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; 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: 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.     

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 device warning letter draft pilot; availability--FDA. Notice

The Food and Drug Administration (FDA) is planning to initiate a pilot program involving the medical device industry that is a continuation of the "medical device industry initiatives." This draft pilot concerns the issuance of warning letters for quality system, premarket notification submission (510(k)), and labeling violations. This draft pilot is intended to optimize resource utilization, enhance communication between industry and FDA, and provide firms with incentives to promptly correct violations or deficiencies. The draft pilot includes eligibility criteria and procedures for the issuance of warning letters and will not be implemented until after the public comment period has expired.     

Medical devices; device tracking; new orders to manufacturers--FDA. Notice

The Food and Drug Administration (FDA) is announcing that the agency has issued new orders to manufacturers of devices that were subject to tracking. These new orders became effective on February 19, 1998, and require manufacturers to continue tracking the devices under the revised tracking provisions of the recently enacted Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA allows the agency discretion in issuing orders to manufacturers to track devices that meet certain criteria. FDA is soliciting comments on what factors should be considered in exercising its discretion in determining whether the agency should not track a particular device, even though it meets the statutory criteria. FDA specifically is requesting comments on whether there are factors that FDA should consider in exercising its discretion in releasing certain devices listed in this notice from tracking requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance that addresses device tracking under FDAMA, including the application of certain requirements under the current tracking regulations.     

Medical devices; Mammography Quality Standards Act of 1992; inspection fees--FDA. Notice

The Food and Drug Administration (FDA) is announcing the fees it will assess for inspections of mammography facilities during fiscal year 1995 (FY 95). The Mammography Quality Standards Act of 1992 (MQSA) requires FDA to assess and collect fees from mammography facilities to cover the costs of annual inspections required by the MQSA. This notice explains which facilities are subject to payment of inspection fees, provides information on the costs included in developing inspection fees, and provides information on the inspection, billing, and collection processes.     

Medical devices; Mammography Quality Standards Act of 1992; inspection fees--FDA. Notice

The Food and Drug Administration (FDA) is announcing the new fees the agency will assess for inspections of mammography facilities starting on February 13, 1998. The Mammography Quality Standards Act of 1992 (the MQSA) requires FDA to assess and collect fees from mammography facilities to cover the costs of annual inspections required by the MQSA. Because these costs have increased since inspections began in 1995, FDA is raising the fees accordingly. This notice explains which facilities are subject to payment of inspection fees, provides information on the costs included in developing inspection fees, and provides information on the inspection, billing, and collection processes. This is the first increase in inspection fees under the MQSA since the initial fee was established in 1995.     

Medical care collection or recovery--VA. Notice

In a companion document published in the "Proposed Rules" section of this issue of the Federal Register, we proposed to amend VA's medical regulations concerning collection or recovery by VA for medical care or services provided or furnished to a veteran: (i) For a non-service connected disability for which the veteran is entitled to care (or the payment of expenses of care) under a health-plan contract; (ii) For a non-service connected disability incurred incident to the veteran's employment and covered under a worker's compensation law or plan that provides reimbursement or indemnification for such care and services; or (iii) For a non-service connected disability incurred as a result of a motor vehicle accident in a State that requires automobile accident reparations insurance. The proposed rule includes methodology for establishing charges for VA medical care or services. Using this methodology, information for calculating proposed charge amounts at individual VA facilities for inpatient facility charges, skilled nursing facility/sub-acute inpatient facility charges, outpatient facility charges, and physician charges is set forth below. If this methodology were adopted subsequently as a final rule, the applicable data in this document, designed for the period August 1998 through September 1999, would be used for the period from the effective date of the final rule through September 1999. Accordingly, interested parties may wish to retain this document for future reference.     

Medical Radiation Advisory Committee; request for nominations for membership--FDA. Notice

The Food and Drug Administration (FDA) is requesting nominations for membership on the Medical Radiation Advisory Committee. There is currently one vacancy on the committee and there will be three additional vacancies on June 30, 1985.     

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.     

Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice

The Food and Drug Administration (FDA) is publishing a list of class I devices, subject to certain limitations, that will be exempt from premarket notification requirements on February 19, 1998. FDA is also publishing a list of those class I devices that FDA believes will remain subject to premarket notification requirements because they meet the new statutory criteria for premarket notification requirements. These lists do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. FDA is taking this action in order to meet a requirement of the Food and Drug Administration Modernization Act of 1997 (the FDAMA). The agency requests comments on whether the list of class I devices that will remain subject to the premarket notification requirements should be modified.     

The Safe Medical Devices Act of 1990--FDA. Notice

The Food and Drug Administration (FDA) is announcing the passage of the Safe Medical Devices Act of 1990 and FDA's initial plans for implementing its requirements. The intent of this notice is to provide a summary of the new legislation and to inform the public of FDA's plans for its implementation.     

Medical care reimbursement rates for FY 95--VA. Notice

In accordance with provisions of OMB Circular A-11 section 12.5(a), revised reimbursement rates have been established by the Department of Veterans Affairs for inpatient and outpatient medical care furnished to beneficiaries of other Federal agencies during FY 1995. These rates will be charged for such medical care provided at health care facilities under the direct jurisdiction of the Secretary on and after December 1, 1994.     

Medical and dental services fiscal year 1998--DoD. Notice

Notice is hereby given that the Deputy Chief Financial Officer in a memorandum dated September 26, 1997 established the following reimbursement rates for inpatient and outpatient medical care to be provided in FY 1998. These rates are effective October 1, 1997.     

Medical devices; humanitarian use of devices--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule amending the regulations governing humanitarian use devices (HUD's). These amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Medical care reimbursement rates for FY 92--VA. Notice

In accordance with provisions of OMB Circular A-11 section 13.5(a), revised reimbursement rates have been established by the Department of Veterans Affairs for inpatient and outpatient medical care furnished to beneficiaries of other Federal agencies during FY 1992. These rates will be charged for such medical care provided at health care facilities under the direct jurisdiction of the Secretary on and after December 1, 1991.     

Medical devices; humanitarian use of devices--FDA. Direct final rule; withdrawal

The Food and Drug Administration (FDA) published, in the Federal Register of April 17, 1998 (63 FR 19185), a direct final rule to implement the amendments to the humanitarian use devices provision of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The comment period closed July 1, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.     

Medical devices; humanitarian use of devices--FDA. Direct final rule

The Food and Drug Administration (FDA) is amending the regulations governing humanitarian use devices. These amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.