National Direct-to-Consumer Advertising Survey

Forms and Documents

Document Name	Status
CDER DTC Advertising Survey SS Part B.pdf Supporting Statement B	2016-10-21
CDER DTC Advertising Survey SS Part A.pdf Supporting Statement A	2016-10-21

IC Document Collections

IC ID	Document Title	Status
224064	Main Survey Other-Survey	New
224063	Pilot Survey Other-Survey Landing page	New

ICR Details

OMB Control No: 0910-0828	ICR Reference No: 201610-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: National Direct-to-Consumer Advertising Survey
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: 01/23/2017
	Date Received in OIRA: 10/21/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved
Responses	5,142	0	0
Time Burden (Hours)	1,927	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this survey is to collect updated insights on consumer experiences with and attitudes towards direct-to-consumer (DTC) promotion of prescription drugs. This study will build on previous research by recruiting a wider range of respondents, weighting the data to make it nationally representative, and asking a wider range of questions about DTC promotion, including in online formats. We will conduct a pilot survey with 35 respondents and the main survey with 1,765 respondents. 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 short statement mentioning the previously paid incentive increases survey response, thereby testing whether social exchange can be extended past the initial contact attempt.

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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:
	81 FR 10257	02/29/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 51450	08/04/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Pilot Survey
Main Survey

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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	5,142	0	0	5,142	0	0
Annual Time Burden (Hours)	1,927	0	0	1,927	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 information collection in support of an agency survey.

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Annual Cost to Federal Government: $281,207

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: 10/21/2016

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