FDA Scientific & Regulatory Support Services(SRS)

ding 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. Objectives: The objective of the contemplated SRS acquisition is to provide FDA with responsive, high-quality scientific and regulatory support across a broad range of mission requirements. Depending on the task order, services may support scientific research, regulatory review, clinical and nonclinical analyses, epidemiology and surveillance, scientific data interpretation, laboratory activities, technical writing, training, and scientific program coordination. The Government is interested in sources capable of providing the scientific depth and operational capacity needed to: Conduct scientifically sound analyses and prepare defensible, traceable technical products supporting FDA review and public-health decisions. Provide qualified personnel across multiple scientific and regulatory disciplines, including specialized and emerging areas. Support clinical and nonclinical study-data review, standardized scientific datasets, statistical computing, data fitness, quality assessment, and interpretation. Respond to multiple simultaneous task orders, changing priorities, time-sensitive scientific questions, and evolving requirements across FDA organizations. Maintain scientific quality, data integrity, documentation, confidentiality, and continuity of performance. Deliver effective scientific training, technical writing, knowledge transfer, and program-management support tied directly to scientific and regulatory missions. Project Requirements: The following descriptions are illustrative of the types of services that may be ordered. They are provided to inform industry responses and do not establish final task-order requirements. Each task order would define its own objectives, tasks, deliverables, performance expectations, staffing qualifications, and period of performance. Scientific Research and Regulatory Review Support: Support scientific investigations, literature and evidence reviews, research planning, study design, methodological assessments, scientific consultations, and technical analyses relevant to FDA-regulated products. Prepare scientific assessments, briefing materials, review support documentation, and other products that allow Government scientists and reviewers to evaluate scientific evidence and communicate findings. Provide subject-matter expertise to address complex or emerging regulatory science questions. Clinical and Nonclinical Study-Data Review and Analysis: Support the scientific review of clinical and nonclinical datasets submitted for regulatory purposes, including data fitness and completeness assessments, exploratory safety analyses, descriptive and inferential statistical analyses, and preparation of tables, listings, figures, and visualizations. Experience with standards such as CDISC SDTM, ADaM, and SEND may be relevant. The RRS BPA describes review-oriented services that assess study data and produce analyses for FDA reviewers; SRS would focus on the scientific and analytical performance of those services rather than maintenance of the underlying software platforms. Epidemiology, Biostatistics, Pharmacovigilance, and Surveillance: Conduct epidemiological and Pharmacoepidemiological research, biostatistical analyses, pharmacovigilance assessments, signal detection and evaluation, public-health surveillance, and interpretation of real-world data and evidence as required by individual scientific programs. Activities may include protocol and analysis-plan support, assessment of study limitations and bias, statistical programming, results interpretation, and technical reporting. Scientific Data Standards, Quality, and Analytics: Provide scientific expertise related to data standards, controlled terminology, study-data interpretation, data quality and fitness, and reproducible analytical methods. Support scientific data preparation and validation, biostatistics, bioinformatics, computational science, and other specialized analyses when the primary deliverable is scientific or regulatory in nature. Distinguish these activities from enterprise database administration, application development, platform engineering, and IT operations. Laboratory and Specialized Scientific Support: Provide laboratory-related scientific and technical expertise, research assistance, analytical method support, study coordination, quality documentation, and interpretation or reporting of laboratory findings where required by a task order. Respondents should identify the specific laboratory disciplines, facilities, qualifications, and methods they can support rather than assume that all clinical trial operations