OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Healthcare Professional Survey of Professional Prescription Drug Promotion

ICR 201903-0910-004 · OMB 0910-0869 · Historical Active

Forms and Documents
Document
Name
Status
Supporting Statement B
2019-03-07
Supporting Statement A
2019-03-07
IC Document Collections
IC ID
Document
Title
Status
235233 New
235232 New
235231 New
235230 New
235229 New
235228 New
ICR Details
0910-0869 201903-0910-004
Historical Active
HHS/FDA CDER
Healthcare Professional Survey of Professional Prescription Drug Promotion
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 04/16/2019
Retrieve Notice of Action (NOA) 03/11/2019
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
04/30/2020 36 Months From Approved
9,150 0 0
1,238 0 0
0 0 0
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.
None
None
Not associated with rulemaking
  83 FR 11539 03/15/2018
84 FR 8721 03/11/2019
Yes
  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
Yes
Miscellaneous Actions
No
This is a new data collection.
$642,813
Yes Part B of Supporting Statement
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
03/11/2019