Subpart D - FDA Action on Applications

Applications for FDA Approval to Market a New Drug

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0001 can be found here:

Documents and Forms

Document Name Document Type
0429 GFI PDUFA Meetings.pdf Other-Agency Guidance
CDER CBER Dispute Res at Div Level GFI.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Subpart D - FDA Action on Applications	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.100-314.170

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0429 GFI PDUFA Meetings.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			CDER CBER Dispute Res at Div Level GFI.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: 1,620	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	6,666	6,515	151
Annual IC Time Burden (Hours)	83,778	83,028	750
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.