FDA-SSN-RFI-Scientific Services_10 12 2022.pdf

FDA-RFI-10122022

Scientific Services

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Document Type: Request for Information Solicitation Number: FDA-RFI-10122022 Posted Date: 10/12/2022 Response Date: 10/26/2022 NAICS Code: 541990 - All Other Professional, Scientific, and

Technical Services

Part 1 – Description This is a Sources Sought Notice only. This is not a request for proposal, but a survey to locate potential sources. This Sources Sought does not constitute an Invitation for Bids, Request for Proposals or a Request for Quotations, and is not to be construed as a commitment by the Government to issue an order or otherwise pay for the information solicited, nor is it a guarantee of a forthcoming solicitation or contract. It is for market research purposes only. Respondents will not be notified of the results of the evaluation.

The purpose of this Sources Sought Notice is to gain knowledge of interest, capabilities, and qualifications of the Small Business Community: Small Business, Section 8(a), Historically Underutilized Business Zones (HUB- Zone), Service-Disabled Veteran-Owned Small Business (SDVOSB), Women-Owned Small Business (WOSB), and Economically Disadvantaged Women-Owned Small Business (EDWOSB). The Government must ensure there is adequate competition among the potential pool of responsible contractors. Small business, Section 8(a), HUBZone, SDVOSB, WOSB, & EDWOSB businesses are highly encouraged to participate.

Part 2 – Description/Specifications

Statement of Work

Purpose:

The Scientific Services Task Areas are intended to provide scientific professional services to appropriate FDA Centers. The Scientific Services acquisition aligns with the Mission/Business Needs within CDER's Acquisition Strategy (Approved 2017). Specifically, the scientific research, technical guidance, investigations, analysis, laboratory and reporting services will enable applicable Centers and offices to accomplish FDA science objectives.

Background/Objectives The Food and Drug Administration seeks to establish an Indefinite Delivery/Indefinite Quantity (IDIQ) for professional services in support of scientific service requirements.

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.

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Scope 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 following table provides an overview of the activities for each area.

Task Area No.

Task/Service Area

Task Area Overview

1 Research and Technical Guidance

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).

2 Scientific Consultation (IT and Information Management Systems)

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.

3 Scientific Investigations, Task Orders may encompass scientific investigations on evaluating the feasibility and capability for various regulatory policies and actions including Standard

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Task Area No.

Task/Service Area

Task Area Overview

Procedures and Analysis

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, conducting data collections, performing data analysis, and writing assessment reports that may address data quality, sufficiency and integrity.

4 Publishing Task Orders may encompass submitting material to the Government for consideration to publish or present health research/consultation related to drug shortages and access due to quality and manufacturing, and public health emergencies due to drug quality, surveillance and manufacturing processes that may have negative impacts on public health.

5 Laboratory Technical and Administrative Support

Task Orders may encompass assisting, operating, maintaining, calibrating and repairing various laboratory systems, instrumentation and equipment. Examples include but are not limited to benchtop bioreactor systems, cell and biochemical analyzer systems, bio-layer interferometer, and protein purification systems.

Additional support may include assisting with the upkeep of inventory of lab supplies, sample-collection, -management and -analysis, data analysis and other laboratory project specific support tasks.

6 Task Management

All task orders shall encompass the project management activities related to establishing or reestablishing control, staffing management, monitoring and notification mechanisms; ensuring that contracted tasks stay on track and important milestones and performance measures are met.

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See Attachment for the draft Statement of Work.

Part 3 – Instructions for Response Responses: All interested parties should notify this office in writing by mail or e-mail within the posted date.

Responses shall include:

(I) Capability statement that demonstrates minimum requirements outlined in Scope section, including the labor categories in Appendix A.

Capability statement is limited to 10 pages.

(II) Provide the following Business Information:

• Company Name

• Company Address

• Company Point of Contact, name, phone number, and e-mail address

• Type of business (i.e. commercial, academia), as validated via the System for Award

Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. any potential government contractor must be registered on SAM located at https://sam.gov/content/home.

• Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.)

• DUNS Number

• Classified as a small business based on size standard that accompanies NAICS code

541990. Also list any small, disadvantaged status you hold [HUBZone, 8(a), Service Disabled Veteran Owned Small Business (SDVOSB), Women Owned Small Business (WOSB), Economically Disadvantaged Women-Owned Small Business (EDWOSB), etc.].

• Indicate if your company can provide the professional services needed to fulfill requirements in all 6 areas identified in the table above and the labor categories in Appendix A.

• If you plan to partner with other organizations to accommodate all requirements areas and labor categories, please include relevant information to that partnership.

• If your company cannot provide services in all areas and/or labor categories, then please identify which areas and/or labor categories that can be supported through teaming arrangements.

(III) Relevant past experience/performance through the description of completed projects.

Responses to this Sources Sought are due no later than 2:00 PM Eastern time 10/26/2022 http://www.sba.gov/ https://sam.gov/content/home

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Questions and Responses are to be e-mailed to Howard Yablon, Contract Specialist, at Howard.Yablon@fda.hhs.gov

Please be advised that .zip and .exe files cannot be accepted.

The contact information for the Contract Specialist is the following:

Howard Yablon U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705 Howard.Yablon@fda.hhs.gov