Sickness benefits. Railroad Retirement Board. Final rule

The Railroad Retirement Board (Board) hereby amends its regulations under the Railroad Unemployment Insurance Act (RUIA) to permit a "nurse practitioner" to execute a statement of sickness in support of payments of sickness benefits under the RUIA. The Board does not currently accept statements executed by a nurse practitioner, which in some cases may delay payment of benefits.     

Amendments to the quick disability determination process. Final rule

We are amending our regulations to extend the quick disability determination process (QDD), which is operating now in the Boston region, to all of the State disability determination services (DDSs). We also are removing from the QDD process the existing requirements that each State DDS maintain a separate QDD unit and that each case referred under QDD be adjudicated within 20 days. These actions stem from our continuing effort to improve our disability adjudication process.     

How we collect and consider evidence of disability. Final rule

We are modifying the requirement to recontact your medical source(s) first when we need to resolve an inconsistency or insufficiency in the evidence he or she provided. Depending on the nature of the inconsistency or insufficiency, there may be other, more appropriate sources from whom we could obtain the information we need. By giving adjudicators more flexibility in determining how best to obtain this information, we will be able to make a determination or decision on disability claims more quickly and efficiently in certain situations. Eventually, our need to recontact your medical source(s) in many situations will be significantly reduced as a result of our efforts to improve the evidence collection process through the increased use of Health Information Technology (HIT).     

Administrative review process for adjudicating initial disability claims. Final rule

The Social Security Administration is committed to providing the high quality of service the American people expect and deserve. In light of the significant growth in the number of disability claims and the increased complexity of those claims, the need to make substantial changes in our disability determination process has become urgent. We are publishing a final rule that amends our administrative review process for applications for benefits that are based on whether you are disabled under title II of the Social Security Act (the Act), or applications for supplemental security income (SSI) payments that are based on whether you are disabled or blind under title XVI of the Act. We expect that this final rule will improve the accuracy, consistency, and timeliness of decision-making throughout the disability determination process.     

Federal-State Joint Board on Universal Service--FCC. Final rule

This Order changes the funding year for the schools and libraries universal service support mechanism from a calendar year cycle to a fiscal year cycle. This Order also adjusts the amount of money available for schools and libraries, and rural health care providers for the period from January 1, 1998 through June 30, 1999. In addition, this Order establishes rules of priority when a filing window is in effect.     

Nondiscrimination on the basis of disability in air travel. Final rule

The Department of Transportation is amending its Air Carrier Access Act (ACAA) rules to apply to foreign carriers. The final rule also adds new provisions concerning passengers who use medical oxygen and passengers who are deaf or hard-of-hearing. The rule also reorganizes and updates the entire ACAA rule. The Department will respond to some matters raised in this rulemaking by issuing a subsequent supplemental notice of proposed rulemaking.     

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.     

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.     

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.     

Miscellaneous amendments--HHS. Final rule

This final rule will remove appendixes I and J, which contain the test of Office Management and Budget (OMB) Circulars A-128 and A-133, from 45 CFR part 74. It will also update several items to conform them to the Federal Acquisition Streamlining Act of 1994 and correct a confusing statement which resulted from two typographical errors in that portion of OMB Circular A-110 upon which this statement is based.     

Determining disability and blindness; substantial gainful activity guides. Social Security Administration. Final rules

We are revising our rules to reflect amendments to the Social Security Act (the Act) concerning the trial work period and the disability insurance reentitlement period. We are also clarifying certain standards we use to determine whether work is substantial gainful activity and whether an individual is entitled to a trial work period, thereby further explaining how we determine disability under titles II and XVI of the Act.     

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.     

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.     

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.