Compound testing for inhibition of wild-type kinase enzymes and block of cardiac ion channels
INTRODUCTION This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE The NAICS code applicable to this requirement is 541380-Testing Laboratories with associated small business size standard of 15 Million USD. 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) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. 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 anti-cancer agents. Prior work at NCATS has produced a series of small molecule IRAK4 / FLT3 kinase dual 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. Scientists are NCATS are currently synthesizing structurally-novel analogs of NCGC00371481 that may show improved properties relative to previously syntesized analogs. In order to assess these analogs' selectivity, we need to test them against structurally-related kinase enzymes. The full 'kinome' is known to contain >400 wild-type kinase enzymes, and these are all closely related in terms of protein structure and function. As such, compounds that inhibit our intended targets (IRAK1, IRAK4 and FLT3) will likely also inhibit many other closely related kinase enzymes as unintended off-targets. Such activity - termed 'off-target inhibition' - can cause undesired safety-related side-effects when compounds are dosed in preclinical species, or in the clinic. In order to minimize the chances of unwanted side-effects, we need to minimize the inhibition of kinase off-targets, and thus need to test for inhibition of the full kinome panel. To promote efficiency in estimating inhibition of the full kinome, NCATS has recently devised kinome mini-panels, which are representative sets of kinases that are meant to predict inhibitory activity against the full kinome. It is believed that a testing against a representative set of 50 kinase enzymes can be predictive of the inhibitory activity that a compound will display against the full kinome of >400 kinases. Testing against a representative set of 50 is more efficient than testing against a full set of >400 kinases and thus is more desired to use in early rounds of research as a more ideal method of estimating kinase selectivity. Testing of 10 small molecule compounds for inhibition of a representative set of 50 wild-type kinase enzymes will allow a determination of their 'off-target' activity. That data will facilitate the further prioritization and optimization of compounds in this series for therapeutic use against a variety of cancers, including MDS and AML. Testing of 5 small molecule compounds for inhibition of the full kinome panel of 374 wild-type kinase enzymes will allow a determination of their 'off-target' activity. Prior analogs in this series were tested against IRAK1, IRAK4, FLT3, and other relevant kinase enzymes using Kinase HotSpot assay technology. The current set of compounds need to be tested using Kinase HotSpot assay technology, or its equal, to ensure consistency of data and produce consistent results to prior and existing research at NCATS. In order for a candidate compound to advance into clinical trials, it must display a wide range of acceptable properties. For this program, the compounds must display potent inhibition of the desired targets (IRAK4 and FLT3). Candidate compounds also need to be free of various types of cardiotoxicity, for instance any undesired effects on heart rate (bradycardia or tachycardia, abnormally slow or fast heart rate), blood pressure (too high or too low), or the potentially lethal condition known as 'torsades de pointes', which results from prolongation of the cardiac QT interval. These undesired cardiotoxicities can often be traced directly to block of a key ion channel: hERG for QT prolongation, Nav1.5 for effects on heart rate, or Cav1.2 for effects on blood pressure. Preclinical testing of candidate drug compounds for block of these important ion channels is a widely-used strategy for the early identification of potential sources of cardiotoxicity. Optimization of compounds within a series so that key compounds do not block these channels is typically a prerequisite for identifying a drug candidate that can advance into human clinical trials. A variety of different biological assay formats are available to test ion channel block. These include binding assays, functional assays, and a specific type of functional assay known as patch-clamp. Of these, patch-clamp assays shall be used in testing of these compounds. Such assays shall be conducted in automated formats providing high-quality data in testing compounds. The testing of an initial set of 30 small molecule compounds for block of hERG, Nav1.5 and Cav1.2 in automated patch-clamp assays will allow a determination of the compounds' activity against these targets, and will help to identify any unwanted properties that would need to be removed in subsequent, more advanced compounds. Purpose and Objectives This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement. The purpose of this potential requirement is to obtain results for the following types of testing: 1. Ten (10) novel small molecule compounds for inhibition of a set of 50 wild-type kinase enzymes. This testing will inform on kinase inhibitory activity in the NCATS' compound series, and will facilitate further optimization and development of these IRAK4 / FLT3 inhibitor compounds as potential treatments for cancers such as AML and MDS. 2. Five (5) novel small molecule compounds for inhibition of a set of 374 wild-type kinase enzymes. This testing will inform on kinase inhibitory activity in the NCATS' compound series, and will facilitate further optimization and development of these IRAK4 / FLT3 inhibitor compounds as potential treatments for cancers such as AML and MDS. 3. Initial testing of 30 small molecule compounds for block of the important cardiac-related ion channels hERG, Cav1.2 and Nav1.5. These drug molecule compounds are being evaluated for dual purpose in the IRAK4-FLT3 kinase program. Testing of the compounds for their capacity to block hERG, Cav1.2 and Nav1.5 will help to identify potential souces of cardiotoxicity, and alert any such issues that would need to be solved in order for drug candidates to advance into human clinical testing. Project Requirements This Small Business Sources Sought notice seeks responses from qualified sources that are capable of providing the following salient service requirements of this potential government requirement deemed as the essential features needing to be achieved. Specifically, Offerors to this Small Business Sources Sought notice shall possess the capability to provide the following types of testing as essential requirements: Task 1: 1. Perform experiments using the Kinase HotSpot assay platform testing each of 10 small molecule compounds for inhibitory activity against at least 50 wild-type kinase enzymes. 2. Provide a comprehensive report with the results of the 10-dose IC50 singlet titrations of each of the 10 compounds against the 50 wild-type kinases. Task 2: 1. Perform experiments using the Kinase HotSpot assay platform testing each of 5 small molecule compounds for inhibitory activity against at least 374 wild-type kinase enzymes. 2. Provide a comprehensive report with the results of the 10-dose IC50 singlet titrations of each of the 5 compounds against the 374 wild-type kinases. Task 3: 1. Perform single-dose (single concentration) experiments in triplicate, testing each of 30 small molecule compounds in automated patch-clamp assays for block of hERG, Nav1.5 and Cav1.2. 2. Provide a comprehensive report with the results of the experiments of each of the 30 compounds against hERG, Nav1.5 and Cav1.2. Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features identified in this notice and provide documented evidence to be able to fully achieve the characteristicis of the subject requirement described herein. Period of Performance The contractor is expected to deliver results of tasks 1 and 2 within 6 months of the effective date of contract award and final batch of material to analyze. The contractor is expected to deliver results of task 3 within 2 months of receipt of material for analysis by the Government. The Government will send the contractor the material to synthesize after the effective date of contract award. A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Teshold is anticipated for any contract resulting from this requirement. The anticipated award date is June 1, 2019. Delivery/Warranty Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or warranty considerations applicable. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852. CAPABILITY STATEMENTS/INFORMATION SOUGHT Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. Respondents must provide clear and convincing evidence of possessing the knowedge, skills, abilities and experience to successfully perform the requirements described in this announcement. Detailed prior experience in implementing similar requirements to the requirement described in this announcement must be clearly delineated in any response provided. Technical experience can include, but is not limited to: Experience (> 5 years) in the testing of small molecule compounds for kinase inhibitory activity using the Kinase HotSpot assay platform; Access to all critical instrumentation necessary for this statement of work; Testing the aforementioned compounds in all the assays described above in. 75N95019Q00124 Department of Health and Human Services National Institutes of Health
4/16/19, 1:33 PM Compound testing for inhibition of wild-type kinase enzymes and block of cardiac ion channels
(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 75N95019Q00124 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; FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is NOT expected to exceed the simplified acquisition teshold at $250,000. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Reaction Biology Corporation, located at 1 Great Valley Pkwy, Ste 2, Malvern, PA 19355-1423 for services for compound testing using the Kinase HotSpot profiling and screening platform. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). (iii) The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) Number 2019-01, with effective date January 22, 2019. (iv) The associated NAICS code is 541380-Testing Laboratories with associated small business size standard of 15 Million USD. This requirement is solicited on a Total Small Business set-aside basis. (v) This requirement is for the following general requirements: 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 described herein. Prior work at NCATS has produced a series of small molecule IRAK4 / FLT3 kinase dual 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. Scientists are NCATS are currently synthesizing structurally-novel analogs of NCGC00371481 that may show improved properties relative to previously syntesized analogs. In order to assess these analogs' selectivity, we need to test them against structurally-related kinase enzymes. The full 'kinome' is known to contain >400 wild-type kinase enzymes, and these are all closely related in terms of protein structure and function. As such, compounds that inhibit our intended targets (IRAK1, IRAK4 and FLT3) will likely also inhibit many other closely related kinase enzymes as unintended off-targets. Such activity - termed 'off-target inhibition' - can cause undesired safety-related side-effects when compounds are dosed in preclinical species, or in the clinic. In order to minimize the chances of unwanted side-effects, we need to minimize the inhibition of kinase off-targets, and thus need to test for inhibition of the full kinome panel. To promote efficiency in estimating inhibition of the full kinome, NCATS has recently devised kinome mini-panels, which are representative sets of kinases that are meant to predict inhibitory activity against the full kinome. It is believed that a testing against a representative set of 50 kinase enzymes can be predictive of the inhibitory activity that a compound will display against the full kinome of >400 kinases. Testing against a representative set of 50 is more efficient than testing against a full set of >400 kinases and thus is more desired to use in early rounds of research as a more ideal method of estimating kinase selectivity. Testing of 10 small molecule compounds for inhibition of a representative set of 50 wild-type kinase enzymes will allow a determination of their 'off-target' activity. That data will facilitate the further prioritization and optimization of compounds in this series for therapeutic use against a variety of cancers, including MDS and AML. Testing of 5 small molecule compounds for inhibition of the full kinome panel of 374 wild-type kinase enzymes will allow a determination of their 'off-target' activity. Prior analogs in this series were tested against IRAK1, IRAK4, FLT3, and other relevant kinase enzymes using Kinase HotSpot assay technology. The current set of compounds need to be tested using Kinase HotSpot assay technology to ensure consistency of data and produce consistent results to prior and existing research at NCATS. (vi) The salient characteristics of project requirements for this procurement, deemed essential features needing to be achieved, include the following types of testing: Task 1: 1. Perform experiments using the Kinase HotSpot assay platform testing each of 10 small molecule compounds for inhibitory activity against at least 50 wild-type kinase enzymes. 2. Provide a comprehensive report with the results of the 10-dose IC50 singlet titrations of each of the 10 compounds against the 50 wild-type kinases. Task 2: 1. Perform experiments using the Kinase HotSpot assay platform testing each of 5 small molecule compounds for inhibitory activity against at least 374 wild-type kinase enzymes. 2. Provide a comprehensive report with the results of the 10-dose IC50 singlet titrations of each of the 5 compounds against the 374 wild-type kinases. Task 3: 1. Perform single-dose (single concentration) experiments in triplicate, testing each of 30 small molecule compounds in automated patch-clamp assays for block of hERG, Nav1.5 and Cav1.2. 2. Provide a comprehensive report with the results of the experiments of each of the 30 compounds against hERG, Nav1.5 and Cav1.2. 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 lead compound in order to contractor to accomplish the necessary work. DELIVERABLES Deliverables shall consist of providing results for the following types of testing. Contractor will provide monthly updates on the progress of the project, or more often as appropriate. Contractor will provide the data analysis and report for the contents of this statement of work. 1. Ten (10) novel small molecule compounds for inhibition of a set of 50 wild-type kinase enzymes. This testing will inform on kinase inhibitory activity in the NCATS' compound series, and will facilitate further optimization and development of these IRAK4 / FLT3 inhibitor compounds as potential treatments for cancers such as AML and MDS. 2. Five (5) novel small molecule compounds for inhibition of a set of 374 wild-type kinase enzymes. This testing will inform on kinase inhibitory activity in the NCATS' compound series, and will facilitate further optimization and development of these IRAK4 / FLT3 inhibitor compounds as potential treatments for cancers such as AML and MDS. 3. Initial testing of 30 small molecule compounds for block of the important cardiac-related ion channels hERG, Cav1.2 and Nav1.5. These drug molecule compounds are being evaluated for dual purpose in the IRAK4-FLT3 kinase program. Testing of the compounds for their capacity to block hERG, Cav1.2 and Nav1.5 will help to identify potential souces of cardiotoxicity, and alert any such issues that would need to be solved in order for drug candidates to advance into human clinical testing. TRAVEL No travel cost will be reimbursed. CONTRACTOR EXPERIENCE REQUIREMENTS - KEY PERSONNEL N/A DATA RIGHTS NCATS shall have unlimited rights to and ownership of all data including reports. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and made a part of this contract/order. Any data schemas will be the exclusive right of the government. Publications and Publicity: The Contractor shall not write or publish articles of data produced as a result of the requirements of the SOW. SECTION 508 - ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS No EIT is anticipated to be generated as a result of this requirement. (vii) Period of Performance: The contractor is expected to deliver results of tasks 1 and 2 within six (6) months of the effective date of contract award and final batch of material to analyze. The contractor is expected to deliver results of task 3 within two (2) months of receipt of material for analysis by the Government. The Government will send the contractor the material to synthesize after the effective date of contract award. A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Teshold is anticipated for any contract resulting from this requirement. The anticipated award date is June 1, 2019. (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) 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 (OCT 2018) 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 (Jan 2019) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.225-13 Restriction on Certain Foreign Purchases (Jun 2008) 52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Oct 2018) The following provisions and clauses apply to this acquisition and are incorporated in full text: NIH Invoice and Payment Provisions (2/2014) (ix) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition. 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. A tradeoff approach will be used to evaluate and select a contractor. Price will be considered in the evaluation and selection, but Price will not be rated. Price will be considered to be of lesser importance than technical factors. Quotations will be evaluated using adjective ratings and no numeric point system will be used. Excellent (Risk level: Very low); Good (Risk level: Low); Acceptable (Risk Level: Neutral); Marginal (Risk level: High); Unacceptable (Risk level: Very high). Offerors' responses to this RFQ should address all contractor requirements contained in the statement of work in sufficient detail to demonstrate a clear understanding of the work objectives and compliance with requirements. Quotations will be evaluated based on the following Sub-factors, equally weighted: a) Technical Approach: 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) Organizational Experience: 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 tee (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 contract number and the subcontract number); (iii) Contract Type; (iv) Total Contract Value; (v) Description of Requirement; (vi) North American Industry Classification System(NAICS) Code. Cost: The Offeror(s) cost/price quotation will be evaluated for reasonableness and best value to the government. Basic cost and price information in the Offerors' quote must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services and/or supply. 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. The Government intends to make an award(s) to that offeror whose proposal provides the best overall value to the Government. Discounts may be taken into account for this selection criterion, however the government reserves the right to make a selection decision with tradeoffs. Price Quote: The Vendor shall submit a Fixed-price quote for the period of performance including unit pricing, total price proposed and all other relevant information and documentation that the item(s) quoted meets the salient physical, functional, or performance characteristics as specified in this solicitation. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (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. All quotations must be received no later than the closing date and time specified in the solicitation. The solicitation number must be referenced on all correspondence submitted for this requirement. Responses must be submitted electronically to Hunter Tjugum at Hunter.Tjugum@nih.gov. Fax responses will not be accepted. (xvi) The name and telephone number of the individual to contact for information regarding the solicitation: Hunter Tjugum, Contract Specialist, 301-827-5304, hunter.tjugum@nih.gov.. 75N95019Q00124 Department of Health and Human Services National Institutes of Health
5/10/19, 3:28 PM