Information Collection

Third party disclosure: adverse reactions, test requirements, labeling, "lookback" requirements, donor notification

IC 200671 under ICR 201201-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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:	Third party disclosure: adverse reactions, test requirements, labeling, "lookback" requirements, donor notification	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 606.170(a) 21 CFR 610.40(c) and (h) 21 CFR 610.42(a) 21 CFR 610.46(a)-(b) 21 CFR 630.6(a) and (d) 21 CFR 610.47(a)-(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: 4,908	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 20 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	534,142	534,142
Annual IC Time Burden (Hours)	61,329	61,329
Annual IC Cost Burden (Dollars)	0	0

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