Temporary Assistance for Needy Families program (TANF). Administration for Children and Families, HHS. Final rule

The Administration for Children and Families (ACF) issues regulations governing key provisions of the new welfare block grant program enacted in 1996--the Temporary Assistance for Needy Families, or TANF, program. It replaces the national welfare program know as Aid to Families with Dependent Children (AFDC) and the related programs known as the Job Opportunities and Basic Skills Training Program (JOBS) and the Emergency Assistance (EA) program. These rules reflect new Federal, State, and Tribal relationships in the administration of welfare programs; a new focus on moving recipients into work; and a new emphasis on program information, measurement, and performance. They also reflect the Administration's commitment to regulatory reform.     

National Medical Support Notice. Office of Child Support Enforcement, Administration for Children and Families, HHS. Final rule

This rule implements provisions of the Child Support Performance and Incentives Act of 1998 (CSPIA), Public Law 105-200, that require State child support enforcement agencies, under title IV-D of the Social Security Act (the Act), to enforce the health care coverage provision in a child support order through the use of the National Medical Support Notice (NMSN). A proposed rule was published in the Federal Register on November 15, 1999 (64 FR 62074). After consideration of the written comments received, changes have been made in this final regulation, including changes to the NMSN found in the Appendix.     

Reauthorization of the Temporary Assistance for Needy Families (TANF) program. Final rule

This final rule implements changes to the Temporary Assistance for Needy Families (TANF) program required by the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171). The DRA reauthorized the TANF program through fiscal year (FY) 2010 with a renewed focus on work, program integrity, and strengthening families through healthy marriage promotion and responsible fatherhood. On June 29, 2006, ACF published an interim final rule implementing the required statutory changes with a 60-day comment period that ended on August 28, 2006. We have considered all comments received during this period and made necessary changes as reflected in this final rule.     

Implementation of section 403(a)(2) of Social Security Act; bonus to reward decrease in illegitimacy ratio. Administration for Children and Families, HHS. Final rule

The Administration for Children and Families is issuing a final rule describing how we will award a bonus to those States that experience the largest decreases in out-of-wedlock childbearing and also reduce their abortion rates. The total amount of the bonus will be up to $100 million in each of fiscal years 1999 through 2002, and the award for each eligible State in a given year will be $25 million or less. This incentive provision is a part of the welfare reform block grant program enacted in 1996--the Temporary Assistance for Needy Families, or TANF, program.     

Aid to Families with Dependent Children: Social Security Administration. Final rule

These final regulations implement changes made in the Aid to Families With Dependent Children [AFDC] program by the Omnibus Budget Reconciliation Act of 1981 [Pub. L. 97-35]. The statutory changes are generally effective October 1, 1981.     

Medicare program; changes to the Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule

The purpose of this final rule is to set forth limited changes to the Medicare+Choice regulations published in our June 26, 1998 interim final rule (63 FR 34968). Those regulations implemented section 4001 of the Balanced Budget Act of 1997 (BBA), which established the Medicare+Choice (M+C) program. This final rule addresses selected issues raised by commenters on the June 26, 1998 interim final rule where we have identified the need for changes or where we believe that clarifications are needed as soon as possible. Among these issues are provider participation procedures, beneficiary enrollment options, and several access-related issues, including initial care assessment requirements, notification requirements when specialists are terminated from an M+C plan, and several coordination of care requirements.     

Methodology for determining whether an increase in a state's child poverty rate is the result of the TANF program--Administration for Children and Families, HHS. Proposed rule

The Administration for Children and Families is proposing a methodology to determine the child poverty rate in each State. If a State experiences an increase in its child poverty rate of 5 percent or more as a result of its Temporary Assistance for Needy Families (TANF) program, the State must submit and implement a corrective action plan. This requirement is a part of the new welfare reform block grant program enacted in 1996.     

Cooperation in identifying and providing information to assist states in pursuing third party health coverage--Family Support Administration, HHS. Final rule

This final rule implements section 12304 of the Consolidated Budget Reconciliation Act (COBRA) of 1985 which requires each applicant or recipient to cooperate with the State in identifying and providing information to assist States in pursuing any third party who may be liable to pay for care and services available under State plans for medical assistance under title XIX, unless such individual has good cause for refusing to cooperate as determined by the State agency in accordance with standards prescribed by the Secretary. The regulations are applicable to the AFDC program in all jurisdictions.     

Laxative drug products for over-the-counter human use. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing that the over-the-counter (OTC) stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering data and information on the safety of danthron and phenolphthalein.     

Organ Procurement and Transplantation Network. Health Resources and Services Administration, HHS. Final rule

This document sets forth improvements to the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), published in 1998. It reflects the advice of a panel convened by the National Academy of Science's Institute of Medicine, as called for in the Department's appropriation act for 1999. It also reflects comments on the 1998 rule and consultation with representatives of the organ transplantation community, as recommended in the same legislation; and it summarizes new transplant data developed in the period since enactment of the appropriations act.     

Medicare program; solvency standards for provider-sponsored organizations. Health Care Financing Administration (HCFA), HHS. Final rule

The Balanced Budget Act of 1997 established a new Medicare+Choice (M+C) program that offers eligible individuals Medicare benefits through enrollment in one of an array of private health plans that contract with us. Among the new options available to Medicare beneficiaries is enrollment in a provider-sponsored organization (PSO). This final rule revises and responds to comments on solvency standards that certain entities must meet to contract as PSOs under the new M+C program. These standards, originally established in an interim final rule published on May 7, 1998, apply to PSOs that have received a waiver of the requirement that M+C organizations must be licensed by a State as risk-bearing entities.     

Over-the-counter human drugs; labeling requirements. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products. This final rule is intended to assist consumers in reading and understanding OTC drug product labeling so that consumers may use these products safely and effectively. This final rule will require all OTC drug products to carry the new, easy-to-read format and the revised content requirements within prescribed implementation periods.     

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.     

Medicare program; Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period responds to comments on the June 26, 1998 interim final rule that implemented the Medicare+Choice (M+C) program and makes revisions to those regulations where warranted. We also are making revisions to the regulations that are necessary to reflect the changes to the M+C program resulting from the Balanced Budget Refinement Act of 1999 (BBRA). Revisions to the regulations reflecting changes in the law made by the BBRA are subject to public comment. Issues discussed in this rule include eligibility, election, and enrollment policies; marketing requirements; access requirements; service area and benefit policy; quality improvement standards; payment rates, risk adjustment methodology, and encounter data submission; provider participation rules; beneficiary appeals and grievances; contractual requirements; and preemption of State law by Federal law. This final rule also addresses comments on the interim final rule published on December 2, 1997, which implemented user fees for section 1876 risk contractors for 1998, and formed the basis for the M+C user fee provisions in the June 26, 1998 interim final rule, and the provider-sponsored organization (PSO) interim final rule published April 14, 1998.     

New drug applications; drug master files. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revising its regulation governing drug master files (DMF's). FDA is removing the provision for submitting Type I DMF's and will no longer permit information submitted in a Type I DMF to be incorporated by reference in investigational new drug applications (IND's), new drug applications (NDA's), abbreviated new drug applications (ANDA's), or amendments or supplements to any of these. This rule is intended to eliminate submissions of information that are not necessary either to conduct inspections of manufacturing facilities or to review the chemistry, manufacturing, and controls sections of IND's, NDA's, and abbreviated applications.     

Medicare program; payment for nursing and allied health education. Health Care Financing Administration (HCFA), HHS. Final rule

This final rule sets forth in regulations Medicare policy for the payment of costs of approved nursing and allied health education programs. In addition, the rule clarifies the payment methodology for certified registered nurse anesthetist education programs. In general, the final rule clarifies and restates payment policies previously established in the Provider Reimbursement Manual and other documents, but never specifically addressed in regulations. The final rule carries out a directive made in the Omnibus Budget Reconciliation Act of 1989 and addresses changes required by the Omnibus Budget Reconciliation Act of 1990.     

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing regulations on the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis and monitoring of diseases. FDA is issuing these regulations in accordance with the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). These regulations are intended to clarify existing regulations applicable to the approval of radiopharmaceutical drugs and biologics under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act).     

Medicare program; coverage of, and payment for, paramedic intercept ambulance services. Health Care Financing Administration (HCFA), HHS. Final rule

This final rule responds to public comments received on a final rule with comment period published on January 25, 1999 that implemented section 4531(c) of the Balanced Budget Act of 1997 concerning Medicare coverage of, and payment for, paramedic intercept ambulance services in rural communities. It also implements section 412 of the Medicare, Medicaid, and State Children's Health Insurance Programs Balanced Budget Refinement Act of 1999 by adding a new definition of a rural area.     

Medicare program; prospective payment system for home health agencies. Health Care Financing Administration (HCFA), HHS. Final rule

This final rule establishes requirements for the new prospective payment system for home health agencies as required by section 4603 of the Balanced Budget Act of 1997, as amended by section 5101 of the Omnibus Consolidated and Emergency Supplemental Appropriations Act for Fiscal Year 1999 and by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999. The requirements include the implementation of a prospective payment system for home health agencies, consolidated billing requirements, and a number of other related changes. The prospective payment system described in this rule replaces the retrospective reasonable-cost-based system currently used by Medicare for the payment of home health services under Part A and Part B.