SOURCES SOUGHT
R -- Screening biological samples for biomarkers of neurological diseases
- Notice Date
- 7/19/2016
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-2016-548
- Archive Date
- 8/13/2016
- Point of Contact
- Hunter A. Tjugum, Phone: 301 827 5304
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a Small Business Sources Sought (SBSS) 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. This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential 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 small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies 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 541990 -- All Other Professional, Scientific, and Technical Services with associated business size standard $15,000,000.00. BACKGROUND The National Institute of Aging (NIA) is one of 27 Institute Centers at the National Institutes of Health (NIH) committed to making important discoveries that improve health and save lives. The Drug Design and Development Section (DDDS) is part of the NIA Intramural Research Program (IRP), Translational Gerontology Branch (TGB) in the Experimental Gerontology Section. The DDDS is designed to identify drugs that improve brain function and/or forestall the neurodegenerative process in age-related neurodegenerative disorders. Data arising from studies on neurodegenerative and neuroprotective signaling pathways are used to identify potential drug targets. Candidate drugs are first screened for efficacy in cell culture or animal models, and the most effective compounds are moved through preclinical studies to clinical trials. Several drugs that enhance cognitive function are currently in clinical trials, and novel neuroprotective compounds are at various preclinical stages of development. Dementia and other Alzheimer (AD) like disease can be caused by multiple biological changes in the brain. Some are known to be related to gene mutations; however, individuals who develop dementia/AD through this mechanism represent a relatively small percentage of the total numbers of patients. The largest numbers of patients who develop AD are often referred to as sporadic in nature due to an unknown cause of the disease. Recent epidemiological evidence has provided information showing a link between AD and AD-like dementias with concussive traumatic brain injury (TBI). Presently there are no truly effective drug treatments for AD or TBI. This is, in part, due to the lack of bio-markers for either condition. Our laboratory has expertise in studying brain pathology changes in AD and TBI and we have published on several candidate drug treatments for both conditions. Information on effective bio-markers of TBI and AD are absent. DDDS has a potential requirement for contractor support to identify candidate bio-markers of acute neurological injury in a pre-clinical model. Data obtained from the contract will allow DDDS to move forward with the initiation of a human clinical trial examining subject candidate drugs on treating traumatic brain injury and preventing the conversion in later life to AD. PURPOSE AND OBJECTIVES The DDDS has a potential requirement to seek contractor support for the identification of time-dependent bio-markers of neurological dysfunction after an acute brain insult. The data obtained would help to identify drug treatments for neurological disease and allow for the detection of candidate bio-markers derived from brain tissue prepared from a noninvasive peripheral body fluid (i.e. blood derived plasma). Contractor support will provide screening of the protein contents of small volumes of brain exosomes to identify changes in brain protein concentrations after an acute brain injury. Samples will be drawn from a unique library of over 1300 targets and shall be conducted simultaneously over a wide range of concentrations in each sample through utilizing contractor assay. The purpose of this potential requirement is to obtain critical insight into effective biomarker of TBI pathology that may convert to an AD phenotype. Scanning will use specialized tissues derived from the brain and obtained from plasma, by examining the contents of 'neuronal derived exosomes'. The aim is to identify novel bio-markers that will provide a simple method to assess for positive efficacious activity of candidate drug treatments in pre-clinical models of TBI, which provides a baseline for the initiation of a clinical study of candidate drugs to treat human TBI. Essentially, the DDDS is evaluating a wide range of potential proteins in plasma exosomes derived from brain to find specific proteins that are time-dependently elevated following a TBI insult. DDDC may then follow in the clinical stages of drug development studies. PROJECT REQUIREMENTS Contractors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government features of this potential requirement. Specifically, Offerors to this Small Business Sources Sought notice MUST document evidence of being able to achieve the following critical elements of this potential requirement. Offerors shall specify the sensitivity, reproducibility, and throughput factors, and any other qualifications the Offeror deems applicable, for individual proteins measured repeatedly in replicate runs of serum and plasma samples. Simultaneously screening over 1300 protein targets in one biological sample using assay; Possessing large detection range of (logs) with typical lower levels of detection (pg/ml); Low variation between samples using assay critical for statistical analysis; Low protein sample yield (μI) for the isolation of brain derived exosomes to screen for the 1300 targets; Possessing bioinformaticians highly trained in biomarker discovery to provide analysis. Period of Performance: The aniticpated period of performance for this potential requirement will be effective on or around September 2016. The Government's expected delivery date of sample analysis after receipt of an order and samples to be analyzed is 5 weeks. 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 clear and convincing evidence of their capability to analyze samples described in this announcement on a deep sequencing system capable of achieving the scale described in this announcement. Detailed past experience in implementing similar requirements to the requirement described in this announcement must be clearly delineated in any response provided, including items delivered; Evidence of any published manuscripts or other documentation produced shall be used to support past experience. Respondents must provide clear and convincing documentation of their capability in providing analytical quality control and any other requirements and 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. The Respondent must also provide 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. 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. One (1) copy of the response is required and 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. The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, CV's or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must reference the solicitation number and be submitted to Hunter Tjugum, at hunter.tjugum@nih.gov prior to the closing date specified in this announcement. The response must be received on or before the closting date/time specified in this announcement. 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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