Information Collection

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

IC 5935 under ICR 202302-0910-011 · OMB 0910-0338.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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
FDA-3988_Instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx	Instruction
FDA-3988_Instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx	Instruction
FDA-3989_instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx	Instruction
FDA-3989_instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx	Instruction
Form FDA 3674 Certification of Compliance Instructions.pdf	Instruction
Form FDA 3674 Certification of Compliance Instructions.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
FDA 3988 Transmittal of PMR/PMC Submissions for Drugs and Biologi FDA-3988_Dyn_Sec_Ext_09-02-22.pdf	Form
FDA 3988 Transmittal of PMR/PMC Submissions for Drugs and Biologi FDA-3988_Dyn_Sec_Ext_09-02-22.pdf	Form
FDA 3989 PMR/PMC Annual Status Report for Drugs and Biological Pr Draft_FDA-3989_Dyn_Sec_Ext_09-02-22 (002).pdf	Form
FDA 3989 PMR/PMC Annual Status Report for Drugs and Biological Pr Draft_FDA-3989_Dyn_Sec_Ext_09-02-22 (002).pdf	Form
FDA 3674 Certification of Compliance FDA-3674 Certification of Compliance.pdf	Form
FDA 3674 Certification of Compliance FDA-3674 Certification of Compliance.pdf	Form

Information Collection (IC) Details

View Information Collection (IC)

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 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:

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	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
Form	FDA 3988	Transmittal of PMR/PMC Submissions for Drugs and Biological Products	FDA-3988_Dyn_Sec_Ext_09-02-22.pdf		Yes	Yes	Fillable Fileable
Instruction			FDA-3988_Instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx		Yes	Yes	Fillable Fileable
Form	FDA 3989	PMR/PMC Annual Status Report for Drugs and Biological Products	Draft_FDA-3989_Dyn_Sec_Ext_09-02-22 (002).pdf		Yes	Yes	Fillable Fileable
Instruction			FDA-3989_instructions_revd ORP.OND.CBER_08.26.2022_clean copy.docx		Yes	Yes	Fillable Fileable
Form	FDA 3674	Certification of Compliance	FDA-3674 Certification of Compliance.pdf		Yes	Yes	Fillable Fileable
Instruction			Form FDA 3674 Certification of Compliance Instructions.pdf		Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

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 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	67,117	39,433	27,684
Annual IC Time Burden (Hours)	813,017	373,117	439,900
Annual IC Cost Burden (Dollars)	0	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.