Information Collection

IDE Recordkeeping

IC 205260 under ICR 202505-0910-011 · OMB 0910-0078.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
GFI Consent IVD human specimens April 2006.pdf	Other-Agency Guidance
GFI Consent IVD human specimens April 2006.pdf	Other-Agency Guidance

IC Title:

IDE Recordkeeping

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 812

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-Agency Guidance					Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Immunization Management

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 1,500

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	6,059	-6	6,065
Annual IC Time Burden (Hours)	11,994	-12	12,006
Annual IC Cost Burden (Dollars)	0	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.

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