Information Collection

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

IC 5662 under ICR 201412-0910-015 · 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⚠️ Notice: This information collection may be referencing outdated material.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 3331 NDA-Field Alert Report 314.50 (a), (b), (c), (d), (e), (f), and (k)	Form and Instruction
Form 2252 Transmittal of Annual Report for Drug and Biologics for Human Use 314.50 (a), (b), (c), (d), (e), (f), and (k)	Form
Form 2253 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use 314.50 (a), (b), (c), (d), (e), (f), and (k)	Form
Form 356 Application to Market a New or Abbreviated New Drug or Biologic for Human Use 314.50 (a), (b), (c), (d), (e), (f), and (k)	Form
3331 NDA-Field Alert Report FORM FDA 3331 - NDA Field Alert Report 9-11-14.pdf	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

IC Title:

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

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.50

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3331	NDA-Field Alert Report	FORM FDA 3331 - NDA Field Alert Report 9-11-14.pdf	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: 106

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	151	151
Annual IC Time Burden (Hours)	290,373	290,373
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.