Nonsub change request memo

“Healthcare Provider Perception of Boxed Warning Information Survey”

(OMB Control No: 0910-0890)

Change Request 83-C

October 26, 2020

FDA is submitting this nonmaterial/non-substantive change request based on pretest results to revise the Survey Questionnaire for Chronic Hepatitis C. Primarily, we are adding one open-ended clarifying question, bolded in the list below. It will assess whether prescribers test for HBV co-infection before prescribing drugs that treat chronic hepatitis. This will allow us to directly test awareness of this information in the boxed warning, and thereby better understand provider perceptions. The addition of this question will not add to the overall burden of this survey. In the course of survey programming and pretesting, we also corrected typographical errors and made minor wording changes to both surveys.

Below are the proposed changes to each survey questionnaire:

• HCV Questionnaire:

  • Question 5: Minor edits to question phrasing

  • Question 9 ACTIONS: New open-ended question

  • Question 10: Minor edits to an answer option

  • Question 14: Minor edits to preceding scenario sentence and to an answer option

  • Question 16: Changed to single select instead of multi-punch, minor edit to question phrasing, and removed a redundant answer option

  • Question 20: Added a programming note

  • Question 22: Removed an answer option

  • Question P2: Changed to single punch instead of open-ended, minor edits to question phrasing, added answer options

• VVA Questionnaire:

  • Question 2: Minor edit to an answer option

  • Question 3: Minor edit to question phrasing

  • Question 5: Minor edit to question phrasing

  • Question 14: Minor edits to preceding scenario sentence and to an answer option

  • Question 16: Changed to single select instead of multi-punch, minor edit to question phrasing, and removed a redundant answer option

  • Question 20: Added a programming note

  • Question 22: Removed an answer option

  • Question P2: Changed to single punch instead of open-ended, minor edits to question phrasing, added answer options