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

ICR 202106-0910-014

OMB: 0910-0900

Federal Form Document

ICR Details
202106-0910-014
Received in OIRA
HHS/FDA CDER
Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug
New collection (Request for a new OMB Control Number)   No
Regular 06/28/2021
  Requested Previously Approved
36 Months From Approved
4,596 0
812 0
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 4,596 0 0 4,596 0 0
Annual Time Burden (Hours) 812 0 0 812 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$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.
06/28/2021


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