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THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FEDERAL ACQUISITION REGULATION (FAR) SUBPART 12.6 SOLICITATION FOR COMMERCIAL ITEMS, AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND QUOTATIONS ARE HEREBY BEING REQUESTED. A WRITTEN SOLICITATION WILL NOT BE ISSUED. This solicitation number is RFQ-RT-15-00037 and the solicitation is being issued as a 100% small business set-aside Request for Quotation (RFQ) using FAR Part 12 Commercial Items and FAR Part 13 Simplified Acquisition Procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-55, effective February 2, 2012. The associated North American Industry Classification System (NAICS) number 541380, Testing Laboratories, applies to this requirement and the small business size standard is $14M. A firm fixed-price contract is anticipated to result from award of this solicitation. The Environmental Protection Agency (EPA), Office of Research and Development (ORD), National Health and Environmental Effects Research Laboratory (NHEERL), Research Triangle Park, North Carolina has a requirement to Rank of 100 Chemicals for Reactivity Using Electrophilic Index to Estimate Relative Rates of Adduct Reactions. The Government invites contractors with the capability to provide services capable of linking predictable chemical reactivity-based protein adduct formation to a variety of target organ toxicities: Development of putative adverse outcome pathways (AOPs) to submit an offer. A. SCOPE: Statement of Work: Rank 100 Chemicals for Reactivity Using Electrophilic Index to Estimate Relative Rates of Adduct Reactions. a. BACKGROUND INFORMATION - Project Title: Linking predictable chemical reactivity-based protein adduct formation to a variety of target organ toxicities: Development of Putative Adverse Outcome Pathways (AOPs). SCOPE - Many environmental chemicals produce toxic responses through non-receptor mediated actions with endogenous proteins or other biological macromolecules. The volume of chemicals present in the ambient environment necessitates a method for quantifying and predicting corresponding toxic potential. Considerations of structure-activity relationships are often used to screen and make decisions regarding chemicals with little or no toxicity data. The chemical interactions of certain toxicants with their biological targets have been described and predicted by parameters derived from quantum mechanical calculations such as softness (σ), hardness (η) and electrophilicity (ω). These descriptors are based on the Hard and Soft, Acids and Bases (HSAB) theory of Pearson, and have been applied to mechanistic studies of chemicals that produce central-peripheral distal axonopathies. It has also been realized that the HSAB theory could be applied to a broader spectrum of chemical toxicants that produce other forms of toxicity, e.g., reproductive toxicity. The main HSAB hypothesis is that chemicals are toxic because they form covalent adducts (react) with, and consequently deactivate, macromolecules that are important in biological processes. The toxic potency of the compound is related to the rate of the adduct-forming reactions. When polarizability (relative distribution of electrons between the specific atoms within a molecule; viz., polarizable or soft vs. non-polarizable or hard) is combined with a measure of chemical reactivity (strong vs. weak, tendency to react with other chemicals), the resulting parameter (electrophilicity) exhibits quantitative correspondence to the rate of adduct formation and hence, the toxicity. These HSAB predictions are quantitative, and amenable to empirical testing in laboratory settings. The overall approach in this project is to use HSAB molecular descriptors to develop a list of environmentally relevant chemicals (and in some cases corresponding metabolites) ranked by their potency to produce adducts that may result in neuro- and/or reproductive toxicity. Subsequent laboratory verification of these predictions for a subset of these chemicals expand the HSAB theory to include different chemical classes and types of toxicities. An additional outcome is the development of a testable Adverse Outcome Pathway (AOP) for these processes. Identification of key events will allow assays to be developed, with the eventual goal of porting to a High Throughput Screening (HTS) format, thereby increasing the biological space covered by EPA¿s HTS efforts. An additional result will be the demonstration of how a common Molecular Initiating Event (MIE) can be involved in multiple types of toxicity. Such information can inform predive models that can be used by EPA for screening chemicals using only structural features. Success in this effort will allow expansion of the HSAB theory and development of AOPs for additional types of toxicity, increasing the value of EPA's toxicity screening programs. b. PURPOSE AND OBJECTIVES: This statement of work will describe the process by which the contractor will rank 100 chemicals for their potential potency to produce hard or soft protein adducts in biological tissue. The US EPA will provide a list of chemicals that are of interest to EPA and the CSS research program. Using the supplied list and the chemical literature, the HSAB modeling expert will perform the structural analysis necessary to develop HSAB parameters (softness, hardness and electrophilicity) for each substance using quantum mechanical models. The calculated values will be used to predict the MIE (protein adducts), and the specific protein adducts will be used to predict associated AOPs. This work is expected to provide a sufficient range of chemicals from which selections can be made for hypothesis-testing in future work. The Contractor will also develop plans for quality assurance and a cost estimate and time line for delivering the chemical rankings. Following EPA approval of the Contractor-submitted plan, the EPA will provide a list of selected chemicals to the contractor within two months. c. CONTRACTOR REQUIREMENTS: General Overview - The Contractor shall perform the following tasks, which are detailed below: 1 - Provide a quality assurance plan that specifies how the tasks will be completed and documented; 2 - Perform HSAB analysis and rank chemicals (based on softness, hardness and electrophilicity) that are provided by the EPA; 3 - Provide EPA with output of HSAB analysis, including a list of chemicals ranked for reactivity in terms of potency; and 4 - Discuss with EPA the strengths/limitations of the rankings and any confidence limits for the HSAB predictions and rankings. Tasks to be Completed by the Contractor: Task 1 - Demonstrate QA/QC Compliance. Prior to award, the Contractor shall provide a Quality Management Plan (QMP) based upon EPA requirements R-2, as described in http://www.epa.gov/quality/qa_docs.html#noneparqt. After award, the Contractor shall provide a Quality Assurance Project Plan (QAPP), in accordance with requirements R-5, as described in http://www.epa.gov/quality/qa_docs.html#noneparqt. This plan shall describe (a) the methods by which the HSAB ranking will be performed, (b) any known caveats regarding the proposed HSAB methods for the chemicals on the list provided by EPA, and (c) how these actions will be documented and how the documentation will be provided to the EPA. This QAPP shall be provided within 30 business days after award of the contract, and must be approved by the EPA before work can begin. Task 2. Perform HSAB analysis ranking. EPA will provide a list of 100 chemicals that are of interest to EPA and the CSS research program. Using the supplied list and the chemical literature, the HSAB modeling expert will perform the organic structural analysis necessary to chemically classify each substance (hard/soft, electrophile/nucleophile). Values for HSAB parameters (softness, hardness and electrophilicity) of relevant substances will then be calculated using quantum mechanical models. The calculated values will be used to provide a ranking for the likelihood of binding to different types of biological proteins. Task 3. Delivery of HSAB analysis ranking. The contractor will provide the EPA with a ranking based on the HSAB parameters (electrophilic, nucleophilic index, softness, hardness) for each of the 100 chemicals. Predicted protein residues that are likely sites of reaction by the chemical shall be included where possible. For this effort, the contractor will focus on the nervous and reproductive systems in rodents. d. GOVERNMENT RESPONSIBILITIES. The EPA will provide a decision to the Contractor regarding approval or request for changes of the QAPP within 15 business days after receipt of the QAPP. The EPA will provide the initial list of 100 chemicals for HSAB characterization. The contractor can suggest additional chemicals (or metabolites) that may be of interest to the EPA. After discussion, the EPA may modify the final list, keeping a total of 100 chemicals. The period of performance for this contract shall remain active through the completion of production and delivery of the ranked list of chemicals, but no longer than six months after award of the contract. e. REPORTING REQUIREMENTS - The Contractor shall provide the information about all software packages that were used to perform the HSAB analysis and generate the final ranked list of chemicals, their HSAB parameter values, and quality control procedures. The general procedure shall be provided to the EPA, in sufficient detail such that an independent expert should be able to replicate the results. The EPA will consider other reporting options proposed by the Contractor. f. SCHEDULE OF DELIVERABLES - The EPA proposes the following schedule of deliverables: 1. Completion of Task 1: 1 month after award of contract;
2. Completion of Task 2: 5 months after award of contract; 3. Completion of Task 3: 6 months after award of contract. The schedule for completion of Tasks 2 - 3 can be negotiated with the EPA prior to award of the contract, if the Contractor believes that it is either not attainable or can be accelerated. However, once a schedule has been agreed to by both the Contractor and the EPA, then the Contractor shall adhere to the schedule unless changes are authorized by the EPA. If changes are not authorized by the EPA and the Contractor fails to meet the scheduled delivery dates, then the dollar amount of the final payment will be reduced by 10% of the amount remaining in the contract per month of delay. The amount remaining in the contract shall be determined at the time at which completion of the task was scheduled to occur. B. PROVISIONS ¿ This requirement is being solicited with a proposed period of performance from May 1, 2015 thru September 30, 2015. FAR provisions and clauses referenced are available online at http://farsite.hill.af.mil/vffara.htm. Solicitation provision FAR 52.212-2, Evaluation - Commercial Items is hereby incorporated by reference with the fill-in for paragraph ((a) of "Technical Approach, Experience, Delivery Schedule, Past Performance, and Price." 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. The following factors shall be used to evaluate offers: 1) - Technical Approach - Proven ability (through peer-reviewed publications) to predict reactive metabolites from parent compounds for HSAB ranking and the ability of the contractor to demonstrate QA/QC compliance; 2 - Experience - Peer-reviewed publications record for using HSAB model to predict protein reactions for neurotoxic and/or reproductive toxic chemicals. Must be able to supply list of publications to the EPA; 3 - Delivery Schedule - The ability of the Contractor to meet the schedule of deliverables. The Contractor shall specify their methods for reporting as specified in the Statement of Work; 4) - Past Performance - All offerors shall provide with their quote package the names, addresses, phone numbers and email addresses of at least three references in the past five years that demonstrate the ability to perform HSAB modeling and ranking as specified in the contract. The EPA will contact these references regarding work performance; and 5) - Price. In accordance with FAR 15.304, all evaluation factors when combined will be more important than price. In accordance with FAR 52.204-7(b)(1) System for Award Management (SAM), all prospective awardees shall be registered in the SAM database prior to award, during performance, and through final payment of any contract or purchasing agreement resulting from this solicitation. All offerors are to include with their offers a completed copy of provision FAR 52.212-3, Offeror Representation and Certifications - Commercial Items. The following FAR provisions apply to this acquisition: 52.212-1, Instruction to Offerors - Commercial Items; and 52.212-4, Contract Terms and Conditions - Commercial Items. The following additional FAR clauses which are cited in clauses 52.212-5, Contract Terms and conditions Required to Implement Statutes or Executive Orders - Commercial Items are applicable to the acquisition: 52.219-28, Post Award Small Business Program Representation; 52.222-3, Convict Labor (E.O. 11755); 52.222-21, Prohibition of Segregated Facilities; 52.222-26 Equal Opportunity; 52.222-35, Affirmative Action for Disabled Veterans and veterans of the Vietnam Era; 52.222-36, Affirmative Action for Handicapped Workers; 52.222-37, Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era; 52.217-9, Option to Extend the Term of the Contract; 52.222-50; Combatting Trafficking in Persons; 52.222-52, Exemption from Application of the Service Contract Act for Certain Services -- Certification; 52.225-13, Restrictions on Certain Foreign Purchases; 52.229-3, Federal, State, and Local Taxes; 52.232-1, Payments; 52.232-33, Payment by Electronic Fund Transfer-System for Award Management; 52.232-99, Providing Accelerated Payments to Small Business Subcontractors; 52.233-1, Disputes; 52.239-1, Privacy or Security Safeguards (5 U.S.C. 3332); 52.247-34, F.O.B. Destination; EPAAR 1552.209-71, Organizational Conflicts of Interest; EPAAR 1552.211-70, Compliance with EPA Policies for Information Resources Management; EPAAR 1552.211-79, Compliance with EPA Policies for Information Resources Management; EPA-H-09-107, Unpaid Federal Tax Liability & Felony Criminal Violation Certification; EPA-H-42-102, Utilization of FedConnect for Contract Administration; EPA-L-15-102, Technical Questions; and EPA-L-15-104, Electronic Submission of Proposals/Bids/Offers/Quotes. Offerors must submit all technical questions/responses concerning this synopsis/solicitation electronically through FedConnect. Notices of any modifications to this FBO procurement announcement will be posted using the FedConnect web portal. FedConnect can be accessed at https://www.fedconnect.net/Fedconnect/ . The due date for quotes is 12:00 PM Eastern Time on April 22, 2015. Please submit responses to the U.S. EPA, Attn: Louis C. Williams, Jr (MC AA005), RTP Procurement Operations Division, 109 T.W. Alexander Drive, Research Triangle Park, NC 27709. Questions regarding the content of the subject announcement must be submitted through the FedConnect portal. You must register with FedConnect as an interested party to submit questions and to view responses. FedConnect is a web portal that connects agencies and vendors to streamline the process of doing business with the federal government. Through FedConnect contractors will be able to receive, review and respond to contract pre- and post-award actions and documents such as correspondence, request for proposals, tasking instruments and contract modifications. The use of FedConnect also furthers the EPAs commitment to moving towards a paperless acquisition environment by reducing its carbon footprint and conducting its business in an ecologically friendly manner. There is no charge to use FedConnect. Vendors can register with FedConnect at www.fedconnect.net/FedConnect/. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net. In addition, all vendors must be registered in the System for Award Management (SAM) at: https://www.uscontractorregistration.com/ as this facilitates registration for FedConnect. Please note that vendors MUST have their SAM profile set to public, otherwise FedConnect will not be able to access the SAM information required to validate vendor credentials. Registration may be completed and information regarding the registration process may be obtained at http://www.sam.gov. There is no charge for registration in SAM. All responsible sources categorized as a small business under the stated NAICS Code may submit a quote which shall be considered by the Agency. PLEASE NOTE: NO FURTHER SYNOPSIS OR INFORMATION WILL BE POSTED TO FEDBIZOPS. It will be the offeror's responsibility to frequently check the same site where the solicitation is to be posted for any amendments, changes to the RFQ issue and closing date. The Government is not obligated or committed to award any contract as a result of this notice. Hard copies or diskettes will not be available. Telephone and fax requests will not be honored.
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