Clinical Trials Program National Institute on Deafness and Other Communication Disorders (NIDCD)

THE FOLLOWING UPDATES HAVE BEEN MADE (4/29/2024) RFP Amendment 004 attached Questions and Response Document attached Reps and Certs - Commercial FAR 52.212-3 Document attached Pre-Proposal Conference Slides attached RFP Amendment 004 attached; page 20-21 section H.8. removed; see highlighed RFP Amendment 004 attached; page 47-48, section List of Attachments, see highlighted RFP Amendment 004 attached; page 60-61, section Instructions to Offerors RFP Amendment 004 attached; page 71; section Business Proposal; see highlighted RFP Amendment 004 attached; page 73-75 section Small Business Subcontracting Plan removed, see highlighted RFP Amendment 004 attached; page 80; section M General, see highlighted RFP Amendment 004 attached; page 81; section Mandatory Qualification Criteria; see highlighted RFP Amendment 004 attached; page 82-83; section Cost Price Evaluation; see highlighted ________________________________________________________________________ THE FOLLOWING UPDATES HAVE BEEN MADE (4/23/2024) RFP Amendment 003 attached; changes highlighted in yellow, section J List of Attachments Attachment 5 reworded from Reference Response Form to Reference Response Attached Past Performance Questionnaire. The afformentioned document is an electronic file attached to this RFP entiltled: 'Past Performance Questionnaire' RFP Amendment 003 attached; changes highlighted in yellow; section Techncial Proposal Instructions page 67-68 added. Pricing Table added as an electonic file to this RFP; entitled: 'Pricing Table' ______________________________________________________________________________ THE FOLLOWING UPDATES HAVE BEEN MADE (4/12/2024) RFP Amendment 002 attached; changes highlighted in yellow, section Techncial Discussion page 67-68 Technical Evaluation Criteria revised. RFP Amendment 002 attached; changes highlighted in yellow; section Business Proposal Instructions number 10 page 77-78 removed. ______________________________________________________________________________ THE FOLLOWING UPDATES HAVE BEEN MADE (4/3/2024) A Pre-Proposal Conference will be held virtually on Monday, April 8, 2024 from 10:00am-12:00pm EST. Registration is required to attend this event. Please use the following link to register: https://www.eventbrite.com/e/nih-olao-nidcd-clinical-trials-program-pre-proposal-conference-tickets-862980436717?utm-campaign=social&utm-content=attendeeshare&utm-medium=discovery&utm-term=listing&utm-source=cp&aff=ebdsshcopyurl Vendors attending the pre-proposal conference are expected to fully read and understand the RFP prior to the event. There is a maximum number of 500 attendees. If you have specific questions regarding this requirement please send your questions to NIHSmallBusiness@mail.nih.gov by COB April 5, 2024. Registrants will receive the link to access this event on April 6, 2024 by COB. _______________________________________________________________________________________________ THE FOLLOWING UPDATES HAVE BEEN MADE (4/2/2024) Proposal Intent Response Form added as attachment Past Performance Questionnaire Form added as attachement _______________________________________________________________________________________________ THE FOLLOWING UPDATES HAVE BEEN MADE Please note that the Pre-Proposal Conference has been rescheulded to Monday, April 8, 2024. A SAM notice will be publised with additional detals. RFP Page 1: Proposal Response Date is 05/15/2024 (Revised RFP attached see highlighted) RFP Page 61: Questions shall be submitted by 04/15/2024; Notice of Intent shall be submitted 05/01/2024; Proposals shall be submitted 05/15/2024 (Revised RFP attached see highlighted) ________________________________________________________________________________________ The National Institute of Health (NIH) intends to award a service contract to support the National Institutes on Deafness and Other Communication Disorders (NIDCD) Clinical Trials Program (CTP) coordination and operations. The NIDCD cooperative agreement high risk clinical trials continue to expand in number, complexity of scope, risks, and external collaborations e.g., multi-site, intra- and inter-agency. NIDCD needs coordinating and operational services by specialized individuals who have knowledge and expertise in industry standard clinical trial protocol development, readiness for implementation, project management, operations, monitoring, quality management, and data management. The purpose of this contract is to directly work with research teams to provide project management as well as improve clinical trial implementation readiness, quality management and clinical data quality management for NIDCD-funded high risk clinical trials. See Attached Request for Proposal (RFP)