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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 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. Through 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 chromosome 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 [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).