Amendment_4_Questions.pdf

FDA, Economic Study of FDA Regulations Solicitation# 13-223-SOL-00047

1. Reference: General

Question: Can FDA describe how many data collection efforts they would anticipate requiring to follow the paperwork reduction act approval process per year? Is this process required for all FDA collection efforts?

FDA Response: FDA does not expect the frequency of data collection efforts that require following the paperwork reduction act approval process to exceed once every other year. This process is not required for all FDA data collection efforts.

2. Reference: General Question: Can FDA describe whether there is a standard approach or process used in the publication and OMB approval process?

FDA Response: OMB, and specifically the Office of Information and Regulatory Affairs (OIRA) determines and makes available the rules governing the publication and approval process and the length of review time.

3. Reference: General Question: What has been the experience in terms of time required to secure appropriate approvals for data collection efforts?

FDA Response: OIRA determines the rules governing the data collection efforts; the time required differs across approvals. FDA does not have an estimated time to approval for data collection that differs from what is implicit in the OIRA requirements.

4. Reference: Statement of work- section 2.4A (page 5 of 35) item 6 Description: Develop adaptable methods and databases.

Question: Can FDA describe the name, description, and types of internal databases and tools that already exist within the agency that the contractor would have access to? Is there an expectation the databases and methods would leverage preexisting resources or be entirely new databases?

FDA Response: FDA has a large number of databases and tools that the contractor may have access to, based on a determination by the Contract Officer. The contractor should expect to develop entirely new databases, although the contractor may be able to leverage preexisting resources on an as needed basis as determined by the Contract Officer.

5. Reference: Section 2.3 B Description: Baseline measurement Question: Can FDA describe what external commercial databases it has access to? Would contractor be provided access to such databases?

FDA Response: FDA has access to commercial databases concerning products regulated by FDA and may provide access to the contractor as necessary to fulfill the requirements of the task order.

FDA, Economic Study of FDA Regulations Solicitation# 13-223-SOL-00047

6. Reference: Section 5 – Deliveries or Performances Question: Would FDA add the following sentence to the section 5: “The Contractor may retain a complete copy of its working papers and deliverables.” We request this additional sentence to permit us to comply with applicable professional standards. We recognize that the FDA will own the original working papers and deliverables.

FDA response: Each task order awarded for this solicitation will include language allowing the contractor to retain a complete copy of its working papers and deliverables.

7. Reference: Section 5.1 – Anticipated Deliverables – Draft Final Work Product and Final Work Product Question: Will FDA further clarify the statement “The contractor shall also submit, where applicable, PC-compatible raw data collected, software and computer programs for implementation of models, guidance to data and models, and in some instances a final report.”

Specifically, is FDA requiring the contractor to provide “software and computer programs” such that FDA may utilize the tool to conduct its own analyses or data manipulation? If this is the case, how does FDA intend to handle software licensing in the event the contractor utilizes specialized data analytical tools and technology that FDA does not have licenses for or access to?

FDA response: FDA intended to inform offerors that FDA uses standard PC software (MS- Office software programs). FDA also has a SAS contract license. FDA does not intend to receive as part of a task order deliverable any software, specialized data analytical tools or technology to which it does not have the proper license or access. Any additional cost for the licensing or other access fee would need to be included in the task order proposal.