FDA-21-SOL-1238617.pdf

Commercial Marketing and Sales Data Center for Tobacco Products

Office of Science

FDA-21-SOL-1238617

1.0 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 implements and supports various internal and external research activities designed to expand the science base for tobacco regulation. One of these research activities is monitoring tobacco product sales to examine differences in sales across tobacco products at a particular point-in-time, and potential changes in sales of tobacco products over time.

It is important for CTP to obtain information on tobacco product sales: 1) by product category (e.g., cigarettes, cigars, dissolvables, heated tobacco products, hookah tobacco, nicotine gels, pipe tobacco, roll-your-own tobacco, smokeless, e-cigarettes/electronic nicotine delivery systems; and nicotine replacement therapy for tobacco cessation); 2) by channel (e.g., food, drug, convenience, mass merchandise, online/internet, and specialty shops, including cigar bars and “vape shops”); and

3) by certain product attributes (e.g., brand, product type, flavor, and nicotine content).

The purpose of this fixed-price contract is for CTP to have access to information to effectively regulate the tobacco industry and reduce the risks to health from tobacco. Having full knowledge and understanding of the US tobacco industry and tobacco marketplace requires CTP to be able to measure the size, scope, direction of evolution, value and financial condition of the tobacco industry in this country and overseas. Effective regulation necessitates a full knowledge of the history of the individual companies in the tobacco industry and the history of the industry as whole.

1.1 Objectives

As a result of the Request for Proposal, the Government intends to obtain tobacco-related secondary sales data (including, but not limited to, retail scanner data, deidentified household purchasing data, and online purchasing data). The objective of this project is to provide ongoing tobacco product sales data from retailers and consumer purchasing data to understand the effects in the marketplace of CTP regulatory actions.

2.0 WORK STATEMENT

The contractor shall provide FDA with nationally and sub-nationally (i.e., census region, census division, major metropolitan market, and local market) representative existing, commercially available tobacco products sales data; including both retail scanner data and household or consumer purchasing scanner data. For the purposes of this contract, tobacco products include, but are not limited to: cigarettes, cigars, electronic nicotine delivery systems (ENDS), smokeless tobacco, pipe tobacco, roll-your-own tobacco, over-the-counter nicotine replacement therapy, nicotine gels, and tobacco accessories. The contractor shall provide FDA with the data so the tobacco product categories, listed previously, can easily be identified and analyzed on their own. The data shall be collected using scientifically sound and well-documented methodologies. Additional details on FDA’s specifications for these data are outlined below.

2.1 Task 1: Retail Scanner Data

A- Data Delivery: The contractor shall provide existing, commercially available, retail scanner data to the Government on a monthly basis. Aggregated weekly data shall be delivered no more than 30 days after the last day of that month (e.g., data collected from May 1st- May 31st, 2021, should be delivered no later than June 30th, 2021). Data shall be in a form that allows for further analysis by FDA and a contractor working on behalf of FDA, such as a data format that is readable for STATA, SPSS, or SAS. Format shall be proposed by the contractor and approved by FDA. Data shall be delivered via a File Transfer Protocol (FTP) link or another method recommended by the contractor that results in timely and efficient receipt of the data by FDA. Data delivery process shall be proposed by the contractor and approved by FDA.

B- Draft Data Documentation: Data shall be delivered with thorough documentation, including a data dictionary that fully describes the contents, format, labels, and frequencies of each variable and associated variable value(s); detailed methodology reports that cover the scope of the data collection, data collection process, data quality controls, data structure(s), and limitations of the database(s); as well as documentations that describe the relationship between these elements. The contractor shall also submit any other materials the FDA and an FDA third-party contractor working on behalf of FDA needs to fully understand the data for analysis purposes; including, but not limited to, a list of frequently asked questions to the database(s) or detailed information about the file format and instructions on how to use it. The contractor shall provide the COR with a draft data dictionary and other complete descriptions of the databases and variables within 30 calendar days of contract award.

C- Final Data Documentation: Following review and approval of the draft data dictionary and other complete descriptions of the datasets and variables, the contractor shall provide the COR with final documents within ten business (10) days after receiving and incorporating the COR’s comments.

D- Data Disaggregation: Data shall be reported by week.

E- Data Specifications: The contractor shall provide tobacco product retail scanner data. The retail scanner data provided shall include or be available by each of the four components identified below. This data will be aggregated by product UPC code.

1- Geographic Locations: Retail scanner data that are representative of, and can be analyzed at, a national level, and also at the following sub-national levels: census region (Northeast, Midwest, South and West as defined by the US Census Bureau), census division (groupings of states in census regions as defined by the US Census Bureau), and major metropolitan market (as defined by the US Census Bureau).

2- Sales Locations: Retail scanner data available by type of retail outlet or channel. FDA requires sales data from a representative sample of retail outlets and channels. Examples of retail outlets and channels FDA would like data on include convenience stores (including, but not limited to small format stores, convenience independents [franchised, independents with gas, independents without gas]); food and drug markets (including but not limited to chain supermarkets, independent grocery stores, chain drug stores, and independent drug stores); food, drug, and mass merchandisers (including but not limited to food and drug markets, mass merchandisers, club stores, Walmart, military, and dollar stores). FDA would like the data to specify the type of retailer or store, so we are able to examine data by type of retailer or store.

3-Tobacco Product Details: Retail scanner data shall be available in both dollar and volume sales by manufacturer (or brand owner); product type; product sub-type (if applicable); brand; sub-brand; and UPC code. The data shall contain detailed product characteristics, including, but not limited to, product label, package size, product size, product flavor, nicotine strength or content; promotional information (e.g., buy 1 get 1 free), and any other marketing information that is available by UPC code. Contractor shall provide clear documentation on the type of UPC (e.g., type of GTIN number:

http://www.gtin.info/). If applicable, the contractor shall provide clear documentation on how to convert the existing data to a standardized UPC form. Documentation on missing characteristics or data fields is also required.

4- Sales Amount: Retail scanner data shall include any information the contractor has related to tobacco product (as defined above) sales in both dollars and units.

F- Terms of Use: The contractor shall allow FDA to share raw data and aggregate findings from reports and data analyses with its staff and an FDA third-party contractor working on behalf of FDA for FDA-directed analyses. Additionally, the contractor shall allow FDA to share aggregate findings from reports and data analyses with other government agencies, non-governmental organizations, and publish findings. The contractor shall allow FDA to disseminate aggregate findings and results in various formats, such as, but not limited to presentations, scientific publications, white papers, and reports; and through various channels, such as, but not limited to scientific journals, conferences, meetings, and the Internet.

2.2 Task 2: Historical Retail Scanner Data (Option Line Item)

Historical Data: The contractor shall provide access to as many years of historical retail scanner data the contractor has available, not to exceed five years. Historical retail scanner data shall be delivered in the same format as the current data to allow for comparison over time.

2.3 Task 3: Retail Scanner Data by Local Market (Option Line Item)

A- Data Delivery: The contractor shall provide existing, commercially available, retail scanner data by local market to the Government on a monthly basis. Aggregated weekly shall be delivered no more than 30 days after the last day of that month (e.g., data collected from May 1st- May 31st, 2021, should be delivered no later than June 30th, 2021). Data shall be in a form that allows for further analysis by FDA and a contractor working on behalf of FDA, such as a data format that is readable for STATA, SPSS, or SAS. Format shall be proposed by the contractor and approved by FDA. Data shall be delivered via a File Transfer Protocol (FTP) link or another method recommended by the contractor that results in timely and efficient receipt of the data by FDA. Data delivery process shall be proposed by the contractor and approved by FDA.

http://www.gtin.info/

B- Draft Data Documentation: Data shall be delivered with thorough documentation, including a data dictionary that fully describes the contents, format, labels, and frequencies of each variable and associated variable value(s); detailed methodology reports that cover the scope of the data collection, data collection process, data quality controls, data structure(s), and limitations of the database(s); as well as documentations that describe the relationship between these elements. The contractor shall also submit any other materials the FDA and an FDA third-party contractor working on behalf of FDA needs to fully understand the data for analysis purposes; including, but not limited to, a list of frequently asked questions to the database(s) or detailed information about the file format and instructions on how to use it. The contractor shall provide the COR with a draft data dictionary and other complete descriptions of the databases and variables within 30 calendar days of contract award.

C- Final Data Documentation: Following review and approval of the draft data dictionary and other complete descriptions of the datasets and variables, the contractor shall provide the COR with final documents within ten business (10) days after receiving and incorporating the COR’s

E- Data Specifications: The contractor shall provide tobacco product retail scanner data. The retail scanner data provided shall include or be available by each of the four components identified below. This data will be aggregated by product UPC code.

1- Geographic Locations: Retail scanner data that are representative of and can be analyzed at local market level (can be defined by county or a set of zip codes).

2-Tobacco Product Details: Retail scanner data shall be available in both dollar and volume sales by manufacturer (or brand owner); product type; product sub-type (if applicable); brand; sub-brand; and UPC code. The data shall contain detailed product characteristics, including, but not limited to, product label, package size, product size, product flavor, nicotine strength or content; promotional information (e.g., buy 1 get 1 free), and any other marketing information that is available by UPC code. Contractor shall provide clear documentation on the type of UPC (e.g., type of GTIN number:

http://www.gtin.info/). If applicable, the contractor shall provide clear documentation on how to convert the existing data to a standardized UPC form. Documentation on missing characteristics or data fields is also required.

3- Sales Amount: Retail scanner data shall include any information the contractor has related to tobacco product (as defined above) sales in both dollars and units.

F- Terms of Use: The contractor shall allow FDA to share raw data and aggregate findings from reports and data analyses with its staff and an FDA third-party contractor working on behalf of FDA for FDA-directed analyses. Additionally, the contractor shall allow FDA to share aggregate findings from reports and data analyses with other government agencies, non-governmental organizations, and publish findings. The contractor shall allow FDA to disseminate aggregate findings and results in various formats, such as, but not limited to presentations, scientific publications, white papers, and reports; and through various channels, such as, but not limited to scientific journals, conferences, meetings, and the Internet.

2.4 Task 4: Historical Retail Scanner Data by Local Market (Option Line Item)

Historical Data: The contractor shall provide access to as many years of historical retail scanner data by local market the contractor has available, not to exceed five years. Historical retail scanner data by local market shall be delivered in the same format as the current data to allow for comparison over time.

2.5 Task 5: Household Purchasing Scanner Data

The household purchasing data shall be provided to the Government at household level and shall include tobacco product transactions with both purchasing prices and the amount of products acquired at each transaction. The household purchasing scanner data shall include a longitudinal panel that tobacco product purchase information has been obtained from the same households across multiple years.

A- Data Delivery: The contractor shall provide existing, commercially available household purchasing scanner data delivered monthly. Aggregated weekly data shall be delivered no more than 30 days after the last day of that month (e.g., data collected from May 1st- May 31st, 2021, should be delivered no later than June 30th, 2021). Data shall be in a form that allows for further analysis by FDA and a contractor working on behalf of FDA, such as a data format that is readable for STATA, SPSS, or SAS. Format shall be proposed by the contractor and approved by FDA. Data shall be delivered via a File Transfer Protocol (FTP) link or another method recommended by the contractor that results in timely and efficient receipt of the data by FDA. Data delivery process shall be proposed by the contractor and approved by FDA.

B- Draft Data Documentation: Data shall be delivered with thorough documentation, including a data dictionary that fully describes the contents, format, labels, and frequencies of each variable and associated variable value(s); detailed methodology reports that cover the scope of the data collection, data collection process, data quality controls, data structure(s), and limitations of the database(s); as well as documentations that describe the relationship between these elements. The contractor shall also submit any other materials the FDA and an FDA third-party contractor working on behalf of FDA needs to fully understand the data for analysis purposes; including, but not limited to, a list of frequently asked questions to the database(s) or detailed information about the file format and instructions on how to use it. The contractor shall provide the COR with a draft data dictionary and other complete descriptions of the databases and variables within 30 calendar days of contract award.

C- Final Data Documentation: Following review and approval of the draft data dictionary and other complete descriptions of the datasets and variables, the contractor shall provide the COR with final documents with ten (10) business days after receiving and incorporating the COR’s

E- Data Specifications: The contractor shall provide household tobacco product purchasing scanner data based on the following specifications:

1- Geographic Locations: Data shall involve nationwide data collection and can be analyzed on a national level but also at the following sub-national levels: state; census division (groupings of states in census regions as defined by the US Census Bureau); major metropolitan market (as defined by the US Census Bureau); and designated market areas (if applicable).

2- Household Sociodemographic: Data shall include deidentified but unique individual household identification and household sociodemographic information. The household sociodemographic information shall include, but not limited to, household composition (e.g., married, living like married, or living along; with or without children in the household; and/or household size), household income, household head demographics (e.g.

age, race/ethnicity, employment, and/or education).

3- Purchasing Trip Details: Data shall include details associated with shopping trips of households with tobacco product purchases. These details shall include, but not limited to, the date of the shopping trip, total amount paid in dollars, the sales location, and the payment method for each transaction.

4-Tobacco Product Details: Data shall provide details on tobacco product purchased.

These details shall include but not limited to manufacturer (or brand owner); product type;

product sub-type (if applicable); brand; sub-brand; and UPC code. The data shall also contain detailed product characteristics, including, but not limited to, product label; package size, product size, product flavor, nicotine strength or content; promotional information (e.g., buy 1 get 1 free), and any other marketing information that is available by UPC code.

Contractor shall provide clear documentation on the type of UPC (e.g., type of GTIN number: http://www.gtin.info/). If applicable, the contractor shall provide clear documentation on how to convert the existing data to a standardized UPC form.

Documentation on missing characteristics or data fields is also required.

5- Tobacco Product Sales Amount: Data shall include tobacco product purchase amount in both dollar and units for each transaction. This shall include the quantity of each tobacco product purchased; the amount paid for each tobacco product; and the payment method.

F- Terms of Use: The contractor shall allow FDA to share raw data with its staff and an FDA third-party contractor working on behalf of FDA for FDA-directed analysis. Additionally, the contractor shall allow FDA to share aggregate findings from reports or data analysis with other government agencies, non-governmental organizations, and publish findings. The contractor shall allow FDA to disseminate aggregate findings and results in various formats, such as, but not limited to presentations, scientific publications, white papers, reports and through various channels, such as, but not limited to scientific journals, conferences, meetings, and the Internet.

2.6 Task 6: Historical Household Purchasing Scanner Data (Option Line Item) Historical Data: Access to as many years of historic household purchasing scanner data the contractor has available, not to exceed five years. Historic household purchasing scanner data shall be delivered in the same format as the current data to allow for comparison over time.

2.7 Task 7: Online Purchasing Data

The online purchasing data provided to the Government shall contain tobacco product sales through electronic commerce, including online venues of brick-and-mortar stores, or online-only retailers.

The data shall include both sales in dollars and the amount of products on a monthly basis (preferable), or a quarterly basis (less-preferable).

A- Data Delivery: The contractor shall provide existing, commercially available online purchasing data delivered quarterly. Data shall be delivered no more than 30 days after the last day of that month (e.g., data collected from May 1st- May 31st, 2021, should be delivered no later than June 30th, 2021). Data shall be in a form that allows for further analysis by FDA and a contractor working on behalf of FDA, such as a data format that is readable for STATA, SPSS, or SAS.

Format shall be proposed by the contractor and approved by FDA. Data delivery process shall be proposed by the contractor and approved by FDA.

B- Draft Data Documentation: Data shall be delivered with thorough documentation, including a data dictionary that fully describes the contents, format, labels, and frequencies of each variable and associated variable value(s); detailed methodology reports that cover the scope of the data collection, data collection process, data quality controls, data structure(s), and limitations of the database(s); as well as documentations that describe the relationship between these elements. The contractor shall also submit any other materials the FDA and an FDA third-party contractor working on behalf of FDA needs to fully understand the data for analysis purposes; including, but not limited to, a list of frequently asked questions to the database(s) or detailed information about the file format and instructions on how to use it. The contractor shall provide the COR with a draft data dictionary and other complete descriptions of the databases and variables within 30 calendar days of contract award.

C- Final Data Documentation: Following review and approval of the draft data dictionary and other complete descriptions of the datasets and variables, the contractor shall provide the COR with final documents with ten (10) business days after receiving and incorporating the COR’s comments.

D- Data Disaggregation: Data shall be reported by month (preferable), or by quarter (less-preferable).

E- Data Specifications: The contractor shall provide online tobacco product purchasing data based on the following specifications:

1- Geographic Locations: Data shall involve nationwide data collection and can be analyzed on a national and state levels.

2- Individual Sociodemographic: Data shall include sociodemographic information. The sociodemographic information shall include, but not limited to, age, sex, education, and income.

3- Purchasing Details: Data shall include details associated with tobacco product purchases. These details shall include, but not limited to, total amount paid in dollars, the total amount of product purchased, the retailer, shipping/delivery method, and the payment method for each transaction.

4-Tobacco Product Details: Data shall provide details on tobacco product purchased.

These details shall include but not limited to manufacturer (or brand owner); product type;

product sub-type (if applicable); brand; and sub-brand (if applicable). The data shall also contain product characteristics (if applicable), including, but not limited to, purchasing size, product flavor, and any other marketing information.

F- Terms of Use: The contractor shall allow FDA to share raw data with its staff and an FDA third-party contractor working on behalf of FDA for FDA-directed analysis. Additionally, the contractor shall allow FDA to share aggregate findings from reports or data analysis with other government agencies, non-governmental organizations, and publish findings. The contractor shall allow FDA to disseminate aggregate findings and results in various formats, such as, but not limited to presentations, scientific publications, white papers, reports and through various channels, such as, but not limited to scientific journals, conferences, meetings, and the Internet.

2.8 Task 8: Historical Online Purchasing Data (Option Line Item)

Historical Data: Access to as many years of historical online purchasing data the contractor has available, not to exceed three years. Historical online purchasing data shall be delivered in the same format as the current data to allow for comparison over time.

2.9: 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.

SECTION 5- DELIVERIES OR PERFORMANCE

5.1 CONTRACT PERIOD OF PERFORMANCE

The contract period of performance is to begin at the time of award. The exact date will be established when the contract award is made, but for the purposes of the solicitation the estimated award date of September 2021 will be used. Option Period 1 is for one additional year and begins immediately upon the expiration of the Base Year services. Option Years 2-4 are also for the period of one year and will begin upon expiration of the preceding Option Year. If exercised, the option years will extend the length of the contract by four additional years for a total of five years.

If exercised, the contract period of performance for Tasks exercised during the Option Years is to be identified in each modification that exercises the respective option. The aforementioned period of performance terms for the options shall apply only if the Government exercises the option in accordance with FAR 52.217-9.

The actual Period of Performance shall be established at the time of contract award, but estimated dates are provided below for planning purposes:

Base Year Task 1: Retail Scanner Data Task 2: Historical Retail Scanner Data (Option Line Item) Task 3: Retail Scanner Data by Local Market (Option Line Item) Task 4: Historical Retail Scanner Data by Local Market (Option Line Item) Task 5: Household Purchasing Scanner Data Task 6: Historical Household Purchasing Scanner Data (Option Line Item) Task 7: Online purchasing Data Task 8: Historical online Purchasing Data (Option Line Item) Task 9: Meetings

September 2021– September 2022

Option Year 1 Task 1: Retail Scanner Data Task 3: Retail Scanner Data by Local Market (Option Line Item)

Task 5: Household Purchasing Scanner Data Task 7: Online purchasing Data Task 9: Meetings

September 2022 – September 2023

Option Year 2 Task 1: Retail Scanner Data Task 3: Retail Scanner Data by Local Market (Option Line Item) Task 5: Household Purchasing Scanner Data Task 7: Online purchasing Data Task 9: Meetings

September 2023 – September 2024

Option Year 3 Task 1: Retail Scanner Data Task 3: Retail Scanner Data by Local Market (Option Line Item) Task 5: Household Purchasing Scanner Data Task 7: Online purchasing Data Task 9: Meetings

September 2024 – September 2025

Option Year 4 Task 1: Retail Scanner Data Task 3: Retail Scanner Data by Local Market (Option Line Item) Task 5: Household Purchasing Scanner Data Task 7: Online purchasing Data Task 9: Meetings

September 2025 – September 2026

5.2 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.

5.3 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. \

5.4 CONTRACT TYPE

Firm-fixed Price

SECTION 6 – 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 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 7 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Technical Representative: To be determined upon contract award

The Technical Representative 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.

Contracting Officer (CO): Contract Specialist (CS):

Gary Klaff Kyle Smith 4041 Powder Mill Road 4041 Powder Mill Road Beltsville, MD 20705 Beltsville, MD 20705 Gary.Klaff@fda.hhs.gov kyle.smith@fda.hhs.gov Tel: (240) 402-7555 Tel: (240) 402-7553

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 requirements; (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.

Contracting Officer’s Authority

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 statement of work; (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 Contracting Officer hereby delegates the COR as the Contracting Officer's authorized representative responsible for signing software license agreements issued as a result of this contract.

The Government may unilaterally change its COR designation.

Contracting Officer Representative’s Authority/FDA Project Manager

The COR and FDA Project Manager assigned to each order 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 COR and FDA project manager assigned to each order responsible for the technical requirements covered by this contract, as contemplated above, "Technical Monitoring" hereof, will be designated by separate correspondence.

Section 508 Compliance

The Contractor shall be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that documents generated as part of the tasks are fully Section 508-accessible using the available COTS tools. Each order will identif y the standards applicable to that order.

Post Award Evaluation of Contractor Performance (CPARS) mailto:Gary.Klaff@fda.hhs.gov mailto:kyle.smith@fda.hhs.gov http://www.section508.gov/ http://www.section508.gov/

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts.

Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the

CPARS.

Payment Schedule:

Unless otherwise agreed to by the Technical POC, the Contractor shall submit invoices subsequent to the delivery of the required equipment. Installation and training shall be invoiced after installation and training has been completed.

FDA Three-Way Match Invoicing Procedures:

A. The contractor shall submit all invoices to:

U.S FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 – Second Floor

MAIL HUB 2145

Silver Srping, MD 20993-0002 http://www.cpars.csd.disa.mil/cparsmain.htm http://www.cpars.csd.disa.mil/cparsmain.htm http://www.ppirs.gov/ http://www.ppirs.gov/ http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm

301-827-3742 Fdavendorpaymentsteam@fda.hhs.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 award item number 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) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(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 Inspections, 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.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in

(i) through (xiii) 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.

mailto:Fdavendorpaymentsteam@fda.hhs.gov

D. Questions regarding invoice payments should be directed to the 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.

PART 8 – CONTRACT PROVISIONS AND CLAUSES

FAR 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): www.acquisition.gov/far

The following HHSAR and FAR clauses are incorporated by reference:

52.212-1 - Instructions to Offerors – Commercial Items (Oct 2018) 52.212-2 - Evaluation – Commercial Items (Oct 2014) 52.212-3 - Offeror Representations and Certifications-Commercial Items (OCT 2018) 52.204-7 - System for Award Management (Oct 2018) 52.204-16 - Commercial and Government Entity Code Reporting (Jul 2016) 52.204-18 - Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-3 - Offeror Representations and Certifications -- Commercial Items (Oct 2018)

• If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.212-3 with this offer

52.219-1 - Small Business Program Representations (Oct 2014)

• If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.219-1 with this offer 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements- Representation. (Jan 2017) 52.219-8 Utilization of Small Business Concerns (Oct 2018) 52.219-14 Limitations on Subcontracting (Jan 2017) 52.222-26 Equal Opportunity (Sept 2016) 52.222-41 Service Contract Labor Standards (Aug 2018) 52.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 52.227-14 Rights in Data-General (May 2014) 52.227-17 Rights in Data-Special Works (Dec 2007) 52.232-40 Providing Accelerated Payments to Small Business (Dec 2013)

Provisions:

52.217-5 Evaluation of Options (Jul 1990) 52.219-6 Notice of Total Small Business Set-Aside (Nov 2011) 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015)

Full Text FAR Clauses relevant to this requirement:

52.217-8 Option to Extend Services (Nov 1999) mailto:ERIC@fda.hhs.gov http://www.acquisition.gov/far

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor at any time prior the end of the contract. (End of Clause)

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor at any time prior to contract termination; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months. (End of Clause)

FAR 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):

https://acquisition.gov/far/

52.204-13 – System for Award Management Maintenance (Oct 2018) 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013)

52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) (End of clause)

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2021)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(4)…