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

Forms and Documents

Document Name	Status
0900 NonSub Change Request Memo 2021.docx Justification for No Material/Nonsubstantive Change	2021-10-13
Supporting Statement Part B - Study of Disclosures to HealthCare Providers 2021.docx Supporting Statement B	2021-06-25
Supporting Statement Part A - Study of Disclosures to HealthCare Providers 2021.docx Supporting Statement A	2021-06-25

IC Document Collections

IC ID	Document Title	Status
249719	Cognitive Testing Other-Moderator Guide	New
248047	Main Study Completes, Medical Condition 2 Other-Survey Instrument	Unchanged
248045	Main Study Completes, Medical Condition 1 Other-Survey Instrument	Unchanged
248044	Main Study Screener Other-Informed Consent	Unchanged
248043	Pretest Completes Other-Survey Instrument	Unchanged
248042	Pretest Screener Other-Informed Consent	Unchanged

ICR Details

OMB Control No: 0910-0900	ICR Reference No: 202110-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202106-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/13/2021

	Requested	Previously Approved
Expiration Date	08/31/2024	08/31/2024
Responses	4,605	4,596
Time Burden (Hours)	821	812
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 40300	07/06/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 31318	06/11/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Cognitive Testing
Main Study Completes, Medical Condition 1
Main Study Completes, Medical Condition 2
Main Study Screener
Pretest Completes
Pretest Screener

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $209,916

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 10/13/2021

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