SOLICITATION NOTICE
B -- Characterization of the Sponsor's Test Articles via Metabolic Stability, CYP Phenotyping, In Vitro Metabolite Profiling, and In Vivo Metabolite Profiling Assays
- Notice Date
- 8/14/2015
- 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-746
- Archive Date
- 9/8/2015
- 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 Title: Characterization of the Sponsor's Test Articles via Metabolic Stability, CYP Phenotyping, In Vitro Metabolite Profiling, and In Vivo Metabolite Profiling Assays (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 HHS-NIH-NIDA(SSSA)-2015-CSS-746 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. (iii)The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83-2-2, dated August 5, 2015. (iv)This acquisition is unrestricted, open market competition. The associated NAICS code 541380 - Testing Laboratories and the small business size standard is $15 million. (v)Characterization of the Sponsor's Test Articles via Metabolic Stability, CYP Phenotyping, In Vitro Metabolite Profiling, and In Vivo Metabolite Profiling Assays (vi)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) - one of 27 Institutes and Centers at the National Institutes of Health (NIH) - was established to transform the translational process so that new treatments and cures for disease can be delivered to patients faster. The NCATS mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients. The NCATS Chemical Genomics Center (NCGC) is tasked with identifying and developing novel small molecule leads against a wide spectrum of human disease targets, which it accomplishes by screening thousands of small molecules in collaboration with both intra-and extramural researchers. In pursuit of this goal, the Center has a strong internal transdisciplinary team of scientists who continually discover novel small molecules for application against a wide range of human diseases. Purpose The purpose of this requirement is to procure testing services to obtain data on the metabolism of compounds for NCATS programs involving the inhibition of LDHA and mutant IDH1 enzymes. Project Requirements Specifically, the following requirements are requested for Phase I and Phase II of the Metabolic Stability with Identification of Reactive Metabolites testing: 1.Testing on a set of compounds to look for metabolic hot spots in mouse, rat and human microsomes. 2.CYP phenotyping shall be performed in fly cells transfected with human CYPs and this data will compared with fly cells not containing the CYPs. 3.Metabolism ID with structure elucidation in mouse, rat and human shall also be determined. 4.Standard Report shall contain results of accurate mass measurements of up to 10 major detective putative metabolites, determination of biotransformation type based on mass shift, retention time and peak area response ratio. Deliverables: Within two weeks following the completion of services, the Contractor shall provide a standard report including the following: A. Materials and Methods B. Data Processing and Interpretation C. Results and Conclusions D. Table summarizing results of the detection of metabolites: a. Results of accurate mass measurements of up to 10 major (based on AUC comparison or relative abundance) detected putative metabolites b. Determination of biotransformation type based on mass shift c. Retention time d. Peak area response ratio (PARR) of the detected metabolites and parent compound in pooled samples E. Structure elucidation deliverables: a. Recorded MS ion tree and elaboration of MS(n) fragmentation pathway of the parent test compound b. Descriptions of the methodologies used for data acquisition and processing c. MS(n) data and representative extracted ion chromatograms for up to ten major putative detected metabolites per species d. Tentative structure assignment of the major putative metabolites Anticipated Period of Performance and Place of Delivery: Delivery within one (1) month after receipt of the purchase order; period of performance will be defined upon award and the anticipated delivery is: NCATS 9800 Medical Center Drive Rockville, Maryland 20850 (viii)The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (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, to include past performance. The Government intends to issue an award on a firm fixed price Contract for this requirement, on the basis of lowest price technically acceptable. (b)Award Criteria Selection of an Offeror for the award will be on the basis of lowest price technically acceptable. Technical acceptability includes an evaluation on technical factors (which encompasses experience/capability and past performance factors), and cost/price factors. Evaluation of technical acceptability will be made in accordance with the prospective Contractor's demonstrated capabilities of meeting each of the requirements as set forth in this solicitation and all applicable attachments. The merits of each proposal will be evaluated carefully. Offerors must include all specifications/services (including all brand-name or equal requirements so that the brand-name or equal status may be verified), detailed in this solicitation, in its proposal and must also include delivery lead time. Offerors cost/price proposal will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the Government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404. The prices quoted will be evaluated taking into consideration any price reductions. A best value analysis will be performed taking into consideration the results of the technical evaluation and price evaluation. (x)The provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, applies to this acquisition. (xi)FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. An addendum to FAR clause 52.212-4, Contract Terms and Conditions-Commercial Items applies to this acquisition. (xii)FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. (xiv)The Defense Priorities and Allocations System (DPAS) are not applicable to this (xv)Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description, the total cost; and any 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. Responses to this solicitation must include clear and convincing evidence of the offerors' capability of fulfilling the requirement as it relates to the technical evaluation criteria and a price proposal. 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. Questions regarding this combined synopsis/solicitation must be received in this office by 8:00AM (EST) on August 19, 2015. Offers must be received electronically by 8:00 AM (EST) on August 24, 2015. Facsimile submissions are not authorized and collect calls will not be accepted. Submit offers to: Samantha Kelly, Contract Specialist at Samantha.Kelly2@nih.gov Please reference the solicitation number HHS-NIH-NIDA-(SSSA)-CSS-15-746 on your offer. Requests for information concerning this requirement are to be addressed to Samantha Kelly via e-mail only to Samantha.Kelly2@nih.gov prior to the closing date for questions.
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