SAM #75F40127R00007

FDA Market Research for Scientific and Regulatory Support Services

The FDA is conducting market research for a potential agency-wide Scientific and Regulatory Support Services contract. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); scope supports FDA Centers and Offices. The draft Statement of Work identifies the Center for Drug Evaluation and Research (CDER), Office of Computational Science (OCS), under the Office of Translational Sciences (OTS); the specific ordering office is not identified. The FDA Office of Acquisition and Grant Services issued the notice. - Opportunity status: Market research for a potential IDIQ, not a solicitation or commitment to award. - Services requested: Multidisciplinary scientific and regulatory professional support, with specific work and deliverables determined by task orders. Areas include: - Program and project management; IT architecture and integration advisory services. - Statistical computing, data standards, knowledge and records management, data management and quality, and business analysis. - Training, reviewer support, customer service, outreach, and communications. - AI-augmented scientific and regulatory analysis; research, technical guidance, investigations, and publishing. - Laboratory technical and administrative support, and transition services. - Notable scope limitation: IT hardware is excluded unless specifically authorized by a task order. - OEMs and vendors: No OEMs or vendors are named; no products, part numbers, or quantities are requested. - Period: Five one-year ordering periods, with a six-month option to extend services. Individual task orders may not exceed five years, including options; a task order’s final option may extend up to 12 months beyond the final ordering-period end.

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.

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 vendor responding to this SSN shall also fill out and provide responses to “Attachment B-Vendor Feedback Form.” The Vendor Feedback Form is not included in the 15-page limit. A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions or the Vendor Feedback Form). 

Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions:

Is your business a small business under the NAICS code? Is your firm certified under Section 8(a) of the Small Business Act?

Included is a draft Statement of Work that is inclusive of the anticipated Task Areas (Attachment A).

All interested parties can provide written opinions on the draft Statement of Work.  All opinions expressed should focus on strengthening the draft Statement of Work Tasks to ensure industry understands and comprehends the government’s requirements. 

Business Status

Provide the legal business name and address Primary point of contact and the contact information SAM.gov Unique Entity Identifier (UEI) CAGE code Proposed NAICS code and size status Applicable small-business socioeconomic designations (including 8(a), HUBZone, service-disabled veteran-owned, veteran-owned, women-owned, or small disadvantaged business, as applicable) Identify whether the respondent proposes to participate as prime contractor, joint venture, or subcontractor

Responses to this notice shall be submitted via e-mail to Amanda Edger, Contract Specialist, at Amanda.Edger@fda.hhs.gov (with a CC: to Ian Weiss, Contracting Officer, at Ian.Weiss@fda.hhs.gov), by November 19, 2026, at 2:00 pm. After a review of the received responses, a pre-solicitation synopsis and formal solicitation may be published on SAM.gov.

No solicitation is currently available.  This is not a request for proposals and in no way obligates the Government to award any contract.  Responses to this Sources Sought Notice will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation.  Ref. No. FDA-RFI-75F40127R00007/ALP No. OMITS-2027-136942.

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