Information Collection

CGMP for Blood and Blood Components: 3rd Party Disclosures

IC 215607 under ICR 201804-0910-014 · OMB 0910-0116.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0116 can be found here:

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Information Collection (IC) Details

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IC Title:	CGMP for Blood and Blood Components: 3rd Party Disclosures	Agency IC Tracking Number:	CBER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 606 21 CFR 630 21 CFR 640 21 CFR 610

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: 7,264	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	510,030	505,530	4,500
Annual IC Time Burden (Hours)	57,701	50,951	6,750
Annual IC Cost Burden (Dollars)	0	0	0

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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.