Inactive

This Solicitation is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The purpose of this acquisition is for The National Institu... This Solicitation is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The purpose of this acquisition is for The National Institute on Alcohol Abuse and Alcoholism (NIAAA) to establish a network of multiple 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 as part of a network 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)/Clinical Coordinating Center contractor for this Network, Fast Track Drugs and Biologics, LLC, under contract 75N94019D00001 (awarded in 2019 and effective through 01/31/2026). The NIAAA anticipates awarding approximately ten (10) Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts for Clinical Research Sites from this solicitation with a seven-year Task Order ordering period/period of performance. The parent IDIQ contracts will not contain options, however individual Task Orders issued under the parent IDIQ contracts may contain options. Individual Task Orders issued under the parent IDIQ contracts will be cost reimbursement-type and may be either term level-of effort or completion requirements. It is anticipated that the parent IDIQ awards will be made on or around December 18, 2020. Each clinical trial conducted via the issuance of Task Orders under the parent IDIQ contracts 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. This 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). As the NIAAA is approaching the ordering limits established by the current contract earlier than previously anticipated, a re-competition is being conducted at this time via this solicitation. The previous requirement, awarded in 2014 under contract HHSN275401400001I, was a single-award Indefinite Delivery/Indefinite Quantity contract that combined both clinical coordination center activities and the conduct of clinical research in one contract. This re-competition separates the CRO/clinical coordination activities (now a separate contract, already awarded in 2019 to Fast Track Drugs & Biologies, LLC under contract 75N94019D00001 with a period of performance through /1/31/2026) from the clinical research sites/conduct of clinical research itself. Under the previous contract, the CRO/Coordinating Center subcontracted for clinical research sites. In this current re-competition, the NIAAA will contract directly with multiple clinical research sites. Previous clinical sites for this research network (as subcontract clinical sites) 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. Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically on or about May 29, 2020 and may be accessed through SAM (http://beta.sam.gov). This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NICHD on behalf of NIAAA requires proposals to be submitted via the NIH’s 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 to the website (https://ecps.nih.gov) and then click on “How to Submit.” AMENDMENT 1 is issued to provide the correct link for Attachment 8: Technical Proposal Cost Summary, in Section J on page 79. AMENDMENT 2 is issued to extend the deadline for receipt of proposals to 3:00 pm Eastern Standard Time on August 31, 2020 (changed from July 28, 2020). AMENDMENT 3 is issued to provide a list of written questions received to date and answers to those questions to assist potential offerors in the preparation of their proposals. A separate fillable .pdf of Attachment 4, Representations and Certifications is also provided with this amendment for convenience (Attachment 4 is also included within the RFP document). AMENDMENT 4 is issued to provide a list of additional questions and answers for questions received since the posting of Amendment 3 (Q&A's 1-10) on July 9, 2020. (Amendment 3 contains Questions 1-10; this Amendment 4 contains Questions 11-13). AMENDMENT 5 is issued to provide a list of additional questions and answers for questions received since the posting of Amendment 4 (Q&A's 11-13) on July 21, 2020. (Amendment 3 contains Questions 1-10; Amendment 4 contains Questions 11-13; this Amendment 5 contains Questions 14-23). AMENDMENT 6 is issued to extend the deadline for receipt of proposals to 3:00 PM Eastern Standard Time, September 4, 2020 (changed from 3:00 PM Eastern Standard Time, August 31, 2020) and to update the solicitation provisions/contract clauses FAR 52.204-24 and FAR 52.204-25, contained in Article I.4. of the RFP, with the August 2020 updated clauses that became effective on August 13, 2020. Please note that a new "Representation" item, item 2, was added to paragraph d) of FAR Clause 52.204-24. AMENDMENT 7 is issued to correct a typo contained in Attachment 3C, "Sample Clinical Trial Task Order B-2 Statement of Work and Deliverables". Specifically, the last sentence of the Study Design and Duration section of the Draft Protocol Synopsis on page 9 is corrected to read a "1:1" randomization is to be performed (rather than "1:1:1", which was a typo) for this 2-arm study.