FDA-17-RFP-1178035.pdf

Accessing Tobacco Pharmacology/Toxicology and Human Behaviors in Tobacco Users:

FDA-17-RFP-1178035

Accessing Tobacco Pharmacology/Toxicology and Human Behaviors in Tobacco Users

PART 1 – DESCRIPTION

Solicitation number FDA-17-RFP-1178035 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. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be used. The resultant contract and any awarded 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 541690, Other Scientific and Technical Consulting Services.

PART 2 – SERVICES AND SUPPLIES AND PRICES

2.1 CONTRACT TYPE

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

2.2 PRICING

The ceiling amount associated with this IDIQ is $15 million. The minimum guarantee for awardees under this vehicle is $1,000.00

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.

Labor Category *Estimated

Annual Hours

Base Year- Rate

Option Year - Rate

Option Year 2-

Rate

Option Year 3-

Rate

Option Year 4-

Rate Total

Senior Scientist 2,000 $ $ $ $ $ $ Scientist 2,000 $ $ $ $ $ $ Project Manger 2,500 $ $ $ $ $ $ Data Management Associate 1,000 $ $ $ $ $ $ Research Assistant II 600 $ $ $ $ $ $ Lab Technician II 600 $ $ $ $ $ $ Registered Nurse 350 $ $ $ $ $ $ Physician 800 $ $ $ $ $ $ Recruiter 1 500 $ $ $ $ $ $ Recruiter 2 500 $ $ $ $ $ $ Statistician 1,000 $ $ $ $ $ $ Subject Matter Expert 750 $ $ $ $ $ $ Clinical Data Manager 2,000 $ $ $ $ $ $

Pharmacokineticist 1,000 $ $ $ $ $ $ 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.

2.3 OVERVIEW OF PRICING SCHEDULES

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

PART 3 – STATEMENT OF WORK (SOW)

3.1 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 shall assist FDA by assessing tobacco product pharmacology and human behaviors in healthy volunteer male and female tobacco users.

3.2 PROJECT PURPOSE/ OBJECTIVES

The primary objective of this IDIQ contract is to evaluate the impact of tobacco products on human behavior, switching behaviors, topography, and pharmacology/toxicology, including clinical pharmacokinetics and pharmacodynamics. To fulfill these objectives the Government seeks a contractor to perform a series of studies (including in vitro 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 a variety of behaviors including dependence, craving, withdrawal, choice behavior, use behavior and topography, harm perception, physiological and pharmacodynamic effects, toxicology, and measurements of biomarkers of exposure (e.g., nicotine, cotinine, CO, TSNAs) in humans. Laboratory studies may be required to follow Good Laboratory Practices. For all 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.

3.3 SCOPE OF WORK

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 areas:

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

• Selection of a clinical research facility with the appropriate structures to perform the clinical research study (e.g., ventilated smoking rooms).

• Development and/or validation of assessments (e.g., detailed analytical methods to be used to detect biomarkers of exposure and their LLOD and LLOQ), measurement techniques (e.g., capabilities of administering surveys electronically), and study protocols.

• Documentation and other assistance necessary for package submission to the CTP/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.

• Obtain Investigational Tobacco Product (ITP) clearance. (Guidance)

• Provide approval from a certified, Federal wide Assurance IRB.

• Documentation and other information needed for submission of a packet to OMB (Office of Management and Budget) including Information Collection Requests (http://www.hhs.gov/ocio/policy/collection/infocolsub.html).

• Participant recruitment and retention plans, including power analyses, expected drop out rates, and compensation based on the study’s design and objectives.

• Execute recruitment, screening, and selection of participants based on study inclusion and exclusion criteria.

• Administer tobacco products to participants and provide appropriate medical monitoring

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

• Perform data analyses, including statistical analyses and interpretation to support the study objectives.

• Deliver tabulated interim raw data as well as the results of the data analyses in SAS transport (.xpt) or Microsoft Excel.

• Develop a comprehensive quality assurance plan for each task order, including details for study monitoring, data auditing, and source document monitoring.

• Perform and document safety and quality assurance testing to ensure 100% data verification and integrity.

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

• Conduct scientific literature reviews to provide appropriate scientific background for study goals and discussion of results.

• Provide intermediate and final data reports.

• Provide comprehensive minutes of meetings and conference calls.

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM463953.pdf http://www.hhs.gov/ocio/policy/collection/infocolsub.html

3.4 DELIVERABLES

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.

Deliverable Delivery Date* Content of the Deliverable

Monthly Progress Reports per Task

Order

Electronically submit to the

COR/CO by the 10th of each month for each thirty day period prior to the report due date.

The contractor shall deliver a monthly Progress Report to COR documenting the progress of the study, noting all technical areas where effort is being directed and indicating the status of work within each specified task. Information shall include, but not be limited to, recruitment progress

(enrolled, active, drop outs), preliminary data analysis, and adverse and unexpected events.

Other task specific deliverables

As specified in the Individual Task

Order.

As specified in the Individual Task Order.

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

3.5 IRBs AND ASSURANCES

Registering an institutional review board (IRB) and obtaining a Federal wide 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 the Office of Human Research Protections (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.

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.

http://ohrp.cit.nih.gov/efile/Default.aspx

3.6 PACKAGING

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

3.7 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:

Food and Drug Administration 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.

3.8 PERIOD OF PERFORMANCE

Base Year: 9/26/2017 – 9/25/2018 Option Year One: 9/26/2018 – 9/25/2019 Option Year Two: 9/26/2019 – 9/25/2020 Option Year Three: 9/26/2020 – 9/25/2021 Option Year Four: 9/26/2021 – 9/25/2022

3.9 PLACE OF PERFORMANCE

Contractor’s Facility or an offsite appropriate facility will be the place of performance. Any in person meetings will occur at FDA’s White Oak campus, 10903 New Hampshire Ave. Silver Spring, MD facilities or the Contractor’s Facility.

3.10 INVOICING INSTRUCTIONS

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

FDA Three-Way Match Invoicing Procedures (Sep 2016)

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 constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

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

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

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

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

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

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

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

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

mailto: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

(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.

3.11 ORGANIZATIONAL CONFLICT OF INTERESTS

As a regulatory agency charged with protection of public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The Center for Tobacco Products (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:

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

ii. 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.

3.12 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.

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 available at:

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

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 Section I 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.

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 reasonableness.

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

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.

352.211-3 PAPERWORK REDUCTION ACT (DEC 2015)

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND

REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS (APR 2014)

352.203-70 ANTI-LOBBYING (DEC 2015)

352.224-71 CONFIDENTIAL INFORMATION (DEC 2015)

352.231-70 SALARY RATE LIMITATION (DEC 2015)

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)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT

(MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor prior to the expiration of the current period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years .

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].

352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT

OPPORTUNITY INVESTIGATIONS (JAN 2010)

352.223-70 SAFETY AND HEALTH (JAN 2006)

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 purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $ 2.6 million dollars;

(2) Any order for a combination of items in excess of $15 million dollars or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216- 21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within three (3) days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of clause)

HHSAR CLAUSES

352.203-70, Anti-Lobbying (Dec 2015) https://www.acquisition.gov/sites/default/files/current/far/html/52_216.html%23wp1115057 https://www.acquisition.gov/sites/default/files/current/far/html/52_216.html%23wp1115057

352.208-70, Printing and Duplication (Dec 2015) 352.211-3, Paperwork Reduction Act (Dec 2015) 352.219-70, Mentor Protégé Program (Dec 2015) 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.237-75, Key Personnel (DEC 2015) 352.239-74, Electronic and Information Technology Accessibility (DEC 2015)…