ML20126D091

Concurs in Publication of Proposed Rev to 10CFR35 to Authorize Approved Radiopharms for Unapproved Uses

ML20126D091
Person / Time
Issue date:	11/08/1984
From:	Goller K NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Miller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20126D070	List: ML20126D067 ML20126D080 ML20126D084 ML20126D091 ML20126D101 ML20126D104 ML20126D108 ML20126D114 ML20126D120 ML20126D133 ML20126D141 ML20126D149 ML20126D152 ML20126D156 ML20126D183 ML20126D201 ML20126D208 ML20126D212 ML20126D216 ML20127C349
References
FRN-50FR15752, RULE-PR-35 AB72-1, NUDOCS 8506140634
Download: ML20126D091 (1)

Text

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h UNITED STATES y

. E NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20555 NOV 8 1984 I

MEMORANDUM FOR:

Vandy L. Miller, Chief Material Licensing Branch Division of Fuel Cycle and Material Safety, NMSS FROM:

Karl R. Goller, Director

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Division of Radiation Programs and Earth Sciences, RES

SUBJECT:

PROPOSED RULEMAKING TO AUTHORIZE APPROVED RADI0 PHARMACEUTICALS FOR UNAPPROVED USES As requested by your October 18, 1984 memorandum, we have reviewed the proposed rulemaking to amend 10 CFR 35.14(b)(7) to allow licensees to use certain FDA approved drugs for the listed uses.

At the last FDA Advisory Committee meeting it was stated that FDA was in the process of authorizin l

additional clinical procedures for approved radiopharmaceuticals. Since nothing further has happened, it is appropriate for NRC to take the lead.

We concur in the publication of your proposed revision.

/cOf&&

Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES kg61g634850611 30 PDR

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