Information Collection

Requirement for Applicant & Non Applicant to Establish and Maintain Records & Files of New Animal Drug Data That Had Not Been Submitted As Part of The NADA Application

IC 192752 under ICR 201004-0910-008 · OMB 0910-0284.

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Information Collection (IC) Details

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IC Title:	Requirement for Applicant & Non Applicant to Establish and Maintain Records & Files of New Animal Drug Data That Had Not Been Submitted As Part of The NADA Application	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514.80 (e )

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: 646	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	4,651	-38,867	43,518
Annual IC Time Burden (Hours)	65,117	-18,438	83,555
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.