Registration of Oursourcing Facilitites and Payment of Fees

Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K

Documents and Forms

Document Name Document Type
FINAL GUIDANCE FOR USER FEES 8-28-14.doc Other-Guidance
FINAL GUIDANCE FOR USER FEES 8-28-14.doc Other-Guidance
0776 Registration of Outsourcing Facilities under 503B GFI.pdf Other-Agency Guidance
0776 Registration of Outsourcing Facilities under 503B GFI.pdf Other-Agency Guidance
3908 Outsourcing Facilities for Human Drug Compounding Small FDA FORM 3908 USER FEE 8-29-14.pdf Form and Instruction
3908 Outsourcing Facilities for Human Drug Compounding Small FDA FORM 3908 USER FEE 8-29-14.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Registration of Oursourcing Facilitites and Payment of Fees	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			FINAL GUIDANCE FOR USER FEES 8-28-14.doc	Yes	Yes	Paper Only
Form and Instruction	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request	FDA FORM 3908 USER FEE 8-29-14.pdf	Yes	Yes	Fillable Fileable Signable
Other-Agency Guidance			0776 Registration of Outsourcing Facilities under 503B GFI.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 79	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	Previously Approved
Annual Number of Responses for this IC	188	87	101
Annual IC Time Burden (Hours)	852	431	421
Annual IC Cost Burden (Dollars)	0	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.