ML20126D084
| ML20126D084 | |
| Person / Time | |
|---|---|
| Issue date: | 10/18/1984 |
| From: | Miller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Goller K, Olmstead W, Philips J NRC OFFICE OF ADMINISTRATION (ADM), NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES), NRC OFFICE OF THE EXECUTIVE LEGAL DIRECTOR (OELD) |
| Shared Package | |
| ML20126D070 | List: |
| References | |
| FRN-50FR15752, RULE-PR-35 AB72-1, NUDOCS 8506140631 | |
| Download: ML20126D084 (2) | |
Text
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%, UNITED STATES T'I ,
g, NUCLEAR REGULATORY COMMISslON
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l MEMORANDUM FOR: Milliam Olmstead, Director j . Regulations Division, OELD )C, 2hf Q
, [ Karl Goller, Director i' Division of Radiation Programs and
,- Earth Sciences, RES
- ' John Philips, Chief
.c ! Rules and Procedures Branch, ADM W !
Q'- FROM: Vandy L. Miller, Chief
,'- Material Licensing Branch
, : Division of Fuel Cycle and Material Safety
SUBJECT:
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REQUEST FOR. COMMENTS ON PROPOSED RULEMAKING TO AUTHORI p- -
APPROVED RADI0 PHARMACEUTICALS FOR UNAPPROVED USES
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- Attached for your coment is a proposed rulemaking that would amend
.i 35.14(b)(7) of 10 CFR Part 35, " Human Uses Of Byproduct Material." The j
. ; proposed Federal rule is Register on in accordance February with NRC's policy)as described in t 3,1983(48FR5217.
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This proposed rulemaking would amend the regulations to allow licensees
,l to use the following FDA approved drugs for the indicated unapproved uses:
- technetium-99m labeled sulfur colloid for gastroesophageal imaging; technetium-99m labeled sulfur colloid, pertechnetate, or macroaggregated P, j human serum albumin for Leveen, ventriculo-atrial, and ventriculo-peritoneal shunt imaging; and technetium-99m labeled pertechnetate for cystography and
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s dacryocystography.
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Please review the enclosures and submit your comments to me by //!fh .
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' iller, Chief teri Licensing Branch Division of Fuel Cycle and Material Safety
Enclosures:
- 1. Federal Register Notice Package
, 2. 48 FR 5217 e
851127 8506140631 850611
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s-Technetium-99m labeled sulfur colloid can be administered orally either as a solid or liquid test meal. Following oral administration,
. technetium-99m sulfur colloid goes from the esophagus to the stomach, small intestine, and the upper large intestine. This clinical procedure permits external imaging which is helpful in assessing gastric emptying, gastroesophageal reflux, and esophageal transit. The gastric emptying procedure is useful in demonstrating the presence and the severity of gastric motor disorder; the gastroesophageal reflux study may demonstrate backward flow in the digestive tract. The esophageal transit study may demonstrate obstructions or abnormal transit time.
The radiation dose to an average adult patient from 1 millicurie of orally administered technetium-99m sulfur colloid as a liquid is: 0.1 rad to the stomach wall; 0.3 rad to the small intestine; 0.5 rad to the upper large intestine; 0.3 rad to the lower large intestine; 0.1 rad to the ovaries; 0.01 rad to the testes; and 0.02 rad to the whole body.
The estimated absorbed radiation dose to an average adult patient from 1 millicurie of orally administered technetium-99m sulfur colloid as a solid food is: 0.2 rad to the stomach wall; 0.2 rad to the small intestine; 0.4 rad to the upper large intestine; 0.3 rad to the lower large intestine; 0.1 rad to the ovaries, 0.004 rad to the testes; and l
O.02 rad to the whole body.
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