OMB control number
General Licensing Provisions; Section 351(k) Biosimilar Applications
OMB 0910-0719 · HHS/FDA.
OMB 0910-0719
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.
The latest form for General Licensing Provisions; Section 351(k) Biosimilar Applications expires 2022-01-31 and is listed under ICR 201810-0910-003.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0719 Change Request to include BsUFA performance goals JAN 2021.docx | Justification for No Material/Nonsubstantive Change |
 0719 351k Applications SSA 2018 Ext.pdf | Supporting Statement A |
 BsUFA Performance Goals and Procedures for FYs 2018 THROUGH 2022 |
Other-Performance Goals |
| Patent Infringement Notifications - 351(l)(6)(C) |
Information collection |
| Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4) |
Information collection |
| Biosimilar Product Applications - 351(k)(2)(A)(i) and (k)(2)(A)(iii) |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202101-0910-014 | No material or nonsubstantive change to a currently approved collection | 2021-01-27 | Approved without change | |
| 201810-0910-003 | Extension without change of a currently approved collection | 2018-12-06 | Approved without change | |
| 201507-0910-001 | Extension without change of a currently approved collection | 2015-07-08 | Approved without change | |
| 201206-0910-004 | New collection (Request for a new OMB Control Number) | 2012-06-08 | Approved without change |
OMB Details
Biosimilar Product Applications - 351(k)(2)(A)(i) and (k)(2)(A)(iii)
Federal Enterprise Architecture: Health - Consumer Health and Safety