Skin Biopsy Testing for Deep Phenotyping Projects at the National Institute of Neurological Diseases and Stroke (NINDS)

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE SUBJECT Skin Biopsy Testing for Deep Phenotyping Projects at the National Institute of Neurological Diseases and Stroke (NINDS) REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures, and the procedures prescribed in FAR Subpart 13.106-1(b)(1), Soliciting from a single source. The resultant contract will include all applicable provisions and clauses of the FAR in effect through the Federal Acquisition Circular (FAC) 2023-04, dated June 2nd, 2023. DESCRIPTION Pursuant to FAR Subpart 5.2'Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Institute of Neurological Disorders and Stroke (NINDS) intends to negotiate and award a purchase order for a Skin Biopsy Testing for Deep Phenotyping Projects. The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), which mission it is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people. Small nerve fibers cannot be assessed by conventional means of measuring nerve function, such as nerve conduction velocity, amplitude, or quantitative sensory testing. Currently, the best scientific approach to studying small fiber neurons are collecting samples through skin punch biopsies and measurement of intraepidermal fiber density (IENFD). Autonomic function related to small nerve fibers can be studied through sweat gland fiber density (SGNFD). SGNFD requires particular expertise, as it requires time-consuming stereology and sample staining with Vasoactive Intestinal Peptide (VIP). Typical small fiber neuropathies typically follow a length-dependent pattern. However, alterations in small nerve fibers may not always follow such a pattern. For this reason, a two-site punch biopsy will be performed, with one sample collected from the distal lateral leg and one sample collected from the proximal lateral leg. NINDS has recently completed a deep phenotyping study of ME/CFS (Protocol 16-N-0058). As part of that protocol, a contract to perform small nerve fiber analysis was awarded to the Polydefkis lab at John Hopkins University (Contract HHSN271201800024C). The Polydefkis lab performed all of the specified work and met all terms of the contract. The results of this work have been compiled and are awaiting publication. Since the award of the aforementioned contract, NINDS has engaged in studying two other multisymptom illnesses, the Post-Acute Sequelae of COVID-19 (PASC) and Gulf War Illness (GWI). The same deep phenotyping framework is being applied to these conditions, with the intent to compare and contrast the results across conditions. For this reason, it is essential for these projects to have all measures performed using the same exact measures as performed as part of the ME/CFS protocol. There is a great deal of technical variability between labs that perform small nerve fiber analyses. Some of the lab-specific technical details are proprietary, making it impossible to ensure that results measured from different labs can be reliably compared to each other. Studies looking at interobserver variability show that just having different personnel assessing small neuron fiber samples can have a substantial impact on the results (Significant difference between three observers in the assessment of intraepidermal nerve fiber density in skin biopsy | BMC Neurology | Full Text (biomedcentral.com)). Comparisons between the measures made in the ME/CFS protocol and the upcoming PASC and GWI protocols will need to ensure analytic homogeneity to be successful. For this scientific reason, we are seeking a single-source justification to use the Polydefkis lab to analyze the samples being collected on PASC and GWI participants. ANTICIPATED SOURCE Company Name - Johns Hopkins Medicine Company Address - 1550 Orleans Street, Room 362 Baltimore, MD Contact Phone - (410) 955-3254 PERIOD OF PERFORMANCE The anticipated period of performance shall include one 12-month base period and two 12-month option periods as follows. Base: October 1, 2024 through September 30, 2025 Option 1: October 1, 2025 through September 30, 2026 Option 2: October 1, 2026 through September 30, 2027 PLACE OF PERFORMANCE N/A REASON FOR NON-COMPETITIVE ACTION The essential characteristics of the required services that limit the availability to a sole source are that the PVSS lab at NINDS has begun studying two other multi-symptom illnesses, the Post-acute sequelae of COVID-19 (PASC) and Gulf War Illness (GWI). The same deep phenotyping framework that has been used on past studies within the PVSS (contract HHSN271201800024C) is being applied to these new studies, with the intent to compare and contrast the results across conditions. For this reason, it is essential for these projects to have all measures performed the exact same way as the previous protocols. There is a great deal of technical variability between labs that perform small nerve fiber analyses. Some of the lab-specific technical details are proprietary, making it impossible to ensure that results measured from different labs can be reliably compared to each other. Using a different vendor for this purpose could compromise the integrity of the projects. CLOSING STATEMENT This synopsis is not a request for competitive proposals. All responsible sources may submit a capability statement, however, which shall be considered by the agency. Responses to this notice must include clear and convincing evidence of the offeror's capability of fulfilling the requirement. In addition, the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM). A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by 3:00 P.M., Eastern Standard Time on September 9, 2024. Responses must be submitted electronically to the Contract Specialist, Cassandra Conley, at cassandra.conley@nih.gov. Fax responses are not accepted.