performance of state-off-the-art measurements in studies of diabetic kidney disease in type 1 and type 2 diabetes

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to COLORADO UNIV HLTH SCI CTR for the performance of state-off-the-art measurements in studies of diabetic kidney disease in type 1 and type 2 diabetes. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.50. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-06 Effective May 26, 2022 . This acquisition is conducted under the procedures as prescribed in FAR subpart 13'Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1'Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE August 1, 2022 through July 31, 2023 Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 1550 E. Indian School Road Phoenix, AZ 85014 ? DESCRIPTION OF REQUIREMENT The Phoenix Epidemiology and Clinical Research Branch (PECRB) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has conducted studies of diabetes and its complications, including diabetic kidney disease, for more than 50 years. The PECRB recently conducted a series of comprehensive studies of the hemodynamic, metabolic, and molecular determinants of early diabetic kidney disease in type 1 and type 2 diabetes in collaboration with the University of Colorado. In this work, PECRB is integrating state-of-the-art functional imaging techniques with gold-standard renal physiology (presently conducted in our Phoenix laboratory) to examine perturbed energetics in early diabetic kidney disease. This work has been highly successful, and with so much data being generated, PECRB needs to ensure that we were acquiring a comprehensive picture of diabetic kidney disease in these high-risk cohorts. This expanded information will be used to further understanding of the mechanisms responsible for diabetic kidney disease in these cohorts. At the request of the Centers for Disease Control and Prevention (CDC), PECRB is seeking to establish a contract to address this need. The contract will permit PECRB to perform an array of state-of-the-art studies to comprehensively evaluate these high-risk patients. Similar efforts for various aspects of this work have been highly successful in the past, with NIDDK and the CDC providing short-term funds for various activities related to diabetic kidney disease, with subsequent long-term funding sources established by the University of Colorado. _________________________ PURPOSE AND OBJECTIVES The objective of this project is to provide access to critical data that are important to PECRB's efforts to better understand and manage chronic kidney disease in high-risk and understudied populations. Youths with type 2 diabetes are ideal for this purpose because of the aggressive nature of their kidney disease, which can frequently lead to the need for kidney replacement therapy in mid-life. The data generated from this project will compliment those of Determinants of Diabetic Nephropathy (DDN) and Diabetic Renal Disease Study (DRDS) and we also plan to perform comparative analyses to better understand differences of diabetic kidney disease determinants between youth-onset and adult-onset type 2 diabetes. For a complex disease such as diabetic kidney disease, an integrative biological approach is required to advance the field, yet no studies to-date have integrated kidney biopsy data with intrarenal hemodynamic function by clearance studies and renal energetics by state-of-the-art functional imaging (e.g., MRI and PET) in young persons with type 1 diabetes and type 2 diabetes. Accordingly, PECRB provided resources to a comprehensive longitudinal study of the morphometric, molecular, metabolic, and energetic patterns of early diabetic kidney disease in youth. Detailed knowledge of the effects of youth-onset type 2 diabetes on kidney structure and function, and the mechanisms by which perturbed renal energetics and hypoxia mediate these changes, are identifying novel and specific targets for diabetic kidney disease prevention and treatment. This study is also generating a valuable repository of data, biosamples, and kidney tissue for further analysis of diabetic kidney disease in youth-onset type 2 diabetes. There is a paucity of integrated biology studies leveraging renal physiology methods, kidney biopsies and multimodal kidney imaging to examine the distinct features and determinants of early diabetic kidney disease in youth-onset type 2 diabetes. Moreover, the few studies that have sought to determine the morphometric features of early diabetic kidney disease in youth have been limited to type 1 diabetes and constrained by lack of control data. For example, the landmark International Diabetic Nephropathy Study (IDNS) performed research kidney biopsies on 243 youth with type 1 diabetes (mean age of 16.8 years). The morphometric data generated from IDNS were instrumental in enhancing the understanding of early diabetic kidney disease pathogenesis in type 1 diabetes. To our knowledge no such data exist in persons with youth-onset type 2 diabetes. These persons carry a substantially higher risk of diabetic kidney disease than type 1 diabetes. The tissue interrogation in IDNS was limited to morphometrics in lieu of digital pathology driven morphometrics and single-cell transcriptomics proposed in this work. DDN and the DRDS, conducted at NIDDK in Phoenix, provided seminal findings on the determinants of diabetic kidney disease in adult Pima Indians with type 2 diabetes. Although a small subset of participants in DDN and DRDS were diagnosed with type 2 diabetes as youth, their average age and diabetes duration at the time of biopsy were 39.1 and 19.3 years, respectively. Thus, their biopsy data do not represent the earliest structural and functional changes in youth-onset type 2 diabetes. The current studies at the University of Colorado will address this issue and will hopefully greatly expand our understanding of the determinants of diabetic kidney disease in youth-onset diabetes. This purchase will provide extensive new data which can be compared with data already generated in American Indian cohorts in Phoenix. Task The Contractor shall provide: - Ultrasound guided percutaneous kidney biopsies in 20 study participants. - Kidney and brain MRIs in 50 study participants. - Pet + C-11 acetate scans in 30 study participants. Scans must use C-11 acetate production from a cyclotron in close proximity to the PET scanner as the tracer decays in 20 minutes. - Iohexol, p-aminohippurate, and dextran sieving clearance studies in 50 study participants. Contractor shall hold an Investigational New Drug approval with FDA to use p-aminohippurate - J-wire endovascular biopsies in 50 study participants. Contractor shall have expertise in performing J-wire endovascular biopsies in adolescents and young adults. - Pulse wave analysis measurements by SphygmoCor. - Measurement of blood and urine biomarkers in 100 study participants to include urine albumin-to-creatinine ratio, serum creatinine, cystatin C, biomarker panels and for Alzheimer's disease and cognitive impairment. - Full reprogramming of iPSC in 8 samples. Program Management - The tasks described herein shall be primarily performed at the University of Colorado and at the contractor's facilities as determined by the COR. - Provide Monthly Status and Invoice Reports that highlight major events in the reporting period and show tracking of the progress, cost, schedule, and risk management as applicable to the individual task assignments under this SOW. The report shall include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, and any problems/issues encountered. The Contractor shall require and incorporate input from subcontractors (when applicable) where there are critical or significant tasks related to the task order. Critical or significant tasks shall be defined by mutual agreement between the Government and Contractor. The format for the reports shall be agreed upon by the Government and Contractor. As part of the monthly report, the Contractor shall include a section that identifies and communicates lessons learned along with changes planned in response to lessons learned during the life of this contract. The purpose of this section is to imbed changes recommended by the Contractor and the COR to continue quality enhancement and adherence to cost and schedule for the balance of the order. Deliverable 1 Monthly Status and Invoice Reports Due NLT the 15th day of the following month work is performed - Contractor employees shall complete Non-Disclosure Agreements Deliverable 2 Contractor Employee Non-Disclosure Agreement Submitted to the COR prior to performing any work under this acquisition - The Contractor shall provide and maintain a list of Government Furnished Equipment (GFE), Government Furnished Information (GFI) and Contractor Furnished Equipment (CFE) if applicable. - 508 Compliance - NIDDK abides by 508 standards defined and enforced by the Department of Health and Human Services. a. Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio, or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material. b. The contractor must provide a written Section 508 conformance certification due at the end of each contract/order exceeding $100,000 when the contract/order duration is one year or less. If it is determined by the Government that EIT products and services provided by the Contractor do not conform to the described accessibility standards in the Product Assessment Template, remediation of the products or services to the level of conformance specified in the Contractor's Product Assessment Template will be the responsibility of the Contractor at its own expense. c. Prior to the Contracting Officer exercising an option for a subsequent performance period/additional quantity or adding funding for a subsequent performance period under this contract, as applicable, the Contractor must provide a Section 508 Annual Report to the Contracting Officer and COR. Unless otherwise directed by the Contracting Officer in writing, the Contractor shall provide the cited report in accordance with the following schedule. Instructions for completing the report are available in the Section 508 policy on the HHS Office on Disability Web site under the heading Vendor Information and Documents. The Contractor's failure to submit a timely and properly completed report may jeopardize the Contracting Officer's exercising an option or adding funding, as applicable. Deliverable 3 Section 508 Annual Report Annually, and/or as directed by COR. Salient/Required Features and Specifications The procurement of kidney tissue from well-characterized participants with youth onset type 1 or type 2 diabetes for morphometric and transcriptomic evaluation will enhance the NIDDK research goals of establishing the underlying mechanisms of diabetic kidney disease in youth onset individuals and exploring the underlying structural injury that occurs in these high-risk cohorts. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10'Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined COLORADO UNIV HLTH SCI CTR to be the only reasonable available source to provide the performance of state-off-the-art measurements in studies of diabetic kidney disease in type 1 and type 2 diabetes. This acquisition was pursued on a sole source basis centered on the following. The University of Colorado is conducting a unique array of studies in a population of interest to NIDDK (youth onset type 2 diabetes) that is not being done elsewhere in the world outside of NIDDK. These tests are comparable to and extend those NIDDK has already conducted in the NIDDK intramural program in an American Indian population and this activity will permit us to expand understanding of the mechanisms underlying this aggressive form of diabetes and the diabetic complications that frequently develop in early adulthood in this high-risk group. Since no one else is performing these types of studies in this high-risk patient population, another source is not available that could offer the depth, breadth, and comparability of measurements to those already being obtained at the University of Colorado. Moreover, although the equipment necessary to perform some of these tests might be available elsewhere, the inconvenience and costs incurred in transporting patients to alternative facilities and the potential loss of comparability with measurements already performed at the University due to different instrumentation and incompatible software would greatly diminish the value of this acquisition while increasing its costs. Justifications for specific tests are as follows: - Percutaneous kidney biopsies: Over 75 research kidney biopsies have already been performed on study participants at the University of Colorado. The University has a proven track record of safety and quality tissue acquisition. Since participants are seen at the University, performing the biopsies at another location would increase costs and could affect safety. - Kidney and Brain MRI: Over 200 MRIs have been done already on the scanners at the University of Colorado. To ensure comparability of the new scans with those already performed, they need to be performed on the same brand of imaging instrument using the same version of the imaging software. Using another source could result in incompatibility of research results, making valid comparison difficult or impossible. - PET C-11 acetate: Successful PET C-11 acetate imaging requires C-11 acetate production from a cyclotron in close proximity to the PET scanner as the tracer decays in 20 minutes. This is the only research-dedicated facility in Colorado that can perform C-11 acetate PET kidney scanning. Additionally, we are not aware of other sites or groups performing PET C-11 acetate imaging for kidney oxidative metabolism. - Iohexol, p-aminohippurate and dextran clearance studies: Over 200 clearance studies have been performed on study participants at the University of Colorado. Continuation of these studies at the University performed identically with those already done will insure the compatibility and comparability of the measurements. To our knowledge, these renal physiology studies are not performed elsewhere in Colorado. Additionally, Dr. Bjornstad's team holds an Investigational New Drug with FDA to use p-aminohippurate, since it is not commercially available. We are not aware of these procedures being performed in adolescents and young adults with T2D anywhere else in North America. Thus, these procedures could not be performed elsewhere. - J-wire endovascular biopsies: Dr. Bjornstad's team has expertise in performing J-wire endovascular biopsies in adolescents and young adults, and these are performed concurrently with the renal clearance studies. We are not aware of other groups in Colorado performing these procedures during the renal clearance methods. - Pulse wave analysis by SphygmoCor: Dr. Bjornstad's group owns the AtCor SphygmoCor machine and performs pulse wave analysis concurrently with the other procedures to minimize the participant burden and time. Performing this test outside of University of Colorado would add burden to the participants, which would jeopardize study retainment. - Blood and urine biomarkers: To ensure compatibility of blood and urine biomarker measurements with those measured previously in this expanding study cohort, we need to conduct these biomarker measurements in the same laboratory and on the same instruments as those measured previously and in the future. - Full reprogramming of iPSC: Blood samples have already been collected at the University of Colorado from participants for the purpose of creating pluripotent stem cells and the University maintains a core facility capable of reprogramming these samples to create the iPSC clones. Given the track record of successful reprogramming of other samples from these studies and the ability to store the clones on site makes use of another facility for reprogramming non-viable. PECRB has performed market research for the same services and verified that a competitive solicitation would not produce a more advantageous solution. The unique nature and range of measurements and activities required will require unique skills and equipment. The University of Colorado's provides these skills and equipment, and based on past efforts, including supporting the exact measurements needed for the clinical study, it has been determined they will be successful in meeting the challenges of this requirement. Only one known source can meet the Government's needs to provide support for this effort. Competing this requirement could significantly delay the ongoing study and could impact public health and will have a negative impact on the NIH mission. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. 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 to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Friday, June 10, 2022 to the Contract Specialist, Amber Harris, at contact@example.gov . Assessment of Capability Lowest Price Technically Acceptable