RFP_Analysis_of_HPHCs_in_Waterpipe.docx

Analysis of Chemical Constituents and HPHCs in Waterpipe Tobacco, Charcoal, Wastewater

Solicitation Number: FDA-16-RFP -1163178

Part 1 DESCRIPTION

1.1 This is a Request for Proposal (RFP) for Analysis of Chemical Constituents and HPHCs in Waterpipe Tobacco, Charcoal, Wastewater.

1.2 The associated North American Industrial Classification System (NAICS) code for this procurement is 541990. The size standard is $15.0 million. This requirement is posted full and open competition. The Government contemplates a Firm Fixed Price vehicle for 12 months.

PART 2-SUPPLIES OR SERVICES AND PRICE/COSTS

2.1 Prices/Costs

The pricing schedules are as follows:

PART 3-STATEMENT OF WORK/SPECIFICATIONS

3.1 Background

Waterpipes (WPs) have been used to smoke tobacco by indigenous peoples of Africa and Asia for at least four centuries.[footnoteRef:2] WPs and WP tobacco have different names, including “narghile” in East Mediterranean countries (such as Turkey and Syria), “shisha” and “goza” in Egypt and some North African countries, and “hookah” in India.[footnoteRef:3] A typical WP includes a head where charcoal and tobacco are placed, a body through which vapors pass, a bowl that contains water through which vapors pass, and a hose that leads to the smokers’ mouthpiece. [2: Chattopadhyay, A. Emperor Akbar as a healer and his eminent physicians. Bull. Indian Inst. Hist. Med. 2000, 30, 151-158.] [3: Maziak, W.; Wards, K. D.; Soweid, R. A. Tobacco smoking using a waterpipe: A re-emerging strain in a global epidemic. Tob. Control. 2004, 13, 327-333.]

Prior to each use, a WP bowl is partially filled with water in order for tobacco and charcoal smoke to pass through it during the user’s act of smoking the pipe. The water is usually discarded after each use so that the pipe bowl can be cleaned for the next smoking session. Since the WP smoke passes through the bowl water, an accumulation of chemical constituents and harmful and potentially harmful constituents (HPHC) could be left behind after a smoking session. Wastewater is typically dumped on the ground or down a sink drain, eventually ending up at a wastewater treatment facility or an on-site septic system. The constituents in WP waste water could have adverse impacts on the environment.

3.2 Project Objectives

The objectives of this study are to:

· conduct a lab analysis of ten different WP tobacco products, five different WP charcoal products, and wastewater of the WP;

· characterize and quantify the different chemical constituents and HPHCs from the lab analysis for both unheated and heated WP tobacco;

· characterize and quantify the different chemical constituents and HPHCs from the lab analysis for both unburned and burned WP charcoal;

· understand the filtering effect of WP water for WP tobacco and charcoal chemical constituents and HPHCs; and

· determine if the constituents and HPHCs affect public health and/or the environment.

3.3 Scope of Work

The FDA is interested in conducting a study to support characterization and quantity of specific chemical constituents and HPHCs by providing potential chemical constituent and HPHC detection and quantities in unheated WP tobacco, unburned WP charcoal, heated WP tobacco, burned WP charcoal, and the wastewater of the WP. Additionally, determine the filtering effect, if any, of WP bowl water to protect public health.

Requirements:

Over the course of a 12-month period, the Contractor shall:

· Develop a lab protocol and methodology to accomplish all objectives;

· conduct multiple tasks referenced in Task 2 in Developing the Lab Protocol and Analysis Plan;

· characterize and quantify chemical constituents and HPHCs

· measure the amounts of each chemical constituents and HPHC in WP tobacco, charcoal, and wastewater;

· monitor, manage, and maintain data collected; and

· submit a final report that includes the following sections: Executive Summary, Background, Methods, Results, Discussion, and Conclusions.

3.4 Tasks/Requirements

Task 1: Initial Project Briefing 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 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. 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/objectives.

Task 2: Develop the Lab Protocol and Analysis Plan 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. water pipe, electric heat source, rotary smoking machine, tobacco products, 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 the methods for each WP matrix (tobacco, charcoal, and wastewater). The Contractor has the discretion to perform multiple tasks at one time for efficiency. For each tobacco sample, the same smoking session must be used to generate samples for Tasks 2.7 and 2.9 (see below). For each charcoal sample, the same smoking session must be used to generate samples for Tasks 2.8 and 2.10 (see below).

Task 2.1 – The Contractor shall acquire enough WP tobacco from the same batch or lot for each of the ten listed products in Table 3 to perform all of the following analyses. The Contractor shall purchase at least 1810 grams and at least seven packages of each of tobacco products 2 to 10 in Table 3 (see Appendix B for example photos. Packaging may vary slightly, depending on manufacturers’ changes). The Contractor shall purchase at least 7600 grams of Nakhla Two Apples tobacco (product 1 in Table 3). Larger amounts of Nakhla Two Apples tobacco must be purchased because it is indicated for development of the electric heat source and smoking method. If products do not bear a batch or lot number the Contractor shall purchase each WP tobacco product at the same time and from the same vendor. Online purchases are acceptable. Images of the products are provided in Appendix B. If a product listed in Table 3 is discontinued or out of stock prior to the Contractor purchasing it, the Contractor may purchase substitutes. The Contractor shall immediately contact the COR for approval of an alternative to that tobacco product prior to making any substitution purchase.

Task 2.2 – The Contractor shall acquire enough WP charcoal from the same batch or lot for each of the five listed products in Table 4 to perform all of the following analyses. The Contractor shall purchase at least 1,517 grams (at least 252 coals from at least three different packages) of charcoal products 11 and 13 to 15 in Table 4. The Contractor shall purchase at least 6,800 grams of Three Kings “Made in Holland” charcoal (product 12, at least 1,120 coals). Larger amounts of product 12 must be purchased because it is indicated for development of the electric heat source and smoking method. If products do not bear a batch or lot number, the Contractor shall purchase each WP charcoal product at the same time and from the same vendor. Online purchases are acceptable. Images of the products are provided in Appendix B. If a product listed in Table 4 is discontinued or out of stock prior to the Contractor purchasing it, the Contractor may purchase substitutes. The Contractor shall immediately contact the COR for approval of an alternative to that tobacco product prior to making any substitution purchase.

Task 2.3 – The Contractor shall construct and evaluate an electric heating element on the basis of similarity to a charcoal heat source. Three Kings “Made in Holland” 40 mm diameter charcoal and Nakhla Two Apples tobacco shall be used to evaluate the performance electric heating element. The Contractor shall evaluate similarity by measuring tobacco temperature every 60 seconds during the 57-minute smoking session. The sum of the tobacco temperature differences between the charcoal and electric heat sources at each of the 57 minute time points should not total more than 570 °C. The Contractor shall report this dataset to FDA no later than two months after the start of the contract. FDA will decide whether the electric heating source sufficiently approximates coal and may decide to substitute the electric heating element with a charcoal source for all heated tobacco studies or may decide to request additional improvements to the performance of the electric heating element.

Task 2.4 – Prior to beginning sample analysis, the Contractor shall provide to the FDA for review their analytical methods as laboratory protocols, as modified for use in WP tobacco, charcoal, and wastewater. The Contractor shall adapt the Beirut WP smoking method for modification, as detailed in Appendix A, for use with a commercially available smoking machine and report all parameters listed in Table 5. Nakhla Two Apples tobacco shall be used for development of the smoking method. The Contractor shall use the electrical heater developed in Task 2.3 as the heating element for all studies of tobacco. The FDA will evaluate the smoking and analytical methods as to whether each method may be used. The analytical methods shall include the analytes routinely included in each method, the extraction protocols, the instruments used for separation and detection, and, for the specific WP matrix, the limit of detection, method accuracy, and method precision.

Task 2.4a – The Contractor shall use the adapted Beriut smoking protocol for all smoking sessions. The Contractor shall use the electric heater developed in Task 2.3 as the heating element for all tobacco analyses.

Task 2.5 – The Contractor shall analyze ten separate unheated WP tobacco products listed in Table 3 to quantify levels of each chemical constituent and HPHC using the method key in Table 2. The Contractor shall use a WP-validated method and shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. The Contractor shall sample each product at least seven times. For sample mass, the Contractor shall report the data to at least three decimal points, as well as the accuracy of the analytical balance and the date of last calibration. The Contractor shall quantify the chemical constituents and HPHCs listed below:

Task 2.6 – The Contractor shall analyze five separate unheated WP charcoal products listed in Table 4 to quantify levels of each chemical constituent and HPHC using the method key in Table 2 (Tₒ). The Contractor shall use the specific methodology listed for each chemical constituents and HPHC in Table 2 or other validated method and shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. The Contractor shall sample each product at least seven times. For sample mass, the Contractor shall report the data to at least three decimal points, as well as the accuracy of the analytical balance and the date of last calibration. The Contractor shall quantify the chemical constituents and HPHCs listed below:

Task 2.7 – The Contractor shall analyze ten separate electrically heated WP tobacco products listed in Table 3 after a 57-minute smoking session (T₅₇) to quantify levels of each chemical constituent and HPHC using the method key in Table 2. The Contractor shall quantify the chemical constituents and HPHCs listed below:

Task 2.7a – The Contractor shall quantify constituent levels using the specific methodology listed for each chemical constituents and HPHC in Table 2 or other validated method and shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. The Contractor shall sample each product at least seven times, i.e. seven smoking sessions, using 10 grams of product. For sample mass, the Contractor shall report the data to at least three decimal points, as well as the accuracy of the analytical balance and the date of last calibration.

Task 2.8 – The Contractor shall analyze five burned WP charcoal products listed in Table 4 after a 57-minute smoking session (T₅₇) to quantify levels of each chemical constituent and HPHC using the method key in Table 2. The Contractor shall quantify the chemical constituents and HPHCs listed below:

Task 2.8a – The Contractor shall quantify constituent levels using the specific methodology listed for each chemical constituents and HPHC in Table 2 or other validated method and shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. The Contractor shall sample each product at least seven times, i.e. seven smoking sessions. For sample mass, the Contractor shall report the data to at least three decimal points, as well as the accuracy of the analytical balance and the date of last calibration. This is the quality control.

Task 2.9 – The Contractor shall analyze the WP bowl wastewater after smoking the ten separate WP tobacco products listed in Table 3 after a 57-minute smoking session (T₅₇) to quantify levels and percent absorption by water of each chemical constituent and HPHC using the method key in Table 2. The Contractor shall, after each smoking session, replace the WP bowl water with fresh water. The Contractor shall test quantify the chemical constituents and HPHCs listed below:

Task 2.9a – The Contractor shall quantify constituent levels using the specific methodology listed for each chemical constituents and HPHC in Table 2 or other validated method and shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. The Contractor shall sample each product at least seven times, i.e. seven smoking sessions, using 10 grams of product.

Task 2.10 – The Contractor shall analyze the WP bowl wastewater after burning/smoking the five separate WP charcoal products listed in Table 4 after a 57-minute smoking session (T57) to quantify levels and percent absorption by water of each chemical constituent and HPHC using the method key in Table 2. The Contractor shall, after each smoking session, replace the WP bowl water with fresh water. The Contractor shall test quantify the chemical constituents and HPHCs listed below:

Task 2.10a – The Contractor shall quantify constituent levels using the specific methodology listed for each chemical constituents and HPHC in Table 2 or other validated method and shall provide full descriptions of methods used and descriptions of any laboratory issues encountered along with their solutions. The Contractor shall sample each product at least seven times, i.e. seven smoking sessions.

Table 1. List of Harmful and Potentially Harmful Constituents (HPHCs) Along with pH to be Tested for WP Tobacco and Wastewater

*4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone ** N-nitrosonornicotine

Table 2. Method Key

Table 3. List of Ten WP Tobacco Brands and Flavors to be Used in Study

Cherry flavor at least 1,810 g

Table 4. List of Five WP Charcoal Brands to be used in Study

hardwood, apple wood at least 1,517 g(252 briquettes)

Table 5. Parameters to be Specified in WP Smoking Method

interval between puffs air infiltration rate (flow rate through pipe w/ and w/o hose) puff volume flow rate through smoking machine

Task 3: Implement Lab Protocol and Data Analysis Plan The Contractor shall begin performing the Lab Protocol and Data Analysis Plan, specified in Task 2 and in accordance to the Finalized Work Plan. This task work is work- and time-intensive. Therefore, it is important that the Contractor (a) hire and/or assign an adequate number of lab technicians to complete the work, when necessary; (b) train them on the lab protocol and analysis plan; and (c) adhere to a system of quality assurance such as ISO/IEC 17025, OECD Principles of Good Laboratory Practice or similar quality system. Contractor shall follow all federal, state, and local environmental, health, sanitation and emissions regulations. In addition, the Contractor shall follow all applicable Environmental Protection Agency (EPA) and Occupational Safety & Health Administration (OSHA) regulations. Disposal of used/unused purchased products and laboratory waste must follow the above environmental, health and safety regulations.

Task 4: Submit Outline of Final Report Within 10 months of the contract award, the Contractor shall submit a detailed outline of the draft of the final report. The outline shall include: 1) bullet points of major highlights of each section, along with subheadings: Background, Method, Results, Discussion, and Conclusions; 2) proposed appendices.

Task 5: Submit Draft Final Report The Contractor shall submit a draft of the final report within 10.5 months of contract award. The Contractor shall prepare a detailed final report including: 1) a two- to-three page executive summary; 2) background section that will discuss previous research on WPs and objectives; 3) methods, including how the data was collected and analyzed; 4) results of the analysis; 5) discussion, including problems encountered during the study and their solutions; and 6) conclusions, including future directions and opinions on what the FDA should do with the results; and 7) related appendices. As a part of the final report, the Contractor shall submit analytical procedures (including details regarding extraction protocols and/or any other procedures used during sample preparation), validation protocols, validation reports, system suitability protocols, and any other pertinent information for measuring the analytes indicated in Table 1, as detailed in Task 2, in WP tobacco, charcoal products, and wastewater. The analytical procedures must be submitted to FDA as a Microsoft Word document. The raw data (including means and standard deviations) of all analyses and quality control samples of WP tobacco products specifically identified by FDA shall be provided in Microsoft Excel format.

Task 6: Submit Final Report Within two weeks of having received the COR’s comments, 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 include the required elements outlined for the draft report (Task 5) and shall incorporate any revisions based on comments received from the FDA.

The Contractor shall provide the Final Report to the COR in the following manner:

1. An electronic version of the final report.

2. The final report delivered on a CD Rom.

Task 7: Final Briefing Within 12 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.

3.4 Travel

The Contractor shall travel to FDA Headquarters for the Initial Project Briefing and Final Briefing.

PART 4-INSPECTION AND ACCEPTANCE

4.1 The Contracting Officer’s Representative (COR) (see Part 6) will perform inspection and acceptance of materials and services in writing, giving specific reasons, in the event of a rejection of any deliverables.

PART 5-DELIVERIES OR PERFORMANCE

5.1 Deliverables

Performance Milestones and Deliverables The following performance milestones and deliverables shall apply to this Contract and are considered critical to the successful completion of the project. The Contractor shall deliver all reports to the COR. The COR will receive documents, check for completeness, and communicate Government comments on draft documents back to the Contractor.

Table 6. Milestones and Deliverables Schedule

NOTE: Contractor shall provide raw data from the experiments and analyzed/curated summary data.

5.2 Electronic File Specifications

Electronic files containing reports (Progress Reports, Draft Reports, and Final Reports) shall be in MS Word.

Report Format:

· Font = 12 point Times New Roman font shall be used throughout the report

· Page Margins = Top, Right, Left, and Bottom shall be 0.75 inches

· Page Numbering = Lower right hand corner, using 11-12 point Times New Roman font Raw data and tabulated results (means and standard deviations) shall be provided in MS Excel.

5.3 Period of Performance

The period of performance for this contract vehicle shall be the effective date of contract to 12 months.

5.4 Place of Delivery

All deliverable items notated in Deliverable Table shall be sent to the COR electronically and/or physically, where stated, to the following addresses:

Food and Drug Administration Center for Tobacco Products Division of Regulatory Project Management, Branch I ATTN: (To be determined at the time of award) Main Campus, Bldg. 32, Rm 4144 10903 New Hampshire Ave Silver Spring, MD 20993 Telephone:

Email: (To be determined at the time of award)

5.5: Conference Calls The COR may request conference calls to discuss status of deliverables and any other issues which may arise with the contract. The COR will work with the Contractor to determine when the conference calls will occur.

5.6: Meetings At a minimum, there would be two site visits by the Contractor to FDA Headquarters for Initial Project Briefing and Final Briefing. The COR will work with the Contractor to determine when the periodic meetings and site visits will occur. Also, the COR and appropriate FDA staff may travel for site visits, which will be at the expense of the Government.

5.7 Monthly Progress Reports

The Contractor shall furnish one electronic copy to the FDA COR by the 1st of each month. At a minimum, the progress report shall include a narrative description of the following items:

PART 6-CONTRACT ADMINSTRATION DATA

6.1 Contracting Officers Representative (COR)

The following COR will represent the Government for the purpose of this contract:

(To be Determined at Time of Award)

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.

6.2 Contract Specialist

The contact information for the Contracting Specialist are:

Tara Hobson

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

6.3 Contracting Officer

The contact information for the Contracting Officer is:

Department of Health and Human Services Food & Drug Administration, OAGS Attn: Tara Hobson 5630 Fishers Lane Rockville, MD 20857 Phone: (240) 402-7586 Tara.Hobson@fda.hhs.gov

6.4 Contractor Point of Contact

The contact information for the Contractor Point of Contact:

(To be Determined at the Award of the Contract) Name:

Email:

Phone:

6.5 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.

Name Title

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.

In the event that any of the personnel listed as key personnel are unable to perform because of health, resignation from the contractor’s employ, or any other reasons, the contractor shall promptly submit to the Contract Officer, a detailed written explanation of the situation, the proposed substitution, complete resumes for the proposed substitute, and any other information necessary for the approval of the substitution. No substitutions shall be made without prior written approval of the Contract Officer. No increase in contract pricing will be allowed when substitutions are authorized by the government.

6.6 Invoice Submission

The Contractor shall submit all invoices to all addresses in the manner specified below:

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

U.S. Food and Drug Administration Office of Acquisitions and Grants Services ATTN: Tara Hobson, CO/CS 5630 Fishers Lane Room 2115, HFA-500 Rockville, Maryland 20857 E-mail: Tara.Hobson@FDA.HHS.GOV *** Acceptable methods of delivery include: mail, hand delivery and email

(II) One copy to the contracting officer technical representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

U.S. Food and Drug Administration/CDER ATTN: (To be Determined at the Time of Award) 10903 New Hampshire Avenue, Building 51 Silver Spring, MD 20993-0002 E-mail: @FDA.HHS.GOV *** Acceptable methods of delivery include: mail, hand delivery and email 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;

(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 and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contract, as referenced on the purchase order;

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

(XIII) Contractor is □ is not □ required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

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

(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 invoices for the current, active period of performance

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) Format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

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

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

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments fdavendorpaymentsteam@fda.gov

PART 7-SPECIAL CONTRACT REQUIREMENTS

7.1 CONFLICT OF INTEREST

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

The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees. In contracting for review and evaluation of scientific data and information submitted to the agency, it is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offers performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the contractor.

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

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

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

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

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

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

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

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.

This requirement involves subjectivity in analyzing laboratory data in regard to chemical constituents and HPHCs in waterpipe tobacco. Any financial interest or relationship that a potential vendor may have with another party that might be impacted by the results or conclusions of this analysis must be disclosed.

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

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

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

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

7.2 Publication Requirements

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, publically release information from this study on the quantities of analytes listed in Table 1 found in WP tobacco, charcoal products, and in their wastewater; however, details of the analytical methods will not be released publicly. The FDA may, at the agency’s discretion, publically 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 research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the 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 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. Please see the FDA Public Access Policy.

PART 8-CONTRACT CLAUSES

8.1 52.252-2 FAR Clauses Incorporated by Reference. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html

5…