Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents

Forms and Documents

Document Name	Status
Justification Memorandum 0778 for 83-I change request 09-30-2015.doc Justification for No Material/Nonsubstantive Change	2015-09-30
60 DAY ADOLESCENT REVISED 9-18-13ao.doc Supporting Statement B	2014-08-28
SUPPORTING STATEMENT PART A FINAL 7-25-2014.docx Supporting Statement A	2014-08-28
APPENDIX C INVITES AND REMINDERS 7-25-2014.docx Supplementary Document	2014-08-28
APPENDIX B CONSENT FORM 7-25-2014.docx Supplementary Document	2014-08-28

IC Document Collections

IC ID	Document Title	Status
212884	Main study, parents (both acne and ADHD) Other-Questionnaire	Unchanged
212883	Main Study, Young Adults (both acne and ADHD) Other-Questionnaire	Unchanged
212882	Main study, 16-17 year olds (both acne and ADHD) Other-Questionnaire	Unchanged
212881	Main Study, 13-15 year olds (both acne and ADHD) Other-Questionnaire	Unchanged
212880	Pretest 2 (20/medical condition) Other-Questionnaire	Unchanged
212879	Pretest 1 (420/medical condition) Other-Questionnaire	Unchanged
212878	Main Study Screener (ADHD) Other-Questionnaire	Unchanged
212877	Main Study Screener (Acne) Other-Questionnaire	Unchanged
212876	Pretest 2 Screener Other-Questionnaire	Unchanged
212875	Pretest 1 Screener Other-Questionnaire	Unchanged
212872	Cognitive Interviews Other-Questionnaire	Unchanged

ICR Details

OMB Control No: 0910-0778	ICR Reference No: 201509-0910-012
Status: Historical Active	Previous ICR Reference No: 201408-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/06/2015
	Date Received in OIRA: 10/01/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	10/31/2017	10/31/2017
Responses	67,218	0	67,218
Time Burden (Hours)	8,065	0	8,065
Cost Burden (Dollars)	0	0	0

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Abstract: Sponsors for several prescription drug classes market their products directly to adolescents, but research regarding how adolescents use risk and benefit information for health-related decisions is limited. Despite the lack of previous research specific to DTC drug marketing to adolescents, existing theoretical and empirical data make a strong case for treating adolescence as a unique life stage during which vulnerabilities that can affect informed decision-making must be taken into account. We plan to conduct a randomized, controlled study in two different medical conditions that assesses adolescents' perceptions following exposure to DTC prescription drug advertising that varies in benefit and risk onset and risk severity. We plan to compare adolescents' perceptions to those of young adult counterparts. Each participant will view a web-based promotional campaign for either a fictitious Attention Deficit Hyperactivity Disorder (ADHD) medication or a fictitious acne medication. Because adolescents typically depend on their parents for prescription drug purchases, we also will include a sample of parents matched to their adolescent children to explore similarities and differences in perceptions for these matched pairs. The study will enroll three specific age groups (13–15, 16–17, and 25–30). We propose to explore differences in effects of the ad manipulations across these three age groups on a variety of outcomes, including benefit and risk recall, benefit and risk perceptions, and behavioral intentions. The study findings will inform FDA of relevant issues related to DTC promotion directed at adolescent populations.

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Authorizing Statute(s): US Code: 21 USC 393 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service 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:
	78 FR 65326	10/31/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 42333	07/21/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Cognitive Interviews
Pretest 1 Screener
Pretest 2 (20/medical condition)
Main study, parents (both acne and ADHD)
Main Study Screener (ADHD)
Main study, 16-17 year olds (both acne and ADHD)
Main Study, Young Adults (both acne and ADHD)
Pretest 2 Screener
Main Study Screener (Acne)
Pretest 1 (420/medical condition)
Main Study, 13-15 year olds (both acne and ADHD)

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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	67,218	67,218	0	0	0	0
Annual Time Burden (Hours)	8,065	8,065	0	0	0	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: This is a new data collection.

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Annual Cost to Federal Government: $1,082,664

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

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: 10/01/2015

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