Form 3422 Governmental Entity Declaration

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

GOVERNMENTAL ENTITY DECLARATION
FACILITY NAME AND ADDRESS

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Form Approved: OMB No. 0910-0309
Expiration Date: March 31, 2007
See OMB Statement on Reverse.
FACILITY IDENTIFICATION NUMBER (from FDA certificate)

I.R.S. EMPLOYEE IDENTIFICATION NUMBER (EIN)

Facility Operation
1.

Is the entire salary of all on-site personnel of the mammography facility paid directly by a federal department, state,
district, territory, possession, federally-recognized Indian tribe, city, county, town, village, municipal corporation or
similar political organization or subpart thereof?

Yes

No

2.

Is the building, office, or other space occupied by the mammography facility owned by, rented by, or leased to a
federal department, state, district, territory, possession, federally-recognized Indian tribe, city, county, town, village,
municipal corporation or similar political organization or subpart thereof?

Yes

No

3.

Is the facility’s mammography equipment owned by, rented by, or leased to a federal department, state, district,
territory, possession, federally-recognized Indian tribe, city, county, town, village, municipal corporation or similar
political organization or subpart thereof?

Yes

No

4.

Does a federal department, state, district, territory, possession, federally-recognized Indian tribe, city, county, town,
village, municipal corporation or similar political organization or subpart thereof have the ultimate authority to make
day-to-day decisions concerning the management and operation of the mammography facility?

Yes

No

Yes

No

Please provide the name of the federal department, state, district, territory, possession, federally-recognized Indian
tribe, city, county, town, village, municipal corporation or similar political organization or subpart thereof that
operates the facility.
Provide name of the form of government (e.g. County of York)

If you answered "yes" to all of the above questions, your facility qualifies as a governmental entity exempt from
inspection fees.
Funding Under the Breast and Cervical Cancer Mortality Prevention Act of 1990* (www.cdc.gov/cancer/nbccedp)
5.

Were at least 50% of the mammography screening examinations provided during the preceding 12 months funded
under the Breast and Cervical Cancer Mortality Prevention Act of 1990, 42 U.S.C. 300k et seq.?
If you answered "yes" to question 5 above, your facility qualifies as a governmental entity exempt from inspection
fees. Please provide the following information:

6.

Total number of mammography screening examinations in preceding 12 months:

7.

Number of mammography screening examinations funded by
grants under the Breast and Cervical Cancer Prevention Act of 1990:

* A facility providing Medicare/Medicaid services without meeting the governmental entity criteria described above does not qualify as a governmental entity. Additionally, FDA
does not recognize other breast cancer or mammography grants/programs under the governmental entity exemption.

I attest that, to the best of my knowledge and belief, the information provided in this Declaration is true and correct and that the
mammography facility identified above qualifies as a governmental entity under the definitions set forth on reverse of this form. I understand
that FDA may request additional information to substantiate the statements made in this Declaration. I also understand that persons who
knowingly make false statements to the government are subject to civil and criminal penalties.
Signature and address of Chief Financial or Operating Officer (or equivalent)

Signature of Chief Financial or Operating Officer (or equivalent)
Printed Name

Title

Date
Phone Number

(
Street

City

State

)
ZIP Code

Return within 30 days to the following address:
MQSA Governmental Entity Declaration
FDA Mammography Quality Assurance Program
P.O. Box 6057
Columbia, MD 21045-6057
FORM FDA 3422 (1/05)

PSC Media Arts (301) 443-1090

EF

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Instructions for Completion of Governmental Entity Declaration
This form is used to attest that a mammography facility qualifies as a "governmental entity" that is exempt from payment of
inspection fees assessed under the Mammography Quality Standards Act of 1992.
A governmental entity is a mammography facility subject to inspection under section 354(g)(1) of the Public Health Service
Act, 42 U.S.C. 263b(g)(1), that meets either of the following criteria-(1) the facility is operated by any federal department, state, district, territory, possession, federallyrecognized Indian tribe, city, county, town, village, municipal corporation or similar political organization or subpart
thereof. The entire salary of all on-site personnel of the mammography facility must be paid directly by a particular form of
government as listed above. All of the facility’s mammography equipment must be owned, rented by, or leased by a particular
form of government as listed above. The facility’s ultimate authority to make day-to-day decisions concerning the
management and operation of the mammography facility must come from a particular form of government as listed
above. All of theserequirements must be met in order for a facility to be considered a governmental entity. The particular form
of government also must be listed on the Governmental Entity Declaration form (Form 3422) in the space provided.
(2) the facility provides services under the Breast and Cervical Cancer Mortality Prevention Act of 1990, 42
U.S.C. 300k et seq. , (www.cdc.gov/cancer/nbccedp) and at least 50% of the mammography screening examinations
provided during the preceding 12 months were funded under that statute. FDA does not recognize a facility providing
Medicare/Medicaid services without meeting the governmental entity criteria described above. Additionally, other breast
cancer or mammography programs/grants are not recognized under the governmental entity exemption.
See 60 F.R. 14584 (March 17, 1995).
A facility that believes it qualifies as a governmental entity, as defined above, must complete this Declaration, have it signed
by the facility’s Chief Financial Officer or Chief Operating Officer (or equivalent responsible person), and return it within 30 days to
the following address:
MQSA Governmental Entity Declaration
FDA Mammography Quality Assurance Program
P.O. Box 6057
Columbia, MD 21045-6057

If this Declaration is not returned within 30 days, your facility will be categorized as subject to payment of inspection fees. Each
such facility will be billed for all inspections conducted under 42 U.S.C. 263b (g)(1).
If FDA disallows a facility’s claim that it is a governmental entity, FDA will notify the facility and will send a bill for all prior
unpaid inspections.
If FDA determines that a facility is not a governmental entity, but the facility believes it qualifies for exemption the definition of
governmental entity set forth above, the facility may appeal FDA’s determination by explaining and certifying the basis for its belief
in a letter directed to the FDA Ombudsman, c/o Mammography Quality Assurance Program, FDA, P.O. Box 6057, Columbia, MD
21045-6057. Any appeal must be postmarked within 30 days of the original billing date of the first inspection of the facility. The
FDA Ombudsman will review a facility’s claim that it is a governmental entity and will ordinarily reach a decision within 60 days. If
the Ombudsman determines that a facility does not qualify as a governmental entity, the Ombudsman will provide a statement of
the grounds for that determination. The Ombudsman’s decision will constitute the agency’s final decision on the matter.
IMPORTANT. This form must be signed by the Chief Financial Officer or Chief Operating Officer (or equivalent
responsible person) of the facility claiming governmental entity status. If the Declaration is not returned within 30 days, your
facility will be categorized as subject to payment of inspection fees. FDA may ask for additional documentation to substantiate a
facility’s claim that it is a governmental entity. Persons who knowingly make false statements to the government are subject to
civil and criminal penalties.
Paperwork Reduction Act Statement
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB
control number. Public reporting burden for this collection of information is estimated to average .5 hours (minutes) per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the necessary data, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other aspect of this collection of information to:
MSQA Governmental Entity Declaration
FDA Mammography Quality Assurance Program
P.O. Box 6057
Columbia, MD 21045-6057

FORM FDA 3422 (1/05)