SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

CODE 16. ADMINISTERED BYCODE

X

X

541690

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAP

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

07/06/2026 1400 ET

06/04/2026

215-717-3093JANICE HEARD

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40126R00031

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 39 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

North Bethesda MD 20852

13th Floor

11601 Landsdown St.

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$19

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAP WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Investigating associations between acute abuse liability outcomes and switching behavior

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

JANICE S. HEARD

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

39 2 of

75F40126R00031

Offeror Name UEI

Study Title: Investigating associations between acute abuse liability outcomes and switching behavior

SECTION 1: COMBINED SYNOPSIS SOLICITATION

SECTION 2: SUPPLIES

SECTION 3: STATEMENT OF WORK/DESCRIPTION

• 3.1 Background

• 3.2 Scope of Work

• 3.3 Objectives

• 3.4 Task

• 3.5 List of Deliverable

SECTION 4: CONTRACT REQUIREMENTS

• 4.1 Conflict of Interest

• 4.2 Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, OR GFI)

• 4.3 Security

• 4.4 Travel

• 4.5 Special Material Requirements

• 4.6 Other Unique Requirements

• 4.7 Place of Performance

• 4.8 Period of Performance

• 4.9 Contract Type

SECTION 5: GENERAL EVALATUATION INFORMATION EVALUATION AND

AWARD

SECTION 6: CONTRACT CLAUSES AND PROVISIONS / ADDITIONAL TERMS AND

CONDITIONS

• 6.1 Solicitation Provisions

• 6.2 Contract Clauses

• 6.3 Invoice Instructions

• 6.4 RFP Instructions and Questions Due Date

• 6.5 Proposal Submission

SECTION 7: PROPOSAL INSTRUCTIONS

• 7.1 Evaluation Factor for Award

SECTION 8: BASIS FOR AWARD

SECTION 1 - COMBINED SYNOPSIS SOLICITATION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in Far part 12. This announcement constitutes the only solicitation. Offers are being requested, and a separate solicitation will not be issued. This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

The solicitation number is 75F40126R00031 and is issued as a Request for Proposal (RFP). This solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective March 13, 2026. The North American Industry Classification Systems (NAICS) Code 541690 - Other Scientific and Technical Consulting Services.

SECTION 2 – SUPPLIES OR SERVICES/PARTS

The Government intends to award a firm-fixed price contract resulting from this solicitation.

Offerors are requested to provide a fixed price proposal in accordance with the Statement of Work.

SECTION 3 – STATEMENT OF WORK (SOW)

3.1 Background

The primary function of the Food and Drug Administration (FDA) is to promote public health associated with the use of foods, dietary supplements, cosmetics, drugs, tobacco, and other products under its jurisdiction. FDA's Center for Tobacco Products (CTP) implements PL 111-31 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which was signed into law on June 22, 2009. The Tobacco Control Act granted the FDA important authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health. Research that informs our understanding of tobacco product abuse liability and use behavior plays an important role in these regulatory activities. However, to date, no prospective clinical studies have been designed with the primary aim of evaluating the relationships between tobacco product abuse liability outcomes (e.g., nicotine pharmacokinetics (PK), self-administration, subjective effects) collected under acute laboratory conditions and actual use outcomes (e.g., product switching, cessation) associated with use of the same products under real-world conditions. The current study will recruit individuals who smoke combusted cigarettes (CC) and examine the relationships between abuse liability outcomes of a study electronic nicotine delivery system (ENDS) assessed within a laboratory setting and product switching (i.e., uptake of the study ENDS, reduction in CC use) assessed under real-world conditions in the same participants using the same study ENDS. The primary aim of this study is to determine whether the abuse liability outcomes associated with use of the study ENDS in the laboratory are associated with subsequent reduction in CC use in the same individuals when they are provided with the study ENDS for use at home over an extended period (e.g., 3 months). A secondary aim is to determine whether ENDS nicotine concentration influences uptake of the study ENDS and reduction in CC use.

http://www.acquisition.gov/

3.2 SCOPE OF WORK

The primary objectives of this requirement are to determine the relationships between acute abuse liability outcomes associated with use of an ENDS and actual use behaviors under real-world conditions. A secondary objective of this requirement is to assess if ENDS nicotine concentration is associated with differences in actual use behaviors. The Contractor shall recommend an ENDS with both a high and low nicotine concentration that has received FDA marketing authorization. The Contractor shall recommend participant recruitment criteria to achieve sufficient power to evaluate the relationship between acute abuse liability outcomes and actual use behaviors in a two-phase (i.e., acute, ambulatory) parallel randomized controlled trial.

Urine samples and expired carbon monoxide (eCO) from every enrolled participant shall be collected at screening. The Contractor shall recommend and measure urinary biomarkers of exposure (BOE), such as metabolites of nicotine (e.g., cotinine), tobacco-specific nitrosamines (TSNAs; e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)), Polycyclic Aromatic Hydrocarbons (PAH; e.g., 1-hydroxypyrene (1-OHP)), and volatile organic compounds (VOCs;

e.g., S-phenylmercapturic acid (S-PMA)). Qualified participants will be provided instruction on using the study ENDS and an opportunity to familiarize with study ENDS use at the screening visit.

3.3 OBJECTIVES

The Contractor shall conduct a study with two phases: an acute phase (i.e., two experimental sessions conducted in a laboratory setting) and an ambulatory phase (i.e., continued use of the assigned product outside of the laboratory). Participants will be randomized to use ENDS with high (e.g., 5%) or low (e.g., 3%) nicotine concentrations. During the acute phase, participants will be instructed to abstain from using tobacco products (e.g., overnight, 12 hours) prior to each of two experimental sessions. At one session, participants will use their own brand CC, and at the other session, participants will use their assigned ENDS. During each experimental session, participants will use the study product (i.e., CC, ENDS) in a prescribed manner (e.g., 10 puffs with 30 second intervals between puffs) followed by at least 60 minutes of serial blood sample collection. During prescribed product use, the Contractor shall measure plasma nicotine PK (e.g., peak plasma nicotine concentration, area under the nicotine concentration-time curve), pharmacodynamic effects (e.g., heart rate, blood pressure, pulmonary function as assessed by spirometry or other measures), and subjective effects (e.g., product liking, withdrawal symptoms, sensory effects). The blood sample collection period will also serve as a washout period prior to participants completing single-item and cross-commodity (i.e., substitution) hypothetical purchasing tasks and a progressive-ratio self-administration task, during which the input requirement (e.g., lever pulls, mouse clicks, key presses) to receive a puff of the CC or ENDS increases with each subsequent puff over a period of at least 120 minutes. After a second washout period (e.g., 30-60 mins.), the experimental session will conclude with an ad libitum use period in which participants will then be permitted to use the study ENDS or CC for at least 180 minutes. During ad libitum use, the Contractor shall measure use topography (e.g., number of CC used, number of ENDS puff bouts, total puff number, inter-use-interval). Additionally, a safety analysis will be conducted to assess exhaled carbon monoxide (eCO) and blood carboxyhemoglobin (COHb) levels at screening and at the beginning and end of each experimental session, and adverse experiences throughout the study.

At the conclusion of the two experimental sessions, participants will begin the ambulatory phase of the study. The Contractor shall recommend the duration of the ambulatory phase (e.g., 3 months). Participants will be provided with a study ENDS and refill pods, and they will be instructed to substitute the ENDS for their CC for the duration of the study. The Contractor will identify a means (e.g., daily diaries, interactive voice recording, ecological momentary assessment) for participants to self-report CC and ENDS use behaviors (e.g., CC per day, ENDS puffs per day, ENDS use bouts per day, e-liquid consumption). The Contractor shall schedule regular (e.g., monthly) check-in visits with participants to review self-reported use behavior and collect specimens for biomarker of exposure analysis (e.g., eCO, urinary BOE, including metabolites of nicotine, TSNA, VOC, PAH). Check-in visits should occur throughout and at the conclusion of the ambulatory phase.

The primary analyses will evaluate the relationship between the abuse liability outcomes collected during the experimental sessions and use behaviors measured during the ambulatory phase. The study should be powered to address the primary outcome of reduction in CC consumption (i.e., CC/day). Secondary analyses may include outcomes of complete switching (e.g., 7-day point prevalence abstinence), changes in urinary BOE, ENDS consumption, and other CC and ENDS use behavior variables.

The Contractor shall perform all data analyses, provide FDA all raw data, and write study reports. All results and source documents shall be submitted to the Contracting Officer’s Representative (COR) and Study Project Lead(s).

LINE ITEMS AND PRICES

PRICING TABLE

Task Deliverable Quantity Price 1 Kick-off Meeting 1 $ 2 Non-disclosure of Private

Information (NPI) Forms 1 for each staff member involved in clinical study $

3 Biweekly Meetings 1 meeting every 2 weeks $ 4 Monthly Progress Reports 1 electronic version per month

5 Selection of Study Products 1 $

6 Draft Clinical Study Protocol 1 electronic version;

preliminary drafts may be needed

7 Peer Review of Clinical Study Protocol

1 electronic version $

8 Final Clinical Study Protocol 1 electronic version $ 9 Obtain Clearances for the

Study (OMB and IRB) 1 electronic version each $

10 Perform Clinical Study 1 $ 11 Clinical Recruitment

Updates 1 electronic version per week once recruitment begins $

12 Draft Clinical Study Report 1 electronic version;

additional drafts may be needed

13 Final Clinical Study Report 1 electronic version $ OPTION – FDA Audit Costs 1 audit (max) $

3.4 - TASKS

Task 1 – Kick-off Meeting Within ten (10) business days of award, the Contractor shall set up and host a kick-off teleconference with the Study Project Lead(s), COR, and other FDA personnel to discuss roles, expectations, and deliverables associated with this requirement.

Task 2 – NPI Forms All Contractor staff shall sign NPI forms prior to commencing work. All signed forms shall be submitted electronically to the COR/Contract Specialist within thirty (30) days of contract award. If additional staff are added to this contract after contract award, Contractor staff shall sign the NPI form immediately, and the COR shall be notified.

Task 3 – Biweekly Meetings The Contractor shall set up biweekly teleconferences, for the duration of the contract, with the Study Project Lead(s), COR, and other FDA personnel (as necessary) to discuss study progress, challenges, and other study details every two (2) weeks and as needed. Within five (5) business days following each teleconference, the Contractor shall submit teleconference meeting minutes to FDA that include a detailed summary of the discussion as well as the contract progress status.

Task 4 – Monthly Progress Reports The Contractor shall submit monthly progress reports on the 10th day of each month, for the duration of the contract, to the Study Project Lead(s), COR, and Contract Specialist detailing study progress, challenges (and solutions to those challenges), contract budget status, recruitment status, study deviations, adverse events, and other study details pertaining to the prior months progress. Progress reports shall indicate which deliverables or percentages of deliverables were completed during the month and overall progress of the contract and budget.

Task 5 – Selection of Study Products The Contractor shall recommend and, upon FDA approval, obtain the ENDS to be used in the clinical study.

Study ENDS The Contractor shall recommend an ENDS after consideration of marketplace popularity, FDA marketing authorization, and availability. The Contractor shall recommend at least two ENDS, each available with multiple e-liquid nicotine strengths, and two e-liquid nicotine strengths (i.e., high and low nicotine concentrations) for the recommended ENDS. Selection of high and low nicotine concentration shall be made with consideration to the study ENDS product and marketplace popularity and availability.

At the first biweekly teleconference, approximately 20 business days after contract award, the Contractor shall recommend at least two ENDS with marketing authorization and multiple available e-liquid nicotine concentrations to be used in the study. The selected study ENDS should have prior FDA marketing authorization (https://www.accessdata.fda.gov/scripts/searchtobacco/), pod-based e-liquid refills, and with at least two available e-liquid nicotine concentrations. The Contractor’s recommendation shall include: proposed brands, flavors, and nicotine strengths; how the proposed products meet the criteria outlined in the SOW; relevant published data on nicotine PK, abuse liability, HPHC analysis, or chemical characterization of the proposed products; and any potential risks, drawbacks and benefits to using each product in the study.

Task 6 – Draft Clinical Study Protocol The Contractor shall develop a Draft Clinical Study Protocol for the study titled “Investigating associations between acute abuse liability outcomes and switching behavior” based on the following study objectives and protocol requirements:

Clinical Study Objectives:

1. Measure the associations between outcomes assessed during an acute abuse liability clinical study of ENDS and CC use and real-world use behaviors assessed in a subsequent ambulatory phase.

2. Identify which acute abuse liability outcomes best predict subsequent ambulatory use behaviors.

3. Determine whether ENDS nicotine concentration influences uptake of the study ENDS and reduction in CC use.

Protocol Requirements:

1. The study shall consist of two phases: an acute phase consisting of two experimental sessions and an ambulatory phase consisting of a randomized controlled trial of switching. Participants will be adult users of CC with minimal ENDS use experience (e.g., <100 lifetime uses, no use in the past 30 days). Full eligibility criteria will be proposed by the Contractor. The study shall consist of a screening visit, two experimental sessions, and an ambulatory phase with periodic check-in clinic visits. Prior to the first experimental session, participants will be randomized to use ENDS with high (e.g., 5%) or low (e.g., 3%) nicotine concentrations, and they will receive instruction on using the study ENDS and have an opportunity to use and familiarize with the study ENDS. At each experimental session, one study product will be used (i.e., usual-brand CC, assigned study ENDS). Each experimental session shall include a period of prescribed use, progressive ratio self-administration, and ad libitum use of the session study product (i.e., CC, ENDS). The Contractor shall provide statistical considerations for sample size based on study objectives.

At each experimental session, inclusion and exclusion criteria shall be reviewed to ensure participants remain qualified for the study. Participants shall be randomized to determine https://www.accessdata.fda.gov/scripts/searchtobacco/ the order of experimental conditions. During prescribed use, participants shall be directed to take 10-puffs with 30 second intervals between puffs (or an alternative prescribed puffing regimen as recommended by the Contractor) followed by a washout period (e.g., 1 hour) during which additional, acute abuse liability data shall be collected. Following the prescribed use period, participants will complete a hypothetical purchasing task and a progressive-ratio self-administration component in which the response requirement (e.g., lever pulls, key presses, mouse clicks) to receive one puff of the CC or ENDS increases with each subsequent puff (e.g., 10 responses for the first puff, 20 for the second, 40 for the third, etc.). The duration of the progressive-ratio self-administration component shall be recommended by the contractor (e.g., 3 hours). The experimental session shall conclude with an ad libitum use period of a duration recommended by the contractor (e.g., 3 hours).

The following methodological details shall be included:

a. Serial blood samples shall be collected to assess plasma nicotine PK during the prescribed use component of each experimental session (e.g., pre-dose, 1, 3, 5, 7, 10, 15, 30, 45, 60 min following prescribed ENDS or CC use). Maximum blood draw volume shall not exceed 100 mL per participant per study day.

b. Pharmacodynamic endpoints (e.g., vital signs) shall be collected throughout each experimental session, as proposed by the Contractor.

c. Subjective effects measures (e.g., product liking, withdrawal symptoms, sensory effects) shall be measured during the prescribed use phase of each experimental session with existing scales and assessments as proposed by the Contractor, with timing and frequency recommended by the Contractor.

d. Following prescribed use but prior to the onset of the progressive ratio component, participants shall complete hypothetical purchasing tasks for the study product. Participants should also complete a cross-commodity purchasing task during the ENDS session in which participants’ usual CC are available at increasing prices and the study ENDS is available at a fixed price to evaluate substitution.

e. Breakpoint (i.e., the highest response requirement at which a participant earns a puff) and total number of responses should be recorded during the progressive-ratio self-administration component.

f. Product use topography shall be measured during the ad libitum use period (e.g., puff number, puff duration, inter-puff-interval, number of products used, number of ENDS puff bouts, ENDS puff bout duration). Other abuse liability outcomes recommended by the Contractor (e.g., nicotine exposure, subjective effects) may also be measured during the ad libitum use period.

2. The ambulatory phase shall begin at the conclusion of the second experimental study session. Participants should be provided with study ENDS and sufficient e-liquid pods to last until the first check-in visit, which will be scheduled at a duration recommended by the contractor (e.g., two weeks, one month). Participants will be instructed on how to record their CC and ENDS use (e.g., CC/day, ENDS puffs/day, ENDS use periods/day, daily e-liquid consumption) through a mechanism proposed by the Contractor (e.g., daily diary, interactive voice recording, ecological momentary assessment).

The following methodological details shall be included:

a. The Contractor will propose a total duration for the ambulatory phase (e.g., 3 months).

b. The Contractor will propose an in-person check-in frequency throughout the duration of the ambulatory phase (e.g., biweekly, monthly), including a final visit at the conclusion of the ambulatory phase.

c. The Contractor shall recommend a means for measuring CC and ENDS use behavior (e.g., daily consumption), such as interactive voice recording, daily diary, ecological momentary assessment, or others.

d. The Contractor shall recommend and measure other nicotine (e.g., cotinine) and non-nicotine biomarkers (e.g., TSNA, VOC, and PAH) in urine.

e. The contractor shall conduct a safety analysis which may include assessing eCO, carboxyhemoglobin (COHb), and adverse experiences during the screening visit and at the beginning and end of each experimental session. In addition, participants shall be monitored for adverse events throughout the study.

3. The Draft Clinical Study Protocol shall include: study procedures, human subjects’ protection documentation (e.g., consent form, adverse event reporting), data handling and record keeping, publication plan (if applicable), quality assurance plan, and administrative information.

4. A Proposed Statistical Analysis Plan document which shall include:

a. Details regarding data collection, organization, analysis, and interpretation as well as information on the personnel who shall conduct the statistical analyses and their credentials (e.g., training and courses completed).

b. The statistical model(s) and software program(s) that shall be used to analyze the data.

c. Methods and criteria for outlier detection and removal, where applicable.

d. Information on the selection of the significance level and post- hoc analysis, when applicable.

e. Multiple iterations of the protocol draft may be necessary to address feedback from all FDA review processes, but this process shall not exceed 3 protocol iterations

Data Monitoring The draft and final clinical study protocols shall include a section describing the proposed plan for interim data monitoring. This section shall explain who is to be responsible for interim monitoring, what data will be monitored (e.g., performance, risk assessment), the timing of the first data review, and the frequency of interim reviews (which will depend on such factors as the study design, interventions, and anticipated recruitment rate). The plan shall specify "stopping guidelines" and other criteria, if appropriate, for the monitors/auditors to follow in their review of the interim data. Guidance on these topics is available at:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127073.pdf.

With appropriate notification, FDA/CTP/Office of Compliance and Enforcement Quality Assurance and Quality Improvement (QA/QI) Human Subjects Protection Program has the authority to audit this study at any time in order to ensure research activities comply with the study protocol, standard operating procedures, Good Clinical Practice standards and Federal Regulation HHS 45 CFR § 46, as well as any additional applicable agency regulatory http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127073.pdf requirements. Federal or state laws may require FDA to show information to university or government officials (or sponsors), who are responsible for monitoring the safety of this study.

To the extent possible, directly identifying information (e.g., names, addresses) will be safeguarded and maintained under controlled conditions as appropriate. If this study is selected for audit, the Contractor may bill for costs incurred as determined in the optional line item.

Task 7 – Peer Review of Clinical Study Protocol In order to ensure a robust study design, the clinical protocol will need be reviewed by experts in the field. These experts may be external to FDA or may be internal depending on the subject.

Once the Contractor submits the first draft protocol, FDA and the Contractor shall not exceed 3 rounds of edits. Following these edits, the clinical study protocol will undergo peer review by Special Government Employees (SGEs) and/or Regular Government Employees (RGEs). The Project leads and Contractor will edit the protocol based on SGE/RGE feedback and then the clinical study protocol will undergo an FDA internal review process. The Project leads and Contractor may need to edit the protocol based on this internal review process. Together, these two review processes will take up to 2-3 months.

Task 8 – Final Clinical Study Protocol The Contractor shall incorporate FDA feedback (including SGE/RGE and FDA Internal Review feedback) from the Draft Clinical Study Protocol development phase and deliver a Final Clinical Study Protocol for FDA approval. This version of the clinical study protocol will then be submitted for human subjects protections review and approvals (Task 9).

Task 9 – Obtain Required Human Subjects Clearances for the Study The Contractor shall work with the FDA to submit proper human subjects’ clearance documents and obtain necessary human subjects’ clearances to perform the study, including:

1. Institutional Review Board (IRB) approval, as applicable

2. Office of Management and Budget (OMB) approval, if applicable

Approval from the OMB, consistent with the Paperwork Reduction Act, is necessary for data collection from ten (10) or more individuals. Some studies may be granted exemption from OMB based on study procedures. The Contractor shall be responsible for providing the COR and Study Project Lead (s) with the necessary information about the Contractor’s procedures for data collection.

For research exempt from the requirements of 45 CFR Part 46:

(a) The Contractor will submit to FDA a letter from their IRB or human subjects protection entity that the proposed research is exempt (see 45 CFR 46.104).

(b) In accordance with SMG 9001.4, FDA will follow its procedures for exempt research determination. Data collection from human subjects cannot commence under this contract until the FDA COR provides the Contractor with the outcome of the FDA determination.

For nonexempt human subjects research:

(a) The Contractor agrees to protect the rights and welfare of human subjects involved in research under this contract by complying with 45 CFR Part 46 and the clause at HHSAR 352.270-4b.

(b) Initial proof of compliance with 45 CFR Part 46 shall consist of:

(1) A copy of a current Federal-wide Assurance on file with OHRP (https://www.hhs.gov/ohrp/federalwide-assurances-fwas.html). The copy of a current Federal–wide Assurance shall be included with the Contractor’s proposal;

(2) A letter from the Contractor’s local IRB (the Institutional Review Board (IRB) specified in the Offeror’s Assurance of Compliance) stating that it has reviewed and approved the proposed research protocol. The letter from the local IRB shall be submitted to the Contracting Officer Representative (COR).

(3) In accordance with SMG 9001.4, the FDA will determine if FDA is considered engaged in the research for purposes of 45 CFR part 46. Data collection from human subjects cannot commence under this contract until the FDA COR provides the Contractor with the outcome of the FDA determination. When that determination is made, the FDA will confirm the extent to which the terms of “352.270-11 Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required” apply.

In addition, the Contractor shall obtain all necessary internal approvals, such as determination from its own IRB prior to any human subject data collection. All staff working with human subjects or having access to human subjects’ data must complete human subjects training appropriate for this type of clinical study.

Task 10 – Perform Clinical Study Clinical study recruitment should begin within five (5) business days of IRB approval. The Contractor shall perform the clinical study using the Final Clinical Study Protocol developed in Task 8. The Contractor shall submit any relevant source documents to the Study Project Lead(s) upon request. Within five (5) business days of IRB approval, the Contractor shall begin recruitment activities such as posting advertisements, contacting participants in their database, and preparing staff/materials at the clinical site.

The Contractor shall select the clinical research facilities which are equipped to perform the study. The Contractor shall provide nurses, laboratory technicians, and other clinical staff to perform the screening, behavioral assessments, and laboratory tests, to collect specimen samples, and to assay the biologic samples.

The Contractor shall recruit healthy, volunteer, adult male and female current users of combusted cigarettes for the study and assess their inclusion and exclusion criteria to satisfy the protocol.

The Contractor is responsible for proactively ensuring recruitment can be achieved and for identifying measures to increase recruitment, if needed.

The Contractor shall inform the FDA for the measures taken to ensure the confidentiality of data.

Task 11 – Clinical Recruitment Updates The Contractor shall deliver informal weekly updates via email to the Study project Lead(s) and the COR on the status of recruitment and progress of research for the duration of recruitment.

Recruitment updates shall begin one week after the start of recruitment and shall be delivered on the same day of the week throughout the duration of the study.

https://www.hhs.gov/ohrp/

Recruitment updates shall include the number of participants screened/scheduled/completed/withdrawn for the prior week’s duration, the number of participants screened/scheduled/completed/withdrawn from the start of recruitment, the number of participants who are deemed ineligible during pre-screening and screening, and reasons for ineligibility, and any recruitment challenges.

The contractor shall notify the Study Project Leads in writing within five (5) business days if actual enrollment falls more than 15% below the projected enrollment targets for any consecutive two-month period, or if enrollment is delayed by more than thirty (30) calendar days from milestone dates specified in the enrollment timeline. The contractor shall submit a Corrective Action Plan (CAP) within fifteen (15) business days of the notification requirement, or upon request by the Study Project Leads, and implement approved corrective actions within the timeframes specified in the CAP. The CAP shall include, at minimum:

1.Root cause analysis of recruitment shortfalls, including site-specific barriers and systemic issues 2.Specific, measurable corrective measures with implementation timelines 3.Revised enrollment projections with supporting rationale 4.Additional recruitment strategies, which may include expansion of eligibility criteria (if scientifically justified), activation of additional study sites, enhanced advertising and outreach efforts, increased site training and support, or modification of study procedures to reduce participant burden 5.Resource requirements and budget implications for proposed corrective measures 6.Metrics for evaluating effectiveness of corrective actions

Task 12 – Draft Clinical Study Report Within two (2) months of completing the final study participant, the Contractor shall deliver a Draft Study Report to the COR and Study Project Lead(s) containing: the background and purpose of the project, summary of recruiting, biological sampling frame, data collection techniques and procedures, PK analyses, pharmacodynamic analyses, subjective effects analyses, self-administration analyses, use topography analyses, adverse events, any significant problems encountered during the study and their solutions, data preparation and processing, any information necessary to reproduce statistical results and reanalyze datasets (e.g., coding procedures, statistical/analytic code), analyses of the relationships between acute abuse liability outcomes and actual use behaviors, any significant problems encountered during the clinical study and their solutions, and conclusions.

All raw data and data analysis files will be submitted in SAS transport format and Microsoft Excel. The Contractor shall submit all documents relating to study monitoring to the COR. The Contractor shall write up the results of the study in the form of an expanded American Psychological Association (APA; http://www.apastyle.org) format introduction section. The Contractor shall write these documents in MS Word compatible software.

Data files shall be prepared and delivered according to the following specifications:

1. Each record shall be uniquely identified and shall correspond to one respondent's data

2. All data values shall be numeric rather than character

3. Adverse events description with the time in the event table

4. One (1) electronic copy of a finalized, complete, and correct Coding Book

5. One (1) electronic copy of the data analyses report, including files, tables and figures, and appropriate statistical analyses of the results.

Task 13 – Final Clinical Study Report The Contractor shall address all feedback and deliver a Final Study Report to the COR and Study Project Lead(s) within two (2) months after receiving comments from the FDA on the Draft Study Report.

Should the FDA have any additional comments on the Final Study Report, the Contractor shall respond to any comments from the FDA in a revised report to be submitted within one (1) month after receipt of FDA comments.

PERIOD OF PERFORMANCE

Four years in length after issuing the contract.

3.5 List of Deliverables

DELIVERABLE SCHEDULE

Task Number

Deliverable Quantity Delivery Date after Task Award

1 Kick-off Meeting 1 Within 10 business days of award.

2 NPI forms 1 per staff member

Within 30 business days of award.

3 Biweekly Meetings Biweekly Biweekly for the duration of the contract. Start within 10 business days of Kick-off Meeting.

4 Monthly Progress Reports 1 electronic version per month for contract duration

Electronically submit to the COR by the 10th of each month for each thirty-day period prior to the report due date.

5 Selection of Study Products 1 Within 10 business days of Kick-off Meeting.

6 Draft Clinical Study Protocol 1 electronic version

Initial draft within 30 business days of award kick-off meeting. Multiple iterations (no more than 3) may be necessary to address feedback from all FDA review processes.

7 Peer Review of Clinical Study Protocol

1 electronic version

Within 10 business days of receiving final SGE/RGE comments on Draft Protocol.

8 Final Clinical Study Protocol 1 electronic version

Within 10 business days of receiving final Government comments on Draft Clinical Study Protocol.

9 Obtain Clearances for the Study (OMB and IRB)

1 each Variable, approximately 4 months is anticipated.

Clearance must be obtained prior to any data collection.

10 Perform Clinical Study 1 study Within 5 business days of final IRB approval.

11 Clinical Recruitment Updates 1 electronic version per week

Weekly for the duration of the clinical study.

12 Draft Clinical Study Report 1 electronic version

2 months after completion of the last participants.

Approximately 15 months after human subject approval, anticipating the clinical study will take 12 months.

13 Final Clinical Study Report 1 electronic version.

2 months after receiving FDA comments on Draft Clinical Study Report.

INSPECTION AND ACCEPTANCE

The COR shall review and inspect all deliverables furnished under this contract in accordance with the deliverables cited herein.

SECTION 4 - CONTRACT REQUIREMENTS

4.1 CONFLICT OF INTEREST

a) The purpose of this section is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The language in this section applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co- sponsor, joint venture, consultant, or in any similar capacity.

(c) Definition of Conflict of Interest Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501).

(d) Contractor’s Conflict of Interest Responsibilities The individual contractor must be free of interest prior to performing under this contract. Any time prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the contract officer and project officer. The contract officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the contract officer.

(e) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

Prior to award, contractors that disclose potential or actual conflicts of interest shall submit a mitigation of conflicts of interest plan along with their technical and business proposals.

(f) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(g) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(h) Prime Contractor Responsibilities– The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(i) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

4.2 Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) None. GFP will not be furnished to the Contractor.

4.3 Security

There are no unique security requirements associated with performance of this contract.

4.4 Travel

There are no travel requirements associated with performance of this contract.

4.5 Special Material Requirements

There are no special material requirements with this contract.

4.6 OTHER REQUIREMENTS

FDA considers the sharing of FDA-funded research, including digital data, an important means to enhance its value and support future research. When the findings associated with research developed with FDA funds are published, they are required to be made readily available to the public. In addition, investigators seeking FDA funding, in whole or in part, via a contract, grant, or assistance agreement must have an FDA-approved Data Management Plan – a plan for digital data management and sharing – prior to commencing any related services or work.

Upon acceptance for publication, researchers are also responsible for submitting the author’s final manuscript of any peer-reviewed scientific publication resulting from research supported, in whole or in part, with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications resulting from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. FDA expects timely release and sharing of final research data from FDA-funded studies for the research community’s use in accordance with the submitted Data Management Plan. Please see the FDA Public Access Policy available at:

http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pd f).

http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pdf http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pdf

4.7 Place of Performance

The performance of this contract will be conducted at the Contractor’s facility.

Delivery, Installation, and Training visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

4.8 Period of Performance

The period of performance of this contract is Four years from date of award.

4.9 Contract Type

This will be a Firm-fixed price contract.

SECTION 5 - GENERAL EVALUATION INFORMATION EVALUATION AND

AWARD

The Government intends to make award based on best value trade-off.

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc.) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Unique Entity Identification (UEI); 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. The total number of pages for the technical proposal shall not exceed fifteen (15) pages.

The solicitation does not commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

SECTION 6 – CONTRACT CLAUSES AND PROVISIONS / ADDITIONAL TERMS

AND CONDITIONS

6.1 Solicitation Provisions:

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Full text of any provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/far-overhaul and https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

FAR Provisions:

52.204-7, System for Award Management—Registration 52.204-7 System for Award Management (DEVIATION) (RFO AUG 2025) 52.240-90, Security Prohibitions and Exclusions Representations and Certifications 52.204-90 Offeror Identification (DEVIATION) (RFO AUG 2025)

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Products and Commercial Services (DEVIATION)(RFO APRIL 2026) applies to this solicitation.

The following addenda apply:

Instructions to Offerors—Commercial Products and Commercial Services (Deviation Date)

(a) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, offers shall include—

(1) The solicitation number;

(2) The name, address, telephone number of the Offeror;

(3) The Offeror’s Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator;

(4) Information necessary to evaluate the factors contained in the provision at 52.212-2 or as described in the solicitation;

(5) Responses to provisions that require Offeror completion of information, representations, and certifications (other than those collected via the System for Award Management (SAM)); and

(6) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments.

(b) Period for acceptance of offers. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(c) Late submissions, modifications, revisions, and withdrawals of offers.

(1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation.

(2) Any offer, modification, or revision received after the time specified for receipt of offers is “late” and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the…