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.     

Quality standards and certification requirements for mammography facilities--FDA. Interim rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing regulations to implement the Mammography Quality Standards Act of 1992 (MQSA). The MQSA 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 regulation, which amends two previously published interim rules, modifies and adds to the definitions previously set forth. In addition, the interim rule provides a mechanism to request permission to meet alternative requirements, other than those previously set forth, if the proposed alternative requirement is at least as effective as the existing quality standards in achieving quality mammography services for women.     

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.     

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).     

Medicare program; Medicare coverage of screening mammography; correction--HCFA. Correcting amendment

This document corrects a technical error that appeared in the final regulations published in the Federal Register on September 30, 1994 (59 FR 49826). Those regulations, in part, established conditions for coverage of diagnostic mammography that are similar to those we had established for screening mammography. This correcting amendment restates the applicability of diagnostic mammography to men as well as to women.     

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.     

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.     

Quality mammography standards; correcting amendment--FDA. Final rule; correcting amendment

The Food and Drug Administration (FDA) is correcting its regulations governing mammography, published in a document entitled "Quality Mammography Standards" that appeared in the Federal Register of October 28, 1997. The regulations are effective April 28, 1999; except section 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B), which become effective October 28, 2002. The October 28, 1997, document was published with some inadvertent typographical errors. Some of those errors were corrected in a document entitled "Quality Mammography Standards; Correction" that appeared in the Federal Register of November 10, 1997, but additional typographical errors occurred in the publication of this document. In addition, since November 10, 1997, certain other problems with the text of the regulations have been identified that, if uncorrected, would lead to unforeseen and undesirable consequences. This document corrects those errors.     

Quality mammography standards. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Direct final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments are intended to incorporate changes required by the Mammography Quality Standards Reauthorization Act (MQSRA). 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 that the agency withdraws the direct final rule.     

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).     

Medical devices; performance standards for dental and mammographic X-ray devices; amendment--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to exempt panoramic dental x-ray units from the requirement that they be manufactured with exposure timers which 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 subjected to unnecessary radiation due to repeat radiographs. FDA also proposes five changes to align the performance standard with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (MQSA). First, the agency proposes to remove any reference to the use of equipment not specifically designed for mammography from the performance requirements for mammography equipment. Second, FDA proposes that the mammographic field alignment requirements restrict the irradiation beam to less than 2 percent of the source-image receptor distance (SID) beyond the image receptor edges. Third, it is proposed that the definition of an image receptor support device be amended to specify that it must provide a primary protective barrier for any orientation of the x-ray tube and image receptor support device assembly. Fourth, it is proposed that the useful beam must be confined to the dimensions of the primary barrier provided by the image receptor support device (except on the chest wall side). Fifth, it is proposed that exposures not be permitted without the primary barrier in place.     

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.     

Respiratory protective devices--NIOSH. Notice of proposed rulemaking

This proposed rule addresses NIOSH's and the Department of Labor/Mine Safety and Health Administration's (MSHA) certification requirements for respiratory protective devices. Specifically, the proposal would replace existing MSHA regulations with new public health regulations, while also upgrading current testing requirements for particulate filters. This action is the first of a series of modulates which will, over the next several years, upgrade current respirator requirements. This modular approach will allow improvements to be implemented on a priority basis as well as facilitate adaptation to new requirements by the manufacturers and users of respirators. Except for the particulate-filter requirements, most requirements of existing regulations would be incorporated into the new regulations without change. The proposed testing requirements for particulate filters would significantly improve the current approach to evaluating the effectiveness of an air-purifying respirator's filter to remove toxic particulates from the ambient air, updating existing provisions to be consistent with two decades of advances in respiratory protection technology. The certification of air-purifying respirators under these proposed requirements would also enable respirator users to select from a broader range of certified respirators that meet the current performance criteria recommended by CDC for respiratory devices used in health-care settings for protection against Mycobacterium tuberculosis, the infectious agent that causes tuberculosis (TB). This Notice also announces an informal public meeting on the proposed rule, as indicated below. Elsewhere in this issue of the Federal Register, MSHA is publishing a proposal to remove existing regulations at 30 CFR part 11, which would be made obsolete by a final rule resulting from this proposed rule.     

Federal employees health benefits program: miscellaneous changes--Office of Personnel Management. Final rulemaking

The Office of Personnel Management (OPM) is issuing final regulations which implement a number of miscellaneous changes to the Federal Employees Health Benefits (FEHB) Program regulations. The regulations will improve the administration of the FEHB Program and result in better service to enrollees.     

Medical devices; procedures for premarket notification, premarket approval, classification, performance standards establishment, banning devices, and availability of regulatory hearings--FDA. Final rule

The Food and Drug Administration (FDA) is amending the medical device regulations governing procedures for premarket notification, premarket approval, classification, performance standards development, banning devices, and availability of regulatory hearings to conform these procedures to applicable provisions of the Safe Medical Devices Act of 1990 (the SMDA). Its publication promotes clarity and certainty to regulated industry and thus fosters economic growth by correcting the provisions in FDA's existing regulations to conform them to the now-governing statutory provisions.     

行政立法效益评估——美国的做法及启示

行政立法效益评估是美国自上世纪70年代以后逐渐发展起来的通过运用成本——收益分析或成本——效果分析方法对行政立法进行评估以改善行政立法质量的一种制度。目前行政立法效益评估已经成为美国重要行政立法的必经程序之一,有效地促进了管制政策制定的科学性和合理性,对于提升行政效能起到了良好的推动作用。本文从美国行政立法效益评估兴起的背景、主要做法及其对我国行政效能监督的启示三个方面对美国行政立法效益评估进行了阐述,文章认为美国行政立法效益评估中立法谦抑的指导思想,集中统一的审查机制和科学合理的评估方法对于我国行政效能监督建设最具借鉴意义。     

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.