Information Collection

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

IC 191024 under ICR 201706-0910-021 · OMB 0910-0834.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0834 can be found here:

Documents and Forms

Document Name Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

Information Collection (IC) Details

View Information Collection (IC)

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: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 4.105 21 CFR 4.103

Information Collection 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 %

	Approved	Program Change Due to Agency Discretion
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

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.