RFP_Waterpipe_Physical_Design_Parameters.docx

FDA -19-RFP-1209909

Investigation into waterpipe physical design parameters’ effects on HPHC yields in smoke and charcoal emissions

PART 1: DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. FAR Provisions and Clauses set forth herein are current though Federal Acquisition Circular (FAC) The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2019-01 effective Jan 22, 2019. The North American Industrial Classification System (NAICS) code for this procurement is 541990. The Government contemplates a Firm Fixed Price vehicle for 24 months.

PART 2: SUPPLIES /SERVICES AND PRICES

2.1 Brief Description of Supplies or Services

The U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP) requires Investigation into waterpipe physical design parameters’ effects on HPHC yields in smoke and charcoal emissions.

2.2 Pricing Schedule

Part 3: Statement of Work

3.1 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. Although 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 levels of 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 of a waterpipe 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 (i.e., 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 method8 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.

Waterpipes vary in shape, size, and component materials, and their configurations are expected to have an effect on the smoke chemistry. However, there is limited scientific knowledge on the engineering and product design of waterpipes. Even though there has been some research on preferred materials and toxic chemical release from the use of waterpipes, there is no physical design information available to conclude how waterpipe dimension specifications impact smoke chemistry. It is imperative that the FDA develop a working knowledge of waterpipes as soon as possible to assist scientific reviewers with evaluations of newly deemed tobacco products.5, 6 Therefore, in order to characterize the engineering design parameters and their effects on smoke chemistry, further research is necessary.

By taking measurements of HPHCs generated from different conditions, researchers may gain more insight into appropriate comprehensive smoking conditions for further waterpipe tobacco brand comparisons. Future agreement of smoking regimen 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 and engineering research is necessary as FDA considers the approach to regulating waterpipe tobacco products.

3.2 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 (The temperature profile of the heating element will take into consideration the temperature profile and consumption of tobacco from that of Three Kings waterpipe quicklight charcoal).

· Conduct a lab analysis of the mainstream smoke from waterpipe tobacco and charcoal emissions resulting from fabrication material changes and controlled, incremental changes in the engineering parameters of the waterpipe apparatus including the bowl, stem, base, and hose.

· Characterize and quantify the different chemical constituents and HPHCs from the lab analysis for mainstream smoke of controlled incremental changes in the waterpipe engineering parameters.

3.3 Scope of Work

The scope of this project will be directed towards analyzing HPHC yields in waterpipe smoke in response to altering physical waterpipe design parameters. Additionally, the project will identify key engineering design parameters for product assessments.

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

3.4 Tasks

PHASE 1

1. Initial Project Briefing (within one month of award) Within one month of award, the Contractor shall meet with the COR, CS, CO, and other interested FDA personnel via WebEx. The purpose of this meeting is to (1) discuss the administration of this contract, 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 that may include any visuals which might be necessary to address any deviations or adjustments, etc.. 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 brief 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. 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 contract. 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 will occur.

4. Develop the Lab Protocol, Analysis Plan, and Purchase Product Samples (within two months of award) Task 4.1-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, specificity, and stability. The Contractor shall verify and validate the methods for waterpipe smoke. If issues arise during the development of methods, or during the validation process, 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.

5. Baseline Studies (2 months) Task 5.1 – The Contractor shall construct a laboratory waterpipe that is considered to be the baseline for all alterations to the physical parameters and smoking regimen. These alterations will be used to investigate the effect each parameter has on 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 (LOD, 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 FDA before being given the permission to begin task 6.

The contractor shall establish appropriate blank runs and standards 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 seven replicates of the Beirut smoking regimen8 and seven replicates 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, LOD, LOQ, etc.) will 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

6. Heat Source (5 months) Task 6.1 - The Contractor shall construct and evaluate an electric heating element on the basis of 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. This will evaluate the performance of the electric heating element. Additionally, the quantity of the tobacco consumed shall also be taken into account when determining the optimal operating temperature of the electric heating element. The Contractor shall also 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 6.2 - The Contractor shall use the electric heater developed in Task 6.1 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.

PHASE 3

7. Bowl (7 months) Task 7.1 – Bowl Screen The Contractor shall evaluate different materials for a bowl covering as an interface between the waterpipe tobacco and the charcoal. The baseline setup already includes aluminum foil with holes punched in it for aeration. The Contractor shall record and keep the number of aeration holes in the aluminum foil constant when the aluminum foil is used. The Contractor shall change the bowl covering from aluminum foil to a metal screen. 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.

8. Stem (9 months) Task 8.1 - Length of the Stem The Contractor shall evaluate the total length of the stem and its role in HPHC yields in waterpipe smoke. The Contractor shall change the total stem length to 0.1 m, 0.5 m, 0.8 m, 1 m, and 1.5 m. The contractor shall sample each set of unique conditions at least seven times including a blank, fully describe the physical parameters of the waterpipe, and quantify chemical constituents and HPHCs listed in Table 2.

Task 8.2 - Depth of the Stem in the Base Water The Contractor shall evaluate the depth of the stem in the base water and its role in HPHC yields in waterpipe smoke. The Contractor shall change the depth of the stem submerged in the base water to 0.01 m, 0.1 m, 0.25 m, 0.3 m, and 0.5 m. To achieve some depths, the base may need to be increased. 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. Base (12 months) Task 9.1 - Adulterants Added to Base Water The Contractor shall evaluate the effect adulterants in the base water may have on HPHC yields in waterpipe smoke. The contractor shall add the following liquids at room temperature (25°C ± 2°C, besides the ice) to the base of the waterpipe instead of the typical quantity of water:

a. 25 mL Milk + water

b. Acidic juice (orange/lemonade/grapefruit)

c. Ice + water

d. Carbonated Soda

e. 100% ethanol

f. Crushed mints + water (HPHCs + menthol) 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 9.2 - pH of the Base Water The Contractor shall evaluate the effect base liquid pH has on HPHC yields in waterpipe smoke. The Contractor shall change the pH of the base water prior to being smoked to pH values of 6.5, 7.0, 7.5, 8.0, and 8.5. 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.

10. Hose (16 months) Task 10.1 - Hose Length The Contractor shall evaluate the hose length and its role in HPHC yields in waterpipe smoke. The Contractor shall change the length of the PVC hose to 0.1 m, 0.5 m, 1 m, 1.5 m, 2 m. 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 10.2 – Hose Diameter The Contractor shall evaluate the hose diameter and its role in HPHC yields in waterpipe smoke. The Contractor shall change the internal diameter of the PVC hose to 3.5 mm, 6.5 mm, 9.5 mm, 12.5 mm and 15.5 mm, respectively while keeping all other 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 including a blank, fully describe the physical parameters of the waterpipe, and quantify chemical constituents and HPHCs listed in Table 2.

Task 10.3 - Material of the Hose

The Contractor shall evaluate the different materials of the hose and its role in HPHC yields in waterpipe smoke. The Contractor shall change the plastic hose to leather hose. The contractor shall measure the design parameters and the unique physical 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.

11. Extremes of Tasks 6-10 (19 months) Task 11.1 – The Contractor shall consult with the FDA after Tasks 6 through 10 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 11.2 – The Contractor shall consult with the FDA after Tasks 7-12 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.

12. Draft Report (23 months) The Contractor shall provide a Draft Report that presents the background, objectives, methods, results of the analyses, and summarizes the findings and conclusions of the project. The draft 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 Table 2. A summary of all desired experimental conditions may be found in Table 3. A summary of the deliverables may be found below.

13. Final Report (24 months) The Contractor shall provide a Final Report that incorporates all edits and feedback FDA provided on the draft report.

14. Final Briefing (Within 24 months of award) Within 24 months of the award, the Contractor shall conduct a final briefing to FDA personnel and other funding representatives at the FDA Calverton Tower Campus, 11785 Beltsville Road, Beltsville, MD 20705. This briefing shall consist of a 1-2 hour meeting with a 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.

3.4 Inspection and Acceptance

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

3.5 Deliverables and Performance

3.5.1 Deliverables

3.5.2 Period of Performance

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

3.5.3 Place of Performance

The place of performance will be at the Contractor’s site.

PART 4: Contract Administration Data

4.2 Key Personnel

The contractor shall provide the names and resumes of the key personnel assigned to this contract. The individuals cited below are key personnel.

Title Name

Principal Investigator _______________ Project Manager _______________ Lead Scientist _______________ Report Writer _______________

Key Personnel Minimum Qualifications:

· Principal Investigator/Project Manager shall at a minimum possess a Master's or equivalent graduate degree to include at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, toxicology, physical sciences, medical science, engineering, epidemiology, or related scientific fields that provided knowledge directly related to laboratory research work. In addition to the above educational requirements, the individual shall have at a minimum 1 year experience conducting tobacco related experimentation.

· Lead Scientist shall at a minimum possess a Bachelor’s or equivalent undergraduate degree to include at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, toxicology, physical sciences, medical science, engineering, epidemiology, or related scientific fields that provided knowledge directly related to laboratory research work.

· Report Writer shall at a minimum possess a Bachelor’s or equivalent undergraduate degree to include at least 30 semester hours in one or a combination of the following: English, biological sciences, chemistry, pharmacy, toxicology, physical sciences, medical science, engineering, epidemiology, or related scientific fields that provided knowledge directly related to scientific writing and/or research work.

The contractor shall ensure that all personnel are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this SOW prior to being assigned to this task order. In the event that any personnel are found to not be able to perform the tasks listed in the SOW, CTP shall reserve the ability, at any time, to ask the contractor to find adequate replacements within a reasonable timeframe.

4.3 Contract Specialist

The contact information for the Contracting Specialist are:

Department of Health and Human Services Food & Drug Administration, OAGS Attn: Tara Hobson

Tara.Hobson@fda.hhs.gov Phone: (240) 402-7586

4.4 Contracting Officer

The contact information for the Contracting Officer is:

Department of Health and Human Services Food & Drug Administration, OAGS Attn: Matthew Bucher 4061 Powder Mill Road Room 51019 Rockville, MD 20857 Phone: (240) 402-7570 Matthew.Bucher@fda.hhs.gov

4.5 Contracting Officer Representative (COR)

The following COR(s) will represent the Government for the purpose of this IDIQ contract:

Christi Wakefield Christi.Wakefield@fda.hhs.gov

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

The Government may unilaterally change its COR designation.

4.6 Invoice Submission

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A. THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO THE ADDRESS SPECIFIED BELOW:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

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) Purchase order/award number;

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

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

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

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

(d) The contractor shall include the Contract Line Item/Funding line item number 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;

(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 (CO) and the Contracting Officer's Representative (COR) or other program center/office point of contact, as referenced on the order/contract;

(xii) Any other information or documentation required by the purchase order/award.

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

D. Questions regarding invoice payments should be directed to the FDA Payment Office at:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742) (Amend as necessary) 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 (SAM) DATABASE) AND/OR OTHER APPLICABLE FAR CLAUSES SPECIFIED HEREIN.

PART 5: Special Contract Requirements

5.1 Organizational Conflicts of Interest (Simplified)

a. The Contractor warrants that, to the best of its knowledge and belief, and except as otherwise disclosed to the Contracting Officer, he or she does not have any actual or potential conflict of interests pertaining to the subject contract, as defined in Federal Acquisition Regulation (FAR) Subpart 9.5.

b. The Contractor agrees that, if after award he or she discovers an organizational conflict of interest with respect to this contract, he or she shall make an immediate and full disclosure in writing to the Contracting Officer.

c. The Government reserves the right to exercise any remedy available at law or equity, including termination of the contract for cause or convenience, should the Government determine that remedial action is necessary to address any identified actual or potential conflicts of interests.

5.2 Reporting Matters Involving Fraud, Waste, and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector Generals Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W. Washington, D.C. 20201

Information regarding procedural matters is contained on the HHS/OIG website at http://oig.hhs.gov/hotline.html

5.3 Security and Privacy

The contractor agrees that contractor personnel will not divulge, or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval of the Government.

Except as may otherwise be permitted by a data owner, the contractor personnel agree not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation.

Due to the sensitive nature of the information involved, all contractor personnel will be required to sign a non-disclosure agreement before data and information otherwise exempt from public disclosure (e.g. Privacy Act or Data Collected Under an assurance of Confidentiality) may be disclosed to them.

The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster because of staffing changes shall be submitted within 15 calendar days of the change.

Each contractor/subcontractor employee who may have access to non-public Department information under this contract shall complete and submit the FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer or designee prior to performing any work under the contract. The Project officer or designee will inform the contractor of any additional forms and training that are required.

PART 6 - Contract Clauses

6.1 FAR and HHSAR Clauses and Provisions incorporated by reference may be obtained at:

https://www.acquisition.gov/far/ http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Oct 2018)

HHSAR Clause 352.203-70, Anti-Lobbying (Dec 2015) HHSAR Clause 352.208-70, Printing and Duplication (Dec 2015) HHSAR Clause 352.219-70, Mentor Protégé Program (Dec 2015) HHSAR Clause 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR Clause 352.223-70 Safety and Health (DEC 2015) HHSAR Clause 352.227-70 Publications and Publicity (DEC 2015) HHSAR Clause 352.237-75, Key Personnel (DEC 2015) HHSAR Clause 352.239-73, Electronic Information and Technology Accessibility Notice (Dec 2015) HHSAR Clause 352.239-74 Electronic and Information Technology Accessibility (Dec 2015)

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items. (Jan 2019)

(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) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(2) 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)).

(3) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(4) 52.233-3, Protest After Award (Aug 1996) (31U.S.C.3553).

(5) 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:

[Contracting Officer check as appropriate.] 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 2018) (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).

__ (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 (Oct 2018) (41 U.S.C. 2313 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim).

__(10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.657a).

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

__ (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.

_X(16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

_X_ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4)) ___(ii) Alternate I (Jan 2017) 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 (Aug 2018) 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. 657f).

_X_(22) 52.219-28, Post Award Small Business Program Representation (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 (Dec2015) (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 (Jan 2018) (E.O.13126).

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

_X_(28)(i) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

__(ii) Alternate I (Feb 1999) of 52.222-26.

_X_(29)(i) 52.222-35, Equal Opportunity for Veterans (Jan 2019) (38 U.S.C. 4212).

__(i) Alternate I (July 2014) of 52.222-35.

_X_(30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

__(ii) Alternate I (July 2014) of 52.222-36.

_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).

__(33)(i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (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).

_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 (Jun2016) (E.O. 13693).

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

__(i) 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 (Jun2014) of 52.223-14.

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

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

__(i) 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 (Jun2016) (E.O. 13693).

_X_ (45) 52.224-3 Privacy Training (Jan2017) (5 U.S.C. 552a).

__ (i) Alternate I (Jan 2017) of 52.224-3.

_ _(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.

__(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 (Aug 2018) (19 U.S.C.2501, et seq., 19 U.S.C. 3301 note).

_X_(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 (Nov2007) (42 U.S.C. 5150).

__ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (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 (Jan2017) (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 (Oct2018) (31 U.S.C. 3332).

__(56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

__ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).

__(58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

_X_(59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).

__(60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C.Appx.1241(b) and 10 U.S.C. 2631).

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

__(iii) Alternate II (Feb 2006) 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:

[Contracting Officer check as appropriate.] __ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

__ (2) 52.222-41, Service Contract Labor Standards (Aug 2018) (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) (Aug 2018) (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).

(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 3years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

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

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

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (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) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 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…