Biowaiver request: Type A medicated article, same formulation/manufacturing process approach

Abbreviated New Animal Drug Applications

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0669 can be found here:

Documents and Forms

Document Name Document Type
bioequivalence guidance.pdf Other-guidance

Information Collection (IC) Details

IC Title:	Biowaiver request: Type A medicated article, same formulation/manufacturing process approach	Agency IC Tracking Number:	CVM

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-guidance			bioequivalence guidance.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2	Number of Respondents for Small Entity: 1

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	2	2
Annual IC Time Burden (Hours)	10	10
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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