FDA Sources Sought: Center for Drug Evaluation and Research (CDER) Scientific Professional Services

Notice ID: FDARFI1237403

The scope encompasses a range of professional services activities necessary to support the Center for Drug Evaluation and Research (CDER) and other appropriate centers across the FDA in six (6) areas: (1) Research and Technical Guidance, (2) Scientific Consultation (IT and Information Management Systems), (3) Scientific Investigations, Procedures and Analysis, (4) Publishing, (5) Laboratory Technical and Administrative Support, and (6) Task Management services, to be applied across all tasks.

The overall objectives sought through this acquisition include:

The scientific services will support each Center’s mission with increased accuracy on findings, supported data analysis and timely reporting.

The scientific services will represent industry best practices and shared across all offices, divisions and branches located within the structure of the Food and Drug Administration (FDA) in order to achieve improvement and advancement in scientific processes and procedures.

Task Orders may encompass scientific research support that will inform or result in technical guidance and expertise related to regulatory, pharmaceutical, public health and manufacturing functions across the FDA Centers. Examples include, but are not limited to, research areas that address emerging technologies (e.g. continuous manufacturing, 3D printing, nanotechnology, biosimilars, and biologics)…

Task Orders may encompass research information, consultation, technical- and functional-analysis that will assist the FDA with decisions on procurements of hardware and software that can be used to advance scientific-related processes, procedures and workflows; provide technical support to successfully transfer operational databases, models, methods, or tools developed on contractor platforms to FDA internal platforms, including full documentation and code.

Additional support may include identifying functional gaps, efficiencies and participate and coordinate with the Office of Information Management and Technology (OIMT) on design plans for hardware (such as networking, data storage and computing resources) and software solutions to meet the needs of laboratory and other science activities; maintaining the general scientific IT knowledge management infrastructure (e.g. Sharepoint scientific content) and manage the inventory of scientific software licenses for designated offices…

Task Orders may encompass scientific investigations on evaluating the feasibility and capability for various regulatory policies and actions including Standard Operating Procedures (SOPs), Manuals of Policy and Procedures (MAPPs), and Guidance for FDA-agency level, and Center/Office products; investigations shall include data collection, database development and management, analysis (e.g. computational experiments/research, meta-analysis), method development, critical reviews, technical surveys of industry capability and technology gaps that are not currently addressed by policies and actions (e.g. emerging technology guidance). Scientific investigations may also involve the surveillance and testing of pre- and post-market drugs and drug products as it relates to current world events.

Additional support may include reviewing and editing clinical data plans, conduct data collections, perform data analysis, and write assessment reports that may address data quality, sufficiency and integrity…

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