Reporting: FDAAA Section 520(m)(6)(A)(iii)- Immediate Notification to The Agency by HDE Holders if ADN Number is Exceed During the calendar Year.

Guidance: Humanitarian Device Exemption Regulation: Questions and Answers

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0661 can be found here:

Documents and Forms

Document Name Document Type
Guidance - HDE-Questions and Answers.doc Other-Buidance: HDE Holders- Questio

Information Collection (IC) Details

IC Title:	Reporting: FDAAA Section 520(m)(6)(A)(iii)- Immediate Notification to The Agency by HDE Holders if ADN Number is Exceed During the calendar Year.	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Buidance: HDE Holders- Questions and Answers			Guidance - HDE-Questions and Answers.doc		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	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	Previously Approved
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	100	100
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.