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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 621111 Offices of Physicians (except Mental Health Specialists) with size standard 11,000,000 million USD.
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 Tissue BioPrinting Group at NCATS is invested in developing therapeutically relevant three-dimensional tissues for basic research and drug screening.
One of the greatest promises of human stem cells is to transform these early-stage cells into treatments for devastating diseases. Stem cells can potentially be used to repair damaged human tissues and to bioengineer transplantable human organs using various technologies, such as 3D printing. Using stem cells derived from another person (allogeneic transplantation) or from the patient (autologous transplantation), research efforts are underway to develop new therapies for historically difficult to treat conditions. In the past, adult stem and progenitor cells were used, but the differentiation of these cell types has proven to be difficult to control. Initial clinical trials using induced pluripotent stem (iPS) cells indicate that they are far superior for cellular therapy applications because they are better suited to scientific manipulation.
Experts at NCATS are applying the techniques of 3-D printing to develop tissue models that mimic the 3-D structure and organization of cells in the tissues of living organisms. The Tissue BioPrinting Lab is using the iPS cells to bioprint 3D tissue models of the brain to study the effects of new therapies for pain, opioid addiction and overdose. With these cells, scientists at NCATS are developing human 3D tissue models, and the only source of obtaining large amounts of human dopaminergic, gabanergic and glutaminergic is through differentiation of iPSC cells.
Purpose and Objectives
This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement, which is to obtain iPS cell-derived differentiated cells on a BRAND-NAME-OR-EQUAL basis to the iPS cell-derived differentiated cells, or their equal, described in this notice that are manufactured by FUJIFILM CELLULAR DYNAMICS, INC. located at 525 Science Drive, Madison, WI 53711.
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 iPS cell-derived differentiated cells, manufactured by FUJIFILM CELLULAR DYNAMICS, INC., which are deemed essential in meeting the government's needs. Specifically, the following Product Item numbers and features are considered essential for this potential requirement to achieve:
1. R1108: induced pluripotent stem cell (iPSC) - derived dopaminergic (DA) neurons, supplied as 3 vials with approximately 1 million cells each
2. R1032: iPSC - derived DA neurons, supplied as 1 vial with approximately 5 million cells
3. NRC-100-010-000.5: iPSC - derived GABAergic (GABA) neurons, supplied as 1 vial with approximately 2 million cells
4. R1013: iPSC - derived GABAergic neurons, supplied as 1 vial with approximately 4 million cells
5. R1116: iPSC - derived glutamatergic (gluta) neurons, supplied as 3 vial with approximately 1 million cells each
6. R1034: R1116: iPSC - derived glutamatergic neurons, supplied as 1 vial with approximately 6 million cells
7. R1112: iPSC-derived endothelial cells (EC), supplied as 1 vial with approximately 1 million cells
8. M1019: media supplement for growing iPSC-derived ECs
9. M1029: media supplement for growing iPSC-derived DA neurons
10. M1031: media supplement for growing iPSC-derived neuronal cells (DA, GABA, and gluta)
11. M1032: media supplement for growing iPSC-derived GABAergic neurons
Products offered must be essentially equal to the specified supply described in this announcement, which specifically includes the following Product Number, Description, No. of neurons per unit, no. of vials per unit, and Quantity, manufactured by FujiFilm Cellular Dynamics, Inc.
1. R1108, DA 3x1M, 3, 3, 17
2. R1032, DA 5M, 5, 1, 50
3. NRC-100-010-000.5, GABA ~2M, 2, 1, 25
4. R1013, GABA 4M, 4, 1, 50
5. R1116, Gluta 3x1M, 3, 3, 15
6. R1034, Gluta 6M, 6, 1, 30
7. R1112, ECs 1M, 1, 1, 25
8. M1019, EC supp, 0, 0, 20
9. M1029, DA sup B, 0, 0, 30
10. M1031, NSS, 0, 0, 30
11. M1032, GABA sup A, 0, 0, 20
Delivery: Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or factory warranty schedules in accordance with standard commercial practice, as applicable. Shipping shall include FOB-destination. Inspection and acceptance will be performed at a Government facililty located at 9800 Medical Center Drive, Rockville, MD 20850.
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 fifteen (15) pages. This 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).