Information Collection

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

IC 237371 under ICR 201908-0910-009 · OMB 0910-0669.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
bioequivalence guidance.pdf	Other-guidance

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.