Healthcare Professional Survey of Professional Prescription Drug Promotion

Forms and Documents

Document Name	Status
Supporting Statement Part B HCP Survey PPDP 2019.docx Supporting Statement B	2019-03-07
Supporting Statement Part A HCP Survey PPDP 2019.docx Supporting Statement A	2019-03-07

IC Document Collections

IC ID	Document Title	Status
235233	Healthcare Professional Survey (Main Study) Other-Survey Instrument	New
235232	Informed Consent (Main Study) Other-Informed Consent	New
235231	Healthcare Professional Screener (Main Study) Other-Screener	New
235230	Healthcare Professional Survey (Pretest) Other-Survey Instrument	New
235229	Informed Consent (Pretest) Other-Informed Consent	New
235228	Healthcare Professionals Screener (Pretest) Other-Screener	New

ICR Details

OMB Control No: 0910-0869	ICR Reference No: 201903-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Healthcare Professional Survey of Professional 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
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/16/2019
	Date Received in OIRA: 03/11/2019
Terms of Clearance: The OMB Control Number for the 2002 study was 0910-0479 and for the 2013 study was 0910-0730. If changes are needed to the main study based on findings from the pretest, those changes will need to be submitted for review and approval prior to fielding the main study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2020	36 Months From Approved
Responses	9,150	0	0
Time Burden (Hours)	1,238	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In 2002 and 2013, FDA surveyed healthcare professionals (HCPs) about their attitudes toward Direct-to-Consumer (DTC) advertising and its role in their relationships with their patients. The 2013 survey included multiple types of HCPs: primary care physicians and specialists, as well as nurse practitioners and physician assistants. Whereas the focus of both previous FDA surveys was on DTC advertising and promotion, the current study is designed to address issues related to professional prescription drug promotion. The goal is to query a representative sample of HCPs about their opinions of promotional materials and procedures targeted at HCPs, clinical trial design and knowledge, and FDA approval status. We will also take this opportunity to ask HCPs briefly about their knowledge of abuse-deterrent formulations for opioid products. We proposed to conduct a nationally representative survey of approximately 1,240 physicians (primary care and specialists), nurse practitioners, and physician assistants, drawn from WebMD’s subscriber network. The survey, assessed via Internet, is expected to take 15-20 minutes. Analyses will include frequencies, Chi-square, and correlational and factor analysis. The proposed survey is designed to provide further insights about how professionally targeted prescription drug promotion might influence health care professionals’ decision-making processes and practices and how information may be communicated more accurately.

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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 11539	03/15/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 8721	03/11/2019
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
Healthcare Professionals Screener (Pretest)
Informed Consent (Pretest)
Healthcare Professional Screener (Main Study)
Informed Consent (Main Study)
Healthcare Professional Survey (Pretest)
Healthcare Professional Survey (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	9,150	0	0	9,150	0	0
Annual Time Burden (Hours)	1,238	0	0	1,238	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: $642,813

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? Uncollected

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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: 03/11/2019

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