Information Collection

New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective Date

IC 185245 under ICR 201802-0910-006 · OMB 0910-0624.

Documents and Forms

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Document Name	Document Type

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IC Title:

New NDAs/ANDAs/BLAs/Efficacy Supplements Submitted on or After Effective Date, Including Amendments to Applications Pending on Effective Date

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.50 21 CFR 314.60 21 CFR 314.70(b) 21 CFR 601.2 21 CFR 601.12(f)(1)

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: 390

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	3,900	3,900
Annual IC Time Burden (Hours)	156,000	156,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.