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 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 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 tough 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 µm. c. Pore size is less than 1.0 µm 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 µm. 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 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 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. 75N95020Q00063 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
4/1/20, 1:55 PM Electrospun PDLGA scaffold
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 334516 Analytical Laboratory Instrument Manufacturing with size standard 1000 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) is a translational science center whose mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The Division of Pre-Clinical Innovation (DPI) at NCATS plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. The DPI is developing 3-D tissue models that more closely mimic the complexity of tissues in the human body in a reproducible, automated and scalable manner using bioprinting techniques to better predict how potential new drugs will affect humans. The tissue models are used for compound testing and could accelerate drug development for treatments of both rare and common diseases. NCATS launched the 3D Tissue Bioprinting program to improve the predictive success of pre-clinical drug development,. NCATS researchers are using the techniques of 3-D bioprinting to combine living cells with scaffolding materials, to create testing platforms of laboratory-grown human tissues that closely mimic natural tissues in human organs. These innovative tissue models could help scientists better predict the way patients will respond to potential new therapies. Specifically, DPI 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 µm. 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. Purpose and Objectives This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement. The purpose of this potential requirement is to obtain biodegradable poly (D,L-lactide-co-glycolide) (PDLGA) scaffold. 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. Project Requirements The following physical/functional/performance features of the potential requirement 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 µm. c. Pore size is less than 1.0 µm 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. 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 should indicate an estimated delivery time in full after receipt of an order and any other training or warranty provisions applicable. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. Any solicitation resulting from this Small Business Sources Sought notice will require the contractor to deliver the subject supply staggered toughout one year ordering period. CAPABILITY STATEMENTS 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. Interested parties should also provide the following general information: (1) Description of organization, including information on staff expertise, availability, and experience; (2) Description of similar projects completed for both commercial and Government entities; (3) Published journal articles or manuscripts in the same or related scientific field; and (4) Brochures and other product literature describing the commercially available item. 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). 75N95020Q00063 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
3/17/20, 6:01 PM