ML20198J793

Responds to Re Petition for Rulemaking from Tri-Med Specialties,Inc.Nrc Staff Working to Resolve Petition as Soon as Possible.Safety Analysis & Other Evaluations That Form Technical Bases Completed

ML20198J793
Person / Time
Issue date:	09/25/1996
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Burton D HOUSE OF REP.
Shared Package
ML20013E023	List: ML20198H571 ML20198H672 ML20198H718 ML20198H780 ML20198H830 ML20198H875 ML20198H887 ML20198H907 ML20198J119 ML20198J157 ML20198J188 ML20198J224 ML20198J252 ML20198J270 ML20198J298 ML20198J324 ML20198J404 ML20198J418 ML20198J664 ML20198J741 ML20198J766 ML20198J793 ML20198J830 ML20198J869 ML20198J932 ML20198J978 ML20198J988 ML20198J995 ML20198K019 ML20198K055 ML20198K065 ML20198K118 ML20198K151 ML20198K202 ML20198K217
References
FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-066, AF70-1-66, NUDOCS 9801140214
Download: ML20198J793 (2)

Text

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, A rt; p S . UNITED STATES ) 3 g j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20666 4 001 i N g

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• • "* September 25, 1996 The Honorable Dan Burton United States House of Representatives Washington, D.C. 20515

Dear Congressman Burton:

.In response to your letter dated September 3,1996, regarding a petii t on for rulema(ing from Tri-Med Specialties, the NRC staff is working to resolve this petition as soon as possible. The NRC has been communicating with the Food and Drug Administration (FDA) and expects to resolve the petition and make the rule effective in a time frame consistent with FDA approval. However, existing NRC and Agreement State regulations already permit the use of Tri-Med's product by physicians, to the extent permitted by the FDA, provided they are working under an NRC or Agreement State license for medical use. -

The NRC has completed the safety analysis and other evaluations that form the technical bases for resolving the petition. A draft rulemaking plan, reconmending a direct final rule, is in the process of being forwarded to the Agreement States for their comment. After the NRC staff addresses the Agreement State comments, if any, the rulemaking plan will be forwarded to the Commission for approval.

I assure you that the NRC will conti..de working toward resolving the petition in 1996 and expects to publish a rule in the Federal Reoister early in 1997.

Responses to.your three specific questions are included in the attached Enclosure.

Sincerely,

\

k

b. T' ecutive Director P

for Operations

Enclosure:

Response to questions

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l 9001140214 990109 PDR PR PDR 30 62FR.32552

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RESPONSE TO 00ESTIONS Question 1: _ Oo you expect this petition to be ruled upon in 19967 If not, can you provide a time frame as to when petition might be resolved, or do you have any. recommendations on how this process can be completed in the near future?

Response: We expect the petition to be resolved in 1996. A direct final rule is expected to be published for public comment in sarly 1997, pending Comission approval. If no significant adverse comments are received, the direct final rule will become effective. If significant adverse comments are received, the NRC will withdraw the direct final rule, address the public coments under a proposed rule, and publish a final rule. Under this situation, the rulemaking process could be lengthened by several months.

Question 2: Why is the petition now being dealt with as a " rule change" and not as an exemption from licensing as recomended by the ACMUI in October of 19957 Response: The Advisory Comittee on the Medical Uses of Isotopes (ACMUI) indicated, in the minutes of the October 1995 meeting, that it endorsed the

-wide availability of this diagnostic test and that the radioactive Jrug could be used under a general license or an exemption, whichever the NRC thought to be procedurally easier. Either option recomended by the ACMUI would require a " rule change." Since NRC regulations do not contain provisions for a medical use general license, a rule change would be needed to add such provisions. Also, under the current regulations, only physicians who are

" authorized users" (i.e., physicians who meet specific NRC training and experience requirements) or an individual under the supervision of the authorized user can administer radioactive drugs containing byprM uct material to humans. Per:::itting physicians who are not authorized users to administer radioactive drugs to humans, either through a general license or an exemption.

- represents a significant change in NRC's regulations and therefore requires a

" rule change."

Question 3: Is it possible to decrease the numt'er of days the Agreement States have to respond to the proposed rule, and/or to decrease the number of

-days the rule is available for public comment?

, Response: The coment period for Agreement State coments must be long enough to allow a thorough review of the rulemaking plan by each Agreement State.

Because this rulemaking plan is not complicated, the NRC believes that a comment period shorter than 45 days, such as 30 days, may be feasible.

Although this shortened coment period may not be sufficient for some Agreement States because of higher priority comitments, we are asking the Agreement States to provide comments on this rulemaking plan within 30 days.

The public comment period, on the other hand, cannot be decreased for this rulemaking because Executive Order 12662 of December 31, 1988, implementing the United States -' Canada Free Trade Implementation Act, requires "--- not less than 75 days before the comment due date, except where, in urgent circumstances,. delay would frustrate the achievement of a legitimate domestic

. objective." Although.the Order provides for exceptions, this rulemaking would not qualify as " urgent circumstances" since NRC regulations do not currently prohibit the use of this drug by authorized userp.

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