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.     

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.     

Health insurance reform: standards for electronic transactions. Office of the Secretary, HHS. Final rule

This rule adopts standards for eight electronic transactions and for code sets to be used in those transactions. It also contains requirements concerning the use of these standards by health plans, health care clearinghouses, and certain health care providers. The use of these standard transactions and code sets will improve the Medicare and Medicaid programs and other Federal health programs and private health programs, and the effectiveness and efficiency of the health care industry in general, by simplifying the administration of the system and enabling the efficient electronic transmission of certain health information. It implements some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.     

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.     

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.     

National Practitioner Data Bank for Adverse Information on Physicians and other Health Care Practitioners: charge for self-queries. Health Resources and Services Administration, HHS. Final rule

This final rule amends the existing regulations implementing the Health Care Quality Improvement Act of 1986 (the Act), which established the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank). The final rule amends the existing fee structure so that the Data Bank can fully recover its costs, as required by law. This rule removes the prohibition against charging for self-queries and, therefore, allows the Data Bank to assess costs in an equitable manner. This is consistent with both the Freedom of Information Act and the Privacy Act which allow the Government to charge fees for the reproduction of records. The Data Bank will continue its current practice of sending to the practitioner in whose name it was submitted--automatically, without a request, and free of charge--a copy of every report received by the Data Bank for purposes of verification and dispute resolution.     

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.     

Redesignation of Contract Health Service Delivery Area--Indian Health Service, HHS. Final notice

This notice advises the public that the Indian Health Service (IHS) is redesignating the geographic boundaries of the Contract Health Service Delivery Area (CHSDA) for the Grand Traverse Band of Ottawa and Chippewa Indians ("The Band"). The Grand Traverse CHSDA was comprised of Leelanau County in Michigan. This county was designated as the Band's CHSDA when the IHS published its updated list of CHSDAs in the Federal Register of January 10, 1984 (49 FR 1291). The redesignated CHSDA is comprised of six counties in the State of Michigan, i.e., Leelanau, Antrim, Benzie, Grand Traverse, Manistee, and Charlevoix. This notice is issued under authority of 43 FR 34654, August 4, 1978.     

Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect redelegations to other officials within the Center for Devices and Radiological Health (CDRH) pertaining to: Certifying true copies and using the Department seal, disclosing official records, issuing reports of minor violations, and medical device reporting procedures. This amendment is intended to reflect those redelegations.     

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.     

National Library of Medicine programs--PHS. Final rule

These regulations govern the programs of the National Library of Medicine (NLM). The regulations permit the Regional Medical Libraries to recover part or all of the costs of providing photocopies of biomedical materials; improve readability of the regulations; and update references to statutory authorities and uniform administrative requirements.     

Privacy Act of 1974; proposed implementation. Office of the Secretary, HHS. Final rule

The Department of Health and Human Services is exempting a new system of records, 09-25-0213, "Administration: Investigative Records, HHS/NIH/OM/OA/OMA," from certain requirements of the Privacy Act to protect records compiled in the course of an inquiry and/or investigation and to protect the identity of confidential sources who furnish information to the Government under an express promise that the identity of such source would be held in confidence.     

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.     

Health maintenance organizations--PHS. Final rule; confirmation of interim rule

This document finalizes, without change, the interim rule published on January 12, 1983, that amends the Public Health Service regulations on Federal qualification of health maintence organizations (HMOs) to provide for greater flexibility for already existing prepaid health care delivery systems to become transitionally qualified HMOs.     

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.     

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.     

Health care for homeless veterans. Final rule

This final rule establishes regulations for contracting with community-based treatment facilities in the Health Care for Homeless Veterans (HCHV) program of the Department of Veterans Affairs (VA). The HCHV program assists certain homeless veterans in obtaining treatment from non-VA community-based providers. The final rule formalizes VA's policies and procedures in connection with this program and clarifies that veterans with substance use disorders may qualify for the program.     

Medical devices; revocation of cardiac pacemaker registry. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting.     

Medicaid program; Medicaid managed care. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period amends the Medicaid regulations to implement provisions of the Balanced Budget Act of 1997 (BBA) that allow the States greater flexibility by permitting them to amend their State plan to require certain categories of Medicaid beneficiaries to enroll in managed care entities without obtaining waivers if beneficiary choice is provided; establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services; eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. In addition, this final rule expands on regulatory beneficiary protections provided to enrollees of prepaid health plans (PHPs) by requiring that PHPs comply with specified BBA requirements that would not otherwise apply to PHPs.     

Opioid drugs in maintenance and detoxification treatment of opiate addiction; Substance Abuse and Mental Health Services Administration, HHS. Final rule

The Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration (SAMHSA) are issuing final regulations for the use of narcotic drugs in maintenance and detoxification treatment of opioid addiction. This final rule repeals the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and creates a new regulatory system based on an accreditation model. In addition, this final rule shifts administrative responsibility and oversight from FDA to SAMHSA. This rulemaking initiative follows a study by the Institute of Medicine (IOM) and reflects recommendations by the IOM and several other entities to improve opioid addiction treatment by allowing for increased medical judgment in treatment.