Execution of multiple interrelated observational and epidemiological protocols

This Request for Information (RFI)/Sources Sought Notice (SSN) is for market research, information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the United States Army Medical Research Acquisition Activity (USAMRAA) or Uniformed Services University of the Health Science Infection Diseases Clinical Research Program (USUHS IDCRP).

This RFI/SSN is being issued by USAMRAA on behalf of USUHS IDCRP, and is seeking sources that have the knowledge, capabilities, experience and staff to provide the simultaneous execution of multiple interrelated observational and epidemiological protocols. The simultaneous execution of multiple interrelated observational and epidemiological protocols include, but are not limited to, addressing issues integral to informing new and emerging clinical practice guidelines and clinical recommendations as well as modifying or updating existing standards for several different disease therapies, resolving high priority gaps for military operational infectious diseases and providing solutions to the DoD requirements-drive research management process and leveraging results of protocols to rapidly implement clinical studies. The estimated period of performance of the requirement, including option periods, is 12 months (26 September 2022 – 25 September 2023). At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 

If capable sources are not identified through this notice, then USAMRAA intends award a Cost-Plus Fixed Fee Award on a sole source basis under the authority of FAR 6.302-1 to the Henry M. Jackson Foundation for the Advancement of Military Medicine Inc., 6720-A Rockledge Drive, Suite 100 Bethesda, MD 20817-1891. The award of a sole source contract will help with ongoing research and currently established protocol populations and to prevent losses in existing enrolled subjects in follow-up phases of respective studies which would significantly impair the ability of future phases of research to be conducted successfully within the USUHS IDCRP.

This RFI/SSN is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed ten (8.5 x 11 inch) pages using a font size no smaller than 10-point.

Capability Statement Requirements: Your company’s program management plan and control policies that adhere to standard industry practices. Must demonstrate the ability to accurately track projects and ensure timely completion of projects. Must include a recruitment and retention strategy to confirm their capability to provide varying levels of support for the tasks listed below.

1. General information and technical background describing your firm’s experience within the last three to five years; specifically with contracts similar in scope, complexity and size to meet the program objectives in accordance with the draft Statement Of Objectives (SOO) tasks outlined below, to include the simultaneous response to multiple stakeholders to account for program management, business analytics support, application planning, program analysis and support services.
2. Demonstrated working knowledge and experience with the following tasks in order to meet the USUHS mission:

• The prime contractor will be required to partner with the following current collaborators associated with the ongoing trial and present an overarching management plan for coordination and execution of both the extramural and intramural activities:
  • Government management: USUHS
  • Government stakeholders: NIAID
  • DoD clinical sites: (USU campus; Brooke Army Medical Center; Walter Reed National Military Medical Center; Naval Medical Center San Diego; Madigan Army Medical Center; Womack Army Medical Center; Naval Medical Center Portsmouth; Carl R. Darnall Army Medical Center; William Beaumont Army Medical Center; Tripler Army Medical Center; US Naval Academy Annapolis).
  • Academic institutions
• The ability to meet the objectives for the study Aims:
  • Objective 1: Complete 100% of the enrollment and follow-up targets with approximately 1300 yearly data and specimen collections.
  • Objective 2: Execute queries, CHCS and MDR data extraction, cleaning, and processing to support these subject-level data and specimen collections.
  • Objective 3: Ongoing data analysis and review of findings.
  • Objective 4: Prepare and gain approval for an HIV repository protocol to consolidate completed protocols and substudies.
  • Objective 5: Complete data analysis and submit manuscripts.
  • Objective 6: Establish overlap cohort collaborative (existing data) protocol with VACS and complete analysis and submit abstracts and manuscripts.

The Government will consider all capability statements received by the due date of this notice. Submitted responses will be reviewed initially by the Contracting Officer to ensure that they are an affirmative response. An affirmative response is defined as a response that complied with the requirement for a capability statement. A received response that requests for documentation, requests for additional information or submissions that only ask questions will not be considered as an affirmative response. Responses determined to be not an affirmative response are invalid and no further action will be taken with the response.

Capability statements are due by 10:00 AM Eastern Time, Wednesday, 22 August at 3:00PM Eastern Time.   Capability statements shall be submitted, by e-mail ONLY, as a Microsoft Word or Adobe PDF attachment to the following address: brandon.m.roebuck.civ@health.mil.