CDRH 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⚠️ Notice: This information collection may be referencing outdated material.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
Presubmissions Final Guidance 11-7-13.doc Other-guidance document

Information Collection (IC) Details

IC Title:	CDRH Presubmissions	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

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 document			Presubmissions Final Guidance 11-7-13.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Immunization Management

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 %

	Approved	Program Change Due to Agency Discretion
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

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.