SMG 2310.9

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

FINANCIAL MANAGEMENT

BUDGET

USER FEE MANAGEMENT

Effective Date: 09/16/2008

[PDF Version]

1. PURPOSE 

To outline the policy for the management of User Fees by the FDA

2. POLICY 

All User Fees levied by the FDA must comply with the Office of Management and Budget (OMB) Circular A-25 governing fees assessed for Government services and for sale or use of Government goods or resources (Attachment A). In all circumstances, guidance provided by the Circular is superseded by any Legislative statute or Executive action. In such cases, the guidance provided by the Circular would apply to the extent that it is not inconsistent with the statute. The same analysis would apply with regard to executive orders that address user charges.

3. RESPONSIBILITIES 

FDA Offices and Centers responsible for managing User Fees should ensure compliance with the OMB Circular A-25 and any relevant Legislative or Executive action. Questions relating to the management of User Fees should be directed to the Director of Division of User Fees within the Office of Financial Management (OFM).

4. EFFECTIVE DATE 

This policy was signed by John P. Gentile, Associate Commissioner for Operations, effective September 16, 2008.

 5. Document History -- SMG 2310.9, User Fee Management