Inactive Total Small Business Set-Aside (FAR 19.5)

MODIFICATION: Period of Performance - 5/15/2022 – 9/15/2022 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additi... MODIFICATION: Period of Performance - 5/15/2022 – 9/15/2022 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation number is RFQ-NICHD-22-097 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-04. The North American Industry Classification (NAICS) Code is 541990 with a size standard of $15M. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The National Institutes of Health (NIH), National Institute of Digestive, Diabetes & Kidney Diseases (NIDDK) has a requirement to procure Audit-related Support for NIDDK OCRS. This solicitation will be set aside for small business. BACKGROUND The consortium initially conducted a multi-center randomized clinical trial with a Coordinating Center and 20-some clinical centers and then transitioned to a long-term follow-up protocol. During the follow-up period, drug treatments were unmasked, and study-provided drug was continued in those initially randomized to it. Participants have been followed for long-term health outcomes and have two visits each year. Study-provided drug was distributed to participants in that treatment arm at these visits. The initial clinical trial operated under an FDA IND. The IND was withdrawn during the follow-up period, and then a new IND put in place later during that period (for an approximate two-year period) when the study drug supplier was changed to a supplier that had not been inspected by the FDA. Study leadership with concurrence from the Data and Safety Monitoring Board (DSMB) subsequently discontinued study-provided drug therapy. In mid-2020, NIDDK learned that an IRB at one of the clinical centers had identified a potential issue of noncompliance and later in 2020 that IRB made a final determination that the issue was considered to be non-compliant with Federal regulations and GCP guidelines. Following this determination, NIDDK leadership and OCRS personnel consulted with relevant NIH offices and then decided that an assessment to address both funder and sponsor responsibilities should be conducted to determine whether the IRB finding at that clinical center is generalizable to other participating clinical centers. PURPOSE AND OBJECTIVES: The purpose of this requirement is to support the OCRS in the assessment of compliance with study protocol and procedures, Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable laws or regulations at awardee institutions or subaward/subcontract locations of an extramurally funded multi-center consortium. The objective is to complete the audits/assessments and identify any potential issues of non-compliance with the above regulations. TASK AREAS Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work. Specifically, the Contractor shall: Task Area 1 – Review relevant background information, study documents, and information provided by NIDDK OCRS personnel to prepare for and perform activities. Task Area 2 – Coordinate routine meetings/calls with NIDDK OCRS personnel (or others as requested by NIDDK OCRS) to discuss activities, review status and progress, and adapt strategy, plan, timeline, etc. as necessary to complete assessment or as specified by NIDDK OCRS personnel. Task Area 3 – Assist with or perform activities related to sponsor’s assessment of clinical centers compliance with relevant versions of study protocol and procedures, FDA regulations, GCP guidelines, and other applicable laws or regulations as specified under Scope. Task Area 4 – In collaboration with the NIDDK OCRS, establish criteria to assess clinical center, Coordinating Center. Task Area 5 - Provide procedural and reporting documents that will be utilized including SOPs, audit templates, report templates, subject to approval from NIDDK OCRS personnel. Task Area 6 - Provide a plan and report template for NIDDK OCRS review before clinical center or other institution visit. PLACE OF PERFORMANCE The tasks described herein shall be predominantly performed at the contractor’s facilities. PERIOD OF PERFORMANCE The period of performance shall be May 15, 2022, through September 15, 2022 The offeror must include a completed copy of the following provision’s along with their quote: FAR Clause 52.212-3, Offeror Representations and Certifications – Commercial Items; FAR Clause 52.204-24, Representation Regarding Certain Telecommunication and Video Surveillance Services or Equipment; FAR Clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. The provisions of FAR Clause 52.212-1 Instructions to Offerors – Commercial Items; FAR Clause 52.212-2, Evaluation – Commercial Items: Evaluation Factors (1) technical capability to provide all services/consumables, etc.; (2) price; and (3) past performance. Technical capability and past performance, when combined, are significantly more important than cost/price; FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items – Deviation for Simplified Acquisitions applies to this acquisition, apply to this acquisition. The offeror must include their Unique Entity ID: (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.arnet.gov/far . Interested vendors capable of providing the Government with the services specified in this synopsis should submit their quotation to the below address. Quotations will be due five (5) calendar days from the publication date of this synopsis or April 13, 2022, at 11:00 AM. The quotation must reference “Solicitation number” NICHD-22-097. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted by email to Verne Griffin at verne.griffin@nih.gov . Faxed copies will not be accepted