered by the agency. Tailored Capability Statements submitted in response to this notice should supply pertinent information in sufficient detail to demonstrate the offeror's ability to perform the required services. Capability Statements should clearly convey information regarding the offeror's capabilities, including: (a) staff expertise, experience, and formal and other training; (b) awareness of project's needs and ability to perform the tasks; (c) organizational experience and management capabilities; (d) Facilities and Equipment available to perform the required services; and (e) examples of similar, prior completed Government contracts. The capability statement shall not exceed 10 single-sided pages (including all attachments, charts, etc.), must be presented in single-spaced formatting and using minimum 12-point font size, and shall clearly detail the ability to perform the aspects of the notice described above. Capability statements must include the following: Company's DUNS number Company Name and Address Primary Business Point of Contact Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/. Please indicate if your organization will need to utilize the expertise and resources of subcontractors and specialized consultants to perform the full spectrum of requested activities. The Capability Statements must be submitted no later than April 22, 2021, 4:00 PM EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. The capability statements shall be submitted electronically (via e-mail) to Mesfin Alemayehu, Contract Specialist, at mesfin.alemayehu@nih.gov and Pooja Rathore, Contracting Officer, at pooja.rathore@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF). The e-mail subject line must specify the notice number: HHS-NIH-NCI-SBSS-ETSB-00030-10. Facsimile responses will not be accepted. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in beta.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.