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 DATA SCIENCES INTERNATIONAL INC for the purchase of telemetry devices.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 334516 with a Size Standard of 1,000.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2021-06 Effective July 12, 2021.

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
Within 30 Days of Award

Place of Performance
National Institutes of Health 
National Institute of Digestive, Diabetes & Kidney Diseases 
10 Center Drive
Bethesda MD 20892

DESCRIPTION OF REQUIREMENT

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. 

The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology. 

NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities.  The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts.
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The NIDDK’s continuing its efforts to monitor blood pressure and heart rate in a mouse model of sepsis/septic shock/acute kidney injury, where multiple organs fail, including kidneys.  In our efforts to develop animal models for human sepsis and sepsis/AKI, we are undertaking a treatment that is standard of care in sepsis patients, but has not been developed yet for mice, namely the administration of pressors that elevate blood pressure and helps stabilize patients.  This requires monitoring of blood pressure and heart rate to determine if the pressor is working and how much and when to administer it.

We have already purchased a system for receiving and processing the telemetry data from Data Sciences International (DSI), and this project involves the purchase of miniaturized blood pressure/heart rate/temperature monitors that are implanted into mice and use telemetry (radio transmission) to send this data to the receivers.

PURPOSE AND OBJECTIVES

The National Institutes of Health (NIH)’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a requirement for miniaturized blood pressure/heart rate/temperature monitors that use telemetry that will be implanted into mice and use telemetry to send data to the receivers.  We are continuously measuring blood pressure, heart rate, and body temperature to simulate the standard treatment that septic shock patients get, in order to assess which pressors are most effective in the mouse sepsis model, and so that we can better simulate the course of the disease in mice that we observe in patients.  The telemetry devices will also allow us to monitor body temperature, which drops to a much greater extent in mice than in sepsis patients.  This exaggerated hypothermia may also be treated by pressors, so that we may also better select pressors to use in our mouse model..    

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

TASKS AREAS

Independently, and not as an agent of the Government, the contractor shall perform all the detailed Task Areas listed below:

Task Area 1 – Inside delivery of 12 radiotelemetry devices by September 1, 2021 to:

NIH/NIDDK
10 Center Drive
Bethesda, MD  20892

Task Area 2 – Compatibility with all components of the DSI system, including PhysioTel, Matrix 2.0, and Ponemah software v6.0

Task Area 3 – Warranty for up to 9 months total time, up to 6 months implantation time, and up to 6 weeks of use

Task Area 4 – Ability to participate in telemetry device exchange program

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 DATA SCIENCES INTERNATIONAL INC to be the only reasonable available source to provide the requisite telemetry devices .   

This acquisition was pursued on a sole source basis centered on the fact that these devices were previously procured in FY 2019 for this research project and must be compatible with all components of the DSI system, including PhysioTel, Matrix 2.0, and Ponemah software v6.0.  These will allow us to monitor and treat our mouse sepsis model with the same pressors that are used in sepsis patients.  We can then test new treatments for sepsis that affect blood pressure, heart rate, and/or body temperature..

This technology—to be able to continuously monitor blood pressure, heart, rate, and body temperature in conscious, freely moving mice—is essential to our long-term goal of improving mouse models of sepsis and sepsis-induced acute kidney injury, by treating the mice with vasopressors, which are standardly used in clinical practice, but have not yet been used in mice.  Without this technology, we would have no way of knowing if we added too much, too little, or sufficient pressor to reverse the hypotension (low blood pressure) that occurs during sepsis.

DATA SCIENCES INTERNATIONAL INC is the only commercial vendor for telemetry devices compatible with their PhysioTel, Matrix 2.0, and Ponemah software v6.0.  Additionally, the same telemetry devices were purchased in FY2019 for this same research project and are now required to continue the research work.  Without these devices we cannot continue our research on measuring sepsis-induced hypotension as well as hypertension in chronic kidney disease, and our ultimate goal of studying acute on chronic kidney disease, and we are the only research group in the world studying this specialized patient population.  These devices allow us to treat septic mice with pressors, which is the standard of care for septic patients, and we are the only group doing this research in mice as well.

Therefore, the procurement of the requisite telemetry devices is necessary for continued research analysis. The NIDDK must continue using this vendor in the project for scientific continuity. That continuity will help the NIDDK to avoid the introduction of new variables into its research and to avoid long delays and additional costs resulting from retesting products from other potential suppliers.  Failure to procure these deliverables from DATA SCIENCES INTERNATIONAL INC would result in a significant loss of research. 

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 Wednesday, July 28, 2021 to the Contracting Officer, Amber Harris, at [email protected].

Assessment of Capability
Lowest Price Technically Acceptable