ML20217G997
| ML20217G997 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1997 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-62FR42219, RULE-PR-35 NUDOCS 9708080151 | |
| Download: ML20217G997 (9) | |
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NUCLEAR REGULATORY COMMISSION - T AUG -5 P3 t17 10 CFR Part 35 0FFICE OF SECRETARY RIN 3150-AF74 00CKETING & SERVICE trsNC'.i Medical Use of Byproduct Material:
1 lasues and Request for Public input ;
DOCKET NUMBER PROPOSED RULE PR ss AGENCY: Nuclear Regulatory Commission
((o#FRe/ oaf 9)
ACTION: Request for public input on rule development.
SUMMARY
- The U. S. Nuclear Regulatory Commission (NRC) has developed a program for revising the regulations goveming the medical use of byproduct material. The decision to revise this regulation resulted from the NRC Strategic Assessment and Rebaselining Initiative (SA), a process involving identification of the direction-setting issues and associated options for the future of NRC activities. This notice describes the NRC's program for revising the medical use regulation; notifies the public of the availability of documents associated with this action on the NRC Technical Conference Forum and through the NRC Public Document Room; and solicits informal public input on development of proposed rule language and associated documents. The Commission plans to formally propose specific rulemaking text for public coinent during the summer of 1998.
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m DATES: Public input is solicited during development of the proposed rule but, to be most helpful, should be received by March 1,1998. Comments received after this date will be considered if it is practical to do so, but the Commission only is able to ensure consideration of comments received on or before this date, i
ADDRESSES: Send written input and suggestions to Secretary, Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. Hand Deliver comments to 11555 Re:4ville Pike, Rockville, MD, between 7:30 a.m. and 4:15 p.m. on Federal workdays.
Public input may also be submitted electronically on the Intemet via NRC's Technical Conference Forum (http://techconf.llnl. gov /noframe.html). This site provides the ability to post your input as a message. For information about the Technical Conference Forum contact Mary L. Thomas at l
l (301) 415-6230; Email MLT1@nrc. gov.
1 FOR FURTHER INFORMATION CONTACT: Catherine Haney, Diano Flack, or Susanne Woods; Telephone (301) 415-6825, (301) 415-5681, or (301) 415-7267; Email CXH@NRC. GOV, DSF1@NRC. GOV, or SRW@NRC. GOV; Office of Nuclear Material Safety and Safeguards, Nuclear Regulatory Commission, Washington, DC 20555-0001.
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SUPPLEMENTARY INFORMATION:
Backaround 1The NRC has examined the issues surrounding its medical use s program in great detail during the last four years. This process started with I NRC's 1993 intemal senior management review report; continued with the 1996 independent extemal review' report by the National Acade;ny of Sciences, i:
Institute'of Medicine; arid culminated in NRC's SA process. In particular,
- j. medical oversight was addressed in the SA Direction-Setting issue Paper Number 7 (DSI 7) (released September 16,1996).
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l .in its " Staff Requirements Memorandum (SRM) COMSECY 96-057, Materiais/ Medical Oversight (DSI 7)," dated March 20,1997, the Commission
' directed'the NRC staff to revise Part 35, associated guidance documents, and, if necessary, the Commission's 1979 Medical Policy Statement. Further, the-SRM stated Vath respect to the medical program, the' Commission was not persuaded by the National Academy of Sciences, lastitute of Medicine (IOM) report that recommends that NRC should not be
= the Federal agency involved in the regulation of ionizing _
radiation in medicine. The Commission continues to believe that ,
the conclusions in the report were not substantiated and that the recommendations should not be pursued.
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e-The Commission SRM specifically directed the restructuring of Part 35 into a risk-informed, more performance-based regulation. Further, during ,
I development of the rule and associated guidance, as well as during review of l the Medical Policy Statement, the NRC staff was directed to consider the i following issues:
- 1. Focusing Part 35 on those procedures that pose the highest risk.
- 2. Regulatory oversight attematives, for diagnostic procedures, that are consistent with the lower overall risk of these procedures,
- 3. The best way to capture not only relevant safety-significant events, but also precursor events.
- 4. The need to change from the term " misadministration" to " medical event" or other comparable terrrinology.
- 5. Redesigning Part 35 so that regulatory requirements for new treatment modalities can be incorporated in a timely manner.
- 6. Revising the requirement for a quality management program (10 CFR 35.32) to bcus on those requirements that are essential for patient safety.
- 7. The viability of using or referencing available industry guidance and standards, within Part 35 and related guidance, to the extent that they meet NRC needs.
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Pronram for Revision of Part 35 ;
The June 30,1997, SRM informed the NRC staff of the Commission's approval, with comments, of the NRC staff's proposed program in SECY 97-131, Supplemental Information ori SECY 97-115, " Program for Revision of 10 CFR Part 35, ' Medical Uses of Byproduct Material,' and Associated Federal Reaister Notice," dated June 20,1997. With this approval, the NRC staff initiated development of draft language using an entirely modality-based approach. The modality approach places all requirements for
, a given type of treatment into a single section of the regulation, including: who l
-or what organization is licensed; what type of license is issued; the necessary technical requirements, such as surveys and calibration; the training and experience reouirements; the event recording and reporting requirements; and the quality improvement and management objectives. The NRC staff anticipates that the following modalities would be addressed:
(1) Low-dose unsealed materials (diagnostic nuclear medicine);
, (2) High-dose unsealed materials (nuclear medicine therapy);
-(3) Low-dose sealed source applications; (4) Teletherapy; (5) High-dose rate remote afterloaders; (6) Gamma stereotactic surgery; and (7) Emerging technologies.
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This list is not viewed as all-inclusive. - Additional categories may be L developed, depending on the breadth of the areas to be covered, and the similarity of requirements in a given area; Development of rule text altematives, including draft guidance
, documents, would be done using a govemmental working group (or groups) and steering group approach. State participants have been identified for both
. the working and steering groups and will enhance State participation in this process, I
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The NRC staff plans to solicit public input on the revision to Part 35, i
associated guidance, and the 1979 Medical Policy Statement on an informal and formal basis during the rulemaking process, it is expected that the fiist-version of the draft rule language will be available to the public on the NRC Technical Conference Forum and_through the NRC Public Document Room, in August 1997. During the development process, the NRC staff will make drafts
[. publicly available, but will need to cut off consideration of informal public input at a point approximately two to three months before providing the draft proposed rule language and associated draft documents to the Commission for approval. (Currently the draft proposed rule and associated draft documents are scheduled to be provided to the Commission in May 1998.) Public input received after that time would be considered as part of the ongoing interaction process, and as part of the comments received during the formal public comment period on the proposed rule after Commission approval. The NRC staff plans to interact with professional societies on an ongoing basis to solicit input.__ The NRC staff will conduct facilitated public meetings in the Fa af 6
1997. These meetings will be used to focus discussion on specific rule text proposals.- Discussions would also be held in meetings with the Advisory Committee on the Medical Uses of Isotopes (ACMUI) and the Organization of Agreement States in the Fall of 1997.
After Commission approval of the proposed rule language and associated documents, the proposed rule and associated draft oocuments will be published in the Federal Reoister for public comment for 75 days. The NRC staff will also make these documents available on the NRC rulemaking website. The NRC staff plans to hold two public meetings during the formal comment period to facilitate comment submittal.
Development of the final rule, associated documents, and final -
guidance will be done using a govemmental working group and stetring group.
The NRC staff will continue to make draft documents available on the NRC Technical Conference Forum, but will not be able to consider further public input on these documents, beginning approximately four months before the submission of the draft documents for Commission approval (currently scheduled for May 1999). The NRC staff plans to discuss the draft final documents with the ACMUI and the Agreement States before submitting them to the Commission.
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o Reference Information 1- Strategic Assessment Direction Setting issues Paper Number 7 is available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-0001. [ Telephone: (202) 634 3273; fax: (202) 634 3343.)
! 2. The memorai.dum " Management Review cf Existing Medical i
l Use Regulatory Program (COMIS92-026)" (dated June 16, 1993) is available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-0001. [ Telephone: (202) 634 3273; fax: (202) 634-3343.]
- 3. " Radiation in Medicine: A Need for Regulatory Reform" (1996) is available from the National Academy Press at 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055.
- 4. Summary minutes and transcripts of the ACMUI April 1997 meeting or transcripts of the May 8,1997, Commission briefing are available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room.
Washington, DC 20555-0001. [ Telephone: (202) 634-3273; fax: (202) 634-3343.)
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Transcripts of the May 8,1997, briefing are also available by intemet at http://www.nrc. gov.
- 5. ;The NRC Medical Policy Act Statement of 1979 was published in the Federal Realster, Volume 44, page 8242, on February 9, 1979.
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- 6. SECY-97115,- Program for Revision of 10 CFR Part 35, " Medical Uses ;
of Byproduct Material" and Associated Federal Reaister Notice; i SECY-97-131, Supplemental information on SECY-97-131, Supplemental Information on SECY 97-115, " Program for Revision of 10 CFR Part 35, ' Medical Uses of Byproduct Material,' and Associated Federal Reaister Notice; and the associated SRM (asted June 30, 1997) are available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC
- 20555-0001. [ Telephone: (202) 634-3273; fax: (202) 634 3343.]
Cop;es are also available on the NRC Technical Conference Forum at http://techconf.llnl. gov /noframe.html.
Dated at Rockville, Maryland, this 31st day of July,1997.
For the Nuclear Regulatory Commission.
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John,C/ Hoyle, /
SecrMary of the Commission.
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