RFP Questions-Answers.doc

EMR Data RFP Questions.

Please answer the below questions.

1. Question related to the availability of EMR data:

One of the documents states the following: “The successful Contractor(s) shall have continuous direct access to a nonfederal, commercially available, population-based, EMR data resource with access to primary medical records covering a minimum of two million active patients as of June 1, 2008.” Does this mean, we need to buy the data or will it be provided to us by your department?

FDA is not interested in developing this database and expects any qualified organization to own the data as well as have the means to access and manage the data.

2. Is the requirement about Electronic Medical Records Software or just or just EMR data?

Any qualified organization shall have access to the EMR data and have the software interface to access the data.

3. We are a commercial business that sells its products and services in the general public marketplace. We believe our commercial products and services meet the FDA’s needs and that this procurement would be better served under the FAR Part 12 SF1449, Solicitation for Commercial Items.

It is our request that the solicitation be modified to be a FAR Part 12 SF 1449, Solicitation for Commercial Items or a waiver be granted from the FAR Part 15 SF 33 requirements?

The contracting officer has decided that FAR Part 15 will be used. No waivers will be granted. However this does not mean that you can not propose your commercial products if they meet the Governments technical requirements.

4. Page 13 C.1.5.3 and 4 We do not understand what this means. It seems to suggest that the FDA will continue to use the data 12 months after the expiration period. Could you please clarify.

The FDA will require the ability to release aggregated data obtained during the contract period. This provision accounts for the time involved in the evaluation of a drug safety issue, i.e. data extraction, analyses, and formulation of a regulatory position. The FDA will require services from the contractor for processing clearance requests on data that were obtained during the contract period for one additional year after expiration of the contract. After the additional year, the FDA will notify the contractor of the aggregated data release and accept requested revisions, but will not require formal approval for release. A purchase order will be initiated for the post-contract clearance processing services and will be negotiated separately.

Referenced Excerpts from RFP

C.1.5.3 The FDA shall continue to require the ability to release aggregated data through a mutually agreed upon Data Disclosure Clearance process for data obtained during the contract period for a period of one year after Option Year 4. During the one-year period following the expiration of the contract, FDA shall not require data access service, but will require the services of processing clearance requests which will be acquired under a separate follow-on purchase order.

C.1.5.4 After the one-year period for clearance services, the FDA will notify the contractor of the aggregated data release and accept the Contractor’s requested revisions, but will not require formal approval for release.

5.

Page 18 What is required for ‘Performance Requirement’?

The Offeror shall agree to the performance requirements outlined and provide a proposed deduction for not meeting the requirements. The Government will subjectively evaluate these proposed deductions by comparing them to the Contractor’s total contract price and as an indication of the Contractor’s confidence and ability in satisfactorily meeting the performance standards.

6.

Page 39 K.4. We have several offices and it is possible that personnel from these offices may respond to FDA queries. In most cases it will be based in NJ, and my colleagues in London. Do we need to specify all our sites?

You should specify where Key Personnel for this project are working from.

7.

I note that the deadline is 10am EST on Monday 3rd August. Does the same date apply for all formats of the submission, i.e. email, signed paper copy and 8 CDs must be received by then?

Electronic submissions must be received no later then 10 am EST on Monday August 3rd 2009. The signed paper copy and 8 CD’s must be post marked by the due date but can be received later in the week.

8. Would the FDA consider extending the response date for this important RFP given that data provider organizations are also involved on responding to the FDA Sentinel RFP and summer vacation schedule?

The FDA will not extend the response date.

9. Assuming the electronic copy is in by the due date and time, does the paper copy need to be received by the due date and time as well? Or can it just be postmarked by the due date?

See answer to question 7 above.

10. Please provide clarification on the following items for compensation:

Validation Studies & Linkages to other info Validation studies are intended to provide the opportunity to confirm clinical events or therapeutic exposure recorded in the EMR. Linkages to hospital records or death or disease registries are examples of the desired linkage capabilities. The offeror shall include in their pricing schedule, costs for three validation studies to include making anonymized clinical notes available and contacting the treating physicians by questionnaire for 1000 patients per study and include costs for other available data via linkages such as hospital records, death or disease registries and the expected timeline for each step in the process.

Projection or Other Appropriate Methodology Projection or other appropriate methodology of EMR data is not a requirement of this RFP and was included in error.

Documented FDA Disclosure Policy – no compensation, rather documentation of acceptance.

Disclosure Clearance Service – compensation shall be provided for the services associated with clearance approval, e.g. review, validation, proper sources Disclosure Clearance refers to the process whereby FDA notifies a vendor of its intent to release findings based on the vendor’s data to a public and/or non-FDA entity. The core of the clearance process is related to copyright concerns but also accurate representation of the data source and findings. These entities may include but are not limited scientific publications or conferences, an official FDA press release, an internal meeting with non-FDA participants, other Federal agencies, and possibly the U.S. Congress.

11. I have a general question. I have noticed that there is some overlap in the information being requested. To illustrate with a specific example, section L3.1 asks for 2 current users of the database. Section L.3.10 also asks for 3 current clients. Can we refer to the earlier section, or do we need to state the info in each section where it is required?

In your response, reference to the section with the two clients with direct access to the data will be sufficient.

Referenced Excerpts from RF L3. 1 The Offeror shall provide verification of consistent access to a nonfederal, commercially available, population-based, patient-level, electronic medical record (EMR) data resource covering a minimum of two million actively participating patients as of June 1, 2008. Acceptable verification shall consist of at least two references (FDA will contact) from clients who have direct access to a currently available version of the data resource.

L3. 10 The Offeror shall also provide contact information for a minimum of two (2) current clients with direct access to the data to allow FDA to obtain independent references.