A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising

Forms and Documents

Document Name	Status
0929_Change Request_Dec 2024.docx Justification for No Material/Nonsubstantive Change	2024-11-29
Informed Consent.docx Supplementary Document	2024-11-29
Quant Claims SSB FINAL MAY 2024.docx Supporting Statement B	2024-05-14
Quant Claims SSA FINAL MAY 2024.docx Supporting Statement A	2024-05-14

IC Document Collections

IC ID	Document Title	Status
263599	Pre-letter, invitation, reminder, survey Other-Survey	Modified

ICR Details

OMB Control No: 0910-0929	ICR Reference No: 202411-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202311-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
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: 12/02/2024

	Requested	Previously Approved
Expiration Date	06/30/2027	06/30/2027
Responses	4,493	2,993
Time Burden (Hours)	1,250	1,094
Cost Burden (Dollars)	0	0

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Abstract: This survey collects insights on consumer understanding of quantitative claims in direct-to-consumer (DTC) prescription drug advertising. It will build on previous qualitative research by recruiting a wider range of respondents and weighting the data to make it nationally representative. We plan to use an address-based mixed-mode methodology that will direct one randomly chosen member of sampled households to complete a 20-minute online survey, with non-respondents receiving a paper questionnaire. We will also conduct a within-survey experiment to test whether a post-paid incentive increases survey response.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2)(C) Name of Law: FFDCA
   US Code: 42 USC 300u(a)(4) Name of Law: PHS Act
  

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:
	88 FR 24997	04/25/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 87431	12/18/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Pre-letter, invitation, reminder, survey

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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	4,493	2,993	0	0	1,500	0
Annual Time Burden (Hours)	1,250	1,094	0	0	156	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: We anticipated 1,100 participants would respond to the survey from our initial recruitment of 2,993 individuals. However, the response rate was lower than expected due to declining survey response rates seen across Federal surveys, resulting in 480 survey responses. The purpose of this change is to increase the number of respondents to get closer to the previously estimated survey response and therefore increase the power to detect differences among subgroups. We request an additional recruitment of 1,500 individuals, with the intent to yield an additional 214 completed surveys and allow us to detect differences of 14.4 percentage points. Based on the initial recruitment, we are assuming a 15 percent response rate and a 5 percent postage non-deliverable rate for the additional sample.

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Annual Cost to Federal Government: $520,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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.     Yes

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: 12/02/2024

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