ML20235W090
| ML20235W090 | |
| Person / Time | |
|---|---|
| Issue date: | 01/11/1989 |
| From: | Morris B NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | |
| References | |
| FRN-52FR36942, RULE-PR-35 NUDOCS 8903100489 | |
| Download: ML20235W090 (3) | |
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Quality Assurance in the Medical Use' o:M JAN 1219897 w -e comu Byproduct Material; Meeting Notice 7s *
/,\,)p@-}gpyc AGENCY: Nuclear Regulatory Commission
ACTION: Notice of meeting '
SUMMARY
- The Nuclear Regulatory Commission (NRC) has planned a public workshop with medical use licensees to discuss working. drafts of a proposed rule and a regulatory guide concerning quality assurance in the medical use of byproduct material.
DATES: The workshop will be held Monday, January 30, 1989 (for. quality assurance related to the use of radiopha rmaceutic'als ) ; and Tuesday, January 31, 1989 (for quality assurance related to the use of sealed sources for teletherapy and brachytherapy). The' workshop will begin each day at 9:00 am and end about 5:00 pm.
ADDRESS: U.S. Nuclear Regulatory Commission, Room 4B11,
- j. One White Flint North, 11555 Rockville Pike, Rockville, Maryland.
FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Regulation Development Branch, NL/S-129, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 4G2-3797.
8903100409 890111 52 36942 PDR ,_
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1 SUPPLEMENTARY INFORMATION: The NRC is proposing to amend its regulations to require its medical use licensees to develop and implement quality assurance programs designed to prevent, detect, and correct the cause of errors in the administration of byproduct material for medical use.
A proposed rule was published in the Federal Register on October 2, 1987 (52 FR 36942) which prescribed certain quality assurance procedures that the NSC believed should be incorporated in each medical aca program to prevent most human errors in the administration of byproduct material.
Public comments suggested that the prescriptive rule lacked flexibility, and might interfere virh the delivery of medical care. Instead, a performance-based rule was recommended.
Based on consideration of public comments to date, the NRC has prepared a working draft of a performance-based proposed rule. The NRC has also prepared a working draft of a regulatory guide that contains specific quality assurance procedures to meet the performance-based rule.
The purpose of the workshop is to obtain input from and have a round-table discussion with the medical use licensees on the working drafts of the performance-based rule and the regulatory guide.
The working drafts of the performance-based rule and the regulatory guide are available for inspection, and copying for a fee, at the NRC Public Document Room, 2120 L Street, Lower Level, NW., Washington, DC. The transcript of the workshop will be available by about March 1, 1989 at the NRC Public Document Room.
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CONDUCT OF THE MEETING: The workshop will be co-chaired by l Mr. John L. Telford, Section Leader, Rulemaking Section, Regulation Development Branch, Office of Nuclear Regulatory Research, and Dr. John H. Austin, Acting Chief, Medical, Academic and Commercial Use Safety Branch, Office of Material Safety and Safeguards, U.S. Nuclear Regulatory i Commission. The meeting will be conducted in a manner that l will facilitate the orderly conduct of business.
The following procedures apply to public participation in the meeting:
- 1. At the meeting, questions or statements from attendees other than participants (i.e., medical use licensees and NRC staff) will be entertained as time permits. I
- 2. Seating for the public will be on a first come-first served basis.
Dated at Rockville MD, this 11 th day of January , 19g9, For the Nuclear Regulatory Commission.
! / hl );'/m v Bill M. Morris, Director Division of Regulatory Applications Office of Nuclear Regulatory Research l
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