SAM - Pre-Solicitation NICHD-22-227.pdf

Pre-Solicitation NICHD-22-227

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 National Institute on Minority Health and Health Disparities (NIMHD) intends to award a firm-fixed price purchase order to include option year(s) without providing for full and open competition to CIRCADIAN AMBULATORY TECHNOLOGY & DIAGNOSTICS SL for Scientific and Technical Consulting services in support of a Sleep-time Blood Pressure and Chronic Kidney Disease Progression Study.

BACKGROUND

The mission of the National Institute on Minority Health and Health Disparities (NIMHD) is to “lead scientific research to improve minority health and reduce health disparities.” The Digital Health and Health Disparities (DHD) research area resides under the Population and Community Health Sciences Branch of NIMHD’s Intramural Research Program (IRP). DHD’s mission is to leverage health information technologies to improve minority health and reduce health disparities. Sleep-time blood pressure is an important determinant of chronic kidney disease progression. This topic is the focus of a funded Bench-to-Bedside research study, hereafter BtB Sleep-timeBP CKD study, (https://ocr.od.nih.gov/btb/btb_program.html). The trial is registered on clinicaltrials.gov (NCT05189418). The study involves recruiting patients with kidney disease and periodically collecting clinical data on their blood pressure, particularly during sleep time. Patients will participate in the study for at least one year to allow sufficient follow-up time to determine if sleep-time blood pressure is a predictor of kidney disease (and cardiovascular) outcomes. The completion of the BtB Sleep-timeBP CKD study supports the mission of DHD research group. The study will help DHD research team demonstrate the feasibility and utility of using digital wearables to diagnose and monitor health conditions such as blood pressure, which pave the way for the use of digital wearables in clinical practice to improve health outcomes especially among minorities who are disproportionally affected by conditions such as chronic kidney disease and hypertension.

JUSTIFICATION

Understanding the health outcomes of sleep-time blood pressure is only viable through the conduct of a clinical trial with sufficient follow up time to allow for the development and measurement of these outcomes such as progression of chronic kidney disease and cardiovascular disease. To capture such outcomes within the two-year time frame of the bench-to-bedside grant, the research team elected to study patients with advanced chronic kidney disease and follow them for at least one year. Circadian Ambulatory Technology & Diagnostics (CAT&D) is a technology-based company developed by and in partnership with the University of Vigo, Spain. Dr. Ramón Hermida, the Chief Executive Officer of CAT&D, is a principal investigator on the bench-to-bedside funded study. The funding agencies and reviewers make funding decisions on the merit of the proposed work and the credentials of the principal investigators and their ability to carry out the proposed study. Accordingly, the implementation of the research activities outlined in the bench-

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

to-bedside grant is only possible with Dr. Hermida as principal investigator on the research that received the funding. Also, Dr. Hermida has established, through the University of Vigo, the Hygia Network that consists of ~40 clinical centers and 300 medical personnel who are trained and certified in the use of ambulatory blood pressure monitoring and in the conduct of primary care clinical research. Over the last decade, Hygia investigators referred >25000 persons, including >6500chronic kidney disease patients (the population of interest in this study), for periodic ambulatory blood pressure assessments. Access to a large pool of patient population, including those with advanced disease, is critical for the proposed study since it will allow us to recruit the number of patients required for the study. Furthermore, this access allows us to meet our recruitment goals in a short amount of time, which is critical to meet the one-year follow up of enrolled patients per the study protocol. Lastly, CAT&D has a proprietary system (U.S. Patent No 8,428,965 B2) that is needed to be used to automatically analyze all ambulatory blood pressure profiles obtained during the course of the study through dedicated software for individualized evaluation through the SLEEP-BP-CKD Study website. The individualized ambulatory blood pressure monitoring reports will be used to guide changes in treatment, if required. The software program analyzes the participant’s ambulatory blood pressure profile in comparison to circadian (with reference to the rest-activity cycle) time-specified tolerance intervals of systolic and diastolic blood pressure and heart rate constructed for each sex based on databases derived from previous assessments of normotensive individuals (400 men/343 women) who also had been evaluated by 48hour ambulatory blood pressure monitors. This procedure, described in published research by Dr. Hermida, enables the calculation of the so-called hyperbaric index, i.e., area of blood pressure excess above the upper limit of the time-of-day specified reference threshold values, and also the hypobaric index, i.e., area of blood pressure deficit below the lower limit of the time-of-day specified tolerance intervals, of each 48hour ambulatory blood pressure profile. The SLEEP-BP-CKD Study incorporates the hyperbaric index for evaluation of SBP and DBP excess, because it has been shown to be more reproducible than blood pressure mean values in the diagnosis of hypertension, which is critical for this proposed study mainly because of the importance of research reproducibility.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541690 with business size standard of $16.5m.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Federal Acquisition Circular (FAC) 2022-06 effective 5/26/2022. This acquisition is conducted under the procedures as prescribed in FAR Part 13 - Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000), FAR Part 12 - Acquisition of Commercial Items, and FAR Subpart 17.2 - Options.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of FAR 13.106(b)(1) Soliciting from a single source - For purchases not exceeding the simplified acquisition threshold.

PLACE OF DELIVERY

NIH/NIMHD

11545 Rockville Pike Rockville, MD, 20852

DESCRIPTION OF REQUIREMENT

We have a requirement for a base year and option year(s) for Scientific and Technical Consulting services needed to complete data management and research activities in support of a Sleep-time Blood Pressure and Chronic Kidney Disease Progression Study.

• Act as data manager for the BtB Sleep-timeBP CKD study.

• Setup data pipeline for the capture, download, and maintenance of data for the BtB Sleep-timeBP CKD study.

• Maintain and share with NIMHD an itemized budget and a semi-annual progress report

• Maintain and share with NIMHD a monthly report on recruitment and enrollment statuses of patients

• Construct and test an electronic data booklet used for the capture of patient data in the

BtB Sleep-timeBP CKD study and train/certify all study investigators on its use and provide them appropriate access. The training course will provide: (a) detailed explanation of the ambulatory blood pressure monitoring device hardware and software, including how to care for and initialize the device, instruct patients on wearing the device, and transfer of the blood pressure data to the computer, (b) patient instructions and scheduling, and (c) detailed explanation of the study website, the electronic data booklet, dedicated software that generates clinical and ambulatory blood pressure monitoring reports, and how to interpret them.

• Monitor all study sites and ensuring the completeness of patient records, accuracy of entries in the electronic data booklet, adherence to study protocol and good clinical practice standards.

• Transfer a copy of the anonymized raw data to NIMHD at the conclusion of the BtB Sleep-timeBP CKD study.

• Perform analyses on the data as outlined in the study protocol and in consultation with Government and Contractor study investigators.

• Recruit patients to participate in a year-long study according to the inclusion/exclusion criteria outlined in the study protocol.

• Assist with hiring a research nurse or study coordinator or similar position to facilitate patient recruitment and follow up activities during the BtB Sleep-timeBP CKD study.

• Reimburse patients for trips to the clinic per the study protocol.

• Fund any miscellaneous activities such as lab expenses.

• Maintain and share with NIMHD an itemized budget and a semi-annual progress report

• Maintain and share with NIMHD a monthly report on recruitment and enrollment statuses of patients

• Deliver copy of the anonymized raw data to NIMHD at the conclusion of the BtB Sleep-timeBP CKD study

• Perform the study analyses and share with NIMHD all statistical analysis plans, statistical code, and statistical and clinical reports/output

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability in response to this notice and may submit a capability statement, which shall be considered by the agency. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement that includes management, technical data and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. 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 respondents must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses to this notice shall be submitted electronically by 5:00 PM Eastern Standard Time, on 8/18/2022, to jacob.balenson@nih.gov and shall include Pre-Solicitation NICHD-22-227 in the subject line.

http://www.sam.gov/ mailto:jacob.balenson@nih.gov