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10cpiBold.xÐðAp`Univers(((3â©$¤¤Ý ƒ+¤T!ÝÓ  ÓÝ  Ýà  àòòÚ  Ú0Ú  Úóó(#Ã$òòÚ  Ú0Ú  ÚóóB1ž21, 2, 3,NumbersÚƒ7ÚÚ  Ú.Û€7Ûà0 à1, 2, 3,Level 1Level 2Level 3Level 4Level 5ÿU‹ÿÀÀÀ(@øÐ Z ‹6Times New Roman Regular(@øÐ Z ‹6Times New Roman RegularÝ ƒ+¤T!ÝÓ  ÓÝ  Ý›ÓÓÑ8€šUXXdÈdÈ8ÑÌÔ€?X2XXXÔÌÌÔ‡?èçX?X2Ôò òà@‡ ‡ ìàTÔ#†?X2Xç?è”#ÔÔ‡?èçX?X2ÔHE€ADVISORY€COMMITTEEˆÐ ð @ Ðà@ññ)ìàONˆÌà@‡‡ìàIMMUNIZATION€PRACTICES€(¢ACIP£)ˆÌÌÌà@ ìàPOLICIES€AND€PROCEDURESˆÌà@ÞÞìàFOR€DEVELOPMENT€OF€RECOMMENDATIONS€ˆÌà@» » "ìà€FOR€VACCINE€USEˆÌ€à@BB$ìàÔ‡>èçç?èÔANDÔ#†?èçç>è#ÔÔ#†?X2Xç?èì#ÔÔ‡?èçX?X2Ô€FOR€THE€ˆÐ p"À Ðà@  ìàVACCINES€FOR€CHILDREN€ˆÌó óÔ#†?X2Xç?è‚#ÔÌÌà@ÔÔ%ìàò òñú ñJULY,€ñú ññú ñFEBRUA¢RY£€,ñú ñ€1998ó óˆÐ @,' ÐÓÓà@µµ"ìàò òTABLE€OF€CONTENTSó óˆÐ ° ÐÌ€€I.€€Development€of€¢ACIP£€Recommendations€for€UseÌà  à€of€Vaccine€and€related€Biological€ProductsÌ€€€€€A.€€Purpose..................................................................................................................à Ð à€3Ð `° Ѐ€€€€€B.€€Membership...........................................................................................................à Ð à€3Ð L œ Ѐ€€€€€C.€€Member€ResponsibilitiesÌà  àà ` à1.€€Attendance€at€Meetings........................................................................à Ð à€5€Ð $ t Ðà  àà ` à2.€€¢ACIP£€Related€Contacts.........................................................................à Ð à€5Ð  ` Ðà  àà ` à3.€€Media€Interaction..................................................................................à Ð à€5Ð ü L  Ðà  à€D.€€¢Electronc£€Recording€by€Public€Media.............................................................à Ð à€6Ð è 8  Ðà  à€E.€€Financial€InterestsÌà  àà ` à1.€€Prohibition............................................................................................à Ð à€6Ð À  Ðà  àà ` à2.€€Inherent€Potential..................................................................................à Ð à€7Ð ¬ü  Ðà  àà ` à3.€€Waivers.................................................................................................à Ð à€7Ð ˜è  Ðà  àà ` à4.€€Integrity€of€Committee..........................................................................à Ð à€7Ð „Ô  Ðà  àà ` à€€€€€a.€€Scope€of€Waivers.............................................................................à Ð à€7Ð pÀ Ðà  àà ` à€€€€€b.€€Current€Financial€Interest.................................................................à Ð à€7Ð \¬ Ðà  àà ` à€€€€€c.€€€Direct€Financial€Interest..................................................................à Ð à€7Ð H˜ Ðà  àà ` à5.€€Financial€Disclosures€by€Members........................................................à Ð à€7Ð 4„ Ðà  àà ` à6.€€Disclosure€Not€Required€„€Ìà  àà ` àà ¸ àUncontrolled€interests.....................................................................à Ð à€8Ð  \ Ðà  àà ` à7.€€De€Minimus€Financial€Interest€„€€Honoraria€and€Ìà  àà ` àà ¸ àTravel€Support€for€Scientific€Interchange.......................................à Ð à€8Ð ä4 Ðà  àà ` à8.€€Voting€Restrictions...............................................................................à Ð à€8Ð Ð  Ðà  à€F.€€Selection€of€Topics..........................................................................................à Ð à€8Ð ¼  Ðà  à€G.€€Process€for€Developing€Recommendations......................................................à Ð à€9Ð ¨ø Ðà  àà ` à1.€€¢Techncal£€Aspects..................................................................................à Ð à€9€€Ð ”ä Ðà  àà ` à2.€€Policy€Analysis......................................................................................à Ð à11Ð €Ð Ðà  àà ` àà ¸ àa.€€Verify,€define,€and€detail€the€problem.......................................à Ð à11Ð l¼ Ðà  àà ` àà ¸ àb.€€Establish€evaluation€criteria.......................................................à Ð à11Ð X ¨ Ðà  àà ` àà ¸ àc.€€Identify€alternative€policies........................................................à Ð à11Ð D!” Ðà  àà ` àà ¸ àd.€€Evaluate€alternative€policies......................................................à Ð à11Ð 0"€  Ðà  àà ` àà ¸ àe.€€Display€and€distinguish€among€alternative€policies...................à Ð à11Ð #l! Ðà  àà ` à3.€€Resources.............................................................................................à Ð à12Ð $X" Ðà  àà ` à4.€€Developing€the€Recommendations........................................................à Ð à12Ð ô$D # Ðà  à€H.€€Publication€of€Recommendations....................................................................à Ð à12Ð à%0!$ Ðà  à€I.€€Implementation€and€Evaluation€of€the€Recommendations.................................à Ð à13Ð Ì&"% Ðà  à€J.€€Other€issues.....................................................................................................à Ð à13Ð ¸'#& ÐÌ€II.€€¢ACIP£€Recommendations€for€the€Vaccines€for€Children€(¢VFC£)€Program.....................à Ð à13Ð  )à$( ÐÌÌà@„„ìàTHE€ADVISORY€COMMITTEE€ON€IMMUNIZATION€PRACTICES€(¢ACIP£)ˆÌà@: : ìàPOLICIES€AND€PROCEDURES€FOR€DEVELOPMENT€OFˆÌà@²² ìàRECOMMENDATIONS€FOR€VACCINE€USE€AND€FOR€VACCINES€FOR€CHILDRENˆÌÌò òI.à0  àDevelopment€of€¢ACIP£€Recommendations€for€Use€of€Vaccine€and€Related€BiologicalÐ 8 ˆ ÐProductsÐ (#(# ÐÌA.€€Purposeó óÐ ü L  ÐÌà  àThe€¢ACIP£€provides€advice€and€guidance€to€the€Secretary,€the€Assistant€Secretary€forÏHealth,€and€the€Director,€Centers€for€Disease€Control€and€Prevention€(CDC)€on€the€mostÏeffective€means€to€prevent€vaccine„preventable€diseases.€€According€to€its€current€charter,€theÏ¢ACIP£€provides€advice€and€guidance€regarding€the€most€appropriate€application€of€antigens€andÏrelated€agents€(e.g.,€vaccines,€antisera,€immune€globulins)€for€effective€disease€control€in€theÏcivilian€population.€€We€are€proposing€that€the€¢ACIP£€charter€be€modified€to€acknowledge€theÏbroader€scope€of€ACIP€recommendations€(e.g.,€use€of€antivirals,€chemotherapy€or€prophylaxis).€ÏThe€ACIP€develops€written€recommendations,€subject€to€the€approval€of€the€Director,€CDC,€forÏthe€routine€administration€of€vaccines€to€the€pediatric€and€adult€populations,€along€withÏschedules€regarding€the€appropriate€periodicity,€dosage,€and€contraindications€applicable€to€theÏvaccines.€€The€ACIP€is€the€only€entity€in€the€federal€government€which€makes€suchÏrecommendations€taking€into€account€all€available€information€(published€or€unpublished,Ïsubmitted€under€an€IND€or€not)€about€a€vaccine€and€placing€that€information€in€the€larger€contextÏof€the€various€health€care€delivery€systems€in€the€U.S.,€the€current€epidemiology€of€the€disease,Ïimplementation€issues,€ethical€and€legal€constraints,€and€other€factors.€€The€overall€goals€of€theÏACIP€are€to€provide€advice€which€will€assist€the€Department€and€the€Nation€in€reducing€theÏincidence€of€vaccine€preventable€diseases€and€to€increase€the€safe€usage€of€vaccines€and€relatedÏbiological€products,€including€active€and€passive€¢immunoprophylaxis£.€ÌÌ€€€€The€target€populations€for€ACIP€recommendations€are€public€and€private€health€care€providersÏwho€administer€vaccines,€public€and€private€officials€who€make€vaccine€policy,€and€the€generalÏpublic.Ì€Ìò òB.€Membershipó óÐ $X" ÐÌà  àThe€Committee€charter€was€amended€on€May€8,€1997€to€authorize€twelve€regular€votingÏmembers,€selected€by€the€Secretary,€Department€of€Health€and€Human€Services,€from€authoritiesÏwho€are€knowledgeable€in€the€field€of€immunization€practices,€have€multi€disciplinary€expertiseÏin€public€health,€and€have€expertise€in€the€use€of€vaccines€and€immunologic€agents€in€bothÏclinical€and€preventive€medicine.€€ò òÐ )à$( Ðó óà  à¢ACIP£€members€are€selected€based€on€their€expertise€to€contribute€to€the€Committee'sÐ |*Ì%) Ðresponsibilities.€€Departmental€policy€provides€that€committee€membership€be€fairly€balanced€inÏterms€of€points€of€view€represented€and€the€committee's€function.€€Consideration€is€given€toÐ T,¤'+ Ðrepresentation€from€diverse€geographic€areas,€both€genders,€ethnic€and€minority€groups,€and€theÏdisabled.€€Nominees€must€be€U.S.€citizens.ÌÌà  àEach€year,€suggestions€for€regular€voting€members€to€serve€a€4„year€term€are€sought€fromÏa€variety€of€sources€including€current€and€former€ACIP€members,€professional€societies,€vaccineÏmanufacturers,€and€the€general€public.€€These€individuals€are€encouraged€to€contact€members€ofÏtheir€institutions,€professional€organizations,€and€peers€to€develop€a€broad€slate€of€candidates.€€InÏaddition,€suggestions€for€membership€to€the€Committee€are€received€from€various€sources€duringÏthe€year,€and€compiled€for€consideration€at€the€appropriate€time.ÌÌà  àOnce€an€individual€is€submitted€for€possible€nomination€to€the€Committee,€the€name€andÏinformation€received€on€the€candidate€is€held€and€reconsidered€each€time€a€member€needs€to€beÏreplaced.€€The€candidate€€remains€on€the€list€until€withdrawn€or€nominated€to€the€Committee.ÌÌà  àA€listing€of€possible€nominees€to€the€Committee€is€updated€and€submitted€to€the€Chair,ÏACIP;€Executive€Secretary,€ACIP;€Director,€National€Immunization€Program€(NIP);€Director,ÏEpidemiology€and€Surveillance€Division,€NIP;€and€representatives€from€the€National€Center€forÏInfectious€Diseases€and€the€National€Center€for€HIV,€¢STD£€and€TB€Prevention.€€These€individualsÏthen€discuss€the€candidates€for€nomination€to€the€Committee,€and€develop€a€slate€of€possibleÏnominees.€€These€candidates€are€then€contacted€to€determine€their€willingness€to€serve€on€theÏCommittee.€€With€concurrence€of€the€candidate,€the€slate€of€nominees€is€submitted€to€theÏDirector,€CDC€for€permission€to€prepare€the€nomination€package.ÌÌà  àUpon€endorsement€of€the€Director,€CDC,€the€nomination€package€is€prepared€for€theÏSecretary,€¢HHS£.€€If€approved,€the€new€members€are€appointed€to€a€term€of€four€years.€€A€memberÏwho€is€unable€to€fill€the€full€four€year€appointment€to€the€Committee€may€resign€by€submitting€aÏletter€of€resignation.€€When€this€occurs,€a€new€candidate€is€nominated€to€fill€the€remainder€of€theÏunexpired€term€of€the€member€who€has€resigned.€ÌÌñû ññù ñò òñù ññû ñà  àIn€addition€to€the€regular€voting€members,€the€Committee€has€€ex„officio€members€fromÏother€Federal€agenciesñý ñ€(who€may€be€designated€to€vote€in€specific€circumstances€by€theÏExecutive€Secretary)ñý ñ€and€non„voting€liaison€representatives€from€professional€societies€andÏorganizations€responsible€for€the€development€and€execution€of€immunization€programs€forÏchildren€and€adults.€€The€function€of€€ex„officio€members€and€non„voting€liaison€representativesÏis€not€clearly€delineated€in€federal€regulations€or€in€the€Committee€charter.€€However,€in€contrastÏto€ñÿ ñregular€ñÿ ñvoting€members€who€are€expected€to€express€their€òòpersonalóó€òòopinionsóó€on€all€substantiveÐ ô$D # Ðissues€before€the€committee,€ex€officio€and€liaison€members€comments€are€expectedñþ ñ,€to€theÏextent€possible,ñþ ñ€to€òòrepresent€the€position€and€views€of€their€sponsoring€organizationsóó.€€Ex€officioÐ Ì&"% Ðand€liaison€members€are€expected€to€contribute€to€committee€discussions€when€issues€ofÏimportance€to€their€organizations€are€being€discussed€and€when€they€possess€informationÏimportant€to€the€discussion€which€has€not€been€contributed€by€another€member.€€These€membersÏand€others€can€serve€as€appointed€consultants€to€working€groups€and€subcommittees€to€provideÏexpert€advice€and€¢apprise£€the€working€group€of€the€position€their€organization€endorses.ÌÐ T,¤'+ Їò òà  àó óThe€Committee€shall€not€take€a€vote€unless€at€least€seven€members€qualified€to€vote€areÐ ° Ðpresent.€€Whenever€six€or€more€members€are€not€eligible€to€vote€by€reason€of€financial€conflict€ofÏinterest,ñ÷ ñ€the€Executive€Secretary,ñ÷ ññø ññ÷ ñkñ÷ ññø ññ÷ ñ€or€designee,€shall€have€the€authority€to€temporarily€designateÏthe€ex€officio€members€as€voting€members.ñ÷ ñò òÐ tÄ Ðñû ññù ñó óñù ññû ñÌÌC.ó ó€€ò òMember€Responsibilitiesó óÐ 8 ˆ ЀÌà  àò ò1.€Attendance€at€Meetingsó óÐ  d Ðà0  àà ` àThe€¢ACIP£€meeting€dates€are€published€a€year€in€advance.€€Except€in€the€event€ofÏan€emergency,€regular€voting€members€of€the€¢ACIP£€assume€the€responsibility€of€attendingÏall€meetings.€€When€a€member€does€not€attend€a€meeting€or€attends€a€portion€of€aÏmeeting,€the€member€is€provided€background€material€on€the€issues€discussed,€and€isÏexpected€to€be€prepared€for€the€next€meeting.€€If€a€regular€voting€member€finds€it€difficultÏto€attend€meetings,€he/she€has€the€responsibility€to€resign€from€the€Committee.€€This€willÏallow€for€a€new€member€to€be€appointed€to€carry€out€the€term.Ð (#(# ÐÌà  àò ò2.€€¢ACIP£€Related€Contactsó óÐ `° Ðà0  àà ` àà ¸ à¢ACIP£€members€may€be€solicited€to€participate€in€interviews€or€surveys€onÏvaccine€issues€that€are€addressed€by€¢ACIP£.€€¢ACIP£€members€should€not€participate€in€suchÏsurveys€if€they€must€reveal€their€personal€identity€or€if€their€¢ACIP£€membership€status€isÏknown€or€revealed.Ð (#(# ÐÌà0  àà ` àThe€Departmentððs€Standards€of€conduct€prohibit€"speaking"€on€matters€related€toÏan€¢ACIP£€memberððs€official€duties€outside€committee€or€working€group€meetings.€€¢ACIP£Ïmembers€are€prohibited€from€receiving€compensation€for€any€speech€or€publication€inÏwhich€the€purpose€is€to€report€on€the€memberððs€work€on€the€¢ACIP£.€€Also,€the€regularÏvoting€member€should€be€concerned€with,€and€report€to€the€Executive€Secretary,€anyÏsolicitation€of€information€about€the€committeeððs€activities€by€persons€not€officiallyÏaffiliated€with€the€committee.Ð (#(# ÐÌà  àò ò3.€€Media€InteractionÐ H!˜ Ðó óà0  àà ` àAs€a€public€agency,€CDC's€meetings€are€open€to€the€public€and€the€media.€Ð 4"„  ÐTherefore,€committee€members€may€be€approached€by€the€press€for€an€unscheduledÏinterview.Ð (#(# ÐÌà0  àà ` àWhile€members€are€certainly€free€to€give€interviews€and€express€their€opinions,Ïthey€are€not€òòobligatedóó€to€give€an€interview€to€the€press€either€at€the€time€they€areÐ Ð& "% Ðapproached€or€at€a€later€time.€€If€they€choose€to€be€interviewed,€CDC€offers€the€followingÏguidance:Ð (#(# ÐÌà  àððà0 ` à¢ACIP£€members€may€choose€to€do€interviews€with€other€¢ACIP£€members€or€CDCÐ €*Ð%) Ðstaff.Ð ` (#` (# ÐÐ X,¨'+ Ðà  àððà0 ` àOr€they€may€feel€more€comfortable€referring€the€interviewer€to€the€CDC€Office€ofÐ ° ÐHealth€Communications€representative.Ð ` (#` (# ÐÌà  àððà0 ` àCDC€discourages€members€from€speaking€with€the€press€about€the€likely€outcomeÐ tÄ Ðof€an€¢ACIP£€vote€in€a€manner€that€would€indicate€they€have€already€decided€theÏissue€prior€to€presentation€of€the€issue€and€relevant€data€at€the€meeting.€€Views€ofÏœa€member€may€change€during€the€course€of€a€meeting,€and€it€could€be€prematureÏand€misleading€to€make€public€statements€prior€to€the€end€of€the€meeting.Ð ` (#` (# ÐÌà  àððà0 ` àMembers€may€discuss€the€public€meeting€and€their€views,€but€should€be€carefulÐ ü L  Ðnot€to€disclose€any€proprietary€information.Ð ` (#` (# ÐÌà  àððà0 ` àConsider€whether€an€issue€could€come€before€the€advisory€committee€in€theÐ À  Ðfuture.€€Members€should€be€aware€that€any€strong€public€statements€following€oneÏmeeting€could€affect€their€future€participation€in€related€meetings€because€of€theÏneed€to€avoid€the€appearance€of€bias.Ð ` (#` (# ÐÌà  àððà0 ` àMembers€speaking€to€the€press€must€remember€not€to€speak€as€representatives€ofÐ \¬ Ðeither€the€committee€or€the€CDC,€unless€the€agency€designates€a€member€to€speakÏfor€the€committee€(e.g.,€the€Chair).Ð ` (#` (# ÐÌà  àððà0 ` àRegarding€closed€portions€of€committee€meetings,€only€the€topic€of€discussionÐ  \ Ðmay€be€made€public.€€Prior€to€discussing€any€matter,€the€member€should€consultÏwith€the€Executive€Secretary€or€a€knowledgeable€CDC€staff€member.Ð ` (#` (# ÐÌò òD.€€Electronic€Recording€by€Public€Mediaó óÐ ¼  ÐÌà  àIt€is€CDC€policy€that€advisory€committee€meetings€are€open€to€the€public€to€the€extentÏallowed€by€law€and€physical€environment.€€The€Chair€and€the€Executive€Secretary€have€theÏauthority€to€regulate€all€aspects€of€the€meetings,€including€electronic€coverage.€€In€order€to€ensureÏthat€a€meeting€is€conducted€in€a€fair€and€expeditious€manner,€the€Chair€may€restrict€or€deny€useÏof€electronic€recording€equipment.€€Any€member€finding€lights€or€recording€equipment€disruptiveÏto€the€conduct€of€business€at€the€meeting€should€inform€the€Chair€or€Executive€Secretary.€ÏFactors€to€guide€the€Chair€in€this€determination€include€the€potential€for€significant€disruption,Ïprejudicial€impact€on€the€meeting,€fairness,€and€impairment€of€a€participantððs€ability€to€make€aÏpresentationò ò.Ð ô$D # ÐÌE.€€Financial€InterestsÌÌó ó€€€€€Financial€Conflicts€of€Interest€and€208€(b)(3)€WaiversÐ ¨(ø#' ÐÌà  à1.à0 ` àò òProhibition.€€ó óFederal€law€(18€U.S.C.€ðð€208)€prohibits€Federal€executive€branchÐ €*Ð%) Ðemployees,€including€special€government€employees€(i.e.€members€of€FederalÏadvisory€committees€such€as€ACIP),€from€participating€in€matters€in€which,€toÐ \,¬'+ Ðhis/her€knowledge,€he/she,€his/her€spouse,€minor€child,€or€organization€has€aÏfinancial€interest.Ð ` (#` (# ÐÌà  à2.à0 ` àò òInherent€Potential.ó ó€€Federal€advisory€committees€usually€have€members€whoÐ tÄ Ðmay€have€potential€financial€conflicts€of€interest€because€members€are€chosen€forÐ ` (#` (# Ðà  àà ` àÌà  àà0 ` àservice€based€on€their€expertise€in€the€areas€in€which€advice€is€sought€by€theÏgovernment.€Ð ` (#` (# ÐÌà  à3.à0 ` àò òWaivers.ó ó€€Congress€has€recognized€the€need€for€service€by€these€experts€onÐ  P  ÐFederal€advisory€committees,€despite€the€potential€for€conflicts€of€interest,€byÏproviding€for€waivers€of€the€conflict€of€interest€prohibitions€under€18€U.S.C.€ððÏ208€(b)(3)€when€"the€need€for€the€individual's€services€outweighs€the€potential€forÏa€conflict€of€interest€created€by€the€financial€interest€involved."€€Ð ` (#` (# ÐÌà  à4.à0 ` àò òIntegrity€of€Committee.ó ó€€Nevertheless,€CDC€is€sensitive€to€concerns€aboutÐ ŒÜ  Ðpotential€conflicts€of€interest€by€members€serving€on€the€ACIP,€particularly€givenÏthe€ACIP's€role€under€OBRA€'93,€which€involves€decision€making€withÏsubstantial€financial€implications€(i.e.€VFC€resolutions).€€The€agency,€therefore,Ïhas€taken€steps€to€assure€that€there€is€not€only€technical€compliance€with€theÏprovisions€of€18€U.S.C.€ðð€208,€but€that€the€spirit€of€those€provisions€is€alsoÏfulfilled€as€follows€„Ð ` (#` (# ÐÌà  àà ` àa.à0 ¸ àò òScope€of€Waivers.ó ó€€208€(b)(3)€limited€waivers€are€being€issued€to€ACIPÐ ð@ Ðmembers€who€have€potential€conflicts€of€interest€so€that€the€DepartmentÏmay€benefit€from€the€scientific€and€public€health€expertise€of€eachÏmember.€€Under€these€waivers:€€Each€member€with€a€potential€or€actualÏfinancial€conflict€of€interest€is€granted€a€ò òwaiver€to€participate€in€allÐ ¤ô Ðcommittee€discussionsó ó,€but€only€ò òifó ó€(a)€the€ò òmember€publicly€disclosesó ó€allÐ ”ä Ðrelevant€interests€at€the€beginning€of€each€ACIP€meeting€ò òandó ó€(b)€ò òabstainsÐ „Ô Ðon€votesó ó€involving€entities€with€which€the€member€has€a€current€directÐ t Ä Ðfinancial€interest€(except€as€noted€below€under€"De€Minimus€Interest").€Ð ¸ (#¸ (# ЀÌà  àà ` àb.à ¸ àò òCurrent€Financial€Interest.ó ó€ò ò€ó ó€Financial€relationships€within€the€past€12€Ð <#Œ! Ðà  àà ` àà ¸ àmonths€€ÌÌà  àà ` àc.à0 ¸ àò òDirect€Financial€Interestó ó€€(applicable€to€member,€spouse€&€minorÐ &T!$ Ðchildren)€„€examplesÐ ¸ (#¸ (# Ðà0  àà0` (#(#àà ¸ à(1)€€stock„ownershipÐ ` (#` (# Ðà0  àà0` (#(#àà ¸ à(2)€€employmentÐ ` (#` (# Ðà0  àà0` (#(#àà ¸ à(3)€€contractÐ ` (#` (# Ðà0  àà ` àà0¸ (#(#à(4)€€receipt€of€grant€funds,€directly€or€as€part€of€salary,€when€the€memberÏalso€works€on€the€grant€from€which€the€funds€come.€€(The€member€doesÐ +à&* Ðnot€have€to€be€the€principal€investigator€on€the€grant€for€this€to€apply.)Ð ¸ (#¸ (# ÐÌ€à  à€€5.à0 ` àò òFinancial€Disclosures€by€Members.ó ó€€Members€will€be€requested€to€discloseÐ ˆØ Ðrelevant€financial€interests€at€the€beginning€of€each€meeting.Ð ` (#` (# ÐÌÌÌà  à€€6.à ` àò òDisclosure€Not€Required€„€Uncontrolled€Interests.ó óÐ ( x Ðà  àà0 ` àThe€member's€institution€may€have€financial€interests€which€provide€income€toÏthe€member€(e.g.€grant€funds€deposited€into€a€common€account),€but€whichÏinterests€are€outside€the€member's€area€of€work.€€Such€interests€are€consideredÏoutside€the€member's€control,€as€are€the€university's€financial€interests€which€doÏnot€provide€income€to€the€member.€€Given€the€lack€of€control,€those€interests€areÏnot€required€to€be€disclosed€and€there€are€no€restrictions€on€committee€activitiesÏbased€on€such€interests.Ð ` (#` (# ÐÌà  à7.à0 ` àò òDe€Minimus€Financial€Interests€„€Honoraria€and€TravelÐxÈ` (#` (# Ѐà  àà ` àSupport€for€Scientific€Interchange.ó óÐ h¸ Ðà  àà0 ` àSupport€for€expenses€associated€with€attendance€at€scientific€meetings€isÏconsidered€a€de€minimus€financial€interest.€€Honoraria€received€for€presentationsÏat€scientific€meetings€is€also€considered€de€minimus€to€the€extent€that€the€totalÏhonoraria€received€in€each€calendar€year€does€not€exceed€$1,000€per€manufacturerÏor€other€entity.€€(Travel€expenses€included€in€honoraria€payments€are€excludedÏfrom€the€cap,€to€the€extent€that€the€travel€expenses€can€be€segregated€from€theÏhonoraria.)€€The€restriction€on€voting€does€not€apply€regarding€these€de€minimusÏinterests€if€all€relevant€reimbursing€entities€within€the€past€12€months€areÏdisclosed€at€each€ACIP€meeting.Ð ` (#` (# ÐÌà  à€€8.à ` àò òVoting€Restrictionsó ó€Ð ŒÜ Ðà  àà0 ` àWhere€a€direct€financial€interest€exists€with€a€particular€manufacturer,€the€memberÏshould€recuse€himself€or€herself€from€voting€(i.e.€abstain)€on€matters€affecting€anyÏvaccine€of€that€manufacturer.€€(It€is€the€relationship€with€the€manufacturer€thatÏcreates€the€financial€conflict,€not€just€work€on€a€particular€vaccine;€thus,€theÏprohibition€is€on€votes€affecting€any€vaccine€that€is€a€product€of€theÏmanufacturer.)€€However,€the€scope€of€the€voting€restriction€is€limited€to€issuesÏthat€could€potentially€result€in€a€significant€financial€impact€on€the€affectedÏmanufacturer.€€For€example,€votes€to€recommend€additional€doses€of€a€vaccine€orÏto€recommend€administration€of€a€vaccine€to€additional€(or€fewer)€birth€cohortsÏwould€be€subject€to€the€recusal€restriction.€€On€the€other€hand,€no€restrictionÏwould€exist€on€votes€pertaining€to€the€list€of€contraindications€to€administration€ofÏa€vaccine.Ð ` (#` (# Ðà0  àÐ (#(# Ðò òF.€Selection€of€topicsÐ x+È&* ÐÐ d,´'+ Ðó óà  àPotential€topics€for€ACIP€consideration€can€be€suggested€by€anyone,€but€are€most€oftenÐ ° Ðproposed€by€CDC€program€staff,€ACIP€members,€and€vaccine€manufacturers.€€ÌÌà  àApproximately€ten€weeks€prior€to€an€upcoming€meeting,€a€memorandum€requestingÏpotential€agenda€items€is€sent€to€ACIP€members,€CDC€staff,€and€vaccine€manufacturers.€A€list€ofÏtopics€based€on€action€or€follow„up€items€from€the€last€meeting€or€previously€suggested€isÏincluded€in€the€memorandum.€€Also€attached€is€an€information€sheet€to€be€completed€by€theÏperson€suggesting€the€topic€(See€attachment€A).€€The€person€suggesting€an€agenda€item€is€askedÏto€specify€the€topic€to€be€on€the€agenda,€issues€of€concern,€and€specific€questions€to€be€addressedÏby€ACIP.€€Those€proposing€topics€from€outside€CDC€should€identify€one€or€more€possible€CDCÏstaff€members€to€coordinate€the€presentation;€however,€the€final€selection€of€the€appropriate€CDCÏstaff€member€will€be€done€by€the€program€director.ÌÌà  àAgenda€items€are€accepted€for€presentation€by€the€Executive€Secretary€in€consultationÏwith€the€Chair,€and€representatives€from€the€National€Immunization€Program,€the€NationalÏCenter€for€Infectious€Diseases,€and€the€National€Center€for€HIV,€STD,€and€TB€Prevention.€€TheÏExecutive€Secretary€has€the€authority€to€approve,€disapprove,€or€hold€over€to€another€meeting€anyÏagenda€item€submitted€for€the€agenda.€€The€priority€of€a€topic€for€ACIP€consideration€will€beÏbased€on€a€variety€of€factors€including€the€burden€of€illness€(mortality,€morbidity,€disability);€costÏof€the€illness;€cost€of€the€intervention;€availability€of€data€on€the€efficacy,€safety,€costÏeffectiveness€or€economic€impact,€of€the€intervention;€acceptability€of€a€vaccine€in€the€targetÏpopulations€and€the€quality€of€these€data;€availability€of€vaccine€supplies;€current€utilizationÏpatterns€of€the€vaccine€and€variations€in€practice;€the€feasibility€of€implementing€effectiveÏvaccination€programs;€and€the€perceived€potential€of€a€change€in€the€recommendations€toÏimprove€health€outcomes€or€improve€safe€usage€of€vaccines€and€biologicals.ÌÌà  àThe€ACIP€will€review€every€major€vaccine€preventable€disease€at€least€once€every€fiveÏyears€to€consider€whether€a€revised€recommendation€is€needed.€€The€committee€managementÏspecialist€will€maintain€a€tickler€system€to€facilitate€this€process.€€A€file€containing€ACIPÏrecommendations€including€title€and€date€of€publication€is€maintained€on€the€Internet.ÌÌà  àFor€minor€revisions,€ACIP€may€choose€not€to€revise€the€entire€statement€but€instead€issueÏa€short€update€in€the€MMWR€and€on€the€Internet.€ÌÌò òG.€Process€for€Developing€Recommendationsó óÐ $X" ÐÌò òà  àó óAll€recommendations€are€subject€to€extensive€review€by€staff€of€the€CDC,€ACIPÐ à%0!$ Ðmembers,€and€outside€expert€consultants.€ÌÌà  à1.à ` àò òTechnical€Aspectsó óÐ ¤(ô#' Ðà0  àà ` àWorking€groups€are€formed€to€develop€recommendations€and€extensively€analyzeÏthe€research€data€for€presentation€to€the€formal€Committee.€€These€working€groups€1)Ïmust€include€one€or€more€regular€voting€members,€2)€must€include€CDC€staff€membersÏand€3)€may€include€ex„officio€and€liaison€representatives€and€other€consultants.€€ÐX,¨'+(#(# Їà0  àà ` àEither€CDC€staff€from€the€relevant€programs€or€ACIP€members€may€take€the€leadÏfor€drafting€recommendations€for€the€working€group,€but€the€decision€about€who€has€leadÏresponsibility€for€drafting€must€be€made€early€and€reported€to€the€CommitteeÏManagement€Specialist.€€The€process€of€developing€ACIP€recommendations€includes€(1)Ïa€review€of€the€labeling/package€inserts€for€each€vaccine;€(2)€a€thorough€review€of€theÏscientific€literature€(both€published€and€unpublished,€when€available)€on€the€safety,Ïefficacy,€acceptability,€and€effectiveness€of€the€immunizing€agent,€with€consideration€ofÏthe€relevance,€quality,€and€quantity€of€published€and€unpublished€data;€(3)€an€assessmentÏof€cost€effectiveness;€(4)€a€review€of€the€morbidity€and€mortality€associated€with€theÏdisease€in€the€population€in€general€and€in€specific€risk€groups;€(5)€a€review€of€theÏrecommendations€of€other€groups;€and€(6)€a€consideration€of€the€feasibility€of€vaccine€useÏin€existing€child€and€adult€immunization€programs.€€Feasibility€issues€include€(but€are€notÏlimited€to)€acceptability€to€the€community,€parents,€and€patients;€vaccine€distribution€andÏstorage;€access€to€vaccine€and€vaccine€administration;€impact€on€the€various€health€careÏdelivery€systems;€population€distribution€effects;€and€social,€legal€and€ethical€concerns.Ð (#(# ÐÌà0  àà ` àACIP€recommendations€may€be€developed€and€issued€jointly€withÏnongovernmental€professional€organizations€or€other€PHS€advisory€committees.€€WhenÏthis€is€done,€the€composition€of€the€working€group€is€modified€to€include€members€of€theÏother€organization(s).Ð (#(# ÐÌà0  àà ` àWhenever€the€data€permit,€specific€rules€of€evidence,€such€as€those€followed€byÏthe€U.S.€Preventive€Services€Task€Forceòò1óó,€will€be€used€by€the€ACIP€to€judge€the€quality€ofÐ øH Ðdata€and€make€decisions€regarding€the€nature€and€strength€of€the€recommendations.€ÏWhen€requested€by€the€ACIP€members,€evidence€tables€will€be€developed€for€the€vaccineÏor€other€prophylactic€agent.€In€the€absence€of€data€or€when€data€are€inadequate,€the€expertÏopinions€of€voting€members€and€other€experts€will€be€used€to€make€recommendations.€ÏDepending€upon€the€relative€importance€of€the€issue,€either€formal€(e.g.,€Delphi,€nominalÏgroup€techniques)€or€informal€methods€for€soliciting€expert€opinions€will€be€used.€€TheÏmethods€used€for€developing€recommendations€will€be€made€explicit€in€the€publishedÏrecommendations.Ð (#(# ÐÌà0  àà ` àWhen€necessary€for€adequate€decision€making€and€when€requested€by€the€ACIP,€aÏsystematic€review€(meta„analysis)€of€the€literature€will€be€done.€€Such€analyses€shouldÏadhere€to€CDC€recommendationsòò2óó€and€those€on€òòCost€Effectiveness€in€Health€andÐ $X" ÐMedicine.óóòò3óóÐô$D #(#(# Ðò òÌó óà0  àà ` àPublished€and€unpublished€economic€analyses€(e.g.,€cost„effectiveness)€relevant€toÐ Ì&"% Ðvaccine€issues€will€be€routinely€reviewed.€€If€no€such€studies€have€been€done,€the€ACIPÏmay€request€that€they€be€done,€either€prior€to€or€subsequent€to€issuing€a€recommendation.€ÏIssues€of€both€general€cost,€effectiveness,€and€the€cost€effectiveness€of€specificÏcomponents€of€the€recommendations€will€be€considered.Ð (#(# ÐÌà0  àà ` àPublished€recommendations€will€explicitly€state€the€basis€upon€which€theÐ T,¤'+ Ðrecommendations€were€made,€i.e.,€what€inputs€there€were€such€as€controlled€trials,€case„¼control€studies,€case€series,€expert€opinion,€meta„analysis,€Delphi€surveys,€focus€groups,Ïcost€effectiveness€analysis,€and€other€inputs.€Ð (#(# ÐÌò òÌÌà  à2.€€Policy€Analysisó óÐ 8 ˆ Ðà0  àà ` àMany€of€the€issues€addressed€by€the€Committee€are€not€technical€but€policyÏissues.€€In€such€cases,€a€simple€but€formal€policy€analysis€should€be€considered€and€mayÏbe€requested€and/or€performed€by€the€ACIP.€€Although€other€methods€of€analysis€may€beÏproposed€and€accepted,€the€usual€(default)€approach€that€should€be€used€by€theÏCommittee€is€the€process€outlined€by€Carl€Patton€and€David€Sawicki€in€òòBasic€Methods€ofÐ Ô$  ÐPolicy€Analysis€and€Planningóó.òò4óóÐÀ (#(# Ðà  àà ` àThis€process€is:ÌÌà0  àà ` àò òa.à0¸ (#(#àVerify,€define,€and€detail€the€problemó óÐ„Ô ¸ (#¸ (# Ðà0  àà ` àà0¸ (#(#àDo€not€accept€the€initial€statement€of€the€problem€without€questioningÏwhether€it€is€framed€correctly.€€Verify€that€the€problem€actually€exists€andÏis€an€important€problem.€€Be€sure€the€problem€is€relevant€to€the€objectivesÏof€the€ACIP€and€CDC.€€Determine€the€magnitude,€nature,€and€extent€of€theÏproblem.€€Determine€who€is€concerned€about€the€problem€and€why.Ð ¸ (#¸ (# ÐÌà0  àà ` àò òb.à0¸ (#(#àEstablish€evaluation€criteria€ó óÐøH¸ (#¸ (# Ðà0  àà ` àà0¸ (#(#àDetermine€which€criteria€will€be€used€to€evaluate€proposed€solutions.€ÏSome€common€measures€include€cost,€benefits,€cost„benefit€ratios,€relativeÏor€marginal€cost„effectiveness,€effectiveness,€efficiency,€equity,Ïadministrative€ease,€legality,€and€distributive€effects.€€Those€criteriaÏcentral€to€the€problem€must€be€selected€and€the€relative€importance€of€eachÏmeasure€must€be€determined.Ð ¸ (#¸ (# ÐÌò òà  àà ` àc.à ¸ àIdentify€alternative€policiesó óÐ X ¨ Ðà0  àà ` àà0¸ (#(#àAlternatives€can€be€identified€through€a€variety€of€means€such€as€literatureÏsearches,€brainstorming,€public€comment,€and€others.€€The€no„action€or€noÏchange€option€should€always€be€considered.Ð ¸ (#¸ (# ÐÌà0  àà ` àò òd.à0¸ (#(#àEvaluate€alternative€policiesó óÐô$D #¸ (#¸ (# Ðà0  àà ` àà0¸ (#(#àThe€expected€impact€of€each€alternative€policy€should€be€projected€and€theÏextent€to€which€it€satisfies€the€evaluation€criteria€should€be€determined.€€AÏvariety€of€techniques€can€be€used€such€as€risk„benefit€or€cost„benefitÏanalysis,€cost„effectiveness€analysis,€and€linear€programming.€€TheÏmethod(s)€chosen€should€be€appropriate€for€the€problem€and€the€proposedÏalternative€policy;€no€one€method€is€appropriate€for€every€problem€orÏevery€alternative.Ð ¸ (#¸ (# ÐÐ T,¤'+ Ðà0  àà ` àò òe.à0¸ (#(#àDisplay€and€distinguish€among€alternative€policiesó óа¸ (#¸ (# Ðà0  àà ` àà0¸ (#(#àThis€can€be€done€in€a€number€of€ways,€e.g.,€through€matrices,€pros€andÏcons,€value„comparisons,€scenarios,€and€others.€Ranking€or€weightingÏschemes€can€be€used.€€As€the€Committee€assesses€the€policy€options,€inputÏshould€be€sought€from€a€wide€variety€of€stakeholders.Ð ¸ (#¸ (# ЛÌà  àò ò3.à ` àResourcesó óÐ 8 ˆ Ðà0  àà ` à€€Adequate€resources€must€be€available€to€carry€out€the€¢analyses£€outlined€above.€ÏCDC€should€place€a€high€priority€on€identifying€these€resources€so€that€the€high€quality€ofÏ¢ACIP£€recommendations€can€be€maintained€and€enhanced.Ð (#(# Ðò òÌà  à4.€€Developing€the€Recommendationsó óÐ Ô$  Ðà0  àà ` àRecommendations€are€subject€to€extensive€review€by€staff€of€the€Centers€forÏDisease€Control€and€Prevention€(CDC),€¢ACIP£€members,€outside€expert€consultants€andÏvaccine€manufacturers.Ð (#(# ÐÌà0  àà ` àWorking€groups€are€often€formed€to€extensively€analyze€the€research€data€forÏpresentation€to€the€full€Committee.€€They€should€first€seek€additional€data€which€haveÏbeen€overlooked,€corrections€in€data€content,€appropriateness€of€the€interpretation€of€data,Ïand€critique€and€challenge€expert€opinions.€Public€comments€are€solicited€during€theÏCommittee€meetings,€and€are€also€considered€during€the€decision€making€process.Ð (#(# ÐÌà0  àà ` àProgram€staff€compile€and€organize€comments€received€and€discuss€them€with€theÏappropriate€working€group€while€redrafting€recommendations.€€The€chair€of€the€workingÏgroup€is€responsible€for€the€final€review€of€the€draft€recommendations€submitted€forÏdeliberation€and€approval€by€the€full€voting€Committee.€€Controversial€issues€will€alwaysÏbe€brought€to€the€attention€of€the€full€Committee€during€an€open€Committee€meeting.Ð (#(# ÐÌà0  àà ` àAreas€in€need€of€additional€research€or€data€should€be€clearly€identified€and€eachÏstatement€should€include€a€specific€delineation€of€data€gaps.Ð (#(# ÐÌà0  àà ` àDocuments€and€data€which€will€be€discussed€at€the€meeting€must€be€disseminatedÏto€the€Committee€in€a€timely€manner€for€the€members€to€have€the€time€to€¢analyse£€theÏinformation€and€prepare€for€productive€discussions.€€It€is€the€responsibility€of€theÏpresenters/authors€to€meet€the€¢timelines£€set€by€the€committee€management€specialist.€ÏThese€¢timelines£€are€set€ten€weeks€in€advance€of€the€meeting.€€Materials€are€routinelyÏscheduled€to€be€express€mailed€to€the€Committee€members€fourteen€days€prior€to€theÏmeeting€dates.€€€Ð (#(# ÐÌò òH.€Publication€of€Recommendationsó óÐ ¤(ô#' ÐÌà  à¢ACIP£€recommendations€are€one€of€the€most€valuable€products€of€CDC.€€Although€theÏrecommendations€are€those€of€the€Committee,€they€may€or€may€not€be€accepted€by€the€agency.€ÌÐ T,¤'+ Ðà  àAfter€agency€acceptance,€¢ACIP£€recommendations€are€published€in€the€òòMorbidity€andÐ ° ÐMortality€Weekly€Report€Recommendations€and€Reportsóó€series,€and€occasionally€reprinted€inÐ œì Ðother€publications.€€CDC€must€ensure€that€a€high€priority€is€placed€on€providing€adequateÏresources€to€prepare€¢ACIP£€recommendations€for€publication€in€a€timely€manner.€Ìò òÌÌó óà  àThe€format€of€the€recommendations€for€specific€vaccines€will€generally€follow€that€shownÐ 8 ˆ Ðin€attachment€B.€€The€final€document€will€indicate€the€strength€and€quality€of€the€evidenceÏsupporting€each€of€the€major€recommendations.ÌÌò òI.€Implementation€and€Evaluation€of€the€Recommendationsó óÐ è 8  ÐÌà  àImplementation€and€evaluation€of€the€impact€of€the€recommendations€is€the€responsibilityÏof€the€relevant€CDC€program,€and€not€the€¢ACIP£.€€However,€CDC€programs€will€develop€anÏimplementation€and€evaluation€plan€for€each€set€of€recommendations€and€periodically€reportÏinformation€relevant€to€these€activities€to€the€¢ACIP£,€and€others€who€may€be€involved€inÏimplementing€the€recommendation€(e.g.,€managed€care,€private€practitioners).Ìò òÌJ.€Other€issuesó óÐ H˜ ÐÌà  àFor€other€issues€relevant€to€guideline€development€which€are€not€mentioned€in€thisÏdocument,€the€¢ACIP£€will€consult€ò òCDC€Guidelines:€Improving€the€Qualityó ó.òò5óóÐ  \ ÐÌò òII.à0  à¢ACIP£€Recommendations€for€the€Vaccines€for€Children€(¢VFC£)€ProgramÐè8(#(# ÐÌó óà  à¢ACIP£€recommendations€for€the€¢VFC£€Program€are€developed€and€voted€upon€as€a€distinctÐ À Ðprocess,€separate€from€other€¢ACIP£€functions.€€This€process€is€based€upon€the€unique€statutoryÌauthority€for€the€¢VFC£€program€established€by€the€Omnibus€Budget€Reconciliation€Act€of€1993Ï(42€U.S.C.€¢1396s£)€[see€attachment€C].€€This€legislation€gave€the€¢ACIP£€the€responsibility€andÏauthority€to€determine€the€vaccines,€number€of€doses,€schedule€and€contraindications€for€the€¢VFC£ÏProgram.ÌÌà  àThe€¢ACIP£€applies€a€systematic€and€rational€approach€to€developing€¢VFC£Ïrecommendations.€€The€process€for€selection€of€vaccines,€schedules,€doses,€and€contraindicationsÏfor€¢VFC£€begins€with€a€review€of€¢ACIP£€recommendations€for€use€of€each€vaccine€currentlyÏrecommended€for€all€or€some€groups€of€children€or€of€other€available€information,€and€ofÏrecommendations€by€other€groups€such€as€the€American€Academy€of€Pediatrics.€€In€addition€toÏthe€considerations€which€go€into€the€process€of€issuing€general€¢ACIP£€recommendations,€thisÏprocess€also€includes€a€more€intensive€consideration€of€(1)€the€programmatic€feasibility€ofÏimplementing€the€recommendation€in€the€public€and€private€sectors,€(2)€implementationÏstrategies€which€are€most€likely€to€be€successful,€(3)€the€speed€with€which€implementation€can€beÏachieved,€(4)€the€availability€of€adequate€quantities€of€vaccine,€and€(5)€the€cost„effectiveness€ofÏusing€the€vaccine€in€various€relevant€groups.€€For€each€of€these€issues,€background€information€isÏdiscussed,€sometimes€initially€by€a€working€group€of€¢ACIP£€members,€and€subsequently€by€theÐ X,¨'+ Ðfull€Committee.€€Draft€¢VFC£€resolutions€are€discussed€at€full€Committee€meetings,€which€areÏopen€to€the€public,€before€a€formal€¢ACIP£€vote€is€held.ÌÌÌÌÌà  àFor€each€vaccine€considered€for€inclusion€in€the€¢VFC£€program,€written€resolutions€on€theÏvaccine,€schedule,€dose,€contraindications,€and€other€issues€relevant€to€appropriate€uses€ofÏvaccines€are€reviewed€by€the€Committee€and€are€adopted€or€rejected€through€votes€by€votingÏ¢ACIP£€members€only.€€A€record€of€issues€voted€on€is€maintained€at€CDC€by€the€ExecutiveÏSecretary,€¢ACIP£.ÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÐ T,¤'+ ЇÌÌÌÌà  àà ` àà ¸ àà  àà h àà À àà  àà p àà È àà  àà x àÔ‡?Ô^X?X2ÔÔ‡3ÍL ?Ô^Ôññ¢ññ¢ACIP1ññ£ññññ4ññññ5£ññ.RECÔ#†?Ô^ 3ÍLz¤#ÔÔ#†?X2X?Ô^[¤#ÔÐ `° ÐÌÔ€>X2XX?X2Ôà@xx%ìàREFERENCESˆÐ ì < ÐÌÌÌ1.à0  àU.S.€Preventive€Services€Task€Force.€€Guide€to€clinical€preventive€services,€2nd€ed.€Ð œ ì  ÐBaltimore:€Williams€&€Wilkins,€1996.Ð (#(# ÐÌ2.à0  à¢Haddix£€AC,€¢Teutsch£€S,€Shafer€PA,€et€al.€€Prevention€Effectiveness:€A€Guide€to€DecisionÐ `°  ÐAnalysis€an€Economic€Evaluation.€€New€York:€Oxford€University€Press,€1996.Ð (#(# ÐÌ3.à0  àGold€M,€¢Siegal£€J.€€Cost„Effectiveness€Analysis€in€Health€and€Medicine.€€New€York:Ð $t ÐOxford€¢Univeristy£€Press,€1996.Ð (#(# ÐÌ4.à0  àÔ‡?X2XX>X2ÔCarl€Patton€and€David€¢Sawicki£.€Basic€Methods€of€Policy€Analysis€and€Planning.€€2nd€ed.Ð è8 ÐEnglewood€Cliffs,€¢NJ:Prentice£€Hall,€1993Ô#†>X2XX?X2ϧ#Ô.ÐÔ$(#(# ÐÌ5.à0  àCenters€for€Disease€Control€and€Prevention.€€CDC€GUIDELINES:€Improving€the€Quality.€Ð ¬ü ÐAtlanta:€Centers€for€Disease€Control€and€Prevention,€1996.Ð ˜è(#(# ÐÑ,°ÑÑð°ÑÔ‡> ²¯ !X>X2ÔÔ‡1 ‚ ! !> ²¯ÔAttachment€Aò òòòÐ , ÐTHIS€FORM€MUST€BE€FILLED€OUT€FOR€YOUR€ITEM€TO€BE€Ìà@IIìàCONSIDERED€FOR€THE€FEBRUARY€ACIP€MEETINGó óóóˆÐ °„ ÐÔ#†1XX X !1 ‚µ©#ÔÔ#†>X2X X1XXÔ©#ÔÔ‡2X_ XX>X2ÔÌò òà@<< ìàACIP€AGENDA€PROPOSALˆÐ â¶ Ðà@ä ä ìàMeeting€Date:€€€Month€00,€1997ˆÌÒX°ÒÌDueó ó:€00/00/00€to€Gloria€Kovach,€MS€D50€404„639„7250(FAX:404„639„7342)Ð ²† ÐÒ°XÒÌTopic:______________________________________________________ÌÌPresenter(s)€and€Addressà h àà À àà  àà p àà È àà  à€òòPHONE€#óó€€€òòMSóóÐ r F  ÐÌÓ€Ó€€€__________________________________________€€€€€€€____€€€€____Ì€€€__________________________________________€€€€€€€____€€€€____ÌÓ€Ó€€€__________________________________________€€€€€€€____€€€€____ÌÌTime€Required:€€€Presentation€_____________€min.ÌÌ€€€€€€€€€€€€€€€€€Discussion€€€_____________€min.ÌÌ€€€€€€€€€€€€€€€€€Total€€€€€€€€_____________€min.ÌÌQuestions€to€be€Addressed€by€ACIPÌÌ1.€€________________________________________________________Ì2.€€________________________________________________________Ì3.€€________________________________________________________Ì4.€€________________________________________________________ÌÌPlease€circle€all€that€apply:à À àDiscussionà È àInformationÐ 2  ÐÌà  àà ` àà ¸ àà  àà h àà À àDecisionà p àà È àVFC€VoteÐ !æ" ÐÌ*Background€Materials€to€be€Provided€€€€€€€Yes€€€€€€€€€€NoÌÌ*Draft€Statement€to€be€Distributed€€€€€€€€€Yes€€€€€€€€€€NoÌÌVisual€Aids€Required€€€€€€€€€€€€€€€€€€€€€€€Yes€€€€€€€€€€NoÌ€€If€yes,€circle€all€applicableÌÌ€€€€€€€€Slides€€€€€€€€€€€€€€Overheads€€€€€€€€€€Handouts€ÌÌÒX°ÒÒX°Ò*à0 ° àDue€to€Gloria€Kovach,€D50€no€later€than€ò ò14€working€daysó ó€before€theÐ b+6*- Ðmeeting.€€Otherwise,€ò òBRING€100€COPIESó ó€to€the€meeting€and€give€directlyÐ R,&+. Ðto€Gloria.€€We€appreciate€your€input€in€planning€an€interesting€andÏproductive€meeting,€and€we€appreciate€you€providing€backgroundÏmaterials€and€draft€statements€well€in€advance€so€the€Committee€hasÏtime€to€review€them€before€the€discussion.Ô#†>X2X X2X_èª#ÔÐ0æ.2°€%°€% ЇÔ‡1XX XX>X2ÔÔ‡1 ‚ ! X1XXÔÌÌÌÌÌAttachment€BÌà ° àÌà@º º ìàFORMAT€FOR€RECOMMENDATION(S)Ô#†> ²¯ ! !1 ‚f³#ÔÔ#†>X2X !> ²¯…³#ԈРú Î ÐÌÌÔ€0X_ XX>X2ÔSummaryÐ  è  ÐÌPurpose€of€Recommendation(s)ÌÌClinical€Description€of€DiseaseÌÌDiagnosis€and€TreatmentÌÌEpidemiology€of€DiseaseÌÌà ° à1.)€€Route(s)€of€transmissionÌà ° à2.)€€Morbidity,€Mortality,€DisabilityÌà ° à3.)€€Cost€Association€with€IllnessÌ€à ° à4.)à  àRisk€GroupsÐ D ÐÌEfficacy,€Effectiveness,€and€Cost€Effectiveness€of€Intervention(s)ÌÌPrecautions€and€ContraindicationsÌÌAdverse€EventsÌÌRecommendation(s)€of€ACIP€with€summary€score€for€evidence€and€strength€ofÌ€€recommendation€ÌÌRecommendation(s)€of€Other€GroupsÌÌDiscussion€of€Rationale€for€ACIP€Recommendation(s)ÌÌRecommended€Surveillance,€Research,€Education,€and€Program€EvaluationÌ€€ActivitiesÌÐ  4)(( ÐÔ‡1XX X X0X_ÔÔ‡1 ‚ ! X1XXÔAttachment€CÐ , ÐÌÌTo€be€inserted.Ô#†0 ûV! !1 ‚W·#ÔÔ#†0X_ X!0 ûVv·#Ô