Healthcare Provider Perception of Boxed Warning Information Survey

ICR 202007-0910-002

OMB: 0910-0890

Federal Form Document

Forms and Documents
ICR Details
0910-0890 202007-0910-002
Historical Active
Healthcare Provider Perception of Boxed Warning Information Survey
New collection (Request for a new OMB Control Number)   No
Approved with change 08/10/2020
Retrieve Notice of Action (NOA) 07/08/2020
Approved consistent with the understanding that any changes made as a result of the pretest will need to be submitted for approval prior to fielding the main study.
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved
4,423 0 0
499 0 0
0 0 0

This ICR is a web-based survey to investigate healthcare providers’ (HCPs’) awareness, perceptions, and beliefs about the benefits and risks of an FDA-approved product that includes a boxed warning as part of its approved prescribing information. This study will strengthen FDA’s understanding of how HCPs may receive, process, and use boxed warning information and identify HCPs’ potential information needs with respect to the topics addressed by a product’s boxed warning. This research will evaluate two treatment scenarios involving an FDA-approved medication or class of medications that include boxed warning information.


Not associated with rulemaking

  84 FR 38996 08/08/2019
85 FR 40292 07/06/2020

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 4,423 0 0 4,423 0 0
Annual Time Burden (Hours) 499 0 0 499 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
This is a new collection of information.

Yes Part B of Supporting Statement
Ila Mizrachi 301 796-7726 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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