| Specifications | Department of Health and Human Services\r\nFood and Drug Administration\r\nGovernmental Entity Declar\ ation FDA-3422 |
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| Specifications | Department of Health and Human Services\r\nFood and Drug Administration\r\nGovernmental Entity Declar\ ation FDA-3422 |
| Business section |

| Specifications | Department of Health and Human Services\r\nFood and Drug Administration\r\nGovernmental Entity Declar\ ation FDA-3422 |
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| Content | Funding Under the Breast and Cervical Cancer Mortality Prevention Act of 1990* (www.cdc.gov/cancer/nbccedp) Printed Name *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.R.S. EMPLOYEE IDENTIFICATION NUMBER (EIN) FACILITY NAME AND ADDRESS DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration FACILITY IDENTIFICATION NUMBER (from FDA certificate) Form Approved: OMB No. 0910-0309 Expiration Date: October 31, 2013 See OMB Statement on Reverse. 1. 2. 3. 4. FORM FDA 3422 (1/11) GOVERNMENTAL ENTITY DECLARATION Federally-recognized Indian tribe MQSA Governmental Entity Declaration FDA Mammography Quality Assurance Program P.O. Box 6057 Columbia, MD 21045-6057 If you answered yes to all of the above questions, your facility qualifies as a governmental entity exempt from inspection fees. Please check ONE option below that best describes the entity that operates this facility: State, district, territory, or possessionFederal department YesNo YesNo YesNo YesNo City, county, town, village, municipal corporation or similar political organization or subpart thereof 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. ZIP Code Signature of Chief Financial or Operating Officer(or equivalent)Date City Title Signature and address of Chief Financial or Operating Officer (or equivalent) Street Phone Number State YesNo 6. 7. 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.? Facility Operation Total number of mammography screening examinations in preceding 12 months: Number of mammography screening examinations provided during the preceding 12 months funded by grants under the Breast and Cervical Cancer Prevention Act of 1990: 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? 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? 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? 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? If you answered yes to question 5 above, your facility qualifies as a governmental entity exempt from inspection fees. Please provide the following information: 5. Return within 30 days to the following address: PSC Publishing Services (301) 443-6740 EF |
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| Following Datasheets | UCM080839_1 (3 pages) UCM080858_1 (3 pages) UCM080872_1 (1 pages) ucm080879-1_1 (2 pages) UCM081561_1 (84 pages) UCM081575_1 (32 pages) UCM081600 (76 pages) UCM081603_1 (17 pages) UCM081667_1 (2 pages) UCM081671 (76 pages) |
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