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TRND D3 Newman lead profiling in safety screen panels


Maryland, United States
Government : Federal
RFP
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(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 75N95019Q00239 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: 2019-03 / 07-12-2019.


(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 chemical material as a probe to investigate the mechanisms of diseases and to potentially assist in the development of new methods of treating such diseases.


Alzheimer's disease (AD) is a highly complex and rapidly progressive neurodegenerative disorder characterized by the systemic collapse of cognitive function and formation of dense amyloid plaques and neurofibrillary tangles. AD pathology is derived from the cholinergic, amyloid and tau hypotheses, respectively. Current pharmacotherapy with known anti-cholinesterases, such as Aricept and Exelon, only offer symptomatic relief without any disease-modifying effects. It is now clear that in order to prevent the rapid progression of AD, new therapeutic treatments should target multiple AD pathways as opposed to the traditional "one drug, one target" approach.
In one project (c-Abl Kinase Project) at NCTAS, collaborators have identified the kinase c-Abl as playing a key role in neuronal cytoskeleton remodeling and apoptosis induced by toxic insults. The activation of c-Abl signaling by amyloid aggregates is related by tau pathology in the AD brain and is also involved in neuronal death, connecting the main hallmarks of AD neurodegeneration. After rounds of structure-activity relationship (SAR), NCATS has isolated compound selections in determining a preclinical candidate to move forward. NCATS is in need of contractor support to evaluate the top compounds for safety against unwanted off-target effects in making this determination.


(vi)    The purpose of this requirement is to obtain contractor results of compound testing from profiling panels that provide early identification of significant off-target interactions for the optimization of safety margins of various compounds. This project is to determine the percent inhibition values of six (6) compounds in lead optimization and safety profiling panels using 44 selected targets and four (4) compounds in lead optimization and safety profiling panels using 87 selected targets.


Statement of Work: The contractor will perform safety profiling to check the potential off-target toxicity of the government's lead compounds. The selected targets associated with toxicity observed in drug discovery, recommended by major pharmaceutical companies in the drug discovery process.


1.    Determine percent inhibition values of 6 compounds in the lead optimization and safety profiling panels of 44 selected targets and 4 compounds in the lead optimization and safety profiling panels of 87 selected targets.


2.    The selected targets shall be gathered in a cost-effective panel that brings together both robustness (each assay is HTS-compatible) and the strategic choice of information-rich targets in the drug discovery process.


3.    Items shall include Assay mode using Single Point, 2 compounds, 1 concentration, 2 replicates, quantity two (2) per batch consisting of default test Conc. 10 uM.


4.    Profiling panels used shall provide the early identification of significant off-target interactions for the optimization of safety margins required.


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 12 months to commence after Effective Date of Contract. Project Initiation Date: receipt of purchase order and the compounds. Anticipated Project Completion Date: 2 weeks after receipt of the compounds.


(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 (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 (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)


(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 of the item offered to meet the Government requirement;
b. Price; and
c. Past performance [see FAR 13.106-2(b)(3)].


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 shipping cost and estimated time of delivery after receipt of order if applicable. Prices shall be quoted on an itemized basis with 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 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 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.


(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

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