SOLICITATION NOTICE
B -- Testing Service to Provide Polymorph Screen of (2R, 6R) Hydroxynorketamine
- Notice Date
- 5/26/2015
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(SSSA)-2015-CSS-348
- Archive Date
- 6/20/2015
- Point of Contact
- Samantha A. Kelly, Phone: 3014028855
- E-Mail Address
-
samantha.kelly2@nih.gov
(samantha.kelly2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Combined Synopsis/Solicitation Introduction: 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. The solicitation number is HHS-NIH-NIDA(SSSA)-2015-CSS-348 and the solicitation is issued as an request for quotation (RFQ). Competition Status: This requirement is posted as unrestricted. North American Industry Classification System (NAICS) Code: The intended procurement classified under NAICS code 541380 with a Size Standard of $15 million. Acquisition Authority: 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-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-05-82, dated May 7, 2015. Description of Requirement: Background: NCATS is a translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. First, our quantitative high throughput screening (qHTS) paradigm, which tests all compounds at multiple concentrations in the primary screen, is unique. Second, the NCATS is distinctive in its focus on collaboration with outside investigators to produce high-quality chemical probes to define and assess new biology. This focus is reflected in our unprecedented Outreach program, which reaches hundreds of potential new investigators every year, and accounts for much of the new science being done at the NCATS. Third, the NCATS is uniquely focused on new technologies and paradigms to improve the process of translational science, typified by qHTS, our informatics platform, our utilization of structural biology to accelerate probe development, development of new synthetic and analytical chemistry paradigms. Ultimately, 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 biological discoveries into potential pharmaceuticals which can greatly assist patients. Determining polymorphism is critical in the development of pharmaceutical agents. Some pharmaceutical agents will be active as one polymorph, while inactive as the second. Many pharmaceuticals can only obtain regulatory approval for a single crystal form or polymorph. In nearly all cases, changes in the crystal form will change the pharmacodynamics of a molecule. In order to move forward with the potential Investigational New Drug status for this project, it is critical the polymorphism of the molecule is determined. Purpose: The purpose of this acquisition is to procure testing services to provide Polymorph Screen of (2R,6R)-Hydroxynorketamine. Contractor Requirements: The specific requirements are as follows: 1.Polymorph Screening for (2R,6R)-Hydroxynorketamine 2.Determination of the relative thermodynamic stability for any new forms. 3.Characterization for any new forms found. Evaluation Criteria- FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provisions are as follows: 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, technical, price and other factors considered. The vendor shall provide all of the services listed below for the desired molecule/compound. The selection criteria is as follows: 1.Characterization of the molecule by: a.X-Ray powder diffraction (XRPD) b.Differential scanning calorimetry (DSC) c.Thermogravity (TG) d.Dynamic vapor sorption (DVS) e.NMR spectroscopy 2.Determination estimates of the solubility of the molecule in 8-12 solvents 3.Polymorphic screening of the target molecule a.Use of a variety of techniques (more than 3) to induce nucleation b.Initial analysis by XRPD c.Follow-up analysis of new forms by DSC, TG 4.Characterization of up to three new crystal forms via: a.XRPD b.DSC c.TG d.DVS e.Determination of the relative thermodynamic stability 5.Company must provide a professional and comprehensive report with all the relevant results, procedures and characterization from the service rendered within 56 working days of compound receipt. Government Responsibilities NCATS will provide 2-3 grams of the target compound. Deliverables: All work will be done in accordance in this Solicitation for the Polymorph Screen of (2R,6R)-Hydroxynorketamine. Invoicing should be completed as services are rendered and accepted by NCATS. Interim reports will be provided as appropriate. Anticipated Period of Performance: Up to 12 weeks after receipt of the awarded Purchase Order Contract Type: The Government intends to issue a firm fixed price Contract for this requirement. Applicable Clauses and Provisions: All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov The provision of FAR clause 52.212-1, Instructions to Offerors - Commercial Items applies to this acquisition. The provision of FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, is required with any offer submitted. The FAR clause is located at http://www.acquisition.gov/far/. This requirement may be met by completion of the provision in the System for Award Management. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial items apply to this acquisition. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. There are no additional contract requirement(s) or terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. Response Format: Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement. The price quote shall include: unit price, list price, shipping and handling costs, the delivery period after contract award, delivery terms, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), the certification of business size, product or catalog numbers, product description and other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All questions to this solicitation must be received by May 29, 2015 at 8:00AM EST and must reference number HHS-NIH-NIDA(SSSA)-2015-CSS-348. Responses may be submitted electronically to Samantha Kelly, Contract Specialist at samantha.kelly2@nih.gov. All responses must be received by June 5, 2015 at 8:00AM EST and must reference number HHS-NIH-NIDA(SSSA)-2015-CSS-348. Responses may be submitted electronically to Samantha Kelly, Contract Specialist at samantha.kelly2@nih.gov. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
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