Disease Awareness and Prescription Drug Promotion on Television

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Supporting Statement Part B Disease Awareness and PDP on TV 2019.docx	Supporting Statement B	Uploaded 2019-06-27	Available
Supporting Statement Part A Disease Awareness and PDP on TV 2019.docx	Supporting Statement A	Uploaded 2019-06-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
236701	Study 2	Other-Survey Instrument	New
236700	Study 1	Other-Survey Instrument	New
236699	Study 2 - Pretest	Other-Survey Instrument	New
236698	Study 1 - Pretest	Other-Survey Instrument	New
236696	Study 2 - Screener	Other-Screeners	New
236694	Study 1 - Screener	Other-Screener	New
236693	Study 2 - Pretest Screener	Other-Screeners	New
236692	Study 1 - Pretest Screener	Other-Screeners	New

ICR Details

OMB Control No: 0910-0874	ICR Reference No: 201906-0910-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Disease Awareness and Prescription Drug Promotion on Television
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: 08/06/2019
	Date Received in OIRA: 06/28/2019
Terms of Clearance: Any changes made as a result of the pretest will need to be submitted for review prior to initiation of the full study.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved
Responses	10,166	0	0
Time Burden (Hours)	4,425	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This research concerns disease awareness and prescription drug promotion communications on television. When pharmaceutical companies market a new drug, they often also release disease awareness communications about the medical condition the new drug is intended to treat. FDA is interested in whether and to what extent this practice may result in consumers confusing or otherwise misinterpreting the different information and claims presented in disease awareness communications and prescription drug promotion. We propose two studies designed to provide insights on this topic.

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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:
	83 FR 52472	10/17/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 30724	06/27/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

table that charts list of burden

IC Title	Form No.	Form Name
Study 1 - Pretest Screener
Study 2 - Pretest Screener
Study 1 - Screener
Study 2 - Screener
Study 1 - Pretest
Study 2 - Pretest
Study 1
Study 2

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ICR Summary of Burden

table that charts list 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	10,166	0	0	10,166	0	0
Annual Time Burden (Hours)	4,425	0	0	4,425	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: $568,507

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

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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: 06/28/2019

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