Hearing, Aging, and Direct-to-Consumer Television Advertisements

Forms and Documents

Document Name	Status
Q&A Hearing Aids 6-21-16.docx Supplementary Document	2016-06-21
SUPPORTING STATEMENT PART B FINAL HEARING, AGING 1-11-2016.docx Supporting Statement B	2016-01-11
SUPPORTING STATEMENT PART A FINAL HEARING, AGING 1-11-2016.docx Supporting Statement A	2016-01-11

IC Document Collections

IC ID	Document Title	Status
219546	Main Study Other-Appendix A - Screener and Informed Consent	New
219545	Main Study Screener Other-Appendix A - Screener and Informed Consent	New
219544	Pretest Other-Appendix A - Screener and Informed Consent	New
219543	Pretest Screener Other-Appendix A - Screener and Informed Consent	New
219542	Cognitive Interviews Other-Appendix C - Telephone Screener/Informed Consent/Testing G	New
219541	Cognitive Interview Screener Other-Appendix C - Telephone Screener	New

ICR Details

OMB Control No: 0910-0818	ICR Reference No: 201601-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Hearing, Aging, and Direct-to-Consumer Television Advertisements
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 without change	Conclusion Date: 06/21/2016
	Date Received in OIRA: 01/13/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	5,193	0	0
Time Burden (Hours)	1,560	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Because older adults use a disproportionate number of prescription drugs and watch more television than other age groups, their understanding of DTC television advertising is important to investigate. Age-related changes in hearing are nearly universal and may influence the understanding of speech and therefore the understanding of DTC television ads. A large part of hearing and understanding speech involves both the physical structure of the ears as well as sufficient cognitive processes, meaning that cognitive factors specific to hearing and understanding speech are important to examine. This study will explore how hearing and cognitive declines in older adults affect comprehension of DTC television ads in general and of the major statement of risks in particular. In this study, approximately 1,000 individuals will visit a facility in-person to complete a hearing test, watch a direct-to-consumer television ad, and answer questions about what they saw. Outcomes of interest include risk and benefit recall, risk perceptions, and attitudes and behavioral intentions. The results of this study will inform the Office of Prescription Drug Promotion about the communication of DTC information to older adults.

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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:
	80 FR 36545	06/25/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 79909	12/23/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Cognitive Interviews
Pretest Screener
Cognitive Interview Screener
Pretest
Main Study Screener
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	5,193	0	0	5,193	0	0
Annual Time Burden (Hours)	1,560	0	0	1,560	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: $994,588

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 01/13/2016

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