Sponsor and Payor Feedback for the Early Payor Feedback Program (CDRH)

OMB No: 0910-0360

Expiration Date: 10/31/2023

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0360. The time required to complete this information collection is estimated to average 8 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

Sponsor and Payor Feedback for the Early Payor Feedback Program

Sponsor Questions for feedback on the Early Payor Feedback Program:

• How did you find out about the Early Payor Feedback program?

• Why did you choose to use this program?

• Did you find value in your payor interaction? If so, what was the value of the feedback received? Did you find any of the payors’ feedback more helpful than others?

• How did your participation in the payor program impact your clinical trial development or FDA submission?

• Do you have any general feedback to improve the program?

• Would you be open to publicly comment/share your experiences with the opportunity?

Payor Questions for feedback on the Early Payor Feedback Program:

• In general, what would you say is working well about the Early Payor Feedback Program?

• Is there anything you would want to change or improve?

• We hope to do more outreach and promotion of our Early Payor Feedback Program.  Would you be willing to go on record supporting the effort?

• As this is truly a ”team” effort, we’d like to be sure you know we are a resource for you all as well.  Are there any questions about CDRH/programs you have?  Connections we can help you with?