QUESTIONS_AND_ANSWERS__2_FDA-RFP-1162339.doc

QUESTIONS AND ANSWERS #2

SOLICITATION NUMBER # FDA-17-RFP-1162339

Access to Hospital Inpatient and Emergency Department Drug Utilization Data

Question 01 If the FDA intends to keep the FAR clause 52.211.11 Liquidated Damages, Supplies, Services or Research and Development (Sept 2000) is FAR clause 52.249-8 Default (Fixed Price Supply and Services) to be included in the solicitation?

Answer 01 See Amendment 3-FDA will delete Part 8.2 FAR Clause 52.211-11 Liquidated Damages, Supplies, Services or Research and Development (Sept 2000)

Question 02 If the FDA intends to keep the FAR clause 52.211.11 Liquidated Damages, Supplies, Services or Research and Development (Sept 2000) what is the basis for the Liquidated Damages? FDA did not provide any parameters concerning the basis for the liquidated damages. As a result, vendors may determine the financial risk is too great to the company and not submit a bid.

Is it:

a. Not meeting the 24 hour turnaround time for urgent clearance requests?

b. Not meeting the 48 hour turnaround time for standard clearance requests?

c. Not meeting the 72 hour turnaround time for Third Party Agreements?

d. Not meeting the 15 day turnaround time for Ad-hoc Dataset Requests? Is the 15 days calendar days or business days?

e. Any loss of access to the data other than scheduled downtime?

f. Any time the Contractor tools are experiencing technical problems? Does the FDA expect 100% for a Service Level Agreement for a commercial product that is sold to the general public and is not developed or modified for the FDA? No vendor can guarantee 100% system availability.

g. Any user who can’t get access when it is required?

h. Lack of 48 hours notification for routine maintenance and updating of the data?

i. Lack of valid data that is technically correct and conforms to contract requirements? What is considered “valid data that is technically correct” when the contractor is offering a commercial product per RFP requirements that is sold to the general public and is not developed or modified for the FDA? What is considered “conforms to the contract requirements” when the contractor is an offering commercial product that is sold to the general public per RFP requirements and is not developed or modified for the FDA?

j. What constitutes a delay in delivering or performance that is beyond the control and without the fault of negligence of the contractor? Is FDA using the definition in FAR 52.212-4 – Contract Terms and Conditions – Commercial Items (May 2015) or the definition in FAR clause 52.249-8 Default (Fixed Price Supply and Services)?

k. How is FAR 52.211.11 Liquidated Damages, Supplies, Services or Research and Development (Sept 2000) required when FAR 52.212-4 Contract Terms and Conditions – Commercial Items (May 2015) already covers warranty and limitation of liability?

How does FDA intend to evaluate an Offeror’s performance under the Performance Evaluation Plan and in conjunction with FAR 52.211.11 Liquidated Damages, Supplies, Services or Research and Development (Sept 2000)?

Answer 02 See response to Question 01

Question 03 Can Contractors propose CLIN 1002 and 2002 without proposing on 0002?

Answer 03 No. In order to propose on an Option CLIN, the offeror must propose on its corresponding Base CLIN.

Question 04 Can Contractors propose CLIN 0002 with a launch data sometime in 2017, when full access when the data and tool can be made available to the FDA according to the RFP requirements, and propose pricing that reflects less than a full year?

Answer 04 The offeror may propose an alternate start date within the Base Year for CLIN 0002. The Technical Proposal must fully address CLIN 0002; “To Be Determined” or its equivalent is not acceptable. Also, committed pricing for CLIN 0002 must be submitted with the Business Proposal. The completeness of the proposal and the level at which it addresses the Government’s needs will be taken into consideration when conducting evaluations.

Question 05 Question # 27 in the Questions and Answers states, Question 27 (Attachments, throughout document) Within Appendix I, it states “Date and time of drug administration (Y/N)” and “Date and Time of procedures related to hospitalization or ED visit (Y/N)

Question: Full date and time are not available in our data offering (by month is only available). Will the FDA accept with the month provided only?

Answer 27 Yes.

Follow up Question: Does the FDA understand that the data is aggregated and projected to the monthly period provided to the FDA through the tool while the full date and time is collected and available in the raw data?

Answer 05 Yes. We expect national-level data through the online tool and raw data through an ad-hoc requested if needed.

Question 06 Question # 30 in the Questions and Answers states, Question 30 (CLIN 0002-Data Requirements; Section G Appendix I, Page 13)The RFP states, “Hospitalization and/or ED episode data shall be required, and include the

Question: Full dates are not currently available in our data offering. Would the FDA please reconsider amending this requirement to replace “dates” with “discharge month”? Note: This would also apply to language included in Appendix I (replacing “FDA Change Admission & ED from “Date” to “Month” dates of the ED visit and/or hospitalization.”

Answer 30 Discharge month is acceptable Follow up Questions:

If discharge month is acceptable per the Q&A, will the SOW be changed?

Is it acceptable to FDA if discharge dates are aggregated and projected nationally then provided to the FDA in the tool in monthly time periods?

Answer 06 Access to data on discharge month can be made available through ad-hoc reports, if needed, for epidemiologic studies. There is no need to amend the SOW.

Question 07 Question # 36 in the Questions and Answers states, Question 36 (Page 8, Section 3.2 Letter C) The RFP states, “Provide FDA personnel with direct, unlimited, Internet or network-based access via an interface tool to the entire data resource for adult and pediatric hospital inpatient data and emergency department (ED) data in a multi-user environment and in real time.”

(Page 8, Section 3.2 Letter D)The RFP states, “Provide FDA personnel with the ability to download (or using other means that are compatible) large datasets as needed, for the purpose of conducting epidemiological drug safety studies.”

(Page 10, Section 3.3 Letter J) The RFP states, “Access to a data resource for hospital inpatient and ED data for adult and pediatric patients shall be through a currently existing, commercially available, HIPAA-compliant interface tool.”

(Page 10, Section 3.3 Letter M) The RFP states, “Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Access shall include all upgrades, enhancements, and modifications to interface software and data.”

(Page 11, Section 3.3 Letter O) The RFP states, “Access shall be through an interface and this interface shall be user-friendly (easy to understand and methods fully disclosed), transparent and flexible for conducting data queries.”

What is the purpose of the interface tool? Is it acceptable to provide the FDA with the ability to download the datasets quarterly via a link to an FTP site with a password?

Answer 36 FDA requests direct, unlimited, Internet or network-based access via an interface tool to the entire data resource per the RFP. The Offeror may propose an alternative for consideration that must include a hands-on demonstration during the trial subscription.

Follow up Question: Can the FDA confirm that the interface tool is intended for access to the entire data resource per the RFP, specifically the national–level projected estimates, not raw sample data?

Answer 07 See response to question 5.

Question 08 Question # 38 in the Questions and Answers states, Question 38 (Page 9, Section 3.3 CLIN 0001, Letter D)(Page 12, Section 3.3 CLIN 0002, Letter D) The RFP states, “. . . the following information shall be provided to the FDA: the number of years of valid data available overall and on-line in real time to FDA personnel; the process and procedures for accessing data that are no longer on-line; the lag time between the date of service for the hospitalization and on-line availability of the data; and data collection and management procedures.

Can the government define the term “on-line” as it relates to these requirements?

Answer 38 On-line refers to direct, desktop access to data (raw or sample numbers) for authorized FDA personnel from their own computers (i.e., no special or customized hardware shall be required for access).

Follow up Question: The FDA’s answer to Question #38 contradicts the RFP requirement for projected, national-level estimates based on inpatient and ER drug utilization data. Does the FDA also require access to raw or sample numbers through an online tool? Or does the FDA intend to obtain raw, sample patient-level data only through extracts as defined in Answer 06?

( Note: The FDA’s response to Answer 06 in the Questions and Answers states, Answer 06 CLINS 0003, 1003 and 2003 refer to patient level dataset extracts. A dataset extract is a file of data consisting of de-identified, HIPAA compliant unique patient level records containing the demographic and drug utilization data necessary to address a particular study question. Each dataset extract may contain multiple USC classes, markets or years of data. Yes, FDA intends for the contractor to provide the extract upon request. Up to 2 data extracts are required for the base and all option years of the contract. (We revised the number per year of Access to Patient Level Dataset Extracts from 12 to 2 in CLINS 0003, 1003 and 2003 and added the definition of Dataset Extract in the Glossary in Amendment 2 of the solicitation)) Answer 08 The FDA does not require access to raw or sample numbers through the online tool.

Question 09 If a vendor provides a data dictionary as part of our response, will it be incorporated into the contract?

Answer 09 No, the data dictionary will not be incorporated into the contract

Question 10 Third Party Agreements (TPAs) typically take 3 weeks to be fully executed between the vendor, FDA and the third party. Will the FDA increase the turnaround time for TPAs to 15 business days?

Answer 10 We are requesting a standard of 72 hours for data clearance of TPAs

Question 11 Because of the additional clarifications needed to support the development of a complete technical proposal, will the contracting office grant an extension to 12/2 to provide sufficient time to modify existing proposal drafts to align with new clarifications?

Answer 11 No, the response date will remain unchanged