Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion

Forms and Documents

Document Name	Status
Supporting Statement Part A Terms and Phrases 2020.docx Supporting Statement A	2020-09-21
Supporting Statement Part B Terms and Phrases 2020.docx Supporting Statement B	2020-09-21

IC Document Collections

IC ID	Document Title	Status
243691	Phase 2: Number of Completes Other-Survey - HCP	New
243690	Phase 2: Screener Completes (assumes 90% eligible) Other-HCP Survey	New
243689	Phase 1: Number of Completes Other-HCP Consent	New
243688	Phase 1: Screener Completes (assumes 30% eligible) Other-Screener - HCP	New
243686	Phase 2: Number of Completes Other-Consumer Survey	New
243685	Phase 2: Screener Completes (assumes 90% eligible) Other-Consumer Survey	New
243683	Phase 1: Number of Completes Other-Consumer Guide	New
243682	Phase 1: Screener Completes (assumes 35% eligible) Other-Phase 1: Screener Completes	New

ICR Details

OMB Control No:	ICR Reference No: 202009-0910-009
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Assessment of Terms and Phrases Commonly Used in 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	Date Submitted to OIRA: 09/22/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	4,956	0
Time Burden (Hours)	1,052	0
Cost Burden (Dollars)	0	0

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Abstract: The proposed research involves assessment of how consumers and primary care physicians (PCPs) interpret terms and phrases commonly used in prescription drug promotion. This includes both what these terms and phrases mean to each population (e.g., definitions) and what these terms and phrases imply (e.g., about efficacy and safety). Understanding the most prevalent interpretations of these terms and phrases can help OPDP determine the impact of specific language in prescription drug promotion. For example, certain terms and phrases might overstate the efficacy or minimize the risk of a product. Additionally, from a health literacy perspective, it is helpful to ascertain general understanding of such terms and phrases as this may aid in the development of best practices around communicating these concepts. We plan to conduct this research in two phases. First, we will conduct formative semi-structured interviews with 30 members of each population (general population consumers and PCPs). Second, we will conduct nationally representative, probability-based surveys of more than 1,000 members of each population.

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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:
	84 FR 59833	11/06/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 58362	09/18/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Phase 1: Screener Completes (assumes 35% eligible)
Phase 1: Number of Completes
Phase 2: Screener Completes (assumes 90% eligible)
Phase 2: Number of Completes
Phase 1: Screener Completes (assumes 30% eligible)
Phase 1: Number of Completes
Phase 2: Number of Completes
Phase 2: Screener Completes (assumes 90% eligible)

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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	4,956	0	0	4,956	0	0
Annual Time Burden (Hours)	1,052	0	0	1,052	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: $658,901

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: 09/22/2020

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