Information Collection

Signature Manifestation - 11.50

IC 213243 under ICR 202312-0910-007 · OMB 0910-0303.

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IC Title:

Signature Manifestation - 11.50

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 11.50

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: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 5,000

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 90 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,000	500	4,500
Annual IC Time Burden (Hours)	100,000	10,000	90,000
Annual IC Cost Burden (Dollars)	0	0	0

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