Information Collection

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

IC 256583 under ICR 202210-0910-015 · OMB 0910-0800.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0800 can be found here:

Documents and Forms

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

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Outsourcing Facilities: Registration and reporting of drugs under 503B(b)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Statutory Authority			21 USC 353b Sec 503B FFDCA OCT 2022.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			0800 GFI Outsourcing registration and reporting of drugs DEC 2016.pdf		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 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	8,111	8,111
Annual IC Time Burden (Hours)	214	214
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.