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RE:
Request for Public Comment of Draft Version 1.0 of the Proposal Review Process
PTACProposalReviewProcess
Draftversion1.0forPublicCommentAllComponentsSubjecttoChange
April20,2016
PhaseI:ProposalPreparationandSubmission
1. RequestforProposals:OnceSecretarialcriteriaarefinalized,thePTACwillissueaRequestfor
ProposalsincludingaproposaltemplateandinstructionsforPFPMproposalpreparationand
submissionguidelines.
a. Noletterofintentwillberequired.StakeholdersmaysendthePTACinformational
materialspriortothecriteriabeingfinalized,butwithnoexpectationof
review/response.Stakeholderswillberequiredtosubmitaformalproposalafterthe
CommitteeissuesitsRequestforProposalsregardlessofwhethertheyhavesubmitted
informationalmaterialsinadvanceornot.
b. Voluntarysubmissiontimelineswillbeincludedininstructions,forexample:proposals
submitted[xweeks]priortoanupcomingmeetingwilllikelybereviewedatthat
meeting,proposalssubmitted[lessthanxweeks]priortoameetingareunlikelytobe
considered.
c. Contentofproposals:OnceSecretarialcriteriaareavailable,theCommitteewillworkto
identifywhatinformationstakeholderswillbeaskedtoincludeintheirproposal
submissions.
d. Generaltechnicalassistancewillbeofferedonanongoingbasis,intheformof
webinars,whitepapers,etc.
2. ProposalSubmission:Stakeholderswillprepareandsubmitproposals.
a. Submissionswillbeacceptedonanongoingbasisoncecriteriaarefinalized.
3. ProposalReceiptandEvaluationforCompleteness:Uponreceiptofaproposal,ASPEstaffwill
evaluateproposalsforcompletenessandadherencetoPTACproposalpreparationguidelines.
a. APTACmemberwillreviewtheproposalforconfirmationifinitialreviewsuggestsitis
incompleteornonadherent.
b. Incompleteornonadherentproposalswillbereturnedtothesubmitterwithin30days
withtheopportunitytoreviseandresubmit.
c. Acompleteandadherentproposalwilladvancetopreliminaryreview.
d. Foreachproposalthatadvances,theCommitteewillidentifyconflictsofinterestand
willmakeadecisionabouteachmembersparticipationinthereviewprocess.
PhaseII:PreliminaryReview
4. Preliminaryreviewersassembled:PTACstaffwillassigncompleteproposalsto[23]PTAC
Committeemembersforpreliminaryreview.
a. ProposalswillbedistributedamongallCommitteemembers,excludingthose
determinedtohaveaconflictofinterestfortheproposalbeingreviewed.
b. Eachteamwillhaveatleastonephysician.
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PTACProposalReviewProcess
Draftversion1.0forPublicCommentAllComponentsSubjecttoChange
April20,2016
c. Committeememberswillbeassignedtoreviewteamsof[23]people;withineach
team,eachproposalwillbeassignedaleadreviewerandtheotherteammemberswill
serveascoreviewers.Leadreviewersmaybeassignedaccordingtoexpertise.
d. TeamsarefreetoseekcounselfromotherPTACmembersorASPE/HHSstaffwith
specificexpertise.
5. Preliminaryreview:Reviewwillbeguidedbyproposalreviewcriteriaestablishedbythe
Secretary.
a. AssignedCommitteemembersmaycompletethereviewinternally,and/ormayrequest
additionalinputfromexternaltechnicalexpertstoassistintheirreview.
b. Ifpreliminaryreviewershavequestionsaboutaproposal,submitterswillbeinvitedto
respondinwriting.TheCommitteemaydecidetoinvitesubmitterstorespondduringa
dedicatednonpublicsession[eitherinpersonorbyphone].
c. Proposalswillbescoredaccordingtoastandardizedscoringmethodology(tobe
developed).ScoreswillbeusedtoinformtheCommitteesoverallevaluationof
proposals;however,scoresalonewillnotbedeterminativeindevelopingcommentsand
recommendationsfortheSecretary.
d. Proposalsdeterminedduringpreliminaryreviewtobetechnicallydeficientwillbe
returnedtosubmittersforrevisionandresubmission.
i. Targetedtechnicalassistancemaybeprovidedtosubmittersusing(someorall
of)thefollowingapproaches:
1. Writtensummariesofdeficienciesand/orweaknesseswillbereturned
tosubmitterstoassisttheminrevisionandresubmission.
2. SubmitterswillhaveanassignedPTACstaffprogramofficer,whowillbe
availabletoanswerquestionsaboutthecommentsprovidedandthe
processforrevisionsandresubmission.
3. SubmittersmayreceiveguidancefromPTACreviewersonapproaches
tocorrectdeficienciesand/orweaknesses.
e. Proposalsconsideredtohavenotechnicaldeficiencieswillbeadvanceddirectlytothe
fullCommittee.
f. Publiccommentwillbesolicitedonlyonproposalsthatwillbeconsideredbythefull
Committee;proposalsreturnedtosubmittersforrevisionwillnotbepostedforpublic
commentuntilafterresubmission.
g. Afterpreliminaryreview,theleadreviewerandASPEstaffwillcompilepreliminary
reviewscoring,comments&recommendations,andpubliccommentsintheformofa
decisionmemorandumforthefullCommitteetoreview.
PTACProposalReviewProcess
Draftversion1.0forPublicCommentAllComponentsSubjecttoChange
April20,2016
PhaseIII:FullCommitteeReview
6. FullCommitteereview:EachCommitteememberwillreviewtheproposalandresultsfrom
thepreliminaryreview.
a. IfPTACmembershavequestionsaboutaproposal,submitterswillbeinvitedtorespond
inwriting.TheCommitteemaydecidetoinvitesubmitterstorespondduringa
dedicatednonpublicsession[eitherinpersonorbyphone].
7. Publicmeetingpresentationanddeliberation:Proposalswillbepresentedtothefull
Committeeduringapublicmeeting.
a. Everysubmittedproposalthatiscompleteandhasnotechnicaldeficiencieswillbe
consideredduringapublicmeeting.
b. Ingeneral,proposalswillbeconsideredintheorderinwhichtheyarereceived,but
dependingonvolume,proposalsthathavesimilargoalsorapproachesmaybereviewed
asagroup.
c. Theleadreviewerfromthepreliminaryreviewteamwillmakeabriefpresentation
summarizingtheproposalandcommentsandrecommendationsfromthepreliminary
reviewteam.
d. TheCommitteewillhaveaperiodofdeliberationontheproposal,duringwhich
Committeemembersmaycommentontheproposalaswellassuggest
recommendationstheCommitteeshouldmake.
e. Attheconclusionofthedeliberationperiod,thefullCommitteewillmakeadecisionon
theproposalunderconsideration.Decisionsmayinclude:
i. Recommendhighpriorityforimplementation
ii. Recommend
iii. Doesnotmeetcriteriabutdesirabletoimplement
iv. Requiresadditionalanalysisorinformation
v. Donotrecommend,butencouragerevisionandresubmission
vi. Donotrecommend
8. CommentsandRecommendations:ThefullCommitteewillfinalizecommentsand
recommendationsandadvancethemtotheSecretary.
a. TheleadreviewerfromthepreliminaryreviewteamandASPEstaffwillrevisethe
preliminarycommentsandrecommendationstoreflectfullCommitteedeliberation.
FinalcommentsandrecommendationswillberecirculatedtotheCommitteefor
approvalpriortobeingsubmittedtotheSecretary.Finalcommentsmayincludeboth
majorityandminorityopinion(s)asapplicable.