Non-medical Use (NMU) Data Report Services

Questions & Answers / Clarifications

This document provides clarification regarding the inclusion of references and citations within proposals for the solicitation.

• References and Citations: Offerors are permitted and encouraged to include references and citations as needed. However, these will count towards the overall page limit for the proposal.
• Background Information: Extensive background information on substance misuse is not required. The FDA is familiar with the issue and encourages offerors to concentrate their responses on their proposed approach, methodology, and relevant experience.

This clarification directly impacts proposal preparation by defining how references and citations are handled concerning page limits and by guiding the scope of background information required.

Questions & Answers / Clarifications

This document addresses a bidder's question regarding the inclusion of Other Direct Costs (ODCs) in pricing for the solicitation.

• Pricing ODCs: Bidders are instructed that if their proposal includes associated ODC costs, these costs should be incorporated into their fully burdened labor rates as part of their overhead and General & Administrative (G&A) costs. There is no separate line item for ODCs in the provided pricing template.
• Narrative Requirement: Bidders must provide a brief narrative within their pricing volume explaining the ODCs they are proposing.

This clarification provides specific guidance on how to account for ODCs in the proposal's pricing, which is crucial for accurate submission and to avoid disqualification due to changes in the pricing file.

Questions & Answers / Clarifications

This document provides clarifications and answers to questions submitted by potential offerors regarding Solicitation no. 75F40126R00013, "Non-Medical Use (NMU) Surveillance Indefinite Delivery Indefinite Quantity (IDIQ) Contract."

• RFQ Due Date: The correct RFQ due date is March 19, 2026. Initial documentation contained conflicting dates.
• Page Limits: Quotation submissions are limited to 50 pages total (Volume I - Technical and Volume II - Business/Price). This includes coversheets, tables of contents, and appendices. Pages exceeding this limit will not be considered.
• Submission Documents: Offerors only need to submit Volume I (Technical) and Volume II (Business/Price). The Contract Specialist will contact offerors if additional documents are required.
• Data Scope: FDA is primarily interested in standardized self-reported data but will consider other approaches contributing to surveillance goals. FDA utilizes branded and generic product details, and at a minimum, requires information on active pharmaceutical ingredient (API).
• Data Sources: FDA prefers single, large, established data systems for trend analysis but will consider proposals integrating multiple data systems if programmatic goals are met. Offerors are expected to independently provide and maintain access to a database of at least 50,000 subjects.
• Surveillance Scope: Surveillance includes FDA-approved prescription and over-the-counter drugs, illicit substances, and emerging regulatory interest substances (e.g., psychedelics, tianeptine, xylazine, cannabis, etc.).
• Task Orders: FDA anticipates issuing 2-4 task orders over the contract life, with 0-2 ad hoc analytic requests issued annually under the current contract.
• Data Lag: The typical lag between data collection and inclusion in surveillance analyses ranges from 45 days to 6 months, potentially up to 12 months.

These clarifications resolve ambiguities regarding submission deadlines, page limitations, data requirements, and the scope of surveillance. Offerors should ensure their proposals address these points accurately.

Solicitation / RFP / RFQ

This solicitation is for a multiple-award Indefinite Delivery Indefinite Quantity (IDIQ) contract for Non-Medical Use (NMU) Surveillance services for the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). The primary objective is 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. This data will inform FDA's pharmaceutical regulatory and oversight efforts, help identify emerging substances of concern, and support NMU prevention programs.

• Task Area 1: Post-Market Surveillance: Provide bi-annual summary reports, ad-hoc reports, and analytical datasets from existing surveillance data. This includes population-based, de-identified data from individuals entering substance use disorder treatment, covering at least ten years of historical data.

• Task Area 2: Topic-Specific Studies/Analyses: Conduct focused studies or analyses on drug products and emerging substances of regulatory interest, potentially leveraging real-world data, subject-matter expertise, or literature reviews. This may include internet panel surveys, qualitative analyses of internet postings, and other non-traditional data sources.

• Task Area 3: Project Management: Includes a kick-off meeting, submission of a Project Management Plan and Data Management Plan, and Quality Assurance Surveillance Plan (QASP). Quarterly teleconferences are also required.

• Deliverables: Specific deliverables will be defined at the task order level but will include reports (monthly, annual, final project) submitted electronically in Microsoft Word compatible format, compliant with Section 508 accessibility standards.

• Contract Type: Multiple-Award IDIQ

• Period of Performance: Anticipated Base Year (Sept 30, 2026 - Sept 29, 2027) with four Option Years (totaling 5 years for the IDIQ ordering period).

• IDIQ Estimated Value: Minimum guarantee of $3,000.00. Maximum aggregate dollar value of all task orders over the 5-year period is $8,500,000.00.

• Task Order Period of Performance: May not exceed five (5) years but may extend up to 36 months beyond the IDIQ expiration date.

• 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 (Contract Specialist).

• 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.

• NAICS Code: 541720 (Research and Development in the Social Sciences and Humanities).

• Registration: Active registration in SAM.gov is required.

• Set-Aside: The solicitation indicates it is "UNRESTRICTED" but lists various small business set-aside options (Small Business, HUBZone, WOSB, EDWOSB, SDVOSB, 8(A)) which may be applied at the task order level.

• The FDA anticipates awarding a maximum of two IDIQ contracts, but reserves the right to make additional awards.

• Offerors must submit proposals in two volumes: Volume I-Technical and Volume II-Business/Price, kept separate.

• No travel is anticipated under the contract, but may be included in individual task orders if pre-negotiated and approved.

Form / Attachment / Pricing Sheet

This document is an Excel spreadsheet containing Attachment A, the Pricing Table, which must be completed and returned with the proposal. It outlines the structure for providing loaded labor hour prices for various labor categories across five ordering periods.

• Activities/Deliverables: Includes Kick-Off Meeting, Project Plan, Quarterly Teleconferences, Task Order Reports, Contingency Labor Rates, and Closeout Meeting.

• Labor Categories: Project Manager, Senior Computer Systems Analyst, Statistician, Pharmacist, Epidemiologist, Survey Scientist, and Subject Matter Expert.

• Ordering Periods: Pricing is structured across five distinct ordering periods.

• Estimated Quantities: Pre-set estimated quantities of labor hours are provided for each labor category within each ordering period.

• Pricing: Bidders must provide a "Loaded Labor Hour Price" for each category.

• Subtotal/Block Price: A column for the calculated subtotal or block price is included.

• Do not adjust pre-set quantities.

• Do not add labor categories or activities.

• Failure to comply with these instructions, or failure to provide per-hour pricing or a total price, will result in the proposal being discarded as unacceptable.

This pricing table is critical for proposal preparation. Bidders must accurately input their loaded labor hour rates for each specified labor category and activity. The estimated quantities are not guaranteed, but the pricing structure provided must be adhered to strictly. The completed table will form a significant part of the proposal submission and will be used for evaluation.