Information Collection

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

IC 6248 under ICR 201309-0910-009 · OMB 0910-0530.

Documents and Forms

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Document Name	Document Type

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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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.