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7 Nov 2011 Opposition to CBER Motion to Deny Hearing and for ASJ With Supporting Memo

7 Nov 2011 Opposition to CBER Motion to Deny Hearing and for ASJ With Supporting Memo

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Published by: Cause of Action on Jun 26, 2012
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04/08/2013

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INTHEMATTEROFTRENTC.ARSENAULT38068CanyonHeightsDriveFremont,California94536
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)
)
)))
DocketNo.DEPARTMENTOFHEALTHANDHUMANSERVICESFOODANDDRUGADMINISTRATIONTRENTARSENAULT'SOPPOSITIONTOCBER'SMOTIONTODENYMR.ARSENAULT'SREQUESTFORAHEARING
&
FORADMINISTRATIVESUMMARYJUDGMENTANDCROSS-MOTIONFORADMINISTRATIVESUMMARYJUDGMENTMr.TrentArsenault,byandthroughtheundersignedcounsel,herebyfilesthisoppositiontotheCenterforBiologicsEvaluationandResearch'smotiontodenyhisrequestforahearingandforadministrativesummaryjudgmentandalsocross-movesforadministrativesummaryjudgment.
In
supportthereof,hestatesasfollows:1.OnNovember1,2010,theCenterforBiologicsEvaluationandResearch(hereinafter"CBER")deliveredanOrdertoCeaseManufacturingofHCT/Ps(hereinafter"Order")..2.TheOrderspecifiedthatitsbasiswasMr.Arsenault'slackof"compliancewiththeregulationsin21C.F.R.
§
1271."Orderat
1.
3.11r.ArsenaultwrotealetteronNovember1,2010toBarbaraCassensandMaryMalarkeyoftheFDA,requestingahearinginaccordancewith21C.F.R.§1271.440(e)and21C.F.R.
§
16.Mr.Arsenaultstatedthathecouldprovidedocumentationbyandtestimonyfromwomentowhomhehaddonatedsementosubstantiatetheassertionthathewasasexuallyintimatepartner(hereinafter"SIP',)ofthosewomen,andtherebywasexemptfromtheregulatoryrequirementsapplicabletodirecteddonorsunder21C.F.R.§1271.
1
 
4.OnFebruary7,2011,CBER:filedamotionarguingthatnogenuineandsubstantialissueAmberTaylorSeniorAttorneyCauseofActionoffactexistsandthereforeMr.Arsenault'srequestforahearingshouldbedenied.5.However,anevidentiaryhearingunderPart16isrequiredtodetermine,basedonthecontentandcredibilityofstatementsfromMr.Arsenaultandthedonees,thefactualquestionofwhetherMr.ArsenaultandhisdoneeswereSIPs.6.Alternatively,Mr.Arsenaultmovesforadministrativesummaryjudgmentunder21C.F.R.
§
16.26(a)onthegroundthatthefactscurrentlyontherecordsupportMr.Arsenault'scontentionthat,becauseofMr.Arsenault'sstatusasanSIP,theOrderwasissuedinerror.7.Mr.ArsenaultalsomovesforrescindmentoftheOrderbecauseitconstitutesanarbitraryandcapriciousapplicationofthelaw,itsissuancefailedtocomportwithconstitutionalrequirementsforproceduraldueprocess,anditseffectunconstitutionallyburdens
111'.
Arsenault'sexerciseoffundamentalrights.Respectfullysubmitted,
d..4-~
Date:November7,2011
2
 
INTHEMATTEROFTRENTC.ARSENAULT38068CanyonHeightsDriveFremont,California94536
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)
)
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DocketNo.
DEPARTMENTOFHEALTHANDHUMANSERVICESFOODANDDRUGADMINISTRATIONMEMORANDUMINSUPPORTOFTRENTARSENAULT'SOPPOSITIONTOCBER'SMOTIONTODENYMR.ARSENAULT'SREQUESTFORAHEARING
&
FORADMINISTRATIVE
SUMMARYJUDGMENTANDCROSS-MOTIONFORADMINISTRATIVE
SUMMARY
JUDGMENT
1
TrentArsenaultisaprivateindividualwhodonatesfreshsemen,'onanuncompensatedbasis,towomenwhowishtoconceiveachild.Mr.Arsenaultprovidespotentialdoneeswithsubstantialinformationabouthispersonalandmedicalhistory,includingthecurrentandhistoricalresultsoftestsforcommunicablediseasesorinfections.Ifthedoneeissatisfiedbythesedisclosures,Mr.Arsenaultprovidesfreshsementothewomanwiththehopethatthiswillleadtoconceptionandbirth.Shouldthisbesuccessful,Mr.Arsenaultandthemotherwillhavealifelongconnectionthatallowsthechildtoknowboththefather'sidentityandhealthstatusthroughoutthechild'slife.CBER,however,hasattemptedtointerveneinthisprocess.CBERarguesthatbecauseMr.Arsenaultdeliversthesemeninalabeledreceptacleforartificialinsemination,asopposedtonaturalinsemination.'Mr.Arsenaultcannotfatherchildrenusingthismutually-agreed-uponmethod.Instead,Mr.Arsenaultmustcomplywithapanoplyoffederalregulationsthatwouldmakeitimpossibleforhimtoprovidefreshsementowillingdoneesbecauseheisa
1
Manywomenprefertousefreshsemeninsteadofpreviously-frozensemen,believingthatdoingsomaxhnizesthechanceofconception.
2
Manyuncompensatedsemendonorsaccomplishinseminationviaanactofsexualintercourse.Tillsisreferredtoas"naturalinsemination."

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