ML20126D156
| ML20126D156 | |
| Person / Time | |
|---|---|
| Issue date: | 04/20/1984 |
| From: | Axelson W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Muller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20126D070 | List: |
| References | |
| FRN-50FR15752, RULE-PR-35 AB72-1, NUDOCS 8506140660 | |
| Download: ML20126D156 (3) | |
Text
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UNiTEC STATES 'hb 8,p "4,k g
NUCLEAR REGULATORY COMMISSION REGION 111 fDl2 g -
799 ROOSEVELT ROAD ((
GLEN ELLYN, ILLINOIS 60137 (g
APR 201984 MEMORANDUM FOR: Vandy L. Miller, Chief, Material Licensing Branch, NMSS FROM: William L. Axelson, Chief, Materials and Safeguards Branch
SUBJECT:
' REQUESTSFOREXEMPTIONTOSECTION35.14(b)(6) 0F 10.CFR PART 35 We are forwarding the attached requests for exemptions / exceptions to Section 35'.14(b)(6) of 10 CFR Part 35 from The Methodist Hospital of Gary, Gary, Indiana and The Alexian Brothers Medical Center, Elk Grove, Illinois for your review in accordance with Federal Register Notice, Volume 48, No. 25, February 4, 1983 (enclosed).
We have notified the licensee that we are forwarding their requests to you and that no exception is required for the use of technetium-99m as pertechnetate for radionuclide cystography (letters enclosed).
[4 Wil iam L. Axelson, Chief Materials and Safeguards Branch
Enclosures:
As stated cc w/encls: D. R. Chape11, NMSS e
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.f GLEN ELLYN, ILLINOIS 60137 Methodist Hospital of Gary License No. 13-16558-01 ATTN: Ivan Chermel, M.D.
Radiology 600 Grant Street Gary, Indiana 46410
Dear Dr. Cherinel:
This is in iesponse to your letter dated November 25,1983,1(iwhichyou request an exemption to Section 35.14(b)(6) of 10 CFR Part 35 to use technetium-99m as sodium pertechnetate and sulfur colloid for the evalu-ation of ventriculo-peritoneal, ventriculo-atrial, and or Leveen shunt patency. We are forwarding your request to our Office of Nuclear Material Safety and Safeguards for review in accordance with Federal Register Notice, Volume 48, No. 25, February 4,1983 (enclosed). Please be advised that this review may take several months; consequently, you m'ay want to consider alternatives such as applying to the Food and Drug Administration (FDA) for acceptance of a " Notice of Claimed Investigational Exemption for a New Drug" (IND) or petitioning to the FDA Radiopharmaceutical Drug Advisory Committee to review for inclusion in the product labeling.
If you have any further questions or require clarification on any of the information stated above, please contact me at (312) 790-5625.
Sincerely, LBm Bruce S. Mallett, g LD., Chie'f Materials Licensing Section
Enclosure:
As stated cc w/o enc 1:
J. E. Glenn, RI J. R. Potter, RII R. J. Everett, RIV R. D. Thomas, RV R. Beyer, Vice President Clinical / Professional Services .-
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UNITED STATES 8- ~o NUCLEAR REGULATORY COMMIS310N
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, . 790 ROOSEVELT ROAD
- GLEN ELLYN, ILLINOIS 60137 Alexian' Brothers Medical Center License No. 12-129}9-01
-ATTN:. Thomas Rozek, Division Director Professional Services 800 West Biesterfield Road
-Elk Grove Village, Illinois 60007
Dear Mr. Rozek:
This is in ' response to your application, received on October 5,1983, in
!. which you request an exception to the requirements in Section 35.14(b)(6) l of 10 CFR Part 35 for the use of technetium-99m as sodium pertechnetate f~ for radionuclide cystography and as macroaggregated human serum albumin f (Tc-99m MAA) for assessing patency of Leveen shunts. An exception is L not required to use Tc-99m as sodium pertechnetate for cystography via i catheterization of the urinary bladder, since the Food and Drug
( Administration (FDA) has approved the inclusion of this procesfure in the L product labeling for the Tc-99m generator manufactured by the Union Carbide Corporation, Tuxedo New York, and it is our understanding that the FDA has sent a letter (August 1982) to all approved manufacturers of technetium generators and sodiurn pertechnetate requesting that they include the procedure for cystography in their product labeling.
As discussed in a telephone conversation between Mr. N. Lembares of your staff and Mr. R. Meyer of my staff on January 25,1984, we are forwarding your request for.an exception to the requirements to use Tc-99m for assessing patency of Leveen shunts to our Office of Nuclear Materials Safety and Safeguards-(NMSS) for review in accordance with Federal Register Notice, Volume 48, No. 25, February 4,1983 (enclosed).
Please be advised that this review may take several. months; consequently.
you may want to consider alternatives such as applying to the FDA for acceptance of a " Notice of Claimed Investigational Exemption for a New Drug" (IND) or petitioning to the FDA Ridiopharmaceutical Drug Advisory Comittee to review for inclusion in the product labeling.
If you have any further questions or require clarification on any of the f information stated above, please contact me at (312) 790-5625.
X Sincerely, YLO% .
$~
Bruce S. Mallett, .D . Chief Materials Licensing Section
Enclosures:
As stated cc: See Attached List Cd to/c [mel CymM 0 A'
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