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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
New registrations, including new labeler codes requests
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 CFR Part 207 (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
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
FDA-2656.doc
No
No
Paper Only
Form
FDA Form 2658
Registered Establishment
FDA-2658.pdf
No
No
Paper Only
Instruction
2658instruc..htm
No
No
Paper Only
Instruction
form2656.htm
No
No
Paper Only
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
FDA-2657.pdf
No
No
Paper Only
Other-guidance document
Reg and list final guid 12-5-08 to OMB.doc
No
No
Paper Only
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:
39
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
0 %
Approved
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
574
0
0
0
0
574
Annual IC Time Burden (Hours)
2,583
0
0
0
0
2,583
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.