# FDA Scientific & Regulatory Support Services(SRS)

Notice 4401d0ad8f5944f69db2a47cf40e1e07 (solicitation 75F40127R00007) from HEALTH AND HUMAN SERVICES, DEPARTMENT OF, FDA OFFICE OF ACQ  GRANT SVCS, posted 2026-11-05, responses due 2026-11-23T19:00:00.000Z. Status: open.

| Field | Value |
| --- | --- |
| Notice ID | 4401d0ad8f5944f69db2a47cf40e1e07 |
| Solicitation number | 75F40127R00007 |
| Type | Sources Sought |
| Agency | HEALTH AND HUMAN SERVICES, DEPARTMENT OF |
| Sub-tier | FOOD AND DRUG ADMINISTRATION |
| Office | FDA OFFICE OF ACQ  GRANT SVCS |
| Posted | 2026-11-05T16:26:41.000Z |
| Response deadline (UTC) | 2026-11-23T19:00:00.000Z |
| Set-aside | Small Business Set Aside - Total |
| NAICS | 541990 |
| PSC | R799 |
| Place of performance | Silver Spring, MD, USA |
| Award | - |

## Description

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. 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

## Sources

- View on SAM.gov: https://sam.gov/opp/4401d0ad8f5944f69db2a47cf40e1e07/view
- Data as of 2026-11-14. Source: https://sam.gov/data-services/Contract%20Opportunities/datagov

## Cite this

"FDA Scientific & Regulatory Support Services(SRS), SAM.gov contract opportunity 4401d0ad8f5944f69db2a47cf40e1e07." samgovapi.io, https://samgovapi.io/opportunity/4401d0ad8f5944f69db2a47cf40e1e07, data as of 2026-11-14. Primary record: https://sam.gov/opp/4401d0ad8f5944f69db2a47cf40e1e07/view

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