Form FDA 3792, the Biosimilars User
Fee Cover Sheet, requests the minimum necessary information to
determine the amount of the fee required, and to account for and
track user fees. The form provides a cross-reference of the fees
submitted for a submission with the actual submission by using a
unique number tracking system. The information collected is used by
FDA's Center for Drug Evaluation and Research (CDER) and Center for
Biologics Evaluation and Research (CBER) to initiate the
administrative screening of biosimilar biological product INDs,
applications, and supplements, and to account for and track user
fees associated with BPD meetings, biosimilar biological product
INDs, applications, and supplements.
US Code:
21
USC 735 Name of Law: Federal Food, Drug, and Cosmetic Act
(FD&C Act)
US Code: 21
USC 379h Name of Law: (FD&C Act)
US Code: 42
USC 262 Name of Law: 351(k) Public Health Service Act
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.