BsUFA Performance Goals and Procedures for FYs 2018 THROUGH 2022

General Licensing Provisions; Section 351(k) Biosimilar Applications

OMB: 0910-0719

IC ID: 245442

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BsUFA Performance Goals and Procedures for FYs 2018 THROUGH 2022
No New
Required to Obtain or Retain Benefits
21 CFR 601

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Performance Goals 0719 BsUFA II Performance Goals FY 2018 thru 2022.pdf No   Printable Only
Other-Agency Guidance Formal-Meetings-Between-the-FDA-and-Sponsors-or-Applicants-of-BsUFA-Products-Guidance-for-Industry.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety


69 0
Private Sector Businesses or other for-profits
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 159 0 0 159 0 0
Annual IC Time Burden (Hours) 3,405 0 0 3,405 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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