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.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0014 can be found here:

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Information Collection (IC) Details

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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:

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 %

	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

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