Medical Conference Attendees’ Observations about Prescription Drug Promotion

Forms and Documents

Document Name	Status
0901 NonSub change request memo 2022.docx Justification for No Material/Nonsubstantive Change	2022-02-14
Supporting Statement Part B - Medical Conference Attendees Study 2021.docx Supporting Statement B	2021-06-25
Supporting Statement Part A - Medical Conference Attendees Study 2021.docx Supporting Statement A	2021-06-25

IC Document Collections

IC ID	Document Title	Status
248053	Main Test Other-Consent Form	Modified
248052	Pretest Other-Consent Form	Modified
248051	Screener Other-Screener	Modified

ICR Details

OMB Control No: 0910-0901	ICR Reference No: 202202-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202106-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Medical Conference Attendees’ Observations about Prescription Drug Promotion
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: 02/15/2022

	Requested	Previously Approved
Expiration Date	08/31/2024	08/31/2024
Responses	1,427	1,326
Time Burden (Hours)	219	204
Cost Burden (Dollars)	0	0

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Abstract: The current study focuses on the landscape of healthcare provider (HCP)-directed promotion of prescription drugs at medical conferences in general and, more specifically, at pharmaceutical promotional booths. We will ask attendees who are prescribers within different disciplines (primary care physicians, specialists, nurse practitioners, and physician assistants) general questions about their attendance at medical conferences, including questions about their motivations for attending, activities they participate in (e.g., symposia, poster sessions, social events, exhibit halls), and their opinions about the prescription drug treatments promoted at medical conferences. We will also embed an experimental manipulation into the survey, whereby participants watch a video that mimics a pharmaceutical representative/HCP interaction, and varies in the professional expertise of the pharmaceutical representative (medical vs. business) and whether or not the discussion includes a disclosure of important limitations. Approximately 350 HCPs will be recruited from 12 medical conferences over the course of one year. The entire online survey, including the experiment, will take approximately 20 minutes.

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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 58366	09/18/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 37160	07/14/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Main Test
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	1,427	1,326	0	101	0	0
Annual Time Burden (Hours)	219	204	0	15	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: This is a new data collection.

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Annual Cost to Federal Government: $499,832

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: 02/15/2022

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