Large fragment Knockin Gene mutation project
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 541990- All Other Professional, Scientific and Technical Services with associated small business size standard of 15 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, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people's lives. Included in this process is the development of unique small molecules as potential anticancer agents.
The Cures Acceleration Network (CAN) was established to advance the development of high-need cures and reduce significant barriers between research discovery and clinical trials. The CAN funds a variety of initiatives designed to address scientific and technical challenges that slow down transitional research and currently is supporting projects through the Tissue Chip for Drug Screening, Biomedical Data Translator and 3-D Tissue Bioprinting programs at NCATS. NCATS CAN has a need for a contractor to develop and obtain three mouse models for cblB (MMAB) deficiency for the Platform Vector Gene Therapy project supported by CAN. The CAN is within the Division of Preclinical Innovation (DPI), Therapeutics Development Branch (TDB) at NCATS.
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 acquire three mouse models to support a basket trial gene therapy project for cblB (MMAB) deficiency. These animal models are critical for pre-clinical pharmacology studies to determine efficacy, dose finding and biodistribution of the lead gene therapeutic candidate for MMAB deficiency.
Project Requirements
This Small Business Sources Sought notice seeks responses from qualified sources that are capable of providing the following salient service requirements of this potential government requirement deemed as the essential features needing to be achieved. Specifically, Offerors to this Small Business Sources Sought notice shall possess the capability to provide the following.
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:
MMAB gene ROSA26 knockin: the mouse ROSA26 gene (NCBI Reference Sequence: NR_027008.1) is located on mouse chromosome 6. For the KI model, the "mouse Mck promoter-Kozak-mouse Mmab CDS-Intron-polyA" cassette will be inserted into intron 1 of ROSA26 in reverse orientation.
Mouse Mmab (R180w) Knockin: the mouse Mmab gene (NCBI Reference Sequence: NM_029956.3; Ensembl: ENSMUSG00000029575) is located on mouse chromosome 5. The p. R180W (CGC to TGG) mutation will be introduced into exon 7. Two synonymous mutations p. R184 (CGT to AGG) and p.R185 (CGT to CGC) will also be introduced to prevent the binding and re-cutting of the sequence by gRNA after homology-directed repair and the AscI restriction site will be used for genotyping.
Mmab Point mutation: The mouse Mmab gene (NCBI Reference Sequence: NM_029956.3; Ensembl: ENSMUSG00000029575) is located on mouse chromosome 5. The p. Q228X (CAA to TGA) in donor oligo will be introduced into exon 9. Two synonymous mutations p. G226 (GGC to GGA) and p.S227 (AGC to TCC) will also be introduced to prevent the binding and re-cutting of the sequence by gRNA after homology-directed repair and the BamHI restriction site will be used for genotyping.
Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features identified in this notice and provide documented evidence to be able to fully achieve the characteristicis of the subject requirement described herein.
Period of Performance
The period of performance will be effective for 12 months from the Effective Date of Contract.
Delivery/Warranty
Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or warranty considerations applicable. 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 clear and convincing evidence of possessing the knowedge, skills, abilities and experience to successfully perform the requirements described in this announcement. Detailed prior experience in implementing similar requirements to the requirement described in this announcement must be clearly delineated in any response provided. Technical experience can include, but is not limited to:
1) Experience (> 5 years) in running similar experiments;
2) Access to all critical instrumentation necessary for this statement of work;
Respondents must provide clear and convincing documentation of their capability in providing analytical quality control and any other requirements and services specified in this notice. Respondents must provide a general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts.
The Respondent must also provide information in sufficient detail of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, or other related information.
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.
One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, CV's or references, if requested.
The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required.
The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.
Respondents must reference the 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).
Hunter A Tjugum, Contract Specialist, Phone 3018275304, Email hunter.tjugum@nih.gov
