FDA-RFQ-1238678 solicitation FINAL 7 28 2021 2 18 PM.pdf

FDA-RFQ-1238678

Tobacco Youth and Adult Sentinel Surveillance Reports

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Document Type: Combined Synopsis/Solicitation Solicitation Number: FDA-RFQ-1238678 Posted Date: 28 July 2021 Response Date: 18 August 2021 Contractor Questions Date: 04 August 2021 NAICS Code: 541910: Market Research and Public Opinion Polling

Small Size Standard: $15,000,000.00 Full and Open Competition

Part 1 – Description The U.S. Food and Drug Administration’s (FDA) needs to obtain sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on tobacco use (including the use of e-cigarettes/vaping products) and related measures f rom youth and young adults. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-05, March 10, 2021. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541910 Market Research and Public Opinion Polling, Small Size Standard

$15,000,000.00. THIS REQUIREMENT IS A FULL AND OPEN COMPETITION.

Part 2 – Supplies or Services and Prices Contract Type: Firm-Fixed Price

CLIN Service and Supply Description Quantity Unit Price

Firm-Fixed Price

Base Year Task 1: Sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on tobacco use (including the use e-cigarettes/vaping products) and related measures from youth and young adults:

Reports summarizing data from their data collection efforts: including monthly reports from a continuous tracking survey implemented with an online sample of youth and young adults. This tracking survey should yield data from approximately 250 respondents (aged 15 – 24 years reports

2 | P a g e of age)/week(12 reports);

Base Year Task 2 OPTIONAL: Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults- topic-specific reports (2 reports summarizing recent tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored e-cigarettes; use of newly FDA-authorized tobacco products; do-it-yourself behaviors of youth and young adults related to tobacco products, such as mixing of e-liquids).

2 reports

Base Year Task 3: AdHoc Topic-Specific Reports:

topic-specific reports (2 reports summarizing tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored tobacco products). These reports shall be delivered by the end of each period of performance.

Base Year Task 4: Kickoff Meeting - Project kick-off call with FDA staff within 14 business days after period of performance start date. The contractor shall meet with FDA staff to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting minutes to FDA staff within 48 hours of meeting date.

Meeting minutes

Base Year Task 4a: Monthly Status Report Meeting - Monthly basis, or more frequently if necessary, to discuss progress. 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 provide meeting agendas at least 24 hours prior to meeting with FDA and shall provide meeting minutes to FDA staff within 48 hours of meeting date.

monthly status

BASE YEAR TOTAL

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Option Year 1: Task 1- Sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on tobacco use (including the use e-cigarettes/vaping products) and related measures from youth and young adults: - Reports summarizing data from their data collection efforts: including monthly reports from a continuous tracking survey implemented with an online sample of youth and young adults. This tracking survey should yield data from approximately 250 respondents (aged 15 – 24 years of age)/week(12 reports);

Option Year 1: Task 2 OPTIONAL - Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults- topic-specific reports (2 reports summarizing recent tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored e-cigarettes; use of newly FDA-authorized tobacco products; do-it-yourself behaviors of youth and young adults related to tobacco products, such as mixing of e-liquids).

Option Year 1 : Task 3: AdHoc Topic-Specific Reports: topic-specific reports (2 reports summarizing tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored tobacco products). These reports shall be delivered by the end of each period of performance.

Option Year 1: Task 4: Kickoff Meeting - Project kick-off call with FDA staff within 14 business days after period of performance start date. The contractor shall meet with FDA staff to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting

Minutes

0010 Option Year 1: Task 4a: Monthly Status Report Meeting - Monthly basis, or more frequently if

4 | P a g e necessary, to discuss progress. 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 provide meeting agendas at least 24 hours prior to meeting with FDA and shall provide

OPTION YEAR 1 TOTAL

Option Year 2 : Task 1-Sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on tobacco use (including the use e-cigarettes/vaping products) and related measures from youth and young adults:

Reports summarizing data from their data collection efforts: including monthly reports from a continuous tracking survey implemented with an online sample of youth and young adults. This tracking survey should yield data from approximately 250 respondents (aged 15 – 24 years of age)/week(12 reports); ]

Option Year 2: Task 2 OPTIONAL - Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults- topic-specific reports (2 reports summarizing recent tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored e-cigarettes; use of newly FDA-authorized tobacco products; do-it-yourself behaviors of youth and young adults related to tobacco products, such as

Option Year 2 : Task 3: AdHoc Topic-Specific Reports: topic-specific reports (2 reports summarizing tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored tobacco

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Option Year 2: Task 4: Kickoff Meeting - Project kick-off call with FDA staff within 14 business days after period of performance start date. The contractor shall meet with FDA staff to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting

Option Year 2: Task 4a: Monthly Status Report Meeting - Monthly basis, or more frequently if necessary, to discuss progress. 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 provide meeting agendas at least 24 hours prior to meeting with FDA and shall provide

OPTION YEAR 2 TOTAL

Option Year 3: Task 1-Sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on tobacco use (including the use e-cigarettes/vaping products) and related measure Reports summarizing data from their data collection efforts: including monthly reports from a continuous tracking survey implemented with an online sample of youth and young adults. This tracking survey should yield data from approximately 250 respondents (aged 15

– 24 years of age)/week(12 reports);

Option Year 3: Task 2 OPTIONAL - Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults- topic-specific reports (2 reports summarizing recent tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored e-cigarettes; use of newly FDA-authorized tobacco products; do-it-yourself behaviors of youth and

6 | P a g e young adults related to tobacco products, such as

Option Year 3 : Task 3: AdHoc Topic-Specific Reports: topic-specific reports (2 reports summarizing tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored tobacco

Option Year 3: Task 4: Kickoff Meeting - Project kick-off call with FDA staff within 14 business days after period of performance start date. The contractor shall meet with FDA staff to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting

Option Year 3: Task 4a: Monthly Status Report Meeting - Monthly basis, or more frequently if necessary, to discuss progress. 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 provide meeting agendas at least 24 hours prior to meeting with FDA and shall provide

OPTION YEAR 3 TOTAL

Option Year 4 : Task 1-Sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on tobacco use (including the use e-cigarettes/vaping products) and related measures from youth and young adults:

Reports summarizing data from their data collection efforts: including monthly reports from a continuous tracking survey implemented with an online sample of youth and young adults. This tracking survey should yield data from

7 | P a g e approximately 250 respondents (aged 15 – 24 years of age)/week(12 reports);

Option Year 4: Task 2 OPTIONAL - Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults- topic-specific reports (2 reports summarizing recent tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored e-cigarettes; use of newly FDA-authorized tobacco products; do-it-yourself behaviors of youth and young adults related to tobacco products, such as

Option Year 4 : Task 3: AdHoc Topic-Specific Reports: topic-specific reports (2 reports summarizing tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored tobacco

Option Year 4: Task 4: Kickoff Meeting - Project kick-off call with FDA staff within 14 business days after period of performance start date. The contractor shall meet with FDA staff to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting

Option Year 4: Task 4a: Monthly Status Report Meeting - Monthly basis, or more frequently if necessary, to discuss progress. 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 provide meeting agendas at least 24 hours prior to meeting with FDA and shall provide

OPTION YEAR 4 TOTAL

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GRAND TOTAL

Company Name: ________________________ DUNS Number: ________________________

Payment is only authorized for the respective firm-fixed-price upon successful completion of the respective CLINs, including delivery and acceptance of all deliverables, as determined by the FDA Contracting Officer’s Representative (COR) according to the Statement of Work, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below. (Invoices shall be submitted per instructions for each CLIN #)

Part 3 – Description/Specifications:

Background:

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act. This historic legislation granted the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products. The FDA then established the Center for Tobacco Products (CTP) to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by youth. CTP oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. To inform tobacco regulation, CTP’s Office of Science needs sentinel surveillance reports summarizing findings from existing data collection efforts implemented with youth and young adults about their use of tobacco products and other tobacco products, including e-cigarettes/vaping products; and related measures including access; experimentation; device type and flavor; knowledge, beliefs, and attitudes; exposure to pro-tobacco and anti-tobacco marketing.

Objectives/Purpose:

As a result of this Request for Proposal, 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 tobacco use (including use of e-cigarettes and vaping products) and related measures from youth and young adults.

3.2 Statement of Work:

a. For the base year and option years 1 – 4, the contractor shall provide FDA with reports summarizing data from their data collection efforts: including monthly reports from a 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. This tracking survey should yield data from a minimum of 250 respondents (approximately 15 – 24 years of age)/week(12 reports); OPTIONAL; and topic-specific reports (2 reports summarizing recent tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored e-cigarettes; use of newly

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FDA-authorized tobacco products; do-it-yourself behaviors of youth and young adults related to tobacco products, such as mixing of e-liquids).

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, 2021, should be delivered no later than June 30th, 2021). Each monthly 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 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 to present the summary of the report.

Task 2: Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults - OPTIONAL For the base year and option years 1 – 4, the contractor shall provide a total of 2 reports report 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 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 to present the summary of the report.

Task 3: AdHoc Topic-Specific Reports

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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, e.g., access to tobacco products; 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 FDA staff within 14 business days after award. The contractor shall meet with FDA staff to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting minutes to FDA staff within 48 hours of meeting date.

B- Monthly Status Meetings-The contractor shall meet with FDA staff (via teleconference) on a monthly basis, or more frequently if necessary, to discuss progress. 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 provide meeting agendas at least 24 hours prior to meeting with FDA and shall provide meeting minutes to FDA staff within 48 hours of meeting date.

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Tasks, Deliverables and Milestones:

Base Year Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults or similar data collection effort to obtain sentinel surveillance information from youth and young adults Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth and Young Adults (OPTIONAL) Task 3: Ad-Hoc Topic-Specific Reports Task 4: Meetings

September 2021– September 2022

Option Year 1 Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults or similar data collection effort to obtain sentinel surveillance information from youth and young adults Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth and Young Adults (OPTIONAL) Task 3: Ad-Hoc Topic-Specific Reports Task 4: Meetings

September 2022 – September 2023

Option Year 2 Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults or similar data collection effort to obtain sentinel surveillance information from youth and young adults Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth and Young Adults (OPTIONAL) Task 3: Ad-Hoc Topic-Specific Reports Task 4: Meetings

September 2023 – September 2024

Option Year 3 Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults or similar data collection effort to obtain sentinel surveillance information from youth and young adults Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth

September 2024 – September 2025

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September 2025 – September 2026

KEY PERSONNEL:

The Key Personnel specified for this contract are essential to work performance. Pursuant to HHSAR Clause 352.237-75, Key Personnel (December 2015), the Key Personnel for this contract are identified below.

The Contractor shall provide a Project Director (PD) who will serve as the principal point of contact for the Government. The Project Director shall:

• Assign, supervise, and coordinate contractor staff and consultants/subcontracts.

• Be responsible for ensuring that no contractor staff, nor subcontractors, has any conflict of interest, nor is engaged in any activity that might give rise to an appearance of a conflict of interest, with respect to the evaluation projects or tasks they have been assigned.

• Assure that data on the cost and progress of all tasks is available in regular reports and upon request.

• Maintain budget control.

• Serve as a liaison between contractor staff and CTP; keep COR apprised of progress made toward each assigned project.

• Assure and monitor the quality of all work products, notify the COR as soon as practicable of any problems encountered in completing any work tasks.

• Maintain close communication with the COR.

• Provide staffing continuity.

• Monitor progress on each assigned project and ensure that requirements are fulfilled.

• Prepare reports.

The PD shall be in contact with the COR on a regular basis, including monthly conference calls to discuss and review completed work, active work, quality control issues, staff assignments, timelines, and costs. The COR and FDA staff shall meet with the Contractor for, at least as often as every two weeks, and provide technical guidance for program activities. The PD shall provide copies of all relevant reports, emails and other communications.

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Subject Matter Expert – Desired Qualifications: Expert in the field of tobacco research , with specific expertise in surveillance as it relates to monitoring changes in tobacco use attitudes and behaviors among youth and young adults.

Project Director – Desired Qualifications: Experience managing projects, especially tobacco-related research projects focused on youth and young adults

CONTRACTOR NOTICE REGARDING LATE DELIVERY

In the event the contractor, for any reason, anticipates or encounters difficulty in complying with the contract delivery schedule or performance date or in meeting any of the requirements of the contract, the contractor shall immediately provide written notification to the Contracting Officer, via the cognizant Contract Administration Service Office, if assigned, giving pertinent details. This data shall be informational in character and that its receipt by the Government shall not be construed as a waiver by the Government of (a) any delivery schedule or date or (b) compliance with other requirements by the contractor or (c) any other rights or remedies provided to the Government by law or under this contract.

CONFLICT OF INTEREST

Organizational 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 of section VII 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

14 | P a g e 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.

PART 4: Inspection and Acceptance:

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• The COR will inspect and accept the deliverables. In the event a deliverable is not accepted, CTP will provide edits to the contractor within 30 days, the contractor has 10 business days to update and resubmit the deliverable.

• The COR must approve final deliverable(s) and coordinate the appropriate level of clearance before printed, recorded, etc.

• The COR and contractor will meet monthly to discuss progress of the various tasks.

Period of Performance:

9/20/2021 - 9/19/2022 – Base Year 9/20/2022 - 9/19/2023 – Option Year 1 9/20.2023 - 9/19/2024 – Option Year 2 9/20/2024 - 9/19/2025 – Option Year 3 9/20/2025 – 9/19/2026 – Option Year 4

Place of Performance:

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

Contract Type:

Firm-Fixed Price

Government Furnished Property (GFP)/Information (GFI):

Not applicable.

PART 5: Contract Administration

5.1 Representative’s

For this PART, Janine Delahanty is the authorized representative of the Contracting Officer.

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment and services to be provided.

The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances;

and (5) assisting in the resolution of technical problems encountered during performance.

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The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or o therwise change any terms and conditions of this order.

The contact information for the COR is the following:

Janine Delahanty U.S. Food and Drug Administration

CTP

janine.delahanty@fda.hhs.gov 240-402-9705

The contact information for the Contracting Officer is the following:

Terry Frederick U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 terry.frederick@fda.hhs.gov

The contact information for the Contract Specialist is the following:

Howard S. Yablon U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 howard.yablon@fda.hhs.gov 240-402-7630

5.2 FDA Three-Way Match Invoicing Procedures

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Office of Financial Services 10903 New Hampshire Ave WO32 - Second Floor mailto:janine.delahanty@fda.hhs.gov mailto:terry.frederick@fda.hhs.gov mailto:howard.yablon@fda.hhs.gov

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MAIL HUB 2145

Silver Spring, MD 20993-0002

Phone: 301-827-3742 Email: FDAVendorPaymentsTeam@fda.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Time-and-Materials and Labor-Hour Awards, 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;

(xiii) Any other information or documentation required by the award.

mailto:FDAVendorPaymentsTeam@fda.gov https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html

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C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the email address or phone number provided above in Section A.

Part 6 – Contract clauses

6.1 HHSAR Clauses Incorporated by Reference

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: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses.

352.202-70 ANTI-LOBBYING (DEC 2015)

352.211-3, PAPERWORK REDUCTION ACT (DEC 2015)

352.222-70, CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS (DEC 2015)

352.2224-71, CONFIDENTIAL INFORMATION (DEC 2015)

352.227-70, PUBLICATIONS AND PUBLICITY (DEC 2015)

352.237-75 KEY PERSONNEL (DEC 2015)

352.239-75 ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE (DEC

2015)

6.2 FAR Clauses Incorporated by Reference

52.204-22, Alternative Line Item Proposal (Jan 2017) 52.204-70 System for Award Management (Oct 2018) 52.212-1, Instructions to Offerors—Commercial Items (Jun 2020) 52.212-4, Contract Terms and Conditions—Commercial Items (Oct 2018) 52.227-15, Rights in Data – General (May 2014) 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

6.3 FAR Clauses Full Text

52.204-8 Annual Representations and Certifications.

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Annual Representations and Certifications (Oct 2018) (a)

(1) The North American Industry Classification System (NAICS) code for this acquisition is 541990 All Other Professional, Scientific and Technical Services

(2) The small business size standard is $15,000,000.00.

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is $15,000,000.00.

(b)

(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

[_] (i) Paragraph (d) applies.

[_] (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)

(1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures;

or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements—Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations—Representation.

(vii) 52.209-5; Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(viii) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

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(ix) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(x) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xi) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(xii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiii) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xiv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xvi) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xvii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA- designated items.

(xviii) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals— Representation. This provision applies to solicitations that include the clause at 52.204-7.

(xix) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xx) 52.225-4, Buy American--Free Trade Agreements--Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $80,317, the provision with its Alternate II applies.

(D) If the acquisition value is $80,317 or more but is less than $100,000, the provision with its Alternate III applies.

(xxi) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan--Certification.

This provision applies to all solicitations.

(xxiii) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certification. This provision applies to all solicitations.

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(xxiv) 52.226-2, Historically Black College or University and Minority Institution Representation.

This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.] ___ (i) 52.204-17, Ownership or Control of Offeror.

___ (ii) 52.204-20, Predecessor of Offeror.

___ (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

___ (iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Certification.

___ (v) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification.

___ (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Alternate I only).

___ (vii) 52.227-6, Royalty Information.

___ (A) Basic.

___ (B) Alternate I.

___ (viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The Offeror has completed the annual representations and certifications electronically in SAM accessed through https://www.sam.gov. After reviewing the SAM information, the Offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of Provision)

52.204-21, Basic Safeguarding of Covered Contractor Information Systems

BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)

(a) Definitions. As used in this clause– https://www.sam.gov/

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“Covered contractor information system” means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

“Federal contract information” means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

“Information” means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

“Information system” means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

“Safeguarding” means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information http://uscode.house.gov/

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