Information Collection

Applications, including labeling and requests for samples

IC 5935 under ICR 202606-0910-003 · OMB 0910-0338.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE Applications, including labeling and requests for samples	Form and Instruction
Form Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE Applications, including labeling and requests for samples	Form and Instruction
Form Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE Applications, including labeling and requests for samples	Form
Form FDA 3988 Transmittal of PMR/PMC Submissions for Drugs and Biological Products Applications, including labeling and requests for samples	Form
Form FDA 3989 PMR/PMC Annual Status Report for Drugs and Biological Products Applications, including labeling and requests for samples	Form
Form FDA 3674 Certification of Compliance Applications, including labeling and requests for samples	Form
Form 356h Application for FDA Approval to Market a New Drug Applications, including labeling and requests for samples	Form and Instruction
0338 BLAs GFI for Cooperative MFR Arrangements NOV 2008.pdf www.fda.gov/media/70712/download	Other-Agency Guidance
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
Form FDA 3674 Certification of Compliance Instructions.pdf	Instruction
Cooperative Manufacturing Arrangements for Licensed Biologics; Guidance for Industry.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-manufacturing-arrangements-licensed-biologi	Other-Agency Guidance
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies, Guidance for Industry.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-consensus-standards-recognition-program-regen	Other-Agency Guidance
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 FDA 2252.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 3674 Certification of Compliance FDA-3674 Certification of Compliance.pdf	Form
356h Application for FDA Approval to Market a New Drug FORM FDA 356h.pdf www.fda.gov/about-fda/reports-manuals-forms/forms	Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Applications, including labeling and requests for samples

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR Subchapter F: Biologics 21 CFR 601 - Licensing 21 CFR 600; 610-680 (Product Stds.) 21 CFR 10.115; 601.29 - Guidance (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.	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 2253		Yes	Yes	Fillable Fileable
Form and Instruction	Form FDA 2252		Yes	Yes	Fillable Fileable
Form	Form FDA 2252		Yes	Yes	Fillable Fileable
Other-Agency Guidance		https://www.fda.gov/media/70712/download	Yes	Yes	Fillable Fileable
Form	FDA 3988		Yes	Yes	Fillable Fileable
Instruction			Yes	Yes	Fillable Fileable
Form	FDA 3989		Yes	Yes	Fillable Fileable
Instruction			Yes	Yes	Fillable Fileable
Form	FDA 3674		Yes	Yes	Fillable Fileable
Instruction			Yes	Yes	Fillable Fileable
Other-Agency Guidance		https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-manufacturing-arrangements-licensed-biologics	Yes	Yes	Fillable Fileable
Other-Agency Guidance		https://www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-consensus-standards-recognition-program-regenerative-medicine-therapies	Yes	Yes	Fillable Fileable
Form and Instruction	356h	https://www.fda.gov/about-fda/reports-manuals-forms/forms	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
	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	65,814	-1,303	67,117
Annual IC Time Burden (Hours)	812,607	-410	813,017
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.

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