This guidance is intended to assist
applicants in developing labeling for outcome claims for drugs that
are indicated to treat hypertension. The appropriate use of these
drugs can be encouraged by making the connection between lower
blood pressure and improved cardiovascular outcomes more explicit
in labeling.
The information collection
reflects fewer respondents. This is explained more fully at Q15 of
the agency's supporting statement.
$370
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733
domini.bean@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.