First Year (one time)

Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0700 can be found here:

Documents and Forms

Document Name Document Type
Submission Report.pdf Other-Submission Report

Information Collection (IC) Details

IC Title:	First Year (one time)	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-Submission Report			Submission Report.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Immunization Management

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 533	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 Agency Discretion
Annual Number of Responses for this IC	533	533
Annual IC Time Burden (Hours)	22,386	22,386
Annual IC Cost Burden (Dollars)	15,990	15,990

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.