ML20198H780
| ML20198H780 | |
| Person / Time | |
|---|---|
| Issue date: | 05/20/1997 |
| From: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Burton D HOUSE OF REP. |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-014, AF70-1-14, NUDOCS 9801130393 | |
| Download: ML20198H780 (2) | |
Text
,^ g C
e nog k UNITED STATES /
-7
-j NUCLEAR REGULATORY COMMISSION l WASHINGTON, D.C. 30046 4001
%,******/g May 20, 1997 ,
The Honorable Dan Burton
~
United States Hcase of Representatives Washington, DC 20515
Dear Congressman Burton:
This letter is in response to your letter dated April 18, 1997 regarding the-petition for rulemaking submitted by Tri-Hed Specialties. Inc. (Tri-Hed).
5)ecifically, I am responding to your concerns regarding: (1) why the NRC clanged its process and decided to proceed with publication of a proposed rule instead of a direct final rule: (2) that the petition may not be completed until 1998: and (3) that the NRC com consistent with the FDA's approval. plete the petition in a timeframe Regarding your first concern, our original plan to ism a final rule unfortunately could not be followed. In accordance with Commission procedures, the draft rulemaking plan was sent to the Agreement States for review and comment. Some Agreement States indicated that permitting distribution of capsules containing carbon-14 urea under a general license could be burdensome to both Agreement States and their licensees and instead recommended exempt distribution, i.e., distribution of the capsules to persons exempt from NRC or Agreement States licensing requirements, The NRC agreed with this approach. However, distribution of the capsules by exempt distribution will result in a change to the NRC's information collection requirements on licensees who manufacture or distribute the ca)sules. The paperwork Reduction Act requires NRC to obtain approval from tie Office of Management and Budget (0MB) for the information collection before the final rule is aromulgated, and whenever OMB ap3roval is required, a proposed rule.
rather tlan a direct final rule, should Je published. Additional information collection burdens on the regulated industry have the potential for stimulating _ comment and controversy on the agency's approach. Consequently, use of a direct final rule would not be appropriate.
With respect tc your second concern. I do not expect that action on the petition will extend into 1998. The proposed rule was sent to the Commission
.on April 28, 1997, for their approval. After approval, the proposed rule will be published in the Federal Reaister for a 30-day public comment period. The actual date the final rule is comment on the proposed rule. published will depend on the extent of public Regarding your final concern. we have been working to com action in a timeframe consistent with the FDA's approval.plete However,this rulemaking if the FDA were to approve use of the capsules, the fact that NRC has not yet finalized its rule will not limit patients' access, even in rural areas, because there are about 6,000 NRC and Agreement State medical use licensees across the nation who are authorized to use the capsules under current regulations.
9901130393 990109 32552 PDR e
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The Honorable Dan Burton 2 Should you have any further concerns or questions pertaining to this issue, please do not hesitate to contact us.
Sincerely, i
/ oh
. Jos h Callan Execut 've Director for perations t
..