Complied_Q_and_Answers_for_HPJ.pdf

Questions and Answers for RFQ 1179639 Hookah Purchase Journey

1. Reconcile difference between section 2.2 and 3.4 reference to number of tasks.

Within 2.2 Sample Contract Pricing Table Per Task it states, “Offerors shall complete this table for each of the five Tasks listed in Part 3.” However, within Part 3.4 it specifically lists seven tasks. We assume that a pricing table needs to be provided for all seven (7) tasks and not just the

“five Tasks” listed in 2.2 – is this correct? If not, please explain.

Response: This is an internal inconsistency in our document. Tasks 6 and 7—meetings, updates, and final reports—all apply to each of Tasks 1-5 and should be included in their prices, i.e., no separate pricing for Tasks 6 and 7. Your pricing table should appear like the sample pricing table in 2.2 for Tasks 1-5.

2. Within “3.4.1 Task 1 - Supply chain for U.S. waterpipe tobacco”

Under subsection “2” point “a”: There is an expectation to identify companies that perform the

“majority” (more than 50%) of waterpipe tobacco 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.

Questions:

Is there an estimate of the total number of waterpipe processors, manufacturers, and distributors that this may ultimately include?

Response: There is no estimate. In your proposal, you may consider including

“preliminary information gathering phases” to help determine whether identifying the majority as defined in the SOW is pragmatic. See Technical Proposal Instructions, page

31. It may be the case, that the definition for majority will need modification.

Can you clarify the phrase “companies that perform” – how do you measure performance for both volume and value for “distributing” to get to the “majority” of distribution – are you basing it on volume/value of overall total waterpipe tobacco that goes through distributors?

What if more than one “distributor” is involved in the process for delivery of the same unit of waterpipe tobacco?

Response: By performance, we are basing it on the volume/value of overall total waterpipe tobacco that goes through distributors. You are correct—more than one distributor could be involved in the same unit of waterpipe tobacco. We expect that such value would be accretive.

The Government objective is to understand how waterpipe tobacco is distributed in the

U.S. and which companies participate in distribution. If you believe there is a better method to address the Government’s objective, include it in your proposal. For example, it may be more practical to describe waterpipe tobacco distribution as networks of companies with the contribution of each network to the total distribution chain.

It appears that the majority of volume and value is only focused within the verticals being measured (i.e., “processors”, “manufacturers”, and “distributors”). This would suggest that we need to size each vertical for volume/value to the vertical, so that we can understand when we have actually reached the “majority” level required for each vertical – is this correct? It also would indicate that for each company we need to understand specifically how much waterpipe tobacco volume/value it handles within its vertical. Is this correct? If not, please explain.

Response: You are correct for both assumptions. That said, if, for example, you propose an alternative method to analyze by distribution networks, as described above, or some other alternative method, you may need to make an adjustment in your document for this Task section for consistency.

3. Under Section 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.

What, if any, is there any flexibility in this timeline for completion?

Response: There is flexibility. Propose your preferred schedule with a rationale.

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

Subsection 3: “Identify companies that process or manufacture waterpipe charcoal sold in the

U.S.” How is this subsection different than the elements within Task 1 for “processors” and

“manufacturers”? Any difference?

Response: The difference is that Task 1 pertains to waterpipe tobacco; Task 2 pertains to waterpipe charcoal.

5. Section 2.3 Labor category descriptions include either “masters level” or “bachelors level” for each. Should we interpret “level” to mean “degree” (e.g. Masters degree or bachelors degree) or commensurate experience? Please clarify.

Response: “Level” can mean either degree or commensurate experience. A description of the latter can be included in the narrative for key project personnel.

6. Section 3(a) page 4 states: “This is primarily a qualitative task that could contain some quantitative information if available…” Question: Is our assumption correct that Tasks 1, 2, and 3 will also require qualitative primary research to speak directly with representatives from these companies?

Response: Tasks 1 and 2 likely require qualitative primary research. We do not believe that

Task 3’s sales information requirement needs primary work. This information likely exists with vendors of consumer product sales data.

7. Section 7.1 page 28 states: "Relevant past performance supporting documentation, including questionnaires received from Offeror's References as required.” Question, does the government want bidders to submit past performance questionnaires (PPQs) with their proposal? If so, can the government provide a copy of the PPQ and due date for their submission?

Response: This is a typographical error. The last bullet point in Section 7.1, page 28 should read:

Relevant past performance as requested under Section 7.3, PART C.

To be clear, PPQs are not required for this RFQ.

8. Section 7.2.B page 29 states:

Proposed hourly rates shall be supported by the submission of the employee's most recent payroll stub or leave and earnings statement. Documentation to verify salaries for new hires shall consist of written offers of employment, employment agreements or contracts, which indicate the position, annual salary, and hourly rate for each new hire.”

Our rates were submitted to the GSA for Professional Services Schedule, which we anticipate being awarded this summer.

Question: Can the government confirm that this material and information is required, or can we use our proposed GSA rates? We have never seen this requirement and it seems quite onerous.

Please advise.

Response: Your proposed GSA rates are acceptable.

9. Section 7.2.B.3 page 29 states:

Offerors shall provide additional supporting budget documentation as necessary, including profit/fee policy, etc. to substantiate all proposed costs.” And in the same section on page 30, the solicitation states: " The Offeror shall make readily available all supporting pricing data used in the derivation of their proposed prices should the FDA elect to do so. In addition, the FDA reserves the right to negotiate, any, part or all of the proposed prices prior to the award decision.

Response: The nature of the question is not clear. Please clarify.

10. What are the specific intended uses of the information gathered through this process for and by the FDA? What decisions will be made based upon the information gathered? How will it be applied once completed?

Response: The background and objectives for this project are described in Sections 3.1 and

3.2.

11. Why is the program intended to last as long as it has been outlined? These tasks would be typically completed in a matter of months rather than over two years, can you help us understand the expectations of the time required to complete it?

Response: The lengthy time is due to potential delays for Government review processes.

Since it is likely that primary market research will be needed for this RFQ, any screeners and questionnaires need to be reviewed by FDA’s Institutional Review Board. In addition, the Government has a requirement under the Paperwork Reduction Act, that any primary research with more than nine subjects must undergo Office of Management and Budget

(OMB) review.

12. How much of the information that needs to be compiled, analyzed, and acted upon exists within the FDA vs. data outside that needs to be discovered?

Response: None of the information we seek exists within FDA.

13. What are the expected next steps upon completion of the tasks associated with this RFQ? The

RFQ is entitled Hookah Purchase Journey, but the tasks assume a focus on understanding the dynamics of production and supply chain and profits, etc. Is there intended to be a follow-up step focused on mapping the dynamics of how consumers purchase and utilize the products?

Response: Post-completion, next steps depend upon: (1) the information we learn during the project; and (2) the priorities of our Agency.

14. Please confirm that steam stones (small synthetic pebble-like rocks coated with flavored viscous fluids) are excluded from this analysis.

Response: When we met on Industry Day, the draft SOW did require steam stones sales.

Since writing that draft, we have learned that steam stones may be declining in use by hookah smokers. So, in the final SOW, we replaced “steam stones” with a broader category called “additive or alternative products.” “Additives” may be smoked together with waterpipe tobacco; “alternatives” are smoked in lieu of waterpipe tobacco. See first paragraph under 3.4.3. These products 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. The latter, hookah capsules, is like

Keurig pods for coffee. So, steam stones may be included or not included in the analysis.

The SOW goes on to say: “[T]he 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.” See 3.4.3 Part 2. We added this language to give both Offerors and the Government some flexibility since this market (additives and alternatives) is continually evolving. Note also that triangulation is acceptable for this category of products.