Information Collection

CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports

IC 189313 under ICR 202308-0910-009 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Document Name Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.23(a)(1) Cover sheet 21 CFR 312.20-312.38

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,075	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Previously Approved
Annual Number of Responses for this IC	22,510	22,510
Annual IC Time Burden (Hours)	5,440,784	5,440,784
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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