Advisory Circular - Civil Aviation Safety Authority

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Advisory CircularAC 67-1OriginalMedical standards and certification General01 July 2016GeneralCivil Aviation Authority Advisory Circulars contain information about standards,practices, and procedures that the Director has found to be an Acceptable Means ofCompliance with the associated rule.An acceptable means of compliance is not intended to be the only means of compliancewith a rule, and consideration will be given to other methods of compliance that may bepresented to the Director. When new standards, practices, or procedures are found to beacceptable they will be added to the appropriate Advisory Circular.This Advisory Circular also includes guidance material (GM) to facilitate compliance withthe rule requirements. Guidance material must not be regarded as an acceptable means ofcompliance.PurposeThe Advisory Circular provides details on general requirements related to Part 67 Medicalstandards and certification.Related RulesThis Advisory Circular relates specifically to Civil Aviation Rule Part 67.Change NoticeNo change.

Advisory CircularAC 67-1OriginalTable of ContentsSUBPART B – Medical certification . 3Rule 67.55Applications for medical certificates . 3SUBPART D – Designated Aviation Medical Examiners. 3Rule 67.153Medical examiner certification requirements . 3SUBPART E – Operating Requirements for DAMEs. . 4Rule 67.203 Continued Compliance . 4Appendix 1– DAME Exposition template . . 4Appendix 2– PNG Medical Manual. . 4Appendix 3 – CAA Forms. . 401 July 20162CASA PNG

Advisory CircularAC 67-1OriginalSUBPART B – Medical certificationRule 67.55Applications for medical certificatesRule 67.55(b)(i) provides for an equivalent form of photographic identification.The equivalent forms of photographic identification that are acceptable to the Director are:§A valid and current PNG or foreign passport§A valid and current PNG Drivers's Licence§A valid and current photographic national identity document issued by a foreign StateSUBPART D – Designated Aviation Medical ExaminersRule 67.153 Medical examiner certification requirementsRule 67.153(a)(2) requires a person applying for a medical examiner certificate to havesuccessfully completed aviation medicine training acceptable to the Director.The aviation medicine training that is acceptable to the Director includes any of the following:§Completion of a post-graduate Diploma of Aviation Medicine from either theUniversity of Otago or the Royal College of Physicians (London) ;or§Completion of both the aviation physiology and clinical aviation medicine papersoffered on a post-graduate basis by the University of Otago; or§Completion of MD Aviation Medicine from the University of Medical Sciences,Bangalore, India; or§Board Certification in Aviation Medicine (USA); or§Australia Certificate of Civil Aviation Medicine (ACCAM), Monash University,Australia; or§IAASM- SAA Certification in Aviation Medicine for Medical Examinersand Assessors (ICAO Compliant Training Package), Singapore AviationAcademy(SAA).Rule 67.153(a)(3) requires a person applying for a medical examiner certificate to demonstratean awareness of aviation regulatory medicine and the conditions in which applicants formedical certificates are employed.The aviation medicine regulatory awareness training that is acceptable to the Director includesany of the following: DAME Workshop conducted by CASA PNG is acceptable for the purpose of this rule.01July 20163CASA PNG

Advisory CircularAC 67-1OriginalSUBPART E – Operating Requirements for Medical examinersRule 67.203 Continued ComplianceRule 67.203(a)(5) requires that a person who holds a medical examiner certificate must attendongoing training courses in aviation medicine and aviation regulation, as may reasonably berequired by the Director.The ongoing training courses in aviation medicine and aviation regulation, required by the Directorare:For holders of a Medical Examiner 1 certificate:§ Undertaking training activities which are acceptable under a points systemprescribed by the PNG Aviation Medical Society (PAMS), in respect of aviationmedical practice during the previous 36 months.For holders of a Medical Examiner 2 certificate:Undertaking training activities which are acceptable under a points system§prescribed by PAMS in respect of aviation medical practice during the previous36 months.(Note: Activities such as attendance of aviation medicine conferences overseas are acceptable forgaining points for this purpose, and the point value will be considered on a case by case basis bythe PAMS.01 July 20164CASA PNG

----------ANYBODY’S DAME EXPOSITION----------Appendix 1DESIGNATED AVIATION MEDICALEXAMINERPART 67 EXPOSITIONReference : Specimen / Expo / 1Copy Number :Issue :OriginalHolder :Date :June 2016

----------ANYBODY’S DAME EXPOSITION----------THE SPECIMEN EXPOSITIONThis specimen Exposition has been prepared to provide policy and procedural guidance to thoseAviation Medical Examiners (AMEs) wishing to obtain delegation approval from the Director. Thecontents relate directly to the requirements of Rule Part 67.161.The text of this guide has been arranged so that each subject is dealt with insofar as the CA Act,CAR Part 67 and advisory circulars defines it. The "Notes" which explain the recommended textand suggest ways in which the DAME might expand it to suit his/her own purposes. It will beappreciated that no single specimen Exposition can meet the needs of all types and sizes ofsurgery/practices or, indeed, reflect the different organisational structures and corporate policies,which emerge as companies develop.The guidance given has been expanded by including a suitable text or procedure whereverpossible. It must be appreciated that this is not the only method of compliance and may, in fact, beunsuitable for some organisations. Its purpose is only to illustrate the nature of the informationrequired.

----------ANYBODY’S DAME EXPOSITION----------LIST OF CONTENTSList of ContentsPage Effectivity ListAmendment RecordDistribution ListPART 1Page (i)(v)(vi)(vi)MANAGEMENT1.1Statement signed by the Medical Examiner [CAR 67.161(a)(1)]1/21.2Scope of Aviation Medical Practice [CAR 67.161(a)(2)]1/41.3Titles and Names of all Medical Personnel in the Surgery [CAR 67.161(a)(3)]1.3.1 Titles and Names of Doctors working at Surgery1.3.2 Titles and Names of Nurses working at Surgery1.3.3 Titles and Names of other personnel1.4Duties and Responsibilities of Medical Personnel [CAR 67.161(a)(4)]1.4.1 Chief Executive /Admin Manager1.4.2 Doctors working at Surgery1.4.3 Nurses working at Surgery1.4.4 Other specialist medical personnel working at Surgery1.5Management Organisation Chart(s)1.6Facilities [CAR 67.161(a)(5) & (6)]1.8.1 Location – Main Clinical facilties where aviation medicals conducted1.8.2 Location – other Facilities where aviation medicals conducted1.8.3 Administration Facilities1.8.4 Communication Facilities1.8.5 Layout of Facilities1.7Notifying the Director/Principal Medical Officer (PMO) [CAR 67.161(a)(7)]1.9.1 Referral of Medical Certificates for Assessments by PMO1.9.2 Reporting of Changes in a Person’s Medical condition1.9.3 Prior Notification to Director of changes in sections 1.2, 1.3, 1.4 & 1.6PART 2 PROCEDURES2.1Procedures for: [CAR 67.161(a)(7) – (12)]2.1.1 Control, Inspection and testing of medical equipment2.1.2 Control and amendment of Exposition2.1.3 Identification, collection, indexing, storage, maintenance & disposal of records2.1.4 Training, Assessment & Authorization to carry out functions/responsibilities in 1.42.1.5 Identifying & managing any possible conflict of interest issues2.1.6 detailes of internal quality audit programme to ensure continued compliance2.1.7 Distribution of copies of exposition to Director /Other personnelAnybody’s DAME ExpositionOriginal:June 2016Page i

----------ANYBODY’S DAME EXPOSITION----------PAGE EFFECTIVITY LISTPage No.iiiiiivvviDateJUN 2016JUN 2016JUN 2016JUN 2016JUN 2016JUN 2016PART 11/11/21/31/41/51/61/71/81/91/101/11Page No.DatePage No.DatePART 1 (continued)1/131/141/151/16JUN 2016JUN 2016JUN 2016JUN 2016PART 2JUN 2016JUN 2016JUN 2016JUN 2016JUN 2016JUN 2016JUN 2016JUN 2016JUN 2016JUN 2016JUN 2016Anybody’s DAME ExpositionOriginal:June 2016Page ii

----------ANYBODY’S DAME EXPOSITION----------AMENDMENT tedByDateIncorporatedDISTRIBUTION LISTCopy No. 1Director of Civil AviationCopy No. 2Copy No. 3Copy No. 4Copy No. 5Copy No. 6Copy No. 7 Copy No. 8.Anybody’s DAME ExpositionOriginal:June 2016Page iii

----------ANYBODY’S DAME EXPOSITION----------DAME EXPOSITIONPART 1MANAGEMENT

----------ANYBODY’S DAME EXPOSITION----------1.1 CORPORATE COMMITMENT BY THE MEDICAL EXAMINER.DAME EXPOSITION.This Exposition and any associated referenced manuals defines the organisation and proceduresupon which the Designated Aviation Medical Examiner delegation is based as required by rulepart 67.161.These procedures are approved by the undersigned and must be complied with, as applicable,when work/orders are being progressed under the terms of the DAME delegation.It is accepted that these procedures do not override the necessity of complying with any new oramended rule published by the Director from time to time where these new or amended rules arein conflict with these procedures.It is understood that the Director will approve this Medical Surgery whilst the Director is satisfiedthat the procedures are being followed and work standards maintained. It is further understoodthat the Director reserves the right to suspend,limit or revoke the DAME delegation if the Directorhas evidence that procedures are not followed or standards not upheldSigned.Dated DAME . (Signature) .For and on behalf of. . (quote organisation's name) .NOTES :-(not for inclusion in the Exposition)1.This statement satisfies the intent of rule 67.153 & 161(a)(1).2.Any modification to the statement must not alter its intent.3.Whenever the DAME is changed it is important that the new DAME signs the statement atthe earliest opportunity as part of his/her acceptance by the Director.Anybody’s DAME ExpositionOriginal June 2016Page

----------ANYBODY’S DAME EXPOSITION----------Note: Chapters 1.2 to 1.7 are self-explanatory and each DAME should provide a simpleaccount of the how they manage each subject within the context of their medical surgerypractice.Anybody’s DAME ExpositionOriginal June 2016Page

----------ANYBODY’S DAME EXPOSITION----------DAME EXPOSITIONPART 2PROCEDURESNOTES :-(not for inclusion in the Exposition)1.This specimen exposition is to provide guidance on an acceptable path to compliance withthe CAR Part 67.161 requirements. In each case subject headings in the table of contentsare suggested in which the particular nature of the organisation's actual procedures shouldbe defined. Subject headings should be deleted if they do not apply and others may beincluded if that is the most suitable method of describing the particular organisation.2.TO REDUCE THE SIZE OF THIS DOCUMENT THE REMAINING SUBJECTS ARE NOTALLOCATED INDIVIDUAL PAGES AS IN PART 1. IT IS RECOMMENDED, HOWEVER,THAT THE FORMAT OF PART 1 IS ADOPTED FOR THE WHOLE EXPOSITION, INORDER TO FACILITATE FUTURE AMENDMENT.Anybody’s DAME ExpositionOriginal June 2016Page

APPENDIX 2 - Medical Examiners’ - Medical ManualPart 1 – IntroductionApproved By: Principal Medical OfficerVersion: 01Date:17/06/ 2016Table of ContentsSubsections to Part 1 are identified as:PageMedical Examiners’ - Medical Manual . 11.1About this Manual . 21.2Who will use this Manual . 21.3Structure of this Manual . 21.4Copies of this Medical Manual . 31.5Terminology . 31.6Definitions . 31.7Abbreviations . 3

1.1About this ManualThis Medical Manual aims, in conjunction with the relevant legislation, to provide information,guidance, policy, and requirements relating to medical certification under the Civil AviationAct 2000(as amended).This document is to be used in conjunction with: The Civil Aviation Act 2000 The Civil Aviation Rules (CARs) including Rule Part 67; The General Directions and Emergency Directives issued by the Director of CivilAviation; Civil Aviation Authority (CAA) medical certification forms; Advice from the CAA Principal Medical Officer-Dr Robin Sios via e-maildr@robinsios.comWhenever an inconsistency occurs between this document and any legislation, the legislationprevails.1.2Who will use this ManualThis Medical Manual is published primarily for Medical Examiners (MEs) to assist themin discharging their civil aviation regulatory responsibilities.It may also provide auseful resource to those who hold or are applying for Papua New Guinea medical certificates.1.3Structure of this ManualThis Medical Manual is divided into 2 parts:Part 1: IntroductionPart 2: The medical certification systemIn addition each part may contain annexed supportive documents.Civil Aviation Safety Authority of Papua New Guinea– June 2016Part 1 – Introduction2

1.4Copies of this Medical ManualThis Medical Manual is intended to be accessed via the CASA website. No printed copiesare provided by the CASA. Users who refer to printed copies of this Medical Manual mustensure that they are using the most up-to-date version.Medical Examiners will be advised, by e-mail, when updated versions of this MedicalManual are available on the CASA website.1.5TerminologyTerms used in the civil aviation regulatory environment can be found at Section 3 of the CivilAviation Act 2000 as well as interpretation sections at the start of some parts and sections ofthe Civil Aviation Act 2000 (e.g.PART IVA – Medical Certification), in Civil Aviation Rule Part1 and Part 67.03, and in section 64G-General Directions and Emergency Directives.1.6DefinitionsThroughout this document: The Act means the Civil Aviation Act 2000(as amended); The Director means the Director of Civil Aviation; The Delegate means a Medical Examiner with delegation to act on behalf of theDirector, but only in accordance with the terms of the delegated authority; Medical standards mean the medical standards contained within Civil Aviation RulePart 67;1.7 Part 67 means Civil Aviation Rule Part 67; The Rules mean the Civil Aviation Rules.AbbreviationsThroughout this document the abbreviations mean as follows:AMC Accredited Medical ConclusionCAACivil Aviation AuthorityCARCivil Aviation RuleCivil Aviation Safety Authority of Papua New Guinea– June 2016Part 1 – Introduction3

GDGeneral DirectionMEMedical ExaminerME1Medical Examiner 1ME2Medical Examiner 2MOCAA Medical OfficerSMESpecial Medical ExaminerPMO CASA PNG Principal Medical OfficerCivil Aviation Authority of PNG– June 2016Part 1 – Introduction4

Medical Examiners’ - Medical ManualPart 2 – The Medical Certification SystemApproved By: Principal Medical OfficerVersion: 01Date: 17/06/2016Table of ContentsSubsections to Part 2 are identified as:PageMedical Examiners’ - Medical Manual . 12.1 Introduction . 22.2 Legislation . 22.3 Application for a Medical Certificate . 32.4 Examination by Medical Examiner . 52.5 Use of General Directions (GDs) . 72.6 Assessment by Medical Examiner . 112.7 Extending a Medical Certificate . 192.8 Issue of Medical Certificate . 212.9 Communication . 292.10 Review of Assessment by CASA .312.11 Change in Medical Condition / Suspension Process . 322.12 Review of Director’s decision by the Convener . 362.13 Replacement Certificate. 372.14 Medical Examiner absence . 38

2.1IntroductionThis part of the Medical Manual describes the administration procedure(s) that may be relevantwhen an applicant applies for a medical certificate, or when advising a medical certificateholder.2.2LegislationOn May 2016 an amendment to the Civil Aviation Act 2000 (the Act) established a newmedical certification system. At the core of this system are Medical Examiners (MEs) who aredesignated as such by being issued a delegation. This delegation is an Aviation Document,the privileges of which enable the ME to conduct examinations for a specified class ofaviation medical certificates as described in the Civil Aviation Rules (the rules).Medical Examiners may also be delegated certain powers and functions of the Director ofCivil Aviation (the Director), such as the power to issue medical certificates. Only theDirector has the power to suspend or revoke a medical certificate under section 64I of theAct.The rules are made by the Minister for Civil Aviation under the Act. The medical standardsare prescribed in Civil Aviation Rules (CAR) Part 67.General Directions (GDs) are issued by the Director under section 64G of the Act.are items of legislation and as such are mandatory.TheyThey provide direction(s) to MEs inrelation to the conduct of medical examinations, and other requirements.In that regardthey address matters of a clinical nature, refer to subsection 2.5 – Use of GeneralDirections. Links to the GDs are in Part 4 of this Medical Manual.Civil Aviation Safety Authority of PNG-June 2016Part 2 – The Medical Certification System2

2.3Application for a Medical CertificatePrimary Legislation: Civil Aviation Act s48,49Secondary Legislation: CAR Part 67.51 to 67.55 Form:Application for Medical Certificate (CAA form 67/02)To be completed by: ApplicantFor the purpose of certification an “Application for Medical Certificate” form must becompleted. It is available on the Civil Aviation Authority (CASA) website. The applicant isresponsible for accurately completing the Application for Medical Certificate.This shouldinclude explanations of any positive answers in the space provided under question 31, oron a separate sheet if necessary. The application is to be signed in front of the ME priorto the commencement of any examination, investigation, or assessment.The ME must ensure that the form has been completed in full prior to proceeding further withthe examination.As the application includes a declaration, it is important that the ME does not complete the formon behalf of the applicant or make any changes to the entries made by the applicant. Giventhat the Application for Medical Certificate is the responsibility of the applicant, the ME shouldsign only in the final section as a witness to the applicant signing the form. The ME shouldensure that the consent on the last page of the application has not been altered by theapplicant.The ME who first receives the completed Application for Medical Certificate mustforward a copy of the front page to the CASA within five (5) working days of the applicationbeing made (the page may be faxed or emailed to pyareki@casapng.gov.pg).This isimportant in order to inform the CASA PEL Branch that an application has been made with aparticular ME.Civil Aviation Safety Authority of PNG – June 2016Part 2 – The Medical Certification System3

Key Points: Applicant to fill in an application with no omissions. Applicant to expand on “yes” answers in the space provided, or on a separatesheet as necessary. Applicant to sign the application in front of the ME. Medical Examiner to identify the applicant and witness the signature prior to anyquestioning or examination. Medical Examiner must not write on the application form except for signing. The ME must forward to CASA the front page of the application within 5working days.Civil Aviation Safety Authority of PNG – June 2016Part 2 – The Medical Certification System4

2.4Examination by Medical ExaminerPrimary Legislation:Civil Aviation Act s64B(1) refers to “the report of the medicalexaminer”.Secondary Legislation: CAR 67.57Form: Medical Examination ReportTo be completed by: Medical ExaminerOnce a properly completed Application for Medical Certificate has been received, the ME cancommence history taking, examination and investigation as necessary.2.4.1Medical Examination ReportThis form is the examining ME’s responsibility and contains the following: Confirmation by the ME of the applicant’s identity, refer to subsection 2.4.2 –Identification of applicant; Relevant medical history (including follow-up questioning concerning positive responsesmade in the application and any other matter of clinical relevance); Details concerning height and weight, blood pressure and pulse, urinalysis,electrocardiogram and blood lipid evaluations; Cardiovascular risk assessment; Systems review of the applicant; Spirometry; Dates of tests conducted; Report of any other matters identified; Signature, date and stamp of the ME.If additional space is required the ME should attach additional page(s) to the MedicalExamination form.If the ME has the appropriate delegation(s), that ME can assess the applicant for the issue ofa Medical Certificate. Refer to subsection 2.6 – Assessment by Medical Examiner.If not, the necessary report(s) must be forwarded to a ME who holds the appropriatedelegation(s).Civil Aviation Safety Authority of PNG– June 2016Part 2 – The Medical Certification System5

2.4.2Identification of applicantUnder rule 67.55(2) an applicant must produce a current PNG Passport, a current PNGDriver Licence, or an equivalent photographic identification that is acceptable to the Director.Advisory Circular AC 67-1 Original. Lists equivalent forms of photographic identifications thatare acceptable to the Director.The ME should attach a photocopy of the photographic identification produced by the applicantat the time of a first application.Key Points: The examining ME is to only write comments on the medical examination report,not on the application form. The examining ME must complete the examination in full and attach any otherrelevant documentation. The examining ME must submit the application and the examination reportswithout delay to the ME who will be conducting the assessment, if different.Civil Aviation Safety Authority of PNG– June 2016Part 2 – The Medical Certification System6

2.5Use of General Directions (GDs)Primary Legislation: Civil Aviation Act 64GSecondary Legislation: CAR 67.57, 67.67, 67.103, 67.105 and 67.107Form: Not ApplicableUse by: Medical Examiner conducting examination and Medical Examiner conducting theassessment.The Act states that the Director may issue General Directions in relation to Conducting examinations of applicants and licence holders and reporting the results ofthose examinations to the Director; and providing exceptions for temporary medical conditions to the reporting requirements setin section 64C, refer to subsection 2.11 - Change in Medical Condition / Suspensionprocess; and specifying the requirements of examinations or other clinical matters, which must bereasonable, including but not limited to:- the medical content of examinations;- the interpretation and analysis of results of examinations;- the significance of results of examinations for the purpose of determining whetheror not an applicant is eligible for a medical certificate under section 64B.General Directions are items of legislation and as such must be adhered to. A briefdescription of some of the GDs is offered below:2.5.1Timetable for Routine Examinations GDThis GD prescribes the timing of routine examinations. An important feature of this GD is theseries of tables that detail the examination requirements needed to issue a certificateand includes examples. Here are other examples.Example 1:A 43 years old applicant presents for a first examination for issue of a Class 2 certificate.The requirements are those for an initial general medical examination as demonstrated in thefirst line of the table “Class 2 medical certificate”.Civil Aviation Safety Authority of PNG– June 2016Part 2 – The Medical Certification System7

Thus the applicant will need, as per the first medical examination requirements:12 lead ECG, Cardio-vascular risk estimation – only if note 1 applies, blood lipids estimationand blood sugar estimation, a chest X-ray – only if note 2 applies, Spirometry, Audiometry –refer to note 3, and Colour vision testing.Part 2Class 2 medical certificateTiming of12-lead ECGCardioBlood lipids Chest X-rayroutinevascular risk estimation &examinationestimation Blood sugarestimationFirst ourvisionscreeningexamin-ation(Ishihara)99 see note 3999if note 1appliesif note 2appliesNotes:1. This examination is required if the applicant is 35 years of age or older.2. This examination is required only if the applicant’s history indicates a high likelihood ofasymptomatic pulmonary disease. An example of such history is if the applicant has had aprolonged stay in an area in which infective pulmonary disease is endemic.3. Routine periodic audiometry is only required for class 2 applicants who undertake InstrumentFlight Rules flights. If audiometry is not undertaken as specified in the schedule then any medicalcertificate that is issued must be endorsed “Not valid for IFR flight”.Example 2:The same applicant presents again at age 45 for a subsequent examination for re-issue of hisClass 2 medical certificate.One needs to look at the relevant age. This is the current age of 45 plus the age(s) inbetween the age of 43 (when he had his last examination) and the current age of 45. In thisinstance the ‘in between age’ is 44.Part 2Class 2 medical certificateTiming of routineexamination12-lead ECGCardiovascularrisk estimationBlood liplidsestimation &Blood sugarestimation999SpirometryAudiometryAge 43Age 449 see note 3Age 45Thus the applicant needs: 12-lead ECG, Cardio-vascular risk estimation, blood lipids estimationand blood sugar estimation and Audiometry – refer to note 3.Civil Aviation Safety Authority of PNG-June 2016Part 2 – The Medical Certification System8

Example 3:An applicant aged 65 presents for a subsequent Class 1 examination. His last examination wasat age 64. The examinations required under the GD “timetable for routine examinations” are:Part 1Class 1 medical certificateTiming of routineexamination12-lead ECGCardiovascularrisk estimationBlood lipidsestimation &Blood sugarestimation999SpirometryAudiometryAge 63Age 649Age 65The examinations required under the current age of 65: Nil.If the last examination had occurred at age 63, there would be an age in between the currentage of 65 and the age at the time of the last examination. The examinations required at age 64would have to be completed.2.5.2Examination Procedures GDThis GD prescribes how to conduct, interpret and report a number of examinations as wellas their validity periods. MEs should become familiar with this GD, which is by and largeself-explanatory.2.5.3Clinical GD(s):These GDs prescribe which examination(s) or investigation(s) are to be conducted in relationto specific medical conditions and how to interpret and analyse tests and reports. TheImpaired Hearing and Hearing Aids GD is the first clinical GD to be available.Clinical GDs allow MEs to determine if particular conditions are safety relevant and assistin deciding if an applicant meets the standard prescribed in CAR Part 67.Medical Examiners having any difficulty with the interpretation of a clinical GD are advisedto contact the CASA PNG Principal Medical Officer.2.5.4Conditions that do not need reporting GD (Temporary Medical Conditions):This GD (still under development) describes changes in medical condition that do not needreporting to the Director.Civil Aviation Safety Authority of PNG – June 2016Part 2 – The Medical Certification System9

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Advisory Circular AC 67-1 Medical standards and certification - General Original 01 July 2016 General Civil Aviation Authority Advisory Circulars contain information about standards, practices, and procedures that the Director has found to be an cceptable Means of A Compliance with the associated rule.

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