Information Collection

361.(d)(8) -- Adverse Reactions

IC 183839 under ICR 201404-0910-014 · OMB 0910-0053.

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IC Title:

361.(d)(8) -- Adverse Reactions

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 361.1(d)(8)

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: Illness Prevention

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 10

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	50	-290	340
Annual IC Time Burden (Hours)	25	-9	34
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.