Information Collection

Outsourcing Facilities: Registration and reporting of drugs under 503B(b)

IC 256583 under ICR 202603-0910-014 · OMB 0910-0800.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
21 USC 353b Sec 503B FFDCA OCT 2022.pdf	Other-Statutory Authority
0800 GFI Outsourcing registration and reporting of drugs DEC 2016.pdf	Other-Agency Guidance

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Statutory Authority					Yes	Yes	Fillable Fileable
Other-Agency Guidance					Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 75

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	8,111	0	8,111
Annual IC Time Burden (Hours)	203	-11	214
Annual IC Cost Burden (Dollars)	0	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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