QandA_in red.docx

Q&A: 97469 Market Forecast WNV

1. Will CDC/DVBD provide existing epidemiological datasets or prior analyses as inputs? Or are we expected to source all data independently?

A. In addition to publicly available data on CDC's website and previous publications as noted in the SOW, specific requests can be made to CDC for additional epidemiologic data from ArboNET, the national arboviral disease surveillance system. These data might include information such as additional data on sex, age category, race, ethnicity, or county of residence of West Nile virus cases.

2. Are there existing Target Product Profiles (TPPs), or does the vendor develop assumed TPPs from publicly available information?

A. The TPPs will be provided as inputs for this project.

3. For the peer-reviewed manuscripts: does CDC have a target journal or journal tier in mind? What's the expected timeline for submission relative to the contract period?

A. We would prefer these papers are published in high-impact journals commensurate with scientific interest, potential public health impact, etc. A possible range could be JAMA, Lancet Infectious Disease, and Vaccine. CDC could engage in shared decision making with the contractor about the best possible journal(s).

B. As outlined in the scope of work, we anticipate the contractor will submit the manuscripts for publication in month 12 of the contract.

4. The labor categories (Principal Investigator, Postdoctoral Fellow, Health Economist, Research Analyst) read like academic and government research roles, not consulting titles. Are you open to us mapping our consulting team across these categories with justified qualifications and experience equivalencies, rather than staffing literal PIs and Postdocs?

A. Yes, these were meant as guidelines. Mapping to alternative job titles with justification should be acceptable.

And on the pricing side, given the prescribed hours, do you have any visibility into what CDC considers a competitive price point for this work? That would help us make sure we're in the right ballpark before putting the full package together.

B. Unfortunately, CDC cannot provide guidance on a target or competitive price range for this work. We would encourage you to develop your proposed budget based on your assessment of the level of effort, staffing, and other requirements described in the funding opportunity announcement. Proposals will be evaluated according to the criteria and requirements outlined in the announcement.

5. The SOW mentions assessing manufacturing considerations, cold-chain/storage, and associated costs. Is the intent here for these to be market-level considerations that inform the forecast (e.g., how cold-chain complexity affects uptake or distribution costs), or a deeper technical dive into manufacturing and supply chain logistics?

A. The intent is the former, that is, market-level considerations that inform the forecast. For instance, a vaccine that requires cold chain would likely be costlier to distribute and keep in storage.

6. For the financial and ROI analyses, will we be provided baseline development and investment cost assumptions for us to work from, or are we expected to independently estimate those as well?

A. Baseline development and investment costs will need to be gathered from external sources (i.e., stakeholder interviews, independently estimated).

As well as the below:

1. Our company roles and titles are different than the required labour categories mentioned below. We hope this is acceptable.

A. Yes, these were meant as guidelines. Mapping to alternative job titles with justification should be acceptable.

2. Is there a preferred format (Word, PPT) for our proposal response? Noted regarding 25-page limit for the total quotation package A. A Microsoft Word document would be preferable but not required.

3. Will TPPs for 1) human West Nile virus (WNV) vaccine; and 2) anti-WNV monoclonal antibody (mAb) given as seasonal pre-exposure prophylaxis to prevent severe WNV disease be provided as input to this project? Or are we expected to develop the TPP?

A. The TPPs will be provided as inputs for this project.

4. In terms of external stakeholder engagement, is this the preferred approach: structured interviews, including interviews with up to 20 subject matter experts, industry leaders, and Federal agency stakeholders? Is there openness to quantitative survey methodologies?

A. Yes, the language from the SOW reads, “Synthesized findings from structured interviews with up to 20 subject matter experts, industry leaders, and federal agency stakeholders.”

B. CDC does maintain openness to survey methodologies that would result in key data that could inform forecast modeling.

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