19-223-SOL-00022-FBO.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

DAP

Beltsville MD 20705 4041 Powder Mill Road ATTN: Richard Robinson

DHHS/FDA/OAGS/DAP

WO75 CODE 16. ADMINISTERED BYCODE

X

X

541720

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAP

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

04/22/2019 1400 ET

03/20/2019

301-796-6508RICHARD ROBINSON

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

19-223-SOL-00022

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 76 1201023OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Silver Spring MD 20993 Building 75 10903 New Hampshire Avenue The US Food and Drug Administration

WHITE OAK CAMPUS, BUILDING 75

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Richard Robinson

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$20.50

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAP

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The U.S. Food and Drug Administration intends to award a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract for services in support of the requirement entitled, "Multi-Method Consumer Perception Investigations." Award will be made to the offeror representing the best value to the Government. See attached pages for specific terms and conditions regarding this solicitation.

Period of Performance: 07/02/2019 to 07/01/2024 Continued ...

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

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

MATTHEW J. BUCHER

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

3/20/2019

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

1 IDIQ for Multi-Method Consumer Perception

Investigations

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

76 2 of

19-223-SOL-00022 – Multi-Method Consumer Perception Investigations

PART I

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 SOLICITATION DESCRIPTION

The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary in a requirement titled, “Multi-Method Consumer Perception Investigations”.

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-01. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541720 – Research and Development in the Social Sciences and Humanities. Its associated Small Business Size Standard is $20.5M.

This requirement is for full and open competition. All responsible offerors are permitted to submit a proposal as a result of this solicitation.

B.2 CONTRACT TYPE

In accordance with FAR 52.216-27, the government intends to make a single Indefinite- Delivery, Indefinite-Quantity (IDIQ) Contract award with the issuance of Time and Material, Labor Hour and Firm-Fixed (or hybrid) price task orders. The structure of the contract shall be a five (5) year base period.

B.3 CONTRACT CEILING

The IDIQ guaranteed minimum amount will be $5,000.00 over five (5) years. The contract maximum ceiling amount will be $31,000,000.00 over five (5) years.

B.4 PRICING

The pricing chart below outlines the labor categories that are anticipated throughout the life of the contract. Minimum requirements for these labor categories are described in greater detail in Attachment 1. The Contractor shall provide services in accordance with the Statement of Work with fully loaded, fixed hourly rates.

Labor Category

Est. Annual Hours

Year 1 Rates Year 2 Rates Year 3 Rates Year 4 Rates Year 5 Rates

Project Director*

1,272

Project Manager*

3,454

Senior Social Scientist*

2,464

Mid-Social Scientist 4,414

Social Scientist

7,936

Research Assistant

9,424

Statistician

Data Analyst 1,056

Programmer 1,040

Editor 3,072

TOTAL 34,6922

*denotes labor category defined as Key Personnel.

Expense QTY Unit Estimated Unit Price

Estimated Total

Non-Labor ODCs 1 LOT $6,500,000.00 $6,500,000.00 Travel 1 LOT $500,000.00 $500,000.00

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 BACKGROUND

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law (Public Law 111-31). The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted the Food and Drug

Administration (FDA) authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health.

The FDA Center for Tobacco Products (CTP) has responsibility, among other things, for reviewing tobacco product labels, labeling, advertising, and other promotional materials and activities to ensure that they are in compliance with the FD&C Act and its implementing regulations. CTP engages in a variety of actions to carry out this responsibility, including conducting reviews of regulated materials; initiating enforcement actions against adulterated, misbranded, or other violative tobacco products; and coordinating with other FDA offices and Federal agencies to ensure compliance with the FD&C Act and implementing regulations.

To support its compliance and enforcement activities, CTP may seek input from consumers and other individuals, for example, to understand the environmental and individual factors that have contributed or may contribute to the use of particular tobacco products, or to determine whether a particular statement or representation on product labeling or advertising is false or misleading, or explicitly or implicitly represents reduced risk or harm. At FDA, such input is generally elicited via a quantitative methodology, such as surveys, and/or a qualitative methodology, such as group interviews and one-on-one in-depth interviews. Quantitative methodology is used for generating and studying statistical estimates and relationships, e.g., how many consumers use tobacco products or how product statements and representations may affect consumer perception of a product. Such information may or may not be based on probability samples and generalizable to the target population in question. Qualitative methodology is used to obtain non-statistical, in-depth understanding of the “why’s” and “how’s” of consumer opinions and behaviors, e.g., why consumers may select certain tobacco products in lieu of other marketed products, or what consumers think of specific marketing strategies or statements or representations on tobacco product labeling or advertising. When appropriate, the FDA may determine both methodologies are required to elicit input on a certain research topic.

C.2 OBJECTIVE

The FDA requires, on an as-needed basis, data on reactions and interpretations of consumers and other individuals regarding questions of immediate concern to CTP through formative, qualitative, and/or quantitative research methodologies to support CTP’s enforcement of matters relating to tobacco products’ labeling, marketing, advertising, and promotion and/or to support CTP’s rulemaking efforts, policy decisions, and guidance development.

C.3 SCOPE OF WORK

The Contractor shall conduct and furnish all of the necessary personnel, materials, services, facilities, (except as otherwise provided), and otherwise do all things necessary for or incidental to the performance of the functional areas set forth below:

• Copy Tests

• Focus Groups

• In Depth Interviews

• Literature Reviews

• Eye Tracking Studies

The size, scope, type, timeline, and other details of each functional area (i.e., copy test, focus group, interview, literature review, and eye tracking study) may vary and will be specified within each task order. Each task order may include multiple types of functional areas and may include multiple functional areas of the same type.

C.4 FUNCTIONAL AREAS

Tasks may require the contractor to perform the following functional areas and require all deliverables to be submitted electronically, as approved by the FDA Contracting Officer Representative (COR).

Functional Area 1: Copy Test

The Contractor shall provide copy test services that may include stimuli construction, sample selection, and data collection on a national basis (with the capability of collecting data via internet), statistical analysis, and interpretation. The timing of the copy tests will be dictated by the needs of FDA and delineated in each task order. The Contractor may be required to complete multiple tests concurrently.

Representative activities under this functional area include but are not limited to:

• Develop protocol, questionnaire, and other study materials for data collection (including locating, editing, and/or creating stimuli provided by FDA), and obtain the stimuli (e.g., actual label, package, advertisement) in U.S. commerce and provide documentation of when and where the stimuli were located

• Provide FDA with a draft protocol, questionnaire, and screener and incorporate feedback and revisions to the final documents

• When necessary, obtain dual human subjects approval. Obtain IRB (Institutional Review Board) approval from contractor’s IRB to assure human subjects protection, and work in conjunction with FDA to obtain FDA RIHSC (Research Involving Human Subjects Committee) approval. Otherwise, ensure an appropriate IRB Authorization Agreement (IAA) is put in place to address human subject protections.

• Obtain OMB PRA approval as required by FDA. Not all functional areas will require OMB PRA approval. This will be defined at the individual task order level.

• Pretest and field the copy test with sample of the target audience, in consultation with

FDA

• Conduct copy tests on print or electronically (e.g., internet, other media) of one or more packaging, labeling, and/or advertising pieces for tobacco products with multiple conditions as identified by FDA

• Document sample selection procedures, response rates, cooperation rates, and other methodologies undertaken

• Prepare U.S. population weights for analysis in consultation with FDA

• Code and enter data, including manual coding of open-ended questions

• Conduct statistical analyses (e.g., frequencies, t-tests, ANOVAs) with analysis plans developed by the Contractor in consultation with FDA

• Interpret and write up reports summarizing the methods and results of each copy test

• Provide a draft report and a final report electronically in Microsoft Word in APA style

At the task order level, the FDA shall provide the Contractor with the desired target population, direction/feedback on survey design, and constructs of interest for the questionnaire. FDA will provide the criteria for the target population for each copy test. Each copy test may involve one or more packaging, labeling, and/or advertising stimuli and may test one or more conditions.

Functional Area 2: Focus Groups

The Contractor shall conduct focus groups to evaluate awareness, perceptions, attitudes, behaviors, and use of specific tobacco products, including packaging, labeling, and/or advertising as requested by FDA.

• Produce the stimuli to be used in the focus groups based on FDA supplied stimuli examples, or locate and obtain the stimuli (e.g., actual label, package, advertisement) in U.S. commerce and provide documentation of when and where the stimuli were located

• Provide draft and final versions of study materials, such as moderator’s guide, protocol, screener, and stimuli

• Obtain dual human subjects approval. Obtain IRB approval from contractor’s IRB to assure human subjects protection, and work in conjunction with FDA to obtain FDA RIHSC approval.

• Obtain OMB PRA approval as required by FDA. Not all functional areas will require OMB PRA approval. This will be defined at the individual task order level.

• Identify and suggest locations for focus groups based on population demographics provided by FDA. Multiple locations may be required for a single focus group project.

• Provide the facility/facilities and/or web-based platform, recording (audio), and recruit and screen participants for the focus groups

• Provide scheduling and reminder follow-up services to ensure attendance requirements are met for focus groups

• Conduct focus groups using an experienced moderator and provide support services including greeting participants and signing them in; audiotaping the focus groups; and paying each participant a cash stipend upon completion of the focus group

• Produce transcripts of the recordings to assist in report writing and provide FDA with a written record of the sessions

• Provide draft and final versions of a report in APA format summarizing methods and findings from the focus group sessions

Functional Area 3: In-Depth Interviews (IDIs)

The Contractor shall conduct formative IDIs in-person and/or via web-based platform about awareness, perceptions, attitudes, behaviors, and/or use of specific tobacco products, including packaging, labeling, and/or advertising, as requested by FDA.

• Produce the stimuli to be used in the interviews based on FDA supplied stimuli examples

• Provide draft and final versions of study materials, such as interviewer’s guide, protocol, screener, and stimuli

• Obtain dual human subjects approval. Obtain IRB approval from contractor’s IRB to assure human subjects protection, and work in conjunction with FDA to obtain FDA RIHSC approval.

• Obtain OMB PRA approval as required by FDA. Not all functional areas will require OMB PRA approval. This will be defined at the individual task order level.

• Identify and suggest locations for IDIs based on population demographics provided by FDA. Multiple locations may be required for a single IDI project.

• Provide the facility/facilities and/or videoconferencing platform, recording (audio), and recruitment and screening of participants for the interviews

• Provide scheduling and reminder follow-up services to ensure attendance requirements are met for IDIs

• Conduct IDIs using an experienced interviewer and provide support services including greeting participants and signing them in; audiotaping of the IDIs; and paying each participant a cash stipend upon completion of the interview

• Produce transcripts of the recordings to assist in report writing and provide FDA with a written record of the sessions

• Provide draft and final versions of a report in APA format summarizing methods and findings from the interviews

Functional Area 4: Literature Reviews

The Contractor shall conduct literature reviews as required by FDA. The literature reviews will each focus on one tobacco descriptor. Each will come in one of two forms:

A) A narrow literature review consists of comprehensively researching, reviewing, analyzing, evaluating, and/or summarizing scholarly materials, such as, but not limited to, peer-reviewed journal articles, book chapters, and other relevant information about a specific topic, such as, but not limited to, the effect of a specific labeling design element or advertising claim on perceptions of tobacco product risk and harm; or

B) A comprehensive literature review consists of comprehensively researching, reviewing, analyzing, evaluating, and/or summarizing scholarly materials, such as, but not limited to, peer-reviewed journal articles, book chapters, tobacco and/or other industry documents, grey literature, white papers, and other relevant information about a specific topic, such as, but not limited to, the effect of a specific labeling design element or advertising claim on perceptions of tobacco and other similar product risk and harm. The reports may vary in length depending upon the amount of literature that is comprehensively reviewed.

• Search FDA-identified databases for potential studies and complete additional tasks including, creating search inclusion and exclusion criteria, and creating and documenting keyword searches

• Identify, provide a list, and/or use research databases that will serve as the most suitable information repositories to answerer FDA-specified research questions

• Review, analyze, evaluate, and/or summarize scholarly materials, such as, but not limited to, peer-reviewed journal articles, book chapters, and other relevant information about a specific topic

• Create an article database to house all full text articles retrieved for literature reviews.

The database shall be housed on contractor servers, and transferred to FDA servers upon contract completion

• Create a report in APA format that includes a description of the research question(s), the methodology for reviewing scholarly materials, and the main findings of the literature review

Functional Area 5: Eye Tracking Studies

Conduct eye tracking studies to gather objective physiological measurements of interest, including visual attention, cognitive processes, and memory related to tobacco advertisements (both images and text). The Contractor shall provide eye tracking services that may include stimuli construction, sample selection, data collection, statistical analysis, and interpretation.

Representative activities under this functional area include but are not limited to:

• Develop protocol, questionnaire, and other study materials for data collection (including locating, editing, and/or creating stimuli provided by FDA), and obtain the stimuli (e.g., actual label, package, advertisement) in U.S. commerce and provide documentation of when and where the stimuli was located

• Provide FDA with a draft protocol, questionnaire, and screener and incorporate feedback and revisions to the final documents

• Obtain dual human subjects approval. Obtain IRB approval from contractor’s IRB to assure human subjects protection, and work in conjunction with FDA to obtain FDA RIHSC approval.

• Obtain OMB PRA approval as required by FDA. Not all functional areas will require OMB PRA approval. This will be defined at the individual task order level.

• Pretest and field the eye tracking study with an FDA-approved sample of the target audience

• Conduct an eye tracking study using electronically-reproduced stimuli of one or more packaging, labeling, and/or advertising pieces for tobacco products with multiple conditions as identified by FDA

• Provide the facility, recruitment, and screening of participants for the study

• Provide scheduling and reminder follow-up services to ensure attendance requirements are met for the study

• Conduct the eye tracking study using an experienced investigator and provide support services including greeting participants and paying each participant a cash stipend upon completion of the study

• Code and enter data, including manual coding of open-ended questions, as necessary

• Conduct statistical analyses appropriate for eye tracking data with analysis plans developed by the Contractor in consultation with FDA

• Interpret and write up reports summarizing the methods and results of each copy test

• Provide a draft report and a final report electronically in Microsoft Word in APA style

C.5 ANTICIPATED LABOR/KEY PERSONNEL

The following Labor Categories are anticipated as being necessary to support the requirements of this contract:

Project Director Project Manager Senior Social Scientist Mid-Social Scientist Social Scientist Research Assistant Statistician Data Analyst Programmer Editor

Additional information regarding the labor category descriptions and minimum qualifications are set forth in Attachment 1.

All labor categories under this contract are considered non-personal services. The Government shall 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 its 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 believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contracting Officer (CO) immediately.

The contract Project Director, Program Manager, and Senior Social Scientist are considered Key Personnel.

Additional requirements regarding Key Personnel are subject to the terms pursuant to the following clause:

352.237-75 – Key Personnel (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request shall identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than 30 days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

SECTION D - PACKAGING AND MARKING

All deliverables required under this contract shall be packaged, marked and shipped/submitted in accordance with the Government specifications below. At a minimum, all deliverables shall be marked with the contract number and contractor name.

1. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

2. The Contractor shall scan all deliverables for viruses before submitting to the FDA.

3. Deliverables under this contract shall be prepared and packaged for shipment using standard shipping practices to ensure safe and timely delivery.

Electronic delivery is the preferred method of delivery and all deliverables shall assume to be submitted electronically, unless otherwise specified by the COR.

SECTION E - INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) will, in accordance with FAR 52.212-4, perform inspection and acceptance of all the services. Inspection and acceptance will be performed at the location identified in individual task orders. Acceptance shall be communicated within 30 days of receipt in writing.

SECTION F - DELIVERIES OR PERFORMANCE

F.1 ANTICIPATED DELIVERABLES

Note: Actual deliverables, deliverable schedules, Progress Reports and Status meetings shall be established in the issuance of each individual task order. Additional Reporting Requirements may be included in each Task Order. Below represent known, recurring deliverables expected to be required on all Task Orders.

Progress Reports - The Contractor shall submit one (1) electronic copy of the Progress Report to the COR and Contracts Specialist. The report shall include a status update on each task worked on and deliverables submitted, any problems encountered, and suggestions for addressing problems each period. If the tasks are cost reimbursable in nature, an accounting of applicable staff who worked on the tasks as well as any deviations from the original projection of hours planned vs. actually incurred will be required.

Monthly reports shall be submitted electronically as a “PDF” attachment emailed to the Contracting Officer’s Representative (COR).

Program Status Review meetings (PSRs) - The Contractor shall facilitate and participate in PSR meetings as needed. PSRs shall be held in person at the Contractor’s facility or remotely via teleconference, at FDA’s discretion. PSRs shall encompass review of Contractor’s overall performance under the applicable task order, quality and quantity of services (including review of inspection services, results, and all facets of performance), quality and timeliness of deliverables, and any other issues pertaining to performance of the task order under this contract.

If requested by FDA, the Contractor shall provide advance copies of all relevant performance and QA data requested by FDA prior to a scheduled PSR.

F.2 ORDERING PERIOD

Task Orders may be issued up to the final day of this contract, and the contract shall remain in force to allow for the completion of all task orders issued (See FAR 52.216-22 for more information). However, the Government shall not issue, and the Contractor shall not accept any new task orders issued subsequent to the performance period of this contract.

F.3 PERIOD OF PERFORMANCE

The period of performance for the base period of the contract shall be five (5) years from the effective date of the contract.

F.4 PLACE OF PERFORMANCE

The place of performance will be specified at the Task Order level, though it is anticipated that all performance will be at the Contractor’s site. Task orders may be issued for performance in any of the United States or its territories.

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 ORDERING PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the requirements to be performed. All task orders issued under this contract shall conform to the provisions of the contract clauses in Part II, Section I entitled “Contract Clauses” (See FAR 52.216-18 and 52.216-19). The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer.

TASK ORDER PROCESSING

All task orders issued hereunder are subject to the terms and conditions of this contract.

This contract shall control in the event of conflict with any task order. A task orders shall be “issued” for purposes of this contract upon the effective date of the order.

The general process for individual task orders is as follows:

a) The FDA will prepare a statement of work. The SOW will include, at a minimum, the following elements:

1. Description of work in terms of the purpose or objectives of the work and location to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

3. Period and place of performance

4. Reporting requirements and deliverables

5. Whether the order will be fixed price, labor hour, time and material or a hybrid type task order.

b) Requests for Task Order Proposals (RTOPs) shall only be issued by the Contracting Officer.

c) The Contractor shall prepare and submit a task proposal addressing all areas of the requirement. The Contractor shall submit the task proposal within the time period specified in the RTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

The Government shall evaluate task order proposals for technical acceptability and price reasonableness.

G.2 CONTRACTING OFFICERS REPRESENTATIVE (COR)

The following COR will be assigned to this contract: (To Be Determined Upon Contract 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 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.

G.3 CONTRACTING OFFICER (CO)

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 a task order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

Matthew J. Bucher Email: Matthew.Bucher@fda.hhs.gov mailto:Matthew.Bucher@fda.hhs.gov

Tel: (240) 402-7566

The contact information for the Contract Specialist is:

Richard Robinson Email: Richard.robinson@fda.hhs.gov Tel: (301) 796-6508

G.4 INVOICE SUBMISSION

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Office of Financial Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 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 Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

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

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

NET 30);

mailto:Richard.robinson@fda.hhs.gov mailto:FDAVendorPaymentsTeam@fda.hhs.gov

(vii) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

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

(ix) Taxpayer Identification Number (TIN);

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

(xi) Name and telephone number of the FDA Approving Official (i.e., Contracting Officer (CO) or Contract Specialist (CS), as referenced in the award document);

(xii) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced in the award document;

(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) 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;

(xiv) Any other information or documentation required by the contract/order award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

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

SECTION H. – SPECIAL CONTRACT REQUIREMENTS

H.1 CONTRACTOR PERFORMANCE EVALUATION(S)

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 http://www.cpars.csd.disa.mil/cparsmain.htm 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 14 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.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

H.2 352.211-3 PAPERWORK REDUCTION ACT (DEC 2015)

(a) This contract involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) shall apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance.

Contractors and the Contracting Officer's Representative shall be guided by the provisions of 5 CFR part 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB clearance.

(b) The Contractor shall not expend any funds or begin any data collection until the Contracting Officer provides the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor shall allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the control and without the fault or negligence of the Contractor in accordance with the Excusable Delays or Default clause of this contract.

H.3 CONFLICT OF INTEREST

As a regulatory agency charged with protection of public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The http://www.ppirs.gov/ http://www.cpars.gov/allapps/cpcbtdlf.htm

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

(a)Purpose. The purpose of this clause 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 restrictions described herein shall apply 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 activities covered by this clause as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity. For the purpose of this clause, affiliation occurs when a business concern is controlled by or has the power to control another or when a third party has the power to control both.

(c)Warrant and Disclosure. The warrant and disclosure requirements of this paragraph apply with full force 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.

(d)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.

(e)Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement at any tier expected to exceed the simplified acquisition threshold. The terms “contract,” “contractor,” and “Contracting Officer” shall be appropriately modified to preserve the Government's rights.

(f)Prime Contractor Responsibilities. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507-1, and shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. 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.

(g)Waiver. The parties recognize that this clause has potential effects which will survive the performance of this contract and that it is impossible to foresee each circumstance to which it might be applied in the future. Accordingly, the contractor may at any time 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.

H.4 352.224-70 PRIVACY ACT (DEC 2015)

This contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations.

The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C.

552a(i)).

The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees.

These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C.

552a(m)(1)). The contract work statement:

(a) Identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and

(b) Specifies the disposition to be made of such records upon completion of contract performance.

H.5 352.224-71 CONFIDENTIAL INFORMATION (DEC 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract:

Data and information either provided to the Contractor, or to any subcontractor or generated by activities under this contract or derived from research or studies supported by this contract, shall be used only for the purposes of the contract. It shall not be duplicated, used or disclosed for any purpose other than the fulfillment of the requirements set forth in this contract. This restriction does not limit the Contractor's right to use data or information obtained from a non-restrictive source. Any questions concerning "privileged information" shall be referred to the Contracting Officer.

Some data or information may require special consideration with regard to the timing of its disclosure so that preliminary findings which could create erroneous conclusions are not stimulated. Also, some data or information, which relate to policy matters under consideration by the Government, may also require special consideration with regard to the timing of its disclosure so that the open and vigorous debate, within the Government, of possible policy options is not damaged.

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are: The government interest requires the restriction of the information above for two reasons. First, it “protects the integrity of the deliberative or policy-making processes within the agency.” (FOIA (Exemption 5) Second, it “would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law.” [FOIA Exemption 7(F)]

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i).

The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

H.6 352.227-70 PUBLICATIONS AND PUBLICITY (DEC 2015)

(a) Unless otherwise specified in this contract, the Contractor may publish the results of its work under this contract. The Contractor shall promptly send a copy of each article submitted for publication to the Contracting Officer’s Representative. The Contractor shall also inform the Contracting Officer’s Representative when the article or other publication is published, and furnish a copy of it as finally published.

(b) Unless authorized in writing by the Contracting Officer, the Contractor shall not display the HHS logo including Operating Division or Staff Division logos on any publications.

(c) The Contractor shall not reference the product(s) or service(s) awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies HHS approval or endorsement of the product(s) or service(s) provided.

(d) The contractor shall include this clause, including this section (d) in all subcontracts where the subcontractor may propose publishing the results of its work under the subcontract.

H.7 352.239-73 Electronic Information and Technology Accessibility Notice (DEC 2015).

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic…