REGULATIONS REQUIRE PRESCRIPTION DRUG
ADS TO CONTAIN A BRIEF SUMMARY OF THE DRUG'S LIMITATIONS AND HAVE
BEEN INTERPRETED AS REQUIRING AN EXTENSIVE SEPARATE SECTION. THE
COST AND COMMUNICATION EFFECTIVENESS OF THIS BRIEF SUMMARY ARE
CONTROVERSIAL. THE PROPOSED STUDY WILL EXPLORE THE EFFECTS OF
REQUIRING A SIMPLIFIED DISPLAY OF THE PRODUCT'S MAJOR
LIMITATIONS.
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.