SOLICITATION NOTICE
B -- ADME and Toxicity Studies for target compound
- Notice Date
- 6/24/2015
- Notice Type
- Presolicitation
- 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-PSOL373
- Archive Date
- 7/17/2015
- 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
- INTRODUCTION: THIS IS A PRE-SOLICIATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPOSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Center for Advancing Translational Services (NCATS) intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Cyrpotex USA, LLC at 313 Pleasant St. STE 12, Watertown, MA 02472 for comprehensive ADME profiling, comprehensive Mebolite profiling and comprehensive toxicity screening. The solicitation number is HHS-NIH-NIDA-SSSA-2015-PSOL373 and the solicitation is issued as a pre-solicitation notice of intent to award on a sole-source basis. NORTH AERMICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The intended procurement is classified under NAICS code 541380 with a Size Standard of $15 million. REGULATORY AUTHORITY: The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-82, dated May 7, 2015. This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. STATUTORY AUTHORITY: This acquisition is conducted under the authority of 41 U.S.C 3304(a)(1) under provisions of the statutory authority of FAR Subpart 6.302-1(a)(2)(i)(A)- Only one responsible source and no other supplies or services will satisfy agency requirements. DESCRIPTION OF REQUIREMENT: The National Center for Advancing Translational Services (NCATS) intends to procure, on a sole source basis, ADME and Toxicity studies for one compound. Background: The National Center for Advancing Translational Sciences (NCATS) requires Absorbtion, Distribution, Metabolism, & Excretion (ADME) and Toxicity studies for one compound. ADME assesses the effects of a drug or drug-like compound against a variety of assays, designed to analyze how a drug is distributed and processed within the human body. Early ADME assays are critical to determine the effect and potential side effects of drug-like compounds in the human body. Metabolite profiling gives insight into the potential degradation pathways. Toxicity is related to ADME, in that a drug that is too toxic may not be administered to humans, even if it is effective. Purpose and Objectives: The purpose of this acquisition is to procure ADME and Toxicity studies for one compound. Deliverables/Period of Performance: Results shall be delivered within eight (8) weeks after receipt of award. Contractor Requirements: Specifically, the NCATS DPI Chemistry Technology group requires the following: Comprehensive ADME profiling, including a.Cytochrome P450 induction b.Cytochrome P450 Inhibition i.Across 7 isoforms ii.With Determination of IC50 values c.Hepatocyte stability for both human and mouse d.Microsomal metabolic stability in both human and mouse e.Plasma protein binding f.Blood binding for both human and mouse g.Determination of LogP h.Determination of aquous pKa i.Determination of thermodynamic solubility j.Determination of bidirectional Caco 2 permeability k.Determination of MDR1 MDCK permeability Comprehensive Mebolite profiling, including a.Initial metabolite profiling of any metabolites of the target compound b.The ability to do follow-up assays to determine the exact structures of any metabolites Comprehensive Toxicity Screeening a.hERG channel inhibition b.Ames testing, with and without S9 c.Mitochondrial toxicity d.Phospholipidosis and Steatosis e.Lysosomal Trapping. Specific Requirements: 1)Data turnaround or "Lead Time": data will be obtained with 20 working days of compound receipt 2)Comprehensive ADME services: any company should be able to provide all the services that are listed for the target compoint a.Cytochrome P450 induction b.Cytochrome P450 Inhibition i.Across 7 isoforms ii.With Determination of IC50 values c.Hepatocyte stability for both human and mouse d.Microsomal metabolic stability in both human and mouse e.Plasma protein binding f.Blood binding for both human and mouse g.Determination of LogP h.Determination of aquous pKa i.Determination of thermodynamic solubility j.Determination of bidirectional Caco 2 permeability k.Determination of MDR1 MDCK permeability 3)Comprehensive Metabolite profiling a.Initial metabolite profiling of any metabolites of the target compound b.The ability to do follow-up assays to determine the exact structures of any metabolites 4)Comprehensive Toxicity Screeening, including a.hERG channel inhibition b.Ames testing, with and without S9 c.Mitochondrial toxicity d.Phospholipidosis and Steatosis e.Lysosomal Trapping. 5)Analysis should be supported by appropriate controls to ensure robustness and reproducibility of the service. 6)Company must provide a professional and comprehensive report with all the relevant results from the service rendered. 7)Company must provide experimental procedures for the above assays and screens when requested. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION: The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research, specifically the review and evaluation of the responses to the sources sought notice published in the FedBizOpps on May 28, 2015, synopsis number HHS-NIH-NIDA-SSSA-SBSS-2015-372. This sources sought was posted on May 28, 2015 for the ADME and Toxicity Screening, for which there were no responses as of the closing date, June 5, 2015. Due to the importance of consistency of the results and data as well as the protocols and procedures that have been developed; there are no other sources besides the proposed Contractor that can provide the requested testing services. Therefore, Cyprotex USA, LLC is the intended source for this award. CLOSING STATEMENT: This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to include ability to meet each of the project requirements, for which the party is able to provide, to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All questions must be received by June 29, 2015 at 8:00AM and must reference number HHS-NIH-NIDA-SSSA-2015-PSOL373. Responses may be submitted electronically to Samantha Kelly at Samantha.Kelly2@nih.gov. All responses must be received by July 2, 2015 at 8:00AM and must reference number HHS-NIH-NIDA-SSSA-2015-PSOL373. Responses may be submitted electronically to Samantha Kelly at Samantha.Kelly2@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
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- Record
- SN03774233-W 20150626/150624234636-8554104e99b8737e504bc26164654374 (fbodaily.com)
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