SOURCES SOUGHT
B -- ME/Chronic Fatigue Syndrome Skin Biopsy Testing for NINDS
- Notice Date
- 3/6/2018
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- SBSS-NIH-NIDA-18-4876747
- Archive Date
- 3/20/2018
- Point of Contact
- Jason Williams, Phone: 3014965985, Nancy Lamon-Kritikos, Phone: 301-480-2447
- E-Mail Address
-
Jason.Williams1@nih.hhs.gov, nancy.lamon-kritikos@nih.gov
(Jason.Williams1@nih.hhs.gov, nancy.lamon-kritikos@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address : Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, NINDS Contracts Management Branch, 6001 Executive Blvd, Rm 4223, Bethesda, MD 20892-9531 (FedEx/courier: use Rockville, MD 20852). Introduction : 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. 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. This notice is strictly for research and information purposes only. North American Industry Classification System (NAICS) CODE : The NAICS code applicable to this requirement is 541380 - TESTING LABORATORIES. The small business size standard for this NAICS code is $15.0 Million. Background Information : The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose 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, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the cause, treatment, and prevention of neurological disorders. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. Small fiber neurons play an important role in the regulation of homeostasis and the modulation of organ function. Small fibers mediate pain responsiveness, autonomic function, blood vessel, sweat gland function, and gastrointestinal peristalsis. Alterations in small fiber nerve density have been noted in several ill-defined multisymptom illnesses, such as fibromyalgia and Gulf War Illness. To deeply phenotype ME/CFS patients, the role of small fiber function in the development and maintenance of ME/CFS symptoms requires exploration. Small nerve fibers cannot be assessed by conventional means of measuring nerve function, such as nerve conduction velocity, amplitude, or quantitative sensory testing. Currently, the best scientific approach to studying small fiber neurons are collecting samples through skin punch biopsies and measurement of intraepidermal fiber density (IENFD). Autonomic function related to small nerve fibers can be studied through sweat gland fiber density (SGNFD). SGNFD requires particular expertise, as it requires time-consuming stereology and sample staining with Vasoactive Intestinal Peptide (VIP). Typical small fiber neuropathies typically follow a length-dependent pattern. However, alterations in small nerve fibers may not always follow such a pattern. For this reason, a two-site punch biopsy will be performed, with one sample collected from the distal lateral leg and one sample collected from the proximal lateral leg. As the ME/CFS protocol is a hypothesis-generating study, the skin biopsy samples will be used to explore other potential findings beyond standard IENFD measurements. Statement of Need and Purpose : The purpose of this acquisition is to aquire skin biopsy testing services for a Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) study protocol to rigorously assess the vasculature in the dermis, small fiber nerve innervation of blood vessels, and other potential biomarkers such as Schwann cells, tyrosine hydroxylase positive nerve fibers, and vasoactive intestinal peptide positive nerve fibers. The Government is interested in using these small fiber nerve biospy findings as a step toward biomarker development for ME/CFS. Specific Requirements : The Contractor shall: A.Receive individual skin samples shipped by the Government. The contractor shall receive the sample within 24 hours and ensure proper sample processing. The testing analysis described below will be performed on the samples within a 3 month period after receipt. A summary of results shall be submitted to the Government via email spreadsheet every 6 months. B.Provide measurements of intraepidermal fibers for each of the two site skin biopsies. C.Provide sweat gland nerve fiber measurement with vasoactive peptide intestinal peptide staining and stereology for each of the two site skin biopsies. D.Provide measurements of dermal vasculature and its small fiber innervation for each of the two site skin biopsies. E.Provide measurements of Schwann Cells for each of the two site skin biopsies. F.Provide measurements of tyrosine hydroxylase positive small nerve fibers for each of the two site skin biopsies. Anticipated Type of Contract : A firm fixed price contract with a one-year Base Period and four successive one-year Term Options is anticipated. Quantity : Between 1-4 patients per month are enrolled in the ME/CFS protocol. This number may increase in the future due to the possibility of expanding this study; therefore, there will be a base ordering quantity and option quantities for each one-year period (Base Period of one year and four successive one-year Term Options). The Government shall submit a minimum of 12 samples per annum, each requiring two tests. Additional testing may be purchased by the Government in increments of 4, but not to exceed 32 per annum total (applies to the Base Year and for each of the four successive one- year Term Options). Delivery : The contractor shall receive the sample(s) from NIH within 24 hours and ensure proper sample processing. Testing shall be completed on the sample(s) within a 3-month period of receipt. A summary of results shall be submitted to the Government via e-mail spreadsheet every 6 months for the duration of the contract period of performance. Period of Performance : The period of performance shall be for one (1) base year from date of award, with up to four (4) option years. Capability Statement / Information Sought : Contractors that believe they possess the ability to provide the required product(s) should submit documentation of their ability to meet the project requirements to the Contract Specialist. Contractors should also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information and if applicable, Federal Supply Schedule (FSS) contract number. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All responses to this notice must be submitted electronically to the Contracting Officer. Facsimile responses are NOT accepted. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Jason Williams, Contracting Officer, at willjas@nida.nih.gov in MS Word format. All responses must be received by the specified due date and time in order to be considered. The response must be received on or before March 16, 2018 at 5:00 PM EST. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate a fixed-price contract.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/SBSS-NIH-NIDA-18-4876747/listing.html)
- Place of Performance
- Address: Contractor's facility, United States
- Record
- SN04845164-W 20180308/180306231934-9eb39957874108be8e0ec4b3e63a4b31 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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