FDA-RFP-2017-179955_8-10-2017.pdf

Title: FDA-RFP-2017-179955

PART 1: DESCRIPTION

Solicitation number FDA-RFP-2017-179955 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 05-95. The North American Industrial Classification System (NAICS) code for this procurement is 541720, Research and Development in the Social Sciences and Humanities.

PART 2: SUPPLIES /SERVICES AND PRICES

2.1 BRIEF DESCRIPTION OF SERVICES

The primary function of the Food and Drug Administration ("FDA" hereinafter) 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" hereinafter) 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 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 and tobacco product constituent pharmacology and dependence behaviors using nonclinical models.

2.2 CONTRACT TYPE

This is an Indefinite Delivery Indefinite Quantity (IDIQ) type contract with a Five (5) year ordering period.

FDA has chosen to pursue an IDIQ contract to reduce lead time to award task orders and to maximize the flexibility of selecting contract types appropriate to the specific tasks under consideration. At the discretion of the Contracting Officer, the government may use a Time and Materials, Labor-Hour, Firm Fixed Price or a combination thereof for the task orders. Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government's determination of contract type.

2.3 PRICING

The ceiling amount associated with this IDIQ is $10 million. The minimum guarantee for awardees under this vehicle is $1,000.00.

Base IDIQ Pricing Table 1: 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.

Labor Categories *Estimated

Yearly Hours

Base Year Rate

Year 1 Rate

Year 2 Rate

Year 3 Rate

Year 4 Rate

Total

Senior Scientist 300 $ $ $ $ $ $ Project Director 300 $ $ $ $ $ $ Project Manager

Laboratory Technician 2080 $ $ $ $ $ $ Research Assistant 1256 $ $ $ $ $ $ Data Manager 550 $ $ $ $ $ $ Analytical Chemist 300 $ $ $ $ $ $ Statistician 15 $ $ $ $ $ $ Subject Matter Expert 100 $ $ $ $ $ $ Writer/Editor 25 $ $ $ $ $ $

Total Price $

Other direct costs will be proposed on each individual task order and shall include volunteer compensation, assays, and tobacco product reimbursement. The offeror shall use their fully burdened labor rates to propose on all task orders

2.4 OVERVIEW OF PRICING SCHEDULES

Fixed Price, Time and Materials and Labor Hour Tasks may be ordered via the issuance of individual Task Orders. The prices set forth shall apply throughout the life of the agreement.

PART 3: STATEMENTOF WORK

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law. The Tobacco Control Act amended the Federal Food, Drug and Cosmetic Act (FD&C Act) by, among other things, adding a new chapter granting the Food and Drug Administration (FDA) authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

Section 906 of the Tobacco Control Act provides FDA with the authority to enter into contracts for research, testing, and demonstrations of tobacco products and to obtain products for research, testing, and demonstration purposes. Based on this authority, FDA is seeking a Contractor to assess tobacco products and tobacco product constituents on pharmacology and behavior using nonclinical models.

3.1 PURPOSE/OBJECTIVE

The primary objective of this contract is to evaluate the impact of tobacco product constituents on pharmacology and behavior using nonclinical models. To fulfill these objectives, the Government seeks a Contractor to perform a series of nonclinical studies with a wide range of tasks to accomplish the objectives as further described in the Statement of Work (SOW).

The range of tasks required for each task order will vary. These tasks shall include but not be limited to: providing input on scientific protocols and methodologies, providing animal subjects protection including Animal Care and Use Committee (ACUC) documentation and approval, providing documentation for FDA ACUC, administering the test constituent(s), collecting behavioral, pharmacological and toxicological data, performing data analyses, and creating scientific reports. Studies will assess the impacts of tobacco product constituents on pharmacological, toxicological and behavioral outputs, including histopathology and gross pathology, clinical chemistry and hematology, safety pharmacology endpoints for cardiovascular and respiratory systems, midbrain neurotransmitter release, reinforcement/reward, dependence, withdrawal, choice behavior, and physiological effects (e.g., peak plasma levels). Data collected under this contract will inform FDA on the behavioral and pharmacological effects associated with tobacco products and tobacco product constituents, and may guide tobacco product policies and regulations.

3.2 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. Animal facilities where the work is to be performed must be Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) (http://www.aaalac.org/) certified at the time of contract award. The Contractor shall provide support in accordance with the timelines stated in the deliverable schedule.

The Contractor shall conduct the following Task:

A. Pharmacological assessments may include, but are not limited to:

• Neurobiological assessments including dopamine release in the brain

• Techniques to measure brain nicotinic receptor binding, upregulation, and activity

• Toxicological assessments - histopathology and toxico/pharmacokinetics of tobacco constituents, cardiovascular and respiratory safety pharmacology parameters

B. Behavioral assessments may include, but are not limited to:

• Motor activity using automated locomotor activity chambers

• Reinforcement assessments using self-administration procedures (e.g., intravenous and/or oral)

• Reward assessments using place conditioning

• Dependence and withdrawal assessments including somatic withdrawal assessed through ratings of videotaped behaviors

• Choice behavior assessments

• Drug discrimination http://www.aaalac.org/

C. Assess physiological measurements, including peak plasma levels of constituent(s)

D. Analytical assessments of tobacco product smoke condensate and/or aqueous solutions

E. Prepare documentation for ACUC package submission. Work with study Technical Leads to obtain FDA ACUC approval. The Contractor shall not proceed with laboratory testing until written FDA/ACUC approval is received.

F. Deliver tabulated interim raw data as well as the results of the data analyses and a written report to the Government by a specified date during the task period.

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:

• Ordering, housing, handling and maintenance of cells and/or animals.

• Selecting the research facility to perform the study.

• Providing scientific expertise during the development of protocols and methodologies.

• Providing scientists and research assistants to execute laboratory protocols, including pharmacological, toxicological, behavioral, and analytical assessments.

• Monthly written reports documenting animal care (including issues related to animal care and use), progress on each activity of current task orders, interim data analysis (when scientifically feasible), and discussion of any problems or issues, including steps taken to resolve them and the results of those steps.

• Providing comprehensive written minutes of all meetings and conference calls.

• Providing staff to perform quality assurance assessments.

• Use Good Laboratory Practices

(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58)-

• Analyzing pharmacological, toxicological and/or behavioral data, including measurement of plasma levels of constituent(s).

• Conducting scientific literature reviews.

• Providing the intermediate as well as final data reports, and working with the study

Technical Leads on scientific manuscripts for peer-reviewed journals.

3.3 REPORTS AND DELIVERABLES

All reports required under this contract shall be typed (12 point font) and submitted electronically to the Contracting Officer’s Representative (COR) in Microsoft Word 2007 compatible format. All tabulated data obtained from the studies shall be submitted in Microsoft Excel format unless otherwise specified. All other reports and deliverables shall be specified in each task order.

3.4 PACKAGING

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58

3.5 INSPECTION AND ACCEPTANCE

The 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 10903 New Hampshire Ave.

Silver Spring, MD 20993

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

3.6 PERIOD OF PERFORMANCE

This contract covers a 5 year - 60 month ordering period.

3.7 PLACE OF PERFORMANCE

All work shall be performed at the Contractor and/or subcontractor’s facilities. All Facilities must be AAALAC certified (http://www.aaalac.org/). Written proof of AAALAC certification must be provided as part of the proposal.

3.8 INVOICING INSTRUCTIONS

The following invoice procedures will be utilized for task orders under this contract:

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

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 http://www.aaalac.org/ mailto:FDAVendorPaymentsTeam@fda.hhs.gov https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

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

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

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

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

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

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

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

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

NET 30);

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

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

(ix) Taxpayer Identification Number (TIN);

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

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

(xii) For all Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

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

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

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

3.9 ORGANIZATIONAL CONFLICT OF INTERESTS

As a regulatory agency charged with protection of public health, the FDA must maintain public confidence in the integrity of its decisions. CTP oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.

The 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) The purpose of this section is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The language of this section applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co- sponsor, joint venture, consultant, or in any similar capacity.

(c) Definition of Conflict of Interest

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

(d) Contractor’s Conflict of Interest Responsibilities

The individual contractor must be free of interest prior to performing under this contract. Any time prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the contract officer and project officer. The contract officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the contract officer.

(e) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

The contractor will be performing lab analysis of tobacco products and providing that analysis to FDA to inform regulatory decision making. The contractor must thoroughly disclose any relevant information regarding financial relationships with private entities that may be affected by this regulatory decision making in its proposal prior to award. If such financial relationships exist, the contractor shall provide a statement as to whether it believes the relationships present a potential or actual conflict of interest and the basis for that determination. If the contractor has identified a potential or actual conflict of interest, a plan for mitigating the conflict of interest must be submitted prior to award.

Prior to award, contractors that disclose potential or actual conflicts of interest shall submit a mitigation of conflicts of interest plan along with their technical and business proposals.

(f) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(g) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(h) Prime Contractor Responsibilities.– The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(i) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

3.10 PUBLICATION OF RESEARCH

FDA considers the sharing of FDA-funded research, including digital data, an important means to enhance its value and support future research. When the findings associated with research developed with FDA funds are published, they are required to be made readily available to the public. In addition, investigators seeking FDA funding, in whole or in part, via a contract, grant, or assistance agreement must have an FDA-approved Data Management Plan – a plan for digital data management and sharing – prior to commencing any related services or work.

Upon acceptance for publication, researchers are also responsible for submitting the author’s final manuscript of any peer-reviewed scientific publication resulting from research supported, in whole or in part, with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications resulting from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. FDA expects timely release and sharing of final research data from FDA-funded studies for the research community’s use in accordance with the submitted Data Management Plan. Please see the FDA Public Access Policy (provided as Attachment/Exhibit XXYY; or, available at http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pd f).

3.11. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pdf http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pdf

c. The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those Contractors with approved Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; Web site: (http://www.aphis.usda.gov/animal_welfare).

(End of Clause)

3.12 PUBLICATIONS AND STUDY PRESENTATIONS

The Contractor shall not present or publish any information obtained through this contract without the express prior written permission of the COR. Should the Government present or publish information obtained through this contract, any Contractor authorship will be at the discretion of the COR.

3.13 PUBLICATION OF DATA

The Contractor shall not present, publish, or otherwise release any information arising out of their contract without the express prior written permission of the COR. The COR will determine what, if any, information may be releasable for publication, presentation, or through another means and will determine the content of the released information, including any authorship decisions.

FDA considers the sharing of FDA-funded research, including digital data, an important means to enhance its value and support future research. When the findings associated with research developed with FDA funds are published, they are required to be made readily available to the public. In addition, investigators seeking FDA funding, in whole or in part, via a contract, grant, or assistance agreement must have an FDA-approved Data Management Plan – a plan for digital data management and sharing – prior to commencing any related services or work.

http://www.aphis.usda.gov/animal_welfare

PART 4: ORDERING PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the services being ordered. All task orders issued under this contract shall conform to the provisions of the contract clause in Part 5. The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the FDA Contracting Officer.

4.1 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 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 (RFTOPs) 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.

PART 5- CONTRACT CLAUSES

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS

(JAN 2017)

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

(1) 52.203-19,Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

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

(4) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004)(Public Laws 108- 77 and 108-78 (19 U.S.C. 3805 note)).

(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 (Sep

2006), with Alternate I (Oct 1995)(41 U.S.C. 4704 and 10 U.S.C. 2402).

__X __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

__ __ (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.)

__X __ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C.

6101 note).

(5) [Reserved] __ __ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub.

L. 111-117, section 743 of Div. C).

_ X__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-

Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__X __ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

__X __ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

____ (10) [Reserved} __ __ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov

2011)(15 U.S.C. 657a).

__ __ (11) (ii) Alternate I (Nov 2011) of 52.219-3.

__X __ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small

Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

__ _ (12) (ii) Alternate I (Jan 2011) of 52.219-4.

(13) [Reserved] __ __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)(15

U.S.C. 644).

__ __ (14) (ii) Alternate I (Nov 2011).

__ __ (14) (iii) Alternate II (Nov 2011).

__ __ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003)(15

U.S.C. 644).

__ __ (15) (ii) Alternate I (Oct 1995) of 52.219-7.

__ __ (15) (iii) Alternate II (Mar 2004) of 52.219-7.

__X __ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C.

637(d)(2) and (3)).

__X __ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C.

637(d)(4)).

__ __ (17) (ii) Alternate I (Nov 2016) of 52.219-9.

__ __ (17) (iii) Alternate II (Nov 2016) of 52.219-9.

__ __ (17) (iv) Alternate III (Nov 2016) of 52.219-9.

____ (17) (v) Alternate IV (Nov 2016) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017)(15 U.S.C.

637(a)(14)).

__X __ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15

U.S.C. 637(d)(4)(F)(i)).

__ __ (21) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small

Business Set-Aside (Nov 2011)(15 U.S.C. 657 f).

__X __ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul

2013) (15 U.S.C. 632(a)(2)).

__ __ (23) 52.219-29, Notice of Set-Aside for, or Sole source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (1 U.S.C. 637(m)).

__ __ (24) 52.219-30, Notice of Set-Aside for, or Sole source Award to, Women- Owned Small Business Concerns Eligible Under the Women- Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

__X __ (25) 52.222-3, Convict Labor (June 2003)(E.O. 11755).

__ __ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies

(Oct 2016) (E.O. 13126).

__X __ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

__X __ (28) 52.222-26, Equal Opportunity (Sept 2016)(E.O. 11246).

__X __ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

__X __ (30) 52.222-36, Equal Opportunity For Workers with Disabilities (Jul

2014)(29 U.S.C. 793).

__X __ (31) 52.222-37, Employment Reports on Veterans (Feb 2016)(38 U.S.C.

4212).

__X __ (32) 52.222-40, Notification of Employee Rights Under the National Labor relations Act (Dec 2010) E.O. 13496).

__X __ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C.

chapter 78 and E.O. 13627).

__ __ (33) (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O.

13627).

__ __ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O.

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.)

__ __ (37) (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.)

__ _ (37) (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.)

__ __ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (June 2016) (E.O. 13693).

__ __ (39) 52.223-12, Maintenance, Service, repair, or Disposal of Refrigeration Equipment and Air Conditioners (June 2016) (E.O.13693).

__ _ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ _ (40) (ii) Alternate I (Oct 2015) of 52.223-13.

__ _ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun

2014) (E.O.s 13423 and 13514).

__ _ (41) (ii) Alternate I (Jun 2014) of 52.223-14.

__ __ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec

2007) (42.U.S.C. 8259b).

__ __ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer

Products (Oct 2015) (E.O.s 13423 and 13514).

__ _ (43) (ii) Alternate I (Oct 2015) of 52.223-16.

__X __ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging

While Driving (Aug 2011) (E.O.13513).

__ __ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693) __ __ (46) 52.223-21, Foams (Jun 2016) (E.O. 13693).

__X __ (47) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (47) (ii) Alternate I, (Jan 2017) of 52.244-3.

__ __ (48) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

__ __ (49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act

(May 2014) (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, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

__ _ (49) (ii) Alternate I (May 2014) of 52.225-3.

__ _ (49) (iii) Alternate II (May 2014) of 52.225-3.

__ _ (49) (iv) Alternate III (May 2014) of 52.225-3.

__ __ (50) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19

U.S.C. 3301 note).

__X __ (51) 52.225-13, Restriction on Certain Foreign Purchases (Jun 2008)(E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury).

__ __ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ __ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007)(42 U.S.C. 5150).

__ __ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007)(42 U.S.C. 5150).

__ __ (55) 52.232-29, Terms for financing of Purchases of Commercial Items (Feb 2002)(41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ __ (56) 52.232-30, Installment Payments for Commercial Items (Jan 2017)(41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ __ (57) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013)(31.U.S.C. 3332).

__ __ (58) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013)(31.U.S.C. 3332).

__ __ (59) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ __ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996)(5 U.S.C. 552a).

__X __ (61) 52.242-5, Payment to Small Business Subcontractors (Jan 2017) (15

U.S.C. 637(d)(12)).

__ __ (62) (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).

__ _ (62) (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:

__ __ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O.

13495).

__ __ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C.

chapter 67).

__ __ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014)

(29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ __ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor

Standards--Price Adjustment (Multiple Year and Option Contracts) (May 2014)(29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ __ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards - Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ __ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C.

chapter 67).

__ __ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014)(41 U.S.C. chapter 67).

__ __ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

__ __ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706. (Jan 2017)

(E.O. 13706).

__ __ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations.

(May 2014) (42 U.S.C. 1792).

__ __ (11) 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 paragraphs (e)(1) of this paragraph 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 (Oct 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-

235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iv) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O.

13495). Flow Down required in accordance with paragraph (l) of FAR clause 52.222-17.

(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(x) 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.

(xi) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

(xii) __X __ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

__ __(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O.

13627).

(xiii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C. chapter 67).

(xiv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

(xv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(xx) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xxi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraphs (e) of FAR clause 52.226-6.

(xxiii) 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.

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE

(JUL 2016)

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND

CERTIFICATIONS (DEC 2014)

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS (JUN 2016)

52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS

(JAN 2017)

52.233-2 SERVICE OF PROTEST (SEPT 2006)

THE FOLLOWING IS FILL-IN DATA FOR CLAUSE 52.212-5 PARA (b)(12):

52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZone SMALL

BUSINESS CONCERNS (JAN 2011)

(c) Waiver of evaluation preference.

__ Offeror elects to waive the evaluation preference.

THE FOLLOWING IS FILL-IN DATA FOR CLAUSE 52.212-5 PARA (b)(22):

52.219-28 POST-AWARD SMALL BUSINESS PROGRAM REREPRESENTATION (JUL 2013)

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code _____________ assigned to contract number ______________________________.

[Contractor to sign and date and insert authorized signer's name and title].

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013)

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS (DEC 2013)

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016)

52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX

LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(b) The Offeror represents that—

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

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 the date of contract award through expiration.

(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.

52.216-22 Indefinite Quantity (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after date of contract expiration.

52.216-19 Order Limitations (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1000.00 the Government is not obligated to…