Standard-setting requirements for medical and nonmedical facilities where SSI recipients reside--Office of Human Development Services, HHS. Final rule with comment period

This rule amends the standard-setting requirements for medical and nonmedical facilities where SSI recipients reside. (These requirements are known as Keys amendment regulations). This action is necessary because of the passage of the Omnibus Budget Reconciliation Act of 1981 which amended section 1616(e) of the Social Security Act and deleted reference to Title XX thereby removing social services plans as the vehicle for providing public notice of standards for certain facilities.     

Removal of standard setting requirements for medical and nonmedical facilities where SSI recipients reside--HHS. Final rule

This notice removes from the Code of Federal Regulations the provisions on standard setting requirements for medical and non-medical facilities where Supplemental Security Income recipients reside. These standard setting requirements implement the requirements of the Keys Amendment, Section 1616(e) of the Social Security Act, as amended. This action is necessary because, as of March 31, 1995, Federal responsibility for the Keys Amendment will be assumed by the independent Social Security Administration as required by statute.     

Child abuse and neglect prevention and treatment program--Office of Human Development Services. Final rule

The Department of Health and Human Services is issuing final regulations to implement the amendments to the Child Abuse Prevention and Treatment Act contained in Title 1 of the Child Abuse Prevention and Treatment and Adoption Reform Act of 1978, Pub. L. 95-266, as amended. The regulations also clarify, simplify and eliminate where repetitive of the statute, the rules governing the Child Abuse and Neglect Prevention and Treatment Program and those related to the coordination of Federal activities related to child abuse and neglect.     

Medicare and Medicaid programs; fire safety requirements for certain health care facilities. Final rule

This final rule amends the fire safety standards for hospitals, long-term care facilities, intermediate care facilities for the mentally retarded, ambulatory surgery centers, hospices that provide inpatient services, religious nonmedical health care institutions, critical access hospitals, and Programs of All-Inclusive Care for the Elderly facilities. Further, this final rule adopts the 2000 edition of the Life Safety Code and eliminates references in our regulations to all earlier editions.     

Exemption from import/export requirements for personal medical use. Final rule

The Drug Enforcement Administration (DEA) is amending its regulations to expressly incorporate the restrictions on personal use importation imposed by Congress in 1998 and to expand upon those restrictions to curtail the diversion that has continued even after the 1998 congressional amendment. Specifically, DEA is limiting to 50 dosage units the total amount of controlled substances that a United States resident may bring into the United States for legitimate personal medical use when returning from travel abroad at any location and by any means. This regulation will help prevent importation of controlled substances for unlawful use while still accommodating travelers who have a legitimate medical need for controlled substances during their journey.     

Health and Human Services policy for protection of human subjects research--HHS. Final rule

The Department of Health and Human Services (HHS) is amending its Human Subjects Protection regulations to rescind the provision requiring prior review and advice from an Ethical Advisory Board for research applications and proposals involving in vitro fertilization (IVF) of human ova as a prerequisite to funding by HHS and its components. The provision was nullified by the National Institutes of Health Revitalization Act of 1993. The regulations are being amended to reflect this statutory nullification. Institutional Review Board (IRB) review and approval of applications and proposals involving in vitro fertilization (IVF) of human ova continues to be required in accordance with other provisions of the Human Subjects Protection regulations. Furthermore, the Secretary may still exercise the option of seeking advice from an Ethical Advisory Board on ethical issues, including IVF, raised by research applications and proposals.     

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.     

Medicare and Medicaid programs; requirements for paid feeding assistants in long term care facilities. Final rule

This final rule permits a long term care facility to use paid feeding assistants to supplement the services of certified nurse aides under certain conditions. States must approve training programs for feeding assistants using Federal requirements as minimum standards. Feeding assistants must successfully complete a State-approved training program and work under the supervision of a registered nurse or licensed practical nurse. The intent is to provide more residents with help in eating and drinking and reduce the incidence of unplanned weight loss and dehydration.     

Medicare and Medicaid programs; fire safety requirements for certain health care facilities; amendment. Final rule

This final rule adopts the substance of the April 15, 2004 tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment allows certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This final rule also requires that nursing facilities at least install battery-operated single station smoke alarms in resident rooms and common areas if they are not fully sprinklered or they do not have system-based smoke detectors in those areas. Finally, this final rule confirms as final the provisions of the March 25, 2005 interim final rule with changes and responds to public comments on that rule.     

Clarification of registration requirements for individual practitioners. Final rule

The Drug Enforcement Administration (DEA) is amending its registration regulations to make it clear that when an individual practitioner practices in more than one State, he or she must obtain a separate DEA registration for each State. This amendment will make it easier for practitioners to understand the requirements of the Controlled Substances Act and its implementing regulations.     

Governing body requirements for health systems agencies--PHS. Final rule

This rule amends the portion of the Health Systems Agency Designation and Funding Regulation (March 26, 1976) prescribing the composition of health systems agency governing bodies and deletes the subsection of that regulation which limits the number of consecutive years a governing body member may serve. This rule is being issued pursuant to a court order.     

Medicare and Medicaid programs; fire safety requirements for long term care facilities, automatic sprinkler systems. Final rule

This final rule requires all long term care facilities to be equipped with sprinkler systems by August 13, 2013. Additionally, this final rule requires affected facilities to maintain their automatic sprinkler systems once they are installed.     

License terms for medical use licenses--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses. License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years. The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing process.     

Additional protections for children involved as subjects in research--Department of Health and Human Services. Final rule

The Department of Health and Human Services (Department or HHS)( is prescribing additional requirements for protection of children involved as subjects in research. These regulations adopt, with some changes, the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) as were presented in the notice of proposed rulemaking (NPRM) 43 FR 31786 which preceded this final rule. Specifically, these regulations impose certain added responsibilities on Institutional Review Boards (IRBs) depending on the degree of risk involved in the research and the extent that the research is likely to be a benefit to the subject or relate to a subject's illness.     

Tamper-evident packaging requirements for over-the-counter human drug products--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on tamper-resistant packaging to require that all over-the-counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed using a tamper-evident technology; to change the term "tamper-resistant" in the labeling of all OTC drug products to "tamper-evident;" and to specify that the required OTC drug product labeling statement must refer to all packaging features used to comply with the tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure, and any capsule sealing technologies used. FDA is taking this action as a result of its continuing review of the potential public health threat posed by product tampering and to improve consumer protection by addressing specific vulnerabilities in the OTC drug market.     

Amendments to sterility test requirements for biological products. Final rule

The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. FDA is taking this action as part of its ongoing efforts to comprehensively review and, as necessary, revise its regulations related to biological products.     

Filing of applications and requirements for widow's and widower's benefits. Final rule

We are revising one of our regulations to clarify that we will protect a title II claimant's filing date as of the date the claimant or other proper applicant on the claimant's behalf completes and transmits to the Social Security Administration (SSA) the Personal Information Identification data on the Internet Social Security Benefit Application (ISBA). This revision addresses an aspect of implementing the ISBA to provide certain rights to Internet filers that we afford to other filers. In addition, we are correcting one word in a different title II regulation. The revision is necessary to correctly reflect the circumstances under which a claimant for widow's or widower's benefits as the insured person's surviving divorced spouse would be considered "unmarried."     

Confidentiality of certain medical records--VA. Final rule

This document establishes Department of Veterans Affairs (VA) regulations to implement specific provisions of the Veterans Omnibus Health Care Act of 1976 and the Veterans' Benefits and Services Act of 1988 concerning the confidentiality of certain medical records. These regulations protect the confidentiality of VA records pertaining to drug abuse, alcoholism or alcohol abuse, infection with the human immunodeficiency virus (HIV), and sickle cell anemia.     

Medical devices; classification for medical washer and medical washer-disinfector. Final rule

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA).