General Licensing Provisions; Section 351(k) Biosimilar Applications

ICR 202101-0910-014

OMB: 0910-0719

Federal Form Document

Forms and Documents
Justification for No Material/Nonsubstantive Change
Supporting Statement A
ICR Details
0910-0719 202101-0910-014
Received in OIRA 201810-0910-003
General Licensing Provisions; Section 351(k) Biosimilar Applications
No material or nonsubstantive change to a currently approved collection   No
Regular 01/27/2021
  Requested Previously Approved
01/31/2022 01/31/2022
179 20
12,883 9,478
0 0

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.

US Code: 42 USC 262(k) Name of Law: Public Health Service Act

Not associated with rulemaking

  83 FR 31153 07/03/2018
83 FR 58583 11/20/2018

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 179 20 0 0 159 0
Annual Time Burden (Hours) 12,883 9,478 0 0 3,405 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
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.

Domini Bean 301 796-5733 [email protected]


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.

© 2023 | Privacy Policy