CBER- Meeting Requests

Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0429 can be found here:

Documents and Forms

Document Name Document Type
FINAL GUIDANCE 0429 10-16-2015.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	CBER- Meeting Requests	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 312.47 21 CFR 312.82

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			FINAL GUIDANCE 0429 10-16-2015.pdf		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 175	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	Previously Approved
Annual Number of Responses for this IC	264	11	253
Annual IC Time Burden (Hours)	2,640	110	2,530
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.