A--Contract Research Organization for the National Institute on Alcohol Abuse and 75N94025R00008

This notice is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). This is a Small Business Sources Sought (SBSS) notice issued for market research purposes only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time and no award will be made on the basis of responses received to this Small Business Sources Sought notice. The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified small business 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; or small disadvantaged businesses; and (3) their size classification according 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 exclusively for small business concerns is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The applicable NAICS code for this requirement is 541715, ¿Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology¿ with a small business size standard of 1,000 employees or less. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking capability statements from small business organizations (NAICS 541715; small business size standard is 1,000 employees) with experience in providing support for medications development. Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol problems. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone. Thus, the search for new molecular targets and more efficacious medications is critical. The creation of the NIAAA's Medications Development program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7-8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct clinical trials of promising compounds to treat alcohol problems. The planned acquisition is a follow-on requirement to active indefinite delivery/indefinite quantity contract 75N94019D00001, ¿, awarded to Fast-Track Drugs & Biologics, LLC with a task order ordering period of 2/1/2019 through 1/31/2026. An indefinite delivery/indefinite quantity (IDIQ) contract with an ordering period of seven years (commencing 2/1/2026) is being contemplated to continue the CRO support services currently provided under the active CRO contract 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 clinical sites for each assigned task order/clinical study will be under separate contracts directly with the NIAAA). The Contractor shall serve as the CRO for the NIAAA Clinical Trials Network to support all aspects of multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder (AUD). 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. It is anticipated that 4-6 trials will be ordered via individual task orders during the seven-year ordering period of the indefinite delivery/indefinite quantity (IDIQ) contract. See the attachment to this announcement entitled SMALL BUSINESS SOURCES SOUGHT 75N94025R00008 for instructions on how to respond to this announcement.

This Pre-Solicitation Announcement 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 IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. NO RESPONSES ARE DUE AT THIS TIME. A REQUEST FOR PROPOSALS (RFP) WILL BE ISSUED VIA SAM.GOV CONTRACT OPPORTUNITIES ON OR ABOUT APRIL 23, 2026. The National Institute on Alcohol Abuse and Alcoholism is planning to issue an RFP 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. An indefinite delivery/indefinite quantity (IDIQ) contract with an ordering period of seven years (commencing 11/15/2026) 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. 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 PENDING 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. All responsible sources may submit a proposal, which shall be considered by the agency. This Pre-Solicitation Notice does not commit the Government to award a contract. No collect calls or facsimile transmissions will be accepted. AGAIN, THIS IS AN ADVANCE PRE-SOLICITATION ANNOUNCMENT ONLY AND NO RESPONSES ARE DUE AT THIS TIME.

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.

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.