The approval is based on the understanding that this formative Mental Models study is the first part of a larger study and that results of this exploratory, qualitative study will not be used to inform policy decisions without further investigation. Specifically, the results from this qualitative study will be used to inform the development of later quantitative studies, with the ultimate goal of better understanding consumer and physician conceptualizations of drug product efficacy. Should FDA publish or otherwise disclose the results of this study, FDA will disclose all study limitations.
The approved incentive amount per physician or specialist participant is $100, with the option to come back to OMB and request a higher amount if response rates are not adequate given the nature and use of information from this study even after attempting to increase participation through non-monetary means. Should FDA request higher incentive amounts, FDA should provide adequate justification as part of that request in the Supporting Statement.
Inventory as of this Action
Requested
Previously Approved
09/30/2012
36 Months From Approved
44
0
0
33
0
0
0
0
0
The Federal Food, Drug, and Cosmetic Act (the Act) requires that manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product's uses and risks. By its nature, the presentation of this risk information is likely to evoke active trade-offs by consumers, i.e., comparisons with the perceived risks of not taking a treatment, and comparisons with the perceived benefits of taking a treatment. The FDA has an interest in fostering safe and proper use of prescription drugs, which is an activity that necessitates understanding of both risks and benefits. Thus, an in-depth understanding of physicians' processing of this information, their thinking on relevant topics, and their informational needs are central to this regulatory task.
Under the Act, FDA engages in a variety of communication activities to ensure that patients and health care providers have the information they need to make informed decisions about treatment options, including the use of prescription drugs. FDA regulations (21 CFR ? 201.57) describe the content of required product labeling, and FDA reviewers ensure that labeling contains accurate and complete information about the known risks and benefits of each drug.
This is a new collection of information where under the Act, FDA engages in a variety of communication activities to ensure that patients and health care providers have the information they need to make informed decisions about treatment options, including the use of prescription drugs.
$125,000
No
No
Uncollected
Uncollected
No
Uncollected
Eliazabeth Berbakos 3018271482
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.
mental models justification 9 2009.doc
Supporting Statement - 9-24- 2009.pdf
Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effecti