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)

1 ENCLOSURE

[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

2 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

3 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

4 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

5 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?

6 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

7 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.

8 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

9 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.

10

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?

11 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.

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 1 First Name Last Name Company Name Address Line 1

Address Line 2

City State ZIP Code Dr.

Timothy Stenzel Director, Office of In Vitro Diagnostrics and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue Silver Spring MD 20993 Ms.

Kathleen Cantwell Director, Office of Strategic Operations and Regulatory Affairs Centers for Medicare &

Medicaid Services 7500 Security Boulevard Baltimore MD 21244 Ms.

Amy Wride-Graney American Board of Health Physics 1313 Dolley Madison Blvd.,

Suite 402 McLean VA 22101 Ms.

Tomi Papanikolao u

Executive Director, American Board of Medical Physics P.O. Box 780518 San Antonio TX 78278 Ms.

Valerie P.

Jackson Executive Director, American Board of Radiology 5441 E.

Williams Circle Tucson AZ 85711-7412 Dr.

Daniel Pryma Chair, American Board of Nuclear Medicine 4555 Forest Park Blvd.,

Suite 119 St. Louis MO 63108-2173 Mr.

Stephen Heinig Office of Government Relations Association of American Medical Colleges 655 K St. NW Washington DC 20001 Dr.

Greg Beavers Executive Director, American Board of Science in Nuclear Medicine 1037 N. Main St.

Kernersville NC 27284 Ms.

Dawn Edgerton Director of Cardiovascular Imaging Certification Board of Nuclear Cardiology 1401 Rockville Pike, Suite 600 Rockville MD 20852 Dr.

Mitchell B.

Pace Chair, American Osteopathic Board of Radiology 142 E. Ontario St.

Chicago IL 60611-2864

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 2 Dr.

T. Bryson Struse Chair, American Osteopathic Board of Nuclear Medicine 142 E. Ontario St., Fl. 4 Chicago IL 60611 Ms.

Nancy Barrett Executive Director, Canadian College of Physicists in Medicine 300 March Rd.,

Suite 202 Kanata Ontari o

K2K 2E2 Mr.

William M.

Ellis Board of Pharmacy Specialities 2215 Constitution Ave. NW Washington DC 20037-2985 Dr.

Eric A.

Orzeck Chair, Certification Board of Nuclear Endocrinology 245 Riverside Ave., Suite 200 Jacksonville FL 32202 Dr.

Patricia M.

Conolly American Board of Internal Medicine 510 Walnut St.,

Suite 1700 Philadelphia PA 19106 Dr.

Gerald H.

Jordan Executive Secretary, American Board of Urology 600 Peter Jefferson Parkway, Suite 150 Charlottesvill e

VA 22911 Nuclear Medicine Technology Certification Board 3558 Habersham at Northlake Rd.

Tucker GA 30084-4009 Thyroid Cancer Survivors Association, Inc.

P.O. Box 1102 Olney MD 20830-1102 Dr.

Richard C.

Wender Chief Cancer Control Officer American Cancer Society 250 Williams St. NW Atlanta GA 30303 Dr.

Alan J.

Balch Chief Executive Officer Patient Advocate Foundation 421 Butler Farm Rd.

Hampton VA 23666 National Patient Advocate Foundation Dr.

George Sledge, Jr.

Chief Scientific Advisor Susan G.

Komen 5005 LBJ Freeway, Suite 526 Dallas TX 75244 Ms.

Karuna Jaggar Executive Director Breast Cancer Action 275 Fifth St.,

Suite 307 San Francisco CA 94103

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 3 The Leukemia &

Lymphoma Society 3 International Dr., Suite 200 Rye Brook NY 10573 Ms.

Leah Eshraghi Dr. Susan Love Research Foundation 16133 Ventura Boulevard Suite 1000 Encino CA 91436 Kidney Cancer Association 9450 SW Gemini Dr.

1. 38269 Beaverton OR 97008-7105 Ms.

Patricia J.

Goldsmith Chief Executive Office CancerCare 275 Seventh Ave.

New York NY 10001 Pancreatic Cancer Action Network 1050 Connecticut Ave. NW, Suite 500 Washington DC 20036 Sarcoma Alliance 775 Blithedale Ave., #334 Mill Valley CA 94941 Sarcoma Foundation of America 9899 Main St.,

Suite 204 Damascus MD 20872 Dr.

Cheryl Healton Board Chair Lung Cancer Alliance 1700 K St. NW, Suite 660 Washington DC 20006 The Lymphoma Research Foundation Wall Street Plaza 88 Pine St.,

Suite 2400 New York NY 10005 Mr.

Michael J.

Guastella Council on Radionuclides and Radiopharmaceutical s, Inc.

500 North Capitol St. NW, Suite 210 Washington DC 20001-7407 Mr.

Joseph W.

Turgeon President and CEO Spectrum Pharmaceutical s

11500 S.

Eastern Ave.,

1. 240 Henderson NV 89052 Mr.

Shaemus Gleason Bayer HealthCare Pharmaceuticals Inc.

Oncology SBU 100 Bayer Blvd.

Whippany NJ 07981 Mr.

John Witkowski United Pharmacy Partners 5400 Laurel Springs Parkway Suwanee GA 30024 Cardinal Health 7000 Cardinal Place Dublin OH 43017

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 4 GE Healthcare 945 N.

Edgewood Ave., #A1 Wood Dale IL 60191 Lantheus Medical Imaging, Inc.

331 Treble Cove Rd.

North Billerica MA 01862 Ms.

Rachel Semon Advanced Accelerator Applications The Empire State Building 350 Fifth Ave.,

Suite 6902 New York NY 10118 Ms.

Cindy Tomlinson Senior Patient Safety and Regulatory Affairs Manager American Society for Radiation Oncology 251 18th St.

South, 8th Fl.

Arlington VA 22202 Ms.

Caitlin B.

Kubler Associate Director, Health Policy and Regulatory Affairs Society of Nuclear Medicine and Molecular Imaging 1850 Samuel Morse Drive Reston VA 20190 Ms.

Tina Getachew Program Specialist, Government Relations American College of Radiology 505 9th St.

NW, Suite 910 Washington DC 20004 American Association of Physicists in Medicine 1631 Prince Street Alexandria VA 22314 American Brachytherapy Society 11130 Sunrise Valley Dr.,

Suite 350 Reston VA 20191 Health Physics Society 950 Herndon Parkway, Suite 450 Herndon VA 20170 Ms.

Ruth McBurney Executive Director Conference of Radiation Control Program Directors 1030 Burlington Lane, Suite 4B Frankfort KY 40601 American Thyroid Association 6606 Leesburg Pike, Suite 550 Falls Church VA 22401

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 5 American Society of Nuclear Cardiology 9302 Lee Highway, Suite 1210 Fairfax VA 22301 American College of Nuclear Medicine 1850 Samuel Morse Drive Reston VA 20190 American Society of Hematology 2021 L St. NW, Suite 900 Washington DC 20036 American Society of Clinical Oncology 2318 Mill Rd.,

Suite 800 Alexandria VA 22314 American Nurses Association 8515 Georgia Ave., Suite 400 Silver Spring MD 20910-3492 American Association of Nurse Practitioners Office of Government Affairs 1400 Crystal Drive, Suite 540 Alexandria VA 22202 Dana-Farber Cancer Institute Radiation Oncology Training and Fellowship Program 450 Brookline Avenue Boston MA 02215-5450 Dr.

Robert Miletich Interim Chair and Professor Unversity at

Buffalo, Department of Nuclear Medicine 105 Parker Hall, 3435 Main St.

Buffalo NY 14214 University of Findlay, Nuclear Medicine Institute 1000 N. Main St.

Findlay OH 45840 Ms.

Jacqueline Cross Medical Training Coordinator Johns Hopkins University 601 N.

Caroline St.,

Suite 3233 Baltimore MD 21287 Dr.

Angela Bires Nuclear Medicine Technology Program Director School of Nursing and Health

Sciences, Robert Morris University 6001 University Blvd.

Moon Township PA 15108

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 6 Dr.

Kraig Chugg Department Chair Department of Health

Sciences, Weber State University Marriott Health Sciences Building, Room 363F, 3875 Stadium Way, Dept. 3909 Ogden UT 84408-3909 Dr.

Kyle P.

Meyer Dean, College of Allied Health Professions University of Nebraska Medical Center 42nd and Emile Omaha NE 68198 Dr.

William R.

Law Dean, College of Science c/o Nuclear Medicine Disciplines, Benedictine University 5700 College Road Lisle IL 60532 Dr.

Dinko Franceschi Division Chief, Nuclear Medicine Stony Brook University Hospital 101 Nicolls Road Stony Brook NY 11794 Ms.

Kellee George Program Director, KU Nuclear Medicine Technology Department of Respiratory Care and Diagnostic

Science, University of Kansas 3901 Rainbow Blvd.

Kansas City KS 66160 Dr.

Scott R.

Sechrist Associate Professor, Medical Diagnostic &

Translational Sciences Old Dominion University 2128 Health Sciences Building Norfolk VA 23529 Mr.

Joseph Hawkins Program Director, Nuclear Medicine Technology Adventist University of Health Sciences 671 Winyah Drive Orlando FL 32803 Dr.

Emogene Fox Professor and Chairperson Department of Health

Sciences, University of 201 Donaghey Ave.

Conway AR 72035

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 7 Central Arkansas Baptist Health College Little Rock School of Nuclear Medicine Technolgoy 11900 Colonel Glenn Road Little Rock AR 72210-2820 Dr.

Richard Hoylman Program Director, Nuclear Medicine and Molecular Imaging Technology Oregon Institute of Technology 3201 Campus Drive Klamath Falls OR 97601 South College School of Health and Therapy 3904 Lonas Drive Knoxville TN 37909 Baptist College of Health Sciences Department of Nuclear Technology Medicine 1003 Monroe Avenue Memphis TN 38104 Dr.

Gerhild Packert Department of Medical Technology College of Nursing and Health Sciences, Barry University 11300 NE 2nd Ave.

Miami Shores FL 33161-6695 Dr.

Norman E.

Bolus Program Director, Assistant Professor Nuclear Medicine Technology, University of Alabama at Birmingham 1705 University Blvd.

Birmingham AL 35294 Roosevelt University Nuclear Medicine Technology, College of Arts and Sciences 430 S.

Michigan Ave.

Chicago IL 60605 Lewis University Nuclear Medicine Technology, 1 University Parkway Romeoville IL 60446

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 8 College of Arts and Sciences Ms.

Crystal Botkin St. Louis University Nuclear Medicine Technology Allied Heath Building, 3437 Caroline St.,

3004 St. Louis MO 63104 Dr.

Richard M.

Kliman Cedar Crest College, Chair, Department of Biological Sciences c/o Nuclear Medicine Technology 100 College Drive Allentown PA 18104 Dr.

Gary Marano Nuclear Medicine Preceptor West Virginia University, Ruby Memorial Hospital 1 Medical Center Drive Morgantown WV 26505 Dr.

David Gilmore Program Director &

Associate Professor, Nuclear Medicine Technology Massachusetts School of Pharmacy and Health Sciences 179 Longwood Ave.

Boston MA 02115 Dr.

Vesper Grantham Program Director, Nuclear Medicine Department of Medical Imagings and Radiation

Sciences, College of Allied Health, The University of Oklahoma Health Sciences Center 1200 North Stonewall Ave.

Oklahoma City OK 73126-0901 Dr.

Paula Deming Endowed Professor of Health Sciences, Chair, Department of Medical Laboratory and Radiation Sciences College of Nursing and Health

Sciences, University of Vermont 302B Rowell Building Burlington VT 05405

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 9 Ms.

Terri Mosley Program Coordinator and Advisor, Department of Radiation and Technology Loma Linda University, School of Allied Health Professions Nichol Hall A829 Loma Linda CA 92350 Dr.

Ryan Fisher Chair, Department of Biology, Nuclear Medicine Technology Concentration Salem State University 352 Lafayette St.

Salem MA 01970 Thomas Jefferson University Jefferson College of Health Professions Edison Building, 130 S. Ninth St.,

Suite 100 Philadelphia PA 19107 Prof Miriam Espada Caro University of Puerto Rico, Medical Sciences Campus School of Health Professions Main Building, 7th Fl., Office

1. 723 Monacillo Area, Rio Piedras PR Dr.

J. Lynne Williams Nuclear Medicine Technology, Department of Clinical and Diagnostic Sciences Oakland University 433 Meadow Brook Rd.

Rochester MI 48309-4452 Dr.

Matthew Foradori Professor & Director of Medical Technology &

Nuclear Medicine Technology Department of Biology and Health

Services, Edinboro University of Pennsylvania Cooper Hall, 127B, 219 Meadville St.

Edinboro PA 16444 Ms.

Peggy Fortsch Dean, School of Health Sciences Radiography Program

Director, Professor, Allen College 1825 Logan Avenue Waterloo IA 50703

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 10 Ms.

Elizabeth Hodgson Coordinator, Nuclear Medicine Technology York College of Pennsylvania Appell Life

Sciences, Room 224, 444 Country Club Rd.

York PA 17403-3651 Dr.

Kayla Valentino Chair, Radiological &

Health Professions Manhattan College 4513 Manhattan College Parkway Riverdale NY 10471 Dr.

Stevee McIntyre Program Coordinator, Radiologic Sciences Program University of New Mexico 1 University of New Mexico Albuquerque NM 87131-0001 Dr.

Elias R.

Melhem Chair, Dept. of Diagnostic and Radiology & Nuclear Medicine University of Maryland School of Medicine 655 W.

Baltimore St.

Baltimore MD 21201 Dr.

Marc Fischer Nuclear Medicine Technology, Dept. of Allied Health Sciences Molloy College 1000 Hempstead Ave., Casey Building Room 10A Rockville Centre NY 11571-5002 Dr.

Gerald Dodd University of Colorado Denver, Nuclear Medicine Leprino Building, Dept.

of Radiology, MS L954 12401 E. 17th Ave.

Aurora CO 80045 Dr.

Martin Charron Virgina Commonwealth University Medical Center School of Medicine, Dept.

of Radiology 1200 E. Broad St., West Hospital, Room 2-013 Richmond VA 23298 Dr.

Gary R.

L'Abbe Regis College Medical

Imaging, Nuclear Medicine Technology Concentration 235 Wellesley St.

Weston MA 02493

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 11 Dr.

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

Columbia MO 65211 Dr.

Otto Casal Radiology Tech Administrator Department of Radiology, University of Utah 30 North 1900 East Salt Lake City UT 84132 Joint Review Committee on Educational Programs in Nuclear Medicine Technology 820 W.

Danforth Rd.,

1. B1 Edmond OK 73003 University of Arkansas College of Pharmacy College of

Pharmacy, Dean's Office, Unversity of Arkansas of Medical Sciences 4301 W.

Markham St.

Little Rock AR 72205 Dr.

Miguel Hernandez Pampaloni Associate Professor, Chief of Nuclear Medicine, Director, Nuclear Medicine Residency &

Fellowship Programs University of California San Francisco 505 Parnassus Ave.

San Francisco CA 94117 Dr.

Mark King Associate Professor of Radiology, Diagnostic Radiology Program Director Associate Program Director Interventional Radiology, The Ohio State University Wexner Medical Center 410 W. 10th Ave.

Columbus OH 43210 Dr.

Lilja Bjork Solnes Program Director, Diagnostic Radiology Residency, Assistant Johns Hopkins Medicine -

White Marsh 4924 Campbelle Boulevard Nottingham MD 21236

Distribution List for the Training and Experience Federal Register Notice (84 FR 18874) 12 Professor of Radiology and Radiological Science Association for Program Directors in Radiology 820 Jorie Boulevard Oak Brook IL 60523 Dr.

Jennifer Scheler Assistant Professor of Radiology Department of Radiology, University of Cincinnati Medical Center 234 Goodman St.

Cincinnati OH 45219 Mr.

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

Cincinnati Oh 45219