CBER - Information Packages

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⚠️ Notice: This information collection may be referencing outdated material.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 - Information Packages	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: 142	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	193	-10	203
Annual IC Time Burden (Hours)	3,474	-180	3,654
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.