Information Collection

Withdrawal of de novo request

IC 227791 under ICR 202111-0910-009 · OMB 0910-0844.

⚠️ Notice: This information collection may be referencing outdated material.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
0844_Guidance_2019.docx Other-Guidance: De Novo Classificati

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Withdrawal of de novo request	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 860.250

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: 5	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to New Statute	Previously Approved
Annual Number of Responses for this IC	5	0	5
Annual IC Time Burden (Hours)	1	-49	50
Annual IC Cost Burden (Dollars)	5	0	5

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.