Questions_for_openFDA_Support_(5).pdf

Questions for openFDA Support (5)

FDA-SOL-1159692

1) For the "Technical Writer/ Editor and Communication Specialist" position, there is a statement regarding "Assists in performing financial and administrative functions." Could you clarify if these financial and administrative functions for this role will primarily involve editing and communicating budget and progress reports, or is this role expected to be involved with other financial and administrative activities (e.g. invoicing, hiring, etc.)?

It would be more related to “communicating budget and progress reports as well as invoicing.

2) Would the government be able to clarify what it means by "platform" in SOW Tasks 7, 8, and 9? Could the government provide examples of platforms to help clarify this meaning?

A platform is an underlying computer system on which application programs can run. The following example is on the openFDA about page.

https://open.fda.gov/about/

“OpenFDA provides APIs and is investigating raw download access to a number of high-value structured datasets, including adverse events, drug product labeling, and recall enforcement reports. The platform is currently in public beta.”

3) Task 4 of the SOW (Section 2.4) is listed as “Integration of FDA APIs Developed by Third Parties,” but the requirements within the task ask for cost estimates of migrating and integrating outside APIs. Task 5 is listed as “Regarding measures of the costs of developing new APIs, harmonizing the APIs, linking with outside APIs, and ongoing maintenance of each API,” but the requirements of the task are A. Develop, and B.

Implement the measures. Can you confirm that either the requirements for each task are correct as written, or that the requirements of the two tasks were somehow switched in the

RFP?

The requirements are correct as written.

Task 4 states that the cost is associated with the “moving” of the third party API into the openFDA environment and the “linking” of the third party API into openFDA.

For Task 5, it is the linking of a new API (internally created by FDA) to an outside API. FDA also wants to know the cost associated with development of new APIs, linking with outside APIs, and ongoing maintenance of each API. This differs from linking of the 3rd party API to openFDA as described in Task 4.

4) Tasks 7, 8, and 9 are all very similar and we would like to get additional clarity on their intent. We understand that these tasks present three possible scenarios, each with subtle differences, but want to get more details about how to differentiate them.

Task 7 "Move within the same vendor-provided cloud": does this refer to a scenario such as https://open.fda.gov/about/

Questions for openFDA Support (5)

FDA-SOL-1159692

switching from a single AWS instance to an auto-scaling instance, or a similar switch from one architecture to another?

Move openFDA from one platform to another within the same vendor-provided cloud using open source technology, such as Docker, which has been used in openFDA to maximize portability.

Ensure no disruption to users, test and deploy openFDA on the new platform, and update all the relevant documentation.

Task 8 "A similar platform": does this refer to switching from AWS to a service such as Digital Ocean, or even a specialized service such as Aptible or Catalyze?

Move openFDA from the platform of a vendor-provided cloud to a similar platform in a cloud provided by a different vendor using open source technology, such as Docker which has been used to maximize portability. Ensure no disruption to users, test and deploy openFDA on the new platform, and update all the relevant documentation.

Task 9 "A different platform": does this refer to switching from AWS to self-hosting, on hardware purchased for openFDA

Move openFDA from the platform of a vendor-provided cloud to a different platform in a cloud provided by a different vendor using open source technology, such as Docker which has been used to maximize portability. Ensure no disruption to users, test and deploy openFDA on the new platform, and update all the relevant documentation.

5) Tasks 1-6 occupy their own place in the proposal, tasks 7-9 seem like hypotheticals.

Could you elaborate on which (if any) of these tasks are a priority, and which ones are viewed as alternatives or contingency plans?

All tasks are a priority; however, Tasks 7-9 represent possible alternatives or contingency plans.