Quality standards and certification requirements for mammography facilities--FDA. Interim rule with request for comments

The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (the MQSA), which requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This rule establishes requirements for certification of mammography facilities, including quality standards for mammography. This action is being taken to assure safe, accurate, and reliable mammography on a nationwide basis. The agency requests comments on the contents of this document.     

Requirements for accrediting bodies of mammography facilities--FDA. Interim rule with request for comments

The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (MQSA), which requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accrediting bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. This rule establishes procedures for application to FDA for approval as an accrediting body and requirements and responsibilities of such bodies. This action is being taken to assure adequate and consistent evaluation of mammography facilities on a nationwide level and to help assure their compliance with quality standards. The agency requests comments on the contents of this document.     

State certification of mammography facilities. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments implement the "States as Certifiers" (SAC) provisions of the Mammography Quality Standards Act of 1992 (MQSA). These amendments permit FDA to authorize individual States to certify mammography facilities, conduct facility inspections, enforce the MQSA quality standards, and administer other related functions. The amendments establish the standards to be met by States receiving this authority. They also establish procedures for application, approval, evaluation, and withdrawal of approval of States as certification agencies. FDA retains oversight responsibility for the activities of the States to which this authority is given. Mammography facilities certified by those States must continue to meet the quality standards established by FDA for mammography facilities nationwide.     

Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1; availability. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1." The final regulations implementing the Mammography Quality Standards Act of 1992 (the MQSA) will become effective April 28, 1999, and will replace the interim regulations which, under the MQSA, currently regulate mammography facilities. The guidance is intended to assist facilities and their personnel to meet the MQSA final regulations.     

Medicare program; Medicare coverage of screening mammography--HCFA. Final rule

This final rule revises interim final regulations on Medicare coverage of screening mammography that were published in the Federal Register on December 31, 1990 (55 FR 53510). Those regulations implemented section 4163 of the Omnibus Budget Reconciliation Act of 1990, setting forth payment limitations and conditions for coverage of screening mammography. The conditions consist of quality standards to ensure the safety and accuracy of screening mammography services performed by qualified physicians and other suppliers of these services. As a result of the implementation of the Mammography Quality Standards Act of 1992 (MQSA) by the Food and Drug Administration (FDA), we are conforming the conditions for coverage to the applicable FDA certification requirements that all Medicare suppliers of services must meet effective October 1, 1994. The revisions in this final rule also respond to certain comments we received on the interim final rule published on December 31, 1990; they provide clarification of certain of its provisions; and they establish conditions for coverage of diagnostic mammography that are similar to those we have established for screening mammography. In addition, this final rule reflects changes resulting from the final rule on the fee schedule for physicians' services, which was published in the Federal Register on December 2, 1993 (58 FR 63626).     

Quality mammography standards--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. Amendments are being made to the requirements for accreditation bodies; procedures for facility certification; and quality standards for mammography personnel, equipment and practices, including quality assurance. This action is being taken to provide increased assurance of adequate and consistent evaluation of mammography facilities on a nationwide level and compliance of the facilities with quality standards. It also carries out the intent of Congress that FDA replace the existing interim rules with more comprehensive final regulations.     

Medicare program; Medicare coverage of screening mammography--HCFA. Interim final rule with comment

This interim final rule implements section 4163 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508), which provides limited coverage for screening mammography services. It amends current Medicare regulations to set forth payment limitations and conditions for coverage of screening mammography. The conditions consist of quality standards to assure the safety and accuracy of screening mammography services performed by qualified physicians and other suppliers of these services.     

The hazardous waste management system--Environmental Protection Agency. Interim final amendments to interim final and final rules

The Resource Conservation and Recovery Act (RCRA) requires that EPA set regulatory standards for all facilities which treat, store, or dispose of hazardous waste. In partial implementation of its requirement, on January 23, 1981, EPA set regulatory standards for incinerators that burn hazardous waste. These regulations were issued as "interim final," which means that, although they were issued in final form, the Agency invited public comment on them with a view to future amendment. Today, EPA is amending, on an interim final basis, certain of its regulations applicable to hazardous waste incineration facilities. Today's amendments include revisions to: the general standards for permitting hazardous waste incinerators (Part 264, Subpart O), published in the Federal Register on January 23, 1981; the interim status standards for hazardous waste incinerators (Part 265, Subpart O), revised on January 23, 1981; and the consolidated permit requirements for incinerators (Part 122), published on May 19, 1980 and January 23, 1981.U     

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 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.     

Quality mammography standards--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing mammography that published in a document entitled "Quality Mammography Standards." The purpose of these amendments is to eliminate a conflict between the mammography regulations, which must be followed by all facilities performing mammography, and FDA's Electronic Product Radiation Control (EPRC) performance standards, which establish radiation safety performance requirements for x-ray units, including mammographic systems.     

Funding of health-related facilities and other projects under the Public Works and Development Facilities Program--Economic Development Administration. Interim rule

This interim rule modifies two regulations setting forth requirements for funding certain types of projects under the Public Works and Development Facilities Program. One regulation is amended to clarify its scope by noting that its requirements apply to Public Works Impact Program projects. The other regulation is amended to tighten its standards relating to economic impact and to specify that projects involving health-related facilities must be reviewed and approved by the Department of Health and Human Services and, if appropriate, the State Health Planning and Development Agency. In addition, a third regulation regarding project modification is amended to clarify the scope of one provision.     

Medicare program; Medicare and laboratory certification program; enforcement procedures for laboratories--HCFA. Final rule

These regulations set forth the rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. These include the principal sanctions of suspending, limiting, or revoking the laboratory's certificate issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and cancelling the laboratory's approval to receive Medicare payment for its services, and the alternative sanctions that may be imposed instead of or before the principal sanctions. These amendments are necessary to conform HCFA regulations to changes made in the law by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and the 1988 amendments to section 353 of the Public Health Service Act (PHS Act). The latter are commonly referred to as "CLIA 88". The purpose of the amendments is to ensure that functioning laboratories are capable of providing accurate and reliable test results and that the health of individuals served by the laboratory and that of the general public is not adversely affected by laboratory operations and by testing procedures that do not meet the standards set forth in other subparts of part 493 of the HCFA regulations.     

Presumptions of service connection for diseases associated with service involving detention or internment as a prisoner of war. Affirmation of interim final rule as final rule

This document affirms as final, without change, an interim final rule that established presumptions of service connection for atherosclerotic heart disease, hypertensive vascular disease, and stroke in former prisoners of war; set forth guidelines to govern future actions by the Department of Veterans Affairs (VA) to establish presumptions of service connection for other diseases associated with service involving detention or internment as a prisoner of war; and revised VA's regulations to conform to statutory changes made by the Veterans Benefits Act of 2003.     

Federal employees health benefits program; limitation on inpatient hospital charges and FEHB program payments--OPM. Final rule

The Office of Personnel Management (OPM) is issuing final regulations that implement section 7002(f) of the Omnibus Budget Reconciliation Act of 1990. The law sets a limit on the charges and Federal Employees Health Benefits Program (FEHBP) benefit payments for certain inpatient hospital services received by a retired enrolled individual. These regulations finalize interim regulations that defined a retired enrolled individual and set forth the circumstances under which the limit on charges and FEHBP benefit payments take effect.     

Medicare program; changes to the Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule

The purpose of this final rule is to set forth limited changes to the Medicare+Choice regulations published in our June 26, 1998 interim final rule (63 FR 34968). Those regulations implemented section 4001 of the Balanced Budget Act of 1997 (BBA), which established the Medicare+Choice (M+C) program. This final rule addresses selected issues raised by commenters on the June 26, 1998 interim final rule where we have identified the need for changes or where we believe that clarifications are needed as soon as possible. Among these issues are provider participation procedures, beneficiary enrollment options, and several access-related issues, including initial care assessment requirements, notification requirements when specialists are terminated from an M+C plan, and several coordination of care requirements.     

Medical devices; performance standard for diagnostic x-ray systems; amendment. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Final rule

The Food and Drug Administration (FDA) is issuing a final rule that amends the diagnostic x-ray systems performance standard for dental panoramic systems and mammography systems. This rule exempts panoramic dental x-ray units from the requirement that they be manufactured with exposure timers that automatically reset to zero upon premature termination of an exposure. Removing the automatic timer reset requirement will not compromise the quality of the radiographic image and will protect patients from being subject to unnecessary radiation due to repeat radiographs. This action also is intended to align the performance standard for mammography systems with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (the MQSA).     

Medicare and Medicaid programs; hospital conditions of participation: patients' rights. Final rule

This final rule finalizes the Patients' Rights Condition of Participation (CoP) which is applicable to all Medicare- and Medicaid-participating hospitals and contains standards that ensure minimum protections of each patient's physical and emotional health and safety. It responds to comments on the following standards presented in the July 2, 1999 interim final rule: Notice of rights; exercise of rights; privacy and safety; confidentiality of patient records; restraint for acute medical and surgical care; and seclusion and restraints for behavior management. As a result of comments received, we have revised the standards regarding restraint and seclusion and set forth standards regarding staff training and death reporting.     

The Family and Medical Leave Act of 1993--Wage and Hour Division, Department of Labor. Interim final rule; request for comments

This document contains interim regulations implementing the Family and Medical Leave Act of 1993 called ("FMLA" or "the Act"). The Act is effective on August 5, 1993, six months from the date of its enactment. Where a collective bargaining agreement is in effect on August 5, 1993, the Act is effective when the collective bargaining agreement terminates or February 5, 1994, whichever is earlier. The purpose of these regulations is to set forth the requirements of Title I and Title IV of the Act. Title I applies to covered private employers and public agencies (except for most of the Federal Government, which is governed by Title II). Title IV of the Act primarily concerns the relationship between FMLA and other laws, as well as collective bargaining agreements and other employer plans and programs.