Custom Cloning and lentiviral preparation services for the development of assays and therapeutics for NGYL1 disease for the Therapeutic Development Branch (TDB) at the National Center for Advancing Translational Sciences (NCATS).
NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Custom Cloning and lentiviral preparation services for the development of assays and therapeutics for NGYL1 disease for the Therapeutic Development Branch (TDB) at the National Center for Advancing Translational Sciences (NCATS). (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 75N95021Q00106 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. 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) to Genewiz, LLC, 115 Corporate Boulevard, South Plainfield, New Jersey 07080 for custom cloning and lentiviral preparation services for the development of assays and therapeutics for NGYL1 disease for the Therapeutic Development Branch (TDB) at NCATS. 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 2021-05, with effective date March 10, 2021. (iv) The associated NAICS code 541380 and the small business size standard is $16.5 million. No set-aside restriction is applicable. (v) Background: 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. Within NCATS, the TDB biology group works to encourage and speed the development of new treatments for diseases with high-unmet medical needs. This acquisition specifically addresses the new therapeutic for NGLY1 rare disease project, which specifically applies breaktoughs in translational science to advancing new treatments for rare diseases. The purpose of this requirement is for a Contractor to provide custom cloning and lentiviral preparation services, to be used in the TDB-Biology laboratory at NCATS. The purpose of the service is to obtain high quality lentiviral particles containing specific genes of interest for the NGLY1 disease. These lentiviral preparations will be used in cell-based assay development and for testing feasibility of gene therapy-based approaches for NGLY1 disease. (vi) Project Requirements: 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 attached to this solicitation. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition with an anticipated period of performance of tee (3) months from the date of award. (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 (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Jun 2020) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Aug 2020) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) 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 (Aug 2020) FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020). FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018). Addendum to this FAR clause applies to this acquisition and is attached. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2021) Invoice Instructions (ix) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition. (a) 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. The following factors shall be used to evaluate offers: (i.) technical capability, (ii.) past performance and (iii.) price. Technical capability and past performance, when combined, are significantly more important than price. (b) 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. Addendum to this FAR clause applies to this acquisition and is attached. (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 attached in full text. (xiii) 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 the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. 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. All quotations must be received by 3:00 p.m., Eastern Daylight/Standard Time, on Tuesday, April 13, 2021 and reference Solicitation Number 75N95021Q00106. Responses must be submitted electronically to Jeanette Russell, Contract Specialist, at jeanette.russell@nih.gov. Fax responses will not be accepted. (xvi) The name and telephone number of the individual to contact for information regarding the solicitation: Jeanette Russell, Contract Specialist 301-827-5140 Jeanette.Russell@nih.gov
75N95021Q00106 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
4/8/21, 6:53 AM Custom Cloning and lentiviral preparation services for the development of assays and therapeutics for NGYL1 disease for the Therapeutic Development Branch (TDB) at the National Center for Advancing Translational Sciences (NCATS).
This is a Small Business Sources Sought 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 of qualified companies technically capable of meeting the 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. This notice is strictly for research and information purposes only. Background: This request is for custom cloning and lentiviral preparation services for the development of assays and therapeutics for NGYL1 disease for the Therapeutic Development Branch (TDB) at the National Center for Advancing Translational Sciences (NCATS). Purpose and Objectives: 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. Within NCATS, the TDB biology group works to encourage and speed the development of new treatments for diseases with high-unmet medical needs. This acquisition specifically addresses the new therapeutic for NGLY1 rare disease project, which specifically applies breaktoughs in translational science to advancing new treatments for rare diseases. TDB biology is requesting a service to clone genes of interest into lentiviral vector and lentiviral preparations for the same. The contractor will custom clone tee different types of constructs, prepare mega-scale endo-free DNA preparation as well as lentiviral particles at >10^9 IFUs/mL. These lentiviral preparations will be used at NCATS to test two different therapeutic approaches for the NGLY1 disease: One of the constructs and its lentiviral preparation will be used to develop a cell-based assay adapted from researchers at Yale University. Two other constructs and their lentiviral preparation will be used to test potential RNA therapy for the NGLY1 disease. Project requirements: PCR cloning of the NGLY1 from pcDNA3.1-Hygro-NGLY1 template into pCDH-CMV-MCS-EF1α-GreenPuro (Ampicillin) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1985bp); making NGLY1 in pCDH-CMV-MCS-EF1α-GreenPuro and delivered as an endo-free mega-scale DNA sample. PCR cloning of the NGLY1-Del8 from pcDNA3.1-Hygro-NGLY1-Del8 template into pCDH-CMV-MCSEF1α-GreenPuro (Ampicillin) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1874bp); making NGLY1-Del8 in pCDH-CMV-MCS-EF1α-GreenPuro and delivered as an endo-free mega-scale DNA sample. PCR cloning of the ss-Rluc-C124-N290 from pcDNA-ss-Rluc-C124-N290 template into pCDH-CMVMCS-EF1α-GreenPuro (Ampicillin) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1016bp); making ss-Rluc-C124-N290 in pCDH-CMV-MCS-EF1α-GreenPuro and delivered as an endo-free mega-scale DNA sample. PCR cloning of the NGLY1 from pcDNA3.1-Hygro-NGLY1 template into EF1α-MCS-T2A-GFP (Ampicillin) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1985bp); making NGLY1 in EF1α-MCS-T2A-GFP and delivered as an endo-free mega-scale DNA sample. PCR cloning of the NGLY1-Del8 from pcDNA3.1-Hygro-NGLY1-Del8 template into EF1α-MCS-T2AGFP (Ampicillin) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1874bp); making NGLY1-Del8 in EF1α-MCS-T2A-GFP and delivered as an endo-free mega-scale DNA sample. PCR cloning of the ss-Rluc-C124-N290 from pcDNA-ss-Rluc-C124-N290 template into EF1α-MCST2A-GFP (Ampicillin) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1016bp); making ss-Rluc-C124-N290 in EF1α-MCS-T2A-GFP and delivered as an endo-free mega-scale DNA sample. Lentivirus packaging with 3rd generation packaging system and the above 6 constructs. Ten 25μL aliquots (250μL total) of VSV-G pseudotyped lentiviral particles at >10^9 IFUs/ml titer will be provided, along with titer measurement based on infectious particles. Lentivirus packaging with 3rd generation packaging system and Firefly luciferase control, CMV-rFLuc-T2A-EGFP-mPKG-Puro. Ten 25μL aliquots (250μL total) of VSV-G pseudotyped lentiviral particles at >10^9 IFUs/ml titer will be provided, along with titer measurement based on infectious particles. PCR cloning of the NGLY1 from pcDNA3.1-Hygro-NGLY1 template into pLenti-P2A-tGFP (Chloramphenicol) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1984bp); making NGLY1 in pLenti-P2A-tGFP and delivered as an endo-free mega-scale DNA sample. PCR cloning of the NGLY1-Del8 from pcDNA3.1-Hygro-NGLY1-Del8 template into pLenti-P2A-tGFP (Chloramphenicol) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1873bp); making NGLY1-Del8 in pLenti-P2A-tGFP and delivered as an endo-free mega-scale DNA sample. PCR cloning of the ss-Rluc-C124-N290 from pcDNA-ss-Rluc-C124-N290 template into pLenti-P2AtGFP (Chloramphenicol) via 5’ NheI and 3’ NotI by recombination, with sequence verification across the insert (1015bp); making ss-Rluc-C124-N290 in pLenti-P2A-tGFP and delivered as an endo-free megascale DNA sample. PCR cloning of the NGLY1 from pcDNA3.1-Hygro-NGLY1 template into pEF1alpha-IRES-ZsGreen1 (Kanamycin) via 5’ EcoRI and 3’ BamHI by recombination, with sequence verification across the insert (1983bp); making NGLY1 in pEF1alpha-IRES-ZsGreen1 and delivered as an endo-free mega-scale DNA sample. PCR cloning of the NGLY1-Del8 from pcDNA3.1-Hygro-NGLY1-Del8 template into pEF1alpha-IRESZsGreen1(Kanamycin) via 5’ EcoRI and 3’ BamHI by recombination, with sequence verification across the insert (1872bp); making NGLY1-Del8 in pEF1alpha-IRES-ZsGreen1 and delivered as an endo-free mega-scale DNA sample. PCR cloning of the ss-Rluc-C124-N290 from pcDNA-ss-Rluc-C124-N290 template into pEF1alpha-IRES-ZsGreen1 (Kanamycin) via 5’ EcoRI and 3’ BamHI by recombination, with sequence verification across the insert (1014bp); making ss-Rluc-C124-N290 in pEF1alpha-IRES-ZsGreen1 and delivered as an endo-free mega-scale DNA sample. Anticipated period of performance: Tee months from date of award. Capability statement /information sought. Respondents must provide, as part of their response, a capability statement that clearly identifies information regarding: (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, and other related information. Please note that NCATS is particularly interested in small business sources. If you are a small business, please state the type of small business (small business; HUBZone; service-disabled, veteran-owned; 8(a); veteran-owned; woman-owned; or small disadvantaged businesses) and your 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. 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 information submitted must be in an outline format that addresses each of the elements of the project requirements and in the capability statement /information sought paragraphs stated herein. 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. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Jeanette Russell, Contract Specialist, at e-mail address Jeanette.Russell@nih.gov. The response must be received on or before March 31, 2021 at 3:00 pm, Eastern Time. “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 presolicitation 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).”
75N95021Q00106 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
3/16/21, 6:47 AM