Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion

Forms and Documents

Document Name	Status
Supporting Statement Part B - Endorser Status 2020.docx Supporting Statement B	2020-10-29
Supporting Statement Part A - Endorser Status 2020.docx Supporting Statement A	2020-10-29

IC Document Collections

IC ID	Document Title	Status
244274	Study 2 - Main Test Other-Survey Instrument	New
244272	Study 2 - Pretest Other-Survey Instrument	New
244271	Study 2 - Screener Other-Screener	New
244270	Study 1 - Main Test Other-Informed Consent	New
244269	Study 1 - Pretest Other-Informed Consent	New
244268	Study 1 - Screener Other-Screener	New

ICR Details

OMB Control No:	ICR Reference No: 202010-0910-011
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/08/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	3,702	0
Time Burden (Hours)	635	0
Cost Burden (Dollars)	0	0

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Abstract: Advertisers have used celebrity endorsers for years, and direct-to-consumer prescription drug promotion is no different. A rich literature on promotional endorsement exists in non-pharmaceutical promotion, but has some limitations. We propose to extend previous research by examining four types of endorsers in two separate studies (celebrity, physician, patient, non-celebrity influencer ) and examining whether the presence of a disclosure of their payment status influences participant reactions. We propose to also test one direct and one less direct disclosure. Participants will view one promotional piece either in print or in social media and answer questions via the Internet. The study is expected to take less than 20 minutes to complete. Dependent variables will include attention to disclosure statement and risk/benefit information; retention of risk/benefit information; recognition of piece as promotion and endorser as paid; perceived benefits and risks, attitudes toward the product, endorser, and ad; and behavioral intentions such as asking a doctor about the drug. Data will be analyzed using established statistical approaches, such as Analysis of Variance. Results will be disseminated through presentations and publications in peer-reviewed journals.

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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 4994	01/28/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 78859	12/07/2020
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
Study 2 - Screener
Study 1 - Screener
Study 1 - Pretest
Study 1 - Main Test
Study 2 - Pretest
Study 2 - Main Test

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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	3,702	0	0	3,702	0	0
Annual Time Burden (Hours)	635	0	0	635	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: $447,205

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: 12/08/2020

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