Electrospun PDLGA scaffold

(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 75N95020Q00063 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 threshold 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 nPDLGA scaffold material with Biosurfaces, Inc. located at 200 Homer Avenue, Unit 1P, Ashland, MA 01721-1717. 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 through Federal Acquisition Circular (FAC) Number 2020-05, with effective date 3/30/2020. (iv) The associated NAICS code is 334516-Analytical Laboratory Instrument Manufacturing with size standard 1000 employees. (v) This requirement is for the following general requirements: to obtain biodegradable poly (D,L-lactide-co-glycolide) (PDLGA) scaffold from Biosurfaces, Inc. Electrospun PDLGA scaffold is required for building multi-tissue layers including vascularized tissue and epithelium to mimic blood retina barrier (BRB), which requires pore size control, biodegradation period, retaining mechanical strength and bioprinting capability with bioink including multi cell types and epithelial cell monolayer formation. Biodegradation of scaffolds will be required for cell-cell communications and cell migration in disease models. An additional manufacturing step is required to get the final products of precut scaffolds with 10~12mm diameter, which will facilitate and accelerate the bioprinting process. The following features are: The following physical/functional/performance features include: a. 10~12mm diameter pre-cut (laser cut) scaffolds from 9cm (W) x 10cm (L) of scaffold sheets containing ~500nm of electrospun nanofibers. b. Thickness is less than 10 - m. c. Pore size is less than 1.0 - m diameter to prevent from cell migration and to separate culture media from top to bottom without leakage for 3 weeks using pre- and post- thermal process. d. Capable of maintaining mechanical strength at least for 3 weeks. e. Half degradation time is about a month. f. Is biocompatible, biodegradable, and bioprintable with bioink. g. Capable of cell monolayer formation on the surface. h. Quantity eight (8) NRE Study to Provide nPDLGA Material for Use in Non-Human Experiments Specifically, the following salient characteristics are deemed essential that this potential requirement will achieve: a. Small pore size to enhance tissue engineering capability including multi cell types; b. Biodegradation of scaffolds to help integration of 3D tissue layers, which is a key feature to mimic cell-cell communications within tissues in various pathological conditions; c. Each item should be properly sterilized and labeled, pursuant to the product description requirements set forth herein. (vi) BACKGROUND: The Division of Preclinical Innovation (DPI) at NCATS is focused on developing a 3D tissue of blood retina barrier (BRB) to mimic pathological conditions in age-related macular degeneration (AMD) using bioprinting technology and patient specific induced pluripotent stem cells (iPSCs). In this model, biodegradable scaffold plays a role as a substrate of both retina pigment epithelial (RPE) cells and bioprinting of choroid tissue including choriocapillaris. This scaffold is considered as a temporary Bruch's membrane, which is the basement membrane located between RPE and choroid. Bruch's membrane allows molecular interaction between RPE and choroid, and its thickness is about 2~4 - m. In wet form of AMD, vessel growth from choroid, choroidal neovascularization (CNV), compromises Bruch's membrane and RPE. Engineered tissue requires capability to show CNV and cell-to-cell interaction. To achieve these aims, the scaffold thickness is required to be as thin as Bruch's membrane, and the half-time of biodegradation needs to be approximately one month to allow cell communications during tissue development. In wet AMD model, these features of scaffold thickness facilitates access of molecules secreted by RPE to printed choroid, and biodegradation helps CNV development to reach RPE layer. (vii) Inspection and Acceptance 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 April 30, 2020. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. (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 three (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 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. Respondents that believe that they are manufacturers or authorized resellers of any BRAND-NAME product 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; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. 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 a Fixed-price quote including unit pricing, quantity, and total price proposed and all other relevant information and documentation, including installation, training and/or applicable warranty, that the item(s) quoted meets the salient physical, functional, or performance characteristics as specified in this solicitation. 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 COMLETED 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: Mr. Hunter Tjugum, Contract Specialist, 301-827-5304, hunter.tjugum@nih.gov.