High Resolution Connectivity Profiles of the Human Vagus Nerve

DESCRIPTION High-Resolution Connectivity Profiles of the Human Vagus Nerve In accordance with FAR 15.201(e), this is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. This RFI is issued for the purpose of obtaining knowledge and information for market research and project planning purposes. The National Institutes of Health (NIH) is issuing this RFI to ensure two (2) primary goals: (1) facilitate early (pre-Request for Proposal [RFP]) engagement with industry, in accordance with FAR 15.201(e); and (2) improve NIH's understanding of market capabilities to perform the objectives as outlined in the Draft Statement of Objectives (See Attachment 1). BACKGROUND The NIH Stimulating Peripheral Activity to Relieve Conditions (SPARC) program aims to advance the field of peripheral neuromodulation, or - bioelectronic medicine, by providing access to high-value datasets, maps, and predictive simulations on the peripheral neural control of visceral organ function. Understanding the organ targets of axons and fascicles within the vagus nerve along its length, remains a high priority area of study towards these goals. The Government is seeking information relative to approaches towards developing circuit-level anatomical schematics of vagal nerve connectivity profiles, as described in the draft Statement of Objectives (SOO) (Attachment 1). REQUESTED INFORMATION (six-page limit) The NIH is seeking information on how to best characterize the anatomy and connectivity of the human vagus nerve, in order to facilitate identification of optimal approaches for neural stimulation (location along the nerve, location within the nerve, and parameters) to modulate organ function for therapeutic purposes. Please address the following questions and topics: What are the risks and considerations for the overall objectives? Specify significant hurdles or obstacles to achieve the objectives. What is the feasibility of existing experimental and analytical approaches to meet the objectives in the draft SOO? Would the timeline provided enable the development of new approaches if necessary? Is the target sample size (100 cadaveric donors) appropriate to understand gender- and age-based variation of human vagal nerve anatomy and connectivity? Is the target sample size feasible and realistic in the timeline (3 years) provided? What is the feasibility for a single vendor to reach this target? Provide a rough order of magnitude budget based on the draft SOO. Provide a brief rationale to support the draft budget. Provide additional comments on the draft SOO. The comments should identify any gaps in the SOO including areas requiring clarification, missing or ambiguous requirements, staffing considerations and any other concerns. SUBMISSION INSTRUCTIONS Responses should be submitted electronically to: sparc-v@od.nih.gov. Responses are requested by 5:00 p.m. Tuesday October 5, 2021. Responses received after the due date may not be included in the development of the acquisition strategy. All questions regarding this RFI shall be submitted via email to sparc-v@od.nih.gov by 5:00 p.m. Tuesday, September 28, 2021. The NIH reserves the right to determine whether to respond to questions and may consolidate responses to similar questions. If NIH decides to publish questions and responses, they will be posted for visibility to the public on sam.gov. Respondents may answer as many or as few questions as they wish. The questions provided are intended to guide but not restrict the scope of the RFI responses. Responders are encouraged to submit any value-oriented information that is relevant to the purpose of this requirement. Any additional comments that do not respond directly to a question requested specifically for this RFI should be referenced as "Additional Comments". This section will not be subject to the page six (6) page limitation. DISCLAIMER AND IMPORTANT NOTES. This RFI is issued solely for information and planning purposes to facilitate the acquisition planning process. It does not constitute a Request for Proposal (RFP)/Request for Quotation (RFQ) or a promise to issue an RFP/RFQ in the future, nor does it restrict the Government as to the ultimate acquisition approach. This notice does NOT obligate the Government to award a contract or otherwise pay for the information provided in response. Further, NIH is not seeking proposals through this RFI and will not accept unsolicited proposals. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Any contract that might be awarded based on information received or derived from this RFI will be the outcome of a competitive process. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback with respect to any information submitted. Potential respondents should continue to monitor NIH announcements for additional information pertaining to this RFI. Please note that NIH will not respond to questions about the policy issues raised in this RFI. NIH may or may not choose to contact individual commenters. Such communications would only serve to further clarify written responses. CONFIDENTIALITY. Information obtained as a result of this RFI may be used by the Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. All submissions become Government property and will not be returned.