General Licensing Provisions;
Section 351(k) Biosimilar Applications
material or nonsubstantive change to a currently approved
The information collection establishes
an abbreviated licensure pathway for biological products shown to
be biosimilar to, or interchangeable with, an FDA-licensed
biological reference product, and sets forth the requirements for
an application for a proposed biosimilar product and an application
or a supplement for a proposed interchangeable product. The
information submitted in a 351(k) application or supplement is used
by FDA to make a determination of biosimilarity or
interchangeability of a proposed 351(k) product.
We are requesting a
non-substantive change to the information collection to incorporate
the the document entitled “BsUFA Reauthorization Performance Goals
and Procedures Fiscal Years 2018 Through 2022” (BsUFA II letter).
We have adjusted the overall burden by 159 annual responses and
3,405 annual hours to account for the change.