Solicitations › Department of Health and Human Services › Food and Drug Administration

The Food and Drug Administration (FDA) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its ts congressionally mandated regulatory mission across 16 project areas

Closed — responses were due 21 Sep 2026 · No Set aside used · Food and Drug Administration (FDA), HHS · Silver Spring, MD · NAICS 541618 · Solicitation FDASSOC136354

Solicitation details

Solicitation number	FDASSOC136354
Notice ID	43375f32d074401ebb2bb3897fc0cad9
Agency	Department of Health and Human Services (HHS)
Sub-agency	Food and Drug Administration (FDA)
Contracting office	FDA NEGOTIATED CONTRACTS BRANCH
NAICS code	541618 — Other Management Consulting Services
Product / service code (PSC)	R799
Set-aside	No Set aside used
Notice type	Special Notice
Posted	14 September 2026
Response deadline	21 September 2026 (closed)
Place of performance	Silver Spring, MD, USA

Description

The Food and Drug Administration (FDA) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its congressionally mandated regulatory mission across 16 project areas addressing high-priority regulatory science gaps and public health challenges. The work spanning structured stakeholder engagement, independent scientific convening, and landscape research is a prerequisite to FDA's ability to develop sound regulatory frameworks and fulfill statutory obligations. Each project area targets a specific gap where FDA cannot act without the scientific foundation, stakeholder input, or evidence infrastructure this contract provides. The contract is framed as a high-value investment: the cost of inaction measured in delayed regulatory frameworks, preventable harm, and eroded public trust exceeds the cost of the engagement. See Attachment for Intent to Sole Source Posting See Attachment for Draft Statement of Work

Documents in the solicitation package

2 files are attached to this notice.

STATEMENT OF WORK DRAFT 9 14 2026.pdf
Intent to Sole Source DRAFT 9 14 2026 1152 AM.pdf

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Market context: HHS and NAICS 541618

About the buyer and the industry, not this specific solicitation. Source: USASpending.gov award data, updated nightly.

In fiscal year 2026, HHS obligated $127.8M across 22 contract actions under NAICS 541618.
34 contracts worth $117.4M in this category end within the next 18 months.

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