TRND D3 Newman lead profiling in safety screen panels
(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 teshold 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 tough 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.. 75N95019Q00239 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
8/9/19, 4:43 PM TRND D3 Newman lead profiling in safety screen panels
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 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 of our projects (c-Abl Kinase Project) here at NCTAS, our 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 many rounds of structure-activity relationship (SAR), we have narrowed down our compound selections and are close to deciding upon a preclinical candidate to move forward. To help us in this decision, we need to evaluate our top compounds for safety against unwanted off-target effects. 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 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. 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 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. Item description includes 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. 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 work within two (2) weeks of the effective date of contract award and batch of material to analyze. 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 September 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 a capability statement with 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 shall be clearly delineated in any response provided. Technical experience may include, but is not limited to: Experience (> 5 years) in the testing of small molecule compounds as described in this announcement; evidence of published manuscripts in peer-reviewed journals of this or a related field; Access to all critical instrumentation necessary for this statement of work; Testing the aforementioned compounds in all the assays described above in 2 weeks time. Respondents must provide clear and convincing documentation of their capability in providing analytical quality control and any other requirements and services specified in this notice. Respondents must provide a general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. The Respondent must also provide information in sufficient detail of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, or other related information. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, CV's or references, if requested. The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. Respondents must reference the announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at hunter.tjugum@nih.gov, and be received prior to the closing date specified in this announcement. CONCLUDING STATEMENTS Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).. 75N95019Q00239 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
7/15/19, 2:32 PM