Medical Device Labeling Regulations; Third-Party Disclosure

Medical Device Labeling Regulations

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0485 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Medical Device Labeling Regulations; Third-Party Disclosure	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 801.1 21 CFR 801.5 21 CFR 800.10 21 CFR 800.12 21 CFR 801.61 21 CFR 801.62 21 CFR 801.109 21 CFR 801.110 21 CFR 801.150 21 CFR 801.405 21 CFR 801.420 21 CFR 801.421 21 CFR 801.430 21 CFR 801.435 21 CFR 809.10 21 CFR 809.30 21 CFR 1040.20

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: 5,000	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	22,043,773	22,043,773
Annual IC Time Burden (Hours)	9,025,056	9,025,056
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.