This is not a solicitation announcement. This is a Sources Sought Notice (SSN) only . This SSN is issued solely for market research and planning purposes – it does not constitute a Request for Quotation (RFQ) or a promise to issue an RFQ in the future. Further, the SSN does not commit the Government to contract for any supply or service whatsoever. The FDA is not seeking proposals and will not accept any unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this SSN; all costs associated with responding to this SSN will be solely at the expense of the interested respondents. Not responding to this SSN does not preclude participation in any future RFQ, if issued. The purpose of this sources sought notice is to gain knowledge of potential qualified vendors to include large business sources, small business sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned Small Business, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) code. Responses to this Sources Sought Notice will be used by the Government to make appropriate determinations about potential sources. Project Title: Professional, Scientific, and Non-Scientific Support and Pandemic Readiness Services for FDA/CDRH Background/Overview: To assist the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in fulfilling its mission, the CDRH requires consultants that have sufficient skilled capacity that includes general microbiology, microbiology with expertise in virology, toxicology, chemistry as it relates to material compatibility, ultraviolet sterilization, and in reprocessing of medical devices in real world settings. Additionally, the CDRH is interested in personnel with expertise in diagnostics testing, such as molecular testing, serology testing, antigen testing, infectious disease testing, clinical laboratory testing. Other specialties and studies CDRH requires includes Biology, Chemistry, Epidemiology, General Engineering, Physics, Statistics, Computer Science, Virology, Toxicology, Pulmonology, Anesthesiology, and Infectious Diseases. During the COVID-19 State of Emergency, the CDRH acted quickly to acquire surge support to assist CDRH’s Offices with project/program management in conjunction with the CDRH’s mission. This contractor support was essential to the CDRH’s response to the COVID-19 Pandemic. In order to be prepared for a similar scenario, the CDRH requires a vendor that has an extensive database of experts that can be quickly onboarded to provide surge support during times of undue stress on the public health. Purpose: The primary purpose of this acquisition is to obtain support services of advanced professional and scientific consultants to assist CDRH’s Offices with project/program and portfolio management in conjunction with CDRH’s mission. The services provided will be critical professional and scientific expertise in support of CDRH’s mission and used for the evaluation of the continued performance, safety, and effectiveness, of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of infectious diseases or other emerging threats; facilitation of advanced continuous manufacturing activities related to production of vaccines and related materials; facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to infectious diseases; review of devices authorized for use for the treatment, prevention, or diagnosis of infectious diseases; and oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices approved, cleared, licensed, or authorized for use for the treatment or prevention by the FDA. The secondary purpose of this acquisition is to obtain support services of advanced professional, scientific, and non-scientific consultants to assist CDRH’s Offices during a pandemic situation that requires surge support to fulfill the CDRH’s mission during a public health emergency. Instructions for Responses: Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 15 pages (font size Times New Roman 11 or larger). In addition to responses to the below questions, each vendor responding to this SSN shall also fill out and provide responses to the Vendor Feedback Form, Attachment B, to this SSN. The Vendor Feedback Form is not included in the 15-page limit. A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions or the Vendor Feedback Form). The anticipated period of performance consists of one (1) Base Year and four (4) Option Years. After review of the responses received, a formal solicitation may be published on SAM.gov or GSA eBuy. Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions: Is your business a small business under the NAICS code? Does your firm qualify as a Small Disadvantaged Business? If disadvantaged, specify if your firm is certified under Section 8(a) of the Small Business Act? Are you considered a certified HUBZone firm? Are you considered Woman-Owned or operated business? Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business? Included is a draft Statement of Work that is inclusive of the anticipated Task Areas (Attachment A). All interested parties can provide written opinions/questions on the draft Statement of Work. All opinions/questions expressed should focus on strengthening the draft Statement of Work Tasks to ensure industry understands and comprehends the government’s requirements. Responses to this notice shall be submitted via e-mail to Nicholas Bisher, Contracting Officer (
[email protected]), and Melinda Kim, Contract Specialist (
[email protected]), by October 16, 2024, at 2:00 pm EST . After a review of the received responses, a formal solicitation may be published on SAM.gov or GSA eBuy. No solicitation is currently available. This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this Sources Sought Notice will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. Ref. No. 75F40125Q00003. Attachments: Attachment A: Draft Statement of Work Attachment B: Vendor Feedback Form