Information Collection

New registrations, including new labeler codes requests

IC 183172 under ICR 201203-0910-007 · OMB 0910-0045.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) New registrations, including new labeler codes requests	Form
Form FDA Form 2658 Registered Establishment New registrations, including new labeler codes requests	Form
Form FDA Form 2657 Drug Product Listing (New Drug Listing) 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

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:

table that charts list of instruments
Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA Form 2656	No	No	Paper Only
Form	FDA Form 2658	No	No	Paper Only
Instruction		No	No	Paper Only
Instruction		No	No	Paper Only
Form	FDA Form 2657	No	No	Paper Only
Other-guidance document		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 %

table that charts list of burden
	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

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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