OTC Hearing Aids Final Rule - One Time Burden

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⚠️ Notice: This information collection may be referencing outdated material.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:	OTC Hearing Aids Final Rule - One Time Burden	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 800; 801; 808; 874 (To search for a specific CFR, visit the Code of Federal Regulations.)

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: 105	Number of Respondents for Small Entity: 100

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	945	945
Annual IC Time Burden (Hours)	87,570	87,570
Annual IC Cost Burden (Dollars)	10,100,000	10,100,000

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.