Materials Prospective Applicant and Pre-application Engagement Resources

Welcome to the NRC’s pre-application resources for prospective applicants in the materials program areas overseen by the Division of Materials Safety, Security, State, and Tribal Programs (MSST) in the Office of Nuclear Material Safety and Safeguards (NMSS). MSST oversees the various categories of materials uses and activities (i.e., program areas) referenced in the Materials Licensees Toolkits Index. The content and resources on this page are intended to inform prospective applicants for materials licenses and sealed source and device registration certificates in any of the materials program areas overseen by MSST. These resources are designed to orient prospective applicants to the relevant NRC application processes and to increase awareness of the availability and potential benefits of requesting pre-application engagements with the NRC prior to submitting applications.  

On this page:

• Introduction
• Licensing Application Process Generic Flow Diagram

Additional resources:

• Materials Pre-application Engagements FAQs
• Materials Licensing FAQs
• Sealed Source and Device Registration FAQs
• Contact Us

Introduction

In accordance with the regulations in 10 CFR Part 30 and 10 CFR Part 40, an applicant or licensee may submit to the NRC an application for a materials license or sealed source and device registration related to byproduct or source material for medical, industrial, and academic uses. This page also encompasses applications for certain materials licenses issued under 10 CFR Part 70 for special nuclear material of less than critical mass.

Relevant terminology, and more detailed resources relating to each topic, are as follows: 

• Specific license. Issued to a named applicant or licensee that has filed an application for that license, authorizing the licensee to engage in certain activities (e.g., possession and use) involving byproduct, source, and/or special nuclear material.
• Sealed source and device registration certificate. Issued to a named certificate holder that has filed an application requesting evaluation of the radiation safety information for a sealed source or device and its registration in the national Sealed Source and Device Registry. The registration certificate summarizes radiation safety information for the sealed source or device and generally contains certain provisions and limitations regarding licensure, possession, use, or other topics of relevance to maintaining radiological safety.
• Exempt distribution license. A specific license that authorizes distribution of byproduct or source material to persons exempt from regulatory requirements for an NRC or Agreement State license. 
• Master materials license. A specific license issued to a Federal organization, which authorizes the possession and use of radioactive materials at multiple sites. The Master Materials License (MML) authorizes the licensee to issue its own radioactive materials permits to its various facilities, which are then responsible for adhering to NRC and MML requirements and inspection programs.  

The NRC makes available the lists of materials licensing and related actions.

Licensing Application Process Generic Flow Diagram

Licensing Timeliness:

Timeliness is an essential part of the NRC application review process, which consists of acceptance review and detailed technical review. The NRC staff guidance for processing of materials applications is provided in NUREG 1556, Volume 20. Generally, the NRC processes applications in the order they are received. However, the NRC may prioritize certain applications on its own initiative or upon applicant or licensee request, after making a determination that an expedited review process is warranted due to considerations such as dire public health and safety needs or commercial hardship for the applicant or licensee. A decision to prioritize an application is clearly communicated to the applicant or licensee. During the detailed technical review, the NRC will evaluate how the proposed activities involving regulated materials will meet the requirements in NRC regulations, using applicable guidance in the NUREG 1556 series, and may generate requests for additional information from the applicant or licensee. Upon receiving sufficient information from the applicant or licensee, the NRC makes a regulatory determination and, if granting the request, issues the new or amended materials license or Sealed Source and Device registration certificate. The NRC has established the following goals for timeliness for completing licensing actions:

Quick Cross-Reference of Guidance for applying for NRC license or Sealed Source and Device registration