Pre-Solicitation Notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract with: Acumen LLC 500 Airport BLVD STE 100 Burlingame, California 94010-1980, United States UEI: XVMTJF1497P1 This is not a solicitation. The Department of Veterans Affairs intends to award the purchase of Acumen Statistical Services for the VAMC White River Junction, VT. Acumen LLC is a specialized provider of statistical analysis and policy. The nature of this research project necessitates a combination of high-level statistical expertise and extensive familiarity with models designed to monitor and evaluate vaccine effectiveness. Acumen is uniquely qualified with a dedicated team of biostatisticians who specialize in health sciences and have unparalleled experience in these domains. The contractor will provide the required services. Since the intent is to procure this on a sole source basis, no solicitation will be posted to Contracting Opportunities SAM.gov. The authority for this action is FAR 6.302.1-1 Only One Responsible source and no other supplies or services will satisfy the agency s requirements. The NAICS 541720. The size standard is $28.0 million. The PSC/FSC is AN22. Interested persons may contact the Contracting Specialist by email at Chelsea.Cortright@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer. Response must be received by 07/25/2025 NLT 11:00am EST. PERFORMANCE WORK STATEMENT GENERAL INFORMATION 1. Title of Project: Development of methods for the evaluation of the effectiveness of COVID-19 vaccines and other vaccines and drugs for potentially pandemic infectious diseases in the VA system 2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this Performance Work Statement (PWS), except as may otherwise be specified. The scope of work includes providing methodological and statistical guidance on the development of methodologies to model vaccine effectiveness. Additionally, the contractor shall communicate any sort of challenges that arise that may warrant input from the study team. The statistician(s) at Acumen who work on this project will be invited to attend project calls with study team members and FDA sponsors. Ad-hoc meetings or consultations will be scheduled as needed. 3. Background: The COVID-19 pandemic alerted the regulatory and public health community about the need to obtain highly reliable data on the real-world effectiveness of vaccines and other regulated products during the pandemic in near real time, including among high risk and frail populations, while accounting for unmeasured confounding and other sources of bias. Multiple vaccines and drugs for COVID-19 and other pandemic viruses have been authorized or licensed by the United States Food and Drug Administration (FDA). In preparation for a future pandemic, which could be a coronavirus, influenza or other infection, we need to develop reliable and unbiased methods for the real-world evaluation of the effectiveness of vaccines and drugs to prevent and treat any potentially pandemic infectious disease. Evaluating methods for the timely and reliable assessment of the effectiveness and comparable effectiveness of vaccines in the large and diverse VHA population would provide data generalizable to Veterans along with other high-risk groups in the U.S. and abroad. Identifying the most effective vaccines and strategies may inform and enhance care of Veterans in the future, particularly given the high proportion of comorbidities among Veterans and that individuals with more comorbidities may be at greater risk of severe outcomes of infection. Given this, the study aims to develop methodologies for estimating vaccine effectiveness and monitoring waning of effectiveness over time. 4. Performance Period: The contractor shall complete the work required under this PWS within the time frames stated in each individual task order, unless otherwise directed by the Contracting Officer (CO). The contract shall have a 5-year term. GENERAL REQUIREMENTS 1. For every task, the contractor shall identify in writing all necessary subtasks (if any), associated costs by task, along with associated milestone dates. The contractor's subtask structure shall be submitted with the technical proposal and detailed work plan. 2. All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms. A final written report detailing progress, problems encountered and solved, and other observations shall be submitted within 30 days of task order expiration. 3. Where a deliverable is required in draft form, the VA will complete their review of the draft deliverable within 14 calendar days from the date of receipt. The contractor shall have 14 calendar days to deliver the final version from date of receipt of the Government s comments. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated on individual task orders. Integral to the tasks outlined below will be effective project coordination on the part of the contractor and reliable communication between the contractor and the White River Junction VA PI (Dr. Caroline Korves) and study team. The contractor will engage in day-to-day project management as necessary to ensure that methods development occurs according to protocol and timeline. The contractor shall provide updates during project calls at least monthly along with a document summarizing developments to date and assist in the preparation of written methods and results for manuscripts for peer-review. Communication between the contractor and the team will be ongoing and will include phone calls and email correspondence as needed. If the contractor encounters difficulties with methods development, they will consult as needed with the study team. If the contractor anticipates they will be unable to complete a task within the associated timeframe, they shall communicate this to the team so that all parties can make adjustments to the timeline and associated deliverables as needed. Task 1:Â Work closely with the team to develop methodology for modeling time and offset terms in models of waning vaccine effectiveness To expand the use of self-controlled methods for assessing vaccine effectiveness and waning of immunity, it is essential that different approaches for modeling time be considered as these different approaches may better approximate actual waning of immunity. Furthermore, self-controlled methods must account for time-varying confounders, such as changes in viral circulation over the course of an influenza season. These changes are captured in offset terms in models. Additional work on the validation of offset terms currently included self-controlled methods for assessing waning immunity are necessary to ensure that time-varying confounders are adequately adjusted. The contractor is responsible for working on this vital component of the study with the study team. They shall complete this portion of the study by working collaboratively with the aforementioned parties. The contractor will have no access to any patient-level data from VHA; they will utilize datasets of hypothetical patients with disease onset dates to develop methodology. The study team will collaborate with the contractor on the development of the methodology; The study team will apply methodology to VHA data and only share results from VHA data with the contractor in aggregate, summary form. Deliverable:Â The contractor shall work collaboratively with previously mentioned parties to develop new approaches to modeling time in waning of vaccine effectiveness models and to validate offset terms in models. The contractor will provide the team with a written summary of methodology and accompanying SAS code. [Months 01-02] Task 2: Implementation of new methodologies for evaluation of influenza vaccine effectiveness and waning of immunity Following the above described work on modeling time and the offset term, the study s aim is to evaluate influenza vaccine effectiveness and estimate waning of immunity. Two influenza seasons will be analyzed. The contractor will critically review results that the study team produce and provide guidance for refinement in methodology given specific characteristics of each season and distribution of vaccine types within each season. The contractor shall conduct reviews of study results that the study team share and provide guidance on ways to cross-validate finding; guidance may include written methodology and SAS code. Deliverable: The contractor shall provide feedback during at least monthly project calls as well as brief reports. After analyses are complete, the contractor will assist in writing data analysis methods and results in manuscripts and conference presentations. [Months 03-08] EVALUATED OPTIONAL TASKS AND ASSOCIATED DELIVERABLES As work progresses, there may be other areas of exploration discovered. In this event a project statement will be drafted by VA and a budget for the additional work may be requested from the contractor. Issuance of additional task orders is based upon the availability of funding. SCHEDULE FOR DELIVERABLES 1. If for any reason any deliverable cannot be completed within the scheduled time frame, the contractor is required to explain why in writing to the CO, including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response, in accordance with applicable regulations. CHANGES TO PERFORMANCE WORK STATEMENT Any changes to this PWS shall be authorized and approved only through written correspondence from the CO. The Contracting Officer s Representative will keep a copy of each change in a project folder along with other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. The risk of performing work without a valid funding order in place is entirely upon the contractor. REPORTING REQUIREMENTS 1. The contractor shall provide the project team with monthly and annual written progress reports (original plus 1 copy). These are due by the second workday following the end of each contract year, throughout the contract's duration. 2. The monthly progress report shall cover all work completed during the preceding month. The annual progress report shall cover all work completed during the preceding year and shall present the work to be accomplished during the subsequent year. Both the monthly and annual report shall also identify any problems that arose, along with a statement explaining how the problem was resolved. Both reports will list specific revisions as requested, as well as steps taken to modify the system according to feedback. Both reports shall also identify any problems that have arisen but have not been completely resolved, with an explanation. TRAVEL No travel is expected or defined in this contract. CONTRACTOR EXPERIENCE REQUIREMENTS The government will determine what positions are considered key personnel. The contractor shall identify, by name, the key management and technical personnel who will work under this contract at the time the proposal is submitted. If a key person becomes unavailable, the proposed substitutions of key personnel shall be made only as approved by the Contracting Officer and the COR. The government will not dictate specific experience and education requirements of the employees initially proposed to perform the work stated herein. The contractor shall submit a resume for all direct employees proposed for the project. All Contractor employees will be approved by the COR prior to bringing on duty. If, at any time from date of award to the end of the contract, non-key Contractor personnel are no longer available, VA reserves the right to review the qualifications of the proposed replacement personnel and to reject individuals who do not meet minimum standards needed to accomplish the work. Replacement personnel shall be at least as qualified as the exiting personnel. The contractor must notify VA White River Junction in advance and we will approve or reject proposed contractor key personnel for the performance of this contract. If, at any time from date of award to the end of the contract, Contractor personnel are no longer available, the VA will approve the qualifications of proposed replacement personnel and will reject individuals who do not meet minimum standards required to accomplish the work. The contractor must inform the COR, and Project Manager/Task Manager when personnel are removed from the contract for any reason. The Contractor shall remove any employee from the performance of this contract within five (5) workdays of receiving notice from the Contracting Officer that the employee's performance or behavior is unsatisfactory. All Contractor employees are subject to immediate removal from performance of this contract when they are involved in a violation of the law, VA security, confidentiality requirements and/or other disciplinary reasons. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables, and the specific deliverables associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this contract, are the exclusive property of the U.S. Government and shall be submitted to the project team at the conclusion of the contract. 2. The COR will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to task order deliverables specifically. Any request for information relating to this contract, presented to the contractor, shall be submitted to the COR for response. 3. Press releases, marketing material, or any other printed or electronic documentation related to the project task order deliverables, shall not be publicized without the written approval of the COR. 4. Any publication resulting from the work done regarding specifically the final deliverables for this contract shall be in accordance with VHA Publications Handbook 1200.19; the appropriate legend citing VA support shall be utilized. RECORDS MANAGEMENT LANGUAGE for STATEMENT of WORK (SOW): The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.
