Content of Labeling Submissions in NDAs, ANDAs, Supplemental NDAs and ANDAs, and Annual Reports

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

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Content of Labeling Submissions in NDAs, ANDAs, Supplemental NDAs and ANDAs, and Annual Reports	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 21 CFR 314.94(d)(1)(ii) 21 CFR 314.81(b)(2)(iii)(b)

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: 500	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,750	750	5,000
Annual IC Time Burden (Hours)	7,188	938	6,250
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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