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