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

General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0338 can be found here:

Documents and Forms

Document Name Document Type
Form Form FDA 2253 Biologics; Licensing; General Biological Products Standards; and Additional Standards Form and Instruction
0338 BLAs GFI for Cooperative MFR Arrangements NOV 2008.pdf www.fda.gov/media/70712/download Other-Agency Guidance
0338 BLAs GFI for Cooperative MFR Arrangements NOV 2008.pdf www.fda.gov/media/70712/download Other-Agency Guidance
FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf Instruction
FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf Instruction
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING F FDA Form 2253.pdf Form and Instruction
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING F FDA Form 2253.pdf Form and Instruction
Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO FORM FDA 2252 SUPPLEMENT.pdf Form and Instruction
Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO FORM FDA 2252 SUPPLEMENT.pdf Form and Instruction
Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO FDA 2252.pdf Form
Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO FDA 2252.pdf Form
FDA 356h Application to Market a New Drug or Abbreviated New Drug Form FDA 356h with comments noting changes Aug 2022.pdf Form
FDA 356h Application to Market a New Drug or Abbreviated New Drug Form FDA 356h with comments noting changes Aug 2022.pdf Form

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: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601 21 CFR 610 21 CFR 640, 680 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 2253	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE	FDA Form 2253.pdf		Yes	Yes	Fillable Fileable
Form and Instruction	Form FDA 2252	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE	FORM FDA 2252 SUPPLEMENT.pdf		Yes	Yes	Fillable Fileable
Form	Form FDA 2252	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE	FDA 2252.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			0338 BLAs GFI for Cooperative MFR Arrangements NOV 2008.pdf	https://www.fda.gov/media/70712/download	Yes	Yes	Fillable Fileable
Form	FDA 356h	Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use	Form FDA 356h with comments noting changes Aug 2022.pdf		Yes	Yes	Fillable Fileable
Instruction			FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.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: 424	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	27,684	27,684
Annual IC Time Burden (Hours)	439,900	439,900
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.