NOTICE_OF_INTENT_NICHD-22-162.pdf

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.

The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), intends to award a purchase order without providing for full and open competition (Including brand-name) to University of Michigan, Michigan Kidney Translational Medicine Core, 1150 W Medical Center Drive, Room 1552, Ann Arbor, MI 48109 to perform renal tissue biopsies provided by the research team of Dr. Bjornstad from University of Colorado. The research team at U Michigan will process the tissue core obtained for molecular analysis for RNA extraction and RNA sequencing-based gene expression profiling in a compartment specific manner. In parallel a segment of the biopsy will be used to perform single cell RNA sequencing analysis. RNAseq and single cell RNAseq data sets will undergo gene expression profiling analysis to identify activated transcriptional pathways in a cell type specific manner.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 with a Size Standard $16.5M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2022-06 effective 05-26-2022. 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) and FAR Subpart 12- Acquisition of Commercial Items.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6— Competition Requirements.

Place of Performance National Institutes of Health 1550 E Indian School Rd Phoenix AZ 85014 United States

DESCRIPTION OF REQUIREMENT

To acquire kidney tissue from research participants with youth onset type 1 or type 2 diabetes.

Tissue from these biopsies will undergo quantitative morphometry and RNA sequencing studies performed either in single cell preparations or in the glomerular and tubulointerstitial compartments after microdissection. Spatial transcriptomics will also be performed using the Visium Spatial platform.

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

Specific objectives of this work are to:

To characterize structural and transcriptomic features of early diabetic kidney disease in youth with diabetes; to identify distinct structural and transcriptomic differences of kidney disease, if they exist, between youth with T1D and youth with T2D and to define the structure-function relationship between renal energetics, tissue integrity and gene expression in youth with diabetes.

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. In this acquisition, we will acquire the services needed to perform quantitative morphometry on the research kidney biopsies acquired at the University of Colorado. The morphometric work will be performed at the University of Michigan.

Task Areas:

a) Perform quantitative morphometry using light and electron microscopy of the kidney tissue acquired from research kidney biopsies. This work should be performed according to the protocol of the Kidney Precision Medicine Project. We anticipate 2-3 kidney biopsies to be performed each month.

b) Perform special staining and immunofluorescence as per the Kidney Precision Medicine

Project protocol.

c) Provide a standard clinical pathology report on each kidney biopsy specimen.

d) Provide clinical and morphometric data to NIDDK as it becomes available and provide a final dataset at completion of the project.

e) Publish results with NIDDK investigators as authors

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 that the University of Micigan, is the only contractor performing this specific type of transcriptomic work that includes spatial transcriptomics of kidney tissue. Moreover, they have performed these morphometric and transcriptomics measures on past kidney tissue specimens for this study and to change providers at this time could introduce errors and biases in the data that could significantly reduce the value of these precious data.

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. Respondents are advised that the

Government is under no obligation to acknowledge receipt of the information received or provided feedback to respondents with respect to any information submitted. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement, unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Vendor/Contractor’s (UEI) the Unique Entity ID from SAM.gov is now the authoritative identifier for those doing business with the federal government. The DUNS Number is no longer valid for federal award identification, 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 (75N94022Q00130) shall be submitted electronically by 11:00 AM Eastern Standard Time, on July 11, 2022.

http://www.sam.gov/