Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads

Forms and Documents

Document Name	Status
Justification Memorandum for 83-C change request 0910_0861.doc Justification for No Material/Nonsubstantive Change	2019-07-24
Supporting Statement PART B Risk Info and Amount Location 2018.docx Supporting Statement B	2018-08-10
Supporting Statement PART A RAAL 2018.docx Supporting Statement A	2018-09-17

IC Document Collections

IC ID	Document Title	Status
232120	Completes, Study 2 Other-Survey	Unchanged
232119	Completes, Study 1 Other-Survey	Unchanged
232118	Completes, Pilot Other-Survey	Unchanged
232117	Study 2 Screener Other-Screener	Modified
232115	Study 1 Screener Other-Screener	Modified
232113	Pilot Screener Other-Screener	Unchanged

ICR Details

OMB Control No: 0910-0861	ICR Reference No: 201907-0910-021
Status: Historical Active	Previous ICR Reference No: 201807-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads
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 with change	Conclusion Date: 07/24/2019
	Date Received in OIRA: 07/24/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	09/30/2020	09/30/2020
Responses	1,760	0	1,760
Time Burden (Hours)	486	0	480
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request collects information from an adult sample of individuals who self-identify as having rheumatoid arthritis or overactive bladder regarding their perceptions of the important safety information and brief summary in direct-to-consumer prescription drug print advertising. Additionally, we will collect eye-tracking data to observe participants’ gaze maps while reading the information. Using an in-person interview methodology, we plan to conduct two 60-minute pilots with a total of 40 adults and two 60-minute studies with a total of 400 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:
	82 FR 27842	06/19/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 40295	08/14/2018
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
Study 1 Screener
Study 2 Screener
Pilot Screener
Completes, Pilot
Completes, Study 1
Completes, Study 2

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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	1,760	1,760	0	0	0	0
Annual Time Burden (Hours)	486	480	0	6	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: $798,027

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.     Yes

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

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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: 07/24/2019

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