Information Collection

CBER - Information Packages

IC 189764 under ICR 201510-0910-004 · OMB 0910-0429.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
FINAL GUIDANCE 0429 10-16-2015.pdf	Other-Guidance

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.