RAML application components
The RAML packages everything the regulator needs to evaluate the program. Each numbered item below corresponds to a section of NRC Form 313 (or the Agreement State equivalent) and the supporting documentation expected for a targeted alpha therapy program.
1. Application type
New license, amendment, or renewal. Adding Ac-225 to an existing RLT or nuclear medicine program is almost always an amendment.
2. Applicant details
Legal entity name, mailing address, and contact information for the radiation safety program. Include both an institutional address and a contact phone/email that is monitored daily.
3. Radionuclides requested
Ac-225 listed by isotope, chemical and physical form, maximum activity to be possessed at any one time, and the purpose(s) for use. Be specific — generic 'alpha-emitting therapeutics' language tends to draw RAIs.
4. Key individuals
RSO and each AU — name, credentials, training, experience, and certification basis (board certification or alternate pathway). May include the AMP depending on the regulator's expectations.
5. Training of restricted-area workers
Description of initial and annual training for staff working in restricted areas, including alpha-specific contamination control and competency sign-off process.
6. Facilities and equipment
Floor plan, hot lab specifications, administration room, decay storage room, and a list of survey and counting instruments — including alpha-capable detectors.
7. Radiation protection program
Written program addressing ALARA, dosimetry, bioassay, surveys, contamination control, and incident response specific to alpha emitters. References the AMP-validated dose calibrator setting for Ac-225.
8. Waste management
Decay-in-storage procedure sized for the Ac-225 decay chain, classification of alpha-bearing waste streams, release-survey methodology, and manifest templates.
9. Financial assurance
For higher-quantity authorizations, financial assurance for decommissioning may be required. Confirm the threshold with your specific regulator before assuming it does or does not apply.
The application package is what your regulator will work from, so it can help to treat written procedures as finished deliverables rather than drafts — and to get RSO and AMP sign-off on each one before submission. Clean packages tend to move faster than comprehensive-but-rough ones.
- NRC Form 313 — Application for Materials License.
- NUREG-1556, Vol. 9, Rev. 3.