Sections 551 through 557 of the
Federal Food, Drug and Cosmetic Act permit drug, biologic, and
device manufacturers to disseminate certain written information
concerning the safety, effectiveness, or benefits of a use that is
not described in the product's approved labeling provided that the
manufacturer has: (1) Submitted a supplemental application for the
new use; (2) completed the studies needed for a supplemental
application for the new use and certified that such studies are
completed and that a supplemental application will be submitted
within 6 months of the initial dissemination; (3) provided a
proposed...
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.