ML18236A300
| ML18236A300 | |
| Person / Time | |
|---|---|
| Issue date: | 08/21/2018 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | |
| Beardsley M | |
| Shared Package | |
| ML18236A295 | List: |
| References | |
| Download: ML18236A300 (3) | |
Text
NRC Letter dated 12/27/2016 ORC Section NRC Section RATS ID Category Subject and Comments ORC Actions 420-3.02(10)(t) 32.72 2007-1 2007-3 B
Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35.
AL omits an equivalent regulation to 10 CFR 32.72(b)(3). AL needs to add an equivalent regulation to 10 CFR 32.72(b)(3) to 420-3-26-.2(10)(t) to meet the requirements of a compatibility category B designation.
AL omits no later than 30 days after the date that the licensee allows, under paragraphs 420-3-26-.02(10)(t)(2)(ii)(I) and (III), the individual to work as an authorized nuclear pharmacist from the end of 420-3-26-.02(10)(t)(5)(v).
AL needs to make the above changes in order to meet the compatibility category B designation assigned to 10 CFR 32.72.
COMMENT STANDS FROM NRC LETTER DATED AUGUST 19, 2016 Note: AL provided a rationale for not addressing this comment in their submitted comment resolution document (ML16314D996).
As written, ALs proposed regulations are not essentially identical to NRCs and as such, cause inconsistency and have transboundary implications. They do not No actions.
meet the Compatibility Category B designation assigned to 32.72. For example, ALs proposal to omit the equivalent regulation to 10 CFR 32.72(b)(3) would allow AL to issue license conditions that are less restrictive, which is inconsistent and not essentially identical for compatibility category B designation.
Similarly, ALs proposal for the equivalent regulation to 10 CFR 32.72(b)(5) is more restrictive, which is also not essentially identical for compatibility category B designation 420-3.02(3) 40.13 2013-2 B
Unimportant quantities of source material AL omits the word delivers from 420 26-.02(3)(a).
AL needs to remove 420-3.02(3)(c)2.(ii) from its regulations.
AL needs to add a regulation equivalent to 10 CFR 40.13(c)(2)(ii)
Piezoelectric ceramic containing not more than 2 percent by weight source material to 420-3-26-.02(3)(c)2.
AL needs to remove 420-3-26-.02(3)(c)8.
from its regulations.
delivers was added to 420-3.02(3)(a) 420-3-26-.02(3)(c)2.(ii) was deleted in its entirety.
An equivalent 40.13(c)(2)(ii) was added as 420-3-26-.02(3)(c)2.(ii) 420-3-26-.02(3)(c)8. was deleted in its entirety..02(3)(c)9. was renumbered as
.02(c)8. for sequential numbering purposes.
AL needs to add a regulation equivalent to 10 CFR 40.13(c)(9) The exemptions in this paragraph (c) do not authorize the manufacture of any of the products described. to 420-3-26-.02(3)(c).
AL lists the incorrect reference in 420 26-.02(3)(c)10.(ii). AL needs to reference Section 40.52 instead of Section 40.42.
AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 40.13 (except 10 CFR 40.13(c)(5)(iv) which is a compatibility category NRC).
An equivalent 40.13(c)(9) was added as 420-3-26-.02(3)(c)9.
The reference was corrected in 420 26-.02(3)(c)10.(ii).