M:\Data\CompanySharedFolders\1 wp8\Boice\Boeing\Final Report

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ROCKETDYNE WORKER HEALTH STUDY
Appendix I
Institutional Review Board
and Other Human Subjects
Committee Approvals
July 13, 2005
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Table of Contents - Appendix I
Appendix I. Institutional Review Board and Other Human Subjects Committee Approvals
Department of Energy approval for linkage with dosimetry records (Oct 2003)
Nuclear Regulatory Commission approval for linkage with dosimetry records (Dec 2001)
Study description (PHS 398, Page 2)
Letter of support from Steve Lafflam, Division Director, Safety, Health & Environmental
Affairs, Rocketdyne, The Boeing Company (Jan 2001)
Institutional Review Board approval from Vanderbilt University (Dec 2002)
Institutional Review Board approval from The Boeing Company (Jan 2001)
Institutional Review Board approval from Oak Ridge National Laboratory (Jan 2002)
National Center for Health Statistics approval for mortality linkage (Apr 2001)
Social Security Administration approval for vital status linkage (Feb 2001)
Health Care Financing Administration (Centers for Medicaid & Medicaid Services) approval for
vital status linkage (Dec 2003)
United States Air Force approval for dosimetry linkage (Feb 2004)
Recent IRB Approval from Vanderbilt University (through 12 October 2005)
1
a-
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October9,2003
CraigA. Refosco,Maj, USAF,BSC
HealthPhysicist
RadiationProtectionDivision
USAF RadioisotopeCommitteeSecretariat
Air ForceMedicalOperationsAgency
Office of the SurgeonGeneral
AFMSA/SGPR
1l0 Luke Avenue,Room405
Bolling AFB, DC 20032-7050
RE: Requestto MatchRosterof the RocketdyneRadiationWorkerStudywith Air ForceDosimetry
Records
DearMajor Refosco:
We would like to sendour rosterof 55,000formerworkersat Rocketdyne(AtomicsIntemational,
Roclcwell,Boeing)to the Centerfor RadiationDosimetryat BrooksAir ForceBasefor recordlinkageand
wereemployedby the Air Forceandweremonitoredfor radiation'
leamhow manyworkerssubsequently
I thoughtit mightbe helpful to includemoredetailsaboutour studyandthe extensive
Perour discussions,
approvalswe havereceivedalongtheway.
by both theBoeingCompanyandby the UAW. It is a mortalitystudyandwe are
The studyis sponsored
attemptingto obtaincompletecareer(or lifetime)historiesof radiationexposurefor the workers. Most of
the exposureoccurredwhile employedin the earlyyearsof the atomiceraat Rocketdyneandsubsequent
exposure,e.g., atmilitary facilities,wassmall. The InternationalEpidemiologyInstituteandVanderbilt
Universityareconductingthe study. I've enclosedthe following:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Approvalfrom the Departmentof Energyfor linkagewith their dosimetryrecords(Oct 2003)
Approvalfrom NuclearRegulatoryCommissionfor linkagewith their dosimetryrecords
(PHS398,Page2)
Studydescription
Letterof supportfrom SteveLafflam,Division Director,Safety,Health& EnvironmentalAffairs,
Rocketdyne,The BoeingCompany
InstitutionalReviewBoardapprovalfrom VanderbiltUniversity
InstitutionalReviewBoardapprovalfrom The BoeingCompany
InstitutionalReviewBoardapprovalfrom OakRidgeNationalLaboratory
Approvalfrom theNationalCenterfor HealthStatisticsfor mortalitylinkage
Approvalfrom the SocialSecurityAdminishationfor vital statuslinkage
BouLpveno
1455 R-Esp^.ncH
Surs 550
Rocrvtr-r-p,MenvleNo 20850 USA
Trlrpxoxr
301-517-4060
Fex 301-517-4063
158 of 189
October8. 2003
Craig A. Refosco,Maj, USAF
Page2
The 55,000 workers were employed between 1948-1999,and at least 6,000 worked with radiation. The
non-radiation workers were in large part involved with rocket engine testing (Saturn Apollo engines, shuttle
engine, SNAP, etc). Workers left Rocketdyneover the years and received occupational exposuresat
different nuclear facilities, and occasionally at military installations. To make our radiation study as valid
as possible, we wish to capture all the radiation dosesin a worker's career.
What we've done in the past is send our entire roster of 55,000 workers to various agenciesfor record
linkage with their files. We send a file with Social Security number, name, and date of birth. We have
done such matching with the Nuclear Regulatory Commission (REIRS files), the Department of Energy
(REMS, historical and termination files), 9 different nuclear installations, the Landauer dosimetry
company, and most recently the U.S. Army (RedstoneArsenal). We would like to send this file to the
Center for Radiation Dosimetry at Brooks Air Force Base for similar linkage.
We would not anticipate a large number of Rocketdyne/Atomic International workers to have been involved
with air force activities. If the U.S. Army experienceis relevant, the number would be less than 150.
Again, our interest is in being as complete as possible in characterizingthe radiation exposurehistories of
theseworkers and thus would find any experiencewith the U.S. Air Force important to include. As
mentioned, however, including or not including the radiation dose record of the relating small number of
workers who were subsequentlyemployed by the U.S. Air Force will not affect the validity of our
epidemiologic investigation, only the completenessand quality.
In responseto queries raised in your e-mail of last month, unfortunately we do not know which of the
55,000 workers are the approximately 150 who joined the Air Force after employment at Rocketdyne.
Further, even if we could identify theseworkers, it would be extremely difficult to locate them today and
obtain any consent. Most worked at Atomics International/Rocketdynein the 1950sand 1960s,and many
have also died; over 11,000of the workforce have died to date. I suspectthe Privacy Issuesmay not be
relevant to those who have died, at least that is our understandingfrom the federal agenciesproviding
linkages for us. We also have not had any agencyconsider exposureinformation (i.e., the dosimetry
record) to be part of the medical record of an individual. In fact, our experienceat Rocketdyne and other
facilities is that theserecords are physically separatedand even stored in different buildings.
I look forward to hearing from you if it might be possible for the U.S. Air Force to help us out.
Sincerelyyours,
o
)
JDB/ra
Enclosures(9)
JohnD. Boice,Jr.,Sc.D.
ScientificDirector
(phone)
301-5174021
com
boicej@compuserve.
(r)
EXTENSION OF
ARRANGEMENT FOR COLLABORATION
AMONG
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THE DEPARTMENT OF ENERGY OF THE UNITED STATES OF AMERICA
AND
THE BOEING COMPAI{Y
AND
THE INTERNATIONAL EPIDEMIOLOGY INSTITUTE
(attached)hasprovisionsin SectionV (partA) to extendthe
The existingagreement
arrangement
for additionalperiodsby mutualagreement.
"This Arrangementshallbecomeeffectiveupon
signatureby all Parties,and shall
remainin effectfor oneyear. ThePartiesmayextendthis Arrangementfor
additionalperiods."
The Departmentof Energyof theUnitedStatesof America(DOE),the BoeingCompany
@oeing),andthe InternationalEpidemiologyInstitute(IEI), agreeto extentthe existing
arrangement
for an additionalyear,effectiveuponsignatureby all Parites.
FOR THE DEPARTMENT OF ENERGY
OF THE UNITED STATESOF AMERICA:
Date:to/s/t z
AssistantSecretary
Environment,Safetyand Health
Washington,D.C.
FOR THE BOEING COMPAITI"Y:
Date: lrr
?
{u:
SteveLafflam
Division Director
Safety, Health & Environmental Affairs
Canoga Park, CA
Page I of 2
160 of 189
FOR THE INTERNATIONAL EPIDEMIOLOGY
INSTITUTE:
Date:r{.4V
Dr. John D. Boice,Jr.
ScientificDirector
Rockville, MD
Attachments
betweentheDepartmentof Energy,theBoeing
2002signedArrangement
Companyandthe lntemationalEpidemiologyInstitute.
Page 2 of 2
2aa3
ARRANGEMENT FOR COLLAS ORATI ON
AMONG
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THE DEPARTMENT OF ENERGY OF THE UNITED STATES OF AMERICA
AND
THE BOEING COMPAI{Y
AND
THE INTERNATIONAL EPIDENfl OLOGY INSTITUTE
The Departmentof Energyof the United Statesof America(DOE), the Boeing Company
@oeing),and the lnternationalEpidemiologyInstitute(IEf), hereafterthe "parties":
Noting that iEI is conductinga study involving over 55,000workersemployedat the
Rocketdynefacilitiesin California(now ownedby Boeing),to evaluatethe cancerrisk
associated
with occupational
exposures
to ionizingradiation;
Noting that the IEI RocketdyneWorker Study hasa documentedprotocol that requires
eachworker'sradiationdoseto be ascompleteaspossibleover the worker's entire
career:
Noting that the RocketdyneWorker Sfudyincludesworkerswho were alsoincludedin
otherDOE worker cohortssuchas the Hanford and Oak Ridge National Laboratory
cohorts;and
Noting that IEI, which hasthe approvalof the U.S.NationalDeathIndex and the
lnstitutionalReview Boardsof the Boeing Company,VaaderbiltUniversity and the Oak
Ridge National Laboratoryto participateand conductthe RocketdyneWorker Study,is
responsiblefor preparingthe vital statusand dosimetryanalysisfiles,
Have agreedas follows:
L
Purpose
A' The purposeof this Arrangementis to providea frameworkfor DOE to contribute
datafrom the DOE RadiationExposureMonitoringSystem
[REMS), to provideas
conlpleteinformationaspossibleon the totalcareerradiationdosefor eachU.S.
radiationworkerincludedin the RocketdyneWorkerStudy.
B. The Partiesexpectthat a successful
RocketdyneWorkerStudywill provideadditional
infonnationof healthrisk at low dosesandlorv doseratesof occupationalexposure.
II. ImplententingProvisions
Page t of :
A. Pursuantto the PrivacyAct, 5 U.S.C.552a(b)(3),andunderRoutineUse Number5 of
DOE-35,PersonnelRadiationExposureRecords(whichpennitsdisclosureto
collaboratingresearchers
in the performanceof health-relatedstudies),DOE shall162 of 189
provide IEI and Boeing with dosimetryinformation,as recordedin REMS, for each
worker identified as being includedin the RocketdyneWorker Study.
B . IEI and Boeing shall usethis information only for the abovedescribedresearch
purposes.
C. IEI andBoeing shall maintainthe confidentialityof the subjectinformation and make
no disclosureof it to third partieswithout the prior written consentof the DOE. Iq
during the examination of DOE-provided data, errorsor omissions are found and
corrected,thesecorrecteddatashall be provided back to DOE REMS.
D. IEI andBoeing'sobligationto maintainthe confidentialityof the DOE-provided
informationshallremainin effectthroughoutthetermof this Arrangementandafter
its termination,unlessanduntil the saidinformationandall copiesthereofare
returnedto DOE.
III. Contacts
Theprincipalcontactfor DOE is Ms. NirmalaRao,Offrceof WorkerProtection
ProgramsandHazardsManagement.The principalcontactfor Boeingis Dr. Michael
FieldStation.Theprincipalcontactfor IEI is Dr. John
Sullivan,Boeing,SantaSusanna
D. Boice,Jr.,ScientificDirector.
IV. Management
andshallassess
ThePartiesshallconsulteachotherwheneverthey deemit necessary,
the
resultsof thework carriedout andin progress.
V. GeneralProvisions
A. This Anangement shall becomeeffective upon signatureby all Parties, and shall
remain in effect for one year. The Partiesmay extendthis Arrangement for
additionalperiods.
B . The terms of this Arrangementmay be altered in writing by the Parties. If any
Party wishes to ceaseits activities under this Arrangement,it shall give ninety
(90) days advancewritten notice to the other Parties.
C . Cooperationunder this Anangementshall be in accordance
with the applicablelaws
and regulationsunder which eachParty operates.
D . Unlessotherwiseagreedin writing, eachParty shall assumeresponsibilityfor, and
providefirnding to cover,the costsindividually incurredin participatingin the
Page z ot I
collaborationcontemplated
by this Arrangement.The collaborativeactivitiesare
subjectto theavailabilityof fundsandpersonnel.
163 of 189
FOR THE DEPARTMENT OF ENERGY
OF'THE UMTED STATESOF AMERICA:
Date:Z/, /rt
AssistantSecretary
Environmenf Safetyand Health
Washington,D.C.
FOR THE BOEING COMPANY:
Date: Lltf
/"r_
Date: tA &/
Jaa-L
SteveLafIIam
DivisionDirector
Safety,Health & Environmental Alfairs
CanogaPark, CA
FOR THE INTERNATIONAL EPIDEMIOLOGY
INSTITUTE:
Dr. John D. Boice,Jr.
ScientificDirector
Rockville, MD
Attachments
NuclearRegulatoryCommissionapprovalto accessREIRS
Boeingletterregardingdosimetrysupport
BoeingIRB approval
VanderbiltUniversityIRB approval
OakRidgeNationalLaboratoryIRB approval
NationalDeathIndexapproval
Page 3 of 3
(L)
UNITED STATES
NUCLEAR REGULATORYCOM MISSION
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wASHtNGTON, D.C. 2055SO00t
j8. 2001
December
Dr.JohnD. Boice,Jr.,Sc.D.
Scientific
Director
International
Epidemiological
Institute,
Inc.
1455Research
Boulevard
Suite550
Rockville,
MD20850
DearDr. Boice:
This is in responseto your requestfor accessto RadiationExposurelnformationand Reporting
System(REIRS)datafor an epidemiological
studyof radiation-exposed
workersat Rocketdynj
(Atomiclnternational,
Rockwell,Boeing).In youroriginalrequestof February29, ZOO1,
you
indicated
thatthe purposeof the Studyis to determine
if radiation
exposuresmight
be reiatedto
increasedmortalityrisksof certaincancers.
We understand
thatThe BoeingCompanyandthe UnitedAutoworkers
havecontracted
with
the International
Epidemiological
Institutelnc.(lEl)to conducta Study,involving
morethan
6,000workersemployedsince1950at threeRocketdyne
facilitiesin Californialnd compare
themto causeof deathinformation
obtainedfromthe California
DeathIndex,Socialsecurity
Administration,
PensionBenefitInformation
andthe NationalDeathIndexplusto estimate
directlythe cancerriskassociated
with lowdose,protractedexposureto ionizingradiation.
We alsounderstand
thatlEl, whichhasthe approvalof the SocialSecurity
Administration,
the
U.S.NationalDeathIndexPlusandThe BoeingCompanyInstitutional
ReviewBoardto
participatein the Study,is the organization
responsible
for preparingthe vitalstatusand
dosimetry
analysisfilesfor the Rocketdyne
workersto be usedin the study.
Pursuantto the PrivacyAct,5 U.S.C.552a(b)(3)
and underRoutineUseb, for NRC-27,REIRS
Files,whichpermitsreturnof dataprovidedby a licenseeuponrequest,
the NRCwillprovide
Boeingwithdosimetry
information
it suppliedfor recording
in REIRSfor eachRocketdyne
workeridentified
as beingincludedin the Study.The NRCwillprovideas completeiniormation
as possibleon the dosefor eachworker.
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Mr.JohnD. Boice
-2-
We wouldexpectBoeingand lEl to maintainthe confidentiality
of the subjectinformation
and
makeno publicdisclosure
of it to thirdpartieswithoutthe priorwrittenconsentof the NRCor the
individualfrom
whomthe information
pertains.lf, duringtheexamination
of NRC-provided
data,
errorsor omissionsare foundandcorrected,we requestthatthesecorrecteddata be provided
backto NRCREIRS.
We appreciate
the opportunity
to supportthisimportanthealtheffectsresearch.
c r/-l
ThomasL. King,Director
Divisionof SystemsAnalysisand RegutatoryEffectiveness
Officeof NucfearRegulatory
Research
U.S.NuclearRegulatory
Commission
cc: DerekHagemeyer,
SAIC
BB
Principal
Investigator/Program
Director
(t_asl/irst,middle):BOiCe, JOhn D. Jf
(s)
DESCRIPTION:Statethe application's
broad,long-termobjectivesand specificaims, makingreferenceto the healthrelatedness
project. Describe
of theof
166
189
conciselythe researchdesignand methodsfor achievingthese goals. Avoid summariesof past accomplishments
and the use of the firsf person. Thii
descriptionismeanttoserveasasuccinctandaccuratedescriptionoftheprqposedrarorkwtrenseparatedfromtheapplication.
lftheapplicationisfunded,this
description,
as is, willbecomepublicinformation.Therefore,do not includeproprietary/confidential
information.DO HOf fXCeeO fHe'dpeCe PROV|DED.
ThepossiblehealthrisksassociatedwithworkingattheRocketdynefacilities(SantaSu'u@
ConogaPark, and Desoto)have not been fully assessed.We proposea retrospectivecohort mortality study of
approximately55,000 former and current Rocketdyneemployeesto addressthis issue. In addition, nested-casecontrol
studiesof specific cancersites (lung, leukemia,lymphoma and, basedon the resultsof the cohort study, other sites) will
be conducted to further characterizeworkplace exposures and lifestyle factors. The primary goals of this research
include: to identify the entire Rocketdyne workforce employed since 1950; to update vital status information for all
cohort members; to identifu and quantify exposuresto important chemicals and physical agents (such as radiation,
trichloroethylene, hydrazine, and asbestos); and, to identifu appropriate control populations for comparisons with
mortality ratesamongthe Rocketdyneexposedworkforce (i.e., Califomia generalpopulation, "non-exposed"Rocketdyne
workforce, Lockheed Martin Burbank workforce). In addition, for workers who were potentially exposed to radiation,
we will obtain and integrate complete radiation work histories for employmentperiods both before and after emplolrnent
at Rocketdyne (through information from Rocketdyne, the Landauer dosimetry company, the Nuclear Regulatory
Commission,and the Departmentof Energy), estimateradiation dosesto specifrc organs from all sourcesof radiation
(externalgarnma,neutron, and internal radionuclide), and validate the radiation dosimetry with biological measuresof
exposuresamong a sample of workers. The classification of chemical exposureswill include the development of a
detailedjob matrix linking exposurepotential to specific jobs and a qualitativeexposurescore taking into account the
variation of exposurepotential over calendar years, due to numbers of engine tests, lpes of engines, chemical use
patterns,and introductionof protectiveequipment.
The study will be conductedby the Intemational Epidemiology Institute (IEI) using rigorous epidemiologic
methodsin study design, data collection, entry, and analysis, and interpretation and presentationof the study results. The
research team assembled includes internationally recognized leaders in radiation epidemiology, dosimetry and
occupationalstudies.
SITE(S)(organization,city, state)
1. Intemational
Epidemiology
Institute(IEI), Rockville,MD
2. OakRidgeNationalLaboratories
(ORNL),OakRidge,TN
3. Universityof Pittsburgh(UPitt),Pittsburgh,PA
4. LovelaceRespiratory
Research
lnstitute,Albuquerque,
NM
5. Universityof SouthemCalifornia(USC),Los Angeles,CA
KEY PERSONNEL.See instructionson Page 11. lJse continuationpagesas neededto providethe requiredinformationin the formatshownberow.
Name
Organization
Roleon Project
JohnD. Boice Jr, ScD
IEI
Primary Investigator
Jon P. Fryzek, PhD
IEI
Field Management
Donald E. Marano, CIH PE
IEI
Senior Indusfial Hygienist
JosephK. Mclaughlin, PhD
IEI
Co-lnvestigator
William, J. Blot, PhD
IEI
ORNL
ORNL
UPitt
Lovelace
USC
Statistician
Keith F. Eckerman,PhD
Richard W. Leggett, PhD
William L. Bigbee,PhD
Bruce B. Boecker.PhD
Brian E. Henderson,MD
page2
PHS 398 (Rev.4/98)
Numberpagesconsecutively
at thebottomthroughout
theapplication.Do!E! usesuffixessuchas 3a,3b
Health Physicist
Health Physicist
Laboratory analyses(FISH)
Consultant,RadiationDosimetry
Consultant,Epidemiologist
BB
167 of 189
(s)
VanQerbilt
University
168 of 189
D-3232Medicat
CenlerNodhNashviile,
T"nnessee-EZilliil
$15, 3n-29't\ Fax (6i5) 343-2648
ww.mc.vanderbilt.edu/irb
December
6,2OOz
JohnD Boice,Jr.,Sc.D.
Medicine
International
Epidemiology
lnstitute
Rockville,MD 20850
RE: IRB#010018 A Gohort MortatltyStudy of tfie Rockebdyne
Wortforce. (tntemational
Epiderniology
Instilute,)
DearDr. Boice,
At its meellngon December4,2oQ2,the Institrrtional
ReviewBoard reviewedthe App/icalion
for
Continuing
Reviewldentifiedabove.The Commltteedetermined
nat $restuovposesminimatrisklo
partioipants'
The committe".qqgg!1"! the requestfor walverof d;cum;ntaiion
sf consentis approveo
in acoordance
with45 cFR 46-'116(d).
The Commltteedetermlned
tni" stuov"un be reviewedin
accordanoe
with45 cFR 46.1i O(FXS)
and (7) for expeditedreviewIn he fulure.
As.he Principallnvestigator,
you are responsible
for the accuratedocumentration,
Investigation
and
followuPof all possiblestudy-relaled
adverseeventsand unanticipateJ
pioor"r. involvingrisksto
participants'
The IRBAdverseEventreportingpolicyil.F. is tocatedon the IRBwebsileat
http:/Auww.mc.vanderbilt.edulvbl.
Foryourconvenience,
a flowcharlis attaclred.
Pleasenote that approvalls for a 12'monthperlod. Accordingto federalregulations,
lhis periodis
calculated
from the dateof the-convened
meeiingas notedabovJ. Any changesto lhe iesearchstudy
mustbo prcsentedto the IRBfor approvalpriorto implemenlaUon.
DATEOF IRB APPROVAL: 12I4IO2
DATEOF IRB EXP|MT|ON: 1214/03
""[l{.rhL*
JamesT. Forbes,Ph.D.,Chair
lnstlutionalRevlewBoard
HealthSclencesGommlttee#2
JTF{o
Boice,JohnD Jr. IRB# 010018
1?,06t2002
169 of 189
(r)
170 of 189
OAK FIIDGEAESOCIATEO UNIVERSITIES
OakRidgeSite-wide
InstitutionalReviewBoard
(865)576-1725Facsimile(865) 576-9557
Telephone
E-mailhawkinsb@orau.
gov
TO:
Keith Eckerman,
Ph.D.lElizabeth
Ellis,Ph.D.
FROM:
ElizabethEllis, Ph.D.
Chair,Oak RidgeSite-wideInstitutionalReviewBoard(MPA #1394)
DATE:
January16,2002
RE:
ORNL(01)-64ROCKETDYNEwoRKXR HEALTH STUDY
The subjectprojectqualifiedfor continuingreviewby the expeditedprocess(45 CFR 46; l0 CFR 745).
Accordingly,I reviewedtheprotocolandtheprogressreportfor continuationfor a periodof up to 12
monthseffectiveDecember1,2001. At theBoardmeetingon November8,2001,theFull Boardof the
Oak RidgeSite-wideInstitutionalReviewBoard (ORSIRB)unanimouslyconcurredwith this continuing
approval.
Pleasebe remindedthat asthe PrincipalInvestigatoron this project,you areresponsiblefor immediately
informing the Boardof anyunplannedor unexpected
project-related
outcomesand/orany proposed
changesin theproject'sprotocolsor consentforms. Uponbeingnotified of any sucheventsor situations
the Boardwill reviewthemandinform you whetheror not the project(s)may proceed.Please
understandthat in thesecircumstances
you musthavethe Board'sapprovalfor continuationof the
protocolbeforeproceeding.
cc:
Dr. R Toohey,ORAU
IRB files
':k
(s)
Df,PARTMENT OF HEALTH & HUMAN Sf,RVICES
Centers for DiseaseControland prevention
171 of 189
NationalCenlerlor HealthStatistics
6525 BelcrestRoad
Hyattsvifle, MarylandZO7BZ-2OO3
APR3 0 Ir;Ai
T14pe of
NDf search
Routine
approved
NDI
NDI Plu.r(wital
NDI
Plu.g
NYC NDf
(for
Plu.r
search
ONIef
status
tnorn
untnorn)
11-x017
decedents)
11-K017
approval
J o h n D . B o i ce , Jr.
International
Epiderniology fnstitute
1 4 5 5 R e se a rch B Ivd ., Suite 550
R o c kvi l l e , Ma ryl a n d 2 0850
RE: Approval of NDr Plus Application
#yl_ao:-?
(AD Bpideniorogic
Study of the Rocketdyne lrorkforce)
D e a r Mr. B o i ce :
Your request to use the National Death rndex (NDr) has been
approved (see tabre above) on the basis of the iniormation
you provided in your
Form. To keep your
ryDr Application
application
current,
it is- iurportant that you notiiy'us
in .
writing
whenever there are any planned chaiges in fil your
p r o j e ct's
fu n d i n g .a rra n gem ents, ( 2) your str iay pr otocoi,
( 3)
y o u r co n fi d e n ti a ri ty
pr ovisions, and/or ( 4) oiginizations' oi
consultants receiving identifying
death record-information.
You also must contact us whenever you receive (or feel you
night soon receive) a subpoena or court order for any
identifying
information obtained as a result of your use of
t h e N D r.
You ruay now send your records to our facility
in Hyattsville,
Maryrand.
Please refer to the encrosed cHEcKLrsr when
preparing your records for submission.
The 1979-1999NDr
Prus files
are currentry
availahle
for
searehes.
The
2000 NDr P-lus file
shou]d be avairabl-e
by March
2 0 0 2.
Paqe 2 - John D. Boice,
172 of 189
Jr.
we rook forward to serving you.
please calr ilicherre
Goodier
or me on 301-458-4444.if
you have any guestions.
you may
also reach us by e-mail at MGooaierecac.gov
or
RBilgrad€cdc. gov
Sincerely
yours,
Robert Bilgrad, M.A., lt.p.H.
Special Assistant to the Director
D i vi si on of Vital Statistics
Enclosures
%"fr
(q)
x"l{llo6
173 of 189
SOCIALSECURITY
TGBA
FEB
2 TariOI
John D. Boice, Jx., ScD
fnternational
Epidemiology fnstitute,
1455 Research B1vd, Suite 550
Rockville,
MD 20850
Inc.
Dear Mr. Boice,
we have approved your request for our assistance
in obtaining
epi-demiological
vital
status data for your study ..An
Epidemiologic study of the Rocketdyne workforce."
Enclosed is
the documentation we need to process your request.
T a b A c o n t a i n s t w o c o p i e s o f t h e M e m o r a n d u mo f u n d e r s t a n d i n g
between you and SSA, whlch delineates our joint
responsibilities
in sharing data on your study subjects.
Of particular
importance
are the articles
covering the security of data and the need to
protect the privacy of an individual-'s
you
vital
status data.
are reminded that you are not permitted
to re-dj-sclose
the ssA
data.
Tab B contains two copies of our standard Agreement covering
Reimbursable Servj-ces, Form SSA-1235-U5, showing a cost of
$4,500.00 for processing 55,000 records (the number you recently
gave us).
unit cost for processing is $.165 per record for the
first
25,000 records and $.0125 for all records over 2s,ooo.
As
noted on the reverse side of the agreement, you must send us an
advance payment of 100 percent of the stated cost.
To authorize
-
work on this
project,
please provide
the
forrowing:
One signed original
Memorandumof Understanding;
One original
Reimbursable Services Agreement form
S S A - 1 2 3 5 - U 5w i t h :
-
Your Employer Identificatj_on
Number (EIN) entered;
Signed form with your si-gnature; and
signed form by your organization's
authori zing officlal.
Note: rf necessary,
cost totals.
change and initiar
the record
count and
A check payable to the Social Security Administration,
Office of Finance for the exact amount; and
Your input
data disk.
174 of 189
Send the above to Michael
Risha at:
Social Securj-ty Administration
4-C-15 Operations Building
6401 Security Boulevard
Baltimore,
Maryland
21235
your
Tab C contaj-ns a record specification
for use i-n preparing
You must foll-ow the record layout exactly.
input fil-e.
Please
note that you must put all- input data in upper case.
If you have
questi-ons about any of these instructions,
please contact us
before submitting your request.
The information
to be used in
service is as f ol-lows:
3 - Requestor ID Code:
80041
4 - Contract
SR001009
Number:
5 - Batch Number:
your
identifying
request
for
01
You must put this information
in the
(see record specification).
data file
first
record
of
your
input
We look forward to working with you on this project.
If you have
questions or need assistance j-n preparing your submissi-on, please
contact Michael- Risha at 410-966-4868.
Sincerely,
/
-
/
^
'
ifrl i/rr<- /,t'<dA
Susan Grad
Acting Associate Commissioner
for Research, Evaluation,
and Statistj-cs
Enclosures
175 of 189
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centersfor Medicare & Medicaid Services
7500Security Boulevard, Mail Stop N1-15-03
Baltimore, Marvland 21244-1,850
cwln'
tu MHrmnEa HEUAUDSEnUCE
December12,2003
SarahSchweitzer
Statistician
lnternationalEpidemiologyInstitute
Blvd.
1455Research
Suite550
Rockville,MD 20850
DearMs. Schweitzer:
and
Therequestfor the2003Vital Statusfile createdin supportof yourstudyhasbeenprocessed
The file wascreatedon CD. ASCII format.
is enclosed.
The file characteristicsare as follows:
2003Vital StatusFiIe:
IEI-VSTAT.TXT
DSN:
248
LRECL:
NO. OF RECORDS:430
SSNTo HIC ConversionFile:
IEI-SSNTOHIC.TXT
DSN:
248
LRECL:
N O .OF R E C OR D S5: 3 0 t :We ask that you validatethe media containedwithin this shipment. You shouldcheckthat the
data are readableand the file specifications(recordand block sizes,volsers,and numberof
recordsin eachfile agreewith the information containedin the correspondence.It is our policy
that CMS will replacedefectivemedia or incompleteshipments,providing the media is
returned with an explanation of the problem within 60 days following your receipt of the data.
Media problemsnot reportedwithin 60 daysbecomethe responsibilityof the customer.
It is my obligation to remind you that the datafiles provided are fumishedin accordancewith
data agreementswhich mandatespecific requirementsfor their use, storageand return.
In addition, as part of our ongoing data quality assuranceactivities, we ask that you complete and
retum the enclosedquestionnaireto report any anomaliesin thesedata. Aberrations,inconsistent
page2. - SchweitzerllEl
176 of 189
and/orincongruentdataultimatelyimpacton theutility of the files for decisionsupportor
purposes.Your assistance
research
in pointingout thesedataproblemswill be appreciated.
All
reportedanomalieswill be reviewed,documented,
andif appropriate,
referredfor correctiveaction.
Sincerely,
{ ,
) I
, \,1-LW,t c, ]| /ll'^Jtr{J
DuaneHudson
ComputerSpecialist
Divisionof QualityCoordination
andDataDistribution
EnterpriseDatabases
Group
Offrceof InformationServices
Enclosures
DEPARTMENTOF HEALTH & HUMAN SERVICES
Centersfor Medicare& Medicaid Services
7500SecurityBoulevard,Mail Stop N2-04-27
Baltirnore,Maryland 21244-|BSO
OIS/FnG
177 of 189
CEilfEnSbr rlEDtCAnE
& AED1A4OtEfrytCES
PCDD
October20,2003
Dr. JohnD. Boice,ScientificDirector
IntemationalEpidemiologyInstitute
1455Research
Blvd..Suite550
Rockville,MD 20850
DearDr. Boice:
Enclosedis the officia] copy of the signedData Use Agreement(DUA) you
have entered
into with the Centersfor Medicare& Medicaid Services(CMS). This copy
is for your
recordsso that you may refer to it for informationregardingthe use of
the dataand/or
the dataaccessprivilegesyou have receivedfrom CMS. Pieaserefer to DUA
number
for the project entitled, "An Epidemiologic Study of the Rocketdyne Work
11541
Force," when addressinginquiries of any natureconcerningthis agreement.
I havealsoenclosedthe CMS DUA Guidelineswhich outlinesyour responsibilities
in
terms of safeguardingthe confidentialityof CMS data. If you huu" any questions
aboutthis DUA or the useof cMS data,you may contactme at (410) 7g6-42g5.
Sincerely,
Wxffi*\/
Division of PrivacyCompliance
Data Development(DPCDD)
EnterpriseDatabasesGroup
Office of Infbrmation Services
Enclosures
178 of 189
Centers for Medicare & Medicaid Services(CMS)
Data Use Agreement (DUA) Guidelines
l.
Requestoragreesto notiff CMS if project is completedsoonerthan the expiration
date specifiedin the DUA.
2.
Requestoragreesthat any dataprovidedby CMS will not be physicallymoved or
Electronicallytransmittedin any way from the site indicatedin the DUA.
3.
Upon completionof project and/orexpirationof the DUA, the datamust be returned
to CMS at the requestor'sexpense,or destroyedand a statementcertiffing this action
sentto tMS. Th; Requestoiagreesthat no data,copies,or partsthereof,ihall be
retainedwhen the file(s) are returnedor destroyed,unlessCMS hasauthorizedin
writing suchretentionof said file(s). Theseoptionsare explainedbelow:
a.
Return data(and any derivative files) to CMS along with a letter delineating
the data setnamesand volume/serialnumbersof the files being retumed. The
letter shouldreferencethe DUA numberand studyname. This letter and the
data shouldbe sentto the following address:
Centersfor Medicare& MedicaidServices
CMS DataCenter
North Building
Area
Attention: Data Release
7500SecurityBoulevard
Baltimore,Maryland 21244-1850;
or
b.
Destroydataand provide a letter CMS on your organization'sletterhead
certifuing that this actionhastakenplace. This letter must also referencethe
DUA number and studynameand delineatethe datasetnamesand
volume/serialnumbersof the files beingdestroyed.Requestorshould
forward to:
NedBurford, Director DPCDD
Centersfor Medicare& MedicaidServices
Divisionof PrivacyCompliance
DataDevelopment(DPCDD)
EnterpriseDatabases
Group
7500SecurityBoulevard
Mailstop: N2-O4-27
Baltimore,Maryland 2l24/.-l8SO
4.
If the projectis still activeandthe DUA hasexpired,a one (l) yearextensionmay be
granted. The requestfor extensionwill only be grantedif the datawill continueto be
usedfor the original project purposeand the expirationdatehasoccurredwithin the
past year;otherwise,a new DUA must be negotiated.The letter of requestfor
extensionshouldbe directedto the nameand addressin item 3b above.
5.
Pleasevisit our new website,Privacy ProtectedData: RequestPoliciesand
Proceduresat: http ://www.cms.hhs.gov/data/requests/.
179 of 189
DUA#| lsql
DATA USE AGREEMENT
AGREEMENT FOR USE OF
CENTERS FOR MEDICARB & MEDICAID SERVICES (CMS)
DATA CONTAINING INDIVIDUAL-SPE CIFIC INFORMATIOT9
ln orderto securedatathat residesin a CMS PrivacyAct Systemof Records,andin orderto
ensurethe integrity,security,andconfidentialityof informationmaintainedby the CMS, andto
permitappropriatedisclosureanduseof suchdataaspermittedby law, CMS andIntemational
EpidemiolosyInstituteenterinto this agreement
to complywith the following specific
paragraphs.
1.
This Agreementis by andbetweenthe Centersfor Medicare& MedicaidServices(CMS),
a componentof the U.S. Departmentof HealthandHumanServices(DHHS),and
IntemationalEpidemioloeyInstitute.hereinaftertermed"IJser."
2.
This Agreementaddresses
the conditionsunderwhich CMS will discloseandthe
Userwill obtainandusethe CMS datafile(s) specifiedin section7. This Agreementsupersedes
anyandall agreements
betweenthepartieswith respectto the useof datafrom the files specified
in section7 andpreemptsandoverridesanyinstructions,directions,agreements,
or other
understanding
in or pertainingto anygrantawardor otherprior communicationfrom the
Departmentof HealthandHumanServicesor anyof its components
with respectto the data
specifiedherein. Further,the termsof this Agreementcanbe changedonly by a written
modificationto this Agreementor by thepartiesadoptinga new agreement.The partiesagree
furtherthat instructionsor interpretations
issuedto theUserconcerningthis Agreementor the
dataspecifiedherein,shallnot be valid unlessissuedin writing by the CMS point-of-contact
specifiedin section5 or the CMS signatoryto this Agreementshownin item 23.
The partiesmutuallyagreethat CMS retainsall ownershiprightsto the datafile(s)
3.
referredto in this Agreement,andthat the Userdoesnot obtainanyright, title, or interestin any
of the datafurnishedby CMS.
4.
The partiesmutuallyagreethat the followingnamedindividualis designatedas
Custodianof the file(s) on behalfof theUserandthepersonwill be responsiblefor the
observance
of all conditionsof useandfor establishment
andmaintenance
of security
arrangements
asspecifiedin this Agreementto preventunauthorized
use. The Useragreesto
notify CMS within fifteen(15) daysof anychangeof custodianship.Thepartiesmutuallyagree
thatCMS may disapprovethe appointmentof a custodianor may requirethe appointmentof a
newcustodianat anvtime.
N o . 0 9 3 8 -0 7 3
180 of 189
Page2
SarahSchweitzer
(Name of Custodian)
International Epidemiology Institute
(Company/Organization)
1455ResearchBlvd. Suite 550
(StreetAddress)
Rockville.MD 20850
(CitylStatelZlPCode)
(301)5 [email protected]
(PhoneNo. - IncludingAreaCodeandE-Mail Address,If Applicable)
5.
Thepartiesmutually agreethatthe following namedindividualwill be designated
as
point-of-contactfor theAgreementon behalfof CMS.
4eanni? Vluw<
(Name of Contact)
\\.et lib, 0"lk-tiv.,rntr
*ot rt a}j\x-
.,,? Rfvd
kc
lSDr;
(StreetAddress)
!1-4
'7')
(Mail Stop)
(City/StatelZlf_ Code)
JPk'iruqr ocn"s l''ht2n
$o$sssssssssssssssfu-'{}"r
(PhoneNo. lncluding Area Code and E-Mail Address,If Applicable)
6.
The User represents,and in furnishing the data file(s) specified in section 7 CMS relies
upon suchrepresentation,
that suchdatafrle(s) will be usedsolely for the following purpose(s).
Our study. entitled "An Epidemiologic Study of the RocketdyneWork Force" seeksto identify
the entire Rocketdynework force employedsince 1950 and to updatevital statusinformation for
all cohort members. CMS data files will be used to obtain vital status(alive or dead) and. where
applicable.datesof deathfor cohort members. All information will remain confidential. No
individual information will be reportedin any report or manuscript. Only agereeatedata will be
reported.
181 of 189
Page3
TheUserrepresents
furtherthatthe factsandstatements
madein anystudyor research
protocolor projectplan submittedto CMS for eachpurposearecompleteandaccurate.Further,
the Userrepresents
that saidstudyprotocol(s)or projectplans,ashavebeenapprovedby CMS or
otherappropriateentityasCMS may determine,represent
the total use(s)to which the datafile(s)
specifiedin section7 will be put.
TheUserrepresents
furtherthat,exceptasspecifiedin an Attachmentto this Agreement
or exceptasCMS shallauthoize inwriting, theUsershallnot disclose,release,reveal,show,
sell,rent,lease,loan,or otherwisegrantaccessto the datacoveredby this Agreementto any
person.The Useragreesthat,within theUserorganization,accessto the datacoveredby this
Agreementshallbe limited to theminimumnumberof individualsnecessary
to achievethe
purposestatedin this sectionandto thoseindividualson a need-to-knowbasisonly.
7.
The following CMS datafile(s) is/arecoveredunderthis Agreement.
File
Vital StatusFiles
File
SSNConversion
Year(s)
Current
The partiesmutually agreethatthe aforesaidfile(s) (and/orany derivativefile(s) [includes
8.
anyfile thatmaintainsor continuesidentificationof individuals])maybe retainedby theUseruntil
September30. 2008,hereinafterknown as the "retentiondate." The User agreesto notiff CMS
within 30 daysof the completionof thepurposespecifiedin section6 if thepurposeis completed
beforethe aforementioned
retentiondate. Upon suchnoticeor retentiondate,whicheveroccurs
sooner,CMS will notiff the Usereitherto returnall datafiles to CMS at the User'sexpenseor to
destroysuchdata. If CMS electsto havethe Userdestroythe data,the User agreesto certi$rthe
destructionof the files in writing within 30 daysof receivingCMS's instruction. A statement
certiffing this actionmustbe sentto CMS. If CMS electsto havethedatareturned,theUseragrees
to returnall files to CMS within 30 daysof receivingnoticeto that effect. The Useragreesthatno
datafrom CMS records,or anypartsthereol shallbe retainedwhenthe aforementioned
file(s) are
returnedor destroyedunlessauthorizationin writing for the retentionof such file(s) has been
in item number23 of this
receivedfrom the appropriateSystemsManageror thepersondesignated
thatstringentadherence
Agreement.TheUseracknowledges
to theaforementioned
retentiondateis
required,andthattheUsershallaskCMS for instructionsunderthis paragraphif instructionshave
not beenreceivedafter30 daysaftertheretentiondate.
The Agreementmaybe terminatedby eitherparty at anytime for anyreasonupon30 days
writtennotice. Upon suchnotice,CMS will ceasereleasingdatato the Userunderthis
Agreementandwill notiff the Usereitherto returnall previouslyreleaseddatafiles
Page4
182 of 189
to CMS at the User's expenseor destroy such data, using the sameproceduresstatedin the above
paragraphof this section. Sections3, 6, 8, II,12,13,14,16,17 and 18 shall survivetermination
of this Agreement.
The User agreesto establishappropriateadministrative, technical, and physical
9.
safeguardsto protect the confidentiality of the data and to prevent unauthorizeduse or accessto
it. The safeguardsshall provide a level and scopeof security that is not less than the level and
scopeof security establishedby the Office of Managementand Budget (OlvB) in OMB Circular
No. 4-130, Appendix Ill-Securitv of FederalAutomated Information Systems
(http://www.whitehouse.gov/omb/circularsial30/a13O.html),which setsforth guidelines for
security plans for automatedinformation systemsin Federalagencies. The User acknowledges
that the use of unsecuredtelecommunications,including the Internet, to transmit
individually identifiable or deducible information derived from the file(s) specified in section 7 is
prohibited. Further, the User agreesthat the data must not be physically moved or transmittedin
any way from the site indicated in item number 4 without written approval from CMS.
The User agreesthat the authorizedrepresentativesof CMS or DHHS Office of the
10.
InspectorGeneralwill be granted accessto premiseswhere the aforesaidfile(s) are kept for the
purposeof inspecting security a:rangementsconfirming whether the User is in compliance with
the security requirementsspecified in paragraph9.
The User agreesthat no findings, listing, or information derived from the file(s) specified
11,
in section 7, with or without identifiers, may be releasedif such findings, listing, or information
contain any combination of data elementsthat might allow the deduction of a beneficiary's
identification without first obtaining written authorization from the appropriateSystemManager
or the person designatedin item number 23 of this Agreement. Examples of such data elements
include but are not limited to geographicindicator, age,sex, diagnosis,procedure,
admission/dischargedate(s),or date of death. The User agreesfurther that CMS shall be the sole
judge as to whether any finding, listing, information, or any combination of data extractedor
derived from CMS's files identifies or would, with reasonableeffort, permit one to identiff an
individual or to deducethe identity of an individual to a reasonabledegreeof certainty.
The User agreesthat, absentexpresswritten authorization from the appropriate System
12.
Manager or the person designatedin item number 23 of this Agreement to do so, the User shall
make no attempt to link records included in the file(s) specified in section 7 to any other
identifiable sourceof information. This includes attemptsto link to other CMS data file(s). The
inclusion of linkage of specific files in a study protocol approvedin accordancewith section6 is
consideredexpresswritten authorization from CMS.
The User agreesto submit to CMS a copy of all findings within 30 days of making such
13.
findings. The parties mutually agreethat the User has made findings with respectto the data
coveredby this Agreement when the User preparesany report or other writing for submissionto
any third party (including but not limited to any manuscript to be submitted for publication)
conceming any purpose specified in section 6 (regardlessof whether the report or other writing
expresslyrefersto suchpurpose,to CMS, or to the files specifiedin sectionT or any dataderived
from such files). The User agreesnot to submit such findings to any third party until
Page5
183 of 189
recelvtngCMS's approvalto do so. CMS agreesto makedeterminationaboutapprovalandto
notify theuserwithin 4 to 6 weeksafterreceiptof findings. CMS reviewof the findingsis for
the solepurposeof assuringthat dataconfidentialityis maintainedandthat individual
couldnot be identified. CMS may withholdapprovalfor publicationonly if it
beneficiaries
mayresultin identificationof individual
that the formatin which dataarepresented
determines
The Useragreesfurtherto submitits findingsto the NationalTechnical
beneficiaries.
InformationService(NTIS, 5285PortRoyalRoad,Springfield,Virginia 22161)within 30 days
of receivingnoticefrom CMS to do so.
andagreesthat theymaynot reuseoriginalor derivativedatafile(s)
14. The Userunderstands
in
withoutprior written approvalfrom the appropriateSystemManageror the persondesignated
section22 of this Agreement.
15. Thepartiesmutuallyagreethat the following specifiedAttachmentsarepart of this
Agreement:
The User agreesthat in the event CMS determinesor has a reasonablebelief that the User
16.
has made or may have made disclosureof the aforesaidfile(s) that is not authorizedby this
Agreementor other written authorization from the appropriateSystemManager or the person
designatedin item number 23 of this Agreement, CMS in its sole discretion may require the User
to: (a) promptly investigate and report to CMS the User's determinationsregarding any alleged
or actual unauthorizeddisclosure,(b) promptly resolve any problems identified by the
investigation; (c) if requestedby CMS, submit a formal responseto an allegation of unauthorized
disclosure;(d) if requestedby CMS, submit a corrective action plan with stepsdesignedto
prevent any future unauthorizeddisclosures;and (e) if requestedby CMS, return data files to
CMS. The User understandsthat as a result of CMS's determinationor reasonablebelief that
unauthorizeddisclosureshave taken place, CMS may refuseto releasefurther CMS data to the
User for a period of time to be determinedby CMS.
t7.
The User herebyacknowledgesthat criminal penaltiesunder $1106(a)of the Social
Security Act (42 U.S.C. S 1306(a)),including a fine not exceeding$10,000or imprisonmentnot
exceeding5 years,or both, may apply with to disclosuresof information that are coveredby
S I106 and that are not authorizedby regulation or by Federallaw. The User further
acknowledgesthat criminal penaltiesunderthe Privacy Act (5 U.S.C. $ 552a(i) (3)) may apply if
it is determinedthat the Requestoror Custodian,or any individual employed or affiliated
therewith, knowingly and willfully obtainedthe file(s) under false pretenses. Any person found
guilty under the Privacy Act shall be guilty of a misdemeanorand fined not more than $5,000.
Finally, the User acknowledgesthat criminal penaltiesmay be imposedunder 18 U.S.C. S 641 if
it is determinedthat the User, or any individual employed or affiliated therewith, has taken or
convertedto his own use data file(s), or received the file(s) knowing that they were stolen or
converted. Under such circumstances,they shall be fined under Title t8 or imprisoned not more
than ten years,or both; but if the value of such property doesnot exceedthe sum of $ I ,000, they
184 of 189
Page6
shall be fined under Title l8 or imprisoned not more than one year, or both.
18.
By signing this Agreement,the User agreesto abide by all provisions set out in
this Agreement for protection of the data file(s) specified in section 7, and acknowledgeshaving
receivednotice of potential criminal or administrative penalties for violation of the terms of the
Agreement.
19.
On behalf of the User the undersignedindividual hereby atteststhat he or she is
authorizedto enter into this Agreement and agreesto all the terms specified herein.
(NameandTitle of Individual- Typedor Printed)
InternationalEpidemiolog.vInstitute
(Company/Organization)
1455Research
Blvd. Suite550
(StreetAddress)
Rockville.MD 20850
(CitylStatelZlPCode)
(301)[email protected]
@honeNo. - lncludingAreaCodeandE-Mail Address,If Applicable)
7a B**a
7n s<
(Date)
gnature)
20.
2oa 3
his/herappointmentas
Custodian,asnamedin paragraph4, herebyacknowledges
Custodianof the aforesaidfile(s) on behalf of the User, and agreesto comply with all of the
provisions of this Agreement on behalf of the User.
SarahSchweitzer.Biostatistician
(Typedor PrintedNameandTitle of Custodianof File(s)
(Signature)
s./
?
(Date)
185 of 189
PageT
The disclosureprovision(s)thatallowsthe discretionaryreleaseof CMS datafor the
2I.
purpose(s)statedin paragraph6 follow(s).(To be completedby CMS staff.)
individual
theundersigned
22.
On behalfof
herebyacknowledges
that the aforesaidFederalagencysponsorsor otherwisesupportstheUser's
requestfor anduseof CMS data,agreesto supportCMS in ensuringthat theUsermaintainsand
with thetermsof this Agteement,andagreesfurtherto makeno
usesCMS's datain accordance
statementto theUserconcerningthe interpretationof the termsof this Agreementandto referall
questionof suchinterpretationor compliancewith the termsof this Agteementto the CMS
official namedin item number23 (or to his or her successor).
(Typedor PrintedNameandTitle of FederalRepresentative)
(Signature)
(Date)
(PhoneNo. - Including Area Code and E-Mail Address, If Applicable)
individualherebyatteststhat he or she is authorized
23.
On behalfof CMS the undersigned
the terms
specifiedherein.
rp thrs
this Agreement
Agreementand
andagrees
agreesto all the
termssp
to enter
enterinJo
t
fuanrutt{,Qlt,,h
z( lkallh
(Typed or Printed Name and Title
If, crarlfi
CMS Representative)
According to the Paperwork Reduction Act of I 995, no personsare required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is 09384734. The time required to complete this
information collection is estimatedto average30 minutes per response,including the time to review instructions, search existing data resources,
gather the data needed,and complete and review the information collection. If you have any comments conceming the accuracy of the time
estimate(s)or suggestionsfor improving this form, pleasewrite to: CMS, 7500 Security Boulevard, N2-14-26, Baltimore, Maryland 2l24y'.1850
and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, D.C. 20503.
MEMORANDUM
OF UNDERSTANDING
AMONG
186 of 189
THE UNITED STATES AIR FORCE
AND
THE BOEING COMPANY
AND
THE INTERNATIONAL EPIDEMIOLOGY INSTITUTE
The United StatesAir Force(USAF), the BoeingCompany(Boeing),and the International
"Parties":
EpidemiologyInstitute(IEI), hereafterthe
Noting that IEI is conductinga studyinvolvingover 55,000workersemployedat the
Rocketdynefacilitiesin California(now ownedby Boeing),to evaluatethe cancerrisk
with occupationalexposuresto ionizingradiation;
associated
Noting that the IEI RocketdyneWorker Studyhasa documentedprotocolthat requireseach
worker'sradiationdoseto be as completeas possibleover the worker'sentirecareer;
Noting that the RocketdyneWorker Studyincludesworkerswho subsequently
wereemployed
in the United Statesmilitary,includingthe USAF; and
"for
Noting that the USAF maintainsradiationdosimetryrecords
usein epidemiological
and
statisticalstudiesto determinethe effectiveness
of Air Forcewide radiologicalhealth
programs,trendsin exposuredoses,exposureexperienceof selectedoccupationalgroupsand
similar studies;
Noting that the USAF radiationdosimetryrecordsarePrivacy Act protecteddatato be treated
with the PrivacyAct; and
in accordance
Noting that IEI, which hasthe approvalof the Departmentof Energyof the United States,the
NuclearRegulatoryCommission,U.S, NationalDeathIndex,andthe InstitutionalReview
Boardsof the BoeingCompany,VanderbiltUniversityand the Oak RidgeNational
Laboratoryto participateand conductthe RocketdyneWorker Study,is responsiblefor
preparingthe vital statusand dosimetryanalysisfiles,
Have agreedas follows:
I.
Purpose
A. The purposeof this Memorandumof Understandingis to provide a frameworkfor USAF
to contributedatafrom the USAF Centerfor RadiationDosimetry,to provideascomplete
informationas possibleon the total careerradiationdosefor eachU.S. radiationworker
includedin the RocketdyneWorker Study.
Page I of 3
RocketdyneWorker Studywill provideadditional
B, The Partiesexpectthat a successful
187 of 189
informationof potentialhealthrisk at low dosesand low doseratesof occupational
exposure.
II. Implementing Provisions
A. Pursuantto the PrivacyAct, 5 U.S.C.552a(b)(3),and in accordwith the applicablesystem
noticewhich permitsdisclosurefor usein epidemiologicaland statisticalstudies,the
USAF shallprovideIEI and Boeingwith dosimetryinformation,as recordedin theUSAF
Centerfor RadiationDosimetry,for eachworkeridentifiedas beingincludedin the
RocketdyneWorker Study.
with the PrivacyAct
B. IEI and Boeingshalltreatthe USAF radiationrecordsin accordance
and agreethat therewill be no disclosureof any PrivacyAct information.
C. IEI and Boeingshall usethis informationonly for the abovedescribedresearchpurposes.
D. IEI and Boeingshallmaintainthe confidentialityof the subjectinformationandmakeno
disclosureof it to third partieswithout the prior writtenconsentof the USAF. If, during
the examinationof USAF-provideddata,efforsor omissionsare found and corrected,
thesecorrecteddatashallbe providedbackto the USAF Centerfor RadiationDosimetry.
E. IEI and Boeing'sobligationto maintainthe confidentialityof the USAF-provided
information shall remain in effect throughoutthe term of this Memorandumof
Understanding
and afterits termination,unlessand until the saidinformationand all
copiesthereofare returnedto USAF.
III. Contacts
The principalcontactfor USAF is Lt Col ScottNichelson,Air ForceInstitutefor Operational
Health(AFIOH) RadiationSurveillanceDivision. The principalcontactfor Boeingis Mr.
SteveLafflam, Boeing,SantaSusannaField Station. The principalcontactfor IEI is Dr. John
D. Boice,Jr., ScientificDirector.
IV. Management
The Partiesshallconsulteachotherwhenevertheydeemit necessary,
and shallassess
the
resultsof the work carriedout and in progress.
V. General Provisions
A. This Memorandumof Understanding
shallbecomeeffectiveuponsignatureby all
Parties,and shall remain in effect for one year. The Partiesmay extendthis
Memorandumof Understandingfor additionalperiods.
B. The termsof this Memorandumof Understanding
may be alteredin writing by the
Parties.If any Partywishesto ceaseits activitiesunderthis Memorandumof
Understanding,
it shallgive ninety(90) daysadvancewrittennoticeto the other
Parties.
Pase2 of 3
FEB-aS O4 It=36
FROl"l:AZ?Z,276?
1818585514a
TO:3at 5I7 4A63
PFGEA
: A
188 of 189
C . Cooperarionunder this Memortrndumof Understandingshull be in accordancewith the
applicublelaws and regulutionsunder which eachPirty opcrates.
D . Unless otherwiseagreedin writing, eachParty shall assumeresponsibilityfor, and provide
funclingro cover, the costsindividually incurred in participatingin the collaboration
contemplutedby this Memorandumof Understanding.The collaborativeactivitiesare
subjectto the availability of funds and Slersonnel.
FOR THE I]NITED STA
AIR T.ORCE:
nate:(2 tr&0(
AssistantSurgeonGenoral,Health Cure Operations
Office of the SurgeonGeneral
Bolling AFB, DC
FOR THE IIOEING COMPANY:
*'-W
''
Date: Y
lzd ol
Stevel"afflam
Division Director, Safety,Health & Environmental Affaire
CanogaPark, CA
I-OR THE INTERNATIONA,L EPIDEMIOLOGY
INSTITUTE:
,0*>a,2,.;,
Date: ;Ls 4J
Jea/
Dr. John D. Boice,
ScientiflrcDirector
Rockville,MD
Attachments
Approval from the Depirrtment of Energy fbr linkage with their dosimctry records (Oct 2003)
Approvul from Nuclear RegulntoryCommissionfor linkage with their dosimetry records
Study description(PHS 398. Page2)
Letter of supportfrom SteveLafflam, Division Director, Safety,Health & EnvironmentalAffairs.
Rockctdyne, The Boeing Company
InstitutionalReview Board approvalfrorn Vanderbilt University
lnstitutional Review Board approvalfronr The Boeing Company
InstitutionalReview Board approvaltrom Oak Ridge National Laboratory
Approval from the Nntional Cent€r for Health Stutistics for mortality linkage
Approval frorn the Social Security Administration for vital statuslinkage
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