Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug

ICR 202110-0910-006

OMB: 0910-0900

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-10-13
Supporting Statement B
2021-06-25
Supporting Statement A
2021-06-25
ICR Details
0910-0900 202110-0910-006
Received in OIRA 202106-0910-014
HHS/FDA CDER
Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug
No material or nonsubstantive change to a currently approved collection   No
Regular 10/13/2021
  Requested Previously Approved
08/31/2024 08/31/2024
4,605 4,596
821 812
0 0

Pharmaceutical firms sometimes choose to disseminate publications to healthcare providers (HCPs) that include data that appear to support an unapproved use of an approved product. At the same time, published data that are not supportive of that unapproved use may also exist. The purpose of this research is to examine HCPs’ perceptions and behavioral intentions about an unapproved new use of an approved prescription drug when made aware of other data that are not supportive of the unapproved use. This research will also evaluate the effectiveness of various disclosure approaches for communicating the unsupportive information. Our sample will consist of practicing physicians. We plan to conduct one pretest and two main studies not longer than 20 minutes, administered via internet panel. Participants will be randomly assigned to view one version of a brief study report and then complete a questionnaire that assesses recall and perceptions of the disclosure, the drug, attitudes, and behavioral intentions. We will also measure covariates such as demographics. We will use the results of this research to better understand: (1) HCPs’ perceptions of an unapproved use of a prescription drug; (2) HCPs’ perceptions about an unapproved use of an approved prescription drug when they are aware of the existence of unsupportive information about it; (3) HCPs perceptions of disclosures referencing the existence of unsupportive information about that particular use; and (4) to examine the utility and effectiveness of various approaches to the communication of this information.

None
None

Not associated with rulemaking

  85 FR 40300 07/06/2020
86 FR 31318 06/11/2021
Yes

  Total Request 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 4,605 4,596 0 9 0 0
Annual Time Burden (Hours) 821 812 0 9 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
We are increasing the total number of hours by 9 hours, which results in a total estimated annual reporting burden of 821 hours. Our request to increase the burden hours will allow FDA to conduct an additional round of cognitive testing with nine primary care physicians.

$209,916
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Ila Mizrachi 301 796-7726 [email protected]

  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.
10/13/2021


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