[Federal Register Volume 59, Number 80 (Tuesday, April 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9997]
[[Page Unknown]]
[Federal Register: April 26, 1994]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
Advisory Committee on Medical Uses of Isotopes: Meeting Notice
agency: Nuclear Regulatory Commission.
action: Notice of meeting.
-----------------------------------------------------------------------
summary: The Nuclear Regulatory Commission will convene its next
regular meeting of the Advisory Committee on Medical Uses of Isotopes
(ACMUI) on May 19 and 20, 1994. Topics of discussion will include: A
discussion of the possible need for the inclusion of Quality Assurance
requirements in 10 CFR 35.400, use of sources for brachytherapy; a
presentation by the National Academy of Science; a discussion of the
NRC NUREG: ``Management of Radioactive Material Programs at Medical
Facilities;'' a discussion of inadvertent administration to the wrong
patient; and the discussion of American Osteopathic Board of Radiology
Certification as acceptable training for radiopharmaceutical therapy.
The committee will draft ACMUI Bylaws and will prepare for the
Commission Briefing scheduled for June 22, 1994.
In addition, the NRC staff will provide status reports on proposed
rulemaking, including: ``Proposed Amendments to 10 CFR 35.75, Release
of patients containing radiopharmaceuticals or permanent implants'';
``Proposed Amendments on Preparation, Transfer, and Use of Byproduct
Material for Medical Use''; and ``Administration of Byproduct Material
or Radiation from Byproduct Material to Patients Who May Be Pregnant or
Nursing.'' The NRC staff will also provide a status report on issues
regarding the Abnormal Occurrence (AO) report to Congress.
dates: The meeting will begin at 8 a.m., on May 19 and 20, 1994.
addresses: The Holiday Inn, Bethesda, 8120 Wisconsin Avenue, Bethesda,
Maryland 20814.
for further information contact: Larry W. Camper, Office of Nuclear
Material Safety and Safeguards, MS 6-H-3, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, Telephone 301-504-3417.
supplementary information: The following information is provided
concerning the topics to be discussed at the meeting:
Efficacy of Quality Assurance Requirements for Brachytherapy: The
NRC staff will provide a discussion of the possible need for QA
requirements to be included in 10 CFR 35.400, use of sources for
brachytherapy, similar to those included in 10 CFR 35.600 for
teletherapy.
National Academy of Science Presentation: The National Academy of
Science will brief the ACMUI on the progress of the contract to perform
an independent review of the NRC's medical use regulatory program.
NUREG: ``Management of Radioactive Material Programs at Medical
Facilities.'': The NRC staff will discuss the progress on the Draft
NUREG since the last ACMUI meeting. Included will be the comments
received during the recent peer review, and plans for publication.
Inadvertent administration to the wrong patient: The staff will
seek comments regarding reporting of the inadvertent administration of
byproduct material to the wrong patient or individual when the dose
does not meet the criteria for a misadministration.
American Osteopathic Board of Radiology Certification (AOBR): The
staff will provide the AOBR certification requirements for ACMUI review
to determine ACMUI's recommendation as to whether AOBR certified
individuals meet the criteria specified in 10 CFR 35.930.
Status reports on proposed rulemaking:
Proposed Amendments to 10 CFR 35.75, Release of patients containing
radiopharmaceuticals or permanent implants: The staff will provide a
status report regarding proposed rulemaking in response to three
petitions for rulemaking, one from Carol Marcus, M.D. (February 6,
1991); and two from the American College of Nuclear Medicine (January
14, 1992, and April 21, 1992), regarding criteria for the release of
patients administered byproduct material.
Proposed Amendments on Preparation, Transfer, and Use of Byproduct
Material for Medical Use: In June 1989, the American College of Nuclear
Physicians and Society of Nuclear Medicine (ACNP/SNM) filed a petition
with NRC addressing five issues relating to the preparation and use of
radiopharmaceuticals. A proposed rule was published for public comment
(58 FR 33396; June 17, 1993). The staff has considered comments on the
proposed rule and expects to submit the final rule to the Commission
for approval by June 1994.
Administration of Byproduct Material or Radiation from Byproduct
Material to Patients Who May Be Pregnant or Nursing; Pregnancy and
Breast-feeding: The staff will provide a status report on issues and
recommendations concerning unintended radiation doses or dosages to an
embryo, fetus, or nursing infant, resulting from administration of
radiopharmaceuticals or radiation to pregnant or breast-feeding
patients.
Abnormal Occurrence Criteria: The staff will provide a status
report regarding the proposed revision of criteria for reporting
medical misadministrations as abnormal occurrences.
Conduct of the Meeting
Barry Siegel, M.D., will chair the meeting. Dr. Siegel will conduct
the meeting in a manner that will facilitate the orderly conduct of
business. The following procedures apply to public participation in the
meeting:
1. Persons who wish to provide a written statement should submit a
reproducible copy to Larry W. Camper (address listed above). Comments
must be received by May 13, 1994, to ensure consideration at the
meeting. The transcript of the meeting will be kept open until May 27,
1994, for inclusion of written comments.
2. Persons who wish to make oral statements should inform Mr.
Camper, in writing, by May 9, 1994. Statements must pertain to the
topics on the agenda for the meeting. The Chairman will rule on
requests to make oral statements. Members of the public will be
permitted to make oral statements if time permits. Permission to make
oral statements will be based on the order in which requests are
received. In general, oral statements will be limited to approximately
5 minutes. Oral statements must be supplemented by detailed written
statements, for the record. Rulings on who may speak, the order of
presentation, and time allotments may be obtained by calling Mr.
Camper, 301-504-3417, between 9 a.m. and 5 p.m. EDT, on May 16, 1994.
3. At the meeting, questions from attendees other than committee
members, NRC consultants, and NRC staff will be permitted at the
discretion of the Chairman.
4. The transcript, minutes of the meeting, and written comments
will be available for inspection, and copying, for a fee at the NRC
Public Document Room, 2120 L Street NW, Lower Level, Washington, DC
20555, on or about May 30, 1994.
5. Seating for the public will be on a first-come, first-served
basis.
This meeting will be held in accordance with the Atomic Energy Act
of 1954, as amended (primarily Section 161a); the Federal Advisory Act
(5 U.S.C. App.); and the Commission's regulations in title 10, Code of
Federal Regulations, Part 7.
Dated: April 20, 1994.
John C. Hoyle,
Advisory Committee Management Officer.
[FR Doc. 94-9997 Filed 4-25-94; 8:45 am]
BILLING CODE 7590-01-M
