United States Nuclear Regulatory Commission - Protecting People and the Environment

Background Information for Medical Licensees

On this page:

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"
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Draft guidance; request for comment "Medical Use of Byproduct Material—Medical Events Definitions, Training and Experience." 79 FR 42224

Draft Guidance for the Proposed Rule, "Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments"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

To top of page

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

To top of page

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.

To top of page

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.

To top of page

Page Last Reviewed/Updated Tuesday, August 06, 2019