June and December updates of all drug listing information

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⚠️ Notice: This information collection may be referencing outdated material.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
FINAL GUIDANCE UFI.doc Other-Guidance
SCREENSHOT FORMS and INSTRUCTIONS 6-19-14.PNG www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm Other-Screenshot

Information Collection (IC) Details

IC Title:	June and December updates of all drug listing information	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
Other-Guidance			FINAL GUIDANCE UFI.doc		Yes	No	Paper Only
Other-Screenshot			SCREENSHOT FORMS and INSTRUCTIONS 6-19-14.PNG	http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm	Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,677	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	18,799	18,799
Annual IC Time Burden (Hours)	84,596	84,596
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.