Study of Oncology Indications in Direct-to-Consumer Television Advertising

Forms and Documents

Document Name	Status
0885 Nonsub change request memo 2021.docx Justification for No Material/Nonsubstantive Change	2021-04-01
0885 Nonsub chg request memo 2020.docx Justification for No Material/Nonsubstantive Change	2020-08-11
0885 Nonsub change request memo 2020.docx Justification for No Material/Nonsubstantive Change	2020-07-22
0855 Nonsub change request memo 2020.docx Justification for No Material/Nonsubstantive Change	2020-07-07
Supporting Statement Part B Oncology Indications Study 2020.docx Supporting Statement B	2020-01-27
Supporting Statement Part A Oncology Indications Study 2020.docx Supporting Statement A	2020-01-27

IC Document Collections

IC ID	Document Title	Status
239534	Study 2 Other-Study Pretests and Main Studies Consent Form	Modified
239533	Study 2 Screener Other-Pretest and Main Studies Recruitment Materials	Modified
239532	Study 1 Other-Study Pretests and Main Studies Consent Form	Modified
239531	Study 1 Screener Other-Pretest and Main Studies Recruitment Materials	Modified
239530	Pretests 1 and 2 Other-Study Pretests and Main Studies Consent Form	Modified
239529	Pretests 1 and 2 Screener Other-Recruitment Materials	Modified
239524	Cognitive Interviews Other-Consent Form	Modified
239523	Cognitive Interview Screener Other-Cognitive Interviews Recruitment and Screener	Unchanged

ICR Details

OMB Control No: 0910-0885	ICR Reference No: 202104-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202007-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Study of Oncology Indications in Direct-to-Consumer Television 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: 04/05/2021

	Requested	Previously Approved
Expiration Date	02/28/2023	02/28/2023
Responses	4,704	3,622
Time Burden (Hours)	657	641
Cost Burden (Dollars)	0	0

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Abstract: This study will examine how oncology prescription drug indications are communicated to consumers in direct-to-consumer (DTC) promotional materials. We plan to conduct two rounds of in-person one-hour cognitive interviews (N = 9 in each), two pretests (N = 60 in each), and two main studies (N = 700 in Study 1; N = 520 in Study 2) not longer than 20 minutes, administered via Internet panel. In the first cognitive interview, pretest, and main study, we will vary the indication (hematology or solid tumor), the clinical endpoint (overall survival, overall response rate, or progression-free survival), and the presence of a disclosure in a television ad for a fictitious oncology prescription drug. In the second cognitive interview, pretest, and main study, we will vary the indication (hematology or solid tumor) and the presentation of material information in audio and superimposed text in a television ad for a fictitious oncology prescription drug. In each study, participants will view the television ad and then answer questions about the drug information.

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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 29213	06/21/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 5213	01/29/2020
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
Cognitive Interview Screener
Cognitive Interviews
Pretests 1 and 2
Pretests 1 and 2 Screener
Study 1
Study 1 Screener
Study 2
Study 2 Screener

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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	4,704	3,622	0	1,082	0	0
Annual Time Burden (Hours)	657	641	0	16	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Based on cognitive interviews and pretesting, we made several revisions to the study materials and updated the burden chart to reflect the actual pretest burden and the revised estimated burden for the main studies.

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Annual Cost to Federal Government: $652,824

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: 04/05/2021

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