Terms of Clearance

Terms of clearance.docx

Focus Groups as Used by the Food and Drug Administration

Terms of Clearance

OMB: 0910-0497

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(0910-0497) GenIC: Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients (OC) (201911-0910-015)

Terms of clearance:


  • The agency is expected to consult with relevant local, state, territorial, and/or Tribal health and safety authorities and determine how and when to proceed consistent with available Federal, state, and local jurisdictions' COVID-19-related policy and guidance.


  • Should changes to the protocol, administration, methods, or other approved documents be necessary due to the evolving nature of the COVID-19 Public Health Emergency in the location where the data are being collected, the agency must alert its OIRA desk officer before proceeding with such a change.


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