New registrations, including new labeler codes requests

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0045 can be found here:

Documents and Forms

Document Name Document Type
Form FDA Form 2656 New registrations, including new labeler codes requests Form
2658instruc..htm Instruction
form2656.htm Instruction
Reg and list final guid 12-5-08 to OMB.doc Other-guidance document
FDA Form 2656 Registration of Drug Establishment (New registration, in FDA-2656.doc Form
FDA Form 2658 Registered Establishment FDA-2658.pdf Form
FDA Form 2657 Drug Product Listing (New Drug Listing) FDA-2657.pdf Form

Information Collection (IC) Details

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	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

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	Previously Approved
Annual Number of Responses for this IC	574	574
Annual IC Time Burden (Hours)	2,583	2,583
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.