Healthcare Provider Perception of Boxed Warning Information Survey

ICR 202010-0910-009

OMB: 0910-0890

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2020-10-26
Supporting Statement B
2020-07-02
Supporting Statement A
2020-07-02
ICR Details
0910-0890 202010-0910-009
Active 202007-0910-002
HHS/FDA CDER
Healthcare Provider Perception of Boxed Warning Information Survey
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/30/2020
Retrieve Notice of Action (NOA) 10/26/2020
  Inventory as of this Action Requested Previously Approved
08/31/2023 08/31/2023 08/31/2023
4,423 0 4,423
499 0 499
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.

None
None

Not associated with rulemaking

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

  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 4,423 0 0 0 0
Annual Time Burden (Hours) 499 499 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$297,546
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  No

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.
10/26/2020


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