Information Collection

Subpart B - Applications

IC 5662 under ICR 202002-0910-006 · OMB 0910-0001.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3331a Subpart B - Applications	Form and Instruction
2252 Transmittal of Annual Report for Drug and Biologics for FORM FDA 2252 9-11-14.pdf	Form
2253 Transmittal of Advertisements and Promotional Labeling f FORM FDA 2253 9-11-14.pdf	Form
356 Application to Market a New or Abbreviated New Drug or B FORM 356h - 9-11-14.pdf	Form
FDA 3331a NDA - Field Alert Report Form FDA 3331a DRAFT FEB 2020.pdf www.fda.gov/drugs/surveillance/field-alert-reports	Form and Instruction
FORM FDA 3331 1-19-2016.pdf FDA Form 3331	IC Document

IC Title:

Subpart B - Applications

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.50-314.90

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3331a	NDA - Field Alert Report	Form FDA 3331a DRAFT FEB 2020.pdf	https://www.fda.gov/drugs/surveillance/field-alert-reports	Yes	Yes	Fillable Fileable
Form	2252	Transmittal of Annual Report for Drug and Biologics for Human Use	FORM FDA 2252 9-11-14.pdf		Yes	Yes	Fillable Fileable
Form	2253	Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use	FORM FDA 2253 9-11-14.pdf		Yes	Yes	Fillable Fileable
Form	356	Application to Market a New or Abbreviated New Drug or Biologic for Human Use	FORM 356h - 9-11-14.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 378

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	71,706	71,706
Annual IC Time Burden (Hours)	2,644,204	2,644,204
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
FDA Form 3331	FORM FDA 3331 1-19-2016.pdf	01/19/2016

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.