Health Care Professional Survey of Prescription Drug Promotion

ICR 201210-0910-001

OMB: 0910-0730

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2012-10-11
Supporting Statement A
2013-02-05
IC Document Collections
IC ID
Document
Title
Status
205693 New
204491 New
204490 New
204489 New
ICR Details
0910-0730 201210-0910-001
Historical Active
HHS/FDA
Health Care Professional Survey of Prescription Drug Promotion
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 02/08/2013
Retrieve Notice of Action (NOA) 10/12/2012
  Inventory as of this Action Requested Previously Approved
02/29/2016 24 Months From Approved
7,550 0 0
773 0 0
0 0 0

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.

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
  
None

Not associated with rulemaking

  77 FR 2299 01/17/2012
77 FR 61761 10/11/2012
Yes

4
IC Title Form No. Form Name
Informed Consent
Pretest
Main Study
Screener

  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
Yes
Miscellaneous Actions
No
This is a new information collection.

$364,588
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/12/2012


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