Information Collection

Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable

IC 6305 under ICR 201907-0910-010 · OMB 0910-0582.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0582_Guidance_2019.pdf	Other-Guidance: Guidance on Informed

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 812.2

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable			0582_Guidance_2019.pdf		Yes	No	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 700

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	700	700
Annual IC Time Burden (Hours)	2,800	2,800
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.