# Clinical Trials Program National Institute on Deafness and Other Communication Disorders (NIDCD) Canonical: https://abierto.us/opportunities/75n98024r00012 - Solicitation number: 75N98024R00012 - Notice type: Solicitation - Status: Closed. Deadline was May 15, 2024 at 10:00 AM EDT - Department: Department of Health and Human Services - Agency: National Institutes of Health - Contracting office: National Institutes of Health Olao (75N980) - NAICS: 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) - Product or service code: R499 Other Professional Services - Set-aside: Total small business set-aside - Place of performance: Bethesda, Maryland - County: Montgomery County (FIPS 24031). https://abierto.us/counties/montgomery-county-md-24031 - City: Bethesda. https://abierto.us/cities/bethesda-md-2407125 - First posted: March 12, 2024 - Last posted: April 29, 2024 - SAM.gov: https://sam.gov/workspace/contract/opp/0020cdfd6e7441bba6eadb8b9467cd85/view ## Description 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) ## Publications - March 12, 2024: Solicitation, due April 30, 2024 at 10:00 AM EDT. Notice ac6485d6e4514cab8f9e0a638dcfbadb. https://sam.gov/workspace/contract/opp/ac6485d6e4514cab8f9e0a638dcfbadb/view - March 21, 2024: Solicitation, due April 30, 2024 at 10:00 AM EDT. Notice 986ee0b90ac54c28a471a17082a4172e. https://sam.gov/workspace/contract/opp/986ee0b90ac54c28a471a17082a4172e/view - April 2, 2024: Solicitation, due April 30, 2024 at 10:00 AM EDT. Notice cb9b6e1a858e4ae2bdf2b448bbd0f548. https://sam.gov/workspace/contract/opp/cb9b6e1a858e4ae2bdf2b448bbd0f548/view - April 3, 2024: Solicitation, due April 30, 2024 at 10:00 AM EDT. Notice c608ef580ffa48f09a67d37971218390. https://sam.gov/workspace/contract/opp/c608ef580ffa48f09a67d37971218390/view - April 12, 2024: Solicitation, due April 30, 2024 at 10:00 AM EDT. Notice ba82cd9681194689bfa366c26775ed72. https://sam.gov/workspace/contract/opp/ba82cd9681194689bfa366c26775ed72/view - April 23, 2024: Solicitation, due May 15, 2024 at 10:00 AM EDT. Notice bc630e3265594983961a6428ac127b63. https://sam.gov/workspace/contract/opp/bc630e3265594983961a6428ac127b63/view - April 29, 2024: Solicitation, due May 15, 2024 at 10:00 AM EDT. Notice 0020cdfd6e7441bba6eadb8b9467cd85. https://sam.gov/workspace/contract/opp/0020cdfd6e7441bba6eadb8b9467cd85/view ## Points of contact - Darlene Johnson, darlene.johnson@nih.gov, 3014437810 --- Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/75n98024r00012.