Inactive Total Small Business Set-Aside (FAR 19.5)

The National Institute on Drug Abuse invites you to send a proposal responding to the requirements of this RFP No. 75N95024R00078 for “Pharmacokinetic Analysis Resource Center” This RFP is released un... The National Institute on Drug Abuse invites you to send a proposal responding to the requirements of this RFP No. 75N95024R00078 for “Pharmacokinetic Analysis Resource Center” This RFP is released under SMALL BUSINESS SET ASIDE Procedures. The NAICS code applicable to this buy is 541715. See Section L.1.b. of this RFP. NIDA prepared this Request for Proposal 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. NIDA anticipates awarding one (1) indefinite delivery, indefinite quantity (task order) contract with individually negotiated task orders over a five-year ordering period. NIDA expects to award completion or level of effort, cost reimbursement and fixed-price task orders. NIDA expects to award at least one task order to a single contractor at the time of contract award. Future funding will be made through issuance of task orders and will be dependent on program needs and funding availability. Offerors should anticipate that the ordering period will be from September 2024 to September 2029. The contract will contain a guaranteed minimum of a contract kick-off meeting and not-to-exceed maximum of $2,500,000 over the full five-year ordering period. You should respond with technical and pricing proposals based on the assumptions provided in Section C and L of the RFP. Note: You must include all of the tasks listed in the Statement of Work (SOW) in your technical proposal. All offerors must be REGISTERED and have an ACTIVE System for Award Management http://www.sam.gov/ (www.sam.gov) account at the time an offer/proposal is submitted to the Government. All offerors registered in the System for Award Management http://www.sam.gov/(www.sam.gov) must be in full compliance with FAR 52.204-13 System for Award Management Maintenance and FAR 52.207- 7 System for Award Management to be eligible to submit a proposal. The Government will not accept proposals from offerors who do not meet the SAM requirement. General We direct your attention to Part IV, which contains instructions, provisions, and evaluation factors for the submission and review of proposals. Your attention is further directed to Attachment 2, “Proposal Intent Response Sheet.” Please complete this form and return it to this office on or before May 2, 2024. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which we will make 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. However, you are not to 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 through final negotiations. Requests for clarification, additional information, or correction must be made in writing to the Contracting Officer. You must submit your questions in sufficient time for receipt on or before May 2, 2024. RFIs may be submitted by e-mail to Andrew.varley@nih.gov and Rob.Bailey@nih.gov with the subject line “RFI – RFP 75N95024R00078. Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) before 3:00 p.m., Eastern Standard Time (EST) on May 20, 2024. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal. 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. The Contracting Officer reserves the right to make no award at all to the RFP. In addition, the RFP may be amended or cancelled as necessary to meet requirements. You must have an authorized organizational official sign your Business Proposal. It must contain a detailed breakdown of costs 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. 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 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 must 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 Financial Report with the initial Business Proposal. Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit a proposal may take up to three (3) business days. Please plan accordingly. Additional instructions on how to submit a proposal via eCPS can be found at https://ecps.nih.gov/howtosubmit and in Attachment 01. All notices related to this solicitation will be posted on Sam.gov (https://www.sam.gov). If you would like to receive e-mail notifications of updates to this solicitation, please register with SAM.gov. Disclaimers Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984). 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. You should direct all requests for any information concerning this RFP to Andrew Varley, NIDA Section, Contracts Management Branch who may be reached by e-mail at andrew.varley@nih.gov. as well as the undersigned who may be reached by e-mail at Rob.Bailey@nih.gov. Discussions with any other individual outside the NIDA Contracts Management Branch should not occur. ** Solicitation Amendment No. 01** PLEASE NOTE: This Solicitation is amended to respond to formal questions submitted in response to the solicitation. All other terms and conditions of the RFP remain unchanged. The offeror should acknowledge on the cover page or first page of its businsess and technical proposals receipt of the RFP and this Amendment. Please refer to the file "RFP 75N95024R00078 Amendment 1" attached to this solicitation for additional information and details.

Inactive Total Small Business Set-Aside (FAR 19.5)

The National Institute on Drug Abuse (NIDA), and the Division of Therapeutics and Medical Consequences (DTMC), intend to solicit proposals as a SMALL BUSINESS SET-ASIDE using competitive procedures fr... The National Institute on Drug Abuse (NIDA), and the Division of Therapeutics and Medical Consequences (DTMC), intend to solicit proposals as a SMALL BUSINESS SET-ASIDE using competitive procedures from qualified organizations certified as SMALL BUSINESS under NAICS Code 541715. The purpose of this requirement is to provide clinical research support services and pharmacokinetic resources in support of pharmacokinetic (PK)/pharmacodynamic (PD) studies. No actual clinical or laboratory studies will be carried out under the contract. The successful awardee shall: Prepare study protocols; Monitor clinical studies to assure that pertinent FDA regulations are met; Perform data management for clinical and pharmacokinetic data; Perform statistical, PK and PK/PD analyses of experimental data obtained from clinical studies including clinical pharmacology and drug-drug interaction studies; Perform population pharmacokinetic (PK) and pharmacodynamic (PD) analysis for data obtained from clinical trials to investigate the relationships among dose, plasma concentration, and effect and; Prepare study reports. The data/reports will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications); Provide support services which may include, but are not limited to, preparing progress reports, reviewing/revising protocols, consultation on design and data analysis, preparing PK/PD graphs and tables for presentations, performing literature search, as well as other support tasks; and Develop and maintain archival study records. NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ), task order contract. This award is a re-competition of 75N95019D00009, titled “Pharmacokinetic Analysis Resource Center.” NIDA may award either cost reimbursement and/or fixed price task orders under this contract. Individual Task Orders may include options to extend the period of performance and/or Options for Increased Quantity. If options or option quantities are utilized for an individual task order the 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 or more task orders will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds. RFP No. 75N95024R00078 will be available electronically on or about April 18, 2024. You will be able to access the RFP through SAM.gov and the NIDA website at the following URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps. All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 30 days after release of the RFP. NIDA will consider proposals submitted by any responsible SMALL BUSINESS under NAICS Code 541715. 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. This advertisement does not commit the Government to award a contract.