ML18333A384
| ML18333A384 | |
| Person / Time | |
|---|---|
| Issue date: | 11/30/2018 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | Christian Einberg Office of Nuclear Material Safety and Safeguards |
| Sarah Lopas | |
| References | |
| Download: ML18333A384 (6) | |
Text
C. Einberg UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 November 30, 2018 MEMORANDUM TO: Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Material Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards FROM: Sarah L. Lopas, Project Manager /RA/
Medical Safety and Events Assessment Branch Division of Material Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
SUMMARY
OF PUBLIC MEETING (WEBINAR) TO ACCEPT COMMENTS ON THE U.S. NUCLEAR REGULATORY COMMISSIONS EVALUATION OF TRAINING AND EXPERIENCE REQUIREMENTS FOR ADMINSTERING DIFFERENT CATEGORIES OF RADIOPHARMACEUTICALS (83 FR 54380)
Meeting Identifier: 20181146 Date of Meeting: Wednesday, November 14, 2018 Location: N/A - Webinar Type of Meeting: Category 3 Purpose of the Meeting:
To solicit comments from the public and stakeholders on the U.S. Nuclear Regulatory Commissions (NRC) evaluation of the training and experience (T&E) requirements for a physician to become an authorized user for medical uses under Subpart E, Unsealed Byproduct MaterialWritten Directive Required, of Title 10 of the Code of Federal Regulations (10 CFR) Part 35, Medical Use of Byproduct Material.
General Details:
On October 29, 2018, the NRC published a Federal Register notice (FRN) requesting comments on the NRCs T&E requirements for administering different categories of radiopharmaceuticals requiring a written directive in accordance with the NRCs regulations under 10 CFR 35.300. The FRN (83 FR 54380) can be accessed in the NRCs Agencywide 2
C. Einberg Documents Access and Management System (ADAMS; https://www.nrc.gov/reading-rm/adams.html) under Accession No. ML18276A166, or on the Federal Register Web site at https://www.federalregister.gov/documents/2018/10/29/2018-23521/training-and-experience-requirements-for-different-categories-of-radiopharmaceuticals.
The publication of the FRN opened a three-month public comment period to obtain input on whether the NRC should tailor its T&E requirements for administering different categories of radiopharmaceuticals requiring a written directive. The NRC is interested in obtaining input from as many stakeholders as possible, including members of the Advisory Committee on the Medical Uses of Isotopes, professional organizations, physicians, patients, patient advocacy groups, licensees, Agreement States, and other interested individuals. Four public meetings were planned to accept oral comments, and written comments can be submitted on the Federal governments rulemaking Web site, www.Regulations.gov, by searching docket ID NRC-2018-0230. The comment period ends on January 29, 2019.
Also on October 29, 2018, the NRC published the November 14 meeting notice, which contained webinar registration and bridge line information (ADAMS Accession No. ML18313A077). Approximately 32 people registered for the webinar ahead of the meeting.
The meeting began at 1:00 p.m. EST and included a 30-minute presentation from NRC staff on the staffs planned evaluation of T&E under 10 CFR 35.300. The NRCs slide presentation can be found in ADAMS at Accession No. ML18312A413. Following the staffs presentation, the meeting was then opened to receive public comments. All meeting participants who wanted to provide a comment were given the opportunity to speak. The meeting was transcribed by a court reporter, so staff could capture the comments for the T&E docket (NRC-2018-0230). The meeting transcript can be found in ADAMS at Accession No. ML18330A113. Approximately 32 people participated in the meeting: 25 of the 32 logged into the webinar and the remaining 7 called into the bridge line but did not log into the webinar. Six participants provided comments.
A list of meeting participants who logged into the webinar or identified themselves during their comments is enclosed. The meeting concluded at 2:24 p.m. EST.
Summary of Comments Received:
One commenter on behalf of the American Society for Radiation Oncology expressed strong opposition to any reduction in the T&E requirements in 10 CFR 35.390; stating that they believe the current requirements are appropriate, and that they protect the safety of patients, the public, and practitioners. The commenter further discussed how radiopharmaceuticals are highly effective at treating cancer, but they have possibly harmful side effects if not used correctly and under the supervision of a highly trained physician. The commenter also noted that changing the T&E requirements could create confusion and complexity for licensees, the NRC, and the Agreement States. The commenter also stated that it may be difficult to categorize radiopharmaceuticalsnew radiopharmaceuticals may not clearly or easily fit into a category, thus requiring additional NRC rulemaking and delaying patient access to radiopharmaceuticals.
Another commenter opposed to reducing T&E requirements stated that when considering T&E, one must consider the physicians background in fundamentals of radiation protection and radiation physics; and that training in radiology sciences cannot be simply counted in hours.
The commenter warned that if the physician seeking limited authorization comes from a field where none of this is part of their regular job duties, decreasing the number of hours required for 2
C. Einberg T&E could potentially be harmful. The commenter pointed out that T&E not only prepares a physician for administration of radiopharmaceuticals in an uncomplicated setting, but that it also prepares a physician to handle potential complications during administration.
In contrast, one commenter strongly supported developing tailored T&E requirements, citing evidence that the NRC already has proved this approach works with their regulations under 35.392 and 35.394 for sodium iodide administration. The commenter stated that using a one-size-fits-all approach for T&E was not beneficial to oral administrations, because oral therapeutic radiopharmaceuticals pose less risk than other (parenteral) radiopharmaceuticals.
The commenter further stated that imposing identical requirements for all radiopharmaceuticals contradicted the NRCs risk-informed regulatory approach. The commenter stated that if a physician was seeking limited authorization with no flexibility beyond administration of one relatively safe, unit-dosed agent, 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E was overly burdensome and not warranted.
The commenter pointed out that medical oncologists were skilled in administering very toxic and potentially harmful chemotherapy drugs, and that certifying a medical oncologist to administer a single radiopharmaceutical, also administered via syringe, should not require 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E.
In support of manufacturer attestation, this commenter also pointed out that under other NRC medical regulations, manufacturers are permitted to provide attestation for physicians.
Another commenter affirmed the need for the NRC to gather geographic distribution information of authorized users, and if possible, break that data down by authorized use (35.390, 35.392, 35.394, and 35.396).
Another commenter spoke regarding how the current required T&E could encourage physicians to be dedicated to the field of nuclear medicine, which could potentially encourage and advance research in nuclear medicine. The commenter contrasted this to a doctor who only wanted to administer a single radiopharmaceutical and therefore was unlikely to contribute in a greater way to the field of nuclear medicine. This commenter pointed out that most research and advancement in nuclear medicine is being accomplished in countries other than the U.S., and that simply allowing more single-use physicians would not help the U.S. catch up in that regard.
A commenter from an Agreement State suggested that to better inform its evaluation, the NRC should conduct a review of medical events to determine whether the authorization pathway or the amount of T&E had any connection to events. The commenter suggested that even if this information wasnt contained in the Nuclear Materials Events Database (NMED), that perhaps the Agreement States would have this more detailed information. Another commenter pointed out that NMED reports are not available to authorized users or licensees.
A complete accounting of the comments is contained in the meeting transcript, which is available in ADAMS at Accession No. ML18330A113.
Next Steps: The NRC staff will consider the comments received during this meeting, and during the rest of public comment period, as part of its evaluation of the 35.300 T&E requirements. The NRC staff will document its evaluation and recommendation in a report to the Commission, which is planned to be published in fall 2019. The NRCs Web site on the T&E requirements evaluation will be regularly updated and can be found at:
https://www.nrc.gov/materials/miau/med-use-toolkit/training-experience-evaluation.html. All meeting transcripts and written comments will be available on the regulations.gov T&E docket site: https://www.regulations.gov/docket?D=NRC-2018-0230.
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C. Einberg Additional public comment meetings on T&E are scheduled for December 11, 2018, January 10, 2019, and January 22, 2019. The NRCs public meeting schedule Web site contains participation details for these upcoming meetings: https://www.nrc.gov/pmns/mtg.
ENCLOSURE:
As stated 4
PKG ML18333A385; Meeting Summary ML18333A384 NRC Slide Presentation ML18312A413; Meeting Notice ML18313A077, Meeting Transcript ML18330A113
- via email OFFICE NMSS/MSST/MSEB/PM NMSS/MSST/MSEB/TL NMSS/MSST/MSEB/BC NAME SLopas LDimmick* CEinberg*
DATE 11/28/18 11/29/18 11/30/18 OFFICE NMSS/MSST/MSEB/PM NAME SLopas DATE 11/30/18 Public Meeting (Webinar) to Accept Comments on the U.S. Nuclear Regulatory Commissions Evaluation of Training and Experience Requirements for Administering Different Categories of Radiopharmaceuticals (83 FR 54380)
November 14, 2018 Meeting Participants Name Affiliation (if applicable)
Scott Bloomberg Foley Hoag LLP David Crowley North Carolina Dept. of Health and Human Services Robert Dansereau New York Dept. of Health Christina Gervasi McManus Group Tina Getachew American College of Radiology Munir Ghesani NYU Medical Center Eric Gingold Jefferson University Hospital Richard Green Cardinal Health Alan Jackson Henry Ford Hospital Raymond Johnson JPS Health Caitlin Kubler Society for Nuclear Medicine and Molecular Imaging Ralph Lieto James Logan Bayer Amin Mirhadi Cedar-Sinai Hospital Josephine Piccone Aria Razmaria UCLA Medical Center Gloria Romanelli American College of Radiology A. Robert Schleipman Partners Healthcare Sheila Shaffer Beaumont Michael Sheetz University of Pittsburgh School of Medicine Cindy Tomlinson American Society for Radiation Oncology Forrest Weston Texas Dept. of State Health Services Scott Fuller St. Lukes Health Service Maryann Ayoade NRC/NMSS/MSST/MSEB Christian Einberg NRC/NMSS/MSST/MSEB Ed Harvey NRC/NMSS/MSST/MSEB Donna-Beth Howe NRC/NMSS/MSST/MSEB Janelle Jessie NRC/COMM/OCMJB Sarah Lopas NRC/NMSS/MSST/MSEB ENCLOSURE