NOTICE_OF_INTENT_NICHD-22-0102.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 Colorado Denver, Mail Stop F428, Anschutz Medical Campus, Building 500, 13001 East 17th Place, room W124, Aurora, CO 80045-2571 to perform iohexol and p-aminohippurate clearance studies, furosemide injections during kidney MRI scanning as well as hyperinsulinemic-euglycemic and hyperglycemic clamps and provide supervision of the processing of kidney tissue obtained from kidney biopsies.

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 05-01-2022. 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 9000 Rockville Pike Bethesda MD 20892 United States

DESCRIPTION OF REQUIREMENT

The objective of this work is to perform comprehensive studies of the hemodynamic, metabolic, and molecular determinants of early diabetic kidney disease in type 1 and type 2 diabetes in collaboration with Dr. Petter Bjornstad at the University of Colorado to better understand the mechanisms underlying diabetic kidney disease. This purchase will contribute to the success of this objective by providing professional services for the clinical research studies dealing with youth-onset diabetic kidney disease in type 1 and type 2 diabetes. These services will include infusion studies, IV medicine administration, and kidney tissue processing for ongoing clinical

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

study protocols.

Task Area 1 – Perform and oversee inpatient CTRC infusion studies and IV medication titration and assist with IV placement and blood draws.

Task Area 2 – Administer medications for MRI scanning (e.g., furosemide).

Task Area 3 – Administer medical visits, including collection of physical, history, blood pressure and anthropometrics.

Task Area 4 – Work with medical staff to address the medical needs of participants, including titration of medications, titration of insulin doses, addressing medication side effects.

Task Area 5 – Track participant laboratory results and work with medical staff to problem solve management of abnormal laboratory tests and management of medical co-morbidities.

Task Area 6 – Provide education on diet, exercise, diabetes medications and diabetes care to participants and families.

Task Area 7 – Perform data and sample collection at in person and telephone research visit.

Task Area 8 – Develop and maintain familiarity with study protocols and documents of assigned research studies.

Task Area 9 – Document history and Exam information in Electronic Medical Record.

Task Area 10 – Administer outreach phone calls to participants for maintenance of contact, data collection, home insulin dose titration, and assistance with medical management of prediabetes/diabetes.

Task Area 11 – Work with investigators to educate and provide information to patients, families, and community groups regarding available studies.

Task Area 12 – Work as a team member in coordination of assigned primary studies and support of other staff members on research group studies

Task Area 13 – Assist and support in activities related to subject recruitment.

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 Colorado, Centers for Disease Control and Prevention and NIDDK through an Interagency Agreement to develop and expand the work with this collaborator, so to go with another source would not allow us to receive the benefit of the data and samples we have already collected under this important collaboration.

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 (NICHD-22-0102) shall be submitted electronically by 11:00 AM Eastern Standard Time, on May 23, 2022.

http://www.sam.gov/