Information Collection

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

IC 227824 under ICR 201905-0910-006 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
0844_Supporting Statement_2019.doc	Other-Guidance:De Novo Classificatio

IC Title:

Agency IC Tracking Number:

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: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 %

table that charts list of burden
	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

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.