Information Collection

CDRH Presubmissions

IC 209236 under ICR 201610-0910-002 · OMB 0910-0756.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0756 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0756_Presubmissions guidance.docx	Other-Presubmissions Guidance

IC Title:

CDRH Presubmissions

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-Presubmissions Guidance			0756_Presubmissions guidance.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2,465

Number of Respondents for Small Entity: 200

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	2,465	2,465
Annual IC Time Burden (Hours)	337,705	337,705
Annual IC Cost Burden (Dollars)	0	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.