Reasonable charges for medical care or services. Department of Veterans Affairs. Interim final rule

This document amends the Department of Veterans Affairs (VA) medical regulations concerning "reasonable charges" for medical care or services provided or furnished by VA to a veteran: (1) For a nonservice-connected disability for which the veteran is entitled to care (or the payment of expenses of care) under a health plan contract; (2) For a nonservice-connected disability incurred incident to the veteran's employment and covered under a worker's compensation law or plan that provides reimbursement or indemnification for such care and services; or (3) For a nonservice-connected disability incurred as a result of a motor vehicle accident in a State that requires automobile accident reparations insurance. This document amends the regulations to update databases and other provisions for the purpose of providing more precise charges.     

Public Health Service--health maintenance organizations: final regulations

These rules amend the Public Health Service (PHS) regulations by implementing certain changes made by the HMO Amendments of 1978 with respect to grants and loan guarantees for planning and initial development costs (Subpart D) and to loans and loan guarantees for initial costs of operation (Subpart E). These regulations change Subpart D by including projects for the "expansion of services" of an HMO among the projects eligible for initial development assistance. In addition, they change the limits on the amount of assistance permitted for initial development projects. These regulations also change Subpart E by substituting the words "costs of operation" for the words "operating costs," thereby expanding the scope of assistance for initial operations (1) to include costs of certain small capital expenditures for equipment and alterations and renovations of facilities and (2) to incorporate into the regulations a longstanding policy which specifies the amount of preaward balance sheet liabilities which may be paid for with funds under operating loans (whether made directly or guaranteed by the Secretary).     

Health insurance portability for group health plans--IRS. Notice of proposed rulemaking by cross-reference to temporary regulations

Elsewhere in this issue of the Federal Register, the IRS is issuing temporary regulations relating to group health plan portability, access, and renewability requirements added to the Internal Revenue Code by section 401 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The IRS is issuing the temporary regulations at the same time that the Pension and Welfare Benefits Administration of the U.S. Department of Labor and the Health Care Financing Administration of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations relating to the group health plan portability, access, and renewability requirements added by HIPAA to the Employee Retirement Income Security Act of 1974 and the Public Health Service Act. The temporary regulations provide guidance to employers and group health plans relating to the obligation of plans to comply with new requirements relating to preexisting condition exclusions, discrimination based on health status, access to coverage, and other requirements. The text of those temporary regulations also serves as the text of these proposed regulations.     

Tax treatment of cafeteria plans. Internal Revenue Service (IRS), Treasury. Final regulations

This document contains final regulations relating to section 125 cafeteria plans. The final regulations clarify the circumstances under which a section 125 cafeteria plan election may be changed. The final regulations permit an employer to allow a section 125 cafeteria plan participant to revoke an existing election and make a new election during a period of coverage for accident or health coverage or group-term life insurance coverage.     

Grants for nurse practitioner traineeship programs--PHS. Interim final regulations

These regulations set forth requirements for grants to schools of nursing, medicine, and public health, to public or nonprofit private hospitals, and to other public or nonprofit private entities to meet the costs of traineeships for training nurse practitioners. A trainee must sign a commitment with the Secretary to practice full-time as a nurse practitioner in a primary medical care health manpower shortage area, designated under section 332 of the Public Health Service Act (the Act), for a period equal to 1 month for each month of traineeship support, after completion of the training. If this obligation is not fulfilled, a trainee must pay back traineeship support. The purpose of these regulations is to respond to the comments on the 1980 interim final regulations and to conform 42 CFR Part 57, Subpart AA, with the Paperwork Reduction Act of 1980, Pub. L. 96-511, and with the Omnibus Budget Reconciliation Act of 1981, Pub. L. 97-35, which requires, among other provisions, that the Secretary provide, by regulation, for the waiver or suspension of the repayment obligation under certain conditions. In addition, other minor changes have been made and Office of Management and Budget (OMB) numbers are cited in those sections which have approved reporting and recordkeeping requirements.     

Data breaches. Interim final rule

This document establishes regulations to address data breaches regarding sensitive personal information that is processed or maintained by the Department of Veterans Affairs (VA). The regulations implement certain provisions of Title IX of the Veterans Benefits, Health Care, and Information Technology Act of 2006, which require promulgation of these regulations as an interim final rule.     

Removal of regulations regarding certification of antibiotic drugs--FDA. Direct final rule

The Food and Drug Administration (FDA) is repealing its regulations governing certification of antibiotic drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDAMA also made conforming amendments to the act.     

Removal of regulations regarding certification of antibiotic drugs; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to repeal FDA's regulations governing certification of antibiotic drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDAMA also made conforming amendments to the act.     

Removal of regulations regarding certification of drugs composed wholly or partly of insulin; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to repeal FDA's regulations governing certification of drugs containing insulin and make conforming amendments to other sections of the agency's regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act.     

Semi-annual agenda of regulations: Health and Human Services Department. Publication of semi-annual agenda of regulations

The President's February 17. 1981, Executive Order (12291) and the Regulatory Flexibility Act of 1980 require the Department to publish an agenda of significant regulations being developed and an indication of those regulatory actions that are being analyzed for their effect on small businesses. The Department published its last agenda on November 10, 1981.     

Amendment to the current good manufacturing practice regulations for finished pharmaceuticals. Direct final rule

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and-comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.     

Medicaid program; freedom of choice waiver; conforming changes--HCFA. Interim final rule with comment period

This interim final rule amends existing Medicaid regulations on freedom of choice waivers granted under section 1915(b) of the Social Security Act (the Act) to conform them to the amendments made to the Act by sections 4604 and 4742 of the Omnibus Budget Reconciliation Act of 1990. This rule: Specifies that the Secretary may not waive the requirement that the State plan provide for adjustments in payment for inpatient hospital services furnished to infants under one year of age, or to children under 6 years of age who receive these services in disproportionate share hospitals. Extends to any provider participating under a section 1915(b)(4) waiver the same prompt payment standards that apply to all other health care practitioners furnishing Medicaid services. This rule also makes technical changes in the regulations relating to a recipient's free choice of providers of family planning services and cost-sharing requirements under waivers.     

Removal of regulations regarding certification of drugs composed wholly or partly of insulin--FDA. Direct final rule

The Food and Drug Administration (FDA) is repealing its regulations governing certification of drugs containing insulin and making conforming amendments to other sections of its regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act. FDA is using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. Most of the amendments in this rule are a direct result of the repeal of the statutory certification provision. The remainder of the amendments repeal or update out-of-date, noncontroversial regulations dealing with insulin. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives significant adverse comments and withdraws this direct final rule.     

Contract medical care; non-federal hospital payment rates--DVA and HHS. Final regulations

The Department of Health and Human Services (HHS) and the Department of Veterans Affairs (VA) have jointly amended VA's medical series of regulations to carry out provisions of Public Law 99-576, Veterans' Benefits Improvement and Health-Care Authorization Act of 1986. These regulations describe the payment methodology and amounts for non-Federal public and private hospital care provided at VA expense. Payment methodology and amounts will be determined by the Health Care Financing Administration (HCFA) PRICER.     

Final regulations on school assessments: an attempt to align the NCLBA and the IDEIA

The Secretary of the U.S. Department of Education (DOE) issued final regulations on education assessments under the No Child Left Behind Act (NCLB) and the Individuals with Disabilities Education Improvement Act (IDEIA), which went into effect on May 9, 2007. These regulations cover how students with disabilities are going to participate in state- and district-wide assessments, and are part of the DOE's effort to align the NCLBA and the IDEIA. This article reviews the new assessment regulations and evaluates whether and how they benefit children with disabilities.     

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--DHHS. Notice of proposed rulemaking

The Department of Health and Human Services (the Department or HHS) is proposing to include among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects), research and demonstration projects conducted under the Social Security Act and other Federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. This proposed amendment to the revised final regulations for protection of human research subjects (published January 26, 1981) would, in effect, restore to the regulations an exemption included in the initial notice of proposed rulemaking (NPRM) (published August 14, 1979). These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an IRB would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of an unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation.     

Substance Abuse and Mental Health Services Administration; requirements applicable to protection and advocacy of individuals with mental illness; final rule--Center for Mental Health Services, SAMHSA. Final rule

On December 14, 1994, the Department of Health and Human Services (Department or HHS) published a Notice of Proposed Rulemaking to comply with the requirements of section 116 of the Protection and Advocacy for Mentally III Individuals Act of 1986 (Act) (42 U.S.C. 10801 et seq.) which required that the Secretary promulgate regulations for the implementation of authorized activities of Protection and Advocacy (P&A) Systems to protect and advocate the rights of individuals with mental illness. The Department is issuing this final rule to implement Titles I and III of the Act. These regulations will govern activities carried out by the P&A systems under the Act. The rule includes: definitions: basic requirements regarding determination of, eligibility for and use of allotments, grant administration, eligibility for protection and advocacy services, annual and financial status reports, and remedial actions; and requirements regarding program administration, priorities, the conduct of P&A activities, access of the P&As to residents, facilities and records and confidentiality. DATES: Effective Date: This regulation is effective November 14, 1997 except for the information collection requirements in sections 51.8, 51.10, 51.23 and 51.25. These sections will become effective upon approval under the Paperwork Reduction Act. A notice of approval will appear in the Federal Register.     

Administrative procedures and sanctions; questions and answers relating to the applicability to the petroleum violation escrow funds of regulations of the energy conservation programs--Department of Energy. Ruling

The Department of Energy (DOE) Office of General Counsel issues the appended Ruling to respond to questions relating to the applicability to the petroleum violation escrow funds of the regulations of the energy conservation programs administered by DOE to which these funds can be distributed under Section 155 of the Further Continuing Appropriations Act, Fiscal Year 1983.     

Graduate and professional study fellowships--Department of Education. Final regulations with invitation to comment

The Secretary issues final regulations for the Graduate and Professional Study Fellowships Program. The regulations, which implement Title IX, Part B of the Higher Education Act of 1965, have been amended to reflect the statutory changes in the Education Amendments of 1980 and to reflect changes required by the Education Department General Administrative Regulations (EDGAR). These regulations specify the selection criteria the Secretary uses in evaluating applications for fellowships for graduate and professional study, public service education, and studies in domestic mining and mineral and mineral fuel conservation. These regulations also describe application procedures, eligibility requirements, and the terms and conditions of an award.     

Tribal child welfare. Interim final rule

The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.