QA FDA-RFP-23-115584.pdf

ACCESS TO HEALTHCARE PRACTITIONERS PRESCRIBING DATA

FDA-RFP-23-115584

Questions and Answers

Question #1:

Please clarify the procedure for the use of the Past Performance Questionnaire:

Should Past Performance Questionnaire be Distributed to and Completed by the Offeror’s designated Referenceable Clients and included in the final submitted proposal?

or

Does the FDA independently contact the designated Referenceable Clients requesting that the Past Performance Questionnaire be submitted directly to the FDA?

Government Response: Past performance must be completed by the offeror and submitted with the proposal. The FDA does not independently contact the designated Referenceable Clients. Please refer to Appendix I of the solicitation for further clarification.

Question #2:

Does the FDA have benchmarks regarding the monthly volume of querying and/or the cloud computer overhead that they incurred during the prior performance period?

Government Response: The FDA does not have benchmarks for monthly queries as queriers fluctuate based on need. Please refer to the pricing tables and the number of users to provide an estimate for the pricing model.

Question #3:

Does the FDA have benchmarks from the prior performance period regarding the maximum number of concurrent users of the technical environment in which the data will be accessed from the prior performance period?

Government Response: The FDA is currently soliciting for 70 seat licenses or individual users to have access to the data concurrently. The offeror must be able to give access to all 70 FDA users concurrently if needed.

Question #4:

Is this FDA contracting opportunity open business of all sizes, or is it limited to Small Businesses?

Government Response: The solicitation was previously posted for Small Business to apply, and it was closed because small businesses did not meet the requirements. The current solicitation is not open for small businesses.

Question #5:

Can the FDA supply the spreadsheet that is labeled ‘FDA Usage Report_October2017.xlxs that is in the RFP as APPENDIX F EXAMPLE OF MONTHLY USAGE REPORT?

Copy of Usage Repert.xlsx

Government Response: See attached for the Usage Report Spread Sheet.

Question #6:

Is it sufficient for the Offeror to provide a statement in the body of the RFP response that acknowledges agreement with the DATA DISCLOSURE CLEARANCE PROCEDURES?

Government Response: It is not sufficient for the offeror to provide a statement. The FDA requires the offeror to provide disclosure policy and clearance procedures as stated in Appendix D and Appendix E.

Question #7:

Should the Offeror provide a completed and signed TRIAL SUBSCRIPTION AGREEMENT (APPENDIX H) in the submitted proposal or will the FDA request this after the contract is awarded.

Government Response: Yes, the offeror should provide a complete a trial subscription agreement with the proposal submitted.

Question #8:

In Section 3.3.1 the RFP states “Contractor shall provide continuous automated access to data resources on health care practitioner prescribing practices for seventy (70) users.” As a point of clarification is that 70 different individual outpatients’ or 70 different health care practitioners’ data?

Government Response: This is 70 individual FDA users (staff) who will be using the data. It is not referring to patients or healthcare Practioners’ rather FDA users of the data.

Question #9:

In section 3.4 paragraph 5 it states “FDA requires the ability to make national estimates of visit-based and/or patient-based outpatient…” Does this mean the FDA wants to ensure the data has a strong representation of the population and it can used on a national scale?

Government Response: Yes, that is correct. FDA would like to ensure the data is robust and has a strong nation level representation of the U.S population.

Question #10:

Section 3.4 mentions the data must be “current and commercially available,” can you provide more clarity on the definition of commercially available?

Government Response: Commercially available data means the vendor already has access to this data and can be sold commercially to the government or general public. Please refer to the Appendix A of the solicitation for the definition.

Question #11:

How does the FDA intend to consume this data/analysis from the contractor? Through a data visualization-reporting platform e.g Tableau, Power BI, etc.? And/or including analytical platforms such as a Data warehouse/data lake? Or a different methodology?

Government Response: The FDA plans to consume this data through the Vendor’s interface.

The vendor must have the data available through the interface that the FDA can access.

Direct – Authorized FDA personnel shall be able to access raw or sample numbers from the data source from their desktop (i.e., no intervention on the contractor’s part shall be necessary. In addition, output that consists of formatted reports only will not be acceptable).

Question #12:

Section 3.4.6 discusses Trial Subscription Period. Is this trial subscription the same data sources that will be used during the contract? Or does it need to be an additional data source that showcases how contractor will deliver data to FDA for evaluations purposes only? How does this relate to #4 above?

Government Response: The trial subscription would be the same data source that will be used for the contract. The FDA requests the Vendor to provide a temporary access of their data via their interface to be accessible for 30 days. This is so that the users can familiarize themselves with the data to determine if the data meets the government’s needs.

Question #13:

In the contexts of this contract can you please clarify what constitutes on-line vs off-line data?

Government Response: All requirements for this contract reference online date. Please refer to section 3.3.1.

Question #14:

For this contract should the data set focus on any particular schedule and/or names of prescription drugs? For example, the categories of legally prescribed controlled drugs range from schedule II to V (C-II to C-V) in the U.S. Or should data set be a random sample?

Government Response: The data should be focused on all prescription drugs scheduled and non-scheduled drugs.

Question #15:

Are there any specific prescribers’ specialization (e.g., dermatologists, dermatopathologists, family practitioners, internists, gastroenterologists, and rheumatologists) that the FDA is targeting? If so, which? Or no particular specialization of interest?

Government Response: FDA is targeting all healthcare Practioners with data. Please refer to 3.3.1

Question #16:

When does FDA intend to initiate the trial subscription?

Government Response: The FDA intends to initiate the trial subscription during the evaluation period of the proposal.

Question #17:

How many users does FDA intend to have in the trial subscription?

Government Response: The FDA to have seven (7) users for the 30-day trial subscription period. Please refer to section 3.4.6 of the solicitation

Question #18:

As it relates to the two past performance references, is there a version of the questionnaire I can/should issue to the respondents, or do I need to replicate it manually from the RFP pdf document provided?

Government Response: It can be replicated manually from Appendix I.