Biologics; Licensing; General Biological Products Standards; and Additional Standards

Biologics License Applications; Procedures & Requirements

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR Subchapter F: Biologics 21 CFR 601 - Licensing 21 CFR 600; 610-680 (Product Stds.) (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	Form FDA 2252	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE		Yes	Yes	Fillable Fileable
Form and Instruction	Form FDA 2253	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE		Yes	Yes	Fillable Fileable
Form and Instruction	Form FDA 2252	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE		Yes	Yes	Fillable Fileable
Instruction				Yes	Yes	Fillable Fileable
Other-Agency Guidance			https://www.fda.gov/media/70712/download	Yes	Yes	Fillable Fileable
Instruction				Yes	Yes	Fillable Fileable
Form	FDA 3988	Transmittal of PMR/PMC Submissions for Drugs and Biological Products		Yes	Yes	Fillable Fileable
Instruction				Yes	Yes	Fillable Fileable
Form	FDA 3989	PMR/PMC Annual Status Report for Drugs and Biological Products		Yes	Yes	Fillable Fileable
Instruction				Yes	Yes	Fillable Fileable
Form	FDA 3674	Certification of Compliance		Yes	Yes	Fillable Fileable
Form	FDA 356h	Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 371	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Previously Approved
Annual Number of Responses for this IC	67,117	67,117
Annual IC Time Burden (Hours)	813,017	813,017
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.