Induced pluripotent stem cell (iPSC) lines for Derivation Study
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 325414-Biological Product (except Diagnostic) Manufacturing with size standard 1250 employees. BACKGROUND 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. The National Center for Advancing Translational Sciences (NCATS) focuses on getting more treatments to more patients more quickly. Several thousand genetic diseases affect humans, of which only about 500 have any treatment. NCATS is directly addressing this problem by discovering new technologies and other approaches that could greatly accelerate the process of developing and deploying solutions that can be used by all translational researchers. The opioid crisis highlights the urgent need for novel non-addictive pain medications, as well as improved treatments for opioid addiction and overdose. There is a need for pharmacological agents directed at novel targets to test new therapeutic hypotheses, new clinic-ready drugs directed at those targets, and new testing systems with the potential to be more predictive of human clinical response than traditionally used models. Tough the Helping to End Addiction Long-term (HEAL) Initiative, NCATS will focus on the development of human cell-based models of opioid misuse and addiction and of pain. The Stem Cell Translation Laboratory (SCTL) is a state-of-the-art research facility within NCATS' Division of Pre-Clinical Innovation is dedicated to addressing the scientific and technological challenges in the iPSC field. Specifically, the SCTL aims to develop a renewable supply of human cell-based models focusing on new patient-derived iPSC lines that give rise to specialized, functional nerve cells that are relevant for opioid misuse, addiction, and pain. Phelan-McDermid Syndrome (PMS) is a rare genetic condition that is caused by a deletion or other structural change of the terminal end of comosome 22 in the 22q13 region or a disease-causing mutation of the SHANK3 gene. These patients have little or no pain sensitivity. Samples from 22 patients and 13 family members, which will serve as controls, are already part of the NIMH biorepository managed by Rutgers University/RUCDR. SCTL is interested in establishing new iPSC lines from these samples, with the end goal of making the cell lines available to the scientific community. This potential requirements is critical in order to establish new iPSC lines and derive relevant cell types for further studies. Therefore, the iPSC lines need to be compatible in form, fit and function to the previous results for purposes of maintaining continuity of research. Building this resource for the scientific community will be done as part of the NIH HEAL initiative by the SCTL. Purpose and Objectives The purpose of this potential acquisition is to obtain the derivation of new iPSC lines in order to attain relevant cell types for future studies. The new iPSC lines will be derived from existing samples that are already part of the NIMH biorepository managed by Rutgers University, RUCDR Infinite Biologics, located at 145 Bevier Road, Piscataway, NJ 08854. Project Requirements Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the essential government features specified herein. Products offered must include those salient physical, functional, or other characteristics of the items identified in this notice that are manufactured by the subject vendor deemed essential in meeting the government's needs. Specifically, the following are considered essential characteristics of this potential requirement, or its equal: Vendor is required to derive new iPSC lines by using samples from individuals with Phelan-McDermid Syndrome (PMS). The samples must be derived from 22 patients and 13 family members, and they must be obtained from the NIMH biorepository managed by Rutgers University/RUCDR. During the iPSC derivation process, external sourced cells must undergo reprogramming which includes required QC (Sterility, identity, FACS for Tra-1-60 and Oct-4, viability and expression of Alkaline phosphatase); Reprogramming FCL, ERYB or LCL. Products offered must be essentially equal to the supply described in this solicitation, which specifically includes the following manufacturer description, part code, and quantity: iPSC Derivation; Reprogramming of external source cells including required QC (Sterility, identity, FACS for Tra-1-60 and Oct-4, viability and expression of Alkaline phosphatase); Reprogramming FCL, ERYB or LCL. Includes the required QC (Sterility, identity, FACS for Tra-1-60 and Oct-4, viability and expression of Alkaline phosphatase). Delivers 6-8 frozen vials of 1 clones per subject; 36. Storage; LN2/per ampule/year (estimated 6 vials per subject). Contractors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features of this potential requirement. Specifically, Offerors to this Small Business Sources Sought notice shall document evidence of being able to provide the subject supply that will allow for the essential features described herein to be accomplished. Delivery/Warranty Offerors must indicate an estimated delivery time in full after receipt of an order and any training or warranty applicable. A fixed-price type of Purchase Order contract is anticipated to be awarded on or around September 1, 2019. The Government anticipates six months of effort will be required to fully complete this requirement. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. CAPABILITY STATEMENTS/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 response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in this announcement; (d) quantity; (e) shipping, handling, and/or installation instructions, and/or any special delivery conditions after receipt of an order. Respondents that believe that they are manufacturers or authorized re-sellers of the equipment specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; (d) quantity; (e) estimated price or cost; (f) shipping, handling, and/or installation charges; and delivery date after receipt of order. 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. The information submitted must be in outline format that addresses each of the elements of this 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, 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. Respondents must reference the subject announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at hunter.tjugum@nih.gov, and be received prior to the closing date 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)..
75N95019Q00269 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
7/18/19, 7:00 PM Induced pluripotent stem cell (iPSC) lines for Derivation Study
(i) This is a combined synopsis/solicitation 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. (ii) The solicitation number is 75N95019Q00269 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 NOT expected to exceed the simplified acquisition teshold at $250,000.00. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) for iPSC lines manufactured by Rutgers, The State University Of New Jersey located at 3 Rutgers Plza; New Brunswick, NJ, 08901-8559. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). (iii) The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) Number 2019-05, with effective date August 13, 2019. (iv) The associated NAICS code is 541990- All Other Professional, Scientific and Technical Services with size standard $15 million. (v) This requirement is for the following general requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work described herein. Reprogramming of 36 fibroblasts (FLCs) that currently reside at RUCDR in the NIMH collection into iPSC cell lines is a process that consists of the following steps including targeted time frames for completion: 1. Thawing and expanding each FCL so the reprogramming process can be started (2 weeks) 2. Delivering reprogramming transcription factors to the FCLs and waiting for iPSC colonies to form (4 weeks) 3. Selecting and transferring putative colonies (4 weeks) 4. Expanding and freezing cell lines (4 weeks) 5. QC on resulting cell lines (4 weeks) Each cell line will be released and sent to the client after step 5 (i.e. the QC step) is completed. The contractor shall work on cell lines in separate batches and will work with the client to prioritize the reprogramming order so that access to critical cell lines will be available as quickly as possible. Completion of the batches will be finalized over a 27-month period. Cell processing must be performed by highly trained technicians and all cell lines must have the following services performed: 1.) QC analysis (sterility, identity, FACS for Tra-1-60 and Oct-4, viability and expression of Alkaline phosphatase); 2.) Reprogramming FCL, ERYB or LCL. iPSC line established will be stored in liquid nitrogen cryopreservation at Rutgers University/RUCDR Infinite Biologics in 12-month storage periods. Specifically, the Contractor will perform the derivation of new iPSC lines in order to attain relevant cell types for future studies. The new iPSC lines will be derived from existing samples that are already part of the NIMH biorepository managed by Rutgers University, RUCDR Infinite Biologics, located at 145 Bevier Road, Piscataway, NJ 08854. Vendor is required to derive new iPSC lines by using samples from individuals with Phelan-McDermid Syndrome (PMS). The samples must be derived from 22 patients and 13 family members, and they must be obtained from the NIMH biorepository managed by Rutgers University/RUCDR. During the iPSC derivation process, external sourced cells must undergo reprogramming which includes required QC (sterility, identity, FACS for Tra-1-60 and Oct-4, viability and expression of Alkaline phosphatase); reprogramming FCL, ERYB or LCL. The salient characteristics of project requirements for this procurement, deemed essential features needing to be achieved, include the following: 1. iPSC Derivation; Reprogramming of external source cells including required QC (Sterility, identity, FACS for Tra-1-60 and Oct-4, viability and expression of Alkaline phosphatase); Reprogramming FCL, ERYB or LCL. Includes the required QC (Sterility, identity, FACS for Tra-1-60 and Oct-4, viability and expression of Alkaline phosphatase). Delivers 6-8 frozen vials of 1 clones per subject; 36. 2. Storage; LN2/per ampule/year (6 vials per subject). (vi) BACKGROUND: Phelan-McDermid Syndrome (PMS) is a rare genetic condition that is caused by a deletion or other structural change of the terminal end of comosome 22 in the 22q13 region or a disease-causing mutation of the SHANK3 gene. These patients have little or no pain sensitivity. Samples from 22 patients and 13 family members, which will serve as controls, are already part of the National Institute of Mental Health (NIMH) biorepository managed by Rutgers University/RUCDR. The Stem Cell Translation Laboratory (SCTL) at NCATS has a need to establish new iPSC lines from these samples, with the end goal of making the cell lines available to the scientific community. This requirement is critical in order to establish new iPSC lines and derive relevant cell types for further studies. Building this resource for the scientific community will be done as part of the NIH Helping to End Addiction Long-term (HEAL) initiative by the SCTL. Tough the HEAL initiative, NCATS focuses on the development of human cell-based models of opioid misuse and addiction and of pain. SCTL is dedicated to addressing the scientific and technological challenges in the iPSC field. Specifically, SCTL aims to develop a renewable supply of human cell-based models focusing on new patient-derived iPSC lines that give rise to specialized, functional nerve cells that are relevant for opioid misuse, addiction, and pain. GOVERNMENT RESPONSIBILITIES Government will not furnish property, facilities, workspace, computers, or other equipment. Contractor will not use federal facilities. Government will have the responsibility to review and approve the final report. DELIVERABLES Deliverables shall consist of providing results for the derivation of iPSC cell lines described herein. Contractor will provide updates on the progress of the project as requested or appropriate. Contractor will provide a Final report detailing entire project upon delivery of all 36 iPSC cell lines to the client. TRAVEL No travel cost will be reimbursed. CONTRACTOR EXPERIENCE REQUIREMENTS - KEY PERSONNEL N/A DATA RIGHTS NCATS shall have unlimited rights to and ownership of all data including reports. 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 made a part of this contract/order. Any data schemas will be the exclusive right of the government. Publications and Publicity: The newly derived cell lines must be made available for distribution to the scientific community tough RUCDR. SECTION 508 - ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS No EIT is anticipated to be generated as a result of this requirement. (vii) Period of Performance: The period of performance will consist of one 27-month base year (9/30/2019-12/31/2021) and tee (3) additional option periods to be exercised as optional year periods of performance for cryogenic storage of cell lines. Option Year 1: 1/1/2022-12/31/2022 Option Year 2: 1/1/2023-12/31/2023 Option Year 3: 1/1/2024-9/30/2024 A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Teshold is anticipated for any contract resulting from this requirement. The anticipated award date is September 1, 2019. (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016) FAR 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016) FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018). The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2019) is applicable to this solicitation and inlcuded by reference. 52.222-3 Convict Labor (June 2003) 52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2018) 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Sep 2016) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) 52.222-50 Combating Trafficking in Persons (Jan 2019) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.225-13 Restriction on Certain Foreign Purchases (Jun 2008) 52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Oct 2018) The following provisions and clauses apply to this acquisition and are incorporated as a separate attachment: NIH Invoice and Payment Provisions (2/2014) FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) (ix) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Evaluation will be performed in accordance to FAR 13.106-2 "Evaluation of quotations or offers" and may utilize comparative evaluations using price and the following factors as criteria. a) Technical Capability: Ability of the Offeror to understand the SOW and requirements, adequately describe the proposed approach, identify problems and potential challenges, and demonstrate how all contract requirements will be met. Offerors shall provide evidence of sufficient planning to show that the work will be accomplished and how it will be accomplished within time and other constraints specified in the SOW or as applicable. The Offeror shall utilize all available resources to include controlling the execution of assigned activities, tasks, sub-tasks, monitoring progress, status reporting, resolving critical issues and/or mitigating risks and fulfilling all delivery requirements. b) Price; and c) Past performance [see FAR 13.106-2(b)(3)] Offerors shall show documented evidence of personnel experience related to the subject requirement. Specific and specialized relevant experience, knowledge, skills, abilities, and education of proposed personnel shall be clearly documented. The offeror must submit with their proposal a list of the last two (2) contracts completed during the past tee (3) years and / or contracts awarded currently in process that are similar in nature to the work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Newly formed entities without prior contracts should list contracts and subcontracts as required above for such key personnel. For each contract, subcontract, or reference include: (i) Name of Contracting Organization; (ii) Contract Number (for subcontracts, provide the prime and subcontract numbers); (iii) Contract Type; (iv) Total Contract Value; (v) Description of Requirement; (vi) North American Industry Classification System (NAICS) code. Price Quote: The Vendor shall submit a Fixed-price quote for the period of performance including unit pricing, total price proposed and all other relevant information and documentation that the item(s) quoted meets the salient physical, functional, or performance characteristics as specified in this solicitation. 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. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. (xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is incorporated in full text. (xiii) 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. (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. 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 and the offeror representation in FAR Provision 52.204-24, which is attached, MUST be completed and submitted with any quotation or response to this RFQ. All quotations must be received no later than the closing date and time specified in the solicitation. The solicitation number must be referenced on all correspondence submitted for this requirement. Responses must be submitted electronically to Hunter Tjugum at Hunter.Tjugum@nih.gov. Fax responses will not be accepted. (xvi) The name and telephone number of the individual to contact for information regarding the solicitation: Hunter Tjugum, Contract Specialist, 301-827-5304, hunter.tjugum@nih.gov. .
75N95019Q00269 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
8/22/19, 5:14 PM