SOLICITATION NOTICE
66 -- Wearable Technologies for Patients with Glycosphingolipid Disorders
- Notice Date
- 5/26/2016
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-CSB-(HG)-2016-153-DM
- Archive Date
- 6/16/2016
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME: APARITO LIMITED). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis without providing for full and open competition to Aparito Limited, 25a Ritson Road, London E8 1DE to procure the following: Procurement: 1. Eight wearable devices and six months monitoring (including IT support, analysis and reporting); BRAND NAME: APARITO. 2. Travel costs for study set-up visit at clinic. Background: The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Human Genome Research Institute (NHGRI) mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. The National Human Genome Research Institute (NHGRI), mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. NHGRI supports the development of resources and technology that will accelerate genome research and its application to human health. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. NHGRI also supports the training of investigators and the dissemination of genome information to the public and to health professionals. The National Human Genome Research Institute (NHGRI) Office of the Clinical Director (OCD) is committed to supporting world-class clinical research and enhancing the education of genetics investigators at all levels. The OCD mission is the challenge of finding new and better ways to help patients affected by genetic disorders. To that end, the office provides oversight and guidance to NHGRI scientists working to develop better diagnostic methods, innovative therapeutic approaches and improved medical management strategies for genetic disorders. To achieve its goals, the OCD focuses on the following areas : • Providing expert clinical and administrative infrastructure for all NHGRI clinical research protocols, as well as basic science studies involving clinical specimens. • Assuming an active role in the development and implementation of individual clinical research protocols and clinical research initiatives. • Establishing a presence for NHGRI within the leadership of the National Institutes of Health (NIH) Clinical Center, and helping to integrate the goals of NHGRI's clinical staff with those of the NIH Clinical Center. • Supporting NHGRI's training programs in Medical Genetics and Genetic Counseling. Another important function of the OCD is assisting NHGRI's Institutional Review Board (IRB) in its task of ensuring the protection of participants in NHGRI clinical protocols or in basic science studies involving human specimens. Purpose and Objective : NHGRI seeks the services of Aparito Limited, to assist in the development and implementation of a pilot real time monitoring system for individuals with glycosphingolipid storage disorders. Such a system will include provision of (1) wearable monitoring devices for gait analysis, (2) phone apps for patient reporting of health care usage, medication adherence, patient (parent) reported outcome questionnaires, and event recording, and (3) assistance with web-based data analysis. No patient identifiable data is captured on either wearable or phone app. All publication rights on anonymized data on the patients will be maintained by NIH. Objectives : Phase I: Data Collection Using Wearable Device and Phone App : • The contractor will provide blue tooth-enabled personal wearable devices for each subject in the pilot study up to a maximum of 8 subjects and download a phone app to subject's (subject's parent or guardian's) personal cell phone. They will program the wearable devices for real time data capture of steps, periods of activity, and sleep duration. The contractor will instruct investigators and subjects in the use of the device and the phone app to record data in 4 domains (health care usage, medication adherence, completion of patient reported outcome surveys and recording of events including falls and seizures). The contractor will further instruct investigators on use of the web-based platform to receive downloaded information from the wearable and phone app. Phase II: Data Storage and Transmission : • The contractor will arrange for secure uploading of de-identified patient information into the cloud for storage on a regular basis and enable downloading of data on each subject to the principal investigator on a monthly basis for analysis. The contractor will instruct investigators on use of the web-based platform to receive downloaded information from the wearable and phone app. Phase III: Data Analysis : • The contractor will assist the investigators in data analysis of individual subjects and in all subjects as a cohort. Tasks/Deliverables : Phase I: Data Collection Using Wearable Device and Phone App : • The contractor will travel to the NIH campus for initiation of the study. The Contractor will provide and program wearable units for each subject in the study. The Contractor will download a phone app to the personal cell phone of each subject (or subject's parent or guardian) and instruct subjects in how to enter data in the 4 domains on a regular schedule. The Contractor will answer questions from investigators or subjects as to proper use of the wearable device and phone app. Phase II: Data Storage and Transmission : • The contractor will arrange for uploading and secure storage of de-identified data from the wearable devices and cell phones of each subject. The Contractor will arrange for secure downloading of data to the investigator on a monthly basis for review and analysis. Phase III: Data Analysis : • The Government will arrange monthly teleconferences with the contractor. During the phone conferences the Contractor will assist the scientific investigators in data review and analysis. Period of Performance : Base Year: 12 Months Option 1 Additional Tasks Data Rights : • FAR Clause 52.227-14, Rights in Data - General (May 2014) • FAR Clause 52.227-17, Rights in Data--Special Works (December 2007). The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract will be Government owned and the property of the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials cannot be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government will be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights. Confidential Treatment of Sensitive Information : • The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. Privacy Act: • 45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html • This document is also available at: http://oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm • Privacy Act System of Records Number (NIH link provided) is applicable to this contract and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with the SOW of the contract, and by direction of the Contracting Officer's Representative (COR). http://oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm Regulatory Authority : The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-87-2, April 6, 2016. This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13 Simplified Acquisition Procedures (SAP) at the amount not exceeding the Simplified Acquisition Threshold (SAT) under $150,000.00. Statutory Authority : This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Additional Information : The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). Industry Classification (NAICS) Code is 334516, Analytical Laboratory Instrument Manufacturing, and the Small Business Size Standard is 1000. 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: 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 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. 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: 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 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 must be received no later than 7:30 a.m. Eastern Standard Time (EST), June 1, 2016; and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2016-153-DM, may be submitted to the National, Heart, Lung and Blood Institute, COAC Services Branch, Office of Acquisitions, Office of Management, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell, Contracting Officer. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
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- Place of Performance
- Address: NIH and Contractor's Location, United States
- Record
- SN04131165-W 20160528/160526235250-f6d8aadb807bfb7672f7385b238900c9 (fbodaily.com)
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