Information Collection

Investigational New Drug (IND) Regulations Formerly Known As Investigational New Drug (IND) Application

IC 5666 under ICR 199610-0910-007 · OMB 0910-0014.

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Documents and Forms

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IC Title:

Investigational New Drug (IND) Regulations Formerly Known As Investigational New Drug (IND) Application

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Migrated

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

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
Form	FDA-1572				No	No
Form	FDA-1571				No	No

Line of Business:

Subfunction:

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 4,000

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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	103,226	103,226
Annual IC Time Burden (Hours)	6,238,858	6,238,858
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded

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