De Novo request under 21 U.S.C. 513(f)(2)(ii)

De Novo Classification Process (Evaluation of Automatic Class III Designation)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0844 can be found here:

Documents and Forms

Document Name Document Type
0844_Supporting Statement_2019.doc Other-Guidance:De Novo Classificatio

Information Collection (IC) Details

IC Title:	De Novo request under 21 U.S.C. 513(f)(2)(ii)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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:De Novo Classification Process (Evaluation of Automatic Class III Designation)			0844_Supporting Statement_2019.doc		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 57	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	57	31	26
Annual IC Time Burden (Hours)	10,260	5,580	4,680
Annual IC Cost Burden (Dollars)	6,914	6,914	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.