Pre-submission strategy
The hours spent before the package is filed are the cheapest hours in the entire licensing timeline. A short pre-submission consultation with the regulator and a clean internal review pass can save weeks of RAI cycles after submission.
What to do before you file
Pre-submission meeting with the regulator
Most NRC regions and Agreement States will hold a no-fee pre-submission call with applicants. Walk through the program scope, named individuals, and isotope category. Ask specifically what they want to see for Ac-225 beyond what your existing RLT authorization already covers.
Internal mock review
Have the RSO, AMP, and at least one named AU read the package front-to-back. The most common gaps are inconsistent activity limits between sections and procedures that reference equipment not on the equipment list.
Cross-reference existing RLT SOPs
If the program has an existing RLT RAM authorization, explicitly call out what is being reused vs. what is new for alpha. Regulators read faster when they can see what has changed vs. what is already established.
Name a single application owner
Designate one person — typically the RSO or program manager — as the named owner of the application package. RAIs go to a single inbox, responses are tracked in a single log, and no question to the regulator goes out without that person seeing it.
Minimum requirements
A clean Ac-225 submission packet typically includes:
Forms
- NRC Form 313 (or Agreement State equivalent)
- NRC Form 313A (AUT) for each named AU
- Cover letter summarizing the request and pointing to the relevant package sections
Procedures
- Receipt, handling, and administration SOPs for Ac-225
- Survey, contamination control, and spill response SOPs
- Decay-in-storage and waste release SOPs
Evidence
- Floor plan with restricted areas marked
- Equipment list with alpha-capable instruments and calibration status
- Training records for named staff and template for ongoing competency
Keeping every regulator interaction — calls, emails, meeting notes — in a single log is a small habit that pays off. If reviewers change mid-review, the log is what keeps continuity.