ML20214Q559
| ML20214Q559 | |
| Person / Time | |
|---|---|
| Issue date: | 05/28/1987 |
| From: | Graden K NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Mitchener J PORT HURON HOSP., PORT HURON, MI |
| References | |
| NUDOCS 8706050073 | |
| Download: ML20214Q559 (1) | |
Text
_ _ _ _ _ _ _ _ _ - _ _
MAY 2 81987 James W. Mitchener, M.D.
c/o Port Huron Hospital 1001 Kearney Street Port Huron, MI 48060
Dear Dr. Mitchener:
Pursuant to the letter you received from NRC Headquarters dated Februar 1987, please note that your application for.a specific license dated March 28 1987 was submitted to the NRC after March 31, 1987, and therefore cannot be authorized.
To obtain a specific license in accordance with the revised 10 CFR Part 35 you must submit documentation of training and experience for each physician user as outlined in Section 35.910, Subpart J of 10 CFR Part 35.
that you are subject to all fees that apply to specific licensees.Be aware are Parts 35 and 170 of 10 CFR and NRC Form 313M Supplements A a Enclosed reference.
stated above, you may contact us at (312) 790-5625.If you h Sincerely, Original Signed By Kathy J. Graden Materials Licensing Section
Enclosures:
- 3. NRC Form 313M Supplements A and B E8s 2ing==a PDR RIIIg Graden/pd
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INSTRUCTIONS. SEE THE APPROPRi ATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APP
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TO ALL PHYSICIANS WHO USE A GENERAL LICENSE ISSUED PURSUANT T010 CFR The Nuclear Regulatory Commission (NRC) recently published a revision of 10 CFR Part 35, its regulations that apply to the medical use of byproduct material.
In the revision, the general license that allows physicians to conduct six in vivo clinical procedures (use of iodine-131 for measuring thyroid uptake and blood volume, fodine-125 for measuring blood volume, cobalt-58 and cobalt-60 for measuring intestinal absorption of cyanocobalamin, and chromium-51 for measuring red _ blood cell volume and survival time) has been eliminated.
In the future, these clinical procedures will only be authorized by specific ifcense.
If you'want to continue perfonning just the cifnical procedures authorized by the general license, you must complete items 2., 3., 4., and 13. of the attached application and submit it to the address indicated on the fann by March 31,1987.
The NRC will issue you a specific license that has all the features of the general license.
If you are currently authorized under a specific license to perform the clinical procedures listed in 10 CFR-35.100(a) (Group I, use of prepared radfophannaceuticals for measuring uptake, dilution, and excretion), you probably do not need a separate specific license to continue the generally licensed activities, and need not return the application.
The general license in section 31.11 that allows the in vitro use of byproduct material in radioinsnunoassay kits was not affected by the revision of 10 CFR Part 35. NRC Forms-483, " Registration Certificate-In i
Vitro Testing with Byproduct Material Under General License," are valid and will continue to be issued in the future.
Sincerely, CA f
e andy. Miller, C'11ef j}L i
Material Licensing Branch D1vilion of Fuel Cycle 'and Material Safety Enclosures 1.
10 CFR 35.31 2.
Preprinted Application for a specific ifcense to perform certain in vfvo clinical procedures i
pg g O jg@7,
i cals which are under the generalIlcense in in paragraph (a) of this section. more this paragraph to include the following than:
statement in the label affixed to the con-tainer or in the leaflet or brochure which (1) 200 microcuries of lodine-131.
accompanies the radiopharmaceutical:
(11) 200 microcuries of iodine-125.
This radioactive drug may be received.
(111) 5 microcuries of cobalt-58.
(iv) 5 microcuries of cobalt-60. and ce$ t d peNe dru s in the (v) 200 microcurfes of chromium-51.
c e medicme. Its receipt, possession. use and (2) He shall store the pharmaceutt-transfer are supject to the regulations and a cal until administered in the original general license of the United States Nuclear shipping container or a container pro-Regulatory Commission or of a State with which the Commission has entered into an Viding equivalent radiation protection:
agreement for the exercise of regulatory au-(3) He shall use the pharmaceutical thority.
only for the uses authorized by para-graph (a) of this section:
(4) He shall not administer the phar-(Name of manufacturer) maceutical to a woman with confirmed pregnancy or to a person under 18 (b) No physician shall receive, pos-years of age; sess, use, or transfer byproduct materi.
(5) He shall not transfer the byprod.
al pursuant to the general license es.
uct material to a person who is not au-tablished by paragraph (a) of this see-thorized to receive it pursuant to a li.
tion until he has filed Form NRC-482
" Registration Certificate-MedicalUse cense issued by the Commission or an Agreement State, or in any manner 8 33.31 General license for medical use of of Byproduct Material Under General other than in the unopened labeled certain quantities of byproduct materi-License" with the Director of Nuclear al.
Material Safety and Safeguards. U.S.
shippirig container as received from the supplier, except by administering Nuclear Regulatory Commission. It to a patient.
(a) A generallicense is hereby issued Washington D.C. 20555, and received (d) The registrant possessing or to any physician to receive, possess, from the Commission a validated copy using byproduct material under the transfer, or use for any of the follow. of the Form NRC-482 with registra-general license of paragraph (a) shall ing stated diagnostic uses, in accord. tion number assigned. The registrant report in duplicate to the Director of ance with the provisions of paragraphs shall furnish on Form NRC-482 the Licensing any changes in the informa-(bl. (c), and (d) of this section, the fol. following information and such other tion furnished by him in the'
- Regis-lowing byproduct materials in cap-information as may be required by tration Certificate-Medical Use of sules, disposable syringes or other that form:
Byproduct Material Under Gencral Li-forms of prepackaged individual doses; (1) Name and address of the regis.
cense." Form NRC-482. The report (1). Iodine 131 as sodium todide trant; shall be submitted within 30 days (Na! * * ') for measurement of thyroid (2) A statement that the registrant after the effective date of such uptake; is a duly licensed physician authorized change.
(2) lodine-131 as lodinated human to dispense drugs in the practice of (e) Any person using byproduct ma-serum albumin (IHSA) for determina-medicine, and specifying the license terial pursuant to the general license tions of blood and blood plasma volume:
number and the State in which such of paragraph (a) of this section is license is valid; and exempt from the requirements of (3) lodine-125 as lodinated human serum albumin (IHSA) for determina-(3) A statement that the registrant Parts 19, 20. and 21 of this chapter has appropriate radiation measuring with respect to the byproduct materi-tions of blood and blood plasma Volume:
instruments to carry out the diagnos. als covered by the generallicense.
(4) Cobalt-58 for the measurement tic procedures for which he proposes of intestinal absorption of cyanocoba-to use byproduct material under the (30 FR 8200. June 26.1985, as amended at lamin:
general license of I 35.31 of this part 38 FR 1272. Jan.11.1973; 38 FR 22221. Aug.
(5) Cobalt-60 for the measurement and that he is competent in the use of 17.1973; 42 FR 2#896. June 6.19771 of intestinal absorption of cyanocoba-such instruments.
lamin:
(c) A physician who receives pos-(6) Chromium-51 as sodlum radio
- sesses, or uses a pharmaceutical con-chromate for determination of red taining byproduct material pursuant blood cell volumes and studies of red to the general license established by blood cell survival time.
paragraph (a) of this section shall comply with the following*
Notr Section 32.70 of this chapter re-(1) He shall not possess at any one quires manufacturers of radjopharmaceuti-time, pursuant to the general license
4 4
ATT 5.
A. Iodine-131 A. Sodium iodide A. and B. 200 microcuries:
B. Iodine-131
- 8. Iodinated human serum albumin C. Iodine-125' C. Iodinated human C. 200 microcuries serum albumin D.~ Cobalt-58 D. Cyanocobalamin D. 5 microcuries~
1 E. Cobalt-60 E. Cyanocobalamin E. 5 microcuries 4
F. Chromium-51 F. Sodium chromate F. 200 microcuries ATT 6~.
A. Measurement of thyroid uptake B. Determinations of blood and blood plasma volume C. Determinations of blood and blood plasma volume D. Measurement of intestional absorptica of cyanocobalamin i
E. Measurement of intestional absorption of cyanocobalamin.
F. Determination of red blood cell volumes and studies of red blood cell survival time.
j ATT 7.
I will be personally responsible for the radiation safety program.
I am a licensed physician authorized to dispense drugs in the practice of medicine, and have had training and experience in the use of the instruments that will be used to perform clinical procedures.
ATT 8.
Not applicable 1
ATT 9.
I have on hand ti'e appropriate radiation measuring instruments needed to carry out the clinical procedures that will be performed under this license.
ATT 10.
Not applicable ATT 11.
Not applicable.
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