Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces

Forms and Documents

Document Name	Status
0875 Nonsub change request memo 2020.docx Justification for No Material/Nonsubstantive Change	2020-06-01
Support Statement Part B Physician Interpretation Study 2019.doc Supporting Statement B	2019-07-03
Supporting Statement Part A Physician Interpretation Study 2019.docx Supporting Statement A	2019-07-03

IC Document Collections

IC ID	Document Title	Status
242065	Completes Pretest 2 Other-Survey Instrument	New
242064	Pretest 2 Screener Other-Screener	New
236802	Completes, Main Study Other-Survey Instrument	Unchanged
236801	Completes, Pretest 1 Other-Survey Instrument	Modified
236800	Main Study Screener Other-Screener	Modified
236799	Pretest 1 Screener Other-Screener	Modified

ICR Details

OMB Control No: 0910-0875	ICR Reference No: 202006-0910-002
Status: Active	Previous ICR Reference No: 201907-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces
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: 06/02/2020
	Date Received in OIRA: 06/02/2020
Terms of Clearance: Previous terms continue: Any changes made as a result of the pre-test will need to be submitted and approved prior to fielding the main study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2021	09/30/2021	09/30/2021
Responses	3,469	0	1,621
Time Burden (Hours)	398	0	267
Cost Burden (Dollars)	0	0	0

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Abstract: This study will examine how physician perception of professional prescription drug communications is influenced by variations in information context, methodologic rigor of the underlying clinical study, and time pressure. We plan to conduct one pretest (N = 158) and one main study (N = 566) not longer than 20 minutes, administered via Internet panel. Using a description of a trial for a fictitious prescription drug, we will vary the context of the information, the methodologic rigor of the information, and the amount of time available to read the information. Participants will view the information and then answer questions about the drug information.

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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 52490	10/17/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 34897	07/19/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Completes, Pretest 1
Pretest 1 Screener
Pretest 2 Screener
Completes Pretest 2
Main Study Screener
Completes, Main Study

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ICR Summary 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	3,469	1,621	0	1,848	0	0
Annual Time Burden (Hours)	398	267	0	131	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: $179,670

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: 06/02/2020

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