Adherence Potential and Patient Preference in Prescription Drug Promotion

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Adherence SSB FINAL.docx	Supporting Statement B	Uploaded 2024-12-09	Missing upstream
Adherence SSA FINAL.docx	Supporting Statement A	Uploaded 2024-12-09	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
272787	Screener and study PCPs and Consumers	Other-Recruitment materials	New

ICR Details

OMB Control No:	ICR Reference No: 202412-0910-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Adherence Potential and Patient Preference in Prescription Drug Promotion
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/10/2024

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	12,584	0
Time Burden (Hours)	1,293	0
Cost Burden (Dollars)	0	0

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Abstract: This research is designed to experimentally examine the role of adherence and patient preference claims in prescription drug promotion. We will ask whether the presence or absence of an implied adherence claim and/or an adherence-related patient preference claim affect consumers’ and primary care physicians’ (PCPs’) behavioral intentions or risk, benefit, and adherence perceptions. To complete this research, we propose the following design for a total of eight study conditions (experimental groups): 2 (patient preference claim) x 2 (adherence claim) x 2 (disclosure). Each participant will see one of eight versions of a static web page for a fictitious prescription type 2 diabetes treatment. They will answer a survey designed to take no more than 15 minutes to complete regarding their perceptions of the drug’s risks, benefits, and effect on adherence. Consumers and PCPs will receive slightly different versions of the web page and survey, and their data will be analyzed separately. Results will help inform considerations around adherence and adherence-related patient preference claims in prescription drug promotion.

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Authorizing Statute(s): US Code: 42 USC 300u Name of Law: PHS Act
   US Code: 21 USC 393(d) Name of Law: FFDCA
  

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:
	88 FR 70669	10/12/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 84889	10/24/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Screener and study PCPs and Consumers

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ICR Summary of Burden

table that charts list of burden

	Total Request	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	12,584	0	0	12,584	0	0
Annual Time Burden (Hours)	1,293	0	0	1,293	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.

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Annual Cost to Federal Government: $808,664

Does this IC contain surveys, censuses, or employ statistical methods? No

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? 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: 12/10/2024

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