MODIFICATION
B -- Small Fiber Skin Biopsy Testing and Evaluation Services for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome for NINDS - Amendment 1
- Notice Date
- 4/17/2018
- Notice Type
- Modification/Amendment
- 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
- NIH-NIDA-CSS-18-4876747
- Archive Date
- 4/25/2018
- 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
- Solicitation Amendment 1 -- Extension of due date to April 20, 2018 5 PM EST SOLICITATION IS HEREBY AMENDED TO EXTEND THE DUE DATE FOR PROPOSALS TO APRIL 20, 2018, 5 PM EST. Title: Small Fiber Skin Biopsy Testing and Evaluation Services for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome for NINDS This is a combined synopsis/solicitatio n for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is NIH-NIDA-CSS-18-4876747 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. The associated NAICS code is 541380, "Testing Laboratories" and the small business size standard is $15.0 Million. This acquisition is pursued as an unrestricted, full and open competition, open to all qualified sources. Statement of Need: The Director of NIH has initiated an effort to study Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS). This disorder refers to chronic and disabling fatigue, inability to recover after exercise, and physical and emotional discomfort occurring after a person has an infection. 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. Background Information : The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. 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. Investigators in the NINDS intramural program conduct research in the basic, translational, and clinical neurosciences. 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 multi-symptom 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 [by NINDS], with one sample collected from the distal lateral leg and one sample collected from the proximal lateral leg. Collected samples will be sent to the Contractor for testing and evaluation. 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. Contractor expertise will be required 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 interesting in using small fiber nerve biopsy findings as a stepping stone to biomarker development for ME/CFS. Contract Type : A firm fixed price contract with a one-year Base Period and four successive one-year Term Options is anticipated (total potential performance period of 5 years). 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 (ENFD Processing and Evaluation and SGNFD Processing and Evaluation). Additional sample testing may be purchased by the Government via Quantity Options in increments of 4 samples, but not to exceed 32 samples per annum total (applies to the Base Year and for each of the four successive one- year Term Options). Anticipated Period of Performance : Base Period: May 1, 2018 through April 31, 2019 Option 1: May 1, 2019 through April 31, 2020 Option 2: May 1, 2021 through April 31, 2022 Option 3: May 1, 2023 through April 31, 2024 Option 4: May 1, 2024 through April 31, 2025 Specific Requirements : The Contractor shall: A. Receive individual skin samples shipped by the Government. The contractor shall receive the samples 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. All skin biopsy samples will be returned to NINDS (delivery instructions to be arranged with NINDS COR). REPORTING REQUIREMENTS The contractor shall perform the lab testing analysis described below on the samples within 3 months of receipt. A summary of results shall be submitted to the Government via email spreadsheet every 6 months. OTHER CONSIDERATIONS Key Personnel The primary Investigator and/or senior staff working under this award shall be considered key personnel. Key Personnel requirements are as follows: • Contractor staff supervising the performance of these skin biopsy testing and evaluation services must have a minimum of ten (10) years' working experience with small fiber nerve measurements • Contractor staff supervising the performance of these skin biopsy testing and evaluation services shall have a doctorate degree The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.242-70 KEY PERSONNEL, HHSAR 352.242-70 (January 2006) The Key Personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any Key Personnel without the written consent of the Contracting Officer. The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows: The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The following individual(s) is/are considered to be essential to the work being performed here under: TO BE DETERMINED It is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Personal Identifying Information : No Personal Identifying Information will be provided by the Government to the Contractor. The Contractor will receive coded samples only. Data Rights : The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and shall be made a part of any resulting contract/order. Confidentiality of Information : The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is not of a sensitive nature. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to this solicitation will be most advantageous to the Government in accordance with the stated Evaluation Criteria (see Attachment 1: Evaluation Criteria). Please note that per Factor 1 of the attached Evaluation Criteria, offerors are expected to submit a sample analysis report for ENFD and SGNFD evaluation of skin biopsy samples, similar in nature to the work to be conducted under this requirement, with their proposal which shall be examined by NINDS to evaluate the offeror's Technical Capability to perform the work requirement. Although the technical evaluation of proposals shall be considered paramount in the award selection decision, results from our cost/price and past performance evaluations are also important to the overall contract award decision. All evaluation factors other than cost or price (i.e. technical and past performance), when combined, are significantly more important than cost/price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government. (b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Offerors must include a completed Price Quote template (ATTACHMENT 2), with their response to this Combined Synopsis/Solicitation. (Offer's may also use their own format/templates as long as all of the requested information contained in the attachment is included). Offerors are instructed to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (attached), with its offer. Please note that if your SAM Representations and Certifications are current, you will only need to complete paragraph b) of this provision. Evaluation of Options: The Government will evaluate offers for award purposes by adding the total price for all options to the total price of the basic requirement. Evaluation of options shall not obligate the Government to exercise the option(s). The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. See attached document, "FAR 52.212-5 Applicable Clauses", for clauses applicable to this acquisition. FAR 52.217-7, OPTION FOR INCREASED QUANTITY - SEPARATELY PRICED LINE ITEM (March 1989) This clause applies to the Quantity Options (increments of 4 additional samples) The Contracting Officer may exercise the option by written notice to the Contractor within 30 days of option exercise. FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (March 2000). This clause applies to the Term Options (12-month performance periods) a) The Government may unilaterally exercise any of the Term Options provided that the Government gives the Contractor a preliminary written notice of its intent to exercise said option at least 30 days prior to contract expiration. (Should it be the Government's intent to NOT exercise the next subsequent Term Option, the Government will notify the contractor 60 days prior to contract expiration in order to allow for the preparation of any final contract deliverables). The preliminary notice does not commit the Government to exercise the referenced Option. b) If the Government exercises any of the Term Options, the extended contract shall be considered to include this option clause. c) The total duration of the ordering period of the contract, including the exercise of any Term Options, under this clause, shall not exceed five years. CONTRACTING OFFICER'S REPRESENTATIVE (COR) The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract: TO BE DETERMINED The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. The Government may unilaterally change its COR designation. The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices: There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. This Combined Synopsis/Solicitation does not commit the Government to pay any costs incurred in the submission of quotes/proposals. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All quotes/offers must be received by 5 PM EST April 17, 2018 and reference number NIH-NIDA-CSS-18-4876747. Quotes/offers shall be submitted electronically to Jason Williams, Contracting Officer at willjas@nida.nih.gov Fax responses will not be accepted. For any questions or further information regarding this solicitation, please contact Jason Willliams, Contracting Officer, NINDS Contracts Management Branch, NIDA, NIH at PH: 301-496-5985; E-mail: willjas@nida.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/NIH-NIDA-CSS-18-4876747/listing.html)
- Place of Performance
- Address: Contractor's facility, United States
- Record
- SN04892031-W 20180419/180417230815-db5d124ec9b7908be5ab688487cdab6f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |