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

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⚠️ Notice: This information collection may be referencing outdated material.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_Guidance_2019.docx Other-Guidance: De Novo Classificati

Information Collection (IC) Details

IC Title:	De Novo request under 21 U.S.C. 513(f)(2)(i)	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_Guidance_2019.docx		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 3	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	3	-23	26
Annual IC Time Burden (Hours)	300	-2,300	2,600
Annual IC Cost Burden (Dollars)	364	364	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.