From: Mohammad Saba i To: Sahag~ccf.org Date: 9/20/05 10:24AM · 2012-11-20 · Agreement State,...

iMhamrnad Saba - Follow-u e-mail

From: Mohammad Sabai To: Sahag~ccf.org

Date: 9/20/05 10:24AMSubject: Follow-up e-mail

Dr. Saha,

I have attached to this e-mail the summaries of our telephone conversation on September 8 and 15 of2005.

If you have any questions or concerns, please contact me. Thank you.

Mohammad Saba

Telephone: 301-415-7608

CC: Cynthia Flannery

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Follow-up e-mail9/20/05 10:24AMMohammad Saba

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Dr. Gopal Saha:

Iq This is a follow-up on our telephone conversation on September 8, 2005, in response toyour August 12, 2005 letters in which you were seeking recognition of the AmericanBoard of Science in Nuclear Medicine's (ABSNM) certification processes by the U.S.Nuclear Regulatory Commission (NRC). There are several statements in the letters,which preclude recognition of ABSNM certification processes without further input fromthe board. The issues that require attention are listed and explained below.

1. Section A of the "Current Requirements" states that all the candidates shall hold amaster's or doctor's degree in medical physics, pharmaceutical science,engineering, applied mathematics, pharmacy, biology, or other physical sciencesor health physics from an accredited college or university. ABSNM needs toconfirm that the degree requirements for their candidates seeking certificationunder the Radiation Protection Specialty must meet the requirements in 10 CFR35.50(a)(2)(i).

2. Section B.3 (i) of the "Current Requirements" of ABSNM's application states, inpart, that "training and/or supervised experience must be obtained "under thesupervision of a radiation safety officer...." ABSNM needs to confirm thatcandidates seeking certification under the Radiation Protection Specialty mustobtain their practical training and/or supervised experience in medical physicsunder the supervision/direction of an individual who meets the requirements in 10

(4w CFR 35.50(a)(2)(ii)(A) or 35.50(a)(2)(ii)(B).

3. In accordance with 10 CFR 35.50(a)(2)(iii), ABSNM needs to confirm that theRadiation Protection Specialty certification examination also assesses knowledgeand competence in "clinical diagnostic radiological or nuclear medicine physics."

Review of ABSNM's application for recognition will continue upon receipt of ABSNM'sofficial reply to the issues needing attention that are listed and explained above.

Communications from the ABSNM associated with applying for recognition of itscertification processes should continue to be addressed to:

U.S. Nuclear Regulatory CommissionATTN: Mr. Thomas H. Essig, ChiefMaterials Safety and inspection Branch (MS T8F3)1545 Rockville PikeRockville, MD 20852

For further information or for questions, please contact me at (301) 415-7608,[email protected].

Mohammad Saba

Z

Dr. Gopal Saha:

I am summarizing our teleconference on September 15, 2005, in response to yourclarification e-mail on September 12, 2005. The NRC staff arranged a teleconferencewith you to discuss the ABSNM application for recognition process in detail. Theparticipants of this meeting were Gopal Saha, PhD (ABSNM); Donna-Beth Howe, PhD;and Mohammad Saba.

The conclusions of the meeting are summarized as below:

* The Nuclear Physics and Instrumentation Specialty is more likely to obtaincertification process recognition under 10 CFR 35.50 (a) (2) (A)" Radiation SafetyOfficer Training." Provided that you submit the required information.

* The Radiopharmaceutical Science Specialty is less likely to obtain certification under10 CFR 35.50 'Training for Radiation Safety Officer."

* Radiation Protection Specialty is more likely to conform to the regulations under 10CFR 35.50 (a) (1). Provided that you submit the required information.

Review of ABSNM's application for recognition will continue upon receipt of ABSNM'sofficial reply to the issues needing attention that are listed and explained above.

Communications from the ABSNM associated with applying for recognition of itscertification processes should continue to be addressed to:

(ui U.S. Nuclear Regulatory CommissionATTN: Mr. Thomas H. Essig, ChiefMaterials Safety and inspection Branch (MS T8F3)1545 Rockville PikeRockville, MD 20852

For further information or for questions, please contact me at (301) 415-7608,[email protected].

Mohammad Saba

Mohammad Saba - ABSNM rad pro specialty. Page 1

,..

From: OSaha, Ph.D., Gopal" <[email protected]>To: "Mohammad Saba" <[email protected]>Date: 10/21/05 4:07PMSubject: ABSNM rad pro specialty.

Dear Mr. Saba:

First of all, I like to thank Dr Howe, Dr Zelac and you for theopportunity to meet with you to discuss the issues related tocredentialing requirements of the candidates taking the ABSNM RadiationProtection Specialty Examination for approval of RSO. The meeting was aproductive one, since it would have been difficult to resolve theseissues by correspondences.

It was decided at the meeting that recognition of ABSNM RadiationProtection Specialty by NRC for RSO approval will be made in two ways:health physics pathway (1 OCFR35.50 (a) (1)) and medical physics pathway(1 OCFR35.50 (a) (2)).Accordingly, I have rewritten the requirements forthis specialty in two ways: one with an alternative separate Option D inaddition to Option C, and the other under the same Option C with an OR.These files are attached. Please see which one you prefer and let meknow. Personally I like Option C with an OR, because this will eliminateconfusion with two separate headings for the same specialty.

Also to meet overall requirements by NRC in examination itself, I haverewritten the first part of Section D of the current application and thefile is attached for you review.

fi Once I receive your response, please let me know whether I have tosubmit a new revised application or just this part alone.

Thank you all again.

Gopal B Saha, Ph.D.Director of Nuclear Chemistry and PharmacyDepartment of Molecular and Functional ImagingCleveland Clinic FoundationCleveland, OH 44195216-444-2777

t

Confidentiality Note: This message is intended for use only by the individual 9rEntity to which it isaddressed and may contain information that is privileged, confidential, and ex mpt from disclosure underapplicable law. If the reader of this message is not the intended recipient c r tie employee or agentresponsible for delivering the message to the intended recipient, you are he rety notified that anydissemination, distribution or copying of this communication is strictly prohibited. If you have received thiscommunication in error, please contact the sender immediately and destroy the material in its entirety,whether electronic or hard copy. Thank you..........

Visit us online at our award-winning http:l/www.clevelandclinic.org for a complete listing of Cleveland Clinicservices, staff and locations from one of the country's leading hospitals.

--- - 7m--

I Mohammad Saba - Rad Protec spec req 1 -doc Paae 1 1Moharn mad Saba - Rad Protec spec rea 1 .doc Paae 1 �1

C. Requirements for candidates taking Radiation Protection Specialty

(i) General Education:A master's or a doctorate degree from an accredited college or universityin physical science, engineering, biological science or health physics witha minimum of 20 college credits in physical science, and

(ii) five or more years of professional experience in applied health physics(graduate training may be substituted for no more than 2 years of theexperience) including at least 3 years in applied health physics.

OR

(i) General Education:A master's or a doctorate degree in physics, medical physics, otherphysical science, engineering or applied mathematics from an accreditedcollege or university, and

(ii) Training/Work Experience:Two years (doctorate candidates) or three years (master's candidates) offull time practical training and/or supervised experience in medicalphysics.

(1) Under the supervision of a medical physicist who is certified inmedical physics by a specialty board recognized by NRC or anAgreement State, and who will provide a letter of reference attesting tothe candidate's experience and competency; or

(2) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in 10CFR35.290 and 1OCFR35.390, andwho will provide a letter of reference to the candidate's experience andcompetency;

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I Mohammad Saba - rad Drotection sDec requirement 2.doc ' P'aae 1 1


(i) General Education:A master's or a doctorate degree from an accredited college or universityin physical science, engineering, biological science or health physics witha minimum of 20 college credits in physical science, and


D.. Alternative Requirements for candidates taking Radiation ProtectionSpecialty


(ii) Training/Work Experience:Two years (doctorate candidates) or three years (master's candidates) offull time practical training and/or supervised experience in medicalphysics.


(2) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in 10CFR35.290 and 1OCFR35.390, andwho will provide a letter of reference to the candidate's experience andcompetency;

Mohammad Saba - Examination.doc Page 1

E. Examination: All candidates must pass an examination for certification byABSNM. The examination evaluates knowledge and competence of thecandidates in radiation physics and instrumentation, radiation protection, radiationbiology, radioisotope production, radiopharmaceutical chemistry, radiationdosimetry, and diagnostic nuclear medicine physics and intrumentation. Thecertifying examination is written and consists of two parts as detailed below:

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ABSNM rad pro specialty.10/21/05 4:07PM"Saha, Ph.D., Gopal" <[email protected]>

[email protected]

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4oh~ammd §aba - Followu _ P .f

From: Mohammad SabaTo: Sahag~ccf.orgDate: 11/4/05 4:17PMSubject: Follow-up

Dr. Saha:

This e-mail is a follow-up on my telephone conversation on November 4, 2005, regarding your October21, 2005 e-mail in which you were seeking recognition of the American Board of Science in NuclearMedicine's (ABSNM) certification processes for "Nuclear Physics and Instrumentation Specialty',"Radiopharmaceutical Science Specialty", and " Radiation Protection Specialty" by the U.S. NuclearRegulatory Commission (NRC).

Nuclear Physics and Instrumentation Specialty:

The certification process for ABSNM certification in Nuclear Physics and Instrumentation Specialty meetsthe applicable requirements in 10 CFR 35.50 (a) (2) for NRC recognition. Please provide a date for whichthe revisions to the certification process went into effect.

There are several statements in the e-mail which preclude recognition of ABSNM certification process forthe remaining specialties without further input from the ABSNM. The issues that require attention arelisted and explained below.

Radiopharmaceutical Science Specialty:

This specialty does not meet the applicable requirements in 10 CFR 35.50(a)(2) for several reason thatwere discussed in my e-mail to you dated October 13, 2005.

Radiation Protection Specialty:

There still a few items that preclude this specialty board process from recognition by the NuclearRegulatory Commission ( NRC) that are listed as below:

In section C (i) of the "Credentialing Requirements for ABSNM Certification" for candidates in the"Radiation Protection Specialty" of your application, you need to change "a master or doctoral degree inbiological science" to "a master or doctoral degree in biological science with minimum of 20 college creditsin physical science."

In section C (ii) of the "Credentialing Requirements for ABSNM Certification" for candidates in the"Radiation Protection Specialty" of your application, forth line, you need to change "reference to thecandidate's experience to "reference attesting to the candidate's experience."

In part 1 examination, you need to change "mathematics" to "mathematics pertaining to the use andmeasurement of radioactivity."

Also, please s-mall me the two pathways for the radiation protection specialty that you discussedon the phone.

Review of ABSNM's application for recognition of the certification process for the Radiation ProtectionSpecialty will continue upon receipt of ABSNM's official reply to the issues needing attention that are listedand explained above.

Communications from the ABSNM associated with applying for recognition of its certification processesshould continue to be addressed to:

ivionamnmaa .Paa~a - to-wow-up Page 2ivionammaa �,aDa - 1-ovow-up Paae2


For further information or for questions, please contact me at (301) 415-7608, mss @ nrc.aov. Thank you.

Mohammad Saba

CC: Cynthia Flannery; Ronald Zelac

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EMohammad Saba - ABSNM recognition by NRC Page 1

From: NSaha, Ph.D., Gopal" <SAHAG @ccf.org>c To: Mohammad Saba" <[email protected]>

Date: 11/4/05 4:26PMSubject: ABSNM recognition by NRC

Dear Mr Saba:

It was nice to talk you and thank for your guidance In correcting thewrite-up of our credential requirements for ABSNM candidates. Asmutually agreed, I have attached two files, File land File 2. Both filesare complete requirements for all specialties, except that samerequirements for Radiation Protection Specialty have been presented intwo ways. I prefer the File 1, because it will avoid possible confusionin the minds of prospective candidates.

Thank you for your help and I am looking forward to your positiveresponse.

Gopal Saha, Ph.D.216-444-2777

Confidentiality Note: This message is intended for use only by the individual or entity to which it isaddressed and may contain information that is privileged, confidential, and exempt from disclosure underapplicable law. If the reader of this message is not the intended recipient or the employee or agentresponsible for delivering the message to the intended recipient, you are hereby notified that anydissemination, distribution or copying of this communication is strictly prohibited. If you have received thiscommunication in error, please contact the sender immediately and destroy the material in its entirety,whether electronic or hard copy. Thank you.

Visit us online at our award-winning http://www.clevelandclinic.org for a complete listing of Cleveland Clinicservices, staff and locations from one of the country's leading hospitals.

CC: "Cannon Hugh C." <HCannon~snm.org>, "Robinson Gregg" <GRobinson~snm.org>

I Mohqmmad Saba - filel -doc Page I XF nhmmd aa feldc -'ae1

Credentialing Requirements for ABSNM Certification

A. Requirements for candidates taking Nuclear Physics and InstrumentationSpecialty

(i) General Education:A master's or a doctorate degree in physics, medical physics, engineering,applied mathematics, or other physical sciences from an accredited collegeor university, and

(ii) Training/Work Experience:Two years (doctorate candidates) or three years (master's candidates) offull-time practical training and/or supervised experience in medicalphysics:


(2) In clinical nuclear medicine facilities providing diagnosticand/or therapeutic services under the direction of physicians who meetthe requirements for authorized users in 10CFR35.290 andlOCFR35.390, and who will provide a letter of reference attesting tothe candidate's experience and competency.

B. Requirements for candidates taking Radiopharmaceutical Science Specialty

(i) General Education:A master's or a doctorate degree in physics, nuclear pharmacy, biologicalscience, radiopharmaceutical science, chemistry or other pharmaceuticalscience from an accredited college or university, and

(ii) Training/Work Experience:Three years of full-time practical training and/or supervised experience inradiopharmaceutical science:

(1) Under the supervision of an authorized nuclear pharmacist who is on alicensee's radioactive material license and has experinece in radiationsafety, and who will provide a letter of reference attesting to thecandidate's experience and competency; or

(2) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in IOCFR35.290 and lOCFR35.390,

F ohama Saa-=ie~ Page 2I Mohammad Saba - fuel .doc Page 2�I

and who will provide a letter of reference attesting to the candidate'sexperience and competency.


(i) General Education:A master's or a doctorate degree from an accredited college or universityin physical science, engineering, health physics, or biological science witha minimum of 20 college credits in physical science, and


OR


(ii) TrainingtWork Experience:Two years (doctorate candidates) or three years (master's candidates) offull time practical training and/or supervised experience in medicalphysics.


(2) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in 10CFR35.290 and 1OCFR35.390, andwho will provide a letter of reference attesting to the candidate'sexperience and competency.

D. Examination: All candidates must pass an examination for certification byABSNM. The examination evaluates knowledge and competence of the candidatesin radiation physics and instrumentation, radiation protection, radiation biology,radioisotope production, radiopharmaceutical chemistry, radiation dosimetry, and

E Mohammad Saba - filel .doc ~^Paae 3 1MoamdSb Uel.ocPae3

diagnostic nuclear medicine physics and instrumentation. The certifyingexamination is written and consists of two parts as detailed below:

Part 1: General Examination. Each candidate is required to take this partentitled "General Nuclear Medicine Science." This part involves basic aspects ofatomic and nuclear physics, instrumentation, radiopharmaceuticals, mathematicspertaining to the use and measurement of radioactivity, statistics, radiobiology,dosimetry, radiation protection and regulations, basic anatomy and physiology,pathology, clinical diagnostic nuclear medicine physics and instrumentation,clinical in vivo imaging and in vitro studies.

Part 2: Specialty Examination. Each candidate must take at least one of thefollowing three Specialty examinations. This part examines in depth theknowledge of the candidate in the specialty area.

a. Nuclear Medicine Physics and Instrumentation. This examination includesin-depth materials on atomic and nuclear physics, radioactivitymeasurement, imaging, basic image data processing, statistical analysis,quality control, radiation dose estimation, mathematical modeling,principles of imaging and radioactivity detection and instrumentation,instrument design, health physics and radiation protection and clinicaldiagnostic nuclear medicine physics.

b. Radiopharmaceutical Science. This examination will cover in depth thetopics of radionuclide production, radiopharmaceutical design andformulation, radioactivity measurement and radionuclide identification,pharmacology and tracer methodology, quality control, internal dosimetry,radiation protection and regulations, radiochemistry, radiation biology,physiology, toxicology, clinical diagnostic nuclear medicine physics, andclinical uses of radiopharmaceuticals.

c. Radiation Protection. This examination includes in depth the topics oftypes and properties of radiation, interaction of radiation with matter, doseunits and concepts, radiobiology, regulations, approaches to radiationprotection, shielding, personnel monitoring, internal dose measurements,decontamination, waste disposal, and other aspects of radiation control.

Mr'ba~inadSaba - A Ap catin _Pae 1

From: Mohammad SabaTo: Sahag~ccf.orgDate: 11/8/05 3:16PMSubject: ABSNM Application

Dr. Saha:

This e-mail is in response to your e-mail dated November 4, 2005 to me seeking NRC recognition forcertification process. The application was reviewed and it looks good. However, you need to include thefollowing information to the formal letter that you send to Tom Essig.

1. The website information needs to be submitted as an official signed letter. This is to document theinformation that is being submitted for review and upon which our final decision will be based.

2. Attach a copy of a sample of your certificate for the two specialty board that you are seeking NRCrecognition.

3. The date you identify that the ABSNM meets the NRC criteria.




For further information or for questions, please contact me at (301) 415-7608, [email protected]. Thank you.

Mohammad Saba

CC: Cynthia Flannery

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ABSNM Application11/8/05 3:16PMMohammad Saba

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(ii) Training/Work Experience:Two years (doctorate candidates) or three years (master's candidates) offull-time practical training and/or supervised experience in medicalphysics:


(2) In clinical nuclear medicine facilities providing diagnosticand/or therapeutic services under the direction of physicians who meetthe requirements for authorized users in 10CFR35.290 and1OCFR35.390, and who will provide a letter of reference attesting tothe candidate's experience and competency.




(1) Under the supervision of an authorized nuclear pharmacist who is on alicensee's radioactive material license and has experience in radiationsafety, and who will provide a letter of reference attesting to thecandidate's experience and competency; or

(2) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in lOCFR35.290 and 1OCFR35.390,

I0 Mohammad Saba - file 2.doc Pae 2 II[Mohammad Saba - file 2.doc Pane 2 �1

and who will provide a letter of reference attesting to the candidate'sexperience and competency.


(i) General Education:A master's or a doctorate degree from an accredited college or universityin physical science, engineering, health physics or biological science witha minimum of 20 college credits in physical science, and


D. Alternative Requirements for candidates taking Radiation ProtectionSpecialty


(ii) Training/VWork Experience:Two years (doctorate candidates) or three years (master's candidates) offull time practical training and/or supervised experience in medicalphysics.


(2) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in 10CFR35.290 and 10CFR35.390,and who will provide a letter of reference attesting to the candidate'sexperience and competency.

E. Examination: All candidates must pass an examination for certification byABSNM. The examination evaluates knowledge and competence of thecandidates in radiation physics and instrumentation, radiation protection,radiation biology, radioisotope production, radiopharmaceutical chemistry,radiation dosimetry, and diagnostic nuclear medicine physics and instrumentation.The certifying examination is written and consists of two parts as detailed below:

11Mohammad Saba - file 2.doc Page 3 qI. Mohammad Saba - file 2.doc Paae 3





c. Radiation Protection. This examination includes in depth the topics oftypes and properties of radiation, interaction of radiation with matter, doseunits and concepts, radiobiology, regulations, approaches to radiationprotection, shielding, personnel monitoring, internal dose measurements,decontamination, waste disposal, and other aspects of radiation control.

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ABSNM recognition by NRC11/4/05 4:25PM"Saha, Ph.D., Gopal" <[email protected]>

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From: Mohammad SabaTo: MCannon @snm.org; Sahag~ccf.orgDate: 12/1/05 2:38PMSubject: Follow-up E-mail Regarding the ABSNM Application

Dear Dr. Saha:

This a follow-up e-mail is to summarize our telephone conversation on November 28, 2005, regarding theABSNM letter to Tom Essig applying for NRC recognition of the board certification process.

The following issues we discussed on the phone today:

1. The updated website information needs to be submitted as an attachment to an official signed letter.The website information that was attached to your November 18, 2005 letter was not updated. This is theinformation that upon which the final decision will be based upon.

2. Also, we discussed that the requirements for candidates taking radiation protection specialty, medicalphysics pathway, does not comply with the new regulations under 10 CFR 35.50(a)(2). The reason isbecause in the provisions of the March 30, 2005, Final Rule: *Medical Use of Byproduct Material -Recognition of Specialty Boards - Part 35, Federal Register Nol. 70, page 16351, first paragraph, statesthat the candidate to be qualified as RSO underl 0 CFR 35.50(a)(2) must be certified in either diagnosticradiology or nuclear medicine. The address for this federal registry ishttp:l/www.nrc.pov/readinp-rm/doc-collections/cfr/fr/2005/20050330.pdf.




For further information or for questions, please contact me at (301) 415-7608, [email protected]. Thank you.

Mohammad Saba

CC: Cynthia Flannery; Donna-Beth Howe

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Follow-up E-mail Regarding the ABSNM Application12/1/05 2:38PMMohammad Saba

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The ABSNM would like to submit application for NRC recognition of the Board toapprove- Radiation--Safty--Officer. Included in -this letter for-reference-aretlhe-newrequirements effective June 18, 2005.

A certificate issued by the ABSNM indicates that its holder has successfullycompleted certain requirements of study and professional experience that the Boardconsiders necessary to constitute an adequate foundation in Nuclear MedicineScience. It also indicates that the candidate has passed an examination for abilityand competence in thee field of Nuclear Medicine Science.

The Board requires that applicants for admission to the examination for a certificatein Nuclear Medicine Science shall submit evidence demonstrating that they havemet the following requirements:

Current RequirementsJune 18, 2005

A. General EducationA master's or doctorate degree with a major in a field of medical physics,pharmaceutical science, engineering, applied mathematics, pharmacy, biology orother physical sciences or health physics from an accredited college or university.

B. (1) Nuclear Physics and Instrumentation Specialty Examination:Two years (doctorate candidates) or three years (master's candidates) of full-timetraining and/or supervised experience in nuclear medicine physics:

(i) Under the supervision of a certified nuclear physicist whosecertification is recognized by NRC, and who will provide a letter of referenceattesting to the candidate's experience; or(ii) In a clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet the requirementsfor authorized users in IOCFR35.290 and IOCFR35.390, and who will provide aletter of reference attesting to the candidate's experience.

(2) Radiopharmaceutical Science Specialty Examination:Two years (doctorate candidate) or three years (master's candidates) of full-timetraining and/or supervised experience in radiopharmaceutical science:

(i) Under the supervision of a certified nuclear chemist or phannacistwhose certification is recognized by NRC, and who will provide a letter ofreference attesting to the candidate's experience; or(ii) In a clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet the requirementsfor authorized users in IOCFR35.290 and 10CFR35.390, and who will provide aletter of reference attesting to the candidate's experience.

(3) Radiation Protection Specialty Examination:Two years (doctorate candidates) or three years (master's candidates) of full timetraining and/or supervised experience in radiation protection.

(i) Under the supervision of a radiation safety officer or a medical physicistwho is certified by a specialty board recognized by the NRC or an Agreement State,and who will provide a letter of reference attesting to the candidate's experience; or(ii) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet the requirementsfor authorized users in IOCFR35.290 and IOCFR35.390, and who will provide aletter of reference to the candidate's competency.

C. Examination: All candidates must pass an examination as detailedbelow:

The certifying examination is written and consists of two parts:

Each admitted candidate is required to take Part One entitled "General NuclearMedicine Science." This confers basic aspects of atomic and nuclear physics,instrumentation, radiopharmaceuticals, mathematics and statistics, radiobiology,radiation protection and regulations, basic anatomy (physiology), pathology, andclinical nuclear medicine, including imaging and in vitro studies. Part two examinesin depth the knowledge of a predetermined sub-specialty area of the candidate'schoice and will cover one of the following:

a. Nuclear Medicine Physics and Instrumentation in greater depth than inPart One, including atomic and nuclear physics, radioactivity measurement,imaging, basic image data processing, statistical analysis, quality control, radiationdose estimation, mathematical modeling, principles of imaging and radioactivitydetection and instrumentation, instrument design, health physics and radiationprotection and associated clinical applications.b. Radiopharmaceutical Science. This examination will cover radionuclideproduction, radiopharmaceutical design and formulation, radioactivity measurementand radionuclide identification, pharmacology and tracer methodology, qualitycontrol, radiation protection and regulations, radiochemistry, radiation biology,physiology, and toxicology, clinical uses of radiopharmaceuticals.c.Radiation Protection. This examination includes types and properties of radiation,interaction of radiation with matter, dose units and concepts, radiobiology,regulations, approaches to radiation protection, shielding, personnel monitoring,internal dose measurements, decontamination, waste disposal, and other aspects ofradiation control

By achieving certification, the nuclear medicine scientist recognizes his or herresponsibility to the profession. He or she agrees to maintain technical competence

and commits to remain active in the field by continually being acquainted withpertinent scientific, technical and regulatory developments. implicit withincertification is an agreement to uphold and reflect the highest level of professionaland scienti fic ethics in all areas of Nicler Medkin-e Siewe- Th-erelationshipsbetween the Nuclear Medicine Scientist and colleagues, clients, governmentalagencies and the general public should always reflect the highest level ofprofessional ethics and integrity.

A certificate will be issued to each candidate who meets the requirements of theBoard and passes the examination and will indicate that the holder of the certificatehas adequate training in Nuclear Medicine Science and has demonstratedknowledge adequate to practice Nuclear Medicine Science in one or more of itsspecialties.

A certificate granted by the Board does not of itself confer, or purport to confer, anydegree or legal qualifications, privileges or license to practice Nuclear MedicineScience. A certificate granted by the Board holds lifetime validity from the time it isissued.

Information on the ABSNM and the examination is also available on the ABSNMwebsite. http://www.snm.orRIABSNM

The ABSNM acknowledges its commitment to and responsibility for thecompleteness and accuracy of the information provided to the NRC.

The ABSNM appreciates the opportunity to submit this application and is availableto answer any questions or concerns regarding the examination and the application.We would appreciate prompt recognition by the NRC of the ABSNM as one of theBoards to approve the RSO positions.

Thank you for your time and consideration of this application.

Sincerely,

St Danak, MS Gopal Saha, PhDPresident immediate Past PresidentABSNM ABSNM

Cc: Virginia Pappas, CAE

AMERICA N 8OA RD OF SCIENCE IN NUCLEAR M EDICIN E

October 3, 2005

US Nuclear Regulatory CommissionAttn: Thomas H. Essig, ChiefMaterial Safety and Inspection Branch1545 Rockville PikeRockville, MD 20852

Re: Board Recognition of ABSNM by NRC for Radiation Safety Officers

Dear Mr. Essig:

This letter is a revision to our original application dated August 12, 2005 for therecognition of American Board of Science in Nuclear Medicine (ABSNM) by NRC forRadiation Safety Officers under 10CFR35.50, based on the teleconferences on September8 between Dr. Gopal Saha and Mr. Mohammad Saba, and on September 15 between Dr.Gopal Saha and Dr. Donna-Beth Howe and Mr. Mohammad Saba. The essential points ofthe conference calls have been given in the attachment.

It is indicated that NRC is likely to recognize ABSNM certification with Nuclear Physicsand Instrumentation Specialty under 10CFR35.50(a)(2)A "Radiation Safety OfficerTraining" and ABSNM certification with Radiation Protection Specialty under1OCFR35.50(a)(1) "Radiation Safety Officer Training", provided ABSNM revises thecredentialing requirements for the candidates to meet those of 1OCFR35.50. Accordingly,given below are the revised credentialing requirements, which will be posted on theABSNM website, once approved by NRC.




(ii) Training/VWork Experience:Two years (doctorate candidates) or three years (master's candidates) offull-time practical training and/or supervised experience in medicalphysics:

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(2) In clinical nuclear medicine facilities providing diagnosticand/or therapeutic services under the direction of physicians who meetthe requirements for authorized users in IOCFR35.290 andIOCFR35.390, and who will provide a letter of reference attesting tothe candidate's experience and competency.





(2) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in IOCFR35.290 and 1OCFR35.390,and who will provide a letter of reference attesting to the candidate'sexperience and competency.


(i) General Education:A master's or a doctorate degree from an accredited college or universityin physical science, engineering, biological science or health physics with

a minimum of 20 college credits in physical science, and

(ii) Training/Work Experience:(a) Two years (doctorate candidates) or three years (master's candidates)of full time practical training and/or supervised experience in radiationprotection:

(1) Under the supervision of a medical physicist who is certified in

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medical physics by a specialty board recognized by NRC or an AgreementState, and who will provide a letter of reference attesting to thecandidate's experience and competency; or

(2) Tn clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in IOCFR35.290 and 1OCFR35.390, andwho will provide a letter of reference to the candidate's experience andcompetency;

or

(b) three years of professional experience in applied health physics.

D. Examination: All candidates must pass an examination for certification byABSNM. The certifying examination is written and consists of two parts asdetailed below:

Part 1: Each candidate is required to take this part entitled "General NuclearMedicine Science." This part involves basic aspects of atomic and nuclearphysics, instrumentation, radiopharmaceuticals, mathematics and statistics,radiobiology, dosimetry, radiation protection and regulations, basic anatomy andphysiology, pathology, clinical diagnostic nuclear medicine physics andinstrumentation, clinical in vivo imaging and in vitro studies.

Part 2: Each candidate must take one of the following three Specialtyexaminations. This part examines in depth the knowledge of the candidate in thespecialty area.



c. Radiation Protection. This examination includes in depth the topics oftypes and properties of radiation, interaction of radiation with matter, dose

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units and concepts, radiobiology, regulations, approaches to radiationprotection, shielding, personnel monitoring, internal dose measurements,decontamination, waste disposal, and other aspects of radiation control.

Please note that ABSNM certification with Radiopharmaceutical Science Specialty isincluded for recognition. NRC indicated that ABSNM certification withRadiopharmaceutical Science Specialty may not be recognized under IOCFR35.50.ABSNM would like to request NRC to consider this specialty for RSO approval.

The primary reason for this request is that NRC approves an authorized nuclearpharmacist who has a pharmacy degree and two years of traininglexperience in nuclearpharmacy practice (who is on a radioactive license) to be a radiation safety officer underlOCFR35.50(c)(2). In parallel, ABSNM with Radiopharmaceutical Science Specialtyrequires a master's or a doctorate degree in radiopharmaceutical science, physics,chemistry, biological science, nuclear pharmacy, or other pharmaceutical science, andthree years of training/work experience under the supervision of an authorized nuclearpharmacist or authorized user physicians. The contents of the general and specialtyexaminations given above cover extensive radiation safety training and experiencerequired of the candidates. It is the opinion of ABSNM that ABSNM diplomates arebetter trained and qualified than authorized nuclear pharmacists to be radiation safetyofficers.

Another point of consideration is that RSO approval by way of board certification is atwo-step process: (1) board certification and (2) attestation of competency by a preceptorradiation safety officer. Even if ABSNM certification is recognized by NRC, an ABSNMdiplomate automatically does not become a radiation safety officer. In addition to boardcertification, NRC requires a diplomate to submit an attestation of competency by apreceptor radiation safety officer (IOCFR35.50(d)) in various aspects of radiationprotection (lOCFR35.50(e)). ABSNM strongly contends that these additionalrequirements in radiation safety training/experience beyond board certification and thesubject materials of ABSNM examinations amply justify the recognition of ABSNM withRadiopharmaceutical Science Specialty by NRC for the first part of the RSO approval.

ABSNM, therefore, requests the approval of all three specialties by NRC.

The objective and mission of ABSNM have been given in the original application andthis application serves as a revised application.

We would appreciate your favorable decision on our application and are looking forwardto your positive response.

Subhash Danak, M.S. Gopal B Saha, Ph.D.President tmniediate Past President

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November 18, 2005

U.S. Nuclear Regulatory CommissionATTN: Mr. Thomas Essig, Chief,Materials Safety and Inspection Branch (MS T8F3)11545 Rockville PikeRockville, MD 20852

Subject: BOARD RECOGNITION OF ABSNM BY NRC FOR RADIATION SAFETYOFFICERS

Dear Mr. Essig:

In response to our application dated October 3, 2005 for the recognition of American Boardof Nuclear Medicine Science (ABSNM) by NRC for Radiation Safety Officers (RSO) under10CFR35.50, NRC representatives asked for a meeting at the NRC office in Rockville, MDbetween ABSNM representatives and NRC representatives to discuss our application atlength. The meeting was held on October 20, 2005 and the individuals present were Dr.Donna-Beth Howe, Dr. Ronald Zelac and Mr. Mohammad Saba from NRC and Mr. HughCannon, Mr. Gregg Robinson and Dr. Gopal Saha from ABSNM. The meeting wasproductive and NRC indicated that it will approve Nuclear Medicine Physics andInstrumentation and Radiation Protection Specialties, with some modifications inrequirements for the latter.

With instructions from NRC at the meeting and per e-mail instructions from Mr. Saba,ABSNM submits the following:

1. A revised copy of "Requirements for ABSNM Certification"

2. The ASBSNM website is www.snm.org/absnm. Credentialing requirements andall pertinent information have been posted on the website, as required by NrRC

3. Sample copies of certificates for two specialties that are awarded to the successfulcandidates.

4. Attached credentialing requirements meeting NRC criteria will be implementedeffective June, 2006.

We hope the above are satisfactory for your consideration. We are looking forward to yourpositive response.

Subhash Danak, M.S. palB. SPresident Immediate Past President

c/o Society of Nuclear Medidne 1 1550 Samuel Morse Drive I Reston. %A 201O0-5316 I Tel: 70S.710.9000 I Fax: 703.708.9013ww w. s nm .erg/ absnm

EXAMINATION AND CERTIFICATION

NEW"Application for 2005 Certification .pdf file now online!Click here.

Objectives

The objectives and purposes of the American Board of Science in Nuclear Medicine include thefollowing:

a. To elevate the standards of graduate education in nuclear medical science. For thepurposes of the Board, the practice of nuclear medical science is defined as dealingwith diagnostic, therapeutic (exclusive of sealed radiation sources) andinvestigative uses of radionuclides.

b. To establish and determine qualifications of voluntary candidates requestingexamination for certification in nuclear medical sciences.

c. To arrange, control, and conduct examinations to test the competence of thecandidates for certification.

d. To grant and issue certificates in nuclear medical science to applicants who havebeen found qualified by the Board. No certificates granted or issued by the Boardshall confer or purport to confer upon any person any legal qualification, privilege,or license to practice nuclear medicine or any other specialty or branch ofmedicine, nor shall it purport to be used under, in pursuance of, or by virtue of any

.! statutory governmental authority.e. To maintain a registry of holders of such certificates, and serve the medical and lay

public by preparing and furnishing lists of practitioners who have been certified bythe Board.

f. In general, to encourage the study and improve the practice of nuclear medicalscience.

Certificates

A certificate is issued to each candidate who meets the requirements of the Board and passes theexamination as outlined below and indicates that the holder of the certificate has adequate trainingin Nuclear Medicine Science and has demonstrated knowledge adequate to practice NuclearMedicine Science in one or more of its sub-specialties:

a. Nuclear Medicine Physics and Instrumentationb. Radiopharmaceutical Sciencec. Radiation Protection

A certificate granted by this Board does not of itself confer, or purport to confer, any degree oflegal qualifications, privileges or license to practice Nuclear Medicine Science.

) Meaning of Certification

A certificate from the American Board of Science in Nuclear Medicine indicates that its holderhas successfully completed certain requirements of study and professional experience, which theBoard considers necessary to constitute an adequate foundation in Nuclear Medicine Science. Italso indicates that the candidate has passed an examination for ability and competence in the fieldof Nuclear Medicine Science.

General Requirements to Take the Exam

Applicants for admission to the examination for a certificate in Nuclear Medicine Science arerequired to submit evidence demonstrating that they have met the following standard:

A. General EducationA master's or doctorate degree with a major in a field of medical physics, pharmaceuticalscience, engineering, applied mathematics, pharmacy, biology or other physical sciencesor health physics from an accredited college or university.

B. (1) Nuclear Physics and Instrumentation Specialty Examination:Two years (doctorate candidates) or three years (master's candidates) of full-timetraining and/or supervised experience in nuclear medicine physics:

(i) Under the supervision of a certified nuclear physicist whose certification isrecognized by NRC, and who will provide a letter of reference attesting tothe candidate's experience; or

(ii) In a clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in lOCFR35.290 and lOCFR35.390, andwho will provide a letter of reference attesting to the candidate'sexperience.

(2) Radiopharmaceutical Science Specialty Examination:Two years (doctorate candidate) or three years (master's candidates) of full-timetraining and/or supervised experience in radiopharmaceutical science:

(i) Under the supervision of a certified nuclear chemist or pharmacist whosecertification is recognized by NRC, and who will provide a letter ofreference attesting to the candidate's experience; or

(ii) In a clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in IOCFR35.290 and lOCFR35.390, andwho will provide a letter of reference attesting to the candidate'sexperience.

(3) Radiation Protection Specialty Examination:Two years (doctorate candidates) or three years (master's candidates) of full time

training and/or supervised experience in radiation protection.

(i) Under the supervision of a radiation safety officer or a medical physicistwho is certified by a specialty board recognized by the NRC or anAgreement State, and who will provide a letter of reference attesting to thecandidate's experience; or

(ii) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in 10CFR35.290 and 10CFR35.390, andwho will provide a letter of reference to the candidate's competency.

C. Examination: All candidates must pass an examination as detailed below:

The certifying examination is written and consists of two parts:

Each admitted candidate is required to take Part One entitled "General NuclearMedicine Science." This confers basic aspects of atomic and nuclear physics, instrumentation,radiopharmaceuticals, mathematics and statistics, radiobiology, radiation protection andregulations, basic anatomy (physiology), pathology, and clinical nuclear medicine, includingimaging and in vitro studies. Part two examines in depth the knowledge of a predetermined sub-specialty area of the candidate's choice and will cover one of the following:

a. Nuclear Medicine Physics and Instrumentation in greater depth than in Part One,including atomic and nuclear physics, radioactivity measurement, imaging, basicimage data processing, statistical analysis, quality control, radiation doseestimation, mathematical modeling, principles of imaging and radioactivitydetection and instrumentation, instrument design, health physics and radiationprotection and associated clinical applications.

b. Radiopharmaceutical Science. This examination will cover radionuclideproduction, radiopharmaceutical design and formulation, radioactivitymeasurement and radionuclide identification, pharmacology and tracermethodology, quality control, radiation protection and regulations, radiochemistry,radiation biology, physiology, and toxicology, clinical uses ofradiopharmaceuticals.

c. Radiation Protection. This examination includes types and properties of radiation,interaction of radiation with matter, dose units and concepts, radiobiology,regulations, approaches to radiation protection, shielding, personnel monitoring,internal dose measurements, decontamination, waste disposal, and other aspects ofradiation control.

Examination Schedule

The ABSNM Certification Examination is offered annually on Saturdays preceding the Society ofNuclear Medicine Annual Meetings.

*NEW*Application for Certification .pdf file now online!Click here.

Send mail to Mac Cannon, Leadership Services, at mcannonasnm.org withquestions or comments about this web site.

Copyright C) 2004, 2005 American Board of Science in Nuclear Medicine.

,)

2lntrican foarJ of fienie in Yuckcar f1itdn

The American Board of Science in. Nuclear Medicine, organizedthrough the cooperations of the American College of Nuclear

Medicine, the American College of Nuclear Physicians, and theSociety of Nuclear Medicine,

Hereby certifies that

has met established standards and qualifications, and passedexaminations conducted under its authority

thereby demonstrating to the satisfaction of the Board the abilityto practice Nuclear Medicine Science in all its branches, with

special competence in

kladiation o rotection

2Lnrican 3oard of Scince in Ruckar fftiaICIn

The American Board of Science in Nuclear Medicine, organizedthrough the cooperations of the American College of Nuclear

Medicine, the American College of Nuclear Physicians, and theSociety of Nuclear Medicine,

Hereby certifies that

has met established standardb and qualifications, and passedexaminations condupted lnder its authority

thereby demonstrating to thle sAtisfaction of the Board the abilityto practice Nuclear Medici+ne lSciel#l ce in all its branches, with

special, co petence in

Ruclear flftdiacnt ph sict and Instrumentation

A M E F'N A BO , A A r M f:S r' N a.F I JN (II A t M E D C I X

December 9, 2005

U.S. Nuclear Regulatory CommissionATTN: Mr. Thomas Essig, Chief,Materials Safety and Inspection Branch (MS TSF3)11545 Rockville PikeRockville, ND 20852

Subject: BOARD RECOGNITION OF ABSNM BY NRC FOR RADIATION SAFETYOFFICERS

Dear Mr. Essig:

According to suggestions made by Mr Mohammad Saba of NRC in phone conversationand in his e-mail dated December 1. 2005 and also after consultation with Dr, RonaldZelac of NRC, we are submitting this fourth revision of our application for therecognition of American Board of Nuclear Medicine Science (ABSNM) by NRC forRadiation Safety Officers (RSO) under 10CFR35.50. Enclosed is an attachment onrevised "Requirements for ASBSNM Certification". The information in this documentshould match with the information posted on www.snm.org/absnm. You have twosamples of ABSNM certificates already sent to you along with the last application.

Please note that even though ABSNM does not agree, it has taken out the option of theMedical Physicist candidates taking the Radiation Protection Specialty Examination forRSO approval.

It is hoped that this application will fulfll the requirements for NRC recognition ofABSNM diplomates in Nuclear Medicine Physics and Instrumentation and RadiationProtection Specialties for RSOs.

We are looking forward to your positive response.

Thank you.

Sincerely,

Subhash Danak, MS Gopal B Sala, PhDPresident Past President

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Requirements for ARBSNM Certification

A. Requirements for candidates taking Nuclear Mcdicine Physics andInstrumentation Specialty


(ii) TraininglWork Experience:Two years (doctorate candidates) or three years (master's candidates) offull-time practical training and/or supervised experience in medicalphysics:


(2) In clinical nuclear medicine facilities providing diagnosticand/or therapeutic services under the direction of physicians who meetthe requirements for authorized users in lOCFR35.290 and10CFR35.390, and who will provide a letter of reference attesting tothe candidate's experience and competency.


(i) General Education:A master's or a doctorate degree in physics, nuclear pharmacy, biologicalscience, radiophamnaceutical science, chemistry or other pharmaceuticalscience from an accredited college or university, and



(2) In clinical nuclear medicine facilities providing diagnostic and/ortherapeutic services under the direction of physicians who meet therequirements for authorized users in 1OCFR35.290 and IOCFR35.390,and who will provide a letter of reference attesting to the candidate's

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I

�O experience and competency.


(i) General Education:A master's or a doctorate degree from an accredited college or universityin physical science, engineering, health physics, or biological science witha minimum of 20 college credits in physical science, and

(ii) five or more years of professional experience in health physics(graduate training may be substituted for no more than 2 years of theexperience) including at least 3 years in applied health physics.

1). Examination: All candidates must pass an examination for certification byABSNM. The examination evaluates knowledge and competence of the candidatesin radiation physics and instrumentation, radiation protection, radiation biology,radioisotope production, radiopharmaceutical chemistry, radiation dosimetry, anddiagnostic nuclear medicine physics and instrumentation. The certifyingexamination is written and consists of two parts as detailed below:




b. Radiopharmaceutical Science. This examination will cover in depth thetopics of radionuclide production, radiophannaceutical design andformulation, radioactivity measurement and radionuclide identification,

OOk-d SW/t0d 160-1 OZ06-001-EO1 -ia 33X3 3H1 iO 3313O ANS-WOJi WdSC:ta SO-60-06a

pharmacology and tracer methodology, quality control, internal dosimetxy,radiation protection and regulations, radiochemistry, radiation biology,physiology, toxicology, clinical diagnostic nuclear medicine physics, andclinical uses of radiopharmaceuticals.

c. Radiation Protection. This examination includes in depth the topics oftypes and properties of radiation, interaction ofradiation with matter, doseunits and concepts, radiobiology, regulations, approaches to radiationprotection, shielding, personnel monitoring, internal dose measurements,decontamination, waste disposal, and other aspects of radiation control.

O08-d SO/SO d 165-1 OZ06-BOL-EOL NWa 33X3 3H! iO 33lIO HNS-WO1J WdSEC:O &O-60-28a

From: Mohammad Saba i To: Sahag~ccf.org Date: 9/20/05 10:24AM · 2012-11-20 · Agreement State,...

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