ML20126D141

Summarizies Proposed Rulemaking 10CFR35, Use of Certain Radiopharms for Procedures Not Listed on Fda Approved Label, for RES Independent Review Board Members

ML20126D141
Person / Time
Issue date:	01/08/1985
From:	NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	NRC
Shared Package
ML20126D070	List: ML20126D067 ML20126D080 ML20126D084 ML20126D091 ML20126D101 ML20126D104 ML20126D108 ML20126D114 ML20126D120 ML20126D133 ML20126D141 ML20126D149 ML20126D152 ML20126D156 ML20126D212 ML20127C349
References
FRN-50FR15752, RULE-PR-35 AB72-1, NUDOCS 8506140654
Download: ML20126D141 (4)

Text

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o-T0: RES INDEPENDENT REVIEW BOARD MEMBERS FROM: RAMRB, DRA0, RES TITLE OF RULEMAKING* "USE OF CERTAIN RADI0 PHARMACEUTICALS FOR PROCEDURES NOT LISTED ON FDA-APPROVED LABEL"

SUMMARY

ANALYSIS: (NOTE: This summary sheet is pmvided only for the

• convenience of the RIRB members. It will be removed from the RES independent

' review packa e before the package is dispatched to the EDO or is distributed outside RES.

! This is a minor rulemaking implementing a policy, set out in a final rulemakin i

notice published February 4,1983 (48 FR 5217) to add a new 10 CFR 35.14(b)(7)g ,

that the NRC would amend the specified paragraph to allow NRC-licensed physicians and pospitals to use radiopharmaceuticals for newly developed

' methods of use (that are not listed on their respective FDA-approved package labels), without applying to the NRC for a license amendment.

The proposed rule would modify 10 CFR 35.14(b)(7) to add six new methods of use and the appropriate technetium-99 radiopharmaceuticals for each method of use.

With assistance from its Advisory Committee on the Medical Uses of Isotopes, NRC staff has determined that the proposed clinical procedures involving oral administration or injection of tfte radiopharmaceuticals can be conducted with no unjustified radiation dose to the patient and with a demonstration of adequate -

occupational radiation protection measures. '

The RES Task Leader, J. Foulke, REB, DRPES, agrees with the recommendation of the Director, NMSS, that this rulemaking should be initiated.

)

8506140654 850611 PDR I

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RES INDEPENDENT REVIEW EDARD VOTING SHEET -

TO: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: G. A. Arlotto, RIRB Member TITLE OF RULEMAKING: "USE OF CERTAIN RADI0 PHARMACEUTICALS FOR PROCEDURES NOT LISTED ON FAD-APPROVED LABEL"

!AGREEWITHDRAFTRES REQUEST RIRB d INDEPENDENT RECOMMENDATIONS MEETING.

IN DRAFT INDEPENDENT REVIEW PACKAGE.

MODIFY DRAFT RES NOTPkRTICIPATING.

INDEPENDENT RECOMMENDATIONS

, AS INDICATED BELOW.

COMMENTS AND SUGGESTIONS:

t ,

/ \  !

MEMBER RIRB t/hr DkTE

. RES INDEPENDENT REVIEi' Er, API-VOTING SHEET TO: F. P. GILLESPIE, CHAIRMAN, RIRB

. FROM: 0. E. BASSETT, MEMBER, RIRB TITLE OF RULEMAKING: "USE OF CERTAIN RADI0 PHARMACEUTICALS FOR PROCEDURES NOT LISTED ON FAD-APPROVED LABEL" AGkEEWITHDRAFTRES RE0 VEST RIRE X INDEPENDENT RECOMMENDATIONS MEETING.

IN DRAFT INDEPENDENT REVIEW PACKAGE.

MODIFY DRAFT RES NOT PARTICIPATING.

INDEPENDENT RECOMMENDATIONS AS INDICATED BELOW.

COMMENTS AND SUGGESTIONS:

Straight " approval" on this.

h l hf b W iA. '41 ht

, O. E. BASSETT '

MEMBER, RIRB JANUARY 14, 1985 DATE l

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G DRAFT RES INDEPENDENT REVIEW PACKAGE 6