Reporting and Recordkeeping

Human Subject Protection; Acceptance of data from clinical studies for medical devices

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0741 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:	Reporting and Recordkeeping	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 812.28(b) 21 CFR 814.20 21 CFR 814.104 21 CFR 812.2(e) 21 CFR 812.28(c) 21 CFR 812.140 21 CFR 807.87 21 CFR 812.27(b)(4)(i) 21 CFR 812.27(b)(4)(ii) 21 CFR 812.28(a)(1 21 CFR 21 CFR 812.28(a)(2)

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,010	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 50 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	2,010	2,010
Annual IC Time Burden (Hours)	18,645	18,645
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.