CBER Presubmissions

Requests for Feedback on Medical Device Submissions

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
0756_Presubmissions guidance.docx Other-Presubmissions Guidance

Information Collection (IC) Details

IC Title:	CBER Presubmissions	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-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: 91	Number of Respondents for Small Entity: 7

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	91	12	79
Annual IC Time Burden (Hours)	12,467	1,644	10,823
Annual IC Cost Burden (Dollars)	0	0	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.