Miscellaneous amendments to the HHS procurement regulations--HHS. Final rule

The Office of the Secretary, Department of Health and Human Services is amending its procurement regulations by revising and updating the general provisions for use in fixed price and cost-reimbursement type contracts (HHS-314,-315,-315A, and-316) and related miscellaneous amendments. The revisions will result in the consolidation of all additions, removals and revisions to the general provisions. The effect of the amendment will be the updating of the Department's general provisions.     

Service dogs. Final rule

The Department of Veterans Affairs (VA) amends its regulations concerning veterans in need of service dogs. Under this final rule, VA will provide to veterans with visual, hearing, or mobility impairments benefits to support the use of a service dog as part of the management of such impairments. The benefits include assistance with veterinary care, travel benefits associated with obtaining and training a dog, and the provision, maintenance, and replacement of hardware required for the dog to perform the tasks necessary to assist such veterans.     

Postmarket surveillance. Final rule

The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health.     

Dental conditions. Final rule

The Department of Veterans Affairs (VA) adopts as a final rule the proposal to amend its adjudication regulations regarding service connection of dental conditions for treatment purposes. This amendment clarifies that principles governing determinations by VA's Veterans Benefits Administration (VBA) for service connection of dental conditions for the purpose of establishing eligibility for dental treatment by VA's Veterans Health Administration (VHA), apply only when VHA requests information or a rating from VBA for those purposes. This amendment also clarifies existing regulatory provisions and reflects the respective responsibilities of VHA and VBA in determinations concerning eligibility for dental treatment.     

Data breaches. Final rule

This document adopts, without change, the interim final rule that was published in the Federal Register on June 22, 2007, addressing data breaches of sensitive personal information that is processed or maintained by the Department of Veterans Affairs (VA). This final rule implements certain provisions of the Veterans Benefits, Health Care, and Information Technology Act of 2006. The regulations prescribe the mechanisms for taking action in response to a data breach of sensitive personal information.     

Patients' rights. Final rule

This final rule amends Department of Veterans Affairs (VA) medical regulations to update the patients' rights regulation by bringing its provisions regarding medication, restraints, and seclusion into conformity with current law and practice. The changes are primarily intended to clarify that it is permissible for VA patients to receive medication prescribed by any appropriate health care professional authorized to prescribe medication, and that it is permissible for any authorized licensed health care professional to order the use of restraints and seclusion when necessary. The rule also makes nonsubstantive changes in the patients' rights regulation for purposes of clarification.     

Infectious substances--DOT. Final rule

RSPA published a notice of proposed rulemaking (NPRM) in December 1994 that proposed to revise the regulations pertaining to infectious substances, including regulated medical waste (RMW). In this final rule, RSPA is revising requirements for Division 6.2 materials (infectious substances). This rule clarifies the scope of regulation for infectious substances, provides relief for certain shipments of RMW that conform to other Federal agency regulations, allows certain quantities of RMW to be transported by aircraft, and makes other changes to clarify regulatory provisions applicable to infectious substances. This rulemaking action is necessary to ensure that the regulations for infectious substances and regulated medical waste are cost effective and provide an adequate level of safety in transportation.     

Biomedical telemetry transmitters--FCC. Final rule

By this Report and Order, the Commission amends its regulations regarding the unlicensed operation of biomedical telemetry transmitters in the 174-216 MHz (TV channels 7-13) and 470-668 MHz (TV channels 14-46) bands as proposed in the Notice of Proposed Rule Making ("Notice") in this proceeding, 61 FR 3367, January 31, 1996. These amendments will provide patients in health care facilities the ability to move about in a limited area while being continually monitored, speeding patient recovery times, shortening lengths of stay, and reducing health care costs. The standards being adopted for these devices should protect the licensed services operating in the TV bands. Further, a coordination procedure has been implemented to protect radio astronomy observatories from potential interference from biomedical telemetry systems operating on 608-614 MHz (TV channel 37).     

Legal assistance matters. Final rule

This part establishes a uniform approach for the execution of military testamentary instruments (including wills), powers of attorney, and advance medical directives. It seeks public comment on specific aspects of the activity.     

Medical device reporting--FDA. Final rule

The Food and Drug Administration (FDA) is issuing a final rule that requires manufacturers and importers of medical devices, including diagnostic devices, to report to FDA whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. FDA is taking this action under the Medical Device Amendments of 1976. The final rule is intended to assure that FDA is informed promptly of all serious problems or potentially serious problems associated with marketed devices. FDA is the principal public health agency responsible for ensuring that devices are safe and effective. To carry out its responsibilities, the agency needs to be informed whenever a manufacturer or importer receives or otherwise becomes aware of information about device problems. Only if FDA is provided with such information will it be able to evaluate the risk, if any, associated with a device and take whatever action is necessary to reduce or eliminate the public's exposure to this risk. Depending on the facts and circumstances, these steps could include contacting the manufacturer or importer of the device and monitoring its voluntary actions to respond to the problem, initiating a consumer or user education program, or initiating regulatory action, such as injunction, seizure, or other enforcement action.     

Health maintenance organizations--PHS. Final rule

This rule amends the Public Health Service regulations on health maintenance organizations (HMOs) to elaborate on the 1981 amendments to the HMO statute regarding member protection in the event of insolvency, community rating by class, and primary care within the service area of a non-metropolitan HMO. In addition, the rule removes regulatory provisions that are considered unnecessary or burdensome, such as the specification of contractual provisions, and increases one of the regulatory limits on copayments to permit HMOs to become more competitive. These amendments are made after consideration of public comments on the notice of proposed rulemaking (NPRM) published on March 22, 1983.     

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.     

Informed consent elements. Final rule

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.     

Medical Area Body Network. Final rule

This document expands the Commission's Medical Device Radiocommunications Service (MedRadio) rules to permit the development of new Medical Body Area Network (MBAN) devices in the 2360-2400 MHz band. The MBAN technology will provide a flexible platform for the wireless networking of multiple body transmitters used for the purpose of measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in health care facilities. This platform will enhance patient safety, care and comfort by reducing the need to physically connect sensors to essential monitoring equipment by cables and wires. This decision is the latest in a series of actions to expand the spectrum available for wireless medical use. The Commission finds that the risk of increased interference is minimal and is greatly outweighed by the benefits of the MBAN rules.     

Responding to disruptive patients. Final rule

This final rule amends the Department of Veterans Affairs (VA) regulation that authorizes appropriate action when a patient engages in disruptive behavior at a VA medical facility. This amendment updates VA's current regulation to reflect modern medical care and ethical practices. The final rule authorizes VA to modify the time, place, and/or manner in which VA provides treatment to a patient, in order to ensure the safety of others at VA medical facilities, and to prevent any interference with the provision of medical care.     

Standards Improvement Project-Phase II. Final rule

The Occupational Safety and Health Administration (OSHA) through this final rule is continuing to remove and revise provisions of its standards that are outdated, duplicative, unnecessary, or inconsistent, or can be clarified or simplified by being written in plain language. The Agency completed Phase I of the Standards Improvement Project in June 1998. In this Phase II of the Standards Improvement Project, OSHA is again revising or removing a number of health provisions in its standards for general industry, shipyard employment, and construction. The Agency believes that the changes streamline and make more consistent the regulatory requirements in OSHA health and safety standards. In some cases, OSHA has made substantive revisions to requirements because they are outdated, duplicative, unnecessary, or inconsistent with more recently promulgated health standards. The Agency believes these revisions will reduce regulatory requirements for employers without reducing employee protection.     

Reduction because of hospitalization--VA. Final rule

The Department of Veterans Affairs (VA) has amended its adjudication regulations on reductions of pensions of certain veterans receiving institutional care. These amendments are based on recently enacted legislation and further consideration of previous legislation. The intended effect of these amendments is to minimize pension reductions when VA provides institutional care.     

Student health insurance coverage. Final rule

This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines "student health insurance coverage" as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.