ML19123A222

Outreach Letter to Medical Stakeholders Regarding 84FR18874 - Draft Approaches Regarding Training and Experience Requirements for Radiopharmaceuticals

ML19123A222
Person / Time
Issue date:	05/02/2019
From:	Christian Einberg NRC/NMSS/DMSST/MSEB
To:	Stenzel T US Dept of Health & Human Services, Food & Drug Admin (FDA)
Sarah Lopas 415-6360
References
NRC-2018-0230
Download: ML19123A222 (25)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 2, 2019 Dr. Timothy Stenzel Director, Office of In Vitro Diagnostrics and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Via e-mail to Timothy.Stenzel@fda.hhs.gov

SUBJECT:

U.S. NUCLEAR REGULATORY COMMISSION PUBLIC COMMENT PERIOD AND MEETINGS ON DRAFT APPROACHES FOR TRAINING AND EXPERIENCE REQUIREMENTS FOR RADIOPHARMACEUTICALS

Dear Dr. Stenzel,

The purpose of this letter is to inform you that the U.S. Nuclear Regulatory Commission (NRC) has published a notice in the Federal Register announcing a second public comment period and two additional public meetings on the NRC staffs evaluation of training and experience (T&E) requirements for administration of radiopharmaceuticals requiring a written directive.

The NRC first contacted you in a letter dated November 2, 2018, that described the staffs planned evaluation of the T&E requirements under Subpart E, Unsealed Byproduct Material Written Directive Required, of Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material. Specifically, the staff is evaluating: (1) whether it makes sense to establish tailored T&E requirements for different categories of radiopharmaceuticals, (2) how those categories should be determined, (3) what the appropriate T&E requirements would be for each category, and (4) whether those requirements should be based on hours of training and experience, or focused more on competency. Revising the T&E requirements could provide additional pathways for physicians to become authorized users for specific types of radiopharmaceuticals requiring a written directive.

The November 2, 2018 letter also announced an initial public comment period and public meetings on the NRCs current T&E regulations under 10 CFR 35, Subpart E. Since the end of the initial public comment period the NRC staff has developed several draft approaches regarding the T&E requirements. The enclosed Federal Register notice (FRN) was published on May 2, 2019 (84 FR 18874) and opened a 30-day public comment period for input from the medical community and members of the public on the staffs draft approaches and a series of specific questions about the draft approaches. The FRN contains instructions on how to submit written comments via the Federal rulemaking Web site, www.regulations.gov, using docket ID number NRC-2018-0230. The 30-day comment period ends on June 3, 2019. The FRN is also available at https://federalregister.gov/d/2019-08996.

In addition to accepting written comments using www.regulations.gov, the NRC will also be accepting oral comments during two public meetings scheduled for May 14, 2019 and

T. Stenzel 2 May 23, 2019. The May 14 meeting will be open to members of the public for in-person attendance at the NRCs headquarters in Rockville, MD, and both meetings will be accessible for remote participation by moderated bridge line and webinar. The NRCs public meeting Web site will be updated with meeting details at least 10 days before the meetings:

https://www.nrc.gov/pmns/mtg.

To participate in the meetings via webinar and moderated bridge line, you must register in advance using the following URLs:

• Tuesday, May 14, 2019, 1:00 - 4:00 p.m. EDT:

https://attendee.gotowebinar.com/register/26839476715014924 Bridge Line: 888-452-5182 Pass Code: 2649150

• Thursday, May 23, 2019, 10:00 a.m. - 12:00 p.m. EDT:

https://attendee.gotowebinar.com/register/4099285410908048653 Bridge Line: 888-452-5182 Pass Code: 7476312 Comments received on the FRN will help the staff determine advantages, disadvantages, and other considerations for the draft approaches. The staff will document their evaluation and provide options regarding the T&E requirements in a paper to the Commission planned for issuance in late fall 2019. Additional information on the staffs T&E evaluation can be found at https://www.nrc.gov/materials/miau/med-use-toolkit/training-experience-evaluation.html. If you have questions on this correspondence, please contact Ms. Sarah Lopas of my staff at (301) 415-6360 or Sarah.Lopas@nrc.gov.

Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosure:

Federal Register notice (84 FR 18874)

[7590-01-P]

NUCLEAR REGULATORY COMMISSION

[NRC-2018-0230]

Draft Approaches for Addressing Training and Experience Requirements for Radiopharmaceuticals Requiring a Written Directive AGENCY: Nuclear Regulatory Commission.

ACTION: Draft approaches for training and experience requirements; request for comment and notice of public meetings.

SUMMARY

The U.S. Nuclear Regulatory Commission (NRC) would like input on draft approaches the staff has developed that would potentially revise the training and experience (T&E) requirements for radiopharmaceuticals requiring a written directive. The input will be used to determine whether regulatory changes to the NRCs T&E requirements for authorized users (AUs) are warranted and potential advantages, disadvantages, and other considerations associated with each approach.

DATES: Submit comments by June 3, 2019. Comments received after this date will be considered if it is practical to do so, but the NRC is only able to ensure consideration for comments received on or before this date. Two public meetings to solicit comments will be held on May 14, 2019 and May 23, 2019.

ADDRESSES: You may submit comments by any of the following methods:

• Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0230. Address questions about NRC dockets IDs in regulations.gov to Jennifer Borges; telephone: 301-287-9127; e-mail: Jennifer.Borges@nrc.gov. For technical 1 ENCLOSURE

questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

• Mail comments to: Office of Administration, Mail Stop: TWFN-7-A60M, U.S.

Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Program Management, Announcements and Editing Staff.

For additional direction on obtaining information and submitting comments, see Obtaining Information and Submitting Comments in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Sarah Lopas, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6360, e-mail: Sarah.Lopas@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Obtaining Information and Submitting Comments A. Obtaining Information Please refer to Docket ID NRC-2018-0230 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0230.

• NRCs Agencywide Documents Access and Management System (ADAMS):

You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select Begin Web-based ADAMS Search. For problems with ADAMS, please contact the NRCs Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to 2

pdr.resource@nrc.gov. The ADAMS accession number for each document referenced is provided the first time that it is mentioned in the SUPPLEMENTARY INFORMATION section.

• NRCs PDR: You may examine and purchase copies of public documents at the NRCs PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments Please include Docket ID NRC-2018-0230 in your comment submission. The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at http://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

II. Background On August 17, 2017, the Commission issued a staff requirements memorandum (SRM),

SRM-M170817 (ADAMS Accession No. ML17229B284) directing the staff to evaluate: (1) whether it makes sense to establish tailored T&E requirements for different categories of radiopharmaceuticals, (2) how those categories should be determined (such as by risks posed by groups of radionuclides or by delivery method), (3) what the appropriate T&E requirements would be for each category, and (4) whether those requirements should be based on hours of T&E or focused more on competency. In response to the SRM, the NRC staff documented its 3

initial results, status, and next steps related to this evaluation in SECY-18-0084, Staff Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals in Response to SRM-M170817 (ADAMS Package Accession No. ML18135A276).

In SECY-18-0084, the staff concluded that it may be feasible to establish tailored T&E requirements however, additional outreach with the medical community was needed to determine whether and how to tailor those requirements. Revising the T&E requirements could provide additional pathways for physicians to become AUs for specific types of radiopharmaceuticals under 10 CFR 35.300, Use of unsealed byproduct material for which a written directive is required.

As part of the needed additional outreach discussed in SECY-18-0084, the NRC published a notice in the Federal Register on October 29, 2018 (83 FR 54380) requesting comments on the staffs evaluation of the T&E requirements for radiopharmaceuticals under 10 CFR 35.300. The NRC held four public meetings on this topic and collected public comments through January 29, 2019. Public comments and meeting transcripts are available on the Federal Rulemaking Web site at https://www.regulations.gov/ under Docket ID NRC-2018-0230.

Following the conclusion of the initial public comment period, the staff developed several draft approaches to address the directions in SRM-M170817. The NRC is now interested in obtaining input on these draft approaches.

During the comment period between May 2, 2019 and June 3, 2019, the NRC will hold two public meetings to discuss the draft approaches in this document and accept oral comments on those draft approaches. Both public meetings will be available for remote participation by moderated bridge line and webinar and one meeting will also be open for in-person attendance at the NRCs headquarters in Rockville, Maryland. The public meetings are scheduled for May 14, 2019 (webinar and in-person attendance) and May 23, 2019 (webinar-only). The public 4

meetings will be noticed on the NRCs public meeting Web site at least 10 calendar days before each meeting. Members of the public should monitor the NRCs public meeting Web site at https://www.nrc.gov/pmns/mtg. The NRC will also post the meeting notices on the Federal Rulemaking Web site at https://www.regulations.gov/ under Docket ID NRC-2018-0230.

The NRC may post additional materials related to this document, including public comments, on the Federal Rulemaking Web site. The Federal Rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1)

Navigate to the docket folder NRC-2018-0230; (2) click the Sign up for E-mail Alerts link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

III. Draft Approaches for Comment The NRC staff has developed the following draft approaches based on input received during the initial public comment period and the Advisory Committee on Medical Uses of Isotopes T&E subcommittees report dated February 27, 2019 (ADAMS Accession No. ML19058A598). The NRC is requesting comments on the draft approaches, including potential advantages, disadvantages, and other considerations associated with each and whether some approaches could be revised, combined, or if more than one approach could be implemented.

The NRC staff is also requesting input on specific questions associated with the approaches.

A. Status Quo Status Quo presents no changes to the current T&E requirements for radiopharmaceuticals requiring a written directive under 10 CFR 35.300.

• Question 1: If the Status Quo is maintained, how should the NRC ready itself for the expected increase in number and complexity of future radiopharmaceuticals?

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• Question 2: Is there a challenge with the current T&E requirements-such as concerns regarding patient access to radiopharmaceuticals-that should be addressed through a rulemaking?

B. Tailored Training and Experience Requirements The four approaches under this section would modify the existing T&E requirements under 10 CFR 35.390, Training for use of unsealed byproduct material for which a written directive is required. The approaches described under Sections B.1, B.2, and B.3 would require a set amount of T&E tailored to the specific radiopharmaceuticals, and the Emerging Radiopharmaceuticals approach described under Section B.4 would tailor T&E requirements for each new radiopharmaceutical as they were developed, similar to the approach for regulating new technologies under 10 CFR 35.1000, Other Medical Uses of Byproduct Material or Radiation from Byproduct Material.

• Question 3: How should the complexity of the radiopharmaceutical administration protocol be considered in establishing the T&E requirements for the limited approaches described in Sections B.1 and B.2 below?

1. Limited AU for Alpha- or Beta-Emitting Radiopharmaceuticals Under this approach, any physician could complete at least 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> of T&E to be authorized to administer any alpha- or beta-emitting radiopharmaceutical. The T&E would consist of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training and a minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of supervised work experience tailored to alpha- and beta-emitting radiopharmaceuticals. Preceptor attestation would be required.

• Question 4: How should the NRC categorize radiopharmaceuticals with mixed emissions?

2. Limited AU for Unit-Dose, Patient-Ready Radiopharmaceuticals Under this approach, any physician could complete at least 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> of T&E to be 6

authorized to administer any unit-dose, patient-ready radiopharmaceutical. The T&E would consist of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training and a minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of supervised work experience tailored to unit-dose, patient-ready radiopharmaceuticals. Preceptor attestation would be required.

• Question 5: Under what conditions should a radiopharmaceutical be considered patient ready such that the T&E requirements could be tailored?

3. Limited AU for Any One Parenteral Radiopharmaceutical Under this approach any physician could complete at least 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> of T&E to be authorized to administer any one parenteral radiopharmaceutical. The T&E would consist of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training and a minimum of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of supervised work experience tailored to the radiopharmaceutical they wish to administer. Preceptor attestation would be required. Limited AUs who have initially completed their at least 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> of T&E and then wish to administer a different radiopharmaceutical would be required to complete, minimally, an additional 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of tailored, supervised work experience for each additional radiopharmaceutical.

4. Emerging Radiopharmaceuticals Like the NRCs regulations at 10 CFR 35.1000, under this approach the NRC would conduct individual reviews of each new emerging radiopharmaceutical to determine T&E requirements specific to the new radiopharmaceutical. The T&E requirements could be tailored to consider potential users of the radiopharmaceutical (e.g., non-nuclear medicine or non-radiation oncology physicians wishing to administer the radiopharmaceutical for their patients with indicated cancers), thus creating alternate T&E pathways for each new radiopharmaceutical.

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C. Performance-Based The approaches described in this section would remove prescriptive T&E requirements from the regulations and instead would focus oversight on the performance-based aspects of a licensees medical program for the administration of radiopharmaceuticals.

1. Competency-Based Evaluation Under this approach, proposed AUs would be required to demonstrate competency in radiation safety topics and radiation safety-related job duties through a formal competency evaluation (e.g., an examination or preceptor attestation).

• Question 6: How could a competency-based evaluation ensure appropriate training and experience for AUs administering radiopharmaceuticals?

2. Credentialing of Authorized Users Under this approach, the NRC would no longer review and approve T&E qualifications for all AUs under 10 CFR part 35. Instead, licensees would develop and use their own policies and procedures to make self-determinations of whether their credentialed physicians have the appropriate T&E to be an AU for one or more radiopharmaceuticals under 10 CFR 35.300. Licensees would be required to maintain a training program that ensures compliance with the requirements in 10 CFR 35.41, Procedures for administrations requiring a written directive, and 10 CFR part 20, Standards for Protection Against Radiation.

• Question 7: How could physicians in small practices be credentialed (e.g.,

physicians not associated with hospitals or other large institutions and their credentialing boards)?

D. Team-Based Team-based approaches could remove prescriptive T&E requirements for AUs, focus training requirements on the competency of the entire team, or revise the current 700-hour T&E 8

requirement for AUs based on pairing the AU with another individual with expertise in administering radiopharmaceuticals.

• Question 8: How should the AUs radiation safety responsibilities be clearly distinguished from other members of the team?

1. Radiopharmaceutical Team Licensees would need a team to administer radiopharmaceuticals under 10 CFR 35.300. The team would minimally consist of an AU, a radiation safety officer, and a nuclear medicine technologist. Additional team members could include an authorized medical physicist, a health physicist, an authorized nuclear pharmacist, and other physicians that manage patient care. The T&E for the radiopharmaceutical team approach would be performance-based: licensees would develop policies and procedures to address how their teams would meet the requirements in 10 CFR 35.41 and 10 CFR part 20.

2. Team AUs with Authorized Administrators Licensees would need both an AU and an authorized administrator (AA) to administer radiopharmaceuticals under 10 CFR 35.300. AAs would be individuals authorized by the licensee to administer radiopharmaceuticals in accordance with the written directive (e.g., a nuclear medicine technologist or a nuclear medicine advanced associate). The T&E for AUs would be performance-based and focus on the licensees policies and procedures for written directives, reporting medical events, and patient release criteria. Because AAs would be physically administering radiopharmaceuticals, AAs would be required to have training on radiation safety, written directives, preparation and administration protocols (or vendor training, if available), patient release criteria, and medical event reporting.

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3. Partner Limited-Trained AUs with Authorized Nuclear Pharmacists The T&E for AUs would be at least 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br />, however, the AU would be required to physically partner with an authorized nuclear pharmacist (ANP) for all administrations of radiopharmaceuticals. Unlike the approaches in Sections D.1 and D.2 above, prescriptive T&E would be required for the AU in this approach due to the AUs more prominent role in the administration of radiopharmaceuticals. The minimum of 400 hours0.00463 days <br />0.111 hours <br />6.613757e-4 weeks <br />1.522e-4 months <br /> of T&E for the physician partnering with an ANP would be focused on supervised work experience and patient cases, and preceptor attestation would be required. The AU would be responsible for administration of radiopharmaceuticals in accordance with the written directive, and the ANP would be responsible for radiation safety-related duties.

• Question 9: How should the radiation safety responsibilities be divided between the AU and ANP?

IV. Additional Questions for Consideration The NRC is requesting input on the following questions as they relate to the draft approaches discussed above.

• Question 10: What are the advantages and disadvantages of the draft approaches?

• Question 11: Are there significant costs or benefits associated with any of the approaches?

• Question 12: Would any of the draft approaches impact patient access to radiopharmaceuticals or address stakeholder concerns of overly burdensome (regulatory) requirements?

• Question 13: For the draft approaches that consider tailored hours of T&E, what are the appropriate numbers of hours and what radiation safety topics should comprise the limited T&E?

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• Question 14: Should the NRC consider inclusion of a formal radiation safety competency assessment and periodic reassessments for any of the draft approaches above? If so, who should establish and administer these assessments?

• Question 15: How would the draft approaches impact the medical organizations that use the NRCs T&E requirements as a basis for establishing their training programs?

• Question 16: Are there concerns regarding implementation and/or viability for any of the approaches discussed above?

• Question 17: Are there any unintended consequences of the draft approaches?

• Question 18: Which of the draft approaches best positions the NRC to effectively regulate future radiopharmaceuticals?

• Question 19: Should the NRC continue to play a role in the review and approval of AUs?

Dated at Rockville, Maryland, this 29th day of April 2019.

For the Nuclear Regulatory Commission.

/RA/

Andrea L. Kock, Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards.

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Distribution List for the Training and Experience Federal Register Notice (84 FR 18874)

First Address Line Address Line ZIP Last Name Company Name City State Name 1 2 Code Director, Office of In 10903 New Food and Drug Dr. Timothy Stenzel Vitro Diagnostrics and Hampshire Silver Spring MD 20993 Administration Radiological Health Avenue Director, Office of Centers for Strategic Operations Medicare & 7500 Security Ms. Kathleen Cantwell Baltimore MD 21244 and Regulatory Medicaid Boulevard Affairs Services 1313 Dolley Wride- American Board of Ms. Amy Madison Blvd., McLean VA 22101 Graney Health Physics Suite 402 Executive Director, Papanikolao P.O. Box Ms. Tomi American Board of San Antonio TX 78278 u 780518 Medical Physics Executive Director, 5441 E. 85711-Ms. Valerie P. Jackson American Board of Tucson AZ Williams Circle 7412 Radiology Chair, American 4555 Forest 63108-Dr. Daniel Pryma Board of Nuclear Park Blvd., St. Louis MO 2173 Medicine Suite 119 Association of Office of Government American Mr. Stephen Heinig 655 K St. NW Washington DC 20001 Relations Medical Colleges Executive Director, American Board of 1037 N. Main Dr. Greg Beavers Kernersville NC 27284 Science in Nuclear St.

Medicine Certification Director of Board of 1401 Rockville Ms. Dawn Edgerton Cardiovascular Rockville MD 20852 Nuclear Pike, Suite 600 Imaging Cardiology Chair, American 142 E. Ontario 60611-Dr. Mitchell B. Pace Osteopathic Board of Chicago IL St. 2864 Radiology 1

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Chair, American 142 E. Ontario Dr. T. Bryson Struse Osteopathic Board of Chicago IL 60611 St., Fl. 4 Nuclear Medicine Executive Director, 300 March Rd., Ontari Ms. Nancy Barrett Canadian College of Kanata K2K 2E2 Suite 202 o Physicists in Medicine 2215 Board of Pharmacy 20037-Mr. William M. Ellis Constitution Washington DC Specialities 2985 Ave. NW Chair, Certification 245 Riverside Dr. Eric A. Orzeck Board of Nuclear Jacksonville FL 32202 Ave., Suite 200 Endocrinology American Board of 510 Walnut St.,

Dr. Patricia M. Conolly Philadelphia PA 19106 Internal Medicine Suite 1700 600 Peter Executive Secretary, Jefferson Charlottesvill Dr. Gerald H. Jordan American Board of VA 22911 Parkway, Suite e Urology 150 Nuclear Medicine 3558 30084-Technology Habersham at Tucker GA 4009 Certification Board Northlake Rd.

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Chief Cancer Control American 250 Williams Dr. Richard C. Wender Atlanta GA 30303 Officer Cancer Society St. NW Patient Chief Executive 421 Butler Dr. Alan J. Balch Advocate Hampton VA 23666 Officer Farm Rd.

Foundation National Patient Advocate Foundation 5005 LBJ Chief Scientific Susan G.

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New York NY 10005 Research Foundation Plaza Suite 2400 Council on 500 North Radionuclides and 20001-Mr. Michael J. Guastella Capitol St. NW, Washington DC Radiopharmaceutical 7407 Suite 210 s, Inc.

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Affairs Manager Oncology Society of Associate Director, Nuclear 1850 Samuel Ms. Caitlin B. Kubler Health Policy and Medicine and Reston VA 20190 Morse Drive Regulatory Affairs Molecular Imaging Program Specialist, American 505 9th St.

Ms. Tina Getachew Government College of Washington DC 20004 NW, Suite 910 Relations Radiology American Association 1631 Prince of Physicists in Alexandria VA 22314 Street Medicine American 11130 Sunrise Brachytherapy Valley Dr., Reston VA 20191 Society Suite 350 950 Herndon Health Physics Parkway, Suite Herndon VA 20170 Society 450 Conference of Radiation 1030 Ms. Ruth McBurney Executive Director Control Burlington Frankfort KY 40601 Program Lane, Suite 4B Directors American Thyroid 6606 Leesburg Falls Church VA 22401 Association Pike, Suite 550 4

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Health Technology Sciences Department of Medical Imagings and Radiation Sciences, Program Director, College of 1200 North Oklahoma 73126-Dr. Vesper Grantham OK Nuclear Medicine Allied Health, Stonewall Ave. City 0901 The University of Oklahoma Health Sciences Center Endowed Professor College of of Health Sciences, Nursing and Chair, Department of Health 302B Rowell Dr. Paula Deming Burlington VT 05405 Medical Laboratory Sciences, Building and Radiation University of Sciences Vermont 8

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Program Coordinator Loma Linda and Advisor, University, Nichol Hall Ms. Terri Mosley Department of School of Allied Loma Linda CA 92350 A829 Radiation and Health Technology Professions Chair, Department of Biology, Nuclear Salem State 352 Lafayette Dr. Ryan Fisher Salem MA 01970 Medicine Technology University St.

Concentration Jefferson Edison Thomas Jefferson College of Building, 130 Philadelphia PA 19107 University Health S. Ninth St.,

Professions Suite 100 School of Health University of Puerto Monacillo Prof Espada Professions Miriam Rico, Medical Area, Rio PR

. Caro Main Building, Sciences Campus Piedras 7th Fl., Office

1. 723 Nuclear Medicine Technology, Oakland 433 Meadow 48309-Dr. J. Lynne Williams Department of Rochester MI University Brook Rd. 4452 Clinical and Diagnostic Sciences Department of Professor & Director Biology and of Medical Health Cooper Hall, Dr. Matthew Foradori Technology & Services, 127B, 219 Edinboro PA 16444 Nuclear Medicine Edinboro Meadville St.

Technology University of Pennsylvania Radiography Program Dean, School of 1825 Logan Ms. Peggy Fortsch Director, Waterloo IA 50703 Health Sciences Avenue Professor, Allen College 9

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874)

Appell Life Sciences, Coordinator, Nuclear York College of 17403-Ms. Elizabeth Hodgson Room 224, 444 York PA Medicine Technology Pennsylvania 3651 Country Club Rd.

4513 Chair, Radiological & Manhattan Manhattan Dr. Kayla Valentino Riverdale NY 10471 Health Professions College College Parkway Program Coordinator, University of 1 University of 87131-Dr. Stevee McIntyre Radiologic Sciences Albuquerque NM New Mexico New Mexico 0001 Program Chair, Dept. of University of Diagnostic and Maryland 655 W.

Dr. Elias R. Melhem Baltimore MD 21201 Radiology & Nuclear School of Baltimore St.

Medicine Medicine 1000 Nuclear Medicine Hempstead Technology, Dept. of Rockville 11571-Dr. Marc Fischer Molloy College Ave., Casey NY Allied Health Centre 5002 Building Room Sciences 10A Leprino University of Building, Dept. 12401 E. 17th Dr. Gerald Dodd Colorado Denver, Aurora CO 80045 of Radiology, Ave.

Nuclear Medicine MS L954 Virgina 1200 E. Broad School of Commonwealth St., West Dr. Martin Charron Medicine, Dept. Richmond VA 23298 University Medical Hospital, Room of Radiology Center 2-013 Medical Imaging, Nuclear 235 Wellesley Dr. Gary R. L'Abbe Regis College Weston MA 02493 Medicine St.

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Distribution List for the Training and Experience Federal Register Notice (84 FR 18874)

Program Director, University of 611 Lewis Hall, Dr. Jeff Galen Columbia MO 65211 Nuclear Medicine Missouri 701 S. 5th St.

Department of Radiology Tech Radiology, 30 North 1900 Salt Lake Dr. Otto Casal UT 84132 Administrator University of East City Utah Joint Review Committee on 820 W.

Educational Danforth Rd., Edmond OK 73003 Programs in Nuclear #B1 Medicine Technology College of Pharmacy, University of Dean's Office, 4301 W.

Arkansas College of Unversity of Little Rock AR 72205 Markham St.

Pharmacy Arkansas of Medical Sciences Associate Professor, Chief of Nuclear University of Hernandez Medicine, Director, 505 Parnassus San Dr. Miguel California San CA 94117 Pampaloni Nuclear Medicine Ave. Francisco Francisco Residency &

Fellowship Programs Associate Program Director Associate Professor Interventional of Radiology, 410 W. 10th Dr. Mark King Radiology, The Columbus OH 43210 Diagnostic Radiology Ave.

Ohio State Program Director University Wexner Medical Center Program Director, Johns Hopkins 4924 Dr. Lilja Bjork Solnes Diagnostic Radiology Medicine - Campbelle Nottingham MD 21236 Residency, Assistant White Marsh Boulevard 11

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Professor of Radiology and Radiological Science Association for 820 Jorie Program Directors in Oak Brook IL 60523 Boulevard Radiology Department of Radiology, Assistant Professor of 234 Goodman Dr. Jennifer Scheler University of Cincinnati OH 45219 Radiology St.

Cincinnati Medical Center University of Radiation Safety 234 Goodman Mr. Richard Anderson Cincinnati Cincinnati Oh 45219 Office, UC Health St.

Medical Center 12