Review and Modify SOPs

Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - Final Rule

Documents and Forms

Document Name Document Type

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

Information Collection (IC) Details

IC Title:	Review and Modify SOPs	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 606.100(b)

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: 1,654	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Program Change Due to New Statute	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1,654	190	1,464
Annual IC Time Burden (Hours)	26,464	10,640	15,824
Annual IC Cost Burden (Dollars)	0	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.