[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Proposed Rules]
[Page 66496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32108]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
RIN 3150-AC42
Comprehensive Quality Assurance in Medical Use and a Standard of
Care
AGENCY: Nuclear Regulatory Commission.
ACTION: Advance notice of proposed rulemaking: Withdrawal.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is withdrawing an
advance notice of proposed rulemaking (ANPRM) that requested public
comments on questions related to comprehensive quality assurance and a
standard of care in medical uses of byproduct material. The Commission
has decided to withdraw this ANPRM because of the effective
implementation of the ``Quality Management Program and
Misadministrations'' rule and the NRC's current efforts in revising the
existing regulation for medical uses of byproduct material into a more
risk-informed and performance-based regulation.
ADDRESSES: The Commission paper, the staff requirement memoranda (SRM),
and associated documents are available for public inspection, and
copying for a fee, at the NRC Public Document Room located at 2120 L
Street NW. (Lower Level), Washington, DC 20012-7082, telephone: (202)
512-2249.
FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, telephone (301) 415-6219, e-mail jmm2@nrc.gov.
SUPPLEMENTARY INFORMATION:
On October 2, 1987, the Commission published two notices in the
Federal Register regarding medical use of byproduct material. The first
notice was the proposed rulemaking entitled ``Basic Quality Assurance
in Radiation Therapy'' (52 FR 36942), that proposed a requirement for
medical use licensees to implement some specific basic quality
assurance practices to reduce the number of therapy misadministrations
involving byproduct material. The second notice was an ANPRM entitled
``Comprehensive Quality Assurance in Medical Use and a Standard of
Care'' (52 FR 36949), that requested public comments on the extent to
which a comprehensive quality assurance program requirement was needed.
The NRC believed that this two-pronged approach to the
misadministrations problem would provide the best balance between
assuring public health and safety and avoiding inadvertent interference
in the delivery of quality medical care.
On July 25, 1991 (56 FR 34104), the NRC published a final rule
entitled ``Quality Management Program and Misadministrations'' (the QM
Rule) which was based on the above-mentioned 1987 proposed rule. During
the implementation of the final rule, the NRC decided to assess the
effectiveness of the rule and, based on the results of the assessment,
to determine the need for a rulemaking on comprehensive quality
management.
Subsequently, a Commission SRM on SECY-97-115 dated June 30, 1997,
approved subsuming several Part 35 rulemakings into one major revision
to 10 CFR Part 35 rulemaking activity. The proposed rulemaking entitled
``Medical Use of Byproduct Material,'' was published in the Federal
Register (RIN 3150-AF74 ) (August 13, 1998; 63 FR 43516). The NRC is in
the process of developing the final rule governing medical use of
byproduct material into a more risk-informed and performance-based
regulation. This overall revision includes a consideration as to
whether or not the regulation on the quality management program should
be revised to become more risk-informed and performance-based. For this
reason, the Commission is withdrawing the ANPRM.
Dated at Rockville, Maryland, this 24th day of November, 1998.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 98-32108 Filed 12-1-98; 8:45 am]
BILLING CODE 7590-01-P
