Non-medical Use (NMU) Data Report Services
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), is soliciting proposals for Non-medical Use (NMU) Data Report Services. This is a Multiple-Award Indefinite Delivery Indefinite Quantity (IDIQ) contract to obtain post-marketing data on the nonmedical use of prescription and over-the-counter drug products, illicit substances, and other emerging regulatory interest substances. Proposals are due by 9:00 AM Eastern on Thursday, March 19, 2026.
Purpose & Scope
The primary objective is to inform FDA's pharmaceutical regulatory and oversight efforts, identify emerging substances of concern, and support NMU prevention programs. The scope includes:
- Task Area 1: Post-Market Surveillance: Providing bi-annual summary reports, ad-hoc reports, and analytical datasets from existing surveillance data, including at least ten years of historical, de-identified population-based data from individuals entering substance use disorder treatment.
- Task Area 2: Topic-Specific Studies/Analyses: Conducting focused studies or analyses on drug products and emerging substances, potentially using real-world data, internet panel surveys, qualitative analyses of internet postings, and other non-traditional data sources.
- Task Area 3: Project Management: Including a kick-off meeting, Project Management Plan, Data Management Plan, Quality Assurance Surveillance Plan (QASP), and quarterly teleconferences.
Contract Details
- Contract Type: Multiple-Award IDIQ
- NAICS Code: 541720 (Research and Development in the Social Sciences and Humanities)
- Period of Performance: Anticipated Base Year (Sept 30, 2026 - Sept 29, 2027) with four Option Years, totaling a 5-year ordering period.
- IDIQ Estimated Value: Minimum guarantee of $3,000.00. Maximum aggregate value of all task orders is $8,500,000.00.
- Place of Performance: Silver Spring, MD, United States.
Set-Aside & Eligibility
The solicitation is designated as UNRESTRICTED, but various small business set-aside options (Small Business, HUBZone, WOSB, EDWOSB, SDVOSB, 8(A)) may be applied at the task order level. Offerors must have active registration in SAM.gov.
Submission & Evaluation
- Submission Deadline: Quotes due by 9:00 AM Eastern on Thursday, March 19, 2026.
- Questions Deadline: Questions due by 9:00 AM Eastern on Thursday, March 5, 2026.
- Submission Method: Electronically via email to Nam Nguyen (nam.nguyen@fda.hhs.gov).
- Evaluation Criteria: Best value trade-off process. Technical factors (Data Access and Capabilities, Technical Approach and Understanding, Personnel Qualifications, Quality Assurance and Data Management, Past Performance) are more important than Price. Confidence ratings will be used for technical factors.
- Proposal Structure: Offerors must submit proposals in two separate volumes: Volume I-Technical and Volume II-Business/Price.
Pricing Instructions
Attachment 1 - Pricing_Table.xlsx must be completed. Bidders must provide