FDA-RFQ-1179639_Hookah_PJ_RFQ.docx

1179639 Hookah Purchase Journey

Part 1 – Description

The U.S. Food and Drug Administration (FDA) has a requirement for a service: The Hookah Purchase Journey. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-95. The North American Industry Classification System (NAICS) code for the proposed acquisition is 541618, Other Management Consultant Services, with a size standard of 14.0.

This requirement is for a Service: The Hookah Purchase Journey Part 2 – Services and Prices/Costs

2.1 Contract Type: Time and Materials

2.2 Sample Contract Pricing Table Per Task

Below is a sample pricing table for this project. Offerors shall complete this table for each of the five Tasks listed in Part 3. Category descriptions are listed in Section 2.3.

Senior SME

Junior SME

Analyst

Project Coordinator

Recruiter

Moderator

Materials: ____________________________.

The total price of Tasks 1-5 is $____________.

2.3 Labor category descriptions

2.3.1 Senior subject matter expert (masters level with 10 years of experience) This is an individual with prior experience in marketing and selling consumer products, preferably tobacco products and waterpipe tobacco specifically. The Senior SME has a working knowledge of tobacco manufacturing, product development, and sales. The senior SME has authority to select and engage vendors and consultants.

2.3.2 Junior SME (bachelors level with 5 years of experience) This is an individual with prior experience in marketing and selling consumer products, preferably tobacco products and waterpipe tobacco specifically. The Junior SME has experience in survey research for commercial and government projects. This individual has the ability to develop and field survey instruments and can facilitate discussions with other SMEs, if needed. This person also supports the senior SME in orchestrating and coordinating activities to complete tasks.

2.3.3 Analyst (masters level with 10 years of experience)

Responsible for running all major forms of primary and secondary data analyses, including extraction, organization, and presentation of sales data.

2.3.4 Project Coordinator (masters level with 5 years of experience) This individual serves as liaison between Contractor personnel and Government representatives and has overall responsibility for contract administration, organizing task teams, reviewing technical approaches to ensure proper methodologies and procedures are followed in accordance with client requirements, and ensures that all products and services are of high quality and delivered on time and within budget.

2.3.5 Recruiter (bachelors level with 2 years of experience)

This is an individual with experience in subject recruitment for consumer product studies, including assessment of inclusion/exclusion criteria.

2.3.6 Moderator (bachelors level with 2 years of experience)

This person has experience moderating focus groups and in-depth interviews for consumer products using semi-structured techniques.

Part 3 – Description/Specifications of Project Tasks

3.1 Background

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law. The Tobacco Control Act granted the Food and Drug Administration important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect Americans from tobacco-related death and disease.

Under the Deeming Rule effective on August 8, 2016, FDA’s Center for Tobacco Products (CTP) now regulates waterpipes and waterpipe tobacco. This is a highly fragmented market, with many different product sources, selling channels, customer segments, and places of use. Sellers often play multiple roles, participating as manufacturers, processors, wholesalers, distributors, and retailers. Transparency is limited because many sellers are small businesses with no public reporting requirements. In order to effectively regulate waterpipes and waterpipe tobacco, CTP seeks more information on waterpipe commerce.

In March 2016, the Government held a public workshop on waterpipes. The workshop transcripts, agenda, and archived webcasts are available here. The workshop slides are in Attachment 1.

3.2 Objectives

The Government intends to obtain waterpipe tobacco-related market information. The project objectives are to: (1) understand how waterpipe tobacco is processed and delivered from “field to U.S. consumers,” (2) understand waterpipe charcoal types and subtypes for the U.S. market, (3) determine the U.S. waterpipe tobacco market size over the past decade, (4) determine cost ranges for hookah[footnoteRef:2] tobacco material and price range estimates for consumer smoking sessions in waterpipe establishments, and (5) estimate annual domestic hookah unit sales. Such information assists CTP in understanding the marketplace effects of potential future regulatory actions. [2: For the purposes of this SOW, the words “hookah” and “waterpipe” have the same meaning.]

3.3 Statement of Work

The Government expects to understand the supply chain for waterpipe tobacco and charcoal, the waterpipe tobacco market size with growth trends over time, costs for smoking hookah tobacco in waterpipe establishments, and annual hookah unit sales.

· Final reports upon completion for each of Tasks 1-5

· Final bound volume of final task reports 1-5 with a table of contents at the project’s termination

3.4.1 Task 1 - Supply chain for U.S. waterpipe tobacco

This task’s overarching goals are to understand: (1) how waterpipe tobacco gets from field to consumers, and (2) the process (or manufacture) of making waterpipe tobacco, including source materials and companies that make these tobacco products.

1. Describe the countries of origin, species, and type of tobacco used in waterpipe tobacco products.

The Contractor shall describe the countries of origin, species, and types of tobacco used in waterpipe tobacco products. For example, “plant species” could include Nicotiana tabacum and Nicotiana rustica. Both species can be used in tobacco products. “Tobacco type” refers to how the plant is cured or sometimes where it is grown. For example, flue cured (also known as Virginia) tobacco, burley (air cured), and dark fire cured tobaccos are tobacco types of Nicotiana tabacum. The tobacco type called Oriental, is typically grown in the regions of the eastern Mediterranean, Aegean, Marmara, and Black Sea.[1] It is possible that more than one tobacco plant species and type may be used or combined in waterpipe tobacco.

2. Describe the supply chain for waterpipe tobacco.

a. The Contractor shall identify companies that process, manufacture, and distribute waterpipe tobacco for the U.S. market, including company location. Since the waterpipe tobacco market is highly fragmented, it is not expected that every company will be identified. Rather, the expectation is to identify companies that perform the majority of processing, manufacturing, and distributing. “Majority” means greater than 50% in aggregate, as determined by waterpipe tobacco-related dollar sales and volume in tons or kilograms, for each of processing, manufacturing, and distributing waterpipe tobacco for the U.S. market.

For this Section 2(a), annual reports are unlikely to be useful in determining waterpipe-related sales and volume since very few companies are publicly traded in the waterpipe space. Moreover, using proxies, such as product range or geographic reach, are not acceptable in lieu of sales or volume data. It may be the case that companies play more than one supply chain role, e.g., a company is both a processor and distributor. If that is the case, this should be described in the Final Report.

b. The Contractor shall estimate the channel share between businesses (B2B) and from businesses to consumers (B2C) described by percentage over the past five years. “Businesses” means manufacturers, distributors, and retailers. “Channel share” means the percentage of waterpipe tobacco product flowing between businesses and from businesses to consumers via various distribution methods such as, but not limited to, the Internet, convenience stores, and waterpipe establishments. Channel share can be approximated by percentage of product flow using waterpipe-related sales or volume. Internet sales shall be included in determining channel shares for this task.

3. Describe the process of making finished waterpipe tobacco products.

a. The Contractor shall describe the components of waterpipe tobacco. This is primarily a qualitative task that could contain some quantitative information if available, e.g., percentages for waterpipe tobacco components. At a minimum, the Contractor shall address the following in the Final Report:

i. In addition to tobacco, finished products typically include honey, molasses, propylene glycol, glycerin, and flavors. Are there other components missing from this list?

ii. Do components vary by brand, i.e., do certain processors only use molasses while others only use honey?

iii. Is it the case that even within a company’s product line, components can vary depending upon their availability and price? For example, if a product is usually made with molasses, but the price increases or availability is limited, are cheaper components substituted?

iv. Due to its expense, is honey actually used in waterpipe tobacco products? The Government is aware that not all products labelled as “honey” meet FDA’s definition of honey.

b. The Contractor shall describe the steps in waterpipe tobacco processing after the tobacco is graded and baled to create finished products. These steps could include, but are not limited to, combining with other raw materials and incorporation of flavors and sweeteners.

4. Final Report for Task 1.

The Contractor shall provide a Final Report for Task 1 within 30 (thirty) business days of completing this Task. At least ten (10) business days prior to delivering the Final Report, the Contractor shall give a presentation via Webex or comparable technology on the Final Report detailing findings and results. Final Reports shall show any applicable analyses, assumptions, and references for all work performed.

3.4.2 Task 2 - Supply chain for U.S. waterpipe charcoal

1. Describe the subtypes of waterpipe charcoal sold in the U.S.

There are two waterpipe charcoal types sold in the U.S.: (1) natural and (2) synthetic. [2, 3] The Contractor shall describe the subtypes of natural and synthetic charcoal sold domestically during 2016.[footnoteRef:3] For example, subtypes of synthetic charcoal include, but are not limited to quick light, long burning, or flavored. A single product may have more than one subtype ascribed to it. For example, synthetic charcoal could be both long burning and flavored. “Type” and “subtype” do not include charcoal shape, such as charcoal tablets, disks, cubes, or fingers. [3: “Natural charcoal is made of carbonized wood[s] whilst synthetic charcoal is usually made of processed charcoal, of wood or coconut origin, where the processing may include grinding into powder and adding chemicals to enhance the adhesion between the powder particles and fuel to initiate the burning.” Synthetic varieties can be further distinguished by characteristics such as quick light, long burning, and flavored.[2,3]]

2. Describe accelerants and igniting agents used in waterpipe charcoal sold in the U.S.

“Accelerants” are chemicals and materials introduced into charcoal’s composition to improve or quicken ignition. For the U.S. market, the Contractor shall (1) describe accelerants used in quick light charcoal, and (2) describe whether igniting agents differ from accelerants for waterpipe charcoal, and if so, how they differ.

3. Identify companies that process or manufacture waterpipe charcoal sold in the U.S.

The Contractor shall identify the majority of companies that process or manufacture waterpipe charcoal for the U.S. market. It is not expected that every company will be identified. Rather, the expectation is to identify companies that perform the majority of processing and manufacturing. “Majority” means greater than 50% in aggregate, as determined by waterpipe charcoal-related dollar sales and volume, for each of processing and manufacturing waterpipe charcoal for the U.S. market. Internet sales shall be included in determining majority for this task.

For this Section 3, annual reports are not likely to be useful in determining aggregate majority share for waterpipe charcoal-companies since very few companies are publicly traded who sell waterpipe charcoal. Moreover, using proxies, such as product range or geographic reach, are not acceptable in lieu of sales or volume data.

4. Components and their sources for waterpipe charcoal sold in the U.S.

For the major waterpipe charcoal brands sold in the U.S. and exclusive of accelerants and igniting agents described in 2 above, the Contractor shall describe the components and their sources used to make the types and subtype products. “Major” means brands that comprise 80% of the market. The charcoal description shall include coal types, wood types, casing agents, such as unrefined molasses and starch, and ash-whitening agents.[footnoteRef:4] [4: For example, coal types can include bituminous, sub-bituminous, lignite, and anthracite. Wood types can include hardwoods (beech, birch, hard maple, hickory, oak), and softwoods (long leaf and slash pine, nutshells, fruit pits, vegetable wastes, paper mill residues, wood scraps, treated lumber, and old household furniture). Bamboo, coconut, and dried cane can also be used to make charcoal.[4]]

5. Country of origin for finished waterpipe charcoal sold in the U.S.

The Contractor shall determine the country of origin for finished waterpipe charcoal sold in the U.S.

It is not expected that every country will be identified. Rather, the expectation is to identify the majority of countries of origin, where “majority” means the countries supplying 80% in aggregate of the U.S. market for waterpipe charcoal, as determined by waterpipe charcoal-related dollar sales and volume. The Contractor shall include a market share breakout by percentage and dollar amount for brands sold in 2015 (or 2016, if such data is available). “Brands” means waterpipe charcoal products sold under a brand name, regardless of the type or subtype discussed in Section 1 above and regardless of the charcoal quantity per package. For example, Orange Lemonwood Hookah Coal, Ignite Hookah Charcoals, and Three Kings Hookah Charcoal are all charcoal brands, even though they are different types and subtypes. Any currency translation factors shall be shown with references in the Final Report.

6. Final Report for Task 2.

The Contractor shall provide a Final Report for Task 2 within 30 (thirty) business days of completing this Task. At least ten (10) business days prior to delivering the Final Report, the Contractor shall give a presentation via Webex or comparable technology on the Final Report detailing findings and results. Final Reports shall show any applicable analyses, assumptions, and references for all work performed.

3.4.3 Task 3 - Market estimate of U.S. waterpipe tobacco and charcoal “Shisha” is a term to describe materials smoked in waterpipes, and includes tobacco-based and non-tobacco products. Separate and distinct from shisha are additives that may be smoked together with waterpipe tobacco or alternatively smoked in lieu of waterpipe tobacco. [5] These additives and alternatives include, but may not be limited to: hookah gels, hookah juices, steam stones (small synthetic pebble-like rocks coated with flavored viscous fluids), gel stones, shisha fruits (chemically processed pieces of fruit), hookah squeeze pastes (“squeezes”), hookah ice rocks, and “ready to use” hookah capsules.

1. Annual shisha sales

The Contractor shall describe total annual shisha sales in dollars and units sold over the past ten years for the U.S. and, of this amount, the proportion from tobacco shisha sales. “Units” for the purposes of this Section 1, shall include total tons of shisha and waterpipe tobacco, in addition to package quantities sold at retail annually. “Package quantities” means that packages containing different quantities may be aggregated together such that there is one quantity number reported annually for this request. The Contractor shall determine whether package unit sizes, e.g. 50 gram, 100 grams, etc. are the same for waterpipe establishments compared with packages directly sold to consumers. Of the annual ten year U.S. waterpipe tobacco sales, the Contractor shall provide share splits for waterpipe establishments versus other selling channels.

The Contractor shall provide sales data for this request in both current and constant dollars.[footnoteRef:5] For the constant dollar analysis, the base year and conversion method using annual inflation adjustments shall be reasonably agreed upon with the Government. It is assumed that US retail sales are domestic sales. However, if this is not the case, then the Contractor shall adjust sales with the applicable exchange rate to be reasonably agreed upon with the Government. [5: “Current dollars”, also known as nominal dollars, takes inflation into account whereas “constant dollars,” also known as real dollars, does not take inflation into account. In looking at annual sales over a long period, such as a decade, inflation can substantially affect growth trends. Therefore, the sales analyses for both Subtask 1 and Subtask 4 shall be done with both current and constant dollars allowing the Government to understand tobacco category growth trends with and without inflation effects.]

After contract award, the Government will provide the Contractor with shisha definitions. It is understood that such definitions are for project purposes only and are not official FDA definitions.

2. Annual sales of additive or alternative hookah smoking materials

The Contractor shall describe total annual sales of additive or alternative products (hereinafter “additives and alternatives”) for hookah smoking in dollars and units sold over the past three years for the U.S. and, of this amount, the proportion from nicotine containing additives or alternatives in both sales and units. For the purposes of this Section 2, “additives and alternatives” may include but are not limited to: hookah gels, hookah juices, steam stones, gel stones, shisha fruits, hookah squeeze pastes (“squeezes”), hookah ice rocks, and ready to use hookah capsules. For this Section 2, “sales” means annual dollar sales for each product type and “units” means annual package quantities by weight for each product type. “Product type” means each category comprising additives and alternatives for hookah smoking. For example, hookah gels and steam stones are each categories within additive and alternative products. Only current dollar reporting is required for this requirement.

The Government recognizes that the market for additives and alternatives is rapidly changing. Therefore, the complete list of additives and alternatives will be proposed by the Contractor after contract award and agreed upon with the Government, such agreement not to be unreasonably withheld. The Government will provide a definition for each agreed upon alternative and additive. It is understood that such definitions are for project purposes only and are not official FDA definitions.

It is acceptable solely for this Section 2 to use triangulation to estimate the market size of additives and alternatives, provided that the work product is properly supported with the rationale, assumptions, and references. “Triangulation” is used when sales or unit volume is not available and surrogates or proxies are used in market estimations.

3. Waterpipe charcoal market size

The Contractor shall describe the U.S. waterpipe charcoal market size by dollars and units annually for the last five years, and for this period, estimate the proportion of quick light charcoal versus other charcoal types. “Units” shall include total tons hookah charcoal only. Only current dollar reporting is required for this requirement.

4. Waterpipe tobacco contribution to overall tobacco market

The Contractor shall estimate the contribution of waterpipe tobacco, exclusive of the additives and alternatives described in Section 2, to the entire U.S. tobacco market as measured by percentage of sales and tons over the past ten years. The Contractor shall provide sales data in both current and constant dollars. For the constant dollar analysis, the base year and conversion method using annual inflation adjustments shall be reasonably agreed upon with the Government.

For Sections 1-3 of Task 3, market size may not be available for all years. If so, it is acceptable to estimate missing data by applying growth rates or using some other methodology, provided that the work product is properly supported with the rationale, assumptions, and references.

Forecasting future sales is not within project scope of Task 3.

5. Final Report for Task 3.

The Contractor shall provide a Final Report for Task 3 within 30 (thirty) business days of completing this Task. At least ten (10) business days prior to delivering the Final Report, the Contractor shall give a presentation via Webex or comparable technology on the Final Report detailing findings and results. Final Reports shall show any applicable analyses, assumptions, and references for all work performed.

3.4.4 Task 4: Costs for hookah tobacco in waterpipe establishments Waterpipe establishments (WPEs) are bars or lounges where individuals smoke hookahs and socialize. There are roughly 1,700 U.S. WPEs and hookah smoker density varies geographically. [6,7] As part of the social experience, hookah smoking is often shared among individuals and, to accommodate this, hookah units may have multiple hoses per unit.

1. WPE costs for smoking hookah tobacco

The Contractor shall determine WPE range of costs, i.e. the prices WPEs spend for materials exclusive of indirect costs, to set-up hookahs for patrons to smoke hookah tobacco in 2016. Hookah “set-up” materials include the following: (1) hookah unit, (2) tobacco, and (3) charcoal. For waterpipe tobacco, the Contractor shall determine whether WPEs sell pre-packaged waterpipe tobacco, blend tobacco on site, or offer both pre-packaged and blended-on-site tobacco. For charcoal, the Contractor shall provide an estimate of the proportion of WPEs using: (1) quick light only, (2) non-quick light charcoal types only, or (3) combinations of quick light and non-quick light charcoal types. Indirect costs, such as labor, rent, utilities, and marketing expenses, are not to be included in this analysis. The Contractor shall propose a method for this requirement to be reasonably agreed upon by the Government.

For this analysis, the Contractor shall determine whether waterpipe liquid is usually water or some other liquid, such as juice, soda, milk, or wine—all known to be used in waterpipe smoking—and whether the liquid is refreshed during a single smoking session and between different smoking sessions.[footnoteRef:6] If a liquid other than water is typically used in waterpipe smoking, the Contractor shall determine whether this cost should also be taken into account. [6: Ice is also sometimes added into the waterpipe bowl. ]

2. Consumer cost range for waterpipe smoking in WPEs.

The Contractor shall determine the consumer range of costs, i.e. the price consumers pay, to smoke hookah tobacco per session in WPEs for 2016. Since smoking session duration and number of smokers per hookah unit is variable in a waterpipe establishment, the Contractor shall develop a sensitivity analysis for this requirement. An example sensitivity analysis chart is shown below. Key assumptions underlying this analysis, provided by the Contractor, are estimates of tobacco amount smoked (in grams) and refills per session. The Contractor shall propose a method for this requirement to be reasonably agreed upon by the Government. Since consumer prices may vary by locale and clientele, the Contractor shall propose at least two U.S. city locations for such analysis with a rationale for choice to be reasonably agreed upon by the Government.

Consumer cost range for hookah tobacco smoked in WPEs in 2016

3. Profit margin on materials for smoking hookah at WPEs

Based on the results of Sections 1 and 2 above, the Contractor shall estimate the mark-up range between WPE costs for a hookah set-up and prices paid by consumers to smoke hookah. The Contractor shall propose a method for this requirement to be reasonably agreed upon by the Government.

For Sections 1 and 3 above, it is acceptable to sub-segment WPEs in approximating costs, e.g., chains and standalone establishments.

4. Final Report for Task 4.

The Contractor shall provide a Final Report for Task 4 within 30 (thirty) business days of completing this Task. At least ten (10) business days prior to delivering the Final Report, the Contractor shall give a presentation via Webex or comparable technology on the Final Report detailing findings and results. Final Reports shall show any applicable analyses, assumptions, and references for all work performed.

3.4.5 Task 5 – Annual domestic hookah unit sales:

The Contractor shall determine hookah unit sales annually at retail channels in the U.S. for the past five years. “Hookah units” means assembled units, i.e., minimally the combination of a tobacco bowl, stem, and a waste water bowl to form a single device and sold at retail. The Contractor may propose a different hookah unit definition to be analyzed, if other language is more appropriate.

Hookah pens and e-hookah pens are not to be considered as hookah units in this analysis. After contract award, the Government will provide the Contractor with definitions for excluded products for Task 5. It is understood that such definitions are for project purposes only and are not official FDA definitions.

Final Report for Task 5.

The Contractor shall provide a Final Report for Task 5 within 30 (thirty) business days of completing this Task. At least ten (10) business days prior to delivering the Final Report, the Contractor shall give a presentation via Webex or comparable technology on the Final Report detailing findings and results. Final Reports shall show any applicable analyses, assumptions, and references for all work performed.

3.4.6 Task 6– Meetings and project status updates

The Contractor shall hold an initial project kick-off meeting with the Government and thereafter, monthly status meetings. At monthly meetings, the Contractor shall provide a project Gantt chart for review with the Government. The Gantt chart shall include timelines, milestones, and the Contractor’s personnel responsible for deliverables by Task. In addition, ad-hoc meetings may occur if project activities so require. Within five (5) business days of any meeting, the Contractor shall deliver meeting minutes to the Government.

3.4.7 Task 7–Final Bound Volume of Final Task Reports

Upon completion of Tasks 1-5 and at this project’s termination, the Contractor shall provide via electronic delivery a Final Bound Volume consisting of all Final Reports for Tasks 1-5 with a table of contents.

3.5 Delivery Schedule with Estimated Dates[footnoteRef:7],[footnoteRef:8] [7: The order of task completion is flexible and to be agreed upon with the Government, i.e., tasks do not need to be completed in the order shown above. ] [8: Tasks can be accomplished in parallel.]

Not applicable

Within five (5) business days of any meeting, the Contractor shall deliver meeting minutes to the Government.

3.6 Deliverable Format

1. The Contractor shall format the Section 3.5 deliverables in the following manner: Preliminary and final reports shall include PowerPoint summaries and complete reports in Word or Adobe Acrobat format. “Preliminary Reports” shall contain: (1) an executive summary, (2) methods section, (3) findings, (4) analyses, if applicable, (5) preliminary conclusions, and (6) key issues to be addressed prior to finalizing the report. For each preliminary report, the Government will provide feedback or comments which the Contractor shall incorporate into the final report. “Final Reports” shall contain: (1) an executive summary, (2) methods section, (3) findings, (4) analyses, if applicable, (5) comments from the Government, (6) conclusions, and (7) references. “References” shall include any documents, websites, blogs, written or oral communications, or other sources used in the course of this work.

2. The Contractor shall include all assumptions and references used in the development of Final Reports and Workbooks.

3. The Contractor shall deliver the aforementioned services via electronic mail for reports and, for meetings, Web-based or telephonic conferences.

4. The CTP Contracting Officer Representative will notify Contractor of receipt of work product delivery.

5. For Final Reports, Contractor shall incorporate comments and edits provided by the Government after receipt and review of Preliminary Reports.

6. Final bound volume. The Contractor shall combine all individual Final Reports for Tasks 1-5 and submit them together as one final bound volume with a table of contents. Such bound volume shall be delivered one month prior to the end of the period of performance. After receipt, the Government will review the bound volume and may provide comments or suggest revisions, and the Contractor shall make such changes prior to the end of the performance period.

7. Deliverables requiring sales and unit data, market share splits, or cost analyses shall be delivered in Excel workbooks with formulas that can be displayed. There shall be five Excel workbooks.[footnoteRef:11] Each workbook shall show all assumptions and references for inputs. [11: No workbook is needed for the additive and alternative hookah smoking materials analyses described in Task 3. ]

a. Workbook for Task 3 Section 1: U.S. waterpipe tobacco market This workbook shall describe total annual sales of waterpipe smoking materials (tobacco + non-tobacco without alternative and additive hookah smoking material sales) in dollars and units sold over the past ten years for the U.S. and, of this amount, the portion from waterpipe tobacco sales. Each analysis requiring current and constant dollar values shall be delivered in separate worksheets within the workbook. For each analysis, there shall be stacked area graphs illustrating amounts in dollars and units over the time period. Of the annual ten year U.S. waterpipe tobacco sales and units, share splits for WPEs versus all other selling channels shall be shown in a separate worksheet with a categorized graph type to be reasonably agreed upon by the Government.

b. Workbook for Task 3 Section 3: U.S. waterpipe charcoal market This workbook shall describe the U.S. waterpipe charcoal market size by dollars and units annually for the last five years accompanied by a single line or bar graph.

c. Workbook for Task 3 Section 4: Waterpipe tobacco contribution to overall U.S. tobacco market.

This workbook shall describe the estimated contribution of waterpipe tobacco to the entire U.S. tobacco market as measured by percentage of sales and units, including tons and packages over the past ten years. Each analysis requiring current and constant dollar values shall be delivered in separate worksheets within the workbook. For both current and constant dollar value analysis, there shall be stacked area graphs illustrating amounts for each tobacco category, e.g., cigarettes, roll-your-own tobacco, cigars, pipe tobacco, smokeless tobacco, and waterpipe tobacco, etc., topped with a single line showing total amounts of all categories combined.

d. Workbook for Task 4 Sections 1-3:

This workbook shall describe the WPE costs for smoking hookah tobacco, consumer cost range for waterpipe smoking in WPEs, and profit margin on materials for smoking hookah at WPEs. Each analysis shall have its own worksheet. The mark-up analysis shall be accompanied by a waterfall chart.

e. Workbook for Task 5:

This workbook shall describe hookah unit sales annually at retail channels in the U.S. for the past five years accompanied by a single line or bar graph.

8. Travel It is anticipated that no travel shall be needed for task completion. However, the Contractor shall clarify in their proposal if any travel is needed.

9. Access to Non-Public Information All persons authorized by FDA to work under this contract shall be required to sign Form FDA 3398 – Contractor’s Commitment to Protect Non-Public Information Agreement. If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the COR and Contracting Officer within ten (10) days. Any new person assigned to this contract shall sign the agreement and shall submit it to the Contracting Officer and COR prior to commencement of any work under this contract. No person working under this Contract shall be provided or possess non-public information in any form unless written approval has been granted by the Contracting Officer. The disclosure of any confidential information in violation of the agreement may be subject to civil or criminal sanctions.

10. Data Rights This contract incorporates the Data Rights Clause FAR 52.227-14 Rights In Data-General (May 2014).

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

12. Other requirements 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. See FDA Public Access Policy available at: http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/staffmanualguides/ucm479268.pdf

13. Conflict of Interest

Organizational Conflict of Interest

As a regulatory agency charged with protection of public health, FDA must maintain public confidence in the integrity of its decisions. CTP oversees 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.

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 FDA be assured that there is no actual or apparent conflict of interest on the part of individual contractors. Offerors performing work under this contract must assure the protection of information and data they receive 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.

(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.

Part 4 – Performance

4.1 Place of Performance

The Contractor shall perform all Tasks at its own place of business. Visits to FDA in connection with this project shall be coordinated with Point of Contact (POC), see below.

POC and Contracting Officer’s Representative (COR):

Contact: Sahlee Sabala Phone: 240-402-7789 E-mail: Sahlee.Sabala@f@fda.hhs.gov The US Food and Drug Administration White Oak Campus 10903 New Hampshire Avenue WO Building 75, Room 5409C Silver Spring, MD 20993

4.2 Period of Performance

The contract period of performance is to begin at the time of award. The exact date will be established when the contract award is made. The period of performance will last two years from the date of award.

There are no Optional Periods

Part 5 – Contract Administration

5.1 Representatives

The COR will perform acceptance of services to be provided.

Sahlee Sabala is the authorized representative of the Contracting Officer.

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 and acceptances; and (4) 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.

The contact information for the Contracting Officer is the following:

Ronald R. Rouse U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Ronald.Rouse@fda.hhs.gov 240-402-7615

The contact information for the Contract Specialist is the following:

Robert Maydwell U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Robert.Maydwell@fda.hhs.gov;

(301) 348-1814

The contact information for the Contractor is the following: (TBD)

5.2 FDA Three-Way Match Invoicing Procedures

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

Phone: 301-827-3742 Email: FDAVendorPaymentsTeam@fda.gov

** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

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

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

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

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

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

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

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

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

(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,…