Byproduct material; medical use: Comprehensive quality assurance in medical use and a standard of care; withdrawn,

[Federal Register: December 2, 1998 (Volume 63, Number 231)]

[Proposed Rules]

[Page 66496]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr02de98-27]

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.

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. 98-32108Filed12-1-98; 8:45 am]

BILLING CODE 7590-01-P