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: issues and request for public input--NRC. Request for public input on rule development

The U.S. Nuclear Regulatory Commission (NRC) has developed a program for revising the regulations governing the medical use of byproduct material. The decision to revise this regulation resulted from the NRC Strategic Assessment and Rebaselining Initiative (SA), a process involving identification of the direction-setting issues and associated options for the future of NRC activities. This notice describes the NRC's program for revising the medical use regulation; notifies the public of the availability of documents associated with this action on the NRC Technical Conference Forum and through the NRC Public Document Room; and solicits informal public input on development of proposed rule language and associated documents. The Commission plans to formally propose specific rulemaking text for public comment during summer of 1998.     

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.     

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--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.     

Medical administration of radiation and radioactive materials--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations to clarify that the medical administration of radiation or radioactive materials to any individual, even an individual not supposed to receive a medical administration, is regulated by the NRC's provisions governing the medical use of byproduct material rather than by the dose limits in the NRC's regulations concerning standards for protection against radiation. The rule does not represent a change in policy, but is necessary to indicate clearly that this is the NRC's policy and to clarify the relationship of NRC's regulations.     

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.     

Limited revision of fee schedules--NRC. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations to make two limited changes to its assessment of license and annual fees. The final rule assesses license fees, which are based on the full-cost method, quarterly instead of semiannually and establishes a lower tier small entity annual fee for those licensees that are small entities with relatively low annual gross receipts or supporting populations. These final amendments are intended to improve NRC financial management and further mitigate the impact of the annual fee on small licensees with relatively low annual gross receipts or supporting populations.     

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.     

Federal old-age, survivors, and disability insurance and supplemental security income for the aged, blind, and disabled; evaluating opinion evidence. Social Security Administration. Final rules

We are revising the Social Security and Supplemental Security Income (SSI) regulations concerning the evaluation of medical opinions to clarify how administrative law judges and the Appeals Council are to consider opinion evidence from State agency medical and psychological consultants, other program physicians and psychologists, and medical experts we consult in claims for disability benefits under titles II and XVI of the Social Security Act (the Act). We are also defining and clarifying several terms used in our regulations and deleting other terms.     

Measurement of the activity of radiopharmaceutical dosages: Nuclear Regulatory Commission. Proposed rule

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations on human uses of byproduct material, to require specific medical licensees to (1) Measure the total activity of each radiopharmaceutical dosage, except those containing less than 10 microcuries or a pure beta-emitting radionuclide, before it is administered to a patient; (2) verify that smaller dosages contain less than 10 microcuries; and (3) keep a record of the measurements. The assary of each radiopharmaceutical dosage before it is administered to a patient is currently required as a condition for a specific license. Measurement of the total activity of radiopharmaceutical dosage helps to protect patients from unnecessary radiation resulting from errors in labeling, calculating or dispensing dosages. The purpose of this rulemaking is: (1) To simplify licensing by replacing a condition that appears in all medical licenses with one regulation, and (2) To enhance patient radiation safety by minimizing potential misadministrations caused by not measuring the patient dosage.     

Biomedical waste disposal--Nuclear Regulatory Commission. Final rule

The NRC is amending its regulations to permit licensees greater leeway in disposing of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 (tritium) or carbon-14. These rule changes will primarily affect NRC licensed hospitals and medical research institutions. Most licensees presently dispose of these items by sending them to a radioactive waste burial ground or by obtaining special authorization from NRC for incineration or onsite burial. Under the new regulations, the licensee may dispose of specified concentrations of these materials without regard to their radioactivity. The NRC is also amending its regulations to raise the annual limits for disposal of hydrogen-3 and carbon-14 by release to the sanitary sewerage systems. The rule changes will conserve waste burial capacity that is already in short supply.     

Revision of fee schedules; 100% fee recovery, FY 1992--NRC. Final rule

The Nuclear Regulatory Commission (NRC) is amending the licensing, inspection, and annual fees charged to its applicants and licensees. The amendments are necessary to implement Public Law 101-508, signed into law on November 5, 1990, which mandates that the NRC recover approximately 100 percent of its budget authority in Fiscal Year (FY) 1992 less amounts appropriated from the Nuclear Waste Fund (NWF). The amount to be recovered for FY 1992 is approximately $492.5 million.     

Minor corrections, clarifying changes, and a minor policy change--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations to make minor corrections and clarifying changes to the NRC's 10 CFR Part 20, "Standards for Protection Against Radiation." The final rule is also intended to conform other regulations with the Commission's 1991 revised radiation protection requirements. In addition, the final rule includes a minor policy change that raises the monitoring criteria for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies. The 0.1 rem (1 mSv) in a year deep dose equivalent monitoring criterion is consistent with the public dose limit and represents a quantity more consistent with the measurement sensitivity of individual personnel dosimetry. Licensees are still required to ensure that the occupational dose limit of 0.5 rem (5 mSv) in a year is not exceeded for minors, that the dose limit of 0.5 rem (5 mSv) to an embryo/fetus due to occupational exposure of a declared pregnant woman is not exceeded during the course of the pregnancy, and that sufficient effort is made to ensure that substantial variations above a uniform monthly exposure rate for a declared pregnant woman are avoided. These changes to the threshold for monitoring exposures to radiation and radioactive material to demonstrate compliance with the limits do not change the occupational dose limits for minors or declared pregnant workers.     

Revision of fee schedules; 100% fee recovery; clarification of size standards--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the payment of annual fees to clarify the provisions that identify the size standards used to determine whether an NRC licensee would qualify as a "small entity" under the Regulatory Flexibility Act for the purpose of paying a reduced annual fee. This clarification is necessary because the size standards presented in the regulations did not clearly indicate the complete range of size standards adopted by the NRC.     

Absence and leave; sick leave. Final rule

The U.S. Office of Personnel Management is issuing final regulations on the use of sick leave and advanced sick leave for serious communicable diseases, including pandemic influenza when appropriate. We are also permitting employees to substitute up to 26 weeks of accrued or accumulated sick leave for unpaid Family and Medical Leave Act (FMLA) leave to care for a seriously injured or ill covered servicemember, as authorized under the National Defense Authorization Act for Fiscal Year 2008, including up to 30 days of advanced sick leave for this purpose. Finally, we are reorganizing the existing sick leave regulations to enhance reader understanding and administration of the program.     

Revised standards for protection against radiation; minor amendments--NRC. Final rule: minor corrective and conforming amendments

This final rule makes a number of minor corrective and conforming amendments to the NRC's revised standards for protection against radiation. The final rule is necessary to correct recently discovered errors in the text of the revised standards, to conform portions of regulatory text to the Commission's decision to defer mandatory implementation of the revised standards until 1994, and to reflect the recent OMB approval of the use of NRC Forms 4 and 5.     

Medicare, Medicaid and CLIA programs; revision of the laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs--HCFA. Final rule with comment period

This rule revises regulations for laboratories regulated under the Medicare, Medicaid and Clinical Laboratories Improvement Act of 1967 (CLIA '67) programs. The revisions recodify the regulations for these programs into a new part 493 in order to simplify administration and unify the health and safety requirements for all programs as much as possible. We will now have a single set of regulations for the three programs, with an additional subpart for the licensure procedures unique to the CLIA program. We are revising the regulations to remove outdated, obsolete and redundant requirements, make provision for new technologies and place increased reliance on outcome measures of performance. We provide for new uniform proficiency testing standards. We have also added requirements for additional specialties, such as clinical cytogenetics. We also implement the now and self-implementing provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88).