Inactive

This Pre-Solicitation Announcement is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). THIS PRE-SOLICITATION ANNOUNCEMENT IS AMEN... This Pre-Solicitation Announcement is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). THIS PRE-SOLICITATION ANNOUNCEMENT IS AMENDED FOR A SECOND TIME TO STATE THE RFP WILL BE ISSUED VIA SAM.GOV CONTRACT OPPORTUNITIES ON OR AROUND MAY 29, 2020 (changed from May 22, 2020). THIS PRE-SOLICITATION ANNOUNCEMENT IS AMENDED TO STATE THE RFP WILL BE ISSUED VIA SAM.GOV CONTRACT OPPORTUNITIES ON OR AROUND MAY 22, 2020 (changed from May 8, 2020). THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) WILL BE ISSUED VIA SAM.GOV CONTRACT OPPORTUNITIES ON OR ABOUT MAY 22, 2020 (changed from May 8, 2020). The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is planning to issue an RFP for multiple Indefinite Delivery/Indefinite Quantity type contracts for Clinical Research Sites to conduct Phase II (and Phase I leading to Phase II) clinical research studies involving human subjects for the NIAAA Medications Development Clinical Investigations Network for medications development for the treatment of Alcohol Use Disorder. Awardees will serve as clinical research sites to perform clinical testing of compounds of interest and proprietary compounds supplied to NIAAA from industry suppliers or through purchasing medications approved for other indications. The requirement involves recruitment, enrollment and retention of human subjects for clinical trial participation, Good Clinical Practice testing of compounds, compound storage, administration of study medication to study participants, data collection, and collaboration/coordination of activities with the current NIAAA Contract Research Organization (CRO) for the Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder – Fast Track Drugs and Biologics, LLC (under contract 75N94019D00001, effective through 01/31/2026). Multiple Indefinite Quantity/Indefinite Delivery (IDIQ) – type contracts to Clinical Research Sites for participation in the Network are anticipated with an overall Task Order ordering period of seven years. Each clinical trial conducted via the issuance of Task Orders is anticipated to involve multiple Clinical Site IDIQ contract holders simultaneously (coordinated by the CRO/Coordinating Center contractor, Fast Track Drugs and Biologics, LLC) with an anticipated average recruitment target of around 35 to 40 subjects per site, per clinical trial, to support testing capacity of approximately 1 compound every 1.5 to 2 years over the next seven (7) years. Each clinical trial is anticipated to have a period of performance of approximately 1.5 to 2 years. The planned acquisition is a follow-on requirement to active contract HHSN275201400001I, awarded to Fast Track Drugs and Biologics, LLC, with a period of performance 03/14/2014 through 03/13/2022 (IDIQ Task Order ordering period). This 2014 Indefinite Delivery/Indefinite Quantity contract was awarded to a single source to perform both the CRO clinical coordination activities required by the Network and to also to subcontract out and oversee clinical research sites as needed. Subcontract clinical sites for the Network under this contract have included Boston Medical Center, Johns Hopkins University, University of Pennsylvania, University of Virginia, University of Miami, Dartmouth College, California Pacific Medical Center Research Institute, Stony Brook University Hospital, Mount Sinai St Luke’s and Mount Sinai Roosevelt Hospitals, University of Texas Southwestern Medical Center and the University of California, Los Angeles. Human Lab study sites for the overall network have included Brown University, the Medical University of South Carolina, Indiana University and Yale University. This re-competition has been re-structured from the previous single contract award for both CRO/coordination activities and Clinical Site subcontracting (HHSN275201400001I with Fast Track Drugs and Biologies, LLC) to a single award for CRO/coordination (recently awarded contract 75N94019D00001, effective February 9, 2019, with Fast Track Drugs and Biologics, LLC) and pending multiple direct Indefinite Quantity/Indefinite Delivery-type contract awards to Clinical Sites (the subject of this Pre-Solicitation Announcement). The NIAAA will now contract directly with multiple Clinical Sites for participation in the Network rather have the NIAAA CRO contractor establish multiple clinical site subcontracts. (Though active contract HSN275201400001I indicates an expiration date of 03/13/2022, NIAAA is approaching the maximum ordering limit under this contract earlier than anticipated and will therefore award Clinical Site contracts in calendar year 2020 rather than 2022). The NIAAA anticipates awarding approximately ten (10) Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts under this program with a seven-year Task Order ordering period. It is also anticipated that the IDIQ awards will be made in December 2020. This is NOT a Request for Proposals (RFP). Request for Proposals (RFP) No. NIH-NICHD-NIAAA-2020-04 will be available electronically from SAM.gov Contract Opportunities (URL: http://www.SAM.gov) 15 or more calendar days after the issuance of this Pre-Solicitation Announcement. 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. 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(s). No collect calls or facsimile transmissions will be accepted.