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.

Background

EIM is a tetrapolar technique of noninvasively applying high-frequency low amplitude stimulation through the skin surface and measuring the resultant alteration in voltage responses produced by the underlying muscle. Unlike conventional electrodiagnostic techniques, the EIM results reflect characteristics of the structure and composition of the muscle rather than its specific electrophysiological characteristics, adding a different dimension to characterization of muscle in muscle or nerve diseases. EIM is a painless, quick and relatively simple procedure to perform. EIM has been shown to be a sensitive indicator of disease progression (Clinical Neurophysiology 2009). EIM has potential to accelerate the ability to complete Phase 2 clinical trials because of its sensitivity to follow muscle changes and correlate with survival in Amyotrophic Lateral Sclerosis (ALS) (ALS 2012). EIM has also been used to evaluate longitudinal changes of muscle development in the spinal muscular atrophy compared to normal pediatric muscle development (Muscle & Nerve 2012), as well as demonstrated changes in disuse atrophy (Arch PMR 2009). Recently, EIM is being evaluated longitudinally in Duchenne Muscular Dystrophy (NCT01523964).

Purpose and Objectives

The Electromyography Section at NINDS seeks to provide innovative and reproducible methods for monitoring patients in neuromuscular clinical trials at NIH. A handheld measuring device is needed that can provide a systematic measurement of electrical impedance myography (EIM) in people with neuromuscular disease. This device is required to be able to measure muscle anisotropy in multifrequencies of EIM, and needs to be integrated into a software program that is readily applicable for clinical research.

At a minimum, the Electrical Impedance Myography measurement device should have the following functional specifications:

The ability to deliver multifrequency currents for measuring bioimpedance of muscles;

Software to measure and compute muscle anisotropy from multi-angle assessment of muscle impedance measurements;

Function with a standardized configuration of sensors that can analyze a focal muscle at different angles and frequencies to reproducibly measure muscle physiology; and

Interface for data acquisition by a laptop computer.

Capability Statement/Information Sought

Respondents to this notice must provide, as part of their response, a list of functional specifications for the supply/equipment that meets this proposed requirement and specifications listed above and demonstrate past performance in providing a device used for assessing neuromuscular disorders. The capability statements shall be limited to 10 pages and will be used to determine the ability of small businesses in the commercial marketplace capable of providing the supply/equipment as described in this notice.

Respondents' should include their DUNS number, organization name, address, technical and business point of contact including title(s), telephone and facsimile numbers, e-mail address, business size and type of business pursuant to the applicable NAICS code, 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing, with a Small Business size standard of 500 employees. Submissions in response to this Small Business Sources Sought notice shall be submitted no later than 10:00 A.M. Eastern Time on March 1, 2013.

All information in response to this notice shall be sent electronically to the Contract Specialist contained in this notice, at [email protected], prior to the closing date of accepting responses. Electronic submissions should be contained as an attachment to the email as an Adobe PDF or Microsoft Office file.

Disclaimer and Important News: 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).

Bid Protests Not Available