Description
The Solicitation is amended to provide answers to questions received from potential offerors. Questions and Answers are provided in the 6-page attachment entitled "Amendment 0001 Questions and Answers RFP 75N94025R00008". Additionally, Section L Technical Proposal Instructions, item d. "Enhancing Reproducibility through Rigor and Transparency" (page 108 of RFP) is amended to add previously missing specification language to provide guidance to offerors on how to address this item in their Technical Proposals. See the attachment "Amendment 0001 Questions and Answers RFP 75N94025R00008", question number 6), for full details. FULL TITLE: Contract Research Organization for the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Medications Development Clinical Trials Network This solicitation is issued by the National Institutes of Health, Office of the Director, Office of Acquisitions and Logistics Management, on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). This acquisition is a re-competition for a follow-on contract for Clinical Research Organization (CRO) clinical trial coordination and support services to support all aspects of multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder (AUD). This acquisition represents is a follow-on requirement to indefinite delivery/indefinite quantity contract 75N94019D00001, awarded to Fast-Track Drugs & Biologics, LLC with a Task Order ordering period of February 1, 2019 through January 31, 2026. An indefinite delivery/indefinite quantity (IDIQ) contract with an ordering period of seven years (commencing 11/15/2026) for the issuance of project-specific task orders is anticipated to continue the CRO R&D clinical study coordination and support services currently provided under contract 75N94019D00001 for the NIAAA Medications Development Clinical Trials Network. Individual task orders for assigned clinical trials will be issued as needs arise on a cost plus fixed fee basis. The CRO contractor shall support development, coordination and operation of each task order-assigned clinical trial including but not limited to clinical trial coordination support, clinical site oversight and management support, preparation of study documents, electronic data capture of clinical data from all participating clinical sites, Good Clinical Practice (GCP) monitoring services, acquisition and facilitation of study medication and packaging, shipping and coordination of study medication, logistical and meeting services, regulatory support and services, statistical and data analysis, and final clinical study report preparation and submission and manuscript preparation. The clinical research sites for each assigned task order/clinical study will be established under separate NIAAA contracts. It is anticipated that four to six CRO Clinical Study Support task orders will be issued via individual task orders during the seven-year ordering period of the indefinite delivery/indefinite quantity (IDIQ) contract. It is anticipated that the Base Indefinite Delivery/Indefinite Quantity contract and the Core and Study Development Support task order will be awarded on or around November 15, 2026. This acquisition will be competed as a 100% Set-Aside for Small Business concerns whereby only Small Business concerns will be eligible for award (size standard for associated NAICS 541715, Research and Development in the Physical, Engineering, and Life Sciences [except Nanotechnology and Biotechnology] is 1,000 employees). A small business concern, as defined by FAR 19.001, means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business located in the United States or its outlying areas and that makes a significant contribution to the U.S. economy through payment of taxes and/or use of American products, material and/or labor, etc. "Concern" includes but is not limited to an individual, partnership, corporation, joint venture, association, or cooperative. For more information, see 13 CFR 121.105. Additionally, for acquisitions conducted under a 100% Small Business Set-Aside, per FAR 19.505(b)(1)(i), Limitations on Subcontracting, the concern [small business prime contractor] will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities [e.g. also small businesses concerns]. Any work that a similarly situated entity further subcontracts will count towards the concern's 50 percent subcontract amount that cannot be exceeded. THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE SAM.GOV CONTRACT OPPORTUNITIES WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED AFTER RELEASE OF THE PENDING SOLICITATION. Any responsible small business concern may submit a proposal, which shall be considered by the agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. Proposals must be submitted via the NIH electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go tothe website (https://ecps.nih.gov) and then click on How to Submit. See ATTACHMENT 1 of the RFP for full details. In addition to the ATTACHMENTS provided with this posting, see Section J of the Request for Proposals document for links to other applicable attachments.