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

Investigational New Drug Regulations

⚠️ Notice: This information collection may be referencing outdated material.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
GFI Pharmacogenomic Data Submissions.pdf Other-Agency Guidance Document
GFI Pharmacogenomic Data Submissions.pdf Other-Agency Guidance Document
0470 GFI Special Protocol Assessment April 2018.pdf Other-Agency Guidance
0470 GFI Special Protocol Assessment April 2018.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	CDER: 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 312.20-312.38

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance Document			GFI Pharmacogenomic Data Submissions.pdf		Yes	Yes	Paper Only
Other-Agency Guidance			0470 GFI Special Protocol Assessment April 2018.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 31,025	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	100,566	100,566
Annual IC Time Burden (Hours)	20,218,932	20,218,932
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.