Information Collection

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

IC 5887 under ICR 200006-0910-002 · OMB 0910-0315.

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Information Collection (IC) Details

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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:

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 %

	Approved	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3,768	0	1,405	2,363
Annual IC Time Burden (Hours)	112,360	0	12,160	100,200
Annual IC Cost Burden (Dollars)	655,000	655,000	0	0

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