FDA-16-223-SOL-00029_Sections_B_thru_K_160623.doc

Solicitation No. FDA-16-223-SOL-00029 Solicitation No. FDA-16-223-SOL-00029

Center for Tobacco Products Office of Science Commercial Marketing and Sales Data

SECTION B: SUPPLIES OR SERVICES / PRICES AND COST

B.1 Brief Description of Services

The contractor shall provide the Food and Drug Administration (FDA)/Center for Tobacco Products (CTP)/ Office of Science with nationally and sub-nationally representative, existing, commercially available tobacco products sales data; including both retail scanner data and consumer purchasing scanner data.

B.2 Cost/Price Schedule

Base Year- Task 1 Retail Scanner Data- Firm Fixed Price The contractor shall provide existing, commercially available, retail scanner data to the Government on a monthly basis in accordance with the Statement of Work.

ITEM NO

SERVICES

MAX QUANTITY

UNIT

UNIT PRICE

MAX AMOUNT

1 Year of Data

Base Year- Task 2 Historical Retail Scanner Data

(Option Line Item)-

The contractor shall provide as many years of historic retail scanner data that the Contractor has available, not to exceed eight years (data prior to 2008 is not desired). See SOW for details.

ITEM NO

SERVICES

QUANTITY

UNIT

UNIT PRICE

MAX AMOUNT

Months

Base Year- Task 3 Consumer Purchasing Scanner Data-

The contractor shall provide consumer purchasing scanner data on a monthly basis. See SOW for details.

Option Year 1- Task 1 Retail Scanner Data-

The contractor shall provide existing, commercially available, retail scanner data to the Government on a monthly basis in accordance with the Statement of Work.

ITEM

NO

Option Year 1- Task 3 Consumer Purchasing Scanner Data-

The contractor shall provide consumer purchasing scanner data on a monthly basis. See SOW for details.

ITEM

SERVICES

MAX QUANTITY

UNIT

UNIT PRICE

MAX AMOUNT

1 year of Data

Option Year 1- Task 4 Historical Consumer Purchasing Scanner Data- (Option Line Item)

Firm Fixed Price

The contractor shall provide as many years of historic consumer purchasing scanner data that the Contractor has available, not to exceed eight years (data prior to 2008 is not desired). See SOW for details.

Option Year 2- Task 1 Retail Scanner Data-

The contractor shall provide existing, commercially available, retail scanner data to the Government on a monthly basis in accordance with the Statement of Work.

ITEM

Option Year 2- Task 3 Consumer Purchasing Scanner Data-

The contractor shall provide consumer purchasing scanner data on a monthly basis. See SOW for details.

Option Year 3- Task 1 Retail Scanner Data-

The contractor shall provide existing, commercially available, retail scanner data to the Government on a monthly basis in accordance with the Statement of Work.

ITEM

Option Year 3- Task 3 Consumer Purchasing Scanner Data-

The contractor shall provide consumer purchasing scanner data on a monthly basis. See SOW for details.

Option Year 4- Task 1 Retail Scanner Data-

The contractor shall provide existing, commercially available, retail scanner data to the Government on a monthly basis in accordance with the Statement of Work.

ITEM

Option Year 4- Task 3 Consumer Purchasing Scanner Data-

The contractor shall provide consumer purchasing scanner data on a monthly basis. See SOW for details.

SECTION C: DESCRIPTION /SPECIFICATIONS/ PERFORMANCE WORK STATEMENT

C.1. BACKGROUND AND OBJECTIVES

C.1.1. Background

Tobacco products are responsible for more than 480,000 deaths and between $289 and $332.5 billion per year in health care costs and lost productivity due to premature death from smoking and exposure to secondhand smoke. On June 22, 2009, the President signed the Tobacco Control Act (Public Law 111-31) into law. The Tobacco Control Act granted the Food and Drug Administration (FDA) important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect Americans from tobacco-related death and disease.

C.1.2. Objectives As a result of the Request for Proposal, the Government intends to obtain tobacco-related secondary sales data (both retail scanner data and consumer 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.

C.2. WORK STATEMENT

The contractor shall provide FDA with nationally and sub-nationally representative (i.e., census region, census division, major metropolitan market, and media market), existing, commercially available tobacco products sales data; including both retail scanner data and consumer purchasing scanner data. For the purposes of this contract, tobacco products include, but are not limited to: cigarettes, smokeless tobacco, pipe tobacco, roll-your-own tobacco, cigars, e-cigarettes, waterpipe/hookah tobacco, dissolvable tobacco products, 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 (e.g., waterpipe/hookah tobacco and roll-your-own tobacco should be distinguishable from one another). The data shall be collected using scientifically sound and well-described methodologies. Additional details on FDA’s specifications for these data are outlined below.

C.2.1 Task 1: Retail Scanner Data

A- Data Delivery: The contractor shall provide retail scanner data to the Government on a monthly basis. Monthly 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, 2017, should be delivered no later than June 30th, 2017). Data shall be in a form that allows for further analysis by FDA and a contractor working on behalf of FDA, such as Excel, 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 and approved by the Government 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, and structure of the database(s) and the relationship between their 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 detailed methodology for how the data were obtained, limitations of the methodology, data dictionary, and 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 datasets 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 in the smallest increment of data available, daily or weekly.

E- Data Specifications: The contractor shall provide tobacco product retail scanner data. The sales data provided shall include or be available by each of the four components identified below. This data will be aggregated by product UPC code, so it will not be individual sales transactions.

1- Geographic Locations: 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), major metropolitan market (at least the top 30 metropolitan statistical areas as defined by the US Census Bureau), and media market (region where the population can receive the same television, radio, Internet, and newspaper content).

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); tobacco specialty shops (including but not limited to vape shops, cigar retailers); and liquor stores. FDA is also interested in data on internet sales and wholesale shipments to retail outlets. FDA would like the data to specify the type of retailer/store so we are able to examine data by type of retailer or store.

3-Tobacco Product Details: Data shall be available by brand; sub-brand; UPC code; and carton, pack or other appropriate unit measure. Additional characteristics of interest include sub-label; product attributes (such as flavors, filter, strength or nicotine content); product type; manufacturer; use of promotions (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/). The contractor shall provide clear documentation on how to convert the data as given to a standardized UPC form. Documentation on missing characteristics or data fields is also required.

4- Sales Amount: Data shall include any information the contractor has related to tobacco product (as defined above) sales. Examples of this include, but are not limited to, sales dollars, sales units, and percent of all commodity volume.

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.

C.2.2 Task 2: Historical Retail Scanner Data (Option Line Item) Historical Data: The contractor shall provide access to as many years of historic retail scanner data the contractor has available, not to exceed eight years. Historic retail scanner data shall be delivered in the same format as the current data to allow for comparison over time.

C.2.3 Task 3: Consumer Purchasing Scanner Data CTP is requesting two types of data in this contract. The first is identified in Task 2.1: Retail Scanner Data, which is at the product level and in aggregate. The second is consumer purchasing scanner data, which is at the individual level and would include an individual’s transactions at stores.

A- Data Delivery: The contractor shall provide existing, commercially available consumer purchasing scanner data delivered monthly. Monthly 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, 2017, should be delivered no later than June 30th, 2017). Data shall be in a form that allows for further analysis by FDA and a contractor working on behalf of FDA, such as Excel, SPSS, or SAS. Format shall be proposed by 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, and structure of the database(s) and the relationship between their 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 detailed methodology for how the data were obtained, limitations of the methodology, data dictionary, and 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 datasets 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 week.

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

1- Geographic Locations: Data that are representative of and can be analyzed on a national level but 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); major metropolitan market (at least top 30 metropolitan statistical areas as defined by the US Census Bureau); and media market (region where the population can receive the same television, radio, Internet, and newspaper content).

2- Sales Locations: Consumer purchasing scanner data shall include the store (or a description of the type of store) where each purchase was made.

3-Tobacco Product Details: Data shall be available by brand; sub-brand; UPC code; and carton, pack or other appropriate unit measure. Additional characteristics of interest include sub-label; product attributes (such as flavors, filter, strength or nicotine content); product type; manufacturer; use of promotions (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/). The contractor shall provide clear documentation on how to convert the data as given to a standardized UPC form. Documentation on missing characteristics or data fields is also required.

4- Sales Amount: Data shall include any information the contractor has on sales. This shall include the quantity of tobacco products purchased; the amount paid for each tobacco product; the total amount paid for consumers’ purchases (including tobacco products and all other items) at the individual stores; how consumers paid for the purchase; if consumers were shopping with someone else; and all household demographic information available for consumers.

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.

C.2.4 Task 4: Historical Consumer Purchasing Scanner Data (Option Line Item)

Historical Data: Access to as many years of historic consumer purchasing scanner data the contractor has available, not to exceed eight years. Historic consumer purchasing scanner data shall be delivered in the same format as the current data to allow for comparison over time.

C.2.5: 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 D: PACKAGING AND MARKING

D.1 PREPARATION FOR DELIVERY

All materials to be delivered hereunder shall be afforded the degree of packaging (preservation and packing) required to prevent deterioration and damages due to the hazards of shipment, handling and storage. Best commercial practice will be accepted.

D.2 MARKING OF SHIPMENTS (DATA AND MATERIALS)

Non-electronic deliverables are not anticipated under this contract, but in the even that data hereunder by other than electronic means (e.g. perhaps historical data) shall be marked as specified by the COR on a case by case basis.

D.3 PROHIBITED PACKAGING MATERIALS

The use of asbestos, excelsior, newspaper or shredded paper (all types including waxed paper, computer paper and similar hygroscopic or non neutral material) is prohibited. In addition, loose fill polystyrene is prohibited for shipboard use.

D.4 PACKAGING, MARKING, AND SHIPPING

The delivery address for any deliverables that may need to be delivered under the contract will be provided at the time of contract award.

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SECTION E: INSPECTION AND ACCEPTANCE

E.1 INSPECTION AND ACCEPTANCE – (TIMELINE)

Inspection and acceptance of the supplies/services to be furnished hereunder shall be made at destination by the Government within 10 working days of receipt.

E.2 INSPECTION AND ACCEPTANCE (DESTINATION)

Inspection and acceptance of the services and deliverables to be furnished hereunder shall be made at destination by the Contracting Officer’s Representative (COR). The COR shall provide written notification of the acceptability of services and deliverables to the Contractor within ten days after the completion of services or the receipt of deliverables.

CLAUSES INCORPORATED BY REFERENCE

52.246-4

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SECTION F- DELIVERIES OR PERFORMANCE

F.1 CONTRACT PERIOD OF PERFORMANCE

The contract period of performance for CLIN 0001 and CLIN 0003 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 2016 will be used. Option period1 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 1-3 (CLINS 0005-0012) 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: Consumer Purchasing Scanner Data September 2016 – September 2017

Option Year 1

Task 1: Retail Scanner Data Task 3: Consumer Purchasing Scanner Data

Task 4: Historical Consumer Purchasing

Scanner Data (Option Line Item) September 2017 – September 2018

Option Year 2

Task 1: Retail Scanner Data

Task 3: Consumer Purchasing Scanner Data September 2018 – September 2019

Option Year 3

Task 1: Retail Scanner Data

Task 3: Consumer Purchasing Scanner Data September 2019 – September 2020

Option Year 4

Task 1: Retail Scanner Data

Task 3: Consumer Purchasing Scanner Data September 2020 – September 2021

F.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.

F.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 a video or teleconference.

F.4 OBSERVANCE OF FEDERAL HOLIDAYS & OTHER GOVERNMENT CLOSINGS:

The Contractor is expected to be available for normal communications during regular business hours during all Federal work days. Services will not be performed at the Federal site when the Federal government is closed for reasons such as inclement weather or executive order. No services or deliveries shall be performed at the Federal sites on Federal legal holidays as shown below unless specifically requested by the Contracting Officer.

1. New Year’s Day

January 1st

2. Martin Luther King Day

Third Monday in January

3. President’s Day

Third Monday in February

4. Memorial Day

Last Monday in May

5. Independence Day

July 4th

6. Labor Day First Monday in Sept.

7. Columbus Day

Second Monday in Oct.

8. Veteran’s Day November 11

9. Thanksgiving Day

Fourth Thursday in November

10. Christmas Day

December 25

CLAUSES INCORPORATED BY REFERENCE

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay of Work

APR 1984

52.247-34 F.O.B. Destination NOV 1991

SECTION G: CONTRACT ADMINISTRATION DATA

G.1 CONTRACT TYPE

As contemplated in Section L solicitation provision FAR 52.216-1 “Type of Contract (APR 1984),” the Government contemplates award of a Firm Fixed Price-type contract resulting from this solicitation.

G.2

ACCOUNTING AND APPROPRIATION DATA

To be identified at time of contract award.

G.3

AUTHORIZED CHANGES ONLY BY THE CONTRACTING OFFICER

(a) Except as special in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the Contractor’s facilities or in any other manner communicates with Contractor personnel during the performance of this contract shall constitute a change under the “Changes” clause of this contract.

(b) The Contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirement of this contract and notwithstanding provisions contained elsewhere in this contract; the said authority remains solely the Contracting Officer’s. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in changes incurred as a result thereof. The address and telephone number of the Contracting Officer is:

NAME:

Aaron A. Glazier – Contracting Officer

ADDRESS:

Food and Drug Administration

National Center for Toxicological Research

Attention: Aaron Glazier, Contracting Officer

Office of Acquisitions, HFT-320

3900 NCTR Road

Building 50, Room 417

Jefferson, AR 72079-9502

Telephone: (870) 543-7577

E-Mail: aaron.glazier@fda.hhs.gov G.4

CONTRACTING OFFICER REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this contract:

To be identified at time of award The COR is responsible for:

(1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) interpreting the Performance Work Statement 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 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 Performance Work Statement;

(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 Government may unilaterally change its COR designation.

G.5

TECHNICAL DIRECTION

Performance of the work under this contract shall be subject to the technical direction of the Contract COR. The term “technical direction: is defined to include, without limitation, the following:

· Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

· Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

· Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the general Scope of Work stated in the contract. The COR does not have the authority to and may not issue any technical direction which:

· Constitutes an assignment of additional work outside the general Scope of Work of the contract.

· Constitutes a change as defined in the applicable contract clause entitled: FAR 52.243-1 Fixed Price (AUG 1987).

· Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction will be issued in writing by the COR or will be confirmed by him/her in writing within five (5) business days after issuance.

G.6 POST-AWARD EVALUATION OF CONTRACTOR PERFORMANCE

The government will conduct assessments and evaluate the contractor’s performance through daily observations and reviews of the contractor’s project plan, customer service, level of responsiveness, quality control, stakeholder feedback, receipt of customer complaints and compliments, timeliness and receipt of contract deliverables.

a. Contractor Performance Evaluations

In accordance with the Performance-Based nature of this contract and the Performance Based Requirements Summary Matrix, interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluations will be prepared annually to coincide with the anniversary date of the contract. The Government will use the Contractor Performance Assessment and Reporting System (CPARS) https://www.cpars.gov/ when completing its interim and final evaluations.

G.7

INVOICE SUBMISSION

Invoices for Tasks 1 and Task 3 shall be submitted each month that the Tasks are performed. The level of effort is expected to be relatively similar each month for Tasks 1 and 3, so it makes sense for the Contractor to bill 1/12 of the annual total firm-fixed price amount each month. For Tasks 2 and 4 (Option Item Tasks), the Contractor shall submit the lump-sum invoice once during the month that the Option Task(s) are completed in its entirety and accepted by the COR.

A.THE CONTRACTOR SHALL SUBMIT INVOICES IN THE MANNER SPECIFIED BELOW:

(I)ONE ORIGINAL TO THE APPROVING OFFICIAL:

U.S. FOOD AND DRUG ADMINISTRATION

OFFICE OF ACQUISITIONS AND GRANTS SERVICES

ATTN: AARON A. GLAZIER, CONTRACTING OFFICER

3900 NCTR RD

BUILDING 50, ROOM 417

JEFFERSON, AR. 72079

Or

Via E-mail at: aaron.glazier@FDA.HHS.GOV *** ACCEPTABLE METHODS OF DELIVERY INCLUDE: MAIL, HAND DELIVERY, AND E-MAIL (II) ONE COPY TO THE CONTRACTING OFFICER REPRESENTATIVE (COR) OR OTHER PROGRAM CENTER/OFFICE DESIGNEE, CLEARLY MARKED "COURTESY COPY ONLY":

U.S. FOOD AND DRUG ADMINISTRATION

Send copy of invoice to COR specified in Section D of the contract.

*** ACCEPTABLE METHODS OF DELIVERY INCLUDE: MAIL, HAND DELIVERY, OR E-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 CENTRAL

CONTRACTOR REGISTRATION) AND/OR OTHER APPLICABLEFAR 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 NUMBER (HHSF2232016…);

(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;

(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;

(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 NUMBEROF THE FINANCIAL INSTITUTIONRECEIVIN PAYMENT AND THE NUMBER OF THE ACCOUNT INTO WHICH FUNDS ARE TO BE DEPOSITED;

(XI) NAME AND TELEPHONE NUMBER OF THE FDA CONTRACTING OFFICER REPRESENTATIVE (COR) OR OTHER PROGRAM CENTER/OFFICE POINT OF CONTACT, AS REFERENCED ON THE PURCHASE ORDER;

(XII) ANY OTHER INFORMATION OR DOCUMENTATION REQUIRED BY THE PURCHASE ORDER/AWARD.

(XIII) 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) CORRESONDING 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

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.

D.QUESTIONS REGARDING INVOICE PAYMENTS SHOULD BE DIRECTED TO THE FDA PAYMENT OFFICE AT:

Office of Financial Services

Food and Drug Administration

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments

Phone: 301.827.3742 or 866.807.3742

OFS/PaymentServices@fda.hhs.gov

SECTION H: SPECIAL CONTRACT REQUIREMENTS

H.1

PROHIBITED ACTIVITIES

The Contractor shall not perform tasks under any resultant contract which involves the following:

A. Preparation of any statement of requirements, objectives, or needs to be procured by the Government, whether to be acquired by future orders under the User Fee Contract or by any other contract action at the FDA.

B. Evaluation of the qualifications of a potential source or any proposal for a contract or order by the Government for any supplies or services.

C. Formulation of evaluation criteria, acquisition plans, solicitations, or strategies for the purchase of supplies or services.

D. Preparation of documentation for future User Fee task orders.

H.2

NONPERSONAL SERVICES

A. In performance of this contract, the Contractor shall provide advisory and assistance services and some non-advisory and assistance services support in the form of services and data required by FDA program management and other internal stakeholders. This will be based upon the PWS for the specific effort to be performed.

B. The Government will neither supervise contractor employees nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the Government assign tasks to or prepare work schedules for individual contractor employees. It shall be the responsibility of the Contractor to manage their employees and to guard against any actions that are of the nature of personal services or give the perception of personal services. If the Contractor feels that any actions constitute or a perceived to constitute personal services, it shall be the Contractor’s further responsibility to notify the CO immediately.

C. These services shall not be used to perform work of policy/decision-making or management nature (i.e., inherently Government functions.) All decisions relative to programs supported by User Fee contractors will be the sole responsibility of the Government. Support services will not be ordered to circumvent personnel ceilings, pay limitations, or competitive employment procedures.

H.3 DATA

The Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the government shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest, specifically the data provided in the performance of Tasks 1-4.

The Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

The Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

The Government Agency owns the rights to all data/records produced as part of this contract, specifically the data provided in the performance of Tasks 1-4.

The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

The Contractor must comply with Federal and HHS/FDA records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (links provided in paragraph below). These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

National Archives Records Management Policy - http://www.archives.gov/about/laws/ HHS Records Management Policy - http://www.hhs.gov/ocio/policy/2007-0004.001.html HHS Privacy Site - http://www.hhs.gov/foia/privacy/index.html No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The contractor is responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the government or destroyed without regard to the provisions of the agency records schedules.

The Contractor is required to obtain the COR and Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

H.4

DISCLOSURE OF INFORMATION

The Contractor is reminded that information furnished under this solicitation and resulting contract may be subject to disclosure under the Freedom of Information Act (FOIA). Therefore, all items that are confidential to business, or contain trade secrets, proprietary, or personnel information must be clearly marked. Marking of items will not necessarily preclude disclosure when the U.S. Office of Personnel Management (OPM or The Government) determines disclosure is warranted by FOIA. However, if such items are not marked, all information contained within the submitted documents will be deemed to be releasable.

Any information made available to the Contractor by the Government must be used only for the purpose of carrying out the provisions of this contract and must not be divulged or made known in any manner to any person except as may be necessary in the performance of the contract.

In performance of this contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its subcontractors shall be under the supervision of the Contractor or the Contractor's responsible employees.

Each officer or employee of the Contractor or any of its subcontractors to whom any Government record may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for a purpose and to the extent authorized herein, and that further disclosure of any such information, by any means, for a purpose or to an extent unauthorized herein, may subject the offender to criminal sanctions imposed by 19 U.S.C. § 641. That section provides, in pertinent part, that whoever knowingly converts to their use or the use of another, or without authority, sells, conveys, or disposes of any record of the United States or whoever receives the same with intent to convert it to their use or gain, knowing it to have been converted, shall be guilty of a crime punishable by a fine of up to $10,000, or imprisoned up to ten years, or both.

SECTION I: CONTRACT CLAUSES

Clauses Incorporated in Full Text:

52.217-7 -- Option for Increased Quantity- Separately Priced Line Items

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor any time within the performance year Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(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 within 1 day of expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 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 5 years.

(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):

FAR Clauses:

http://www.arnet.gov/far/loadmainre.html

HHSAR Clauses:

http://www.hhs.gov/oamp/policies/hssar.doc FAR Clauses are intended to be the most current versions available as of FAR version: FAC 2005-87, effective 06 April 2016.

Clause Number Title Date 52.202-1 Definitions (NOV 2013)

52.203-3 Gratuities (APR 1984)

52.203-5 Covenant Against Contingent Fees (MAY 2014)

52.203-6 Restrictions on subcontractor Sales to (SEP 2006) the Government

52.203-7 Anti-Kickback Procedures (MAY 2014)

52.203-8 Cancellation, Rescission, and Recovery (MAY 2014)

Funds for Illegal or Improper Activity

52.203-10 Cost/price or Fee Adjustment for (MAY 2014)

Illegal or Improper Activity

52.203-11 Certification and Disclosure Regarding Payments (SEP 2007) to Influence Certain Federal Transactions

52.203-12 Limitation on Payments to Influence (OCT 2010)

Certain Federal Transactions 52.204-2 Security Requirements (AUG 1996)

52.204-4 Printed or Copied Double Sided on (MAY 2011)

Recycled Paper

52.204-10 Reporting Executive Compensation and First-Tier (OCT 2015)

Subcontract Awards 52.204-13 System for Award Management Maintenance

(JUL 2013)

52.204-14 Service Contract Reporting Requirements (JAN 2014)

52.204-19 Incorporation by Reference of Representations (DEC 2014)

And Certifications 52.209-6 Protecting the Government’s Interest (OCT 2015)

When Subcontracting with Contractor’s

Debarred Suspended, or Proposed for Debarment

52.215-2 Audit and Records – Negotiations (OCT 2010)

52.215-8 Order of Precedence – (OCT 1997)

Uniform Contract Format 52.215-19 Notification of Ownership Changes

(OCT 1997)

52.219-8 Utilization of Small Business Concerns (OCT 2014)

52.219-28 Post-Award Small Business Program (JUL 2013)

Rerepresentation 52.222-3 Convict Labor (JUN 2003)

52.222-4 Contract Work Hours and Safety (MAY 2014) Standards Act – Overtime

52.222-19 Child Labor – Cooperation with (FEB 2016)

Authorities and Remedies

52.222-21 Prohibition of Segregated Facilities

52.222-25 Affirmative Action Compliance (APR 1984) 52.222-26 Equal Opportunity. (APR 2015)

52.222-35 Equal Opportunity for Veterans (OCT 2015) 52.222-36 Affirmative Action for Workers with Disabilities (JUL 2014) 52.222-37 Employment Reports on Veterans (FEB 2016) 52.222-38 Compliance With Veterans’ Employment Reporting (FEB 2016) Requirements

52.222-50 Combating Trafficking in Persons (MAR 2015) 52.222-54 Employment Eligibility Verification

(OCT 2015)

52.223-6 Drug-Free Work Place (MAY 2001) 52.223-18 Encouraging Contractor Policies to Ban Text (AUG 2011)

Messaging While Driving

52.224-1 Privacy Act Notification (APR 1984)

52.224-2 Privacy Act (APR 1984)

52.225-5 Trade Agreements (FEB 2016)

52.225-13 Restrictions on certain Foreign Purchases (JUN 2008)

52.227-1 Authorization and Consent (DEC 2007)

52.227-2 Notice and Assistance Regarding Patent and (DEC 2007)

Copyright Infringement 52.227-3 Patent Indemnity (APR 1984)

52.227-14 Rights in Data – General (MAY 2014)

52.227-18 Rights in Data—Existing Works (DEC 2007)

52.229-3 Federal, State, and Local Taxes (FEB 2013) 52.232-1 Payments (APR 1984) 52.232-8 Discounts for Prompt Payment (FEB 2002) 52.232-9 Limitation on Withholding of Payments (APR 1984)

52.232-23 Assignment of Claims (JAN 1986)

52.232-25 Prompt Payment (JUL 2013)

52.232-33 Payment by Electronic Funds Transfer (JUL 2013) System for Award Management 52.232-39 Unenforceability of Unauthorized Obligations

(JUN 2013)

52.232-40 Providing Accelerated Payment to Small (DEC 2013)

Business Subcontractors 52.233-1 Disputes (MAY 2014) 52.233-3 Protest After Award (AUG 1996)

52.233-4 Applicable Law for Breach of Contract Claim (OCT 2004)

52.237-3 Continuity of Services (JAN 1991)

52.239-1 Privacy or Security Safeguards (AUG 1996)

52.242-13 Bankruptcy (JUL 1995)

52.242-15 Stop Work Order (AUG 1989) 52.243-1 Changes—Fixed Price

(SEP 2000)

52.245-1 Government Property (APR 2012)

52.245-9 Use and Charges

(APR 2012)

52.244-6 Subcontracts for Commercial items and (FEB 2016)

Commercial Components

52.246-25 Limitation of Liability – Services (FEB 1997) 52.249-2 Termination For the Convenience of the Government (APR 2012)

– Fixed Price 52.249-8 Default (Fixed-Price Supply and Services) (APR 1984)

52.253-1 Computer Generated Forms (JAN 1991)

HHSAR Clauses by Reference:

352.203-70 Anti-lobbying

(DEC 2015)

352.208-70 Printing and Duplication

352.211-3 Paperwork Reduction Act

352.222-70 Contractor Cooperation in Equal Employment (DEC 2015) Opportunity Investigations

352.239-73 Electronic Information and Technology Accessibility (DEC 2015)

352.239-74 Electronic Information and Technology Accessibility (DEC 2015)

Notice Applicable 508 standards:

§ 1194.21 Software applications and operating systems.

§ 1194.22 Web-based intranet and internet information and applications.

§ 1194.23 Telecommunications products § 1194.26 Desktop and portable computers

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SECTION J: LIST OF ATTACHMENTS

Attachment 1- Pricing Template

SECTION K: REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR RESPONDENTS

CLAUSES INCORPORATED BY REFERENCE:

52.222-38 Compliance with Veterans Employment Reporting (SEP 2010) Requirements

CLAUSES INCORPORATED BY FULL TEXT:

52.204-8 Annual Representations and Certifications (APR 2016) (a)

(1) The North American Industry classification System (NAICS) code for this acquisition is 541910- Sampling Services.

(2) The small business size standard is $13.5 million.

(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 500 employees.

(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 is not included in this solicitation, and the Offeror is currently registered in the System for Award Management (SAM), and has completed the Representations and Certifications section of SAM electronically, the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certification in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

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

(iv) 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.

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

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

(vii) 52.209-11, Representation by Corporations Regarding Delinquent Tax…