Information Collection

Formal Meeting Requests; Meeting Packages

IC 250904 under ICR 202408-0910-008 · OMB 0910-0718.

Documents and Forms

Document Name Document Type
Formal-Meetings-Between-the-FDA-and-Sponsors-or-Applicants-of-BsUFA-Products-Guidance-for-Industry.pdf Other-Agency Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Formal Meeting Requests; Meeting Packages	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
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: 135	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	311	152	159
Annual IC Time Burden (Hours)	6,661	3,256	3,405
Annual IC Cost Burden (Dollars)	0	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.