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| document type = CORRESPONDENCE-LETTERS, OUTGOING CORRESPONDENCE
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Latest revision as of 07:29, 6 December 2021

Requests Addl Info Re 870724 Application for License, Including Confirmation That Kits Only Will Be Obtained from Mfgs & Distributed Only to General Licensees & List of Radionuclides Contained in Kits
ML20206L616
Person / Time
Issue date: 08/19/1986
From: Matson E
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To: Kent A
FLINT MEDICAL & SURGICAL, INC.
Shared Package
ML20206L532 List:
References
81811, NUDOCS 8704170185
Download: ML20206L616 (7)


Text

.-

e

  1. g *RE!u o NUCLEAR REGULATORY COMMISSION g

$ REGION lli O 799 ROOSEVELT RO AD f GLEN ELLYN, ILUNOIS 60 07 AUG 19 6 Flint Medical and Surgical ATTN: Mr. Al Kent G-5919 Corunna Road Flint, MI 48504

Dear Mr. Kent:

We have reviewed your application dated July 24, 1987 (sic) requesting an NRC byproduct material license and find that we will need additional information as follows:

1. Based on our telephone conversation on August 15, 1986, it is my understanding you wish to be authorized to receive and redistribute R1A kits originally manufactured and distributed by any manufacturer who has an NRC license pursuant to 10 CFR 32.71 to distribute to-general licensees under the provisions of 10 CFR 31.11. Please confinn by stating that your intentions are to obtain kits only from the above named manufacturers and to redistribute them only to general licensees.
2. Please provide a list of the radionuclides contained in the kits to be ,

redistributed.

3. Identify the maximum activity for each radionuclide that will be possessed at any one time.
4. Describe the training of the person who will be responsible for your radiation safety program. This person must have training and experience with radioactive material that is commensurate with the proposed use (storage), type and quantity of radioactive material.
5. Submit procedures for ordering and receiving the radioactive material.

These procedures should be adequate to insure that your license possession limits are not exceeded, that packages are inspected for damage or leaking contents, and that the materials are secured from unauthorized removal.

6. Describe what actions will be taken in the event a package is damaged and appears to be leaking its contents.

-7. Confirm that'all personnel who handle the kits will receive instruction

'in the conditions of your license and contents of your applications and letters to the NRC.

8. Submit a sketch of your facilities. Identify the area (refrigerator) where the radioactive material will be stored. Describe the security of the radioactive material.

0704170185 861017 REG 3 LIC30 PDR

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Am Kro UNITED STATES f

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  • NUCLEAR REGULATORY COMMISSION g

8 p, nEclONlli 5 j 799 ROOSEVELT ROAD o otEn Ettyn. ittinois soia7 AUG 19 $86 Flint Medical and Surgical ATTN: Mr. Al' Kent G-5919 Corunna Road Flint, MI 48504 -

Dear Mr. Kent:

We have' reviewed your application dated July 24, 1987 (sic) requesting an NRC byproduct material license and find that we will need additional information as follows:

1. Based on our telephone conversation on August 15, 1986, it is my understanding you wish to be authorized to receive and redistribute R1A kits originally manufactured and distributed by any manufacturer who has an NRC license pursuant to 10 CFR 32.71 to distribute to general licensees under the provisions of 10 CFR 31.11. Please confinn by stating that your intentions are to obtain kits only from the above named manufacturers and to redistribute them only to general licensees.
2. Please provide a list of the radionuclides contained in the kits to be redistributed.
3. Identify the maximum activity for each radionuclide that will be possessed at any one time.
4. Describe the trainino of the person who will be responsible for your radiation safety progtas. This person must have training and experience with radioactive material that is commensurate with the proposed use (storage), type and quantity of radioactive material.
5. Submit procedures for ordering and receiving the radioactive material.

These procedures should be adequate to insure that your license possession limits are not exceeded, that packages are inspected for damage or leaking contents, and that the materials are secured from unauthorized removal.

6. Describe what actions will be taken in the event a package is damaged and appears to be leaking its contents.
7. Confinn that all personnel who handle the kits will receive instruction in the conditions of your license and contents of your applications and letters to the NRC.
8. Submit a sketch of your facilities. Identify the area (refrigerator) where the radioactive material will be stored. Describe the security of the radioactive material.

. 6,

~.

(

Flint Medical and Surgical 2

9. Will the radioactive material be delivered to your customers by employees or by common carrier? If employees will deliver the kits, describe the instructions they will receive concerning procedures to be followed in case of vehicle accidents or other emergencies. Also, describe how the material will be secured from unauthorized removal during transport.
10. Describe your record maintenance procedures for receipt and distribution of the radioactive material. Include procedures for verifying that your customer is authorized to receive the materials. Refer to Section 30.41 an'd 30.51 of 10 CFR Part 30.
11. Please confirm that prepackage kits containing radioactive material will not be opened at your facilities.
12. Please confinn that you will not alter the kits in any way including packages, labels, inserts, etc.
13. Describe what you will do with any unwanted or unsold kits. Usually they can be returned to the original manufacturer.
14. Will you accept rejected kits from customers? If so, describe procedures for accepting kits and their final disposal.

If you have any questions or require clarification on any of the information stated above, you may contact us at (312) 790-5625.

We will continue our review of your application upon receipt of this infonnation.

Please reply in duplicate, within 30 days, and refer to Control Number 81811.

Sincerely,

{ k i Evelyn R. Matson Materials Licensing Section

Enclosures:

1. 10 CFR Parts 19, 20, 30, 31, 35, 170
2. NRC-3

/

AUG 191986 Flint Medical and Surgical ATTN: Mr. Al Kent G-5919 Corunna Road Flint, MI 48504

Dear Mr. Kent:

We have reviewed your application dated July 24, 1987 (sic) requesting an NRC byproduct material license and find that we will need additional information as follows:

't 1. Based on our telephone conversation on August 15, 1986, it is my understanding you wish to be authorized to receive and redistribute R1A kits originally manufactured and distributed by any manufacturer who has an NRC license pursuant to 10 CFR 32.71 to distribute to general licensees under the provisions of 10 CFR 31.11. Please confirm by stating that your intentions are to obtain kits only from the above named manufacturers and to redistribute them only to general licensees.

'l ' 2. Please provide a list of the radionuclides contained in the kits to be redistributed.

1 3. Identify the maximum activity for each radionuclide that will be possessed at any one time.

4. Describe.the training of the person who will be responsible for your radiation safety program. This person must have training and experience with radioactive material that is comensurate with the proposed use (storage), type and quantity of radioactive material.
5. Submit procedures for ordering and receiving the radioactive material.

These procedures should be adequate to insure that your license possession limits are not exceeded, that packages are inspected for damage or leaking contents, and that the materials are secured from unauthorized removal.

6. Describe what actions will be taken in the event a package is damaged and appears to be leaking its contents.
7. Confirm that all personnel who handle the kits will receive instruction in the conditions of your license and contents of your applications and letters to the NRC.

e 8. Submit a sketch of your facilities. Identify the area (refrigerator) where the radioactive material will be stored. Describe the security of the radioactive material.

S Flint Medical and Surgical 2

9. Will the radioactive material be delivered to your customers by employees or by common carrier? If employees will deliver the kits, describe the instructions they will receive concerning procedures to be followed in case of vehicle accidents or other emergencies. Also, describe how the material will be secured from unauthorized removal during transport.
10. Describe your record maintenance procedures for receipt and distribution of the radioactive material. Include procedures for verifying that your customer is authorized to receive the materials. Refer to Section 30.41 and 30.51 of 10 CFR Part 30.

' 11. Please confirm that prepackage kits containing radioactive material will not be opened at your facilities.

12. Please confirm that you will not alter the kits in any way including packages, labels, inserts, etc.

s

13. Describe what you will do with any unwanted or unsold kits. Usually they can be returned to the original manufacturer.
14. Will you accept rejected kits from customers? If so, describe procedures for accepting kits and their final disposal.

If you have any questions or require clarification on any of the information stated above, you may contact us at (312) 790-5625.

We will continue our review of your application upon receipt of this information.

Please reply in duplicate, within 30 days, and refer to Control Number 81811.

Sincerely, Original Signed by Evelyn R. Matson Materials Licensing Section

Enclosures:

1. 10 CFR Parts 19, 20, 30, 31, 35, 170
2. NRC-3 RIII WN Matson/jl 8/f/86 f

+. .. . .. .. . ..

~

Flint Medical and Surgical 2

9. Will the radioactive material be delivered to your customers by employees or. by common carrier? If employees will deliver the kits, describe the

. instructions:they will receive concerning procedures to be followed in case of vehicle accidents or other emergencies. Also, describe how the material will be secured from unauthorized removal during transport.

10. Describe your record maintenance procedures for receipt and distribution of the radioactive material. Include procedures for verifying that yo'ur  !'

customer is authorized to receive the materials. Refer to Section 30.41.

and 30.51 of 10 CFR Part 30.

11. Please confirm that prepackage kits containing radioactive material will not be opened at your facilities.
12. Please confirm that you will not alter the kits in any way including-packages, labels, inserts, etc.
13. Describe what you will do with any unwanted or unsold kits. Usually they can be returned to the original manufacturer.
14. Will you accept rejected kits from customers? If so, describe procedures for accepting kits and their final disposal.

If you have any questions or require clarification on any of the infonnation stated above, you may contact us.at (312) 790-5625.

We will continue our review of your application upon receipt of this information.

Please reply in duplicate, within 30 days, and refer to Control Number 81811.

Sincerely, A

Evelyn R. Matson Materials Licensing Section

Enclosures:

1. 10 CFR Parts 19, 20, 30, 31, 35, 170

~2. NRC-3

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