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⚠️ Notice: This information collection may be referencing outdated material.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: Modified

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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	100,566	305	100,261
Annual IC Time Burden (Hours)	20,218,932	3,250	20,215,682
Annual IC Cost Burden (Dollars)	0	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.