Disclosures in Professional and Consumer Prescription Drug Promotion

Forms and Documents

Document Name	Status
Supporting Statement Part B 2018.docx Supporting Statement B	2018-08-08
Supporting Statement Part A Disclosures 2018.docx Supporting Statement A	2018-09-17

IC Document Collections

IC ID	Document Title	Status
232573	Healthcare Professional Main Study Other-Questionnaires	New
232572	Healthcare Professional Main Study Screener Other-Screeners	New
232571	Healthcare Professional Eye-Tracking Study Other-Questionnaires	New
232570	Healthcare Professional Eye-Tracking Screener Other-Screeners	New
232569	Healthcare Professional Pretest Other-Questionnaires	New
232568	Healthcare Professional Pretest Screener Other-Screeners	New
232567	Consumer Main Study Other-Questionnaires	New
232566	Consumer Main Study Screener Other-Screeners	New
232565	Consumer Eye-Tracking Study Other-Questionnaires	New
232564	Consumer Eye-Tracking Screener Other-Screeners	New
232563	Consumer Pretest Other-Questionnaires	New
232562	Consumer Pretest Screeners Other-Screeners	New

ICR Details

OMB Control No: 0910-0860	ICR Reference No: 201808-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Disclosures in Professional and Consumer Prescription Drug Promotion
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/17/2018
	Date Received in OIRA: 08/10/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved
Responses	10,474	0	0
Time Burden (Hours)	1,562	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: When promoting their products, pharmaceutical sponsors (sponsors) may present a variety of information including the indication, details about the administration of the product, efficacy information, and clinical trial data. In an effort to present often complicated information concisely, sponsors may not include relevant information in the body of the text or visual display of the claim. In these cases, sponsors typically include disclosures of information somewhere in the promotional piece. The purpose of our study is to determine how useful disclosures regarding prescription drug information are when presented prominently and adjacent to claims. Specifically, are Healthcare Professionals (HCP's) and consumers able to use disclosures to effectively frame information in efficacy claims in prescription drug promotion? To address this research question, we have designed a set of studies that cover both consumers and HCPs, as well as three presentations addressing different types of information: scope of treatment, ease of use, and statistical significance. Each participant will view three different professionally developed mock promotional print pieces for different prescription drug products that mimic currently available promotion. For each of the three promotional pieces, they will be randomized to see an ad with a weak disclosure, a strong disclosure, or no disclosure. Outcomes of interest include attention, recall, comprehension, and behavioral intention. The results of this study will inform the Office of Prescription Drug Promotion about how consumers and HCPs process information presented in disclosure form.

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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:
	82 FR 27268	06/14/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 39441	08/09/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Consumer Pretest Screeners
Consumer Pretest
Consumer Eye-Tracking Screener
Consumer Eye-Tracking Study
Consumer Main Study Screener
Consumer Main Study
Healthcare Professional Pretest Screener
Healthcare Professional Pretest
Healthcare Professional Eye-Tracking Screener
Healthcare Professional Eye-Tracking Study
Healthcare Professional Main Study Screener
Healthcare Professional Main Study

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ICR Summary of Burden

	Total Approved	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	10,474	0	0	10,474	0	0
Annual Time Burden (Hours)	1,562	0	0	1,562	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: $669,354

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? Uncollected

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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: 08/10/2018

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