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Biologics; Licensing; General Biological Products Standards; and Additional Standards
Biologics License Applications; Procedures & Requirements
OMB: 0910-0338
IC ID: 5935
OMB.report
HHS/FDA
OMB 0910-0338
ICR 202407-0910-010
IC 5935
( )
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
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:
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
Instrument File
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
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 %
Requested
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
67,117
0
0
0
0
67,117
Annual IC Time Burden (Hours)
813,017
0
0
0
0
813,017
Annual IC Cost Burden (Dollars)
0
0
0
0
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.