Perceptions of Prescription Drug Products with Medication Tracking Capabilities

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
SSB Med Tracking FINAL.docx	Supporting Statement B	Uploaded 2023-04-18	Repair queued
SSA Med Tracking FINAL.docx	Supporting Statement A	Uploaded 2023-04-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
259758	Screener, Pretest and Main Study: Consumers and Primary Care Physicians	Other-Questionnaire	New

ICR Details

OMB Control No: 0910-0916	ICR Reference No: 202304-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Perceptions of Prescription Drug Products with Medication Tracking Capabilities
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: 06/23/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/09/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2026	36 Months From Approved
Responses	1,360	0	0
Time Burden (Hours)	373	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The focus of this study is to explore patient and health care provider perceptions of a fictitious prescription drug product that is accompanied by software that is intended to track medication use. Research questions include perceptions about the product’s risks and/or benefits (including its effect on medication adherence) when the promotion claims this tracking ability; and whether a disclosure that describes what is known about the effect of medication tracking on medication adherence has an influence on perceptions of the product’s risks and/or benefits (including its effect on medication adherence). Primary care physicians and consumers will be recruited to view one of a number of websites for a fictitious diabetes drug and asked to answer questions about it. We will use statistical methods such as analysis of variance to analyze the data.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2)(C) Name of Law: FFDCA
   US Code: 44 USC 300(u)(4) Name of Law: PHS Act
  

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:
	87 FR 58103	09/23/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 27518	05/02/2023
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, Pretest and Main Study: Consumers and Primary Care Physicians

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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	1,360	0	0	1,360	0	0
Annual Time Burden (Hours)	373	0	0	373	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: $469,684

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: 05/09/2023

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