Information Collection

Submission of a copy of that portion of each annual report containing authorized generic drug information

IC 190230 under ICR 201309-0910-002 · OMB 0910-0646.

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IC Title:

Submission of a copy of that portion of each annual report containing authorized generic drug information

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.81(b)(2)(ii)(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: 70

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 66 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	490	90	400
Annual IC Time Burden (Hours)	25	5	20
Annual IC Cost Burden (Dollars)	0	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.