THE NEW DRUG APPLICATION IS SUBMITTED
BY FIRMS TO REQUEST APPROVAL OF A DRUG FOR DISTRIBUTION IN
INTERSTATE COMMERCE. THE INFORMATION SUBMITTED IS EVALUATED TO
DETERMINE THE SAFETY AND EFFICACY OF THE DRUG, THE ADEQUACY OF
DIRECTIONS FOR USE AND WARNINGS AGAINST MISUSES APPEARING IN THE
PROPOSED LABELING, THE COMPLETENESS OF CLINICAL EXPERIENCE AND THE
ADEQUACY OF CONTROLS USED IN THE MANUFACTURE OF DRUG
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.