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 3‑D 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 throughout 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
[email protected], 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).