Background Information for Medical Licensees
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Federal Register Notices Related to Medical Licensees
The following references were compiled to retain historical information pertaining to Nuclear Regulatory Commission rulemaking activities related to medical licensees. The Statement of Consideration, a subsection of the
Federal Register Notice, can provide valuable information regarding the basis of regulations or to explain past actions of the agency.
| Date |
Title |
| May 2, 2019 |
Draft approaches for training and experience requirements; request for comment and notice of public meetings, "Draft Approaches for Addressing Training and Experience Requirements for Radiopharmaceuticals Requiring a Written Directive," 84 FR 18874 |
| October 29, 2018 |
Training and experience requirements; request for comment, "Training and Experience Requirements for Different Categories of Radiopharmaceuticals," 83 FR 54380 |
| July 16, 2018 |
Final Rule "Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments." 83 FR 33046
Final Guidance Issuance, "Medical Use of Byproduct Material—Medical Events; Definitions and Training and Experience," 83 FR 32759
Guidance for the Final Rule, "Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments" Effective January 2019 and Comment Resolution for Proposed Guidance on the Proposed Rule "Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments"
The slides to a 2018 presentation titled “Final Rule – Medical Use Regulations in 10 CFR 30, 32, and 35,” provided a history of rulemaking, guidance document references, and a summary of changes. |
| November 16, 2015 |
Request for information, "Sodium Iodide–131 Patient Release Information Collection," 80 FR 70843 |
| July 21, 2014 |
Draft guidance; request for comment "Medical Use of Byproduct Material—Medical Events Definitions, Training and Experience." 79 FR 42224
Draft Guidance for the Proposed Rule, "Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments"
|
| July 14, 2009 |
Final Rule, "Medical Use of Byproduct Material—Authorized User Clarification", 72 FR 33901 |
| October 19, 2007 |
Notice of Publication of Transition Plan, "Notification of the Plan for the Transition of Regulatory Authority Resulting From the Expanded Definition of Byproduct Material."72 FR 59157 |
| October 1, 2007 |
Final Rule, "Requirements for Expanded Definition of Byproduct Material (NARM)." - 72 FR 55864 |
| August 13, 2007 |
Direct Final Rule, Medical Use of Byproduct Material - Minor Corrections and Clarifications, 72 FR 45147 |
| March 27, 2006 |
Final Rule, 10 CFR Parts 1, 13, 20, 30, 32, 35, 40, 55, 70, 73, 110, and 140, 71 FR 15005 |
| January 12, 2006 |
Correcting Amendment, Medical Use of Byproduct Material—Recognition of Specialty Boards; Correction, 71 FR 1926 |
| March 30, 2005 |
Final Rule, Medical Use or Byproduct Material – Recognition of Specialty Boards, 70 FR 16336 |
| September 16, 2004 |
Final Rule, Extending Expiration Date for 10 CFR Part 35 Subpart J, 69 FR 55736 |
| April 21, 2003 |
Direct Final Rule, Clarifying and Minor Amendments, 68 FR 19321 |
| April 24, 2002 |
Final Rule, "10 CFR Parts 20, 32, and 35; Medical Use of Byproduct Material," Part I, 67 FR 20249, Part II, 67 FR 20299, Part III, 67 FR 20349
The Stakeholder Workshop presentation introduced the final rule changes and was provided for reference. The presentation was color coded so that white text marked unchanged content, yellow text (new), and brown text (deleted). |
Petitions for Rulemaking
| Name of Petitioner |
Dates |
Federal Register Notices related to Petitions for Rulemaking |
| E. Russell Ritenour, PhD |
11/01/2006 |
Petition for rulemaking; Notice of receipt, "E. Russell Ritenour, Ph.D.; Receipt of Petition for Rulemaking," 71 FR 64168 |
| 05/14/2008 |
Resolution of petition for rulemaking, "E. Russell Ritenour, PhD; Consideration of Petition Rulemaking Process," 73 FR 27773 |
| William Stein, III, M.D. |
06/14/2006 |
Petition for rulemaking; Notice of receipt, "William Stein III, M.D.; Receipt of Petition for Rulemaking," 71 FR 34285 |
| 10/24/2007 |
Petition for rulemaking; Denial, "William Stein, III, M.D.; Denial of Petition for Rulemaking," 72 FR 60285 |
| Peter G. Crane |
12/21/2005 |
Petition for rulemaking; Notice of receipt, "Peter G. Crane; Receipt of Petition for Rulemaking," 70 FR 75752 |
| 05/21/2008 |
Petition for rulemaking: Denial, "Peter G. Crane; Denial of Petition for Rulemaking," 73 FR 29445 |
| Organization of Agreement States |
10/28/2004 |
Petition for rulemaking; Notice of receipt, "Organization of Agreement States; Receipt of Petition for Rulemaking," 69 FR 62831 |
| 03/30/2005 |
Final rule, "Medical Use of Byproduct Material — Recognition of Specialty Boards," 70 FR 16336 |
Past Shortages of Molybdenum-99/Technetium-99m
In December 2007, the industry experienced intermittent shortages of molybdenum-99 (Mo-99) resulting from unplanned reactor outages. These outages were significant because the world's supply of medical Mo-99 was impacted. Mo-99 is required to produce Mo-99/technetium-99m (Tc-99m) generators for medical uses. During the Mo-99 shortages in the United States, the NRC issued an
exemption to certain provisions of 10 CFR Parts 32 and 35 for medical use licensees on July 16, 2009.
2002 Guide for Diagnostic Nuclear Medicine (Archived)
On November 27, 2002, the NRC issued
NRC Regulatory Issue Summary 2002-23, "Availability of Guide for Diagnostic Nuclear Medicine." Through this generic communication, the NRC made the
2002 Guide for Diagnostic Nuclear Medicine available to the public through the NRC website. The guide was published by the American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM). This guide provided information that could have been useful to nuclear medicine professionals in understanding the applicability of NRC requirements to the medical use of byproduct material in diagnostic settings. It provided measures that practitioners could have used to facilitate implementation of the 2002 revision of 10 CFR Part 35. Subsequently, NRC revised 10 CFR Part 35 multiple times and the 2002 ACNP/SNM guide may no longer reflect current requirements. Although, SNM later expanded its guide to include therapeutic nuclear medicine in its publication titled, "Guide for Diagnostic Nuclear Medicine and Radiopharmaceutical Therapy,"
NRC has neither approved nor endorsed this new guide.