Information Collection

General Licensing Provisions: Changes to an Approved Application; Labeling; and Revocation and Suspension

IC 37629 under ICR 200208-0910-007 · OMB 0910-0315.

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IC Title:

General Licensing Provisions: Changes to an Approved Application; Labeling; and Revocation and Suspension

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

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
Form	FDA-2567				Yes	Yes

Line of Business:

Subfunction:

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 190

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 10 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	3,768	3,768
Annual IC Time Burden (Hours)	112,360	112,360
Annual IC Cost Burden (Dollars)	655,000	655,000

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.