Medical use of byproduct material; policy statement, revision. Nuclear Regulatory Commission. Final policy statement; revision

The Nuclear Regulatory Commission (NRC) is revising its 1979 policy statement on the medical use of byproduct material. These revisions are one component of the Commission's overall program for revising its regulatory framework for medical use, including its regulations that govern the medical use of byproduct material. The overall goals of this program are to focus NRC regulation of medical use on those medical procedures that pose the highest risk and to structure its regulations to be risk-informed and more performance-based, consistent with NRC's "Strategic Plan for Fiscal Year 1997-Fiscal Year 2002." The policy informs NRC licensees, other Federal and State agencies, and the public of the Commission's general intentions in regulating the medical use of byproduct material.     

Medical use of byproduct material; draft policy statement--NRC. draft policy statement

The Nuclear Regulatory Commission (NRC) is proposing, for formal comment, revisions of its 1979 policy statement on the medical use of byproduct material. These proposed revisions are one component of the Commission's overall program, as previously announced in the Federal Register, for revising its regulatory framework for medical use, including its regulations that govern the medical use of byproduct material. The overall goals of this program are to focus NRC regulation of medical use on those medical procedures that pose the highest risk and to structure its regulations to be risk-informed and performance-based, where appropriate, consistent with NRC's "Strategic Plan for Fiscal Year 1970 Fiscal Year 2002".     

Medical use of byproduct material; proposed revision--NRC. Proposal rule

The Nuclear Regulatory Commission (NRC) is proposing a revision of its regulations governing the medical use of byproduct material. The proposed rule is one component of the Commission's overall program for revising its regulatory framework for medical use. The overall goals of this program are to focus NRC's regulations on those medical procedures that pose the highest risk to workers, patients, and the public, and to structure its regulations to be risk-informed and more performance-based, consistent with the NRC's "Strategic Plan for Fiscal Year 1997-Fiscal Year 2002". A notice in this issue of the Federal Register announcing the Commission's proposed revision of its 1979 "Medical use Policy Statement" for public comment is published elsewhere.     

Medical use of byproduct material; public meetings--NRC. Notice of public meetings

The Nuclear Regulatory Commission has developed a proposed rulemaking for a comprehensive revision of its regulations governing the medical use of byproduct material in 10 CFR Part 35, "Medical Use of Byproduct Material," and a proposed revision of its 1979 Medical Use Policy Statement (MPS). Throughout the development of the proposed rule and MPS, the Commission solicited input from the various interests that may be affected by these proposed revisions. The Commission now plans to solicit comments on the proposed rule and MPS through two mechanisms--publishing the documents in the Federal Register for public comment (scheduled for August 1998); and convening three facilitated public meetings, during the public comment period, to discuss the Commission's proposed resolution of the major issues. The public meetings will be held in San Francisco, California, on August 19-20, 1998; in Kansas City, Missouri, on September 16-17, 1998; and in Rockville, Maryland, on October 21-22, 1998. All meetings will be open to the public. Francis X. Cameron, Special Counsel for Public Liaison, in the Commission's Office of the General Counsel, will be the convener and facilitator for the meetings.     

License terms for medical use licenses--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses. License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years. The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing process.     

Standards for protection against radiation--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is revising its standards for protection against ionizing radiation. This action is necessary to incorporate updated scientific information and to reflect changes in the basic philosophy of radiation protection. The revision conforms the Commission's regulations to the Presidential Radiation Protection Guidance to Federal Agencies for Occupational Exposure and to recommendations of national and international radiation protection organizations.     

Quality management program and misadministrations--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending regulations governing therapeutic administrations of byproduct material and certain uses of radioactive sodium iodide to require implementation of a quality management program to provide high confidence that the byproduct material or radiation from byproduct material will be administered as directed by an authorized user physician. The Commission believes this performance-based amendment will result in enhanced patient safety in a cost-effective manner while allowing the flexibility necessary to minimize intrusion into medical judgments. This amendment also modifies the notification, reporting, and recordkeeping requirements related to the quality management program and misadministrations.     

Standards for protection against radiation; extension of implementation date--NRC. Final rule

The Nuclear Regulatory Commission (NRC) is extending the implementation date for its revised standards for protection against radiation and making a conforming change to its regulation. See SUPPLEMENTARY INFORMATION for specific regulatory parts affected. This rule extends the date by which NRC licensees are required to implement the revised standards for protection against radiation to January 1, 1994. The 1-year extension provides licensees additional time to examine and implement the regulatory guidance developed to support the rule. It also establishes a concurrent implementation date for NRC licensees and Agreement State licensees.     

License term for medical use licenses--NRC. Proposed rule

The U.S. Nuclear Regulatory Commission is proposing to amend 10 CFR part 35 to eliminate the five-year term limit for medical use licenses in 10 CFR 35.18. License terms for licenses issued pursuant to part 35 would be set, by policy up to ten years, as are the license terms for other materials licenses. The NRC would issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. The amendment would reduce the administrative burden of license renewals for both NRC and licensees, and would support NRC's goal of streamlining the licensing process.     

Open access to public documents – More secrecy,less transparency!

Prospects are grim for greater access to public documents. The recent initiatives of the Council of Europe to enact a new international convention on access to public documents and recent proposal by the European Commission to revise the law on public access would actually narrow the right of access. The proposed laws would allow governments and the EU Commission to increase its discretionary power to control the flow of information. The draft CoE Convention sets an overly-low standard and restricts information held in electronic databases if the information is not “easily retrievable” or does not “logically belong together”. Similarly, the proposed amendments to the EU Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents would exclude access to documents that do not appear on a register. This would give the EU Commission a wide discretion to share documents informally with a limited number of people, such as interest groups. The Commission's proposal would relieve the EU institutions of its current obligation to show concretely the harm that would occur as a result of disclosure when refusing access to documents. The new proposal has been criticised for subordinating transparency rules to data legislation. The proposals initiated under the Swedish leadership would be a step backwards for transparency.     

The development of technical and spectrum requirements for meeting federal, state and local public safety agency communication requirements through the year 2010, establishment of rules and requirements for priority access service--FCC. Proposed rule

The federal Communications Commission (Commission) adopted a Third Notice of Proposed Rule Making ("Third Notice") contemporaneously with a First Report and Order ("First Report") that is summarized elsewhere in this edition of the Federal Register. By its Third Notice, the Commission makes a range of proposals and seeks comment relating to public safety communications in the 746-806 MHz band ("700 MHz band") and in general. The Commission invites comment on how to license the 8.8 megahertz of 700 MHz band spectrum designated as reserved in the First Report and on whether to directly license each state or use a regional planning process to administer the nationwide interoperability frequencies (2.6 MHz of spectrum designated in the First Report) pursuant to the national interoperability plan to be established by the National Coordination Committee. The Third Notice also discusses protection requirements for the Global Navigation Satellite Systems and offers proposals to facilitate use of nationwide interoperability in public safety bands below 512 MHz. Finally, because many of the automated and intelligent machines and systems on which public safety entities depend for their operations were not designed to take into account the date change that will occur on January 1, 2000, the Commission also seeks comment on how best to ascertain the extent, reach, and effectiveness of Year 2000 compliance initiatives that have been or are being undertaken by public safety entities, to better understand the nature of the Year 2000 problem and the potential risks posed to public safety communications networks. This action addresses an urgent need for additional public safety radio spectrum and the need for nationwide interoperability among local, state, and federal entities. By this action, the Commission also takes additional steps toward achieving its goals of developing a flexible regulatory framework to meet vital current and future public safety communications needs and ensuring that sufficient spectrum to accommodate efficient, effective telecommunications facilities and services will be available to satisfy public safety communications needs into the 21st century.     

Exempt distribution of a radioactive drug containing one microcurie of carbon-14 urea--NRC. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations to permit NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 urea to any person for "in vivo" diagnostic use. The NRC has determined that the radioactive component of such a drug in capsule form presents an insignificant radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. This amendment makes the drug more widely available and reduces costs to patients, insurers, and the health care industry. This action grants a petition for rulemaking (PRM-35-12) from Tri-Med Specialties, Inc. and completes action on the petition.     

Consideration of potassium iodide in emergency plans. Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its emergency planning regulations governing the domestic licensing of production and utilization facilities. The final rule requires that consideration be given to including potassium iodide (KI) as a protective measure for the general public that would supplement sheltering and evacuation. KI would help prevent thyroid cancers in the unlikely event of a major release of radioactivity from a nuclear power plant. The final rule responds to petitions for rulemaking (PRM 50-63 and PRM 50-63A) submitted by Mr. Peter G. Crane concerning the use of KI in emergency plans.     

Institutional Radiation Safety Committee--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations regarding hospitals licensed to use radioactive byproduct material for human applications. Currently, such a license requires that the hospital have a Medical Isotopes Committee to review clinical aspects of the use of radioactive materials within the hospital. The amendment requires instead a Radiation Safety Committee with a simplified membership that will focus on the radiation safety of workers and the general public. The rule change acknowledges the Food and Drug Administration's role in regulating the safety and effectiveness of radioactive drugs with respect to the patient. The membership of the new Radiation Safety Committee will include the hospital management and the nursing staff in decisions affecting radiation safety at the hospital and will be easier for smaller hospitals to recruit.     

Revised medical criteria for evaluating visual disorders. Final rules

We are revising the criteria in the Listing of Impairments (the listings) that we use to evaluate claims involving visual disorders. We apply these criteria when you claim benefits based on disability under title II and title XVI of the Social Security Act (the Act). The revisions reflect our program experience and advances in medical knowledge, treatment, and methods of evaluating visual disorders.     

Medical devices; general hospital and personal use devices; classification of the filtering facepiece respirator for use by the general public in public health medical emergencies. Final rule

The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and is specifying what those special controls are. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies." This guidance document will serve as one of the special controls, along with certification of the respirator by the National Institute for Occupational Safety and Health (NIOSH) in accordance with its regulations for non-powered air-purifying particulate respirators, found in 42 CFR part 84, as specified in the classification regulation.     

Revised medical criteria for evaluating endocrine disorders. Final rules

We are revising the criteria in the Listing of Impairments (the listings) that we use to evaluate claims under titles II and XVI of the Social Security Act (Act) involving endocrine disorders in adults and children. The revisions reflect our adjudicative experience, advances in medical knowledge, information from medical experts, and comments we received from the public in response to an advance notice of proposed rulemaking (ANPRM), a notice of proposed rulemaking (NPRM), and at an outreach policy conference.     

The development of technical and spectrum requirements for meeting federal, state and local public safety agency communication requirements through the year 2010, establishment of rules and requirements for priority access service--FCC. Final rule

The Federal Communications Commission (Commission) adopted a First Report and Order ("First Report") contemporaneously with a Third Notice of Proposed Rulemaking that is summarized elsewhere in this edition of the Federal Register. In the First Report, the Commission amends its rules relating to public safety communications in the 764-806 MHz band ("700 MHz band") that the Commission previously reallocated for public safety services and in general. This action commences the process of assigning licenses for frequencies in the 700 MHz band and addresses an urgent need for additional public safety radio spectrum and the need for nationwide interoperability among local, state, and federal entities. By this action, the Commission also takes additional steps toward achieving its goals of developing a flexible regulatory framework to meet vital current and future public safety communications needs and ensuring that sufficient spectrum to accommodate efficient, effective telecommunications facilities and services will be available to satisfy public safety communications needs into the 21st century.     

Establishment of a public docket for medical device/radiological health policy statements and operating procedure guides--FDA. Notice

The Food and Drug Administration (FDA) is announcing that it is establishing a public docket for policy speeches, policy statements, and standard operating procedure guides pertaining to product evaluation and regulatory enforcement for its medical device and radiological health programs. The docket will operate on a 1-year trial basis and will serve both as a repository for critical policy documents generated by the Center for Devices and Radiological Health (CDRH) and as a public display mechanism for access by representatives of the industry and other interested persons. This action is one element of an overall communications initiative to ensure uniform and timely access to important information.