Limb Loss Preservation Registry

THIS IS A RESEARCH AND DEVELOPMENT (R&D) NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Medical Rehabilitation Research (NCMRR) plans to compete and award a contract for a Limb Loss and Registry Preservation. The NICHD is partnering with the Department of Defense (DoD) on this clinical registry for amputation and amputation prevention: The Limb Loss and Preservation Registry. The National Center for Medical Rehabilitation Research, within NICHD, leads NIH efforts to study recovery of function after limb loss. The DoD leads efforts to document the etiology, care, and follow-on needs of military members who have incurred an amputation because of traumatic injury but lacks information on those Service members who leave the military health system and seek care in the private sector. Information from the civilian sector will increase the amount and quality of data available to potentially benefit Service members and their beneficiaries in the future. The proposed registry will not interface with or collect data from Department of Defense (DoD) or U.S. Department of Veterans Affairs (VA) health systems. The contractor would be responsible for all research and all information technology systems necessary to successfully build the proposed registry. The proposed registry will collect data regarding the medical conditions that cause limb loss, clinical efforts to prevent limb loss, limb loss surgical procedures, prosthetic fitting, prosthetic use, rehabilitation and patient reported outcomes. Much of this data will be retrieved from Electronic Health Records (EHRs). The contractor will propose a research plan, conduct research, design the registry, select data elements, build the registry, integrate data, assure the quality of data, and complete any other duties required for a successful registry. The proposed registry will include patients of all ages and etiologies across the spectrum of clinical care. NICHD anticipates that the registry will be self-sustaining following the completion of this contract. The contractor will submit a sustainability plan that details a strategy to financially sustain the registry beyond the term of this contract. A government oversight committee will be formed by the NICHD and DoD to advise the COR. The contractor will have no role in selecting members of the government oversight committee. The contractor will assemble a Scientific Advisory Committee, to be approved by the COR, that will provide stakeholder input to the contractor. Members of the Scientific Advisory Committee may not be employed by the NICHD, or the DoD Clinical and Rehabilitative Medicine Research Program. This RFP (NIH-NICHD-NCMRR-2018-16) will be electronically available on or about March 23, 2018. The RFP may be accessed through the FedBizOpps website, https://www.fbo.gov. All responsible sources may submit proposals. This is not a request for proposals. This requirement is defined as code 541715 under the North American Industry Classification System (NAICS).