Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Supporting Statement Part B - Secondary Claim Disclosures and Biosimilar Disclosures 2021.docx	Supporting Statement B	Uploaded 2021-09-15	Repair queued
Supporting Statement Part A - Secondary Claim Disclosures and Biosimilar Disclosures 2021.docx	Supporting Statement A	Uploaded 2021-09-15	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
249302	Phase 2 Main Study Completes (Consumers)	Other-Informed Consent	New
249301	Phase 2 - Main Study Completes (HCPs)	Other-Informed Consent	New
249300	Phase 2 - Main Study Screeners (Consumers)	Other-Recruitment Email and Screeners	New
249299	Phase 2 - Main Study Screener (HCPs)	Other-Recruitment Email and Screeners	New
249298	Phase 1 - Main Study Completes (Consumers)	Other-Informed Consent	New
249297	Phase 1 - Main Study Completes (HCPs)	Other-Informed Consent	New
249296	Phase 1 - Main Study Screeners (Consumers)	Other-Recruitment Email and Screeners	New
249295	Phase 1 - Main Study Screeners (HCPs)	Other-Recruitment Email and Screeners	New
249294	Phase 2 - Pretest Completes (Consumers)	Other-Informed Consent	New
249293	Phase 2 - Pretest Completes (HCPs)	Other-Informed Consent	New
249292	Phase 2 - Pretest Screeners (Consumers)	Other-Recruitment Email and Screeners	New
249291	Phase 2 Pretest Screeners (HCPs)	Other-Recruitment Email and Screeners	New
249290	Phase 1 - Pretest Completes (Consumers)	Other-Informed Consent	New
249289	Phase 1 - Pretest Completes (HCPs)	Other-Informed Consent	New
249288	Phase 1 - Pretest Screeners (Consumers)	Other-Recruitment Email and Screener 1 and 2	New
249286	Phase 1 - Pretest Screener (HCPs)	Other-Recruitment Email and Screeners 1 and 2	New

ICR Details

OMB Control No: 0910-0902	ICR Reference No: 202109-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials
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: 10/26/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/16/2021
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2024	36 Months From Approved
Responses	7,608	0	0
Time Burden (Hours)	1,242	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this research is to build on prior FDA research on the topic of disclosures by examining the impact of disclosures of two different types of information. Phase 1 of the proposed research will examine the impact of adding a disclosure about a secondary claim in DTC and healthcare provider (HCP)-directed promotion and the effect of the presence of a comparative claim about the secondary claim in the context of a prescription drug website. Phase 2 of the proposed research will assess the impact of a disclosure designating the product as a biosimilar as well as varying basic factual statements about biosimilars in the context of a prescription drug print advertisement. For Phase 1, we plan to conduct one pretest with 252 voluntary adult participants (126 HCPs and 126 general population consumers) and one main study with 900 voluntary adult participants (450 HCPs and 450 general population consumers). For Phase 2, we plan to conduct one pretest with 432 voluntary adult participants (216 HCPs and 216 general population consumers) and one main study with 720 voluntary adult participants (360 HCPs and 360 general population consumers). Both phases will be conducted online and take no more than 20 minutes.

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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:
	85 FR 40659	07/07/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 50888	09/13/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 16

table that charts list of burden

IC Title	Form No.	Form Name
Phase 1 - Main Study Completes (Consumers)
Phase 1 - Main Study Completes (HCPs)
Phase 1 - Main Study Screeners (Consumers)
Phase 1 - Main Study Screeners (HCPs)
Phase 1 - Pretest Completes (Consumers)
Phase 1 - Pretest Completes (HCPs)
Phase 1 - Pretest Screener (HCPs)
Phase 1 - Pretest Screeners (Consumers)
Phase 2 - Pretest Completes (Consumers)
Phase 2 - Main Study Completes (HCPs)
Phase 2 - Main Study Screener (HCPs)
Phase 2 - Main Study Screeners (Consumers)
Phase 2 - Pretest Completes (HCPs)
Phase 2 - Pretest Screeners (Consumers)
Phase 2 Main Study Completes (Consumers)
Phase 2 Pretest Screeners (HCPs)

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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	7,608	0	0	7,608	0	0
Annual Time Burden (Hours)	1,242	0	0	1,242	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: $650,830

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? No

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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: 09/16/2021

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