Information Collection

New Drugs For Investigational Use - 21 Cfr 312

IC 109320 under ICR 198611-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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:	NEW DRUGS FOR INVESTIGATIONAL USE - 21 CFR 312	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?
Form	FDA-1571	No	No
Form	1572	No	No
Form	1573	No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4,300	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	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	73,100	73,100
Annual IC Time Burden (Hours)	654,701	654,701
Annual IC Cost Burden (Dollars)	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.