ML18332A174

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NRC-2019-000035 - Resp 1 - Final, Agency Records Subject to the Request Are Enclosed
ML18332A174
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. UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 I

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June 22, 2000

~N_o_t_e-to~re_q_u_e_s-te_r_:_A~p-u_b_li_c~ly_a_v_a_il_a_b_le_v_e_rs_i_o_n~ /:

of this document, including the attachments, is I

!/l'Ul:f publicly available at

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The American Board of Radiology ATTN: Dr. M. Paul Capp Executive Director*

https://adamswebsearch2.nrc.gov/webSearch2

/main.jsp?AccessionNumber=ML003725736.

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5255 E. Williams Circle, Suite 3200 Tucson, AZ 85711-7409

SUBJECT:

RECOGNITION OF BOARDS

Dear Dr. Capp:

As you know, the Nuclear Regulatory Commission (NRC) is revising its medical use regulations in 10 CFR Part 35, "Medical U~e of Byproduct Material."* I anticipate the Commission wilt' publish the final rule in the Federal Register in 2000, with an effective date 6 months after publication, As part of this revision, the regulatory text will no longer incorporate a listing of the specific boards whose diplomates automatically fulfill the training and experience requirements.

for an authorized medical physicist, authorized nuclear pharmacist, authorized user, or Radiation Safety Officer. Rather, the NRC will recognize ce_rtification boards that require individuals to

  • complete the training and experience requirements specified in the regulatory te~t. Once recognized, the board's name will be placed on lhe list of recognized boards maintained on the NRC website. This change is being made to eliminate the need for a rulemaking each time a board is added or deleted.

lam writing to notify you of our intent to initiate the recognition.process immediately. Other specialty boards whose diplomates are likely to seek authorization are being similarly notified. If you are interested in having your board recognized by the NRC, please submit a letter to me listing each training and experience section of the rule for which you believe your Board's

  • diplomates should be deemed to have met the requirements. Enclosures 1 and 2 s~ould assist
  • you in preparing your letter. Enclosure l lists all areas where NRC plans to recognize boards. is a copy of the draft final regulatory text that lists the training and*experience criteria for authorized medical physicists, authorized nuclear pharmacists, authprized users, and Radiation Safety Officers.

Your letter should clearly state that an individual must have completed the training and experience required by a particular section prior to receiving board certification. For example, if.

your board would like to be recognized under 10 CFR 35.390, "Training for use of unsealed byproduct material for which a written directive is ~equired," the letter should state:

(the name of your organization) has reviewed 10 CFR 35.390 and has determined that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by our board."

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M.Capp 2

The letter should be dated and signed by the chief executive of your board. If you have any questions or comments, please contact Ms. Catherine Haney of my staff (301-415-6825 or E-mail at cxh@nrc.gov).

Enclosures:

Sincerely,

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Donald A. Cool, Djrector

.Division of Industrial and Medical Nuclear Safety

1. Areas where NRC plans to recognize boards
2. Draft Final Regulatory Text - Training and Experience Criteria t

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Officers Robcn R. Ha1tery1 M.D:, Pruident

'OCbe ~mertcan fjoarb* of l\\abtolom, Diagnostic Radiology Radiation Oncology Radiologic Physics M. Paul Capp, M.D., Executive Director

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Assistant Executive Directors George R. Leopold, M.D.. Diagnostic Radiology

~an Diego. Ctilifo~ia Lawrence W. Davis1 M.D., Radialior. Onco/ngy Atlanta, Georgia Steven A. Leibel, M.D.1 Set:rt:laty~Tf'e.Qtufer New York, New York Guy H. Simmons, Jr., Ph.D., Radiologic Ph)*.,ics Le~ingcon, Kentucky Diagnostic Radiology Philip 0. Alderson, M.O.

New York, New York Gary J. Becker, M.D.

Miami, Fiorida William J. Casarella, M.D.

. Arlanra. Goorgia Robtrt R. Hatteiy. Jr., M.D.

RochesrCr, l\\.finnesou George R. Leopold, M.D.

San Diego. California Robert R. Lukin, M.D.

qncinnati, Ohio John E.Madtwcll,M.D.

Houston, Tc>las Chri.stophcr Merrill, M.D.

Philndclphia, Pennsylvania Andrew K. Pozmmsl.:.i, M.0.

Chic:,g;o, lllinoi*

Anlhony V. Proro. M.D,

. N}lld, Virginia

  • *. Scbreibc.r, M.D.

11, Texas k\\Jc.;:it J. Stanley, M.D.

Birmingham. Alabama Michael A. Sullivlll1, M.D.

N_ew Orleans:, Louisiana Kay H. Vydarcny, M.D.

Atlanta. Georgia Jomes E. Youker, M.O.

Milwaukee, Wisconsin Radiation Oncology Sarah S. Donaldson, M.D.

Sranfotd; Califotnin Jay R. Hil.rris, M.D.

Boslon, Massachusetts Richard T. Hopp<, M.D *

. Stanford. Cali:rornia David H. Hussey, M.D.

Iowa City. Iowa Srcvcn /\\. [.eibcl, M.D.

New York. New York H. Rodney Withers, M.D.

Los Angeles, California Radiologic Physics William R. Hendee, Ph.D.

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--\\ Paliwal, Ph.D.

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U-'inglon, Kentucky Donald A. Cool Director of Industrial and Medical Nuclear Safety December 26, 2000 United States Nuclear Regulatory Commission Washington, D.C. 20555-0001

Dear Or. Cool:

Note to requester: This letter is part of the document containing addi.tional letters, that is publicly available at https://adamswebsearch2.nrc.gov/we bSearch2/main.jsp?

AccessionNumber=ML010960517 This is an official response from the American Board of Radiology Jo *your letter of June 22, 2000 regarding the revision of your medical use regula:tions in 10 CFR Part 35, uMedical Use of Byproduct Material." The American Board of Radiology grants certification in three specialties: Diagnostic Radiology, Radiation Oncology, and Radiologic Physics. Consequently, the ABR response is by each of*

the specific disciplines.

Certification in Diagnostic Radiology:

The American Board of Radiology by its certification in Diagnostic Radiology has reviewed 10 CFR 35.190 and has determined that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by* this board The American Board of Radiology by its certification in Diagnostic Radiology has reviewed 10 CFR 35.290 and has determined that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by our board.

The American Board of Radiology by its certification in Diagnostic Radiology has reviewed 10 ~FR ~5.390 and has determined that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by our board. However, at the present' time we would restrict 35.390 toward the "low dose 11 portion of this directive to.not include (G) @ "Oral admmistration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131.

Certification in Radiation Oncology:

The American Board of Radiology by its certification in Radiation Oncology has reviewed 10 CFR 35.390 and has ~.eterri:rined that our 5255 E. WILLIAMS CIRCLE, SUITE 3200

  • TUCSON, AAl~ONA 85711-7409
  • PHONE (520) 790-2900
  • FAX (520) 790-3200 E-mail: into@theabr.org
  • Web Site: www.theabr.org 1\\1\\ Lo I Ool"'.

A Member Board ollhe American Board or Medical Specialties (ABMS)

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certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by our board.

The American Board of Radiology by its certification in Radiation Oncology has reviewed 10 CFR 35.392 and has determined that our *

  • certification process. requires an individual to m~et all the requirements in paragraph (b) of this section prior to being certified by our b9ard.

The Am~can.Board of Radiology by.its certification in Radiation Oncology has reviewed 10 CFR 35.394 and has determined that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by our board.

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The American Board of Radiology by its certification in Radiation Oncc,logy has reviewed 10 CFR 35.490 and has determined.that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by our board, The American Board of Radiology by i~ certification in Radiation Oncolqgy has reviewed 10 CFR 35.491 and has detemuned that our certification process requires an individual lo meet all the requirements in

  • paragraph (b) of this section prior to being certified by our board.

e The American Board of Radiology by its certification in Radiatien Oncology has reviewed 10 CFR 35.690 and has determined that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being ~-ertified by our board.

However, we have some serious concerns regarding the interpretation of the document. This regards the specific number of hours that authorized users must have received. We would.have no probleinin addressing (b)(2) of section 35.490.

However, at the present time many radiation oncology residency programs would not be able to meet the.speciftc requirements of (b)(l)(ii) requiring 500hours of work experience in each of the areas listed above: I have attached a ietter from

  • David H. Hussey, MD, who is a trustee of the ABR and Oi.air of the Radiation Oncology Examination Committee, that was sent tQ Pr. Sam Jones. We would need further cl~cation of this problem.

Certification in Radiologic Physics:

The American Board of Radiology by its certification in Me*dical Nuclear Physics has reviewed 10 CFR 35.50 and has determin!i!d that our certification process requires an individual to meet all the requirements in paragraph (b) of this section prior to being certified by our board.

The,American Board of Radiology by its certification in Therapeutic Radiologic Physics has reviewed 10 CFR 35.51 and has determined that our certification process requires an individual to meet all the require:r:nertts in paragraph (b) of this section prior to being certified by our board.

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However, a strict interpretation of 35.50 could imply that current physicists in training under the supervision of a radiation safety officer may not satisfy the requirement of one year of full-time radiation safety exp~rience.

This could be true foi; phisicists training in both Medical Nuclear Physics as well as Therapeutic ~hysics. I have included a letter from William R. Hendee, PhD, a physicist trustee of the American Board of Radiology that was sent to you dated September 15, 2000.

The American Board of Radiology has always enjoyed a good r~lationship with the Nuc;lear Regulatory Commission in abiding by NRC Guidelines.

  • We hope this relationship continues in the future, and we look forward to hearing from you regarding the above concerns.

Best regards.,

Sincerely,

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M. Paul Capp, M. D.

. MPC/sd enclosures I ! *.

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Robert R. Hnuery, M.D ** Pmident Rochc.stcr. Minnesota William R. Hendee, Ph.D.* V,ce PruidtnJ Milwaukee. Wisconsin Steven A. Leibel, M.o., Secrtlary-Trta1urtr New York, NeW York Diagnostic Radiology Philip o: Aldcnon. M.D.

New York, New York Gary I. B<<ker. M.D.

Mi:imi, Flori~

William I. C.Snre.lla, M.D.

Allon<a. Goorgia Robert R. H:ittcry. Ir.* M.D.

Rochester, Minnc,ota George R. Leop0ld, M.D.

San Diego, California Robeit R. Lukin, ~i.D.

Cincinn.ati, Ohio John E. Madewell, M.D.

Hershey, Pennsylvania Christopher Merrill, M.D.

Philadelphia, PennS)*lvania Andrew K. Poznonski. M.D.

Ch.ieago, Ulinois Anthony V. Proto, M.D.

Richmond, Virginia M* """""§chreibe1, M.D.

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en,4~. Alab:ima Michael A. Sullivon, M.D.

New Orleans. l.ouisjarui Kay H. Vydnreny, M.D, Atlan1,1, Georgia James ll. Youker, M.D.

Milwaukee. Wist~ns1n Radiation Oncology Sarah S. Donaldson. M.D.

Stanford1 California l*y R. llarris. M.D.

Boston, Mnssachu,ens Richnrd T.°icloppe, M.D.

Stanford, California D.-id H. Hussey, M.D.

Iowa CitY., Iowa Steven A. Leibel, M.D.

Loi AngeJe.s, California Radiologic Physics William R. Hendee, Ph,D.

Milwaukee, Wisc'onsin Bhu.\\!.n(tR, ~aliu-al. Ph.D.

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~e ~mertqin fjoarb of ~abtologp Diagnostic Radiology

,Rndi:ition Oncology Radiologic Physics M. Paul Capp, M.D., Executive Director Dr. Sam.Jones

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October 3, 2000 Nuclear Regulatory Commission Washington, D.C. 20555-0001

Dear Dr. Jones:

Assistant Executive Directors George R. Leopold. M.D ** Diognm.1ic Radif1loc,

&~ Diego, California Uwrence W. D:i.vis, M.D.* Radiation Ont:o!ug)'

A1hmta, Georgia Guy H. Simmons. Jr., Ph.D;, Radiologic Phy1ic3.

Lcxingron, Kentucky This letter is in response to your request that! send you a list of my concerns regarding the proposed revisions in the NRC medical use regulation 10 CFR part 35.

I should point out that I did not originally call you to express concerns. I called you for clarification regarding the wording so that I could determine whether I do have any concerns about the proposed revisions. I was specifically calling for clarification regardmg how specific the work experience hour requirements would be. I am speaking as a_private radiation oncologist, n~t as a training director, chair of a training program, :rp.'ember of ASTRO, or trustee of the American Board of Radtology..

I believe that the following sections of 35 apply to radiation oncology training programs: Paragraph 35.390, 11Training for use of unsealed byproduct material for which a written directive is required; 35.392, 'Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 33 millicuries; 35.394, "training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater th~ 33 millicuries; 35.490, "training for use of manual brachytherapy sources; 35.491, 11training for opthalmic use of strontium..:90; 35.690, 11training for use of remote afterloader units, teletherapy units~ and gamma stereotactic radiosurgery units.

In most of thes~ sections, a spe~ific number of hours of training is required, (usually 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, of which 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> must be spent in the classroom, and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> may be spent as work experience under the supervision of an au_thorized user). l do not personally perceive the classroom hours to be a problem, although other radiation oncology traiping directors may. The question I have relates to how specific the work experience must be. I would have concerns if this document intends that authorized users must have the following: 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience specifically-in the use of unsealed by-product material for which a written directive is required, plus significant experience specifically in the oral aclministration of sodium iodide in quantities less than 33 rn.illicuries, plus experience specifically relating to the administration of I-131 in quantities greater than 33 millicuries, plus 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> work experience specifically in manual 5255"E. WILLIAMS CIRCLE, SUITE 3200

  • PHONE (520) 790*2900
  • FAX (~20) 790-3200 E-mail: info@theabt.org
  • Web Sile: www.theabr.org A Member Board of The American Board of Metrical Specialties (ABMS)

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A brachytherapy sources, plus 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of.work experience specifically in the use of remote afterloader units, teletherapy units and gamma stereotactic radiosurgery units. I believe that many radiation oncology residency programs would not be able to meet these requirements if the work experience requirements for each section is specific to the procedure under consideration.

On the other hand, I would have no concerns if the work experience.for each section were broader in scope, and allowed experiences such as that described in paragraph (b) (2) of section 35.490, which states: "has obtained three years of supervised clinical experience in radiation oncology, under an authorized user.who meets the requirements in paragraph 35.490 or equivalent agreeing with state requirements as part of a formal training program approved by the Residency Review Committee f~r Radiation Oncology of the ACGME or the Committee on, Post-doctoral Training of the American Osteopathic Association."

As I mentioned to you in a previous call, several other radiation oncologists have expressed concerns about training program graduates meeting the requirement 35.690 relating to gamma knives.if they trained in a* radiation oncology program whose stereotactic radiosurgery program is linear accelerator based.

However, this is not as great a concern as the work experience hour requirements.

Thank you for your attention.

Sincerely,

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David H. Hussey M. D.

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UNITED STATES NUCLEAR REG~LATORY COMMISSION WASHINGTON, O.C. 20555-0001 March 8, 2001

. 11e.or.r M. Paul Capp, M.D., Executive Director*

,American Board of Science* in Nuclear Medicin*e 1850 Samuel Morse Drive Reston, VA 22090-5316

Dear Dr. Capp:

This* letter acknowledges our receipt of the letter you sent, on behalf of the American Board of Radiology (ABR}, to Donald A. Cool requesting fonnal recognition by the Nuclear Regulatory Commission_of ABR's certification process in Diagnostic Radiology, Radiation Oncology,.and Radiologic Physics.

Your letter will be reviewed by my staff. *NRC expects to begin °listing the names of recpgriized boards on an NRC website prior _to the effective date of the final rule. I anticipate the

  • Commission will publish the final rule in the Federal Register by June 2001 ; with an effective date 6 months after publication.

If you have any questions, ple.ase contact Robert L Ayres of my staff (301-415-57 46 or e-mail RXAl@nrc.gov).

--~/.(Ph.

  • Sincerely,

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Hickey, Chlel Materials Safety and Inspection Branch Division of_ Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l '

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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 July 3, 2002 The American Board of Radiology A TIN: M. Paul Capp, M.D., Executive Director P.O. Box 1502 Galesburg, Illinois 61402-1502

Dear Dr. Capp:

I am responding to your letter of December 26, 2000, to Dr. Donald A. Cool, r~garding Nuclear Regulatory Commission (NRC) recognition of American Board of Radiology (ABR) certification under the new 10 CFR Part 35, "Medical Use of Byproduct Material". In a previous letter to Dr.

William Hendee, dated May 3, 2001, Chairman Meserve provided responses to some.of the Issues you raised that were also in letters from Dr. William Hendee dated September 15, 2000,.*

and from Dr. David Hussey dated October 3, 2000. (See Enclosures 1 - 5).

Please note that the revised Part 35 was issued on April 24, 2002. You may view either the full text of the rulemaking (in PDF format) on our web site at http://ruleforum.llnl.gov/cgi-bin/downloader/finaUib/280*0156.pdf, or just the rule itself at http://ruleforum.llnl.gov/cgi-bin/downloader/finaUlb/280*0161.pdf. The effective date of the new.

rule is October 24, 2002, but there is a 2-year transition period for the new training arid experience requirements, so the previous recognition of the AaR certifications in 1 O CFR 35.900-961 will remain in effect for 2 years from the effective date of the new rule. During this transition period, the NRC staff will continue working with the medical community to resolve any concerns with implementing the training and experience requirements. We are pleased that you and Qr; Hendee was able to speak on this issue at the June 21, 2002, Subcommittee Meeting of the NRC Advisory Committee on the Medical Use of Isotopes.

With respect to NRC recognition of ABR certification under Subparts D, E, F, G, and H of the new Part 35, we have identified several issues which would have to be resolved before the ABR certification process could be recognized. These issues are summarized below:

1. Written Preceptor Certifications.

The new Part 35 requires as a condition for NRC recognition that the board certification process must include a requirement that the candidate obtain a written preceptor statement.

  • The preceptor must meet certain qualifications (e.g., 35.50(a) and (b}(2), 35.51 (a) and (b)(2),

35.690(a) and (b)(3)).

a. The ABR does not appear to require as part of its certification process that a candidate must obtain a.written certification from a qualified preceptor as specified in 10 CFR Part 35.
b. The ABR does not appear to require a preceptor statement which specifies that the the individual has completed the applicable requirements and is qualified to function i,:idependently in the appiicable position; (e.g., authorized user, radiation safety officer, qr authorized medical physicist).

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c. For their Radiation Oncology diplomates, the ABR requests NRC recognition for six separate medical use modalities. Does th~ ABR require a preceptor statement that certifies that the individual has completed the applicable requirements and is qualified to function independently in each of the six separate modalities (as listed in our item 2b) for which recognition is requested? This would require either separate preceptor certifications (covering each modality requested) or a single global certification statement that the individual has achieved a level of competency sufficient to function independently as an authorized user in each.of the six requested modalities..

Furthermore, the required preceptor statement for §35.690 authoriz~tion requires the corresponding preceptor statement to certify competency to. function independently* as an authorized user of each type of medical unit for which your board is requesting NRC recognition.

2~ Requirements for-Authorized Users

a. You request that NRC grant recognition of your ABR certification process in
  • Diagnostic Radiology as meeting of the requirements in the following subsections of the new 1 o CFR Part 35:

§35.190

§35.290

§35.390[except (G)(2)]

Training for uptake, dilution, and excretion studies; Training for imaging and localization studies; and, Tralnirig for use of unsealed byproduct material for which a written directive is required.

We have revie*wed this request,.based on.the lnform~tion provided in your letter and the application requirements listed on your website for certification in Diagnostic Radiology, and find that there is insufficient information regarding whether the ABR's certification.

proc.ess meets the training and experience requirements set forth in the new Part 35 for each of the requested modalities. Therefore, we request that you submit information showing that ABR's certification process meets the applicable training and experience requirements set forth in the new Part 35 for each of the requested modalities.

No~e that under the new Part 35, authorized users qualified under §35.390 are also deemed qualified under both §35.190 and §35.290. Thus, you may wish to consider revising your request for all three modalities and apply only for recognition under

§35.390[except (G)(2)].

b. You request that NRC grant recognition of your ABR certification process in Radiation Oncology as meeting all of the requirements of the following subsections of the new 10 CFR Part 35:

§35.390

§35.392

  • Training for use of unsealed byproduct material for which a written directive is required; Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries);
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§35.394

§35.490

§35.491

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Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than1.22 Gigabecquerels (33 millicuries);

Training for use of manual brachytherapy sources; Training for ophthalmic use of strontium-90; and, Training for use of remote afterfoader units., teletherapy units, and gamma stereotactic radiosurgery units.

We have reviewed this request, based on the information provided in your letter and the application requirements listed on your website for certification in Radiation Oncology, and believe that you board's certification process complies with the training and

. experience requirements set forth for both §35.490 and §35.491 recognitions.

However, we have identified several concerns about the adequacy of training requirements for the four remaining modalities, as. follows:

(1) For ABR's requested §35.390 through §35.394 recognitions, we can find no evidence that your board certification process requires essential specific; training and experience requirements, as set forth in §35.390(b)(1 )(i)(D) and (ii)(B through G). Please provide information *which addresses your board's certification requirements as they pertain to these cited training and experience requirement concerns.

(2) §35.690(b)(3) requires preceptor certification that an individual "..... has achieved a level of competency sufficient to function independently as an authorized user of each type of medical unlt for which the individual is requesting authorized user.status."

Does ABR certification in Radiation Oncology document this level of competency for one or more of the medical units (remote afterloader, teletherapy, and stereotactic radiosurgery) listed in Subpart H_of the new rule? And, if so, which ones?

3. Requirements for Authorized Medical Physicists 10 CFR 35.51 (a) establishes the requirements for the recognition of a medical physics specialty board to be a board whose certification includes all of the training and experience (T&E) requirements contained in section 35.51 (b), and whose certification has been recognized by the Commission or an Agreement State. These requirements includes tasks involving sealed sources and brachytherapy sources, teletherapy units, remote afterfoading units, and gamma stereotactic radiosurgery units (GSUs).

We have reviewed your request for NRC recognition for your diplomates in Therapeutic Radiologic Physics under §35.51 (a). Based on the information contained in your letter and the application requirements, listed on your website for certification in Therapeutfc Radiologic Physics, and find there is insufficient information to determine whether.the ABR's certification process meets the requirements of §35.51 (a). Therefore, we request that you provid_e suffi9ient information for us to determine whether your board certification process either meets all of the training and experience requirements set forth in §35.51 (b) for full recognition or, some subset of these requirements for partial recognition.

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July 3, 2002 4

requirements in §35.50(b)(1) and*has achieved a level of radiation safety knowledge sufficient to function independently as a RSO for a medical use licensee. Your current application process, which requires references certifying that the applicant is qualified to take the board examination in Radiological Physics, does not appear to satisfy the NRC requirement for a signed preceptor statement.

Note that persons alrea~y named as medical physicists on licenses are eligible to be authorized as RSOs in accordance with 35.50(c).

If any of our initial conclusions above are incorrect, or if you would like to submit additional information on.the ABR certification process, you may submit additional information at any time If you have any further questions, please contact Dr. Robert Ayres or meat 301-415-5746.

Sincerely,

~/IP-A-~

  • John W. N. Hickey, Chief cc: Dr. David H. Hussey Dr. William R. Hendee

Enclosures:

1. Letter from M. Capp, dated 12/26/2000
2. Letter from D. Hussey, dated 10/03/2000 Materials Safety and Inspection Branch Division.of Industrial and Medical Nuclear Safety
3. Letter from W. Hendee,*dated 09/15/2000
4. Letter from W. Hendee, dated 03/26/2001
5. Letter from.Chairman Meserve, dated 05/03/2001
6. Lett~r from J. t:lickey, dated 05/31/2002 Note to requester: Enclosures 1 and 2 are included with this response. The remaining enclosures are publicly available in ADAMS (https://www.rirc.govireading-rm/adams.html).

Enclosures 3 and 4 are included in the document at https://adamswebsearch2. nrc.gov/webSearch2/main.jsp? AccessionNumber=ML010960517. is available at https://adamswebsearch2.nrc.gov/webSearch2/main.jsp?

AccessionNumber=ML011070073. is part of a larger ADAMS package, at https://adamswebsearch2.nrc.gov/webSearch2/m*ain.jsp?

AccessionNumber=ML021510136

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Officers Robcn IL flaneiy. MD~ Pmldl!III Rochester. Minoesol3 WilllUI R. Hend:e. Ph.D.* l'lr< Pn,sld<nI Milwauku, W"monisin

-~e-~btttriran ~oarb of l\\abiologp Diagnostic Radiology Radiation Oncology Radiologic Physics M. Paul Capp, M.D., Executive Director Assistant Executive Directors Anlhooy V. Proto. M.D.* £!iognoJJI< Radiolog}'

Rlcbmool. V"uclnl, 1.Gwrcncc W. Davis, M.D ** Rodiation OMO/oay A~anta, Georgia S1evcn A. Leibe~ M.D., Starrll1)"-1na,,,n:r New \\'ode. New York July 16, 2002 Bhumll R. Pali-...J, Ph.D-I/QJijo/"8/c Physic, Madison. Wisconsin Diagnostic Radiology Phltip 0.Aldcfflln. M.D.

Now York, New Yolk GmyJ.B<<:la.M.D.

John W.N. l::lickey Chief Materials Safety and Inspection Branch*

Division of Industrial and Medical Note to requester: This document is also publicly available in ADAMS at https://adamswebsearch2.nrc.gov/web Search2/main.jsp?

MiamLFlorid3 o-ges. Bissel. M.D.

Dwh=. North Carolin*

Robcr1.R. H111:ry, Jr.. M.O.

Roche,ta. Minnesota Valerie Jaclaon, M.D.

hidianDpOlh. lr.diarui Robe11 R. Lukin. M.D.

Cinoinnall. Ohio Johe E. Madewell. M.D.

Homton, Texas Christopher Merritt, M.D.

Philadelpbia. ~nnsylvania Andmw K. l'<>wanskL M.D.

Chioago. Dlinoi, Anih<>n~ V. l'rolo. M.D.

Ricb:nond, Virginia

  • -.'>obcru. M.D.

'lua. Califomla

)s,onlcy.M.D.

    • .,umiogbom, Al*bam*

Michael A. SulliYUn. M.D.

New Oduns, Louisin.'1.1 Kay It Vyd.ucny, M.D.

Amnla,G<O'l!ia Jama E. y;,.1:c,, MD.

Milwmiue, "'**cnnsin Radiation Oncology Jay R, Harris. M.D.

Boston. Ma.sstehuse.tb Rkbanl T. Hoppe. MD:

Swuonl, caliromia D:lvld K. Hom:y, M.0.

S:m Anumio, TeIAS Larry E. Kun. M.D.

Memphis. nnncssu Stoven A. Leibel, M.D.

New York. Nev, York H. RodneyWilhm, M.D.

Los Angc!cs. California Nuclear Safety United States Nuclear Regulatoxy Commission Washington, D.C. 20555-0001

Dear Mr. Hickey:

. AccessionNumber=ML022060171 Thank you for yom recent letter of July 3, 2002, which represents a response to my letter of December 26, 2000 to Dr. Donald A. Cool regarding the Nuclear Regulatory Commission recognition of American Board of Radiology (ABR) certification under the new 10 CFR Part 35 "Medical Use of Byproduct Material" It is our und~rstanding that your response reflects the current status of Part 35 and does not include consideration of the issues.µid recommended changes discussed at the Advisory Committee on Medical Uses of

. Isotopes (ACMUI) subcommittee meeting-recently held in Washington.

As you already.know, much has transpired since the December 2000 letter, particularly the recent ACMUI subcommittee meeting, in which the American Board of Radiology, in concert with several other certification boards, testified. We understand that the subcommittee report has subsequently been accepted by the full ACMUI committee.

The ABR will await further developments in response 1o* the ACMUI recommendations that address our concerns about issues in Part 35.

Thank you for your response. We await further decision by the commissioners in evaluating the ACMUI recommendations. We would appreciate any news of this progress at anytime.

Many thanks.

Best regards.

Sincerely,

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MPC/sd M. Paul Capp, M. D.

'5o'(\\tl Radiologic Physics cc: William R Hendee, PhD 1'

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Milwaukee. WJ=nsin Philip O. Aldezson, MD cf:)

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Robert R Hattery, MD

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  • FAX (520) 790-3200 E-mail: fnfo@theabr.org
  • Web Site: wvm.theabr.org A Member Board ol:Tl>a Amoriean Bo3nlof ~d"ical Sp~ (ABMS)

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UNITED STATES NUCLEAR REGULATORY COMMISSION WA~J.JINGTON £1.C 205S5*0001 June 22, ~000 Note to requester: A versi.on of this letter that also includes both of the attachments is publicly available in The American Board of Nuclear Medicine ADAMS at ATTN: Dr. Ronald L. Van Heertum Chairman 900 Veteran A venue Los Angeles, CA 90024-1786

SUBJECT:

RECOGNITION OF BOARDS

Dear Dr. Van Heertuin:

https://adamswebsearch2,nrc.gov/webSearch2/main.jsp?

AccessionNum ber= M L003725770 As you.know, the Nuclear Regulatory Commission (NRC) is revising its medical us~ regulations in 10 CFR Part 35, "Medical Use of Byproduct Material." I anticipate the Commission will publish the final rule in the Federal Register in 2000, with an effective date 6 months after publication. As part of this revision, the regulatory text will no longer incorporate a listing of the specific boards whose diplomates automatically fulfill the training and experience requirements for ari authorized medical physicist, authorized nuclear pharmacist, authorized user, or Radiation

. Safety Officer. Rather, the NRC will recognize certification boards that require individuals to complete the training and experience requirements specified in the regulatory text. Once recognized, the board's name will be placed on the list of recognized boards-maintained on the NRC website. This change is being made.to eliminate the need for a rulemaking _each time a board is added or deleted.

I am writing to notify you of our intent to initiate the recognition process immediately. Other specialty boards whose diplomates are likely to seek authorization are being similarly notified. If you 'are interested in having your board recognized by the NRC, please submit a letter to me listing each training and experience section of the rule for which you believe your Board's diplomates should be deemed to have met the requirements. Enclosures 1 and 2 should assist you in preparing your letter. Enclosure 1 lists all ai:-eas where NRC plans to re<;ognize boards. *is a copy of the draft final regulatory text that lists the training and experience criteria for authorized medical physicists, authorized nuclear pharmacists, authorized users, and Radiation Safety Officers.

_ Your letter should clearly state that an individual must have completed the training and experience required by a particular section prior to receiving board certification. For example, if your board would like to be recognized under* 10 CFR 35.390, "Training for use of unsealed byproduct material for which a written directive is required," the letter should state:

(the name of your organization) has reviewed 10 CFR 35.390 and has d~termined that our certification process requires an individual to meet all the requirements in paragraph.(b) of this section prior to being certified by our board."

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The letter should be dated and signed by the chief executive of your b~ard. If you have any questions or comments, please contact Ms. Catherine Haney of my staff (301-415-6825 or E-mail at cxh@nrc.gov).

Enclosures:

Sincerely, Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety

l. Areas where NRC plans to recognize boards
2. Draft Final Regulatory ~ext - Training and Experience Criteria h I

_......,___... ~ ---------------------------------------------~------

J I The An1erica11 Board of Nuclear Me.dici11e A ~krnher IJoar<.i u! th,: t\\merican H,iard or Medical Spc,cialtic, Chalrm"n RonolJ L Van lkerrnm,,\\!.D

. RoSe\\*ille, California Secretaq*-T rcasurer

.Marrin L. Nusynowitz, M D.

Gah:e.stnn, Tcx:16 Eva V. Dulx.1,*sky, M.!l.

lliriningh~m. Alabama Michael ~I. Gr:1ham, M.D

_ ln,va City, lOWiJ Lawrence E. Holder, M.D Baltimore, 1'faq:land Alan U. Maurer. M.n:

Philadclphi;i, l'cnnsyh'ania Da\\*jd C. Price 1 M.O S:in Francisco, California

  • \\'- Sandler, M.B., ChlJ j" Tcnne,;sec h,,iJfd El. Silbcr,idn. t,1 D.

Cincinnati. Ohio Andrew l. Taylor. M.Jl Arlanla, Georg:;i S. Ted Tre:v-..".:-., M.D.

Boston. Mas.sa~huSetr~

Executive Director William Il. lJlahd, M.ll.

LDs Ang~les, CJliforni::l A5soclatc E.,ennlv<e Director f!eimich R. Schelbut, M.D Lns Angdc:;, California Admlnlstr.uor Glori:J. \\Y/. Gnrd\\!n, M.P.il.

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Pl~~1se Address All Communication T\\l' 900 Vctt.*r.an r\\1*enue Los Angelt:"s, CA 90024-178(1 Tdephone (.\\10) H2S,67H7

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Donald A. Cool Director, Division of Industrial and Medical Nuclear Safety U.S. Nuclear Regulatory Commission Washington, DC 20555-000 I

Dear Mr. Cool:

I am responding to your letter of June 22, 2000 concerning the recognition of boards whose diplomates

  • automatically fulfill the training and experience requirements for authorized use of byproduct materials. I am writing to you on.behalf of the American Board of Nuclear Medicine {ABNM), which is a medical specialty certifying board recognized by the American Board of Medical Specialties,* the American Medical Association, and the Council of Medical Specialty Societies. Since its inception in 1971, ABNM has ~xamined and certified approximately 5000 physicians as specialists in the dinicaJ use of byproduct materials. Certification by ABNM has been recognized in the

'past by the NRC as sufficient indication of competence in the safe uses of byproduct materials, and it has issued licenses to physicians certified by the ABNM for all categories of use of unsealed byproduct materials In conjunction with the Council on Medical Education of the American Medical Association and the Society of Nuclear Medicine, the ABNM sponsors a Nuclear Medicine Residency Review Committee that establishes criteria for residency training in nuclear me<licim:. The Residency Review Commitiee currentiy oversees 69 nuciear medicine residency training programs. All nuclear medicine training programs are inonitored and routinely audited by the Accreditation Council on Graduate Medical Education.

Nuclear Medicine programs comprise three years of training, which includes one year of preparatory clinical experience and two years of full-time riuclear medicine instruction.

They are highly structw-ed educational programs that encorripass both basic science and clinical instruction. Basic science instruction includes the following areas: radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, _radiation biology and radiation dosimetry, and substantially exceed 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didacti.c instruction. In addition, residents receive

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Donald A. Cool July 10, 2000 Page2 more than 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience in basic radionuclide handling technique~

that are applicable to the medical use of unsealed byproduct material for imaging and localization studies, and for radionuclide therapy that requires a written directive. The programs also provide training in radiation safety~ including shipping,* receiving, and assaying of radioactive materials and the use of instruinentation, such as survey meters and calibration meters;

  • Instruction in the prevention of radionuclide contamination, proper decontamination procedures, and the. disposal of byproduct material also. are included. Upon the completion of training and to obtain certification as nuclear medicine sp~cialist physician's must pass a rigorous eight-hour examination on all aspects of nuclear medicine.

Accordingly, the ABNM requ~sts formal recognition under 10 CFRPart. 35-Medical Use Of Byproduct Material. We have reviewed the iµ-ea listed where NRC plans to recognize

  • boards and have determined that the ABNM certification process requires an individual to meet all of the requirements in the following subsections of Part 35:

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35.190 Training for uptake, dilution, and excretion studies.*

35.29.0 Training for imaging and localization studies.

35.390 Training for use of unsealed byproduct material for which a written directive is required.

  • 35.392 Training for the oral administration of sodium iodide I-131 requiring a
  • written directive in quantities less than or equal to i.22 gigabecquerels (33 millicuries).

35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than l.Z2 gigabecquerels (33 millicuries ).

Your favorable consideration of our request to be listed as a recognized board that provides training and experience in the above use of byproduct materials will be most sincerely appreciated.

Sincerely, Ronald L. VanHeertum, M.D.

Chairman American Board of Nuclear Medicine I

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UNITED ST ATE:S NUCLEAR REGULATORY COMMISSION Ronald L. Van Heertum,.M.D.

Chairman American Board of Nuclear Medicine 900 Veteran Avenue Los Angles, CA 90024

Dear Dr. Van Heertum:

WASHINGTON, D.C. 20555.0001 September 28, 2000 This letter acknowledges.olJr receipt of the letter you sent, on behalf of the American Board of Nuclear Medicine (ABNM), to Dona.Id.A. Cool requesting formal recognition by the Nuclear Regulatory Commission of the ABNM's certification process.

Your letter will be reviewed by my staff. NRC expects to begin listing the names of recognized boards on an NRC website prior to the effective* date of the final rule. I anticipate the Commission will publish the final rule in the Federal Register by spring 2001, with an effective date 6 months after publication:

If you have any questions, please contact Sam Jones of my staff (301-415-6198 or e-mail SZJ@NRC.gov ).

Sincerely, µ~

Patricia Holahan, Branch Chief Rulemaking and Guidance Branch Division of Industrial and

.Medical and.Nuclear Safety Office of Nuclear Material* Safety and Safeguards.

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of Nticlear NI e cl i c i 11 e Donald A. Cool Director, Division of Industrial and Medical Nuclear Safety U.S. Nuclear Regulatory Commission Washington, DC20555-0001

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November 29, 2000 The Amen.can Board of Nuclear Medicine (ABNM) wishes tci submit an addendum to its recent letter that requested formal recognition by the Nuclear Regulatory Commission of the ABNM certification process. Since many of our diplomates are required to act as radiation safety officers in association with their clinical activities, I would like to describe the pertinent training they receive, which we believe would qualify them to act as radiation safety officers.

It is our.opinion that the ACGME-approved Nuclear Medicine Residency Training Programs, as delineated in my letter of July 10, 2000, that lead to certification by the

  • American Board of Nuclear Medicine cover the required Radiation Safety Officer training as described in 10 C~R, part 35, section 35.50. The latter section states that a Radiation Safety Officer is an individual certified by a recognized specialty board whose certification process includes all of the requirements in paragraph (b) of this section: It is our contention that ABNM Diplomates, by virtue of their two years of nuclear medicine residency training, satisfy these requirements and that they acquired a level of radiation safely knowledge sufficien. co fum:iion independently as a Radiation Safety Officer for a*

medical use licensee.

Your favorable consideration of our request to accept the training received by diplomates of the American Board of Nuclear Medicine as satisfying the requirements for Radiation Safety Officer training would be appreciated.

Sincerely;

~~1-Ronald L. Van Heertum, M.D.

Chairman, American Board of Nuclear Medicine J

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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, O.C. 20555-0001 Ronald L. Van Heertum, M.D., Chainnan American Board of Nuclear Medicine 900 Veteran Avenue Los ~ngeles, CA 90024-1786

Dear Dr. Van Heertum:

March 8, 2001 This letter acknowledges our receipt of the letter you sent, on behalf of the American Board of Nuclear Medicine (ABNM), to Donald A. Cool as an addendum requesting formal recognition by the Nucl.ear Regulatory Commission of ABNM's certification process for qualification under 10 CFR 35.50.for Radiation Safety Officer for a medical use licensee.

Your letter will be reviewed by my staff. NRC expects to begin listing the names of recognized boards on an NRC website prior to the effective date of the final rule. i anticipate the Commission will publish the final rule in the Federal Register by June 2001, with an effective date 6 months after publication.

If you have any questions, please contact Robert L Ayres of my staff (301 ~415-5746 or e-mail AXA 1@nrc.gov).

Sincerely, vf~//.:/1~

John W. N. Hickey, Chief Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Sat ety and Safeguards I !

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_J UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 June 2,, 2001 The American Board of Nuclear Medicine ATTN: Dr. Ronald L. Van Heertum, Chairman 900 Veteran Avenue Los Angeles, CA 90024-1786

Dear Dr. Van Heertum:

I am replying to your letters dated July 10, 2000, and November 29, 2000, to Donald Cool, requesting formal recognition, under the new 1 O CFR Part 35, "Medical Use of Byproduct Material",.for American Board of Nuclear Medicine {ABNM) diplomates.

In your letter of July'10, 2000, you stated'that the ABNM certification process meets all of the requirements of the following subsections of new 1 O CFR Part 35:

§35.190

§35.290

. §35.390

§35.392

§35.394 Training for uptake, dilution, and excretion studies; Training for imaging and localization studies; Training for use of unsealed byproduct material for which a written -

directive is required; Training for the oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 1.22 gigabaecquerels (33 millicuries); and, Training for the oral administration of sodium iodide 1-131 requiring a written directive i~ quantities greater than1.22 gigabaecquerels (33 millicuries).

We have reviewed your request, and concluded that the ABNM certification process, as described in your letter and yqur board's application requirements, does meet the new requirements for each of the requested subsections listed ~bove for wh_ich you are requesting recognition. In particular, your.required "Evaluation. of Clinical Competence" certification requirement would appear to meet the individual subsection requirements for written certification, signed by a preceptor authorized user, that the diplomata has. satisfactorily completed the requirements and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses defined in the five subsections for which you have applied for recognition. After Part 35 is issued in final form, we plan to list on our web site the boards which have been recognized. We*will include ABNM on that list.

In your letter of November 29, 2000, you also requested Commission recognition of ABNM diplomates under 10 CFR 35.50(a). for Radiation Safety Officer (RSO), which requires the board certification process to include all of the requirements in §35.50(b). Our review of this request, along with your board's certification process, does not show that your process includes either: *

(1) the requirement for one year of full-time radiation safety experience under the supervision of

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J an RSO; or, (2) written certification, signed by a preceptor RSO that the individual has satisfactorily completed the *requirements in paragraph (b)(1) of this section and has achieved a level of radiation safety knowledge suffi.cient to function independently as a RSO for a medical use licensee. Thus, at this time, your board certification process does not meet the requirements of 1 o CFR 35.50(a) for an RSO.

However, since your board dlplomates are recognized by the Commission to be authorized.

users, they can be appointed RSO'sunder §35.50(c)if they are identified on a*medical use license and have radiation safety experience with similar types of use of byproduct materials for.

which the individual has radiation safety responsibilities. Also,* an ABNM certified Individual can still be authorized as an RSO at a medical use licensee facility, if: (1) the.licensee submits a license amendment request which.demonstrates that the person meets the criteria specified in the new §35.SO(b); or (2) the person Is currently listed as an RSO at a medical use licensee facility as specified in the new §35.57(a).

If you have any questions, please contact pr. Robert Ayres at 301-415-5746 or e-mail at rxa1@nrc.gov.

Sincerely, John W. H!ckey, Chief Materials Safety and Inspection Branch Division of Industrial and *Medical Nuclear Safety

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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 30, 2002 The American Board of Nuclear Medicine ATIN: Dr. Ronald L.Van Heertum, Chairman 900 Veteran Avenue Los Angeles, CA 90024-1786

Dear Dr. Van Heertum:

This is a follow-up to our letter to you, dated June 29, 2001, which concluded that the ABNM certificatton process meets the requirements for recognition under the new 1 o *cFR Part 35,

  • Medical Use of Byproduct Material.
  • Following inquiries from other parties regarding the requirements for preceptor statements, we have determined that we need additional information regarding the ABNM certification process.

The new Part 35 requires, as a condition for NRC recognition, that the board certification process must include a requirement that the candidate obtain a written preceptor statement.

Both the preceptor and the applicant must meet certain qualifications (see for example,

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§35.190(c)(2) and §35.290(c)(2)). We request that ABNM respond to the following questions:

1. Does the ABNM require as part of its certification process that a candidate must obtain a written certification from a qualified preceptor authorized *user?
2. If a preceptor statement is required, does ABNM specify that the statement must certify that the candidate has completed the applicable requirements and it qualified to function independently for the medical use authorization(s) requested?

Please note that the revised Part 35 was issued on April 24, 2002, and the full text of the rulemaking (in PDF format) may be viewed on our web site at http://ruleforum.llnl.gov/cgi-bin/downle>ader/final_lib/280-0156.pdf, or just the rule itself may be viewed at http://ruleforum.llnl.gov/cgi-bin/downloader/final_lib/280-0161.pdf. The effective.date of the new rule is October 24, 2002, but there is a 2-year transition period for the new training and experience requirements, so the previous recognition of the ABNM in 1 O CFR 35.900, 35.910, 35.920, 35,930, and 35.950 will remain in effect for 2 years from the effective date of

, the new rule. During this transition period, the NRC staff will continue working with the medical community to resolve any concerns with implementing the training and experience requirements.

Note to Requester: A publicly available version of this letter is available in ADAMS at https://adamswebsearch2. n re. gov/webSearch2/main.jsp? Accession Number=ML021500449 I

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Dr. Ronald L. Van Heertum 2

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In addition, the NRC Advisory Committee on Medical Use of Isotopes has established a subcommittee to qevelop recommendations on training and experience issues: We would welcome any comments from your Board on concerns related to implementing the training and.

experience requirements ln the new Part 35. We would appreciate receiving any such comments by June 24, 2002.

Please respond to our questions regarding the ABNM certification process within 30 days. If you have any questions, please contact Dr. Robert.Ayres at 301-415-5746 or e-mail at.

rxa1@nrc.gov.

Sincerely, JW';/1,/f~

?!John~- N. Hickey, Qhief Materials Saff;!ty and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

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Thomas Essig amaurer@temple.edu 6/18/03 12:58PM

Subject:

Re: Board Certification Dr. Mauer, My apologies for taking so long to reply to your e-mail. Our response is attached. As noted in the attached; we have determined that the ABNM does not meet the criteria currently stated in 10 CFR 35.190, 35.290, or 35.390 for Boards seeking to be recognized by NRC. Our basis for this conclusion is also contained in the attached file..

This review was performed by Dr. Donna-Beth Howe of my staff and reviewed by Dr. Ronalc:;! Zelac, also of my staff. Should you have any questions regarding our response, please contact Dr. Howe. We believe.

all of the information regarding the content of the ABNM program cited in the attached note to be factual; however, if such is not the case, please advise us.

Thomas Essig, CHP Chief, Materials Safety and Inspection Branch Division of Medical and Industrial Nuclear Safety Office of Nuclear Materials Safety and Safeguards

  • >>> <amaurer@temple.edu>.06/02/03 09:10AM >>>

Th.ank you for your prompt attention to this. I wanted to add that the ABNM is having a board meeting beginlng this week on Thur. 6/6/03.

I am sure there will be many questions raised at the meeting concerning the ABNM status with NRC. I know this is short notice but I will be leaving Thur. to attend the meeting and would like to be able to bring some news concerning our correspondence. Could you please get me some indication of ABNM status by Wed.? If not, the meeting will be at the Chatham Wayside Inn on Cape Cod MA. The telephone number there is 508-945-5550. Please contact me there if you get any news later in the week.

-~-- Original message ----

>Date: Mori, 02 Jun 2003 06:25:59 -0400

>From: "Sandra WasUer" <SLW1@nrc.gov>

Subject:

Re: Board Certification

>To: <amaurer tern le.edu>

>C.Q.;. ___________..... ---

, <abnm@mednet.ucla.edu>,

"Thomas ss1g" <THE@nrc.go~>

>** High Priority **

>Dr. Mauer

>I have forwared the information and your request to Tom Essig, Branch Chief of the Material Safety and Inspection Branch. The responsibility for for reviewing and approving applications for Board certification lies in his Branch. He will be getting back to you shortly regarding your request.

>If you have any questions, please feel free to call or e-mail me or Mr Essig.

>Sandra Wastler

I

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>>>> <amaurer@temple.edu> 05/30/03 04:23PM >>>

Dear Ms. Wastler,

>I forwarded the information you last serit m13 regarding the

>American Board of Nuclear Medicine's request for "deemed"

>status as a recognized board to the ABNM office for further

>clarification. Attached you will find a copy of a reply

>!etter sent June 6, 2002 by Dr. Andrew Taylor who was then

>Chairman of the ABNM. *

>In that letter he provi~ed further details on the

>written preceptor certification process required by the ABNM

  • :>for all diplomats requesting certification. This letter

>would appear to have satified the NRC's request for further

>information.

>I spoke today with Dr. Larry Holder who is current Chairman

>of the ABNM and told him I would send this letter to you. At

>this point it would seem that the ABNM did provide the

>information requested and demonstrated that it does require

>a written certification by the authorized-:user program

>director which documents that ABNM diplomats ~re qualified

>to function Independently.

>Can you clarify for us now what action was taken after

>receipt of the June 6, 2002 letter?

>---. Original message ----

>>Date: Tµe, 27 May 200312:29:06 -0400

>>From: "Sandra Wastler" <SLW1@nrc.gov>

Subject:

Board Certification

>>To: <Amaurer@temple.edu>

>>Cc: "Gary Janosko" <GSJ@nrc.gov>, "Patricia Holahan"<

>PKH@nrc:gov>, "Roger Broseus" <RWB@nrc.gov>

>>** High Priority.**

>>Dr. Mauer

>>During the public meeting on May 20, 2003, you indicated

>that the ABNM had received an letter dated June 29, 2001 in

>which the NRC concluded that the ABNM certification process

>met the requirements for recognition under the new 1 O CFR

>Part 35. Given the is.suance of the new Part 35 on April 24.

>2002 and the public meeting regarding the on~going

>development of a proposed revisions to Part 35 Training and

>Experience, in particular Board certification., you

>questioned.whether ABNM's was still a recognised Board.

>>We have investigated this situation and have found that the

>ABNM was sent another letter ori May 30, 2002 in this regard.

>Specifically, the letter indicated that, as a.result.of

>inquiries from other parties regarding the requirement for

>preceptor statements, NRC had determined that it needed f

r*

t 1*

i,

>additional information regarding the ABNM's certification

>process.

>>I have attached a copy of the letter and it also can be

>found in ADAMS (ML021500449}. I hope this answers your

>question. Should you need anything further, please let me or

>my staff ~now.

>>Thanks

>>Sandra Wastler

>>MLO21500449. pd f (11k bytes)

,_c_c_: _____

A_..m=er.a;ican Board of Nuclear Medicine; Charles Miller;

!Patricia Holahan; Ronald Zelac; Sandra Wastler

..........., ~- _P~g-~ :~:JI Note to Requester: The document referenced as ML021500449 is publicly available at https://adamswebsearch2. nrc.gov/webSearch2/main.jsp? AccessionNumber-ML021500449

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