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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0530 can be found here:

Documents and Forms

Document Name Document Type
praeleclabel-0530 ss (2).doc Other-Other

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: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 314.94

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Other			praeleclabel-0530 ss (2).doc		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 272	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1,839	1,839
Annual IC Time Burden (Hours)	460	460
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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