Request for Small Business Establishment Fee Reduction (FDA Form 3908)

Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the Federal Food, Drug, and Cosmetic Act

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0776 can be found here:

Documents and Forms

Document Name Document Type
FINAL GUIDANCE FOR USER FEES 8-28-14.doc Other-Guidance
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:	Request for Small Business Establishment Fee Reduction (FDA Form 3908)	Agency IC Tracking Number:	CDER

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-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

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 15	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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	15	15
Annual IC Time Burden (Hours)	375	375
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.