Receptor Binding and Predictive Toxicology
A. Objectives: The National Institute on Drug Addiction (NIDA), Division of Therapeutics and Medical Consequences (DTMC), intends to solicit proposals using competitive procedures as a SMALL BUSINESS SET-ASIDE from qualified and capable Small Businesses certified under NAICS Code 541715; to assesses the pharmacological specificity and potential toxicity of lead compounds by screening at a large number of biological targets. The purpose of this contract is to provide the NIDA Division of Therapeutics and Medical Consequences with reports in which the Contractor assesses the pharmacological specificity and potential toxicity of lead compounds by screening at a large number of biological targets. This contract will also support studies to determine the affinity (IC50, Ki) and/or function (EC50, IC50) of test compounds for receptors at specified biological targets indicated by compound profiling or other sources. This contract will provide a way to screen additional compounds, possibly large compound libraries, at one or more receptors or transporters in order to determine biological activity, with the objective of discovering specific receptor or transporter ligands with novel chemical structures. This contract will provide assays to assess predictive toxicology in key areas that could indicate a candidate compound would have difficulties in the drug development process. This contract will allow development of in vitro assays at targets that may be of importance in the development of compounds for the treatment of drug abuse and its consequences. This contract will allow for the purchase of test compounds on an “as needed” basis. B. General Requirements: Independently, and not as an agent of the Government, the Contractor shall provide all necessary labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below. The Government COR shall monitor all work under this contract. The Contract activities will support NIDA in the following Task Areas: Task 1: Receptor Profile Screening Task 2: Receptor Binding Affinity and/or Functional Activity Task 3: Predictive Toxicological and Pharmacokinetic Testing Task 4: Compound Library Screening Task 5: Assay Development Task 6: Compound Purchase NIDA anticipates a Single Award Indefinite Delivery, Indefinite Quantity (IDIQ), contract with and ordering period of five (5) years. NIDA may award either fixed price and/or cost reimbursement task orders under this contract. NIDA expects to award at least one task order to the successful Contractor at the time of contract award. These individual task Orders may include options and/or options for increased quantity. If options or option quantities are utilized for an individual task order they will be clearly defined in the Task order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one task Order will be awarded with the contract. Future funding will be made tough issuance of task orders and will be dependent on program needs and funding availability. C. Mandatory Criteria: This acquisition includes special or unique performance or capability requirements. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess a DEA Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970 at the time of submission of the proposal. In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule 1 controlled substances prior to awarding the contract. D. Additional Information: RFP No. 75N95023R00007 will be available electronically on or about February 15, 2023. Interested vendors will can access the RFP tough www.SAM.gov or tough the NIDA website (URL: https://nida.nih.gov/funding/nida-office-acquisitions-contracting#RFP) . All information required for the submission of a proposal will be contained in or accessible tough the RFP package. Responses to the RFP will be due approximately 45 days from the release date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. PLEASE SEE ATTACHED SYNOPSIS FOR ALL RELEVANT DETAILS 75N95023R00007 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
2/1/23, 3:31 PM Receptor Binding and Predictive Toxicology
The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95023R00007 for "Receptor Binding and Predictive Toxicology". This Request for Proposal is prepared in accordance with the Uniform Contract Format prescribed for Government Wide application by the Federal Acquisition Regulation (FAR). The Uniform Contract Format is both a Request for Proposal and a contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format. We expect to award an indefinite delivery, indefinite quantity (IDIQ) contract with fixed-price or cost-plus-fixed fee (completion or term form) task orders. NIDA anticipates the IDIQ contract will have an ordering period of five years and will include a guaranteed minimum of $1,000 and a maximum value of $5,000,000 for the ordering period. Task orders may include, options for extra quantities and to extend the period of performance. Future year funding will be dependent on the previous year's performance and funding availability. The initial performance period will start on or around September 21, 2023.Interested parties should respond with technical and pricing proposals for the entire project. Please include separate pricing for each individual option. THIS IS A 100 PERCENT SET-ASIDE FOR SMALL BUSINESS. Proposals received from firms that are not small business concerns, as defined by the North American Industry Classification System (NAICS) code, are not eligible for award. The NAICS code applicable to this buy is 541715. See Section L.1.c. of this RFP. In addition, FAR Clause 52.219-14 ‘Limitation on Subcontracting’ is applicable under this solicitation, and this clause requires that at least fifty (50) percent of the cost of contract performance incurred for personnel be expended by employees of the small business firm. General Particularly direct your attention to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Review these parts as to the effects on performance capability and technical and cost considerations in the development of your proposal. Do not fill in blanks or otherwise complete portions of Parts I, II, and III which otherwise appear to require the insertion of data. The Government will complete those Parts prior to contract award and (if negotiations are conducted) will tailor those items tough final negotiations. All offerors must be REGISTERED and have an ACTIVE System for Award Management (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management (www.sam.gov) must be in full compliance with FAR 52.204-7 System for Award Management and FAR 52.204-13 System for Award Management Maintenance to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirements. You must have an authorized organizational official sign your Business Proposal. It must contain a detailed breakdown of costs by year and individual options, for each cost category/element, an explanation of the basis for all costs, and provide documentation to support these costs. We direct special attention to the Breakdown of Proposed Estimated Costs (plus fixed fee) w/Excel Spreadsheet contained in the Business Proposal Cost Information, Attachment 08. Please provide an electronic copy of the spreadsheet in this format. Do not send encrypted files. Use of the above format will hasten review and award. See Section L.2.c. Business Proposal Instructions for additional detail. Please include a completed Form NIH-2043, “Proposal Summary and Data Record” with the Business Proposal. Note that in addition to telephone and fax numbers, you should include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form. Format and content requirements of your Technical Proposal are detailed in Section L.2.b. Technical Proposal. Also, you should complete the “Technical Proposal Cover Sheet” and use it as the cover sheet for each copy of your technical proposal. It is important that you list all professional personnel and organizations named in the proposal who have any role in the proposed work. This includes your staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named. You may use extra sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. We will use this information to ensure that no conflicts of interest exist with the selected review committee members. The Offeror must submit its Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal. If you want to receive an e-mail notice of any amendments to this RFP, you should register on the SAM.gov website. Also, NIDA will post all amendments, or provide an appropriate link, on the SAM.gov website. Offeror Questions and Intent Requests for clarification, additional information, or correction must be made in writing to the Contract Specialist and Contracting Officer. A completed "Proposal Intent Response Sheet."Attachment 02 of the RFP: Please complete this form and return it to this office on or before March 24, 2023. The Completed Proposal Intent Response Sheet and offeror questions, if any, must be submitted on or before 5:00 P.M. Eastern Time on April 17, 2023. The response sheet and offeror questions must be submitted by e-mail to alex.beraud@nih.gov and tracy.cain@nih.gov with the subject line: “Offeror Intent and Questions – RFP75N95023R00007” Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) and no later than 3:00 p.m., Eastern Standard Time (EST) on April 24, 2023. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal. Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to tee (3) business days. Please plan accordingly. Additional instructions on submitting a proposal via eCPS can be found at https://ecps.nih.gov/howtosubmit and in Attachment 1. All notices related to this solicitation will be posted on SAM (https://www.sam.gov). In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary. Disclaimers This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition. Following your proposal submission and our review, the Contracting Officer may seek more information. In accordance with FAR 15.306(a)(3) and FAR 52.215-1, we advise you that the Government intends to evaluate proposals and award a contract without discussions (except clarifications). Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. However, we reserve the right to conduct discussions if the Contracting Officer later decides them to be necessary. Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984). Requests for any information concerning this RFP should be directed to Alexander Beraud, NIDA Office of Acquisitions, Red Branch, who may be reached on (301) 443-6677; collect calls will not be accepted. Discussions with any other individual outside the NIDA R&D Contracts Management Branch should not occur. PLEASE SEE ATTACHED RFP FOR ALL RELEVANT DETAILS 75N95023R00007 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
3/10/23, 4:58 PM Receptor Binding and Predictive Toxicology
Introduction: This is a Sources Sought notice. THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. The purpose of this notice is to obtain information regarding; (1) the availability and capability of qualified 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; small disadvantaged businesses; or other-than-small 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. Background: The National Institute on Drug Abuse (NIDA), Division of Therapeutics and Medical Consequences (DTMC) supports a contract-based research program (the Addiction Treatment Discovery Program) that acts to test potential medications for safety and efficacy in developing them as drugs to be used in the treatment/prevention of drug abuse. Purpose and Objectives: The purpose of this contract is to provide the NIDA Division of Therapeutics and Medical Consequences with reports in which the Contractor assesses the pharmacological specificity and potential toxicity of lead compounds by screening at a large number of biological targets. This contract will also support studies to determine the affinity (IC50, Ki) and/or function (EC50, IC50) of test compounds for receptors at specified biological targets indicated by compound profiling or other sources. This contract will provide a way to screen additional compounds, possibly large compound libraries, at one or more receptors or transporters in order to determine biological activity, with the objective of discovering specific receptor or transporter ligands with novel chemical structures. This contract will provide assays to assess predictive toxicology in key areas that could indicate a candidate compound would have difficulties in the drug development process. This contract will allow development of in vitro assays at targets that may be of importance in the development of compounds for the treatment of drug abuse and its consequences. This contract will allow for the purchase of test compounds on an “as needed” basis. Project Requirements: MANDATORY REQUIREMENTS: Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess a Drug Enforcement Administration (DEA) Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970 at the time of submission of the proposal. In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule 1 controlled substances prior to awarding the contract. Many of the compounds that will be tested will come from private sources (e.g., the pharmaceutical industry) that wish to keep information and data confidential (e.g. until patents are filed). In most cases, NIDA will have signed a confidentiality agreement with the provider indicating that the data obtained will not be released without the provider’s written permission. For this reason, the Contractor may not publish, present, or otherwise disclose the results of studies on test compounds unless the NIDA COR grants written permission to publish or otherwise disclose this information. Tasks to be performed: Task 1: Receptor Profile Screening (screening a compound at approximately 100 sites) Task 2: Receptor Binding Affinity and/or Functional Activity, (IC50, Ki, and Hill slope values by using six (6) or more test ligand concentrations and generate inhibition curves); Task 3: Predictive Toxicology and Pharmacokinetic Testing (Cyp450, hERG channel, genotoxicity (Ames test). Task 4: Compound Library Screening (prepare reports of biological activity describing compound activity as a percent of inhibition at each concentration, or as stated in the Task Order). Task 5: Assay Development (interested organizations may be asked from time to time to submit a proposal to perform an assay not in their current catalog). Task 6: Compound Purchase (interested organizations may be asked from time to time to purchase a compound for testing if it is commercially available in the event that the compound cannot be purchased or otherwise obtained by the Government by other means and shipped to the Contractor in a reasonable time frame). Interested organizations must demonstrate and document, in the capability statement submitted, extensive experience in the technical area under consideration. Send information relevant and specific, on each of the following qualifications: 1) expertise in evaluation and personnel with the knowledge of, and experience in conducting receptor and enzyme binding and/or functional assays as well as in vitro predictive toxicology including cardiovascular (e.g. hERG Channel) and genetic predictive assays (e.g. Ames test); b) state-of-the-art assay methodologies; 2) equipment, instrumentation, facility, and personnel to perform the Tasks 3) DEA Research Registration for Schedules II to V with the potential to apply for Schedule I if required. Capability Statement: Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. All capability statements should provide the following: 1) company name and address; 2) point of contract, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) types(s) of business, if any (e.g.,: small, Veteran-owned, service-disabled Veteran-owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone). Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non­ responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Alexander Beraud, Contract Specialist, at Alexander.Beraud@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published on https://beta.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a firm fixed price contract. PLEASE SEE ATTACHED SOURCES SOUGHT NOTICE FOR ALL RELEVANT DETAILS 75N95023R00007 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
11/18/22, 11:08 AM