General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567

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Information Collection (IC) Details

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IC Title:	General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567	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-356H				Yes	Yes
Form	FDA-2567				Yes	Yes

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 306	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 20 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	14,613	8,898	5,715
Annual IC Time Burden (Hours)	335,088	33,336	301,752
Annual IC Cost Burden (Dollars)	0	-349,000	349,000

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Title	Document	Date Uploaded

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