Sol_QR_75F40126R00013.pdf

1. On the first page of the SF1449, the RFQ closing date is indicated as 04/06/2025;

however, in the “Instructions to Offerors” the closing date is listed as Thursday, March 19, 2026. Please clarify which date is the correct RFQ due date.

The correct due date is March 19, 2026. Apologies for the confusion.

2. The RFQ does not indicate a page limit for the quotation. Is there a maximum number of pages that can be submitted for quotation submission?

The quotation submission must be limited to 50 pages, including both volumes (Volume I-Technical and Volume II-Business/Price). Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the quotation. Quotation coversheet(s), table(s) of contents, and any appendices are included in the page count. Page size shall be 8.5 x 11 inches and font shall be Times New Roman, 11pt or larger.

3. I am working on the Solicitation no. 75F40126R00013 “Non-Medical Use (NMU) Surveillance Indefinite Delivery Indefinite Quantity (IDIQ) Contract” Could you clarify for me that we only need to submit two documents Volume I Technical and Volume II Business/Price? Are there any additional documents required for submission?

Offerors only need to submit those two volumes. The Contract Specialist will contact the offeror if the FDA requires anything further.

4. Historically, do task orders primarily on drug classes (e.g., opioids, benzodiazepines, stimulants), or does FDA anticipate reporting at the individual product level (e.g., specific branded or generic products)?

When available, FDA utilizes branded and generic product detail and details on release type and formulation (e.g., extended release, dosage form). There may be some questions for which product and/or formulation level detail could be utilized, however, we recognize challenges with accurate identification at this level. At a minimum we require information on active pharmaceutical ingredient (API).

5. The solicitation specifies access to self-reported data from individuals entering or being assessed for substance use disorder treatment. Would FDA consider solutions that combine self-reported data with additional real-world data sources (e.g., EHR, claims, surveillance signals, or other epidemiologic datasets) in order to provide broader population-level context and enhanced analytic capabilities?

FDA is primarily interested in obtaining standardized self-reported data from individuals entering or being assessed for substance use disorder treatment;

however, we would consider other approaches that would contribute to FDA’s overarching surveillance program goals.

6. Beyond surveillance reports and analytic datasets, does FDA anticipate that study findings may be developed into peer-reviewed manuscripts, conference presentations, or advisory committee briefing materials?

Yes, there is potential for dissemination depending on the topic area, capacity, and level of priority among the FDA and contractor collaborators.

7. The SOW notes that future task orders may involve establishing linkages to electronic healthcare data or state mortality records. Should offerors describe capabilities for privacy-preserving linkage across multiple healthcare datasets within the base IDIQ proposal?

Yes.

8. Does FDA have a preferred framework for classifying severity of substance use disorder (e.g., DSM-5 criteria, clinical assessment instruments, or other standardized scales)?

FDA does not have a preferred framework; however, we expect any scale or assessment tool used to assess substance use disorder severity has been appropriately validated.

9. How many tasks orders per year and over the life of the contract does the FDA anticipate issuing?

FDA anticipates issuing 2-4 task orders over the life of the contract; however, the number of task orders will vary based on surveillance and regulatory needs.

10. Can FDA provide historical information on the approximate number and scope of ad hoc analytic requests issued annually under the current NMU surveillance contract?

Under the current NMU Surveillance contract, 0-2 ad hoc analytic request were issued annually. The scope of the request varied based on the question of interest but typically involved an in-depth analysis of a single drug class. This may evolve under the new contract as needs/priorities evolve.

11. Can FDA clarify the expected timeliness of surveillance data included in routine reports (e.g., typical lag between data collection and inclusion in surveillance analyses)?

The typical lag between data collection and inclusion in surveillance analyses varies by task order - ranging between 45 days and 6 months; we would expect under 12 months.

12. Does FDA have expectations regarding the frequency of updates to the surveillance dataset (e.g., quarterly updates, rolling updates, or other intervals) throughout the contract period?

This is based on a number of factors; offerors should provide their update capabilities as part of their technical proposal.

13. When new substances of regulatory interest are identified by FDA, what timeline does FDA typically expect for incorporation of those substances into surveillance reporting?

This is based on a number of factors; offerors should provide their capabilities as part of their technical proposal.

14. For task orders involving prospective data collection (e.g., internet-based surveys or follow-up assessments), does FDA have expectations regarding typical study timelines from task order issuance to delivery of analytic results?

This is based on a number of factors; including the research objectives and scope of the individual study.

15. For the minimum requirement of 50,000 subjects entering or being assessed for treatment, can these individuals be derived from multiple integrated datasets or surveillance systems, or must they originate from a single data collection instrument or program?

FDA’s preference is for a single data collection instrument or program as we are most interested in large, established data systems that enable us to examine both snapshots in a target population as well as patterns of drug use over time.

FDA would consider proposals that include integration of multiple data systems if the proposal adequately describes how the programmatic goals would be achieved using such data sources.

16. The solicitation requests documentation of the data collection instrument used to collect NMU-related information. Can this requirement be satisfied through structured clinical documentation captured within electronic health records or digital survey instruments administered within clinical settings?

Yes.

17. Can the FDA explain why ten years of historical data is required?

As noted above in Q15, FDA is interested in obtaining information from large, established data sources that allow for trend analyses.

18. The solicitation references additional nontraditional data sources such as internet surveys, online postings, and diversion-related data. Would FDA consider additional population-level surveillance signals (e.g., wastewater monitoring, retail market data, or other environmental indicators) as complementary data sources for Task Area 2 analyses?

FDA would consider additional non-traditional data sources, beyond the examples provided, to the extent they meet our programmatic goals.

19. Can FDA provide additional detail regarding the anticipated scope and methodological expectations for topic-specific studies under Task Area 2 (e.g., descriptive surveillance analyses, comparative epidemiologic analyses, causal inference studies, or methodological development)?

Topic-specific studies will range in scope depending on the individual research question, as suggested by the examples provided (i.e., descriptive analyses, causal inference studies), and in turn, FDA expects the awarded contractor to have methodological expertise to design, conduct, and report these analyses, in consultation with FDA subject matter experts.

20. Can FDA confirm that the submission deadline is April 6, 2026, at 9:00 a.m. ET? The SAM.gov notice states a due date of March 19, 2026, at 9:00 a.m. ET, while the solicitation notice states April 6, 2026, at 9:00 a.m. ET.

The correct due date is March 19, 2026. Apologies for the confusion.

21. "The solicitation states:

“Since 2016, the FDA has had contractor services to provide post-marketing prescription and over-the-counter drug nonmedical use surveillance data summary reports and analytical datasets generated from aggregated data from individuals entering or being assessed for substance use disorder treatment, i.e., treatment center data.”

To ensure accurate proposal development, we request clarification from FDA on the following:

a. Are offerors expected to independently own or have access to the treatment-center data described above and include the associated costs in their proposed pricing?

Offerors are expected to own or have access to treatment center data as described in the requirement. Associated costs should be included in their proposed pricing

b. Alternatively, does FDA currently have an existing or recent contract that includes these services, with access to these data anticipated to be provided to the IDIQ awardee(s)? If so, can FDA please provide the applicable contract number(s)?"

FDA does not currently have a contract that would provide offerors access to required data; offerors are expected to own or have access to treatment center as described in the solicitation.

22. Task Area 1.C.1 states:

“The Contractor shall own or have access to and be able to use in reports, population-based, de-identified (does not include the person’s name or other PII) data collected from individuals either entering or being assessed for substance use disorder treatment within the United States.”

Under Task Area 1, can FDA clarify whether this requirement means that the contractor is expected to provide both the data described above and the associated analytical and reporting services as part of contract performance?

The contractor is expected to provide the data and the associated analytical and reporting services as part of contract performance.

23. The solicitation states:

“The Contractor shall demonstrate access to a database containing a minimum of 50,000 individual subjects entering or being assessed for treatment as of the contract start date, include subjects/sites from all four U.S. census regions, and shall continue prospective data collection throughout the duration of the contract.”

Can FDA clarify whether this requirement means that the contractor is expected to independently provide and maintain access to such a database, or whether FDA currently has access to a similar database that would be made available to the IDIQ awardee(s)?

Yes, the contractor is expected to independently provide and maintain access to a database containing a minimum of 50,000 individual subjects entering or being assessed for substance use disorder treatment. The FDA does not have access to a database that would be made available to the IDIQ awardee(s).

24. The solicitation references post-market surveillance of unapproved substances.

Can FDA clarify whether this term is intended to include surveillance of substances that may be FDA-approved for one or more indications, but are being used for unapproved indications or in unapproved contexts (e.g., nonmedical use, misuse, diversion, or use outside labeled indications), in addition to substances that are not FDA-approved for any use?

Yes, this is intended to include surveillance of FDA-approved prescription and over-the-counter drug products, use of illicit substances, and/or use of other drugs and substances with emerging regulatory interest (e.g., psychedelics, tianeptine, xylazine, kratom-derived compounds, cannabis, compounded ketamine or off-label ketamine use, falsified/counterfeit prescription drugs, opioid reversal agents, etc.).

25. Can FDA clarify which nonmedical use (NMU) data sources FDA currently has access to or licenses for NMU research (e.g., RADARS, National Poision Data System, Drug Involved Mortality, or similar surveillance systems), and whether offerors should assume that access to such data sources would need to be independently provided as part of contract performance?

Offerors are expected to own or have access to treatment center data as described in the solicitation.

26. Can FDA confirm whether there are any page limits applicable to Volume I –

Technical Quote, including whether page limits apply to the overall volume or to individual technical factors?

The quotation submission must be limited to 50 pages, including both volumes (Volume I-Technical and Volume II-Business/Price). Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the quotation. Quotation coversheet(s), table(s) of contents, and any appendices are included in the page count. Page size shall be 8.5 x 11 inches and font shall be Times New Roman, 11pt or larger.

27. Can the government confirm that cover pages, the table of contents, resumes, tables/figures, and past performance narratives are excluded in any Technical Quote page count?"

The quotation submission must be limited to 50 pages, including both volumes (Volume I-Technical and Volume II-Business/Price). Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the quotation. Quotation coversheet(s), table(s) of contents, and any appendices are included in the page count. Page size shall be 8.5 x 11 inches and font shall be Times New Roman, 11pt or larger.