Information Collection

Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

IC 6248 under ICR 201005-0910-007 · OMB 0910-0530.

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Information Collection (IC) Details

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IC Title:	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 314.50

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 450	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,000	4,889	111
Annual IC Time Burden (Hours)	6,250	6,222	28
Annual IC Cost Burden (Dollars)	0	0	0

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