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⚠️ Notice: This information collection may be referencing outdated material.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
0429 GFI PDUFA Meetings.pdf Other-Agency Guidance
CDER CBER Dispute Res at Div Level GFI.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: Unchanged

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	Previously Approved
Annual Number of Responses for this IC	6,666	6,666
Annual IC Time Burden (Hours)	83,778	83,778
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.