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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Governmental Entity Declaration Form

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Discussion:

A Governmental Entity Declaration, FDA Form 3422, is included with each invoice for MQSA inspection services.

A facility that believes that it qualifies as a governmental entity needs to complete this Declaration, have it signed by the facility’s Chief Financial Officer or Chief Operating Officer (or equivalent responsible person), and return it to:

MQSA Government Entity Declaration
MQSA Hotline
P.O. Box 6057
Columbia, MD 21045-6057

FDA will review each declaration to determine if a facility qualifies as a governmental entity. Facilities determined by FDA to be governmental entities are exempt from paying FDA-imposed MQSA inspection fees. Facilities in SAC States may still be responsible for paying any SAC-imposed fees.