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

Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Final Rule

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0624 can be found here:

Documents and Forms

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

Information Collection (IC) Details

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

Documents for IC

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