Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type a Medicated Articles

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0575 can be found here:

Documents and Forms

Document Name Document Type
Guidance 0910-0575.pdf Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medica IC Document

Information Collection (IC) Details

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IC Title:	Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type a Medicated Articles	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 514.1(b)(7) 21 CFR 514.1(b)(8)

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: 18	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Previously Approved
Annual Number of Responses for this IC	18	18
Annual IC Time Burden (Hours)	265	265
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles	Guidance 0910-0575.pdf	01/12/2009

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