Information Collection

Biologics; Licensing; General Biological Products Standards; and Additional Standards

IC 5935 under ICR 202407-0910-010 · OMB 0910-0338.

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Information Collection (IC) Details

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IC Title:

Biologics; Licensing; General Biological Products Standards; and Additional Standards

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR Subchapter F: Biologics 21 CFR 601 - Licensing 21 CFR 600; 610-680 (Product Stds.) (To search for a specific CFR, visit the Code of Federal Regulations.)

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

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 371

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	67,117	67,117
Annual IC Time Burden (Hours)	813,017	813,017
Annual IC Cost Burden (Dollars)	0	0

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

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