Information Packages: CDER

Guidance for Industry on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants

Documents and Forms

Document Name Document Type
FINAL GUIDANCE FORMAL MEETINGS 6-16-15.doc Other-Guidance

Information Collection (IC) Details

IC Title:	Information Packages: CDER	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			FINAL GUIDANCE FORMAL MEETINGS 6-16-15.doc		Yes	No	Paper Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 15	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 90 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	30	30
Annual IC Time Burden (Hours)	900	900
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.