ML19091A256

Advisory Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on the Germanium-68/Gallium-68 Generator Licensing Guidance, Revision 1, Draft Report, November 30, 2018

ML19091A256
Person / Time
Issue date:	11/30/2018
From:	Advisory Committee on the Medical Uses of Isotopes
To:
Jamerson, Kelle; Holiday, Sophie
References
Download: ML19091A256 (3)

Text

Nuclear Regulatory Commission (NRC)

Advisory Committee on the Medical Use of Isotopes (ACMUI)

Subcommittee Review and Comments on Germanium-68/Gallium-68 Generator Licensing Guidance, Revision 1 Submitted on: November 30, 2018 Subcommittee Members:

Ms. Melissa Martin Dr. Darlene Metter Mr. Michael Sheetz Ms. Megan Shober (Chair)

NRC Staff Resource: Said Daibes-Figueroa, Ph.D.

Background

The subcommittee and its Chair were appointed by ACMUI Chairman, Christopher Palestro, at the ACMUI meeting on September 21, 2018. The purpose of the subcommittee was to review the NRC staffs draft proposed revision to the licensing guidance for Germanium-68 (Ge-68)/Gallium-68 (Ga-68) generators. The NRCs current licensing guidance for Ge-68/Ga-68 generators (Revision 1) was issued on July 13, 2017. At that time, the only Ge-68/Ga-68 generator approved by the U.S.

Food and Drug Administration (FDA) and available on the market was the Eckert and Ziegler GalliaPharm generator. As such, the NRC tailored its licensing guidance to this specific product.

Now that additional Ge-68/Ga-68 generators (IREs [Institute of Radio Elements] Galli Eo' generator and others) are becoming commercially available, the Ge-68/Ga-68 generator licensing guidance is being revised to eliminate reference to any specific generator manufacturer or product.

This document represents the Subcommittees report on the draft proposed revision of this licensing guidance issued by NRC staff in July 2018.

Changes to Guidance Considered by the Subcommittee and its Recommendations General Comment: Throughout the document, ensure that font sizing and bullet size and shape are uniform.

Specific Comments

Title:

The Subcommittee supports the change to the title of the proposed guidance.

Pg 1, 1st paragraph: Delete the sentence Future Ge-68/Ga-68 radionuclide generators will be addressed in revisions to the licensing guidance.

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Pg 2, Section 4.1, 2nd paragraph: Replace the words FDA approved with if utilizing an FDA-approved kit for radiolabeling.

Pg 3, Authorized Use for commercial nuclear pharmacies: Add (Form 313 Item 5) under Radionuclides, Chemical/Physical Form, and Maximum Possession Limit.

Pg 4 Section 4.4, 1st paragraph: Replace to develop/create Ga-68 with to elute Ga-68.

Pg 4, Section 4.4: The training for authorized individuals has omitted an alternate pathway option for ANPs, similar to 10 CFR 35.55(b), and written attestation signed by a preceptor ANP.

Pg 5 Written attestation requirement: Replace 35.1000 Ge-68 generator use with 35.1000 Ge-68/Ga-68 generator use.

Pg 5, Section 4.4, last sentence: Replace Physicians or nuclear pharmacists with Other individuals.

Pg 6, 1st bullet: Delete the word to.

Pg 6, 3rd bullet: Begin the sentence with Eluting Pg 6, 7th bullet: Remove the value of 0.001 percent, as this is specific to a particular manufacturer.

Replace with a generic reference to the manufacturers recommended breakthrough limit.

Pg 6, 7th bullet: Delete the sentence Not knowingly distributing or administering to a patient or human research subject any material containing Ga-68 which is determined to exceed the manufacturers 0.001 percent breakthrough limit. This topic is covered by the revised 8th bullet, below.

Pg 6, 8th bullet: Revise to read During the course of breakthrough testing, if the eluate exceeds the manufacturers breakthrough limits, the eluate will not be distributed or administered to a patient or human research subject; Pg 6, 10th bullet: Move this bullet to be the last bullet in the series.

Pg 6, 11th bullet: The criteria for multiple and unusable are vague. Delete on multiple occasions rendering the generator unusable in human patients and research subjects. Adopt the language from the new 10 CFR 35.3204 for telephone reports to the NRC Operations Center within 7 days.

Pg 6, 12th bullet: Center should be capitalized.

Pg 7, general: Due to the extended time necessary for completing a breakthrough test, the guidance should specify when a generator failure is effective. The Subcommittee recommends specifying that a generator has failed on the date when the breakthrough calculation is 2 of 3

performed. This should be no more than 7 days from the date of the previous breakthrough calculation.

Pg 7, 1st bullet: Remove this bullet. There is no reasonable scenario where a breakthrough failure could cause a reportable medical event due to Ge-68, based on 5 rem effective dose to the whole body or 50 rem dose to an organ.

Pg 7, 2nd bullet: In the first sentence, replace manufactures with manufacturers.

Pg 7, 3rd bullet: Revise the sentence to read Conduct surveys of all areas of licensed material use, including the generator storage and kit preparation areas, for contamination each day of use; and Pg 7, 4th bullet: Remove the bullet. This bullet appears to be less stringent than the guidance in NUREG-1556, Vol. 13, Appendix R, which says that areas where licensed material is stored must be surveyed for contamination weekly. What additional survey should be performed every three months that would not be captured in the required weekly surveys?

Pg 8, Section 7.3.2: Distributor (in 2 cases) should be spelled with an o.

Pg 9, Section 7.4.1, 2nd paragraph: In the last sentence, delete the first for to read must provide financial assurance for decommissioning Pg 10, Section 8, 1st paragraph: Add Medical at the beginning of the first sentence.

Pg 10, Section 8, 2nd paragraph: Delete also.

Other recommendations The subcommittee agrees with the remainder of the licensing guidance document.

Respectfully submitted, November 30, 2018, Subcommittee on Germanium-68/Gallium-68 Generator Licensing Guidance, Advisory Committee on the Medical Use of Isotopes (ACMUI),

Nuclear Regulatory Commission (NRC) 3 of 3