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Federal forms, ICRs, and supporting documents

Information Collection Request

Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women with Chronic Conditions

ICR 200809-0910-002 · OMB 0910-0631 · Historical Active

Forms and Documents
Document
Name
Status
Supplementary Document
2008-11-06
Supplementary Document
2008-09-03
Supporting Statement A
2008-11-05
IC Document Collections
IC ID
Document
Title
Status
186597 New
ICR Details
0910-0631 200809-0910-002
Historical Active
HHS/FDA
Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women with Chronic Conditions
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 11/10/2008
Retrieve Notice of Action (NOA) 09/17/2008
This ICR is approved consistent with revised supporting statement and FDA memo of 10/29/08. FDA agrees that this is a formative research study, and that the qualitative data resulting from this research project will provide a preliminary framework and help FDA decide whether it would be useful to pursue quantitative studies to test the extent of any knowledge gaps. FDA agrees that such further research would be necessary before deciding whether changes to FDA communications, including prescription drug labeling, would are required and how best to change those communications.
  Inventory as of this Action Requested Previously Approved
11/30/2011 36 Months From Approved
60 0 0
60 0 0
0 0 0
The requested data collection and analysis will provide FDA with insight for evaluating and improving current procedures. It is designed to identify knowledge gaps that FDA could then address, which would ultimately improve decision making and hence the health outcomes of the affected patients. In addition to identifying specific opportunities to redress misperceptions or gaps in health care providers' knowledge regarding treating pregnant and nursing women, the data from this study may also help more generally to guide FDA's communications efforts to focus on areas of misinformation in health care providers' mental models regarding treatment decisions for all patients.
US Code: 21 USC 393 Name of Law: FFDCA
  
None
Not associated with rulemaking
  72 FR 70328 12/11/2007
73 FR 50030 08/25/2008
No
  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 60 0 0 0 60 0
Annual Time Burden (Hours) 60 0 0 0 60 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$1,000
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto 3018274659
  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.
09/17/2008