Combined Synopsis-Solicitation NICHD-22-227.pdf

NICHD-22-227

INTRODUCTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation number is NICHD-22-227 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-06, Effective Date 5/26/2022. The North American Industry Classification (NAICS) Code is 541690 and the business size standard is $16.5m. This solicitation is not set-aside for small business. The acquisition is being conducted in accordance with the procedures of FAR Part 12 - Acquisition of Commercial Products and Commercial Services and FAR Part 13 - Simplified Acquisition Procedures. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in support of the National Institute on Minority Health and Health Disparities (NIMHD), intends to procure Scientific and Technical Consulting services in support of a Sleep-time Blood Pressure and Chronic Kidney Disease Progression Study on a sole-source basis from CIRCADIAN AMBULATORY

TECHNOLOGY & DIAGNOSTICS SL.

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.

DESCRIPTION OF WORK

The purpose of this purchase order is to acquire a base year and option year 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.

The contractor shall:

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.

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

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-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.

PERIOD OF PERFORMANCE

The anticipated start/period of performance dates of the base year is 9/1/2022 to 8/31/2023. If the Government decides to exercise its option, the anticipated start/period of performance dates of option year 1 is 9/1/2023 to 8/31/2024.

CLAUSES INCORPORATED BY REFERENCE

FAR 52.212-1 Instructions to Offerors-Commercial Items FAR 52.212-2 Evaluation-Commercial Items FAR 52.212-3 Offeror Representations and Certifications-Commercial Items (Offerors must include a completed copy of this provision with offer) FAR 52.212-4 Contract Terms and Conditions-Commercial Items FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (See attached provision checked as appropriate) FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (See attached provision to be completed as applicable) FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation FAR 52.217-9 Option to Extend the Term of the Contract

These clauses are available in full text at http://www.acquisition.gov/far/.

http://www.acquisition.gov/far/

CLOSING STATEMENT

The proposed contract action is for supplies and/or services not exceeding the simplified acquisition threshold for which the Government intends to solicit and negotiate with only one source under authority of the 13.106-1(b)(1). Interested offerors/vendors capable of furnishing the government with the supplies and/or services specified in this synopsis should submit a copy of their quotation via email to Mr. Jacob Balenson at jacob.balenson@nih.gov and must include the Unique Entity ID Number (UEI) – Note: In order to receive an award the Contractor must have an active registration for all awards in Sam.gov, the Taxpayer Identification Number (TIN), and the certification of business size. Responses to this combined synopsis/solicitation shall be submitted no later than 15 calendar days from the publication date by 6:00 PM EST on 8/17/2022, must reference Request for Quote (RFQ) NICHD-22-227, and should include enough information to establish the interested parties’ bona-fide capabilities of providing all supplies and/or services needed.

mailto:jacob.balenson@nih.gov