Information Collection

Recordkeeping by device-led, drugs and biologics-led combination products; and shared records

IC 191024 under ICR 202008-0910-012 · OMB 0910-0834.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type

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IC Title:

Recordkeeping by device-led, drugs and biologics-led combination products; and shared records

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 4.105 21 CFR 4.103

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 498

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 10 %

table that charts list of burden
	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	-4,059	4,059
Annual IC Time Burden (Hours)	-680	680
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.