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Medical Uses Licensee Toolkit
This toolkit is designed to help licensees find key information easily. Submit medical-related inquiries to MedicalQuestions@nrc.gov.
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Recent Activities
NRC has created a Recent Activities listing medical-related items of interest.
Regulations and Medical Policy Statement
The NRC's regulations are found in Chapter I of Title 10, "Energy," of the
Code of Federal Regulations (CFR).
Chapter I is divided into Parts 1 through 199. The following parts contain
the requirements most relevant to medical use of nuclear materials:
- Part 35 – "Medical
Use of Byproduct Material"
- Final Rule, 10 CFR Parts 20, 32, and 35; Medical Use of Byproduct Material
- Direct Final Rule, Clarifying and Minor Amendments, 68 FR 19321
- Final Rule, Extending Expiration Date for 10 CFR Part 35 Subpart J, 69 FR 55736
- Final Rule, Medical Use or Byproduct Material – Recognition
of Specialty Boards, 70 FR 16336
- Red-Line/Strike-out Part
35 – Training and Experience text including final Rule of March 30,
2005
- Correcting Amendment, Medical Use of Byproduct Material—Recognition of Specialty Boards;
Correction, 71 FR 1926
- Final Rule, 10 CFR Parts 1, 13, 20, 30, 32, 35, 40, 55, 70, 73, 110, and 140, 71 FR 15005
- Direct Final Rule, Medical Use of Byproduct Material - Minor Corrections and Clarifications, 72 FR 45147
- NARM Rule, "Requirements for Expanded Definition of byproduct Material (NARM)" - 72 FR 55864 - final rule
- NARM, "Notification of the Plan for the Transition of Regulatory Authority Resulting From the Expanded Definition of Byproduct Material" 72 FR 59157
- Medical
Policy Statement
- Part 40 – "Domestic
Licensing of Source Material"
- Part 70 – "Domestic
Licensing of Special Nuclear Material"
- Petitions for Rulemaking
See also:
Medical List Server
NRC has created a medical list server for automatic e-mail notifications of medical-related generic communications, NMSS/FSME Newsletters, and Federal Register Notices.
Guidance
Consolidated materials guidance is published in "Consolidated Guidance About
Materials Licenses" (NUREG-1556).
- Volume 9, Rev. 2,
Program-Specific Guidance About Medical Use Licenses
- Volume
11, Program-Specific Guidance About Licenses of Broad Scope
- Volume 13, Revision 1, Program-Specific Guidance About Commercial Radiopharmacy Licenses
- Volume 21, Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator
Other Guidance
- Guide
for Diagnostic Nuclear Medicine
- The American College of Nuclear Physicians (ACNP) and the Society
of Nuclear Medicine (SNM), in 2002, published a "Guide for Diagnostic
Nuclear Medicine." This
guide provides information that was current on October 24, 2002
and maybe useful to nuclear medicine professionals in understanding
the applicability of NRC requirements at that time for the medical
use of byproduct material in diagnostic settings and provides
measures that practitioners may use to facilitate implementation
of the October 2002 revised 10 CFR Part 35. Note: This
document has not been updated to included changes to the training
and experience requirements issued in March 30, 2005 in the "Final
Rule, Medical Use of Byproduct Material - Recognition of Specialty
Boards."
- Erratum
for SNM "Guide for Diagnostic Nuclear Medicine" (December 20,
2002)
- Questions and
Answers About Licensing Medical Uses of Byproduct Material Under Revised 10 CFR Part 35
- Radiation Dose Estimates for
Radiopharmaceuticals (NUREG/CR-6345),
April 1996
- Part
35 Stakeholder Workshop Slide Presentations
- Procedures for Recognizing Certification Process of Specialty Boards
- Specialty
Boards Certification Recognized by NRC in accordance with 10 CFR Part
35 Subparts B, D, E, F, G, and H
- Complying with 10 CFR 35.400(a), 35.500(a), and 35.600(a) requirements
for licensees to only use sources and devices "as approved in the Sealed
Sources and Devices Registry" and "Sealed
Source and Device Registry: Supplement for 10 CFR Part 35 Uses."
- Licensing Guidance for 10 CFR 35.1000 sealed sources and devices
Note: New
entries will be added to the list as additional sealed sources and devices regulated under 10 CFR 35.1000 are
identified. Licensing guidance will be updated when necessary to address
comments from stakeholders. Comments should be sent to the individual listed in the licensing guidance document or MedicalQuestions.Resource@nrc.gov.
- Table of Authorizations - for unsealed byproduct material requiring a written directive. This table contains sample language for licensing actions completed after the revised 10 CFR 35 for the "authorized use" (item 9) and "user authorization" sections of a U.S. NRC medical use license.
Regulatory guides are issued in 10 divisions and are intended
to aid licensees in implementing regulations. The guides most applicable to
medical use are in Division 8, Occupational
Health. (See the detailed list of Division 8 regulatory guides
in Medical, Industrial, Academic
Uses of Nuclear Materials Regulations, Guidance, and Communications for
guides with general applicability to medical uses.)
Web (HTML) versions of some regulatory guides are available for viewing or
downloading at this site. In the index for each division of guides, the number
of each guide available at this site is underscored. All active final and
draft guides are also available in NRC’s Agencywide Documents Access and Management
System (ADAMS).
Inspection Procedures
NRC’s regional offices (Region
I - East, Region III - Midwest,
and Region IV - West/Southwest)
conduct typically unannounced, periodic inspection of licensed activities
using guidance from NRC's Inspection
Manual, Chapter 2800.
The frequency of inspection is based on the hazard of materials used. The
following address inspections directly related to medical use.
- IP
87130
– Nuclear Medicine Programs, Written Directive Not Required
- IP
87131
– Nuclear Medicine Programs, Written Directive Required
- IP 87132 – Brachytherapy Programs
- IP 87133 – Medical Gamma Sterotactic Radiosurgery and Teletherapy Programs
- IP 87134 – Medical Broad-Scope Programs
License Types
NRC assigns a five-digit code to each license to designate the major activity
or principal use authorized in the license. These codes may be used to identify
the appropriate NUREG-1556 guidance documents and secondary activities or
uses authorized in the license. NRC uses approximately 100 program codes to
classify the primary and secondary activities of thousands of active licenses.
Additional information provided in the description of each license type may
be used to identify the fee categories information in the schedules in 10
CFR Part 170 and 10
CFR Part 171. To learn more about the license category and the associated
fee and inspection categories, see "Consolidated Guidance About Materials Licenses:
Guidance About Administrative Licensing Procedures" (NUREG-1556,
Vol. 20, Appendix
G: LTS Program Code Descriptions).
License Types (Program Codes) for Medical Facilities, Practices,
Laboratories
The code used depends upon whether licensee is a medical facility, private
practice, mobile service, or laboratory.
License Title |
License Type (Program Code) |
NUREG-1556 Vol. |
Medical Institution Broad |
02110 |
9 & 11 |
Medical Institution Written Directive Required |
02120 |
9 |
Medical Institution Written Directive Not Required |
02121 |
9 |
Medical Private Practice Written Directive Required |
02200 |
9 |
Medical Private Practice Written Directive Not
Required |
02201 |
9 |
Mobile Medicine Service Written Directive Not Required |
02220 |
9 |
Mobile Medical Service Written Directive Required |
02231 |
9 |
Medical Therapy Other Emerging Technology |
02240 |
9 |
In Vitro Testing Laboratories* |
02410 |
9 |
* not medical use but may be used for medical facilities and practices when
it is the only byproduct material used
Additional License Types (Program Codes) Associated with Medical
Use
The code used depends upon the medical device used.
License Title |
License Type (Program Code) |
NUREG-1556 Vol. |
Eye Applicators Strontium-90 |
02210 |
9 |
High Dose Rate Remote Afterloader |
02230 |
9 |
Teletherapy |
02300 |
9 |
Gamma Stereotactic Radiosurgery |
02310 |
9 |
Pacemaker Byproduct and/or SNM Medical Institution |
22160 |
17 |
Pacemaker Byproduct and/or SNM Individual |
22161 |
17 |
Source Material Shielding |
11210 |
17 |
Additional License Types (Program Codes) Associated with Medical
Use
The code used depends upon radiation program authorizations.
License Title |
License Type (Program Code) |
NUREG-1556 Vol. |
Research and Development Type A Broad* |
03610 |
11 |
Research and Development Type B Broad* |
03611 |
11 |
Research and Development Type C Broad* |
03612 |
11 |
Research and Development Other* |
03620 |
7
|
Measuring Systems Analytic Gauges |
03122 |
7 |
Measuring Systems Gas Chromatographs |
03123 |
7 |
Measuring Systems Other |
03124 |
7 |
Irradiators Self-Shielded Less than or Equal to 10,000 Curies |
03510 |
5 |
Irradiators Other Less than or Equal to 10,000 Curies |
03511 |
6 |
Irradiators Self Shielded Greater than 10,000 Curies |
03520 |
5 |
Waste Disposal (Burial) |
03231 |
|
Incineration - Noncommercial (Secondary Code) |
03235 |
|
Byproduct Material Possession Only - Permanent Shutdown |
03800 |
|
Byproduct Material Standby - No Operations |
03810 |
|
Decommissioning of Byproduct Material Facilities |
03900 |
|
Low Level Waste Storage - Other (Secondary Code) |
06101 |
|
* does not include research on human subjects
Fees
Medical use licensees are required to pay an annual license fee to the NRC.
These fees are explained in our Materials Fee Billing Handbook. Refer to the
schedule
of materials fees for the fees required for each category of license and
each type of fee.
Forms
The following forms
are to be used by medical use licensees.
- Reciprocity Form 214
- Training and Experience NRC
Form 313A Series of Forms and Guidance
- License Application Form
313
- Disposition of Materials Form
314
- NRC Form
3
- NRC Form 4
- NRC Form 5
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