FDA-18-RFQ-1194854A.pdf

FDA-18-RFQ-1194854

Request for Quote: Investigation into waterpipe regimen effects on HPHC yields in smoke and charcoal emissions

This solicitation is a combined synopsis/solicitation using FAR Parts 12 and 13.5 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-100.The North American Industry Classification System (NAICS) code for the proposed acquisition is 541690, Other Scientific and Technical Consulting Services.

Part 1- Background

Waterpipes have been used to smoke tobacco for at least four centuries, beginning with indigenous peoples of Africa and Asia. 1 Historically, waterpipes have been used in social settings or as part of religious ritual.

Though waterpipes have been used for centuries, much is still unknown about the chemical properties of waterpipe tobacco and waterpipe tobacco smoke. Some users of waterpipes have a perception that the smoke from a waterpipe is less harmful than cigarettes, as they feel the chemical constituents or harmful and potentially harmful constituents (HPHCs) are filtered by the liquid in its base. One study showed that the base liquid, (water, in this case), acts like a filter for certain carboxylic compounds; however, the evidence is not conclusive.2 The regulation of waterpipe tobacco products requires additional chemistry research in order to fill numerous research gaps. In particular, studies are needed to inform development of a waterpipe-specific HPHC list. Necessary chemical studies include measurements to quantify aldehyde, nicotine, tobacco specific nitrosamines (TSNAs), such as N-nitrosonornicotine (NNN) and nicotine-derived nitrosamine ketone (NNK), and volatile organic carbon (VOC) levels in waterpipe smoke. A better understanding of the filtering effect of the liquid in the base and main stream smoke is needed to clarify the potential for exposure to chemical constituents or HPHCs and properly protect public health by the regulation of waterpipe tobacco. Studies have shown that altering parameters in the waterpipe topography (user behavior of how the waterpipe is smoked) changes the smoke chemistry and HPHC exposure.3, 4

Topography for waterpipes encompasses parameters that can be measured, such as puff duration, puff volume, maximum puff velocity, interpuff interval, length of a smoking session, and the number of puffs in one smoking session. There are a range of conditions under which waterpipes are smoked, and multiple well-studied smoking regimens allow regulatory entities to assess the different HPHC profiles produced by a product under differing conditions. At the very least, two experimental smoking regimens are desirable for regulatory science, consisting of intense and non-intense smoking regimens that could provide data on the lower- and upper limits of HPHC yields in waterpipe smoke. The Beirut smoking method is a well-documented method that may be suitable for regulatory use once specifications are set for the environmental humidity and temperature, hose length, and influx rate of ambient air (through the bowl, stem, hose, and joints of the waterpipe assembly). However, there are few studies investigating parameters that are altered from the Beirut Method and how they affect the most common HPHC yields in smoke.

By taking measurements of HPHCs generated from different conditions, researchers may gain more insight into appropriate comprehensive topographies for further waterpipe tobacco brand comparisons. Future agreement of user topography and a standardized waterpipe for testing will reduce inter-laboratory variance by normalizing all smoking methods and allow for direct comparisons of results between laboratories. It is evident that this additional chemistry research is necessary as FDA considers the approach to regulating waterpipe tobacco products.

Part 2- Services/Supplies/Price Schedule

2.1 Type: Firm Fixed Price Delivery Order

2.2 Price Schedule

Part 3- Statement of Work

3.1 Objectives

The objectives of this contract are to:

• Conduct a lab analysis of the mainstream smoke resulting from Nakhla Two Apples waterpipe tobacco product heated with (1) Three Kings waterpipe quicklight charcoals and (2) a laboratory built electric heating element.

• Conduct a lab analysis of the mainstream smoke from waterpipe tobacco and charcoal emissions resulting from controlled, incremental changes in the smoking regimen using a laboratory waterpipe.

3.2 Scope

The scope of this project will be directed towards analyzing HPHC yields in waterpipe smoke in response to altering topography to identify intense and non-intense waterpipe smoking regimens for product assessments.

# Deliverable Description Quantity Unit Price Total Price

1 Initial project briefing 1

2 Monthly progress reports/conference Calls 24

3 Lab Protocol and Analysis Plan 1

4 Method validation data (SOP, LOD, LOQ, accuracy, precision) for all HPHCs

5 Final report 1

6 Final Briefing 1

Total Firm Fixed Price

This is a fixed price delivery order to be conducted over 24 months (2 years).

3.3 Tasks

PHASE 1

1. Initial Project Briefing (within 2 weeks of award)

Within two weeks of award, the Contractor shall meet with the COR, CS, CO, and other interested FDA personnel at FDA Headquarters. The purpose of this meeting is to (1) discuss the administration of this order, and (2) to discuss the project’s objectives, planned course of action, milestones and deliverables, and any other issues the Contractor or government identifies. The Contractor shall be prepared with appropriate briefing materials. PowerPoint slides and other supplementary materials shall be submitted to the COR at least five business days before the briefing. After receipt of the briefing materials, the COR will either approve the material, or contact the Contractor with comments. After the Contractor’s prepared briefing, the Contractor, COR, CO, and other FDA personnel will discuss specific details of the project to resolve any differences in approach and/or expected goals and objectives.

2. Monthly Progress Reports (ongoing)

The Contractor shall furnish one electronic copy to the FDA COR by the 10th of each month. At a minimum, the progress report shall include a narrative description of the following items:

1. Accomplishments made during the reporting period.

2. Plans for accomplishments in the next reporting period

3. Interim results, conclusions, trends, or other items of information that the Contractor believes are of interest to the FDA.

4. Problems or delays that the Contractor has experienced in the performance of his/her services, as well as any quality assurance and control measures taken during the reporting period.

5. Specific action(s) that the Contractor would like the FDA to undertake to alleviate a problem.

6. Due dates for upcoming deliverables.

3. Monthly Conference Calls (ongoing)

A regular, monthly conference call shall take place between the Contractor and FDA to discuss status of deliverables and any other issue which may arise with the order. Additional conference calls may be necessary and conducted on an ad hoc basis. The COR will work with the Contractor to determine when the conference calls with occur.

4. Develop the Lab Protocol and Analysis Plan (within the first month of award)

In the Lab Protocol and Analysis Plan, the Contractor shall identify the project timeline and the means of assembling the necessary resources for conducting the tests (i.e. waterpipe, electric heat source, smoking machine, tobacco product, and charcoal). Additionally, the Contractor shall conceptualize how the analysis shall be performed based on the Government’s specifications. The contractor must provide validated methods and/or analyses to achieve the study’s objectives. The methods must be determined to be fit for purpose, which includes consideration of the following method characteristics:

accuracy, precision, robustness, limit of detection, limit of quantification, range and specificity. The Contractor shall verify and validate the methods for waterpipe smoke or if no methods are readily available, the Contractor shall work with FDA to determine the best approach. The Contractor has the discretion to perform multiple tasks at one time for efficiency.

Task 4.1 – The Contractor shall acquire enough Nakhla Two Apples waterpipe tobacco from the same batch or lot to perform all the analyses of HPHCs in mainstream waterpipe smoke and charcoal emissions. If products do not bear a batch or lot number, the Contractor shall purchase the waterpipe tobacco at the same time and from the same vendor. Online purchases are acceptable.

The Contractor shall immediately contact the COR for approval if there is not enough tobacco product purchased from the same company.

Task 4.2 – The Contractor shall acquire enough Three Kings 40 mm diameter waterpipe charcoal to perform all the analyses of HPHCs in mainstream waterpipe smoke and charcoal emissions. The Contractor shall purchase all waterpipe charcoal at the same time from the same vendor. Online purchases are acceptable. The Contractor shall immediately contact the COR for approval if there is not enough charcoal product that can be purchased from the same company.

Task 4.3 – Prior to beginning sample analysis (Tasks 5-8), the Contractor shall provide to the FDA for review their analytical methods and laboratory protocols, as modified for use in mainstream waterpipe tobacco smoke. The Contractor shall adapt the Beirut waterpipe smoking method for modification, as detailed in Table 1, for use with a commercially available smoking machine and report all constituents listed in Table 2.

5. Baseline Studies (within the first 8 months)

Task 5.1 – The Contractor shall construct a laboratory waterpipe that is the baseline for all alterations to the smoking regimen. These alterations will be used to investigate the effect each parameter has upon the HPHCs in mainstream smoke listed in Table 2. The Contractor shall begin with a laboratory waterpipe constructed similarly to the laboratory-validated waterpipe as described by Brinkman, et al. 20167 and use the Beirut method smoking regimen as described by Shihadeh 2004.8

Task 5.2 – The Contractor shall validate the newly constructed laboratory-grade waterpipe using the Beirut method smoking regimen.8 Validation of HPHCs with the laboratory-grade waterpipe shall consist of smoking sessions of waterpipe tobacco with charcoal as the heat source. The

Contractor shall use the Beirut method smoking regimen for establishing the validation. The Contractor shall report analytical figures of merit for each HPHC analyte (LOQ, mean, standard deviation, and measurement of linearity). The Contractor shall report validation data for all HPHCs listed in Table 2 including SRMs, QCs, calibration curves, and blanks. This validation data shall be reported for evaluation to the COR before being given the permission to begin task 6.

The contractor shall establish appropriate blank runs for each set of experimental conditions.

Blanks shall consist of sampling smoking sessions of each set of parameters in the absence of waterpipe tobacco and charcoal.

In all studies, the Contractor shall monitor the temperature of the tobacco in the same physical location (with emphasis on the distance between the thermocouple and the heat source) by taking temperature readings every 60 seconds to ensure proper operation of the heat source. The temperature shall be recorded at three locations in the bowl, at the coal-to-tobacco interface, at a depth of 1 cm in the tobacco, and at the head outlet as described by Monzer et al.9

Task 5.3 – The Contractor shall then conduct one run of the Beirut smoking regimen8 and one run of the smoking regimen described by Brinkman et al. 20167 to generate mainstream smoke, which will then be collected and analyzed for HPHC quantities listed in Table 2. The validation parameters (calibration curves, LOQ, etc.) shall be the same under both smoking regimens. Testing both methods serves the dual purpose of checking the validation while additionally providing preliminary results for HPHC quantities under the two most prevalent smoking regimens in literature.

PHASE 2

(months 9-14)

6. Regimen

The Contractor shall study parameters of the waterpipe smoking regimen to determine the effect the smoking regimen has on HPHC yields in the smoke. Additionally, the study shall establish standard smoking regimen(s) that may be used for future product analysis. The contractor shall sample these conditions at least seven times with a blank (no tobacco and no charcoal) measurement. The list of HPHCs is listed in Table 2.

Task 6.1 – Session length

The Contractor shall utilize the baseline waterpipe setup and regimen but change the session length to 45 minutes, 50 minutes, 60 minutes, 70 minutes, and 75 minutes while keeping all other parameters constant. The inter puff interval may have to be adjusted as it is linked to the number of puffs while holding the puff length and volume constant. The contractor shall sample each set of unique conditions at least seven times. The Contractor shall collect the mainstream smoke from each sampling, fully describe the physical parameters of the waterpipe, and quantify chemical constituents and HPHCs listed in Table 2.

Task 6.2 – Number of puffs per session

The Contractor shall utilize the baseline waterpipe setup and regimen but change the number of puffs per session to 70 puffs, 85 puffs, 100 puffs, 125 puffs, 150 puffs, 175 puffs, and 200 puffs while keeping the other parameters constant. The inter puff interval may have to be adjusted as it is directly linked to the number of puffs while holding the total session time constant. The contractor shall sample each set of unique conditions at least seven times. The Contractor shall collect the mainstream smoke from each sampling, fully describe the physical parameters of the waterpipe, and quantify chemical constituents and HPHCs listed in Table 2.

Task 6.4 – Puff volume

The Contractor shall change the puff volume to 0.5 L/puff, 0.75 L/puff, 0.85 L/puff, and 1.0 L/puff while keeping all other parameters constant. The inter puff interval may have to be adjusted to keep all other regimen parameters constant. The contractor shall sample each set of unique conditions at least seven times. The Contractor shall collect the mainstream smoke from each sampling, fully describe the physical parameters of the waterpipe, and quantify chemical constituents and HPHCs listed in Table 2.

7. Heat Source

(months 15-16)

Task 7.1 - The Contractor shall construct and evaluate an electric heating element based on similarity in waterpipe tobacco temperature to a charcoal heat source. The contractor shall evaluate similarity of the charcoal source to the heat source by measuring tobacco temperature the same distance away from the heating element or charcoal to evaluate the performance of the electric heating element. Additionally, the quantity of the tobacco consumed shall also be considered when determining the optimal operating temperature of the electric heating element. The Contractor shall evaluate similarity by measuring tobacco temperature every 60 seconds during a 57-minute smoking session. The sum of the tobacco temperature differences between the charcoal and electric heat sources at each of the time points over the entire smoking session should not total more than 2850 °C.

Task 7.2 - The Contractor shall use the electric heater developed in Task 7.1 as the heating element while keeping all other parameters constant. The contractor shall sample each new set of parameters seven times. The heating element shall be operated in a manner so the waterpipe tobacco reaches a similar average temperature (±15%) as the charcoal average temperature as well as consuming a similar quantity of the tobacco (±30%) during each smoking session. The Contractor shall provide full descriptions of methods used and of any laboratory issues encountered along with their solutions. The Contractor shall collect the mainstream smoke from each sampling, fully describe the physical parameters of the waterpipe, and quantify chemical constituents and HPHCs listed in Table 2.

8. Extremes of Tasks 6-7

(month 17)

Task 8.1 – The Contractor shall consult with the COR after Tasks six and seven are complete to determine the most intense combination of parameters. The Contractor shall use these parameters as an extreme case analysis. The Contractor shall sample each set of unique conditions at least seven times. The Contractor shall collect the mainstream smoke from each sampling including a blank, fully describe the physical parameters of the waterpipe, and quantify chemical constituents and HPHCs listed in Table 2.

Task 8.2 – The Contractor shall consult with the COR after Tasks six and seven are complete to determine the least intense combination of parameters. The Contractor shall use these parameters as a least intense case analysis. The Contractor shall sample each set of unique conditions at least seven times. The Contractor shall collect the mainstream smoke from each sampling including a blank, fully describe the physical parameters of the waterpipe, and quantify chemical constituents and HPHCs listed in Table 2.

9. Final Report

(month 18)

The Contractor shall provide a Final Report that presents the background, objectives, methods, results of the analyses, and summarizes the findings and conclusions of the project. The final report shall contain all raw data, testing parameters, physical waterpipe measurements, instrumental settings (to include all final settings and all developmental settings with a description of outcomes), validation data, and identification and quantification of HPHCs from each sampling listed in Tasks 5-8 (Table 2). A summary of all desired experimental conditions may be found in Table 3. A summary of the deliverables may be found in Task 11.

10. Final Briefing

(Within 18 months of award)

Within 18 months of the award, the Contractor shall conduct a final briefing to FDA personnel and other funding representatives at the FDA Main Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993. This briefing shall consist of a 20- to 30-minute presentation of the project and shall include a background on the problem, descriptions of methods used, the results of the tasks, and a brief discussion of the results and problems encountered during the study. The Contractor shall be prepared with appropriate briefing materials and shall send their presentation materials to the COR for review within seven days prior to the presentation date.

PART 4- Deliverables Schedule

All written deliverables under this order shall be sent via e-mail the contract specialist, and COR [TBD]

PART 5- Period of Performance

The project is expected to be completed in two years (24 months) from the date of the start of the contract.

PART 6- Place of Performance

All work shall be performed at the contractor’s site.

PART 7- Acceptance, Payment and Invoicing

7.1 Acceptance

FDA will review Contractor deliverables in accordance with specifications and standards established during the first 30 days of the contract or during the kick-off meeting with FDA. The COR will be responsible for accepting or rejecting deliverables. The acceptance of deliverables and satisfactory work performance required herein shall be based on timeliness, accuracy, and suitability of the deliverable. The specific deliverables and schedule for delivery are laid out above; however, specific dates will be identified and documented by the COR and Project Officer. All documents, plans, diagrams, presentations, etc., are to be submitted solely in electronic form and in the native file format of MS Word, MS Excel, or MS Power Point in versions acceptable to FDA. All other formats for project will be as stated in the SOO/SOW or as agreed upon at or near project start.

7.2 Payment

Interim payments will be made on a monthly basis according to the deliverables table/price table located in Part 2, and delivery of a proper invoice. The COR with input from Project Officer will review all reports and invoices, and will approve/reject them as appropriate. The COR with the Project Officer will work with the contractor to remedy any discrepancies and then subsequently approve the documents.

Deliverables Due Date

Initial project briefing Within two weeks of contract award

Monthly progress reports On the 10th of each month

Lab Protocol and Analysis Plan Within one month of contract award

Method validation data (SOP, LOD, LOQ, accuracy, precision) for all HPHCs

Within eight months of contract award

Final report 18 months from start of contract

Final Briefing 18 months from start of contract

7.3 Invoicing

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;

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

(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.

PART 8- Other Order Requirements

8.1 Publication

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 may, at the agency’s discretion, publicly release information from this study on the quantities of analytes listed in Table 2 found in waterpipe tobacco smoke; however, details of the analytical methods will not be released publicly. The FDA may, at the agency’s discretion, publicly release information from this study on the construction details of the electric heat source and the details of the Beirut smoking method as adapted by the Contractor. The Contractor shall inform FDA of any concerns regarding the release of confidential commercial information prior to award.

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.pdf).

8.2 Conflict of Interest

Organizational Conflict of Interest

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 section VII 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.

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

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.

PART 9- Points of Contract

9.1 Contracting Officer’s Representative (COR)

The following COR will represent the Government for the purpose of this order: [TBD]

The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

9.2 The contact information for the Contracting Officer is the following:

Matthew J. Bucher U.S. Food and Drug Administration Office of Acquisitions and Grants Services Rockville, MD 20857 E-Mail: Matthew.Bucher@fda.hhs.gov Telephone: (240) 402-7570

9.3 The contact information for the Contract Specialist is the following:

Christopher R. McGucken U.S. Food and Drug Administration Office of Acquisitions and Grants Services Rockville, MD 20857 E-Mail: Christopher.McGucken@fda.hhs.gov Telephone: (240) 402-7566

9.4 The contact information for the Contractor is the following: [TBD]

PART 10- Contract Clauses

10.1 FAR Clauses

FAR 52.212-4 Contract Terms and Conditions—Commercial Items. (Jan 2017), is hereby incorporated by reference, however upon request, the contracting specialist will make the full text available.

52.212-4 Contract Terms and Conditions-Commercial Items (Deviation 2017-02).

As prescribed in 12.301(b)(3), the following clause applies:

CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (DEVIATION 2017-XX)

(JUNE 2017)

(a)********

Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C.

1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 10 U.S.C 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (Jan 2018)

(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:

https://www.acquisition.gov/far/html/52_200_206.html#wp1158787 https://www.acquisition.gov/far/html/52_207_211.html#wp1146366 https://www.acquisition.gov/far/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_233_240.html#wp1113344 http://uscode.house.gov/

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (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 (June 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].

_X_ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (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).

__ (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).

__ (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).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

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

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

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

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_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)).

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

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

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

__ (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 Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

__ (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) (15 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).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (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).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

https://www.acquisition.gov/far/html/52_217_221.html#wp1136032 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/far/html/52_217_221.html#wp1136058 https://www.acquisition.gov/far/html/52_217_221.html#wp1136174 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_217_221.html#wp1136175 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136186 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1136387 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1139913 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_217_221.html#wp1144950 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_217_221.html#wp1144420 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1147479 https://www.acquisition.gov/far/html/52_222.html#wp1147630 https://www.acquisition.gov/far/html/52_222.html#wp1147656 https://www.acquisition.gov/far/html/52_222.html#wp1147711 https://www.acquisition.gov/far/html/52_222.html#wp1158632 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t37t40+200+2++%2838%29%20%20AND%20%28%2838%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_222.html#wp1162802 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+2+78++%2829%29%20%20AND%20%28%2829%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/far/html/52_222.html#wp1148123 https://www.acquisition.gov/far/html/52_222.html#wp1160019 https://www.acquisition.gov/far/html/52_222.html#wp1151848 http://uscode.house.gov/ https://www.acquisition.gov/far/html/52_222.html#wp1151848

_X_ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

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

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

__ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

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

__ (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

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

__ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

__ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (44) 52.223-21, Foams (Jun 2016) (E.O. 13693).

__ (45)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

_X_ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

__ (47)(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.

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

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

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

__ (48) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (50) 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).

__ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (56)…