Information Collection

Reporting burden: adverse reactions and testing

IC 5725 under ICR 201201-0910-001 · OMB 0910-0116.

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IC Title:

Reporting burden: adverse reactions and testing

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 610.40(g)(2) 21 CFR 606.170(b) 21 CFR 610.40(h)(2)(ii)(A)

Information Collection Instruments:

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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: 78

Number of Respondents for Small Entity: 7

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	Previously Approved
Annual Number of Responses for this IC	78	-540,329	540,407
Annual IC Time Burden (Hours)	1,522	-62,965	64,487
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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