Requirement for Applicants & NonApplicants to Establish and Maintain Records & files of New Animal Drug Data That Had Not Been Submitted As Part of the Application

Records and Reports Concerning Experience with Approved New Animal Drugs

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0284 can be found here:

Documents and Forms

Document Name Document Type

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

Information Collection (IC) Details

IC Title:	Requirement for Applicants & NonApplicants to Establish and Maintain Records & files of New Animal Drug Data That Had Not Been Submitted As Part of the Application	Agency IC Tracking Number:

Is this a Common Form?		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

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
Annual Number of Responses for this IC	4,651	4,651
Annual IC Time Burden (Hours)	65,117	65,117
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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No associated records found

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