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{{#Wiki_filter:August 22, 2019 MEMORANDUM TO:                Christopher J. Palestro, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes FROM:                        Christian E. Einberg, Branch Chief /RA/
Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards
 
==SUBJECT:==
RESPONSES TO THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES NOVEMBER 2018 RECOMENDATIONS ON THE DRAFT GERMANIUM-68/GALLIUM-68 PHARMACEUTICAL GRADE GENERATORS LICENSING GUIDANCE Below are the U.S. Nuclear Regulatory Commissions (NRC) staff responses from the November 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Report (ML19091A256) on the draft Germanium-68 (Ge-68)/Gallium-68 (Ga-68) Pharmaceutical Grade Generators Licensing Guidance (hereafter, the guidance). The NRC staff accepted all ACMUI recommendations and suggested changes.
The Licensing Guidance was issued in July 2019 (Agencywide Documents Access and Management System Accession No. ML19106A367).
: 1. ACMUI Recommendation: Page 1, 1st paragraph: Delete the sentence Future Ge-68/Ga-68 radionuclide generators will be addressed in revisions to the licensing guidance.
Staff Response: Accepted. The NRC staff implemented the change.
: 2. ACMUI Recommendation: Page 2, Section 4.1, 2nd paragraph: Replace the words FDA approved with if utilizing an Food and Drug Administration (FDA)- approved kit for radiolabeling.
Staff Response: Accepted. The NRC staff implemented the change.
: 3. ACMUI Recommendation: Page 3, Authorized Use for commercial nuclear pharmacies: Add (Form 313 Item 5) under Radionuclides, Chemical/Physical Form, and Maximum Possession Limit.
CONTACT: Said Daibes Figueroa, NMSS/MSST 301-415-5441
 
2 Staff Response: Accepted. The NRC staff implemented the change.
: 4. ACMUI Recommendation: Page 4 Section 4.4, 1st paragraph: Replace to develop/create Ga-68 with to elute Ga-68.
Staff Response: Accepted. The NRC staff implemented the change.
: 5. ACMUI Recommendation: Page 4, Section 4.4: The training for authorized individuals has omitted an alternate pathway option for Authorized Nuclear Pharmacists (ANPs), similar to 10 CFR 35.55(b), and written attestation signed by a preceptor ANP.
Staff Response: Accepted. The NRC staff implemented the change and added the alternate pathway as an option to the guidance.
: 6. ACMUI Recommendation: Page 5, Written attestation requirement: Replace 35.1000 Ge-68 generator use with 35.1000 Ge-68/Ga-68 generator use.
Staff Response: Accepted. The NRC staff implemented the change.
: 7. ACMUI Recommendation: Page 5, Section 4.4, last sentence: Replace Physicians or nuclear pharmacists with other individuals.
Staff Response: Accepted. The NRC staff implemented the change.
: 8. ACMUI Recommendation: Page 6, 1st bullet: Delete the word to.
Staff Response: Accepted. The NRC staff implemented the change.
: 9. ACMUI Recommendation: Page 6, 3rd bullet: Begin the sentence with Eluting Staff Response: Accepted. The NRC staff implemented the change.
: 10. ACMUI Recommendation: Page 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.
Staff Response: Accepted. The NRC staff implemented the change.
: 11. ACMUI Recommendation: Page 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.
Staff Response: Accepted. The NRC staff implemented the change.
 
3
: 12. ACMUI Recommendation: Page 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; Staff Response: Accepted. The NRC staff implemented the change.
: 13. ACMUI Recommendation: Page 6, 10th bullet: Move this bullet to be the last bullet in the series.
Staff Response: Accepted. The NRC staff implemented the change.
: 14. ACMUI Recommendation: Page 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.
Staff Response: Accepted. The NRC staff implemented the change.
: 15. ACMUI Recommendation: Page 6, 12th bullet: Center should be capitalized.
Staff Response: Accepted. The NRC staff implemented the change.
: 16. ACMUI Recommendation: Page 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 performed. This should be no more than 7 days from the date of the previous breakthrough calculation.
Staff Response: Accepted. The NRC staff implemented the change.
: 17. ACMUI Recommendation: Page 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.
Staff Response: Accepted. The NRC staff implemented the change.
: 18. ACMUI Recommendation: Page 7, 2nd bullet: In the first sentence, replace manufactures with manufacturers.
Staff Response: Accepted. The NRC staff implemented the change.
: 19. ACMUI Recommendation: Page 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 Staff Response: Accepted. The NRC staff implemented the change.
 
4
: 20. ACMUI Recommendation: Page 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?
Staff Response: Accepted. The NRC staff implemented the change.
: 21. ACMUI Recommendation: Page 8, Section 7.3.2: Distributor (in 2 cases) should be spelled with an o.
Staff Response: Accepted. The NRC staff implemented the change.
: 22. ACMUI Recommendation: Page 9, Section 7.4.1, 2nd paragraph: In the last sentence, delete the first for to read must provide financial assurance for decommissioning Staff Response: Accepted. The NRC staff implemented the change.
: 23. ACMUI Recommendation: Page 10, Section 8, 1st paragraph: Add Medical at the beginning of the first sentence.
Staff Response: Accepted. The NRC staff implemented the change.
: 24. ACMUI Recommendation: Page 10, Section 8, 2nd paragraph: Delete also.
Staff Response: Accepted. The NRC staff implemented the change.
 
ML19228A230                  *via email OFFICE            MSST            MSST          MSST NAME            SDaibes          LDimmick      CEinberg DATE            8/19/19          8/22/19        8/21/19}}

Revision as of 23:14, 7 October 2019

Response Memo to ACMUI on Germanium 68 Generator Report
ML19228A230
Person / Time
Issue date: 08/22/2019
From: Christian Einberg
NRC/NMSS/DMSST
To: Palestro C
Advisory Committee on the Medical Uses of Isotopes
SAID MSST
References
Download: ML19228A230 (3)
v • d • e


Text

August 22, 2019 MEMORANDUM TO: Christopher J. Palestro, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes FROM: Christian E. Einberg, Branch Chief /RA/

Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards

SUBJECT:

RESPONSES TO THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES NOVEMBER 2018 RECOMENDATIONS ON THE DRAFT GERMANIUM-68/GALLIUM-68 PHARMACEUTICAL GRADE GENERATORS LICENSING GUIDANCE Below are the U.S. Nuclear Regulatory Commissions (NRC) staff responses from the November 2018 Advisory Committee on the Medical Uses of Isotopes (ACMUI) Report (ML19091A256) on the draft Germanium-68 (Ge-68)/Gallium-68 (Ga-68) Pharmaceutical Grade Generators Licensing Guidance (hereafter, the guidance). The NRC staff accepted all ACMUI recommendations and suggested changes.

The Licensing Guidance was issued in July 2019 (Agencywide Documents Access and Management System Accession No. ML19106A367).

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

Staff Response: Accepted. The NRC staff implemented the change.

2. ACMUI Recommendation: Page 2, Section 4.1, 2nd paragraph: Replace the words FDA approved with if utilizing an Food and Drug Administration (FDA)- approved kit for radiolabeling.

Staff Response: Accepted. The NRC staff implemented the change.

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

CONTACT: Said Daibes Figueroa, NMSS/MSST 301-415-5441

2 Staff Response: Accepted. The NRC staff implemented the change.

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

Staff Response: Accepted. The NRC staff implemented the change.

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

Staff Response: Accepted. The NRC staff implemented the change and added the alternate pathway as an option to the guidance.

6. ACMUI Recommendation: Page 5, Written attestation requirement: Replace 35.1000 Ge-68 generator use with 35.1000 Ge-68/Ga-68 generator use.

Staff Response: Accepted. The NRC staff implemented the change.

7. ACMUI Recommendation: Page 5, Section 4.4, last sentence: Replace Physicians or nuclear pharmacists with other individuals.

Staff Response: Accepted. The NRC staff implemented the change.

8. ACMUI Recommendation: Page 6, 1st bullet: Delete the word to.

Staff Response: Accepted. The NRC staff implemented the change.

9. ACMUI Recommendation: Page 6, 3rd bullet: Begin the sentence with Eluting Staff Response: Accepted. The NRC staff implemented the change.
10. ACMUI Recommendation: Page 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.

Staff Response: Accepted. The NRC staff implemented the change.

11. ACMUI Recommendation: Page 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.

Staff Response: Accepted. The NRC staff implemented the change.

3

12. ACMUI Recommendation: Page 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; Staff Response: Accepted. The NRC staff implemented the change.
13. ACMUI Recommendation: Page 6, 10th bullet: Move this bullet to be the last bullet in the series.

Staff Response: Accepted. The NRC staff implemented the change.

14. ACMUI Recommendation: Page 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.

Staff Response: Accepted. The NRC staff implemented the change.

15. ACMUI Recommendation: Page 6, 12th bullet: Center should be capitalized.

Staff Response: Accepted. The NRC staff implemented the change.

16. ACMUI Recommendation: Page 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 performed. This should be no more than 7 days from the date of the previous breakthrough calculation.

Staff Response: Accepted. The NRC staff implemented the change.

17. ACMUI Recommendation: Page 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.

Staff Response: Accepted. The NRC staff implemented the change.

18. ACMUI Recommendation: Page 7, 2nd bullet: In the first sentence, replace manufactures with manufacturers.

Staff Response: Accepted. The NRC staff implemented the change.

19. ACMUI Recommendation: Page 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 Staff Response: Accepted. The NRC staff implemented the change.

4

20. ACMUI Recommendation: Page 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?

Staff Response: Accepted. The NRC staff implemented the change.

21. ACMUI Recommendation: Page 8, Section 7.3.2: Distributor (in 2 cases) should be spelled with an o.

Staff Response: Accepted. The NRC staff implemented the change.

22. ACMUI Recommendation: Page 9, Section 7.4.1, 2nd paragraph: In the last sentence, delete the first for to read must provide financial assurance for decommissioning Staff Response: Accepted. The NRC staff implemented the change.
23. ACMUI Recommendation: Page 10, Section 8, 1st paragraph: Add Medical at the beginning of the first sentence.

Staff Response: Accepted. The NRC staff implemented the change.

24. ACMUI Recommendation: Page 10, Section 8, 2nd paragraph: Delete also.

Staff Response: Accepted. The NRC staff implemented the change.

ML19228A230 *via email OFFICE MSST MSST MSST NAME SDaibes LDimmick CEinberg DATE 8/19/19 8/22/19 8/21/19

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