NCATS Project Phase II Supplement – Target Validation and therapeutic evaluation in NGLY1 deficient chip-based models
Title: NCATS Project Phase II Supplement – Target Validation and therapeutic evaluation in NGLY1 deficient chip-based models (i) This is a combined synopsis/solicitation for commercial items prepared ... Title: NCATS Project Phase II Supplement – Target Validation and therapeutic evaluation in NGLY1 deficient chip-based models (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 75N95021Q00149 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 and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. 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 Hesperos, Inc., 12501 Research Pkwy, Suite 100, Orlando, FL 32826 for scientific testing services of herapeutic targets for drug compound TRND00601748-01 for three patient lines of NGLY1 to ameliorate the NGLY1 mediated phenotypes in motoneurons in patch clamp and neuromuscular junction (NMJ) models. This acquisition is conducted as non-competitice for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization). Pursuant to FAR Subpart 13.501(a)(1)(iii) the justification (excluding brand name) will be made available within 14 days after contract award or in the case of unusual and compelling urgency within 30 days after contract award. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-05 dated March 10, 2021 (iv) The associated NAICS code is 541990 All Other Professional, Scientific, and Technical Services and the small business size standard is $16.5 million. No set-aside restriction is applicable. (v) Brief Description of the Requirement: 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. NGLY1 deficiency include abnormal tear production, a movement disorder, and liver disease. Additionally, it includes developmental delay, hypotonia, peripheral neuropathy, EEG abnormalities, and microcephaly. The Therapeutic Develop Branch (TDB) program’s mission is to encourage and speed the development of new treatments for diseases with high-unmet medical needs. NGLY1 deficiency is greatly involved with motor neurons malfunction and therefore NCATS has been collaborating with Hesperos Inc., in phase 1 to differentiate all motor neurons from NGLY1 patient lines. Phase 1 of the project resulted in interesting patch clamp and NMJ data indicating differences in NGLY1 mutated motoneurons, a KO phenotype and wild type motoneurons. Neuromuscular junction analysis data indicated a range of deficiencies depending on the motoneuron mutation including decreases in fidelity and stability. Currently NCATS is in phase 2 of the project and evaluation of therapeutic targets for drug compound evaluation by siRNA knockdown of ENGase or lentiviral transfection of NGLY1 to ameliorate the NGLY1 mediated phenotypes in motoneurons and neuromuscular junction (NMJ) models. NCATS requires an evaluation of therapeutic targets for drug compound TRND00601748-01 for three patient lines of NGLY1 to ameliorate the NGLY1 mediated phenotypes in motoneurons in patch clamp and neuromuscular junction (NMJ) models. See attached Statement of Work. (vi) The place of performance shall be at the Contractor’s on-site facility. The period of performance will be four (4) months effective at time of award. (vii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. (viii) 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. (b) Offers will be evaluated for technical criteria, price, and past performance. Technical criteria acceptability of the services offered to meet the Government requirement shall be evaluated based on the extent to which the offeror meets or exceeds the requirements specified in the Statement of Work.Technical and past performance, when combined, are significantly more important than price. (c) 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. (ix) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with offers. (x) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. Addendum to FAR 52.212-4 Terms and Conditions – Commercial Items (attached) is applicable. The additional contract terms and conditions are as follows: 52.204-7, System for Award Management (Oct 2018) 52.204-13, System for Award Management Maintenance (Oct 2018) 52.204-16, Commercial and Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Entity Code Maintenance (Aug 2020) 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment ( Oct 2020) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015). (xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition and is attached with the applicable clauses. Invoice and Payment Provisions (Rev. 2/10/2021) applicable to this acquisition is attached. (xii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiii) The offeror must complete, sign, and return the following FAR Provision Representations and Certifications (attached) pursuant to FAR 4.2103 Procedures with its offer. FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) Certification FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) Certification (xiv) 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. (xv) In addition, 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. Fax responses will not be accepted. All responses must be received by 6/15/2021 at 9:00 A.M., Eastern Standard Time and reference solicitation number 75N95021Q00149. Responses must be submitted electronically to Nick Niefeld, Contract Specialist, nick.niefeld@nih.gov. The name of the individual to contact for information regarding the solicitation: Nick Niefeld Contract Specialist Email: nick.niefeld@nih.gov Phone: (301) 827-2094.
Data sourced from SAM.gov.
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