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⚠️ Notice: This information collection may be referencing outdated material.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

View Information Collection (IC)

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: 36	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	36	18	18
Annual IC Time Burden (Hours)	530	265	265
Annual IC Cost Burden (Dollars)	0	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.