[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 [email protected].

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]
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