QuestionResponses.docx
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- Solicitation number
- FDA-RFP-2021-1243291
About this file
This document contains a federal contract opportunity solicitation and related question and answer file. The solicitation seeks clinical support services to aggregate patient data from multiple healthcare facilities to analyze potential adverse health outcomes related to metal-containing implantable medical devices. The Food and Drug Administration will award a firm fixed-price contract to procure services including collecting demographic, clinical, and epidemiological real-world data on patients with metal implants or non-metal counterparts as controls. The data will then be analyzed in relation to corresponding device characteristics to further improve health outcomes. A third-party auditor will be identified and paid for by the FDA to audit any required data. Bidders should provide pricing for the one-year base period and three scenarios for the optional one-year extension involving additional patient data collection and analysis or clinical data verification. The North American Industry Classification System code was changed to 541715 for research and development services.
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Other files
| File | Type | Posted |
|---|---|---|
| FDA-RFP-2021-1243291_Amend1.pdf | ||
| FDA-RFP-2021-1243291.pdf | ||
| FDA 1335.docx | DOCX document |
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1. On page 4, a third-party data audit is mentioned. Will the FDA be responsible for identifying and paying the third-party data auditor?
Yes, the FDA will assume responsibility for any required third-party audit.
2. The scope of Optional Year 2 is very high level. We are assuming that we would not be providing a price for Year 2 at this time and would provide a price when it comes time to define the specific work for Year 2. Is that correct?
A proposed price is required for the optional year 2. However, we recognize the scope is not well defined because much of it will depend on the outcome of the year 1 findings. As such, we recommend providing quotes for three distinct scenarios:
Scenario 1: Additional code-based patient data derived from EHRs only. In this scenario, the contractor would provide a final dataset comprised of >=10K unique patients for additional device categories, e.g. gastrointestinal, neurological, intrauterine, surgical.
Scenario 2: Verification of initial findings with additional clinical data only. For a subset of the patients identified in the year 1 study (n>=1000), aggregate and analyze additional clinical information (e.g., surgeon notes, histopathological reports, radiographic and other imaging results, lab test data) to assess the year 1 data set relevance and reliability and provide additional patient factors not available in the code-based data.
Scenario 3: Combination of scenarios 1 and 2. Additional code-based patient data derived from EHRs, where the final dataset is comprised of >=5K unique patients and additional clinical information and analysis on a smaller subset of patients, n>=500.
3. Based on the information provided, will the government consider switching the NAICS to 541715 as the described work reads to be more suited to research than it is to medical staffing? If not possible, will you consider changing the NAICS to 561320, Temporary help services, since the reading of the SOW makes it clear that more data savvy consultants vs medical staff is required along with the one-year period of performance.
Changed to 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
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