FDA-RFP-1114590.doc

FDA-RFP-1114590

PART I-THE SCHEDULE

SECTION A: DESCRIPTION

Solicitation number FDA-RFP-1114590 is issued as a Request for Proposal (RFP).

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 15 and included in this notice. The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-66. The North American Industrial Classification System (NAICS) code for this procurement is 541720, Research and Development in the Social Sciences and Humanities.

SECTION B: SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 CONTRACT TYPE

The government anticipates an Indefinite Delivery/ Indefinite Quantity Contract with Firm-Fixed Price, Time and Material and Labor Hour task orders for assessing tobacco product pharmacology and human dependence behaviors in healthy volunteer tobacco users.

B.2 PRICING

Base IDIQ Pricing Table: The loaded hourly rates for each labor category shall be fully burdened to include wages, indirect costs (including local travel, fringe benefits, overhead, general and administrative, and profit.

Year Hourly Rates Option Year 1 Hourly Rates Option Year 2 Hourly Rates Option Year 3 Hourly Rates Option Year 4 Hourly Rates

*The material handling fee applicable to other direct costs is______.

**The estimated hours and totals for the labor categories will only be used to evaluate pricing only.

***The above labor categories represent FDA’s estimate as to the type of expertise required under this contract.

SECTION C: DESCRIPTION/SPECIFICATIONS

C.1 BACKGROUND

The primary function of the Food and Drug Administration (FDA) is to promote public health associated with the use of foods, dietary supplements, cosmetics, drugs, tobacco, and other products under its jurisdiction. FDA's Center for Tobacco Products (CTP) implements PL 111-31 and H.R. 1256, Family Smoking Prevention and Tobacco Control Act that was signed into law on June 22, 2009. The Tobacco Control Act granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health. Because tobacco products are not regulated as drugs, their effects on human behavior and pharmacology have not been evaluated by FDA. The Contractor will provide the scientific support necessary to assist in the implementation of this law under the Federal Food, Drug, and Cosmetic Act.

Specifically under this contract, the contractor will assist FDA by assessing tobacco product pharmacology and human dependence behaviors in healthy volunteer male and female tobacco users.

C.2 PROJECT PURPOSE/ OBJECTIVES

The primary objective of this IDIQ contract is to evaluate the impact of tobacco products on human behavior, topography, and pharmacology, including clinical pharmacokinetics and pharmacodynamics. To fulfill these objectives, the Government seeks a contractor to perform a series of clinical studies with a wide range of tasks to accomplish the objectives as further described in the Statement of Work.

Studies may assess the impacts of tobacco products on dependence, craving, withdrawal, choice behavior, use behavior and topography, harm perception, physiological and pharmacodynamic effects, and measurements of biomarkers of exposure (e.g., nicotine, cotinine, CO, TSNAs). All laboratory studies are required to follow Good Laboratory Practices. For clinical pharmacology studies, use of a Clinical Pharmacology Unit and Good Clinical Practices are required. Data collected under this contract will inform FDA on the behavioral and pharmacological effects associated with tobacco product use, and may guide tobacco product policies and regulations.

C.3 SCOPE OF WORK

Independently, and not as an agent of the Federal Government, the Contractor shall furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below. The Contractor shall provide support in accordance with the timelines stated in the deliverables.

C.4 TECHNICAL REQUIREMENTS

The contractor's activities shall depend on the individual Task Order requirements, which will define the specific needs of the Government and may include, but are not be limited to, the following:

· Input on scientific protocols and methodologies for human pharmacology, clinical pharmacology, and behavioral studies

· Selection of an appropriate clinical research facility

· Development and/or validation of assessments (including biological assays), measurement techniques, study protocols

· Documentation and other assistance necessary for package submission to the FDA RIHSC (Research in Human Subjects Committee), including comprehensive human subjects’ protection plans, consent forms, data safety and monitoring plan, and security plan for sensitive data

· Provide approval from certified outside IRB

· Documentation and other information needed for submission of a packet to OMB (Office of Management and Budget) including Information Collection Requests (ICR: see Attachments).

· Sampling and retention plans, including power analyses and expected drop out rates

· Recruitment, screening, and selection of participants based on inclusion and exclusion criteria

· Administer tobacco products to participants and provide appropriate medical monitoring

· Collect behavioral, biological, and pharmacological data, including data on use behavior and topography, subjective effects, pharmacokinetic and pharmacodynamic analyses of tobacco and tobacco smoke constituents (e.g., nicotine, cotinine, CO, TSNAs), harm perception, and other possible drug effects.

· Develop data analysis plan and perform data analyses

· Deliver tabulated interim raw data as well as the results of the data analyses in SAS transport (.xpt) format

· Develop a comprehensive quality assurance plan

· Perform and document safety and quality assurance testing

· Use Good Clinical Practices (see Attachments) and industry/research standards to ensure and maintain the confidentiality of data.

· Conduct scientific literature reviews.

· Provide intermediate and final data reports

· Provide comprehensive minutes of meetings and conference calls C.4.1 IRBs and Assurances Registering an institutional review board (IRB) and obtaining a Federalwide Assurance (FWA) are related but separate processes.

An institution must have an FWA in order to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with OHRP.

Before obtaining an FWA, an institution must either register its own IRB, (an “internal” IRB), or designate an already registered IRB operated by another organization, (an “external” IRB), after establishing a written agreement with that other organization.

An IRB is a committee that performs ethical review of proposed research.

A graphic summarizing the decision sequence can be seen and printed in PDF format here, and is available in text form here.

Other federal departments and agencies that conduct or support human subjects research permit use of the FWA as the assurance required by their regulations.

Some require use of their own assurance for research not appropriate for an FWA

The Web page for electronic submission of new IRB registrations and FWAs, or update/renewal of existing IORGs/IRBs and FWAs is at http://ohrp.cit.nih.gov/efile/Default.aspx.

C.5 REPORTS AND DELIVERABLES

All reports required under this contract shall be submitted electronically to the COR in Microsoft Word 2007 compatible format. All raw data obtained from the subjects shall be submitted in SAS transport (.xpt) format. All other reports and deliverables shall be specified on each task order.

Monthly Progress Reports per Task Order

a) Delivered electronically in SAS transport format

b) Each record shall be uniquely identified and shall correspond to one respondent's data

c) All data values shall be numeric rather than character

d) Adverse events description with the time in the event table

e) One (1) electronic copy of a finalized, complete, and correct Coding Book

g) One (1) electronic copy of the data analyses report, including files, tables and figures, and appropriate statistical analyses of the results.

SECTION D: PACKAGING

For electronic deliverables, the title of the document and contract number shall be identified in the subject line of the email.

SECTION E: INSPECTION AND ACCEPTANCE

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

For the purpose of this PART, (Determined at time of Award) is the authorized representative of the Contracting Officer.

Inspection and acceptance will be performed at:

FDA

Center for Tobacco Products

Food and Drug Administration

9200 Corporate Blvd

Rockville, MD 20850

Acceptance may be presumed unless otherwise indicated in writing by the COR.

SECTION F: DELIVERY OR PERFORMANCE

F.1

PERIOD OF PERFORMANCE

Base Year:

July 31, 2013 through July 30, 2014

Option Year One:

July 31, 2014 through July 30, 2015

Option Year Two:

July 31, 2015 through July 30, 2016

Option Year Three:

July 31, 2016 through July 30, 2017

Option Year Four:

July 31, 2017 through July 30, 2018 F.2

PLACE OF PERFORMANCE

Contractor’s Facility or an offsite appropriate facility will be the place of performance. Any in person meetings will occur at 9200 Corporate Blvd, Rockville, MD facilities.

SECTION G: CONTRACT ADMINISTRATION

Contracting Officers Representative (COR)

G.1 The following COR will represent the Government for the purpose of this contract: (Determined at time of Award )

G.1.1The 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.1.2 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 RFP; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

Contracting Officer(CO) and Contract Specialist (CS) G.2 Contact information for the Contracting Officer:

James Chestnut James.Chestnut@fda.hhs.gov 301-827-3366 G.3 Contact information for the Contract Specialist:

Juana Quinteros

Juana.Quinteros@fda.hhs.gov

301-827-6764 Contractor Project Manager G.4 Contact information for the Contractor’s Project Manager:

(To be determined at time of award)

G.5 CONTRACTING OFFICER REPRESENTATIVE (COR) FOR TASK ORDERS

For each task order, a Task Order Contracting Officer Representative (COR) will be assigned. The Task Order COR shall serve as the Contractor's first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (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; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction; and, (7) reviewing of invoices/vouchers.

The Government may unilaterally change its Contracting Officer Representation designation. Technical Leads may assist the Contracting Officer Representative. The Technical Leads will not have the authority to provide technical direction in accordance with the paragraphs above; however, they may be responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (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; (5) assisting in the resolution of technical problems encountered during performance; and (6) reviewing of invoices/vouchers.

G.6 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

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.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

G.7 ORDERING PROCESSES AND PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the types of services being ordered. All task orders issued under this contract shall conform to the provisions of the contract clause in Part 8 entitled “Ordering.” 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 Procedures – When a need for services within scope of this contract arises, the FDA will issue a Request for Task Order Proposal (RFTOP). The process for awarding tasks orders will be as follows:

1.

FDA’s Office of Acquisitions & Grants Services Contracting Officer will issue an RFTOP via email. The RFTOP will include at a minimum a SOW, the period of performance, reporting requirements and deliverables, and any special terms and conditions applicable to the Task Order.

2. 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 RFTOP 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.

3.

Within ten (10) business days (unless another time frame is specified in writing), the contractor will provide a proposal to the Contracting Officer. The proposal will include a brief description of the technical approach and a price build up. The price build up should include the labor categories to be utilized, the number of hours within each labor category, extended pricing for each labor category and a bottom line price/ceiling.

4.

FDA will evaluate the task order proposal for technical acceptability and price reasonableness. FDA will consider the following technical factors: technical approach, whether the labor mix is appropriate; and whether the level of effort is sufficient. If the FDA has questions or concerns the Contracting Officer will contact the contractor, and may ask for a revised proposal.

5.

Once the proposal is acceptable, the Contracting Office will issue the task order.

6.

Orders will include the following:

a. Task Order Number

b. Date

c. Accounting Information

d. SOW

e. Price/Ceiling

f. Period of Performance

g. Any terms, conditions, or instructions unique to the order

h. A Conflict of Interest Statement signed by all employees

7. The offeror shall use their fully burdened labor rates to propose on all task orders.

G.8 SUBCONTRACTING PROVISIONS

a.

Small Business Subcontracting Plan

The Small Business Subcontracting Plan is attached hereto and made a part of this contract.

b.

Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

1.

Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th

October 30th

Expiration Date of Contract

2.

Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer and Contract Specialist shall be included as a contact for notification purposes at the following e-mail address:

Juana Quinteros Contract Specialist Juana.Quinteros@fda.hhs.gov G.9 RELEASE AND USE AND COPYRIGHT OF DATA FIRST PRODUCED FROM WORK PERFORMED UNDER THIS CONTRACT

(a) Release and Use – Data first produced in the performance of the Contract. As permitted in FAR 52.227-17, the provisions of this section shall apply to any release or use of data first produced in the performance of the Contract and any analysis, tools, methodologies, or recorded product based on such data.

(b) Release and Use – Requirements related to confidentiality and quality. To ensure public trust in the confidentiality protections afforded participants in Agency for Healthcare Research and Quality (AHRQ)-supported research, AHRQ requires and monitors compliance by its contractors with section 934(c) of the Public Health Service Act (PHS Act) (42 U.S.C. 299c-3(c)), which states in part that

No information, if the establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under this title, may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented to its use for such other purpose. Such information may not be published or released in other form if the person who supplied the information or who is described in it is identifiable unless such person has consented to its publication or release in other form.

In addition to this requirement, section 933(b) (1) of the PHS Act (42 U.S.C. 299c-2(b) (1)) requires AHRQ to assure that statistics and analyses developed with Agency support are of high quality, comprehensive, timely, and adequately analyzed. Accordingly --

(1) prior to the release or use of data based upon work performed under this Contract, the Contractor agrees to consult with the Project and Contract Officers regarding the proposed release or use. The Contractor will in good faith consider, discuss, and respond to any comments or suggested modifications that are provided by AHRQ within two months of receiving the proposed release or use.

The purpose of such consultation is to assure that:

(A) identifiable information is being used exclusively for the purpose(s) for which it was supplied or appropriate consents have been obtained;

(B) the confidentiality promised to individuals and establishments supplying identifiable information or described in it is not violated; and

(C) the quality of statistical and analytical work meets the statutory standards cited above.

(2) The Contractor must satisfy conditions (1) (A) and (1) (B). At the conclusion of any consultation required by paragraph (b) (1) above, if AHRQ and the Contractor cannot agree that a proposed use or release satisfies condition (1) (C) above:

(A) the research professional at the Contractor responsible for the quality of the Contract work will, in advance of any release or use of such data, certify in a letter to the Contracting Officer what differences of opinion cannot be resolved regarding the statutory standards referenced in condition (1) (C) and the basis for Contractor assertions that these standards have been met; and

(B) the Contractor must print prominently on the release or other product, or on any portion that is released, or state prior to any oral presentation or release of such material, the following disclaimer:

THIS presentation/ publication/or other product is derived from work supported under a contract with THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ) (#). However, this presentation/ publication/or other product HAS NOT BEEN APPROVED by the agency.

(c) Required Statement Regarding Protected Information. On all written material or other recorded products, or preceding any presentation or other oral disclosure, release or use of material based on identifiable information obtained in the course of work performed under this contract, the Contractor shall make the following statement:

Identifiable information on which this report, presentation, or other form of disclosure is based is protected by federal law, section 934(c) of the public health service act, 42 u.s.c. 299c-3(c). No identifiable information about any individuals or entities supplying the information or described in it may be knowingly used except in accordance with their prior consent. Any confidential identifiable information in this report or presentation that is knowingly disclosed is disclosed solely for the purpose for which it was provided.

(d) Copyright – Data first produced in the performance of the Contract. Subject to the terms of this Section regarding release and use of data, AHRQ, through its Contracting Officer, will grant permission under FAR 52.227-17(c) (1) (i) to the Contractor to establish claim to copyright subsisting in scientific and technical articles based on or containing data first produced in the performance of this contract that are submitted for publication in academic, technical or professional journals, symposia proceedings or similar works. When claim to copyright is made, the Contractor shall affix the applicable copyright notice of 17 U.S.C. 401 or 402 and acknowledgment of Government sponsorship (including contract number) to the data when such data are delivered to the Government, as well as when the data are published or deposited for registration as a published work in the U.S. Copyright Office. In such circumstances, the Contractor hereby agrees to grant to AHRQ, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of AHRQ. A description of this license will be incorporated into the copyright notices required above.

(e) Subcontracts. Whenever data, analyses, or other recorded products are to be developed by a subcontractor under this Contract, the Contractor must include the terms of H.1 in the subcontract, without substantive alteration, with a provision that the subcontractor may not further assign to another party any of its obligations to the Contractor. No clause may be included to diminish the Government’s stated requirements or rights regarding release or use of products or materials based on data derived from work performed under this contract.

SECTION H: SPECIAL CONTRACT REQUIREMENTS

H.1 INVOICING INSTRUCTIONS

FDA TWO-WAY-Matching Invoice Clause

A.

The contractor shall submit all invoices to all addressees in the manner specified below:

(I) One original and one copy to the approving official:

U.S. Food And Drug Administration

Office Of Acquisitions And Grants Services

ATTN: Juana Quinteros/CS 5630 Fishers Lane

Room 2122, HFA-500

Rockville, Maryland 20857

E-mail: Juana.Quinteros@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

Office Of Program Operations

ATTN: [INSERT NAME], COR

White Oak Campus

10903 New Hampshire Avenue

Room XXXX

Silver Spring, Maryland 20993

E-mail: xxxx.xxxx@FDA.HHS.GOV

*** 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 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) task order/award number;

(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 task 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’s representative (COR) or other program center/office point of contact, as referenced on the task order;

(xii) any other information or documentation required by the task order/award.

(xiii) contractor is ■ is not □ 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 (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:

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

H.2 CONTRACT FINANCIAL REPORTING FOR TIME AND MATERIALS/ LABOR HOUR TASK ORDERS

Financial reports shall be submitted by the contractor with the invoices for time and materials and labor hour task orders in accordance with the 4 expenditure categories below:

1. Labor hours and total labor charges for each skill level category for the current period and cumulative cost for the total contract to date.

2. Accumulated total for all cost categories (i.e., labor).

3. Task order ceiling and percent expended to date.

4. Estimate to complete.

The Contractor must notify the COR in writing when 75% of the estimated total cost of the task order has been expended.

H.3 ORGANIZATIONAL CONFLICT OF INTERESTS

As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract action.

Offerors submitting proposals to perform work under this contract must assure the protection of the information and data they receive in performance or 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, its employees, or the Government in the performance of this immediate contract and potential participation in future actions. Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found acceptable by the Government and enforced.

Potential Conflicts of Interest specific to this contract

Offerors shall review the Statement of Work included in each RFTOP in detail to identify any particular aspects that may present organizational or individual COI, either actual or apparent.

DEFINITION OF CONFLICT OF INTEREST- Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's or organization's objectivity in performing the contract is or might be otherwise impaired, or that the person or organization has or might acquire an unfair competitive advantage (See FAR 9.501).

a. The contractor and all of its present and future affiliates and subsidiaries agree to:

1) not compete nor assist anyone in competing for any competitive acquisition of the requirements or services described in the documents which the contractor has been provided access to or delivers under this contract and task orders thereof.

2) not furnish either as a prime contractor or subcontractor the requirements or services described in this requirement.

b. The above prohibitions shall also apply to the contractor's employees, subcontractors, consultants or any other person who participates in the performance of this contract. The contractor shall require such persons to sign the below statement agreeing to the above restrictions. The original of the below statement shall be provided to the Contracting Officer, prior to the person beginning work under this contract/order.

c. Noncompliance with the above restrictions and conditions shall be a cause for: termination of this contract for default; and/or, disqualification of any proposal submitted for a competition.

ORGANIZATIONAL CONFLICT OF INTEREST STATEMENT

FDA Contract No. _______

I, (Type name of employee), an employee of ________, agree to:

1) not compete nor assist anyone in competing for any competitive acquisition of the requirements or services described in the documents which the contractor has been provided access to or delivers under this contract; specifically, the FDA's Capital Planning Investment Control documents, process and forms.

2) not furnish either as an employee of a prime contractor or subcontractor the requirements or services described in this requirement.

Signature Date ___________________

PART II-CONTRACT CLAUSES

SECTION I: CLAUSES and PROVISIONS I.1 FAR Clauses:

I.1.1 FAR Clause 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 www.acquisition.gov/far/index.html.

· FAR 52.202-1: Definitions (JAN 2012)

· FAR 52.203-3: Gratuities (APR 1984)

· FAR 52.203-5: Covenant Against Contingent Fees (APR 1984)

· FAR 52.203-7: Anti-Kickback Procedures (OCT 2010)

· FAR 52.212-4: Contract Terms and Conditions—Commercial Items (FEB 2012)

· FAR 52.216-7: Allowable Cost and Payment (JUN 2011)

· FAR 52.217-5: Evaluation of Options (JUL 1990)

· FAR 52.232-1: Payments (APR 1984)

· FAR 52.244-2: Subcontracts (OCT 2010)

· FAR 52.246-4: Inspection of Services-Fixed Price Clause (AUG 1996)

· FAR 52.246-6: Inspection-Time And Material And Labor Hour (MAY 2001)

· FAR 52.219-9: Small Business Subcontracting Plan (JAN 2011)

I.1.2 FULL TEXT:

FAR 52.212-5: Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (JAN 2013):

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

(1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).

____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

_X__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

___ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Aug 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

__X_ (6) 52.209-6, Protecting the Government’ Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Dec 2010) (31 U.S.C. 6101 note).

__X_ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Feb 2012) (41 U.S.C. 2313).

___ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

___ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

_X__ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (11) [Reserved]

___ (12) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (13) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

__X_ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

__X_ (15) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (15 U.S.C. 637 (d)(4).)

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (July 2010) of 52.219-9.

___ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

_x__ (18) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (19) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

___ (ii) Alternate I (June 2003) of 52.219-23.

___ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (21) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

__X_ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2012) (15 U.S.C. 632(a)(2)).

___ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2012) (15 U.S.C. 637(m)).

___ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2012) (15 U.S.C. 637(m)).

__X_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Mar 2012) (E.O. 13126).

__X_ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X_ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

_X_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

_X__ (32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

_X__ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (34) 52.222-54, Employment Eligibility Verification (Jul 2012). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (37) (i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).

___ (ii) Alternate I (Dec 2007) of 52.223-16.

_X__ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

___ (39) 52.225-1, Buy American Act--Supplies (Feb 2009) (41 U.S.C. 10a-10d).

_X_ (40) (i) 52.225-3, Buy American Act--Free Trade Agreements--Israeli Trade Act (Nov 2012) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

___ (ii) Alternate I (Mar 2012) of 52.225-3.

___ (iii) Alternate II (Mar 2012) of 52.225-3.

___ (iv) Alternate III (Nov 2012) of 52.225-3.

___ (41) 52.225-5, Trade Agreements (Nov 2012) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X__ (42) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (43) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (44) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (45) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

___ (46) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__X_ (47) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct. 2003) (31 U.S.C. 3332).

___ (48) 52.232-34, Payment by Electronic Funds Transfer—Other Than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

___ (49) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

___ (50) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (51) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

_X__ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

_X__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

_X__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act -- Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C.206 and 41 U.S.C. 351, et seq.).

___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act -- Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

___ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

___ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

___ (7) 52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O. 13495).

___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Mar 2009) (Pub. L. 110-247).

___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (Jan 2013) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(viii) 52.222-41, Service Contract Act of 1965, (Nov 2007), (41 U.S.C. 351, et seq.)

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.)

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Feb 2009) (41 U.S.C. 351, et seq.)

(xii) 52.222-54, Employment Eligibility Verification (Jul 2012).

(xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xiv) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

· FAR 52.216-18: Ordering (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from July 31, 2013 through July 30, 2018.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

·…