SOURCES SOUGHT
66 -- Wearable Technologies for Patients with Glycosphingolipid Disorders
- Notice Date
- 5/19/2016
- Notice Type
- Sources Sought
- 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)-SBSS-2016-143-DM
- Archive Date
- 6/9/2016
- 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
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." Interested Parties capable of providing under the North American Industry Classification System (NAICS): 334516, Analytical Laboratory Instrument Manufacturing, and the small business size standard in number of employees 1000. (Specified BRAND NAME: APARITO) No Refurbished or Used System Are Acceptable. The capability statement should be submitted electronically (via email) to Dorothy Maxwell, Contracting Officer, at maxwelld@mail.nih.gov, on May 25, 2016, 7:30 AM, Eastern Time (EST), Solicitation Number: HHS-NIH-NHLBI-CSB-SBSS-(HG)-2016-143-DM. Procurement : Base Year : 1. Eight wearable devices and six months monitoring (including IT support, analysis and reporting); BRAND NAME: APARITO-- No Refurbished or Used System Are Acceptable. 2. Travel costs for study set-up visit at clinic. Option 1 : 1. Eight wearable devises and six months monitoring (including IT support, analysis and reporting); BRAND NAME: APARITO-- No Refurbished or Used System Are Acceptable. A. Background : The National Institute 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. 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. B. Purpose and Objectives : NHGRI seeks the services of an organization, hereby referred to as the contractor, 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. C. 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. D. Anticipated Period of Performance : Base Year: 12 Months: Option 1: 12 Months: E. Additional Information: 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 Capability Statement /Information : Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. 2. Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. 3. The respondents' DUNS number, TIN/EIN Number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the North American Industry Classification System (NAICS) code: 334516 Analytical Laboratory Instrument Manufacturing and the small business size standard in number of employees 100. 4. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. 5. The capability statement shall not exceed 10 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. 6. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Closing Statement : The capability statement should be submitted electronically (via email) to Dorothy Maxwell, Contracting Officer, at maxwelld@mail.nih.gov, on May 25, 2016, 7:30 AM, Eastern Standard Time include Sources Sought Notice Number: HHS-NIH-NHLBI-CSB-(HG)-SBSS-2016-143-DM. All responses must be received by the specified due date and time in order to be considered. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
- Web Link
-
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- Place of Performance
- Address: Contractor's and NIH Location, United States
- Record
- SN04122245-W 20160521/160519234204-8ecd8d9069b5ff1df6524b31b78c6b80 (fbodaily.com)
- Source
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