This information collection supports
the Food and Drug Administration’s (FDA, us or we) Biosimilars User
Fee Program. Respondents to the collection are applicants or
sponsors of biological product applications.
US Code:
42
USC 262(k) Name of Law: Public Health Service Act; Biologics
Price Competition and Innovation Act
US Code: 21
USC 379g Name of Law: 351(k) Applications
The information collection
reflects changes and adjustments resulting from consolidating
related activity from OMB control no. 0910-0719 and from and
increase in the number of estimated respondents to the collection.
The result is an increase of 237 responses and 12,929 hours
annually.
$367,500
No
No
No
No
No
No
No
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.