Testing of compounds in rat pharmacokinetic experiments
(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 75N95019Q00264 and the solicitation is issued as a Request for Quotation (RFQ) on a Full and Open competitive basis. 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. This acquisition is NOT expected to exceed the simplified acquisition threshold of $250,000.00. A Fixed-Price type of contract is contemplated for any resulting contract entered into as a result of this solicitation.
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Regulation (FAR) Federal Acquisition Circular (FAC) Number/Effective Date: 2019-05 / 08-13-2019.
(iv) The North American Industry Classification System (NAICS) code for this procurement is 541380-Testing Laboratories with associated small business size standard of 15 Million USD. This requirement is released with no set-aside restriction.
(v) This requirement is for the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). 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 small molecules as potential anticancer agents.
Prior work at NCATS has produced a series of small molecule inhibitors, including NCGC00371481 and its structural analogs. Compounds such as ‘1481 have shown promising results in cellular and mouse models of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Further optimization of the biochemical, physiochemical and pharmacokinetic properties of these compounds is required, and may eventually produce a clinical candidate that could be used to treat cancers such as MDS and / or AML.
In order for a candidate compound to advance into clinical trials, it must display a wide range of acceptable properties. For this program, a potential clinical candidate must display potent inhibition of the desired targets. It must also display suitable pharmacokinetic (PK) properties in a range of preclinical species, including at least one rodent species (mouse or rat), as well as at least one higher preclinical species (dog or monkey). Successful PK profiles in these species are required: 1) in order to build models that predict good pharmacokinetic properties in humans, and 2) to allow compounds be given at high doses and high plasma exposure levels in preclinical safety studies.
In order to characterize and optimize the pharmacokinetic properties of our compounds in rat, NCATS will need to run a series of rat pharmacokinetic experiments. Testing a set of 10 small molecule compounds in rat PK experiments will provide critical data that will identify strengths and weaknesses of current compounds' PK profiles and will help optimize those profiles so that a suitable candidate for clinical trials can be identified.
(vi) The purpose of this requirement is to obtain contractor services for testing of 10 small molecule compounds in rat pharmacokinetic experiments. These compounds are drug molecules that are being evaluated for a kinase inhibitor program. Testing of the compounds for their pharmacokinetic properties in rat will provide critical information on compound clearance, exposure, and bioavailability. Objectives include:
1. Testing each of 10 small molecule compounds in rat pharmacokinetic studies comprised of two dosing arms (one oral, one IV, n = 3 rats per arm);
2. Providing a comprehensive report for each of the 10 compounds detailing results from the pharmacokinetic experiment as described herein.
Statement of Work: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:
Contractor will test compounds in rat pharmacokinetic studies comprised of two dosing arms (one oral, one IV, n = 3 rats per arm). Test compounds will be administered as a single doses (either oral or IV, depending on the study arm), and in each study arm, 7 serial blood draws will be taken at 7 different time points covering a range of at least 8 hours, and up to 24 hours, post-dose. Plasma samples will be analyzed by LCMS to determine the concentration of test compound at each time point. That data will be used to construct a plot of test compound concentration in plasma vs. time for each dosing arm.
A final report will be required that contains these plots, as well as the calculated oral bioavailability (F%), clearance rate (Clp), half-life (t1/2), area under the curve (AUC), maximal concentration (Cmax), and volume of distribution (Vd) for the compound. The report will list the formulation used for dosing and include a table of raw data showing the plasma concentration of test compounds at each time point in each rat, as well as the average or mean concentration across all 3 rats, and the standard deviation or standard error for each mean value.
GOVERNMENT RESPONSIBILITIES: Government will not furnish property, facilities, workspace, computers, or other equipment. Contractor will not use federal facilities. Government will have the responsibility to review and approve the final report. Government will have the responsibility to provide sufficient quantities of the compounds in order for contractor to accomplish the necessary work
DELIVERY OR DELIVERABLES: Contractor will provide the data analysis and report for the contents of this statement of work.
Data Rights: Any data generated as a result of this contract will be the property of NCATS.
Section 508-Electronic and Information Technology Standards: Contractor will not be involved in EIT Standards.
Publications and Publicity: Contractor will not publish results of the work.
Confidentiality of Information: Contractor will keep the results of the acquisition confidential.
(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition. The Period of Performance shall be 6 months to commence after Effective Date of Contract.
(viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html
(End of provision)
The following provisions apply to this acquisition and are incorporated by reference:
• FAR 52.204-7, System for Award Management (Oct 2018)
• FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016)
• FAR 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018)
• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018)
• FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014)
• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)
The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:
https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html
(End of clause)
The following clauses apply to this acquisition and are incorporated by reference:
• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)
• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016)
• FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Oct 2018).
The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2019) is applicable to this solicitation:
52.222-3 Convict Labor (June 2003)
52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2018)
52.222-21 Prohibition of Segregated Facilities (Apr 2015)
52.222-26 Equal Opportunity (Sep 2016)
52.222-36 Equal Opportunity for Workers With Disabilities (Jul 2014)
52.222-50 Combating Trafficking in Persons (Mar 2015)
52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011)
52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Jul 2013)
The following provisions and clauses apply to this acquisition and are incorporated as an attachment:
• NIH Invoice and Payment Provisions (2/2014)
• FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019)
(ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:
a) Technical Capability:
Ability of the Offeror to understand the SOW and requirements, adequately describe the proposed approach, identify problems and potential challenges, and demonstrate how all contract requirements will be met. Offerors shall provide evidence of sufficient planning to show that the work will be accomplished and how it will be accomplished within time and other constraints specified in the SOW or as applicable. The Offeror shall utilize all available resources to include controlling the execution of assigned activities, tasks, sub-tasks, monitoring progress, status reporting, resolving critical issues and/or mitigating risks and fulfilling all delivery requirements.
b) Price; and
c) Past performance [see FAR 13.106-2(b)(3)]
Offerors shall show documented evidence of personnel experience related to the subject requirement. Specific and specialized relevant experience, knowledge, skills, abilities, and education of proposed personnel shall be clearly documented. The offeror must submit with their proposal a list of the last two (2) contracts completed during the past three (3) years and / or contracts awarded currently in process that are similar in nature to the work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Newly formed entities without prior contracts should list contracts and subcontracts as required above for such key personnel. For each contract, subcontract, or reference include:
(i) Name of Contracting Organization;
(ii) Contract Number (for subcontracts, provide the prime and subcontract numbers);
(iii) Contract Type;
(iv) Total Contract Value;
(v) Description of Requirement;
(vi) North American Industry Classification System (NAICS) code.
Offeror's submitting a response must provide a completed Price Quote to be evaluated and considered for award. Price quotes must indicate fixed unit pricing and total cost, including any shipping cost and estimated time of delivery after receipt of order if applicable. Prices shall be quoted on an itemized basis with a fixed-price pricing structure included for all work to be performed in accomplishing this requirement.
(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer.
(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition.
(xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is incorporated in full text.
(xiii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.
(xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
(xv) 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.
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 and the offeror representation in FAR Provision 52.204-24, which is attached, MUST be completed and submitted with any quotation or response to this RFQ.
(xvi) All responses must be received no later than the date specified in this announcement. Late responses will not be accepted. All responses must reference the subject solicitation number. Responses must be submitted electronically to hunter.tjugum@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, contact Hunter Tjugum by email at hunter.tjugum@nih.gov or by phone at 301-827-5304.
Hunter A Tjugum, Contract Specialist, Phone 3018275304, Email hunter.tjugum@nih.gov
