Information Collection

Supplements and other changes to an approved application

IC 214789 under ICR 201610-0910-001 · OMB 0910-0786.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type

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IC Title:

Supplements and other changes to an approved application

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.70(i)

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

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 4

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 75 %

table that charts list of burden
	Approved	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses for this IC	0	0	0	0	0	0
Annual IC Time Burden (Hours)	0	0	0	0	0	0
Annual IC Cost Burden (Dollars)	0	0	0	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.