Quantitative Information in Direct-to-Consumer Television Advertisements Survey

Forms and Documents

Document Name	Status
Quant TV Questionnaire - Study 2 plaque psoriasis.doc Supplementary Document	2018-04-09
0821 Non Sub Change Request 2018.docx Justification for No Material/Nonsubstantive Change	2018-04-09
OMB FINAL SUPPORTING STATEMENT PART B 3-31-2016.doc Supporting Statement B	2016-03-31
OMB SUPPORTING STATEMENT PART A FINAL 3-31-2016.doc Supporting Statement A	2016-03-31

IC Document Collections

IC ID	Document Title	Status
231421	Number to Complete the Survey (85%) Reconduct Survey 2 Other-Survey	New
231420	Number to Complete the Screener (10%) Reconduct Survey 2 Other-Screener	New
220730	Number to Complete the Survey (85%) - Study 2 Other-Survey	Modified
220729	Number to Complete the Screener (10%) - Study 2 Other-Screener	Modified
220727	Number to Complete the Survey (85%) - Study 1 Other-Survey	Unchanged
220726	Number to Complete the Screener (10%) - Study 1 Other-Screener	Unchanged

ICR Details

OMB Control No: 0910-0821	ICR Reference No: 201804-0910-011
Status: Historical Active	Previous ICR Reference No: 201709-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Quantitative Information in Direct-to-Consumer Television Advertisements Survey
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: 05/15/2018
	Date Received in OIRA: 05/04/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	08/31/2019	08/31/2019
Responses	7,239	0	4,826
Time Burden (Hours)	1,119	0	746
Cost Burden (Dollars)	0	0	0

---

Abstract: This project is designed to test consumers’ understanding of quantitative information about prescription drugs in direct-to-consumer (DTC) television ads. We plan to conduct two 20-minute surveys with adults 60 years or older. In Study 1, 900 participants will be randomly assigned to one of nine test conditions. The conditions will vary by the type of quantitative efficacy information (none, simple, or complex) and the type of quantitative risk information (none, general, or specific) in a DTC television ad for a fictitious prescription drug to treat cataracts. In Study 2, 900 participants will be randomly assigned to one of six test conditions. The conditions will vary by the type of quantitative efficacy information (none, simple) and the type of efficacy images in the ad (none, accurate improvement, overstated improvement) in the same DTC ad as in Study 1. Participants will watch the DTC television ad and then will complete a questionnaire that will include measures of recall, perceptions, attitudes, and intentions.

---

Authorizing Statute(s): US Code: 21 USC 393(b)(2)(c) Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 61433	10/13/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 14855	03/18/2016
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Number to Complete the Screener (10%) Reconduct Survey 2
Number to Complete the Survey (85%) Reconduct Survey 2
Number to Complete the Screener (10%) - Study 1
Number to Complete the Survey (85%) - Study 1
Number to Complete the Screener (10%) - Study 2
Number to Complete the Survey (85%) - Study 2

---

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	7,239	4,826	0	0	2,413	0
Annual Time Burden (Hours)	1,119	746	0	0	373	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: Reconduct Study 2 with a slightly revised questionnaire.

---

Annual Cost to Federal Government: $321,746

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? Uncollected

---

Common Form ICR:  No

---

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: 05/04/2018

---