Health Care Professional Survey of Prescription Drug Promotion

Forms and Documents

Document Name	Status
SS Part B .doc Supporting Statement B	2012-10-11
SS Part A Final.doc Supporting Statement A	2013-02-05

IC Document Collections

IC ID	Document Title	Status
205693	Screener Other-Survey	New
204491	Main Study Other-Survey	New
204490	Pretest Other-Survey	New
204489	Informed Consent Other-Survey	New

ICR Details

OMB Control No: 0910-0730	ICR Reference No: 201210-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Health Care Professional Survey of 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 with change	Conclusion Date: 02/08/2013
	Date Received in OIRA: 10/12/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	24 Months From Approved
Responses	7,550	0	0
Time Burden (Hours)	773	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The present study aims to investigate the perspectives of health care professionals with prescribing privileges--including physicians, physician assistants, and nurse practitioners--regarding various aspects of prescription drug promotion. Specifically, the survey will address DTC advertising, professional promotion, use of new technologies including social media, and the Office of Prescription Drug Promotion's (OPDP's) Bad Ad program. This is the first such study to our knowledge that examines the beliefs of health care professionals other than physicians who now have prescribing privileges. The study findings will inform FDA of relevant issues and concerns relating to health care professional exposure to prescription drug promotion.

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Authorizing Statute(s): US Code: 42 USC 300u(a)(4) Name of Law: Public Health Service Act
   US Code: 21 USC 393(d)(2)(c)) Name of Law: Federal Food, Drug, and Cosmetic 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:
	77 FR 2299	01/17/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 61761	10/11/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Informed Consent
Pretest
Main Study
Screener

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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	7,550	0	0	7,550	0	0
Annual Time Burden (Hours)	773	0	0	773	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: $364,588

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 10/12/2012

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