SOLICITATION NOTICE
B -- Evaluation of 30 NIH Compounds in Human HepatoPac® for Assessment of Hepatotoxicity
- Notice Date
- 8/14/2015
- 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-PSOL745
- 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
- EVALUATION OF 30 NIH COMPOUNDS IN HUMAN HEPATOPAC® FOR ASSESSMENT OF HEPATOTOXICITY HHS-NIH-NIDA-SSSA-2015-PSOL745 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. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items. The solicitation number is HHS-NIH-NIDA-SSSA-2015-PSOL745 and the solicitation is issued as a PRE-SOLICITATION, NOTICE OF INTENT, to award a contract on a noncompetitive basis to Hepregen Corporation at 200 Boston Avenue, Suite 1500, Medford, MA 02155. This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13--Simplified Acquisition Procedures and Subpart 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements, 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. The non-competitive determination is based upon the market research conducted as prescribed in FAR Part 10--Market Research, specifically the results of market research concluded no other source of supply has the ability to provide the Human HepatoPac® for the assessment of hepatoxicity for 30 NCATS small molecules 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, who can provide the requested testing services. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83-2-2, dated August 5, 2015. The associated NAICS code for this requirement is 541380, with a size standard $15 million. The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), which mission it 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 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. A 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. NCATS is in need of testing services for the evaluation of 30 NCATS compounds in Human HepatoPac® for assessment of hepatotoxicity. The following requirements are requested: 1.Vendor shall perform evaluation of 30 NIH compounds in Human HepatoPac for assessment of hepatotoxicity 2.Vendor shall have access to Human HepatoPac® for hepatoxicity evaluation and shall create them for this assessment. 3.Vendor shall be responsible to reconstitute small molecules in DMSO if shipped as powder. 4.Vendor shall give 4 doses over 9 days in serum-free medium. 5.Vendor shall assess three separate testing measurements as part of this requirement: albumin, urea, and ATP&GSH assays 6.Vendor shall provide detailed data report within outlined timeframe. 7.The vendor is responsible for submitting annotated data in MS-Excel format with averages, standard errors and EC50 values as well as a detailed study report with graphs and methods upon completion of the testing services. 8.The contractor must deliver the systems a minimum of 8 weeks after receipt of NCATS provided compounds. 9.Invoicing Schedule: Vendor will invoice under the following schedule: oMilestone 1: Project Initiation •An initial 25% of the total amount of the study •* Estimated Delivery Date: Upon execution of the agreement o Milestone 2: Hepatotoxicity Assessment of Compounds 1 through 15 •Delivery of ATP, GSH, albumin and urea data for compounds 1 - 15 •* Estimated Delivery Date: 6 weeks after receipt of test material(s) and purchase order oMilestone 3: Hepatotoxicity Assessment of Compounds 16 through 30 •Delivery of ATP, GSH, albumin and urea data for compounds 16 - 30 •* Estimated Delivery Date: 6 weeks after receipt of test material(s) and purchase order The requirement consists of providing the HepatoPac® assessment of hepatotoxicity for 30 NCATS compounds. The subject matter contractor is the only source of supply or service who can provide these testing services due to the importance of maintaining consistency of the results and data. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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. 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, 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; 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. The following FAR provisions shall apply to this solicitation: 52.212-1, Instructions to Offerors--Commercial Items, 52.212-2, Evaluation--Commercial Items. Evaluation factors that will be used to evaluate the offer most advantageous to the Government, price and other factors considered, include ability to meet the technical requirements stated in this pre-solicitation and on basis of best value to the government. Offerors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer. The Clause at 52.212-4, Contract Terms and Conditions Commercial Items, applies to this acquisition and the 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. 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." All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses must be received by August 24, 2015 at 8:00AM, Eastern Standard Time (EST) and must reference solicitation number HHS-NIH-NIDA-SSSA-2015-PSOL745. Responses may be submitted electronically to Samantha Kelly at Samantha.Kelly2@nih.gov.
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