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⚠️ Notice: This information collection may be referencing outdated material.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:

Documents and Forms

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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:

table that charts list of 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 %

table that charts list of burden
	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

Documents for IC

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