Empirical Study of Promotional Implications of Proprietary Prescription Drug Names

Forms and Documents

Document Name	Status
Supporting Statement Part B - Empirical Study of PI of PPD Names 2021.docx Supporting Statement B	2021-03-22
Supporting Statement Part A - Empirical Study of PI of PPD Names 202l.docx Supporting Statement A	2021-03-22

IC Document Collections

IC ID	Document Title	Status
246366	Healthcare Study Other-Survey Instrument	New
246365	Consumer Study Other-Survey Instrument	New
246364	Healthcare Providers Screener Other-Screener for Healthcare Providers	New
246363	Consumer Screener Other-Screener for Consumers	New

ICR Details

OMB Control No:	ICR Reference No: 202103-0910-011
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Empirical Study of Promotional Implications of Proprietary Prescription Drug Names
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: 03/22/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	3,452	0
Time Burden (Hours)	524	0
Cost Burden (Dollars)	0	0

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Abstract: As part of its premarket review, the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research’s (CDER’s) Office of Prescription Drug Promotion (ODPD) evaluates proposed proprietary drug names for safety and promotional implications. The primary purpose of the main study will be to examine: (1) whether names that reference the drug’s indication affect consumers’ and health care providers’ perceptions and (2) whether names that overstate the efficacy of the drug affect consumers’ and health care providers’ perceptions of prescription drugs. To address these goals, FDA will conduct an experimental study with consumers and health care providers using “target,” “neutral” (control), and “extreme” drug names indicated for either high cholesterol or gastroesophageal reflux disease (GERD). The main study sample will include 448 primary care providers (PCPs) and 448 members of the general population. We will use a within-subjects design for the main study to increase efficiency and keep the sample size small. Participants will view names for two medical indications in random order (one list for high cholesterol and one list for GERD). The main study will include a total of 14 drug names, 7 for each of two medical conditions (one extreme name, one neutral name, and five target names). The survey will not exceed 20 minutes. Survey items will include benefit perception items and attitude and intention items.

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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 3392	01/21/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 14440	03/16/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Consumer Screener
Consumer Study
Healthcare Providers Screener
Healthcare Study

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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	3,452	0	0	3,452	0	0
Annual Time Burden (Hours)	524	0	0	524	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: $469,684

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: 03/22/2021

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