Information Collection

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

IC 5934 under ICR 200206-0910-007 · OMB 0910-0338.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0338 can be found here:

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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; 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-356H				Yes	Yes
Form	FDA-2567				Yes	Yes

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 350	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	5,715	0	-15,537	21,252
Annual IC Time Burden (Hours)	301,752	0	-301,104	602,856
Annual IC Cost Burden (Dollars)	349,000	349,000	0	0

Documents for IC

Title	Document	Date Uploaded

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