Information Collection

Biowaiver request: Type A medicated article, using same API/solubility approach

IC 237372 under ICR 202202-0910-008 · OMB 0910-0669.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
GFI171.pdf	Other-Guidance
Electronic submissions - supporting documentation 9-23-22.pdf	Instruction

IC Title:

Agency IC Tracking Number:

CVM

Is this a Common Form? No

IC Status: Modified

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			GFI171.pdf		Yes	No	Printable Only
Instruction			Electronic submissions - supporting documentation 9-23-22.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 5

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
	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5	-5	10
Annual IC Time Burden (Hours)	100	-100	200
Annual IC Cost Burden (Dollars)	0	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.