314.50 (a), (b), (c), (d), (e), (f), and (k)

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⚠️ Notice: This information collection may be referencing outdated material.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
Form 3331 314.50 (a), (b), (c), (d), (e), (f), and (k) Form and Instruction
3331 NDA-Field Alert Report FORM FDA 3331 7-16-14.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	314.50 (a), (b), (c), (d), (e), (f), and (k)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.50

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3331	NDA-Field Alert Report	FORM FDA 3331 7-16-14.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 85	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Previously Approved
Annual Number of Responses for this IC	92	92
Annual IC Time Burden (Hours)	241,542	241,542
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.