Sol_Doc_75F40126R00013.pdf

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75F40126R00013

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Period of Performance: 09/30/2026 to 09/29/2031

1 Non-medical Use Data Report Services 1

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

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57 2 of

Solicitation no. 75F40126R00013

Food and Drug Administration

Non-Medical Use (NMU) Surveillance Indefinite Delivery Indefinite Quantity (IDIQ) Contract

Table of Contents

1. Background

2. Objective(s)

3. IDIQ Information

4. Statement of Work (SOW)/Work Requirements

Task Area 1: Post-Market Surveillance of NMU of Pharmaceuticals and Unapproved Substances, and Illicit Substance Use: Summary Reports, Ad-Hoc Reports, Analytical Datasets, Surveys, And Other Non-Traditional Data Sources

Task Area 2: Post-Market Surveillance of NMU of Pharmaceuticals and Unapproved Substances, and Illicit Drug Use: Topic-Specific Studies and/or Analyses

Task Area 3: Project Management

5. 508 Accessibility Standards

6. Deliverables

7. Labor Categories and Descriptions

8. Period of Performance

9. Place of Performance/Deliveries

10. Government Furnished Property (GFP), Government Furnished Equipment (GFE), and Government Furnished Information (GFI)

11. Materials

12. Travel

13. Government Points of Contact

14. Organization Conflicts of Interest

15. Clauses and Provisions

16. Contract Administration

17. Instructions to the Offerors

18. Basis of Award and Evaluation Criteria

19. Attachments

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

Non-Medical Use (NMU) Surveillance Indefinite Delivery Indefinite Quantity (IDIQ) Contract

1. Background

The purpose of this requirement is to obtain data reports on nonmedical use (NMU) of 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) for the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). In turn, OSE will use the reports to help inform pharmaceutical regulatory and oversight efforts, identify and understand emerging substances of concern, and support NMU prevention programs.

The FDA is tasked with acquiring, assessing, and responding to post-marketing epidemiologic data related to the NMU of pharmaceutical products with central nervous system activity. These include opioids, benzodiazepines, stimulants, and other drug classes. Due to the high prevalence of polysubstance use and the inter-related nature of pharmaceutical and illicit substance use, it is also critical for FDA to monitor trends and patterns of illicit substance use and associated harms. Moreover, FDA is also tasked with surveillance and regulatory activities related to unapproved drugs. Thus, comprehensive and timely surveillance data on use of these products is essential to inform FDA’s work.

Nonmedical use of drugs presents unique challenges, and typical pharmacoepidemiologic data sources and study designs are generally not sufficient to address all regulatory questions. Therefore, non-traditional data sources and methods must be employed. No single data source can capture all the nonmedical-use-related outcomes of interest, or all individuals at risk for these outcomes. Data collected from individuals entering or being assessed for treatment of substance use disorders have been one source of valuable information on the nonmedical use of individual pharmaceutical products as well as overall patterns and trends in the nonmedical use of pharmaceuticals and other substances in the United States. These types of data contribute to the mosaic of data sources that FDA synthesizes to inform regulatory decisions.

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. These services provided surveillance data via biannual surveillance data reports and allow FDA to, for example, obtain ad hoc data reports to study the impact of scheduling (or rescheduling) actions, and to inform discussion at multiple public advisory committee meetings.

2. Objective(s)

Primary Objective: The primary objective of this effort is for the FDA to obtain post-marketing data on NMU of prescription and over-the-counter drug products, use of illicit substances, and/or use of other drugs and substances with emerging regulatory interest from 1) individuals entering or being assessed for substance use treatment; and, 2) other available sources of relevant data, for example, internet and social media postings, internet panel-based surveys, and data on drug diversion and counterfeit pharmaceuticals.

Primary Programmatic Goal:

On order, provide to the FDA reports and/or analytical datasets based on existing surveillance data collected by the Contractor, as required or requested based on items of regulatory interest.

Secondary Objective: The secondary objective is to conduct focused, topic-specific studies or analyses on drug products and/or emerging substances of regulatory interest. These studies or analyses may leverage real-world data sources, subject-matter expertise, or the biomedical literature; they may be exploratory analyses or pilot innovative methods for surveillance.

Examples of the types of data collection or analyses of interest to FDA under this secondary objective may include:

A. Developing and/or piloting validated Artificial Intelligence (AI) models for analyzing large databases (e.g., social media platforms, electronic health record databases) to enhance FDA’s understanding of novel psychoactive substances and other emerging drugs of concern.

B. Analyzing existing datasets, including longitudinal datasets, to explore adult drug use patterns, correlates, and trajectories over time.

C. Subject matter expert assistance with emerging topics of interest (e.g., interpreting medical toxicology-related research and surveillance, approaches and/or methodologies for identifying use of novel substances).

D. Exploratory studies on non-traditional healthcare delivery settings (e.g., ketamine infusion centers, telehealth platforms, psychedelic-assisted therapy centers/clinics).

E. Systematic literature reviews and informal landscape analyses to increase FDA’s understanding of the nonmedical use of select drugs and substances.

F. Novel data collection and analysis on topics of regulatory interest (e.g., ad hoc internet panel surveys, longitudinal follow-up of individuals being assessed for or entering substance use disorder treatment).

3. IDIQ Information

The FDA intends to issue a multiple-award IDIQ contract to obtain data reports on NMU of prescription and over-the-counter drug products, use of illicit substances, and/or use of other drugs and substances with emerging regulatory interest. The FDA anticipates awarding a maximum of two awards to Offerors who represent the best value to the Government, in accordance with the evaluation criteria set forth in this solicitation; however, the Government may make additional awards if determined to be in the best interest of the Government. The Government has sole authority to decide the final number of awards made under this solicitation.

3.A: Notice of FAC

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-06, effective October 1, 2025.

3.B: Notice of NAICS

The associated North American Industry Classification System (NAICS) code is Schedule 541720, Research and Development in the Social Sciences and Humanities. Offerors must have an active registration in SAM.gov (www.sam.gov), with completed representations and certifications, by the close date of the solicitation. Quotes submitted by Offerors without an active registration in SAM.gov may not be considered.

3.C: Pricing Schedule

The Contractor’s pricing schedules for labor categories shall contain fully burdened hourly labor rates, including all wages, indirect costs, fringe benefits, overhead, general and administrative, and profit.

Hourly rates apply to services at both Government and non-Government sites. By mutual agreement of the parties, additional labor categories may be added to this IDIQ.

3.D: Pricing Terms

The Contractor shall comply with FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services with regard to fixed prices for individual Firm-Fixed-Price (FFP) orders. The total amount specified in FFP deliverables and orders shall be fixed for the order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the order within the time specified in the order.

The Contractor shall comply with FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services—Alternate I, with regard to the ceiling price for individual Labor- Hour (LH) and Time-and-Material (T&M) orders. LH and T&M orders will include a ceiling price. If an order’s stated period of performance must be extended as a result of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period for LH and T&M orders.

3.E: IDIQ Estimated Value

IDIQ Minimum: The minimum guarantee for this IDIQ contract is $3,000.00, which will be obligated at the time of IDIQ award.

IDIQ Maximum: The maximum aggregate dollar value of all task orders awarded over the 5-year ordering period of this IDIQ shall not exceed the IDIQ ceiling amount of $8,500,000.00 per IDIQ award.

The Government is obligated only to the extent authorized by the purchases made on Orders placed under this IDIQ.

3.F: IDIQ Order Types

At the discretion of the Contracting Officer (CO), the Government may use T&M, LH, FFP, or a combination thereof for IDIQ task orders. Each Request for Quote (RFQ) issued under this IDIQ contract will identify the Government’s determination of order type.

3.G: IDIQ Ordering Terms

All Orders placed against this IDIQ are subject to the terms and conditions of the IDIQ.

3.H. IDIQ Ordering Procedures

In accordance with FAR 16.505(a)(2), the following procedures shall be used when placing orders under the IDIQs.

1. The FDA will issue a Request for Task Order Proposal (RFTOP) via email. The RFTOP will include the following information:

A. Statement of Work (SOW) B. Period of Performance (POP) C. Anticipated Contract type D. Reporting requirements and deliverables E. Key Personnel (if applicable) F. Any special terms and conditions specifically applicable to the task order

2. The Contractor will typically have a minimum of ten (10) business days, unless otherwise specified, to provide a proposal in response to the RFTOP. The proposal shall include:

A. Brief description of the technical approach to the task order requirements B. Price buildup (including labor categories, hours for each labor category, extended pricing, total task order pricing, and concurrence with the anticipated contract type) C. Resumes of any Key Personnel identified in the RFTOP

3. The FDA will evaluate the task order proposal for technical acceptability and price reasonableness.

If the FDA has questions or concerns, the FDA will contact the Contractor and may request a revised proposal.

4. If the task order proposal is determined acceptable, the FDA will issue a task order. All task orders will, at a minimum, include the following:

A. Task Order number B. Date of Task Order C. Funding for the Task Order D. Task Order SOW and specific deliverables and due dates E. Task Order pricing F. Period of Performance of the task order G. Any terms, conditions and instructions specific to the task order

Any work that the Contractor undertakes prior to receiving a fully executed task order that has been signed by the Contracting Officer shall be at the Contractor’s risk.

Any authorized FDA Contracting Officer may place Orders under this IDIQ in accordance with FAR 16.505(b).

3.I. Task Order Pricing

1. Proposals submitted in response to a RFTOP must be in accordance with the Ordering Period rates in the IDIQ Price Schedule based on the performance start date of the task order, and that rate must be used for the duration of the task order performance period. The Contractor may propose lower rates in response to a RFTOP.

2. RFTOPs may include option periods in accordance with FAR clause 52.217-9. However, option periods must utilize the Ordering Period rates listed in the IDIQ Price Schedule, based on the performance start date of the option period.

3. Labor-Hour (LH) type task orders will include a ceiling price.

4. If a task order’s stated Period of Performance must be extended as a result of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period for LH type task orders

These task order pricing terms and conditions apply to all task orders issued against this IDIQ contract.

3.J. IDIQ Order Invoicing Procedures

The Contractor shall include the payment address, if it is different from that shown for the Contractor.

Specific invoicing instructions may be provided in each individual task order. Unless otherwise specified, the FDA invoicing procedures shall be in accordance with HHSAR 352.232-71, Electronic Submission of Payment Requests, and as follows:

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (JAN 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/

Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and

(2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)-show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC

(3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

4. Statement of Work (SOW)/Work Requirements

The Contractor shall furnish the scientific personnel, data sources, materials, services, facilities and otherwise do all things necessary for, or incident to, the performance of the work as described below.

The IDIQ contract supports the three task areas described below.

The Contractor shall provide reports from specialized post-marketing surveillance systems that collect data on self-reported NMU of prescription and over-the-counter drug products, use of illicit substances, and/or use of other drugs and substances with emerging regulatory interest. Because of the unique clinical and cultural characteristics of substance use and NMU, the source population for the database is restricted to the United States. For the purposes of the contract, the U.S. population of interest resides in the fifty states and the District of Columbia, not in the U.S. Virgin Islands, the Commonwealth of Puerto Rico, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and Wake Island.

For each task order, FDA will define the parameters of the analyses and the desired elements of the report, including, but not limited to time period, demographic and geographic distribution of the study population, the reported drug products and/or drug classes, route of administration, severity of substance use disorder, source of drug, or other elements based on the surveillance data collected.

The FDA may also issue task orders to collect prospective substance use-related data, for example through internet-based surveys focusing on a particular topic, to inform emerging regulatory questions. Such task orders for prospective data collection may also relate to obtaining longitudinal follow-up data from a cohort, or subset, of individuals entering or being assessed for substance use treatment, or establishing new data linkages (e.g., to electronic healthcare data or state death records).

Task Area 1: Post-Market Surveillance of NMU of Pharmaceuticals and Unapproved Substances, and Illicit Substance Use: Summary Reports, Ad-Hoc Reports, Analytical Datasets, Surveys, And Other Non- Traditional Data Sources

The Contractor shall provide:

A. Bi-annual (fall and spring) summary reports from post-marketing data on self-reported NMU of prescription and over-the-counter drugs, use of illicit substances and/or other drugs or substances with regulatory interest.

B. Ad-hoc reports and/or analytical datasets from existing surveillance data collected by the Contractor, as required or requested based on items of regulatory interest.

C. Minimum Mandatory Data Requirements

1. 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. The U.S. population of interest resides in the fifty states and the District of Columbia, not in the U.S. Virgin Islands, the Commonwealth of Puerto Rico, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and Wake Island. The geographical location should be further categorized based upon the four census regions—Northeast (CT, ME, MA, NH, NJ, NY, PA, RI, and VT); Midwest (IL, IN, IA, KS, MI, MN, MO, NE, ND, OH, SD, and WI);

South (AL, AR, DE, DC, FL, GA, KY, LA, MD, MS, NC, OK, SC, TN, TX, VA, and WV); and West (AK, AZ, CA, CO, HI, ID, MT, NV, NM, OR, UT, WA, and WY). Although not every state must be represented by the available data, the data must represent geographically diverse regions from which results can reasonably be expected to inform questions related to national patterns and trends in the target population. The Contractor must maintain the geographic heterogeneity and data access capability throughout the entire period of performance.

2. 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. The subject-level data must, at a minimum, include the following—information on self-reported NMU of prescription and over-the-counter drugs, non-FDA-approved products with potential for NMU, and illicit substances;

demographic characteristics; and assessment/treatment facility information. At a minimum, subject-level demographic characteristics must include age, ethnicity/race, sex, and geographic location. At a minimum, assessment/treatment facility information must include facility type (or expected treatment modality), geographic location, number of assessments contributed by the site, and number of programs/sites participating for each quarter throughout the contract duration. To aid in understanding and properly interpreting reports and analyses, the Contractor will also need to provide technical documentation, including relevant versions of data collection instruments and data dictionaries. A collection instrument is the exact means by which the data are collected. In the case of a survey or intake questionnaire, it is the battery of questions used to solicit the data.

3. The Contractor shall own or have access to and be able to use in reports, a minimum of ten years of historical data (from 2016 to the present). That historical data must, at a minimum, include the data elements described above.

Task Area 2: Post-Market Surveillance of NMU of Pharmaceuticals and Unapproved Substances, and Illicit Drug Use: Topic-Specific Studies and/or Analyses

The Contractor shall provide:

A. Topic-specific studies or analyses on drug products and/or emerging substances of regulatory interest.

These studies or analyses may leverage real-world data sources, subject-matter expertise, or the biomedical literature; they may be exploratory analyses or pilot innovative methods for surveillance.

B. On order, collect and/or analyze data on NMU of pharmaceutical products and/or use of other drugs or substances of regulatory interest. This may include, for example, internet panel survey data, qualitative analyses of internet postings, and other types of nontraditional data such as data on related to law enforcement efforts or other sources of data that affect trends and patterns of NMU of substances.

Task Area 3: Project Management

The Contractor shall provide:

1) KICK-OFF MEETING

The Contractor shall organize a kick-off meeting within 15 business days of the award. The Contractor is responsible for, providing meeting minutes for this meeting and all other meetings related to this award.

The kick-off meeting is expected to be held within 15 business days following award and may be adjusted based on mutual availability of FDA and Contractor personnel.

2) PROJECT MANAGEMENT PLAN and DATA MANAGEMENT PLAN Within 30 days of award, the Contractor shall submit a Project Plan that addresses the following areas:

Risk Management; Requirements Management; Quality Management; Staffing and Project Organization.

The Project Plan shall identify study team members and contact information (e-mail addresses and phone numbers). The Contractor shall provide a primary point of contact for the collaboration between the FDA and the Contractor. To the extent that the FDA has provided sufficient detail regarding initial reports, the Project Plan shall include a timeline for the project clearly identifying major project activities and their expected duration. A Data Management Plan will be submitted as part of the Project Management Plan.

Please see the pricing table for details.

The Project Plan shall also include a FAR 37.604 Quality Assurance Surveillance Plan (QASP). Accordingly, the Contractor shall develop and maintain an effective Quality Assurance Surveillance Plan (QASP) to ensure that the reports being provided are in accordance with the SOW and applicable task orders. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of inaccurate, incomplete, or duplicative data, or flawed analysis of the data. The QASP shall establish procedures by which the Contractor assures that work complies with the technical requirements specified in the SOW and individual task orders. As part of this, at a minimum, the Contractor shall develop QASP procedures addressing the areas listed below. After FDA accepts the Contractor’s QASP, the Contractor must obtain the contracting officer’s acceptance in writing of any proposed change to the Quality Control (QC) system.

3) QUALITY ASSURANCE SURVEILLANCE PLAN

This quality assurance surveillance plan (QASP) sets forth the procedures and guidelines the government will use in ensuring the required performance standards or services levels are achieved by the Contractor.

Reporting Event Standard Method of Surveillance

For any circumstances resulting in loss of, or lack of, Contractor access to a significant data source as well as any other significant problems or changes the Contractor shall notify FDA.

Within 14 business days of the Contractor’s knowledge of the loss or lack of Contractor access to data from the database; notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics and provided in a written report to the FDA.

COR and staff shall review and document impact on dataset quality.

D. QUARTERLY TELECONFERENCES

The Contractor shall coordinate and schedule teleconferences to discuss scientific research questions and FDA’s satisfaction with all deliverables. These shall occur quarterly, at a minimum, or at a mutually agreed upon frequency to allow necessary discussion between the Contractor and FDA to achieve the project deliverables. An agenda shall be provided to the COR at least 48 hours prior to meetings. Draft meeting notes and action items shall be submitted to the COR for review and comments within two (2) business days after teleconferences. The Contractor shall incorporate revisions into the notes and submit the final version to the COR within one (1) business day after receipt of the COR revisions.

E. TASK ORDER REPORTS

The FDA will issue task orders for specific reports to address questions of regulatory interest. For each task order report, FDA will define the desired data elements, analyses, and other parameters of the report.

These parameters, as well as other specifics of the task order deliverables, will be mutually agreed upon by FDA and the Contractor.

As part of each report, the Contractor shall furnish to the FDA an analytical dataset that is the basis of the report. The analytical dataset shall be limited to information needed to answer specific regulatory questions of interest. An analytical dataset is one where the collected information has been quality checked and formatted so it can be immediately used for further analysis. Analytical datasets shall be provided to the FDA in the SAS, MS Excel, MS Access, or ASCII format. Because the reports and analytical datasets do not contain PII, PHI, or CUI, Contractors may utilize BOX.com, email, or the Collaborative Guest Experience SharePoint to provide required deliverables. Contractors may also use network capturing functionality to transmit any data to the FDA system, except for login information specific to the data and data access (e.g., SQL queries or similar methods) for the Contractor’s application datasets.

Full disclosure of any updates for data collection, coding, and configuration methods and changes.

Within 14 business days of the Contractor’s knowledge; notification shall include percentage of missing or incomplete information for the basic data elements and details of the impact of these changes on data quality, data quantity, and overall data characteristics and provided in a written report to FDA data elements and details of the impact of these changes on data quality, data quantity, and overall data characteristics and provided in a written report to FDA.

COR and staff shall review dataset quality and document impact to appropriately interpret findings.

The Contractor shall provide answers to questions from FDA’s staff regarding technical aspects of the data resource.

The turnaround time for full response is three business days. Automated responses do not count as a full response.

COR and staff shall document and review turnaround times.

F. TECHNICAL SUPPORT

As needed, Contractor shall collaborate with and provide technical support to the FDA in correctly interpreting the data provided and will inform FDA of any major changes in data collection instruments or processes.

The Contractor may be asked to review and advise on proposed announcements, reports, and other FDA communications (whether to the public or intragovernmental communications) to help ensure that FDA is accurately representing Contractor-provided data. The Contractor shall respond within 24 hours. The intent behind this task is to include the Contractor in the process of ensuring that FDA communications to other agencies or to the public are accurate and well founded.

5. 508 Accessibility Standards

The following list of Section 508 accessibility standards of the Access Board EIT Accessibility Standards are applicable to this acquisition:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and

Technical Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical

Requirements)

• Electronic content must be accessible to HHS acceptance criteria.

• Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

6. Deliverables

Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

Deliverables shall be established with the issuance of each task order.

Specific deliverables will be defined at the task order Level. However, it can be assumed each Order will require some sort of report (monthly, annual, final project, etc.). All reports required under this contract shall be submitted electronically to the COR in Microsoft Word compatible format and as needed, in hard copy. All IDIQ order-related electronic deliverables must be compliant with Section 508 of the Rehabilitation Act as amended – 29 U.S.C. § 794d.

https://www.levelaccess.com/wcag-a-and-wcag-aa-conformance/ https://www.access-board.gov/ict/#E101.2 https://www.access-board.gov/ict/#E203-functionality https://www.access-board.gov/ict/#E204-functional-performance-criteria https://www.access-board.gov/ict/#E205-content https://www.access-board.gov/ict/#E208-documentation-Services https://www.access-board.gov/ict/#chapter-6-support-documentation-and-services https://www.access-board.gov/ict/#302-functional-performance-criteria https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

Deliverables per Task Order (TO)

Recipient Quantity (min)

Delivery Schedule

Kick off meeting COR/FDA Program Advisor

Within 15 business days of award

Project Management Plan

COR/FDA Program Advisor

Within 15 business days of kick-off meeting

Data Management Plan

COR/FDA Program Advisor

Within 15 business days of kick-off meeting

Quarterly Teleconferences

COR/FDA Program Advisor

4 per year

Within 30 days of each quarter end or as agreed upon by COR and Contractor

Customized Data Reports

COR/FDA Program Advisor

TBD

As agreed upon by COR and Contractor

Publications COR/FDA Program Advisor

TBD TBD

Monthly status reports

COR/FDA Program Advisor

By the 15th day of the subsequent month

Technical Support COR/FDA Program Advisor

As needed

Within 24 hours of being contacted by COR

Close out meeting COR/FDA Program Advisor

Within 30 business days of end of TO period of performance

7. Labor Categories and Descriptions

The labor category titles below represent the FDA’s terminology for the required skill sets. Offerors may propose different labor category titles in order to comply with their current GSA labor category pricing.

However, the proposed labor categories shall meet the minimum requirements outlined below.

*Please note, minimum experience and educational requirements may be more advanced at the Task Order level to meet the specialized needs of that requirement.

Labor Category Minimum Requirements

Project Manager

Serves as the primary point of contact for the Contractor. Demonstrates experience with planning, conducting, and supervising epidemiological and/or social science projects. Possesses knowledge of the relevant science and the ability to apply new and unique methods and procedures.

At least 5 years relevant experience plus bachelor’s degree in a relevant area of study.

Sr. Computer Systems Analyst

Analyzes science, engineering, business, and other data processing problems to implement and improve computer systems. This role analyzes user requirements, procedures, and problems to automate or improve existing systems and reviews computer system capabilities, workflow, and scheduling limitations.

A senior level requires a Bachelor's degree and 5 or more years of relevant work experience.

Statistician

Performs statistics research tasks of significant technical complexity, applying standard and established theories, concepts, and techniques, but often using innovative approaches and/or complex statistical analysis; develop innovative and creative technical solutions to research problems, questions, and issues, using or extending state-of-the-art methods and technology;

direct development of timely project reports that are organized, clear, and in the proper format. Work is performed with minimal supervision and guidance. Results of work are considered technically authoritative. May be considered a national expert in the field of expertise.

A senior level requires at least 8 years relevant experience plus bachelor’s degree in a relevant area of study; an associate level requires at least 3 years relevant experience plus bachelor’s degree in a relevant area of study.

Pharmacist

Conducts research to understand human diseases and improve human health.

A graduate degree (PharmD) and a current, unrestricted state Pharmacist license is required.

Epidemiologist

Investigates and describes the determinants and distribution of disease, disability, or other health outcomes and may develop methods for prevention and control.

Experience is defined by levels: Junior (up to 3 years), Journeyman (3 to 10 years), and Senior (over 10 years).

Survey Scientist (Survey Researcher)

Plans, develops, or conducts surveys and may analyze and interpret the meaning of survey data, determine survey objectives, or suggest and test question wording.

Experience levels are typically defined as Junior (up to 3 years), Journeyman (3 to 10 years), and Senior (over 10 years).

Labor Category Minimum Requirements

Subject Matter Expert

Provides expertise in the relevant field of work developing key policies and procedures for program implementation and recommending strategic directions.

At least 6 years relevant experience plus bachelor’s degree in a relevant area of study.

8. Period of Performance

The IDIQ period of performance is anticipated to be:

Base Year: 12 months, anticipated September 30, 2026 through September 29, 2027 Option Year I: 12 months, anticipated September 30, 2027 through September 29, 2028 Option Year II: 12 months, anticipated September 30, 2028 through September 29, 2029 Option Year III: 12 months, anticipated September 30, 2029 through September 29, 2030 Option Year IV: 12 months, anticipated September 30, 2030 through September 29, 2031

Individual task order periods of performance will be identified within each individual order. Individual task orders may not exceed five (5) years but may extend up to 36 months beyond the IDIQ contract’s expiration date. The IDIQ contract shall remain in force to allow for the completion of all issued task orders.

The Government will not require support on Saturdays, Sundays, or the Federal holidays shown below:

• New Year's Day

• Birthday of Martin Luther King, Jr.

• Washington’s Birthday

• Memorial Day

• Juneteenth National Independence Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving Day

• Christmas Day

• Inauguration Day (when applicable)

In the case of inclement weather and Government closures and delays, the Contractor staff shall be responsible for checking the operating status of the Federal Government via the Office of Personnel Management (OPM) operating status website. When inclement weather is expected, the Government may allow Contractor staff to telework when unscheduled telework is allowed. All telework related communications need to be sent to the respective CS, CO, and COR.

In the event the Federal Government is closed by order of the President of the United States or the U.S.

Office of Personnel Management for any reason, or the agency, the center, or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by the Contracting Officer and the Contracting Officer’s Representative concerning reporting for work.

9. Place of Performance/Deliveries

It is anticipated that a majority of work will be performed at the Contractor’s location.

Individual task order places of performance will be identified within each individual order.

10. Government Furnished Property (GFP), Government Furnished Equipment (GFE), and Government Furnished Information (GFI)

GFP, GFE, GFI, etc., if required, will be identified in individual task orders.

11. Materials

Individual task order materials, if any, will be identified within each individual task order.

12. Travel

No travel is anticipated under this contract. Any travel costs incurred by the Contractor within the Washington, DC-metropolitan area, including to/from the Contractor’s facility, shall be considered local travel and will not be reimbursed.

If necessary, individual task orders may include travel. All travel must be pre-negotiated in individual task orders and approved and authorized by the Task Order COR. Travel shall be reimbursed in accordance with FAR 31.205-46 and Federal Travel Regulations (https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation-ftr).

Travel requirements under this contract shall be met using the most economical form of transportation available. If economy class transportation is not available, the request for payment voucher must be submitted with justification for use of higher-class travel indicating dates, times, and flight numbers. All travel shall be scheduled sufficiently in advance to take advantage of offered discount rates, unless otherwise directed by the Contracting Officer.

13. Government Points of Contact

Contract Specialist (CS) Nam Nguyen 301-837-4129 Nam.Nguyen@fda.hhs.gov

Contracting Officer (CO) James Whitt 240-402-7627 James.Whitt@fda.hhs.gov

Contracting Officer’s Representative (COR) To be determined at award.

https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation-ftr https://www.gsa.gov/policy-regulations/regulations/federal-travel-regulation-ftr mailto:Nam.Nguyen@fda.hhs.gov mailto:James.Whitt@fda.hhs.gov

Individual task order Government points of contact will be identified within each individual order.

14. Organization Conflicts of Interest

As a regulatory agency charged with protection of public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions.

The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees. It is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offers performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the contractor.

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 of 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.