Inactive

The National Institute on Drug Abuse (NIDA) invites you to submit a proposal responding to the requirements of this RFP No. 75N95024R00045 for "Analytical Chemistry and Stability Testing of Treatment ... The National Institute on Drug Abuse (NIDA) invites you to submit a proposal responding to the requirements of this RFP No. 75N95024R00045 for "Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders". 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. NIDA anticipates the award of a single cost reimbursement plus fixed fee contract. NIDA estimates this requirement will include a one (1) year Base Period and four (4) one (1) year options to extend the period of performance and options for increased quantity. Future year funding will be dependent on the previous year's performance and funding availability. The initial performance period will start on or around August 2024. Interested parties should respond with technical and pricing proposals for the entire project. Please include separate pricing for each individual option period and option quantity. Please refer to Section M for mandatory qualification criteria. Additionally, 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. THIS IS SOLICITED UNDER FULL AND OPEN COMPETITION. The NAICS code applicable to this buy is 541715. See Section L.1.b. of this RFP. 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, 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 through final negotiations. 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 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 10. 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 Instructions. 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 Form." Attachment 02 of the RFP: Please complete this form and return it to this office on or before March 27, 2024. The Completed Proposal Intent Response Sheet and offeror questions, if any, must be submitted on or before 4:00 P.M. Eastern Time on March 27, 2024. The response sheet and offeror questions must be submitted by e-mail to rob.bailey@nih.gov with the subject line: “Offeror Intent and Questions – 75N95024R00045” Submitting a Proposal Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than 4:00 p.m., Eastern Standard Time (EST) on April 11, 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. Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to three (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 Rob Bailey, NIDA Office of Acquisitions, Red Branch, who may be reached on (301) 451-7586; collect calls will not be accepted. 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 business and technical proposals recesipt of the RFP and this Amendment. Please refer to the file "RFP 75N95024R00045 Amendment 1" attached to this solicitation for additional information and details. **Solicitation Amendment No. 02** PLEASE NOTE: This Solicitation is amended to request the submission of a small business subcontracting plan with the offeror's business proposal as outlined in Section L of the RFP Section 2 (Instructions to Offerors) subsection c (Business Proposal Instructions) 6 (Small Business). Specifically, submit a small business subcontracting plan that adheres to subsection d.1. with "goals expressed in terms of percentages of total planned subcontracting dollars." Submissions in SBCX are currently showing goals in terms of total contract value. Please refer to the file "RFP 75N95024R00045 Amendment 2" attached to this solicitation for additional information and details. **Solicitation Amendment No. 03** PLEASE NOTE: This Solicitation is amended to To advise offerors in relation to Amendment 2, that they are now able to submit their subcontracting plan through SBCX with "goals expressed in terms of percentages of total planned subcontracting dollars." All offerors are required to submit their small business subcontracting plan at the following link: https://osdbu.hhs.gov/ subcontracting/ef5dae7b-eea8-4f39-b74b-90abfcb54dca.. Please refer to the file "RFP 75N95024R00045 Amendment 3" attached to this solicitation for additional information and details.

Inactive

A. Objectives: The National Institute on Drug Abuse (NIDA) intends to solicit proposals under full and open competition from qualified and capable offerors having the ability to perform the following ... A. Objectives: The National Institute on Drug Abuse (NIDA) intends to solicit proposals under full and open competition from qualified and capable offerors having the ability to perform the following services: Development and validation of analytical methods for drug substances and/or finished dosage forms; Preparation of reference standards; Physical and chemical characterizations and quality control testing of drug substances and/or drug products; Determination of stability of drug substances and/or finished dosage forms according to the FDA Guidance for Industry: Q1A (R2) Stability Testing of New Drug Substances and Products; Provision of an adequate storage facility for the drug substances and/or finished dosage forms; Shipment of drug substances and dosage forms to NIDA designated sites; and Maintenance of a database to track the shipment and storage of the drug substances and the finished dosage forms. The NIDA Division of Therapeutics and Medical Consequences (DTMC) will use the data produced by this contract in the preparation of Drug Master File (DMF), Investigational New Drug (IND) and New Drug Application (NDA) documentation. Independently and not as an agent of the Government, the Contractor shall furnish all necessary labor, facilities, materials (except experimental bulk drugs and drug products), supplies, equipment, and services (except as otherwise specified herein) and perform the work as generally described above. Bulk drug substances will generally be provided by the Government at the time of approval of the delivery schedule by the Contracting Officer’s Representative. This is a follow-on procurement to Contract Number 75N95019C00042 titled "Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders." It is estimated that a cost reimbursement, level of effort type contract will result from this procurement which will include a one-year base period and four one-year options to extend performance. Additional option quantities will also be included. B. Mandatory Criteria: This acquisition includes the following special or unique performance or capability requirements: DEA RESEARCH REGISTRATION This project involves the use of scheduled drugs under the Controlled Substances Act of 1970. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that the Offeror (prime and/or subcontractor) possess a DEA Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970. In addition, the successful Offeror (prime and/or subcontractor) must either possess, or demonstrate the ability to obtain, a DEA registration for Schedule I controlled substances, as well as the ability to distribute, import and export controlled substances. cGMP Compliance All manufacturing facilities (prime and/or subcontractor) must comply with the FDA’s current Good Manufacturing Practices (cGMP). A copy of the most recent FDA cGMP inspection report (and/or a table referencing the inspection history by the FDA and if findings were noted) for all proposed manufacturing facilities must be included with Offeror’s proposal. Facilities must include a DEA approved vault securely to store controlled drug substances/products. C. Additional Information: RFP No. 75N95024R00045 will be available electronically on or about February 12, 2024. You can access the RFP through the beta.SAM.gov or through 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 through 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. 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 or organizations 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.