RFQ_75F40126Q00407_Final.docx

75F40126Q00407 - Rapid Nicotine Pouch Data

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR), Revolution FAR Overhaul (RFO) Part 12.2 (UPDATE: April 20, 2026), as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-1, 3/13/2026.

This announcement constitutes the only solicitation and a separate solicitation will not be issued. The solicitation number is 75F40126Q00407. This solicitation is issued as a Request for Quotes (RFQ).

The associated North American Industry Classification System (NAICS) code for this acquisition is 541618 - OTHER MANAGEMENT CONSULTING SERVICES; the applicable Small Business Size Standard is $19.0 Million. This requirement is solicited for full and open competition. This requirement is being solicited as an open market. Prospective offerors are responsible for downloading the solicitation and amendments from SAM.gov. The Government reserves the right to award a contract without discussion if the Contracting Officer determines that the initial offer provides the best value and discussions are not necessary.

The U.S. Food and Drug Administration (FDA) is requesting offers for services that entails the contractor providing FDA with reports summarizing data from their data collection efforts related to ENDS and nicotine pouches. At a minimum, reports should include data on the following topics: (i) ENDS and nicotine pouch use overall, (ii) sources of purchase, and (iii) use by top and emerging brands among youth and young adults, and (iv) other potential topics both parties agree upon.

Interested Offerors shall submit any questions concerning the solicitation at the earliest time possible to enable the Government to respond. Questions shall be submitted directly by email to Pamela.Lee@fda.hhs.gov. No phone calls. Questions not received by the question submission deadline of: Wednesday, September 16, 2026, at 3:00 PM ET may not be considered.

The deadline for receipt of offers for this requirement is: Friday, September 18, 2026, at 3:00 PM ET. Proposal submissions must be submitted by email only to Pamela Lee at: Pamela.Lee@fda.hhs.gov. Subject line of the email should be titled: “Proposaal Submission: 75F40126Q00407_ Rapid Nicotine Pouch Data”.

Part 1.0: Proposal Submission Instructions

1.1 Offerors shall submit a firm-fixed price proposal, including details of all prices supporting the required deliverables.

1.2 The offeror shall complete the pricing chart below. Pricing shall include all applicable fees including FOB destination shipping and handling. Any charges presented after contract will not be considered.

1.3 Proposals shall be in two volumes: Volume I shall be Technical and Volume II shall be Price. The volumes shall be separate and complete, so the evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in Volume I.

1.4 Proposals shall clearly reference the solicitation, date of offer, company proposing and point of contact.

1.5 Proposal shall be valid for at least 60 days after close of solicitation.

1.6 Offerors shall include in the proposal:

· a point of contact (name, telephone number, and email address),

· proposed firm-fixed-prices,

· business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.),

· Unique Entity ID (UEI) number,

· certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current.

Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote.

Volume I – Technical Proposal

The technical proposal shall not be longer than 30 pages, single spaced (with one inch margins) in length (not included resumes) and shall contain sections for 1) Technical Understanding and Approach 2) Key Personnel and Staffing and 3) Relevant Past Performance. The resumes of the key personnel and staff should also be included in this volume. Offerors shall use only 8.5 inch by 11-inch (210 mm by 297 mm) paper, single spaced pages with margins no less than one inch on each border; number each page consecutively; do not use font size smaller than Times Roman 12. Volume II shall consist of the price portion of the proposal. 11-point font may be used in exhibits and tables.

Offeror must furnish as part of its technical proposal all descriptive material necessary for the government to determine whether the Offeror can provide services that meet the technical requirements as identified in section C of the solicitation. The proposal shall specifically address each of the performance requirements of the Section 3 – Statement of Work. Offerors may also submit descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror as supplemental information. Offerors are notified that these types of brochures alone will not constitute an acceptable proposal.

The technical proposal should demonstrate a thorough understanding of FDA’s requirement. At a minimum, the descriptive material shall be tailored to the solicitation and shall include the following: a narrative proposal describing their technical approach to the FDA’s requirements. Additionally, the Offeror’s proposal shall include the following:

1. Report - A narrative describing the reports being offered, and describing, in writing, how the reports being offered comply with the specifications listed out in this Request for Quotes (RFQ). Simple statements of compliance (i.e., “understood”; “will comply”) without the detailed description of how compliance will not be considered sufficient evidence that the proposed services technically meet the requirements of this RFP. The proposal shall be specific and complete. The Offeror is urged to examine this solicitation in its entirety and to ensure that the submitted proposal contains all the necessary information and provides all required documentation and is complete in all respects. Evaluation of the proposal will be based on the actual material presented and not based on what is implied.

2. Relevant Past Performance- A narrative and timeline demonstrating that the Offeror can deliver the required deliverables in accordance with the deliverable table. Offeror shall provide written example(s) of previous experience providing these types of reports to public health governmental or non-governmental entity or entities.

3. Sample Report- A sample report that demonstrates the Offeror can provide reports that meet the specifications listed in this RFP.

The Government is interested in efficiency. Please provide only as much information as needed to demonstrate that your firm has the requested capabilities. Additional content beyond what has been requested will not be viewed favorably nor will it impress the Government.

The Technical Volume shall not address price in any way.

Volume II – Business Proposal

Offeror is expected to submit a separate Business Proposal.

As part of its Business Proposal, in addition to completing both the unit prices and the extended total line-item prices of each line item in Part 2 of the Solicitation. The Offeror shall also complete Attachment 1-Pricing Template.

The Business Proposal (Volume II) shall also include the Offeror’s Certifications and Representations, as applicable.

Please submit the price proposal in Microsoft Excel.xls format, not as a PDF file. When completing the Pricing Template(s), Offerors are instructed not to adjust any of the line items, change any of the formulas, markups, etc. Please be sure that all formulas carry through.

Every page of the Pricing Volume and Technical Volume must be numbered. Please only include as much content as was requested in the RFQ. Additional content will not be viewed favorably.

All total dollar amounts provided shall be rounded to the nearest cent.

Certifications:

Proposal Validity: The proposal shall be signed by an official authorized to bind the offeror’s organization and shall contain a statement indicating a period of time the proposal remains valid (not less than 60 days).

Conflict of Interest: The offeror shall identify any potential conflict of interest issues and include the following certification in the technical proposal:

“I represent to the best of my knowledge and belief, that this work does // or does not // involve situations or relationships resulting in any actual or potential conflict of interest.”

Pricing data showing a breakdown of labor hours and rates for all personnel and subcontractors and materials shall be submitted in in Excel format for verification and evaluation purposes. A total price for all phases of the project must be included in the spreadsheet. In addition, all pricing formulas, links between cells, and the basis of estimate shall be shown to support the offeror’s derivation of their proposed pricing.

Price

In this section, the Offeror shall complete Attachment 1, Price Schedule by providing a firm fixed price proposed for the completion of each deliverable. In order to assist the Government’s price evaluation, Offerors are required to provide supporting documentation used as the basis of their proposed price.

1.7 EVALUTION FACTORS, CRITERIA, AND DECISION FOR AWARD

The Government intends to award a single Firm Fixed Price contract as a result of from this solicitation to the responsible Offeror whose proposal represents the best value after evaluation in accordance with the factors identified in the solicitation.

The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit cost or prices offered, unless the Offeror specifies otherwise in the proposal. While not currently anticipated, the Government reserves the right to make multiple awards if, after considering the additional administrative costs, it is in the Government's best interest to do so.

The Government is not responsible for locating or securing any information which is not identified in the proposal. However, the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government.

1.7.1 Basis of Award and Evaluation Criteria

Based on a highest technically rated with a fair and reasonable price approach, the Government intends to select the responsible Offeror whose proposal represents the highest technically rated responsible offeror with a fair and reasonable price in terms of performing the work in accordance with the Statement of Work. This determination will be made after the evaluation of all proposals against the established evaluation criteria listed in this section is complete.

Offerors’ initial proposals should contain their most favorable price and technical terms.

1.7.2 Evaluation Factors

Evaluation Factors are divided into two categories: non-price (Factors 1-3) and price. See below for details on the specific evaluation factors.

The following non-price factors shall be evaluated:

1. Technical Understanding and Approach

2. Relevant Past Performance

3. Qualifications of Key Personnel

Factor 1- Technical Understanding and Approach The Government shall evaluate the Offeror’s overall technical capability to provide the wide range of requirements detailed in the Statement of Work section. The offeror must demonstrate an existing panel and data collection schedule that allows for the delivery of reports in accordance with the SOW, and a full understanding of all the task areas and the ability to satisfy the complete range and complexity of all Task Areas. Also, the Government will evaluate the Offeror’s level of understanding of youth and young adult youth of tobacco products, associated factors, and related measures. This includes the ability to produce and implement a comprehensive plan which includes the purpose of the reports, detailed research approach and analysis plans, and timeline of report delivery.

Factor 2- Experience/Past Performance The Government will assess the relative risks associated with each offer. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance.

The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information.

When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer.

The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance.

The lack of a past performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offer.

Based on the Contractor’s proposal narrative showing timelines and example(s) of past experience providing this type of customized reports to governmental or non-governmental public health entity or entities. The Government shall evaluate the likelihood that Offeror can submit customized reports in a timely manner per the Statement of Work requirements.

Factor 3- Qualifications of Key Personnel

The Government will evaluate Offeror’s demonstrated ability to provide qualified and experienced personnel. This evaluation will be made on how well the proposed personnel meet the requirements as stated in the statement of work. The offeror shall provide a narrative in which the Offeror identifies key personnel under the contract and letters of commitment from proposed key personnel. At a minimum, the project manager and a subject matter expert shall be designated as key personnel. If the Offeror believes that other individuals should be deemed key personnel, it should explain why. The narrative should describe the roles of key personnel and expected contributions of each individual identified.

Price Evaluation - Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options will not obligate the Government to exercise the option(s).

In considering the price of the base period and any option periods, the Government will consider that if the extension of service clause (FAR 52.217-8) is exercised, it will be on the exact same rates and terms, other than length of performance, as the base or option period being extended. Prior to making an award, the Government shall determine that the price, inclusive of all options (including the options available under FAR 52.217-8), is fair and reasonable, and that the price of the base period and all option periods (including any potential option(s) represented by FAR.

1.8 52.252.-1 Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. 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. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

Provisions Number Title

(End of provision)

1.8.1 Authorized Deviations in Provisions (Nov 2020)

(a) The use in this solicitation of any Federal Acquisition Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the provision.

(b) The use in this solicitation of any ______________ [insert regulation name](48 CFR Chapter______) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of provision)

Part 2: Schedule of Services (all shipping and handling shall be included in the price)

Item #

Task 4 B - Monthly Quarterly Meeting

EA

EA

Total:

Task 4 B - Monthly

EA

EA

Total:

Task 4 B - Monthly

EA

EA

Total:

Task 4 B - Monthly

EA

EA

Total:

Task 4 B - Monthly

EA

EA

Total:

Grand Total (All Periods)

Part 3: Statement of Work (SOW)

Rapid Nicotine Pouch Data

3.1 Background

FDA’s Center for Tobacco Products (CTP) regulates the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use, particularly among youth. CTP oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. On August 8, 2016, the U.S. Food and Drug Administration finalized a rule that extends its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco, as part of its goal to improve public health. Additionally, effective April 14 (2022), Congress passed a federal law which went into effect on April 14, 2022, clarifying FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine.

3.2 Objective

To effectively regulate the rapidly changing U.S. commercial tobacco and nicotine marketplace for ENDS and nicotine pouches, as required by the law, the Government intends to obtain sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on predominant and emerging ENDs and nicotine pouch brands and tobacco use among youth and young adults.

3.3 Scope

For the base period and option period 1 – 4, as outlined below, the contractor shall provide FDA with reports summarizing data from their data collection efforts related to ENDS and nicotine pouches. At a minimum, reports should include data on the following topics: (i) ENDS and nicotine pouch use overall, (ii) sources of purchase, and (iii) use by top and emerging brands among youth and young adults, and (iv) other potential topics both parties agree upon.

3.4 Tasks

Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults For the base year and option years 1 – 4, the contractor shall provide a total of 12 monthly reports (1/month) summarizing findings from their existing continuous tracking survey implemented with an online sample of youth and young adults or similar data collection effort to obtain sentinel surveillance information from youth and young adults. Each monthly report shall be delivered no more than 30 days after the last day of that month (e.g., a report based on data from May 1st- May 31st, 2026, should be delivered no later than June 30th, 2026). Each monthly report shall be delivered with thorough and detailed documentation of relevant survey questions, sampling approach, data collection methods employed, and response rates achieved; data analysis methods and relevant data/analytic assumptions.

The report shall include:

· A brief, organized summary of the key findings and overall results in a tabular format or other simple format approved by the government,

· A technical appendix documenting in detail the relevant survey questions, sampling approach, data collection methods employed, and response rates achieved; data analysis methods and assumptions used by the Contractor to obtain the results described; and any additional detail related to the methodology necessary to help the government appropriately interpret the key findings and overall results,

· PowerPoint slides with plugged aggregated monthly and quarterly estimates and charts that include youth use and brand information noted above to present the summary of the report that includes an appendix with a table of monthly estimates for each slide (wherever applicable).

Task 2: Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults For the base year and option years 1 – 4, the contractor shall provide a total of 2 reports from each wave/data collection effort of their longitudinal cohort study implemented with a nationally representative online panel (2 reports). Each report shall be delivered no more than 30 days after the last date of data collection for that wave. Each report shall be delivered with a thorough and detailed documentation of the methodology employed for data collection and analysis.

The report shall include:

· A brief, organized summary of the key findings and overall results in a tabular format or other simple format approved by the government,

· A technical appendix documenting in detail the data collection methods employed including the sampling design/approach and response rates achieved; data analytical methods and assumptions used by the Contractor to obtain the results described; and any additional detail related to the methodology necessary to help the government appropriately interpret the key findings and overall results, and

· A PowerPoint file PowerPoint slides with plugged aggregated monthly and quarterly estimates and charts that include survey findings to present the summary of the report.

Task 3: Ad Hoc Topic-Specific Reports For the base year and option years 1 – 4, the contractor shall provide topic-specific reports (2 reports summarizing tobacco data from youth and young adults pertaining to a specific topic to be determined by the government after contract award, e.g., use of flavored tobacco products). These reports shall be delivered by the end of each base period/option year.

Task 4: Meetings A. Kick-Off Meeting- The contractor shall participate in a project kick-off call with the CTP project team, including the COR, within 14 business days after start of the Period of Performance. The purpose of this meeting is to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting minutes to the COR within 48 hours of meeting date.

B. Monthly Status Meetings-The contractor shall share PowerPoint slides and meeting agenda with latest aggregated monthly and quarterly estimates at least 24 hours ahead of scheduled 30-minute monthly meetings and one-hour quarterly meetings with FDA staff (via teleconference). During these meetings, the contractor shall present and discuss deliverables completed during period; problems or issues projected or identified; and alternatives and/or recommended solution(s) for identified or projected problems or issues. The contractor shall also provide meeting minutes to FDA staff within 48 hours of meeting date.

3.5 Deliverables

1 kickoff meeting

Kick-off meeting: within 14 business days after start of the Period of Performance

Meeting notes: Within 48 hours of the last scheduled meeting

Quarterly meeting: At the end of every quarter

Meeting notes: Within 48 hours of the last scheduled meeting

3.6 Government-Furnished Property (GFP)

No government furnished property will be provided to the Contractor.

3.7 Security Considerations

Not applicable

3.8 Travel

No travel is anticipated in the performance of this contract.

3.9 Special Material Requirements

None

3.10 Other Unique Requirements and Considerations

None

3.11 Place of performance

It is expected that the Contractor shall perform all Task work at its own place of business. Monthly and quarterly meetings shall be held via teleconference or video conference. A kick-off meeting will be held after award via teleconference.

3.12 Period of Performance

The base period is expected to be 12 months from the date of contract execution. Option Year 1 will be 12 months from the end of the base period. All subsequent base periods (i.e., Option years 2-4) will also be 12 months from the end of the previous option year. The total duration of the contract will be 60 months from the date of contract execution.

Part 4: Contract Clauses

4.1 52.252-2 Clauses Incorporated By Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

Clauses Number Title

(End of clause)

4.1.1 Authorized Deviations in Clauses (Nov 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any HHSAR clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

4.2 Department of Health and Human Services Acquisition Regulation (HHSAR) Clauses:

4.2.1 Contractor Compliance with Defending Women and Protecting Children Requirements – Certification (MARCH 2025) (DEVIATION)

(a) Certification. By submission of this offer and during performance of this contract, including the obligation, expenditure, or drawdown of funds, the contractor certifies that: [Offeror shall check each item.] ___ (1) It is compliant with Title IX of the Education Amendments of 1972, as amended, 20 U.S.C. §§ 1681 et seq., including the requirements set forth in Presidential Executive Order 14168 titled Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, and Title VI of the Civil Rights Act of 1964, 42 U.S.C. §§ 2000d et seq., and Contractor will remain compliant for the duration of the contract.

___ (2) The above requirements are conditions of payment that go the essence of the contract and are therefore material terms of the contract.

___ (3) Payments under the contract are predicated on compliance with the above requirements, and therefore the Contractor is not eligible for funding under the contract or to retain any funding under the contract absent compliance with the above requirements.

___ (4) This certification reflects a change in the Government’s position regarding the materiality of the foregoing requirements and therefore any prior payment of similar claims does not reflect the materiality of the foregoing requirements to this contract.

____ (5) Submitting a knowing false statement relating to Contractor’s compliance with the above requirements and/or eligibility for the contract may subject Contractor to liability under the False Claims Act, 31 U.S.C. § 3729, and/or criminal liability, including under 18 U.S.C. §§ 287 and 1001.

(b) Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

(End of provision)

4.2.2 352.209-2 Contractor Compliance with Defending Women and Protecting Children Requirements (March 2025) (DEVIATION)

352.232-71 Electronic Submission of Payment Requests (APR 2026) (RFO DEVIATION)

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements in FAR 32.905(b), and the applicable payment clause included in this contract.

(b) Submission instructions. Except as provided in paragraph (c) of this clause, the Contractor must submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) Alternate submission procedures. The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing.

(d) Submission of alternate payment procedures authorization. If alternate payment procedures are authorized, the Contractor must include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

4.2.3 352.239-79 Information and Communication Technology Accessibility (Feb 2024) (Deviation)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all information and communication technology (ICT) supplies, products, platforms, information, documentation, and services support developed, acquired, maintained or delivered under this contract or order must comply with the Revised 508 Standards, which are located at 36 C.F.R. 1194.1 and Appendices A, B, and C, and are available at https://www.access-board.gov/ict/. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.

(b) Additional Section 508 accessibility standards applicable to this contract or order may be identified in the specification, statement of work, or performance work statement. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) In the event of a modification(s) to this contract or order, which adds new ICT supplies or services or revises the type of, or specifications for, supplies, products, platforms, information, documentation, or services support, the Contracting Officer shall require that the Contractor submit a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies or services conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies, products, platforms, information, documentation, and services support provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(d) If this is an Indefinite-Delivery type contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include ICT supplies, products, platforms, information, documentation, or services support will define the specifications and accessibility standards for the order. In those cases, the Contractor shall be required to provide a completed HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an ACR (based on the VPAT see https://www.itic.org/policy/accessibility/vpat), and any other additional information necessary to assist the Government in determining that the ICT supplies, products, platforms, information, documentation, or services support conform to Section 508 accessibility standards. If it is determined by the Government that ICT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) The contractor shall identify to the Contracting Officer any perceived exception or exemption to Section 508 requirements.

(End of clause)

4.2.4 Contract Administration

a. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is: Name: Madeline Bryant, Contracting Officer Phone: 240-402-7611 Email: Madeline.Bryant@fda.hhs.gov

The contact information for the Contract Specialist is:

Name: Pamela Lee, Contract Support Specialist Phone: 240-402-3847 Email: Pamela.Lee@fda.hhs.gov

b. The COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The following COR will represent the Government for the purpose of this contact: Name: (To be completed at time of award) Email:

Phone:

4.2.5 Inspection/Acceptance

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the COR specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

4.2.6 Payment Terms

Net 30 days after government acceptance of a proper invoice which shall only be submitted after services have been performed. In accordance with the “Advance Payment Statute” at 31 U.S.C § 3324: Advance payments will not be made.

4.2.7 Invoice Submission

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 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…