FDA 3422 (redlined version)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

GOVERNMENTAL ENTITY DECLARATION

Form Approvect: OMS Nu. (1910-0309

E,pir9Ji(,n 09/t,: Ocfub9r 31, 2022

S99 OMG Stat9mcnt on Re,•erse.

FACILITY IDENTIFICATION NUMaeR (from FDA cortific•I•)

FACILITYN/wlE N-JD IIDDRESS

I.RS.·

• • 1ucrol1FICATION NUMF.IF.:R (EIN)

Facilily ov�r:ltioo
l. 1:, the entire: satin)' t)f aU oc�site 1:-ersooocl of the mammography fw.."llity p:-iiJ directly hy a reckral �paflment, State>
,fo;trict, t�1Titory, r1os,,;esi,;io11, P'etlerally-Jeco�nized fnditHl hi� city, count)' , town, ,.;,n�gc.. mu11icip1tl curporut.ion oc
i:dt,)i)ar political ursani;,111iuo ur ,-�hpacc 1he,eofr
2. Is the building, oflier:, orntl..::r:-.poce occupied by the mamrnoga11phyf.1.cility owuod by. �nb:x.l by. or le11se1l Cu .a Federal
department, State-. cJjstri1.:t, r;,,:nitory, J')lt.',sei,;i.iun, Fedemlly-reooguizcd fnd.ian cribc. city, ootmty, town, vHbagc.. municipul
oorpomtion or similar political uxgani>:lllic.m c,ri.uhpurl the1eoJ'!
3. Is the facilitys. 1m.mmogr;1phy cquit>m<.,-nt <,1wnetl h)' , n:nted by, 01 · leased to a federal department, Smtc, distl'ict. territory,
ro��esslo1\ federnlly-rtcoguizod llldian ttilx:.. city, counLy, 1uwn, "ill nge, outuiclpol oorpotation orsimilar political
urgani:,..a60Jl l)C �ubpa,t thereof/
4. T)(.1cs" Fei:Jcnal ,lepurt.ml:nt, Siu� distJfo� cenitOtY., possession, 1-'cdcn1Uy-1ecc.1gn\,.e<.1 lndi»n tril:,o. cily, cuu1t1y, towa,.
village. muni<.-i.pitl c.:orponuic,n or "imihitr polltical o,p,ani2'.ltion or sub part fhtrcof h
..wc tht t1ltim1do authc.1ri1y tu muke
day-to-d;,y dccisious QOUCCnti.ng the 1m1n11gemcnl uud ure,ation of lhe mammography facility'!
.
Jfy:.,u anrweit>.d "y�(' '"oil"fth� ah<,w. qu.,•slfon.-. ·. Jmtr /it'iHty,1uati f,4>s as d f¥Jl>er111nental c1t1itye.Yf.m/t fem

Yos

No

Yes

No

Yo;,;

No

Yes

No

Yes

I\\)

n n

D D
D D
0 lJ

ins,:cCficm .R.es, Please checkON/;, op:itm lw.fow 1ha1 he.,·t dt..,r.rilJeN lhi il1lilJ'lhcu opcraus this Js,:ifity:

0fcdcrally-tocogtU1cd ln<.fom lrihe
osw.�. tlistri1.:I, te(t'i(ory, 01' possession
0 J'odc1•I dcpartnu,,tt
0 Cit)•, 1.:011..nCy, town, villnse,. munki >al corporation orsi11Ul1tr poJ\tical org�1nir.i1tion m imh rt Ou:n:ol"
pa

t

l•'oudlng Under the llrcnsl nnd C•rvic:,J Caoco,· :MorlalUy Prc,0c111Kln Act of 1990*
( www.\°/1;.,n�.,,r/11bx�JOl!p.)
.5.

Weit at lcas.t 5o<'/4 of the Jrul\\\\\'tC.)grl.lph )" �crcening examin-'tions pl'ovidcd dwfog chc preceding 12 month-s funded under
the .Bre.1!>f Md Ccrvict1l Cauccr Mortality Pn.:wnliun Aclof 1990, 42 US.C. 300k et seq.·!

D D

1/Jf)ll a�rorod »)\�t' to que.yiion 5 uhm>t, Jtmr JU:Uil yqua/1,{is as d gowJwn�J//td entit)•exemJX jl)m fntJ�cticm f.,t.,;;.
J'hUJsc µo
· vtdelhe. ft/lowing inj)r111an·on;
6. To�I oumbuof n1.ammog1i1physctocning cx:�m.imitioni; in [u·i::.cc:cling 12 ,nmnll.C::
7. Numbcrof 1TU1m1i,ogruphy ,,;crccming exu.minul iOM l)rovided during the prccoding 12
WOJlths. fuudcd by gt�nfS under th.: R1\\ll\ll 1trKl Cen·ic.al ('..3oceJ ' P1-e,-ention Actofl 990:

..

• A f�dily JIWvWU,g McdiureiM->d.i¢Aid ,o,J'>'icC� \'>j(MU1 OlCCci°' lhe Jrwemmcnml tfllily(.;ri ltria dt>(:1it�� ll-l1uvc d,,x:,;1«>1 qualif� U a &Ovet'IW\COltl cUfi1:;, Addi lion.\ly, ff")A d�
111urt1."1Jtui..w(),lbc/ �l¢1100CI 01 JIJ.IJUUlOClflp}\y{VtJ\l)t.'J:fOf,T\1100 t1fl("ler 1� �w,n ,r,ae,.,,_,I c11t ily t.o.t111p1iul\
-·
., __ ... l ttU�t lh.ut, {o � hc:sluf m>' know1ed..<:;e and belief, 1hc iufortm.tion pruvjdcc.1 i11 thii;, Occlur1tlic,n i:-. {rnc und conect and that the manuuogml)hy
facility idontificd ttb..wc (luulifie\i a,,; u �"t1vcmmc:11ual e11City under (he A MHmmo:_Ce rrog.mw
l'.O. Box 60$7
Columbia. Mil 21045-y any Federal departmen� State, dlslricl, territory, possession, Federally-,-ecognlzed Indian tribe,
i
city, county, tov:,n, vill age. munic lpal corporat on or similzw politica l organiZ(ltion or subpart thereof. The entire sa lary of all on­
site personnel of lhe mammography facility must be paid direcuy by a particular form of govemment as listed above. All or fhe
facility's mammography equipment must be o,..-1<;d, renlod by, or leased by a parUcular form of government as listed above.
The faclll(y's u!Omate surhorily to make day-to-day deoisions conceming the managernent and aperation of Ille m"mmography
faclllty must come kom a parljcu lar form of government as listed above. All of these requ irements must b0 me( in order for a
facility to be considered a governm8fltal entity. The parUcular form of government also must be listed on the Governmental
Entity Declaralja, form (Foon 3422) In lhe space ptol,\ded.
(2) lhe facil ity provides ser-ices under the Breast and Cervical Cancer Mortalit y PrevenUon Act of 1990, 42 u.s.c. 301)1( et seq.
IYl\/0\l S:'1<; 1112vh�e,·mbcCJ!dp) and at least 50% of the mammography screehing examinations provided during the
precedi ng 12 months were fundontify status. If rtie Declaration Is not returned ,�thin 30 clays, your facility \!oill be C>llegorized as
sub;,,ct to payment of inspec�on lees . FDA may ask for add!Oon�I documentation to substantiate a faclll(y's claim that it is a
governmenlal entity. Persons Who knol'Aogly make false state,nents lo Ille government a,e subject (o dvtl and criminal penalties.
Tt.is s,e� 1ion ;,tpplie:s. l)lllf to Jtfllii.s fafufIJ)(ltion oolicclion, inclw:ling in,ggc!ltion!I fur rcducin,t th� llurd�J, l():
Oep11:n:ment of Health 1111d Hun"WI S(1vi oes
J'C)()(l anti n1us. ,\dcni1ijs1n1ti.,n
Ofticc .,fOpcmtioAA
Paptl'\\'('1(1( Rtdu¢1i◊I\ Ai.:l (YM) Stuff
PRAS!a.f@.pa,/lh.t.pp1,·

FORM FDA 3422 (1 OMS)

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