BsUFA Performance Goals and Procedures for FYs 2018 THROUGH 2022

General Licensing Provisions; Section 351(k) Biosimilar Applications

Documents and Forms

Document Name Document Type
0719 BsUFA II Performance Goals FY 2018 thru 2022.pdf Other-Performance Goals
0719 BsUFA II Performance Goals FY 2018 thru 2022.pdf Other-Performance Goals
Formal-Meetings-Between-the-FDA-and-Sponsors-or-Applicants-of-BsUFA-Products-Guidance-for-Industry.pdf Other-Agency Guidance
Formal-Meetings-Between-the-FDA-and-Sponsors-or-Applicants-of-BsUFA-Products-Guidance-for-Industry.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	BsUFA Performance Goals and Procedures for FYs 2018 THROUGH 2022	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 601

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 69	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	159	159
Annual IC Time Burden (Hours)	3,405	3,405
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.