Inactive Total Small Business Set-Aside (FAR 19.5)

NOTE: The solicitation has been updated to include Amendment 0001. Please see the new and updated Attachment list, and ensure to provide signed copies of the solicitation and all amendments with the p... NOTE: The solicitation has been updated to include Amendment 0001. Please see the new and updated Attachment list, and ensure to provide signed copies of the solicitation and all amendments with the proposal. Notice of Combined Synopsis/Solicitation This is a synopsis/solicitation for the acquisition of a single award commercial services FDA IDIQ set aside 100% for Small Business and prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued. This is a request for proposal (RFP) for commercial items IAW the procedures of FAR part 12 – Acquisition of Commercial Items, in conjunction with FAR part 15 – Contracting by Negotiation. CONTRACT TYPE This is a single-award Indefinite Delivery-Indefinite Quantity (IDIQ) type contract, per FAR subpart 16.5. The Authorized Task Order (TO) type under this IDIQ contract is Firm-Fixed-Price (FFP). Minimum and Maximum Contract Value IDIQ Minimum: The minimum guarantee for this IDIQ contract is $2,500, which will be obligated at the time of IDIQ award. IDIQ Maximum: The maximum aggregate dollar value of all task orders awarded over the 5-year ordering period of this IDIQ shall not exceed the IDIQ ceiling amount of $50,000,000. See FAR Clause 52.216-19 (Oct 1995) for individual task order limitations. The resultant base contract ordering period will be 5-years with no options. The amount of individual task orders will be based on need and availability of funding. NOTICE of Set-Aside/ NAICS Code/ sam registration This requirement is being solicited as a 100% Small Business Set-Aside. The associated North American Industry Classification System (NAICS) code is 541714 – Research and Development in Biotechnology (except Nanobiotechnology) and 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), each with a small business size standard of 1000 employees. Offerors must have an active registration in SAM.gov (https://sam.gov/), with completed representations and certifications, by the close date of the solicitation. Proposals submitted by Offerors not registered in SAM.gov will not be considered. This requirement will be competed in the open market. REQUIREMENT The scope of activities FDA may require of the contractor shall include the capability to conduct multiple Phase I clinical trials within a year and at times in parallel, and the provision of a full range of services to support the clinical trials and reporting of the results. All clinical trials shall be carried out in a timely fashion and in compliance with all FDA regulations and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. The contractor should also be able to provide laboratory studies including bioanalytical/biomarker/omics support that includes determination of drug concentration, anti-drug antibodies, and multiple pharmacodynamic biomarkers. Any bioanalytical/biomarker work shall be carried out in a timely fashion. Unless otherwise specified, method validation shall be performed in compliance with FDA’s Bioanalytical Method Validation Guidance (https://www.fda.gov/media/70858/download). Sample analysis does not need to be performed under complete Good Laboratory Practice (GLP) guidelines. The Contractor shall ensure adequate contracting support is provided to the FDA. This Statement of Work (SOW) has been divided into 2 Performance Areas: A) Overall Clinical Operations Support and Clinical Trial Execution in Healthy Subjects or Patients and B) Bioanalytical/Biomarker/’Omics’ Analysis and Laboratory Support. To qualify for award, organizations must have in-house capabilities in Performance Area A, which will represent the majority of the work. Organizations may either have in-house or sub- contracting capability for Performance Area B. See the Section C Statement of Work (SOW) for the full requirement. Notice of Federal Acquisition Circular (FAC) This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2024-05, effective May 22, 2024. FAR provisions and clauses referenced in this solicitation can be found on the following website: www.acquisition.gov Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses referenced in this solicitation can be found on the following website: https://www.hhs.gov/grants/contracts/contract-policies- regulations/hhsar/index.html PRICES AND PROPOSAL SUBMISSION Using the Uniform Contract Format (UCF), Section L provides Proposal Instructions, Conditions, and Notices to Offerors or Respondents, and Section M provides Evaluation Factors for Award for award of this single award FDA IDIQ set aside 100% for small business. Please see Attachment 1, Pricing Worksheet, for completion to be included in submission of proposals. The Contractor’s pricing schedules for labor categories shall contain fully burdened hourly rates. The fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative costs, and profit. Hourly rates shall apply to services at both Government and non-Government sites. PLEASE SEE THE ATTACHMENTS TO THIS POSTING FOR THE COMPLETE SYNOPSIS/SOLICITATION