SOURCES SOUGHT
R -- Point of Care Diagnostics for Hyperammonemia and Aminoacidopathies
- Notice Date
- 9/4/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(SSSA)-SS-2013-3034490
- Archive Date
- 9/26/2013
- Point of Contact
- Hunter A. Tjugum, Phone: 301 435 8780
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought notice. This is NOT a solicitation, request for proposals (RFP), proposal abstracts, nor a request for quotations (RFQ). The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources that includes; (1) other than small businesses (large businesses, education institutions, non-profits, etc.); (2) small business sources; (3) HubZone small businesses; (4) service-disabled small businesses; (5) veteran-owned small businesses; (6) 8(a) small businesses; (7) veteran-owned small businesses; (8) woman-owned small businesses; (9) small disadvantaged businesses; and (10) private contractors and consultants, who can perform the requirements of the size classification relative to the North American Industry Classification System (NAICS) code as specified below. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method, including whether a small business social-economic set-aside, competitive or non-competitive method is possible, and to determine the availability of qualified companies technically capable of meeting the Government's requirement. ALL organizations with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE The NAICS code applicable to this requirement is 541711 - Research and Development in Biotechnology11and the associated small business size standard of 500 employees. PROJECT DESCRIPTION The National Center for Advancing Translational Sciences (NCATS) is the newest of 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). This Center was established in December 2011 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. The mission of the NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. As part of this mission, and specifically in order to provide new technologies and paradigms for development of diagnostics for rare inherited genetic disorders, our institute relies on state-of-the-art biotechnological tools and methods, some of which have only recently been reported initially through the pioneering work of academic laboratories. Recent estimations of the prevalence of metabolic and endocrine disorders in USA reveal that at least 5% of the population suffers from an endocrine disorder and more than 47 million of US residents have a metabolic syndrome. Besides the tremendous human suffering and the high impact on the health care costs, the management of these diseases is difficult and expensive not only in terms of medications, analytical monitoring, and follow-up of patients, but in many cases results in unnecessary procedures and hospitalizations. Although important advances have been made in specific disorders such as diabetes or hypercholesterolemia, advances in others with lower prevalence have been delayed. For example, not much advance has been made in obtaining new diagnostic or therapeutic solutions for patients with Hyperammonemia and Aminoacidopathies. Currently the monitoring of metabolite levels has to be done in a hospital equipped with a specialized mass spectrometry instrumentation, and therefore every time that these patients have an appearance of a crisis, whether related or unrelated to the elevation of the corresponding metabolite, they need to visit the hospital in order for the specialized testing to be performed. It would thus be extremely advantageous, from both a patient quality-of-life and a financial management standpoint, to develop devices capable of detecting these metabolites in real time. NCATS has therefore started a program for the development of small autonomous devices able to conduct real time detection of a wide range of metabolites involved in the numerous metabolic and endocrine disorders. The purpose of this sources sought notice is to obtain responses from capable organizations that can assist NCATS with examining two separate sensing systems for their effectiveness as point-of-care sensors for phenylketonuria and hyperammonemia. In the case of the phenylketonuria, an electrochemical sensing mechanism has been investigated. A colorimetric test was developed and investigated for the detection of hyperammonemia. NCATS demonstrated sensors that respond to levels of glutamate from normal up to diseased concentrations as well as a colorimetric sensor for ammonia in human plasma. Specifically, responses to this Sources Sought notice should describe potential vendors' capability in working with NCATS to examine these detection sensing systems, as it relates to the Electrochemical Detection of Phenylalanine in solution, Nafion as a Blood Filter, and the Colorimetric Detection of Ammonia in a more precise response to hyperammonemic concentrations of ammonia. CAPABILITY STATEMENT /INFORMATION SOUGHT 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. Respondents must provide, as part of their responses, clear and convincing documentation of their capability of providing the services specified in this notice. Respondents must provide 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. Also, information must be provided 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. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. All responses to this sources sought notice must be submitted electronically (via email) to Hunter Tjugum, Contract Specialist, at Hunter.Tjugum@nih.gov on or before September 11, 2013, 4:30 p.m. eastern time. Facsimile responses will be accepted at 301-480-1358. The response must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. CONCLUDING STATEMENTS 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).
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