ML20126D101

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Forwards marked-up Proposed Rule Authorizing Approved Radiopharms for Unapproved Uses.Memo to EDO Requesting Approval & Issuance of New Rule Necessary
ML20126D101
Person / Time
Issue date: 10/29/1984
From: Felton J
NRC OFFICE OF ADMINISTRATION (ADM)
To: Miller V
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20126D070 List:
References
FRN-50FR15752, RULE-PR-35 AB72-1, NUDOCS 8506140637
Download: ML20126D101 (1)


Text

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aur t; UNITED STATES 8 o NUCLEAR REGULATORY COMMISSION g ;y WASHINGTON, D. C. 20555

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OCT 2 91984 MEMORANDUM FOR: Vandy L. Miller, Chief Material Licensing Branch Office of Nuclear Material Safety and Safeguards FROM: J. M. Felton, Director Division of Rules and Records Office of Administration

SUBJECT:

REVIEW 0F PROPOSED RULE AUTHORIZING APPROVED RADI0 PHARMACEUTICALS FOR UNAPPROVED USES The Division of Rules and Records has reviewed the proposed rule that would amend 10 CFR Part 35 to permit medical licensees to use certain drugs without regard to regulatory restrictions concerning FDA labeling.

Enclosed is a marked-up copy of the proposed rule that sets out our comments.

When the regulation package is submitted for concurrence and signature, it must contain a memorandum to the EDO requesting that the ED0 approve and issue the proposed rule (See the NRC. Regulations Handbook, pp. 295-297).

If you have any questions, please contact John Philips, Chief, Rules and Procedures Branch on ext. 27086 or Michael T. Lesar of his staff on ext.

27758. ,

[ g

. M. elton, Director j Division of Rules and Records Office of Administration

Enclosure:

As stated cc: R. Stephen Scott, TIDC e506140637 850611 PDR PR PDR 35 a

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