Any
modifications to the main study as a result of pretesting should be
submitted as a change request prior to fielding the main
study.
Inventory as of this Action
Requested
Previously Approved
12/31/2021
36 Months From Approved
5,880
0
0
839
0
0
0
0
0
As a part of the ongoing evaluation of
FDA's regulations in this area, FDA is proposing to study the
impact of disclosures as they relate to presentations of
preliminary and/or descriptive scientific and clinical data in
promotional labeling and advertising for oncology products. The use
of disclosures is one method of communicating information to health
care professionals about scientific and clinical data, the
limitations of that data, and practical utility of that information
for use in treatment. These disclosures may influence prescriber
comprehension and decision making, and may affect how and what
treatment they prescribe for their patients. To address these
questions, FDA has designed a study that will be conducted in three
independent phases, each phase examining a data display in a
promotional piece for a unique oncology or hematology product.
Independent variables will include: (1) Specific disclosure
(technical, non-technical, none), (2) general statement (present,
absent), and (3) specialty (PCPs, oncologists). Outcome (dependent)
variables will focus on the assessment of the data display as a
whole as well as attention to the disclosure, if present.
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.