FDA Scientific & Regulatory Support Services(SRS)

What the buyer is asking for

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 Proposal (RFP) or a promise to issue an RFP 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 RFP, if issued. The purpose of this sources sought synopsis is to gain knowledge of potential qualified vendors to include potential 8(a) vendors 8(a) relative to the North American Industry Classification System (NAICS) code and capable of providing multidisciplinary scientific and regulatory professional services in support of FDA Centers and Offices. Responses to this Sources Sought Notice will be used by the Government to make appropriate determinations about potential sources. Project Title: FDA Scientific and Regulatory Support Services (SRS) IDIQ Background/Overview: The Food and Drug Administration (FDA) is a science-based regulatory agency critically important to the stability of the nation's public health and health care systems. FDA protects and promotes the health and safety of all Americans by enhancing the availability of safe medical products, foods, and animal products, and by promoting innovation that addresses unmet medical and public health needs. FDA decisions must be based on the best available scientific data and employ the best tools and methods available to ensure products meet the highest quality standards, while fostering innovation in the products it regulates. In support of its regulatory mission, FDA conducts scientific research across a broad range of disciplines including vaccines, drug safety, food safety, medical devices, biologics, toxicology, radiological products, and more. FDA's science is increasingly data-centric, complex, and collaborative, involving multidisciplinary groups across its Centers and Offices. Within the Center for Drug Evaluation and Research (CDER), the Office of Computational Science (OCS), established under the Office of Translational Sciences, supports the data management, technical, and analytic needs of the regulatory review process. OCS manages and supports analytical tools, data standards, and computing infrastructure that form the backbone of modern regulatory review for medical products. Purpose: The FDA is seeking information from experienced sources in Scientific and Regulatory Support Services as it is contemplating the establishment of a Indefinite Delivery Indefinite Quantity (IDIQ) to such services. The FDA’s primary objective for this effect is to obtain Contractor services related to scientific and regulatory support across a broad range of mission requirements. Depending on the requirement, services may support scientific research, regulatory review, clinical and non-clinical analyses, epidemiology and surveillance, scientific data interpretation, laboratory activities, technical writing, training, and scientific program coordination. 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). A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions). The anticipated period of performance is a 5-year ordering period. After review of the responses received, a pre-solicitation synopsis and formal solicitation may be published on SAM.gov. In addition to responses to the below questions, each…

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• Bidders were given 15 days from publication to the deadline; the median for open tenders in United States is 21 days.

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