National Library of Medicine programs--PHS. Notice of proposed rulemaking

The Public Health Service, HHS, proposes to revise the regulations for the programs of the National Library of Medicine. The proposed revisions would: (1) Permit the Regional Medical Libraries to recover part or all of the costs of providing photocopies of biomedical materials, (2) improve readability of the regulations, (3) update references to statutory authorities and uniform administrative requirements, and (4) revoke Part 63 (Traineeships) which is obsolete.     

National Institutes of Health Center Grants. Final rule

The National Institutes of Health (NIH) is amending its regulations governing center grants to reflect their applicability to several new grant programs, including research on autism, Alzheimer's disease, fragile X disease, and minority health disparities and other types of health disparities.     

Chafee National Youth in Transition database. Final rule

This final rule adds new regulations to require States to collect and report data to ACF on youth who are receiving independent living services and on the outcomes of certain youth who are in foster care or who age out of foster care. The final rule implements the data collection requirements of the Foster Care Independence Act of 1999 (Pub. L. 106-169) as incorporated into the Social Security Act.     

Traineeships. National Institutes of Health, HHS. Final rule

The National Institutes of Health (NIH) is amending the regulations governing traineeships to add conditions under which NIH may terminate traineeship awards and revise the authorities for the awards.     

National emission standards for hazardous air pollutants--EPA. Final rule

Today EPA is staying the effectiveness of subpart I of 40 CFR part 61, the National Emission Standards for Hazardous Air Pollutants for Radionuclide Emissions (54 FR 51654, December 15, 1989) as applied to facilities licensed by the Nuclear Regulatory Commission or an Agreement State ("NRC-licensed facilities"), other than nuclear power reactors, until November 15, 1992. The purpose or this rule is to afford EPA the time required to make an initial determination pursuant to section 112(d)(9) of the 1990 Clean Air Amendments before subpart I becomes effective for such facilities. EPA intends to propose a rule pursuant to section 112(d)(9) to rescind subpart I for nuclear power reactors, and to take final action no later than June 30, 1991, concerning a separate proposal to stay the effectiveness of subpart I for nuclear power reactors during the pendency of the rulemaking on recission. This rule staying subpart I for NRC-licensed facilities other than nuclear power reactors, and the Agency's final action on its proposal to stay subpart I for nuclear power reactors, will completely supplant all stays previously entered for such facilities during the Agency's reconsideration of subpart I under Clean Air Act section 307(d)(7)(B).     

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.     

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.     

Participation in the National Practitioner Data Bank--Department of Veterans Affairs. Final rule

This rule sets forth the policy of the Department of Veterans Affairs (VA) for participation in the National Practitioner Data Bank (Data Bank). VA will request information from the Data Bank concerning physicians, dentists and other health care practitioners who provide or seek to provide health care services at VA facilities and will also report information to the Data Bank regarding malpractice payments and adverse clinical privileges actions. The intended effect of this policy is to participate in the Data Bank for the purpose of promoting better health care at VA and non-VA health care facilities.     

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.     

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.     

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.