Information Collection

Annual Report Submission of Revised Labeling for Applications Approved Before 6/30/01 that Contain a Pregnancy Category

IC 185244 under ICR 201412-0910-008 · OMB 0910-0624.

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Information Collection (IC) Details

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IC Title:	Annual Report Submission of Revised Labeling for Applications Approved Before 6/30/01 that Contain a Pregnancy Category	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.70(d) 21 CFR 601.12(f)(3)

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 320	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 New Statute	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	5,440	111	5,329
Annual IC Time Burden (Hours)	217,600	2,220	215,380
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.