Investigating Associations Between Acute Abuse Liability Outcomes and Switching Behavior

SOL #: 75F40126R00031Combined Synopsis/Solicitation

Overview

Buyer

Health And Human Services
Food And Drug Administration
FDA OFFICE OF ACQ GRANT SVCS
Rockville, MD, 20852, United States

Place of Performance

Silver Spring, MD

NAICS

Testing Laboratories and Services (541380)

PSC

Reference Laboratory Testing (Q301)

Set Aside

No set aside specified

Timeline

1
Posted
Jun 8, 2026
2
Submission Deadline
Jul 6, 2026, 6:00 PM

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 Department of Health and Human Services (DHHS), specifically the Food and Drug Administration (FDA), has issued a Combined Synopsis/Solicitation (RFP) for research services titled "Investigating Associations Between Acute Abuse Liability Outcomes and Switching Behavior." The government intends to award a firm-fixed price contract for this study. Proposals are due July 6, 2026, at 2:00 PM ET.

Scope of Work

This opportunity requires a two-phase study to investigate associations between acute abuse liability outcomes and switching behavior related to electronic nicotine delivery systems (ENDS) and combusted cigarettes (CC).

  • Acute Phase: Conduct laboratory-based experimental sessions to assess abuse liability outcomes of ENDS (high and low nicotine) compared to CC.
  • Ambulatory Phase: Monitor real-world ENDS use over an extended period (e.g., 3 months) to assess actual use behaviors and their relationship with acute phase outcomes.

Key tasks include:

  • Recommending and selecting study ENDS products.
  • Recruiting and screening adult participants (current CC users with minimal ENDS experience).
  • Conducting experimental sessions involving prescribed use, progressive ratio self-administration, and ad libitum use.
  • Collecting various data points: plasma nicotine pharmacokinetics (PK), pharmacodynamic effects, subjective effects, use topography, urine samples, and expired carbon monoxide (eCO).
  • Performing data analysis and writing study reports.
  • Developing and submitting a Draft and Final Clinical Study Protocol, including obtaining necessary human subjects clearances (IRB, OMB).

Contract Details

  • Contract Type: Firm-Fixed Price
  • Period of Performance: Four years from the date of award.
  • Place of Performance: Contractor's facility.
  • NAICS Code: 541690 - Other Scientific and Technical Consulting Services.

Submission & Evaluation

  • Questions Due Date: June 22, 2026, 2:00 PM ET.
  • Proposal Submission Deadline: July 6, 2026, 2:00 PM ET.
  • Submission Method: One (1) electronic copy via email to Janice.Heard@fda.hhs.gov.
  • Evaluation Factors (in descending order of importance):
    1. Technical Understanding and Approach
    2. Relevant Past Performance
    3. Staffing Plan
    4. Key Personnel
    5. Pricing
  • Award Basis: Best value trade-off, with technical factors combined being significantly more important than price.

Eligibility

This acquisition is unrestricted and not set-aside for small business concerns. Offerors must be registered and active in SAM.gov.

Additional Notes

Technical proposals are limited to fifteen (15) pages. Offerors must not use macros in submitted documents.

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Combined Synopsis/Solicitation
Posted: Jun 8, 2026
Investigating Associations Between Acute Abuse Liability Outcomes and Switching Behavior | GovScope