Information Collection

Investigational New Drug (IND) Regulations

IC 5668 under ICR 200211-0910-004 · OMB 0910-0014.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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Information Collection (IC) Details

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IC Title:	Investigational New Drug (IND) Regulations	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: 86,410	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	Previously Approved
Annual Number of Responses for this IC	541,986	169,366	372,620
Annual IC Time Burden (Hours)	36,040,829	18,800,264	17,240,565
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded

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