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

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

Documents and Forms

Document Name Document Type
0844_Guidance_2019.docx Other-Guidance: De Novo Classificati
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: Removed

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 %

	Program Change Due to New Statute	Previously Approved
Annual Number of Responses for this IC	-3	3
Annual IC Time Burden (Hours)	-300	300
Annual IC Cost Burden (Dollars)	-364	364

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.