Targeted Mechanism of Action Presentations in Prescription Drug Promotion

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Targeted MoA Study Justification Memo May 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-05-18	Available
Targeted MoA Study Justification Memo May 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-05-18	Repair queued
Targeted MOA Study SS Part B 10-14-22 final.docx	Supporting Statement B	Uploaded 2022-11-15	Available
Targeted MOA Study SS Part B 10-14-22 final.docx	Supporting Statement B	Uploaded 2022-11-15	Available
Targeted MOA Studdy SS Part A 10-14-22 final.docx	Supporting Statement A	Uploaded 2022-10-14	Available
Targeted MOA Studdy SS Part A 10-14-22 final.docx	Supporting Statement A	Uploaded 2022-10-14	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
256440	Screener and Main Study	Other-Questionnaire	Modified

ICR Details

OMB Control No: 0910-0908	ICR Reference No: 202305-0910-004
Status: Historical Active	Previous ICR Reference No: 202210-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Targeted Mechanism of Action Presentations in Prescription Drug Promotion
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: 05/24/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/18/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2025	11/30/2025	11/30/2025
Responses	990	0	990
Time Burden (Hours)	891	0	891
Cost Burden (Dollars)	0	0	0

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Abstract: This research represents the final element of our three-prong strategy to understand the impact of targeted MoA claims in promotional materials on the risk and benefit perceptions and behavioral intentions of consumers and HCPs. This will allow us to provide operational advice to OPDP reviewers on how best to comment on promotional presentations that include targeted MoA claims. The objective is operational. We do not have a guidance planned on this topic at this time but once all data has been analyzed from each part of the strategic assessment of targeted MoA claims, those data may inform future guidance.

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Authorizing Statute(s): US Code: 42 USC 300u(a)(4) Name of Law: PHS Act
   US Code: 21 USC 393(d)(2)(c) 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:
	86 FR 59736	10/28/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 58110	09/23/2022
Did the Agency receive public comments on this ICR? Yes

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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 Main Study

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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	990	990	0	0	0	0
Annual Time Burden (Hours)	891	891	0	0	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:

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Annual Cost to Federal Government: $526,321

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: 05/18/2023

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