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.     

Availability of additional HRSA competitive grants. Health Resources and Services Administration, HHS. Notice of availability of funds

The Health Resources and Services Administration (HRSA) announces the availability of funds for several HRSA programs. This Notice lists several programs that are announcing competitions for fiscal year (FY) 1999 funds but were not published in the fall 1998 HRSA Preview. This Notice includes funding for HRSA discretionary authorities and programs as follows: (1) Special Projects of National Significance, HIV/AIDS Bureau; (2) Extramural Support Program for Projects to Increase Organ and Tissue Donation, HIV/AIDS Bureau; (3) Cooperative Agreement for Emergency Medical Services for Children and Quality Improvement Center, Maternal and Child Health Bureau; and (4) Basic Nurse Education and Practice: Baccalaureate Nursing Education Using Distance Learning Methodologies for Rural RNs, Bureau of Health Professions. These programs were not published in the fall 1998 HRSA Preview and will only appear in the Federal Register and on the HRSA Home Page at: http://www.hrsa.dhhs.gov/. The next edition of the HRSA Preview is scheduled to be published by early summer 1999. The purpose of the HRSA Preview is to provide the general public with a single source of program and application information related to the Agency's competitive grant reviews. The HRSA Preview is designed to replace multiple Federal Register notices which traditionally advertised the availability of HRSA's discretionary funds for its various programs.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); health promotion and disease prevention visits and immunizations--DoD. Final rule

This final rule expands well-baby visits and immunizations to dependents under the age of six and improves access to preventive benefits for dependents age six and above to include health promotion and disease prevention visits in connection with immunizations, Pap smears, mammograms, and colon and prostate cancer screenings.     

Child abuse and neglect prevention and treatment program--HHS. Notice of proposed rulemaking

This rule proposed changes in the regulations that implement the Child Abuse Prevention and Treatment Act. Recent amendments to this Act (Pub. L. 98-457) made changes in several definitions regarding child abuse and neglect which may require State regulatory changes. These and other proposed requirements are the subject of this notice. On December 10, 1984 (49 FR 48160), the Department published a notice of proposed rulemaking to implement the requirement for State child protective service agencies to establish programs and/or procedures for the protection and treatment of disabled infants with life-threatening conditions ("Baby Does"). These requirements were also a part of Pub. L. 98-457.     

Child abuse and neglect prevention and treatment program--HHS. Notice of proposed rulemaking

This rule proposes a new basic State grant requirement to implement the Child Abuse Amendments of 1984 (Pub. L. 98-457). As a condition of receiving State grants under the Child Abuse Prevention and Treatment Act, States must establish programs and/or procedures within the State's child protective service system to respond to reports of medical neglect, including reports of the withholding of medically indicated treatment for disabled infants with life-threatening conditions. Other changes in regulations required by these Amendments will be published as a separate NPRM at a later date.     

Health maintenance organizations; HMO qualification determinations and compliance actions--HCFA. Notice

This notice sets forth the names, addresses, service areas or modified service areas, and dates of qualification or expansion of entities determined to be Federally qualified health maintenance organizations (FQHMOs) during the period April 1, 1992 through September 30, 1992. It also includes the service expansion area for one FQHMO that had been inadvertently omitted from the previous Federal Register notice that covered the period August 6, 1991 through March 31, 1992. Additionally, it sets forth compliance actions taken by the Office of Prepaid Health Care Operations and Oversight for the period April 1, 1992 through September 30, 1992. This notice is being published in accordance with our regulations set forth at 42 CFR 417.144 and 417.163, which require publication in the Federal Register of certain determinations relating to FQHMOs.     

Request for planning ideas. Agency for Health Care Policy and Research, HHS. Notice

The Agency for Health Care Policy and Research (AHCPR) invites recommendations for future initiatives in areas identified as priorities in the Agency's current strategic plan. This plan describes the framework that the Agency will use to guide the development of budget proposals for Fiscal Years 2000, 2001, and 2002 as well as decisions on resource allocations for research, translation (including tool development), dissemination, and evaluation activities that will facilitate the implementation of research findings at all levels of the health care system.     

Hill-Burton program; medical facility construction and modernization; federal right of recovery and calculation of interest charges--HRSA. Notice

On July 18, 1984, the President signed the Deficit Reduction Act of 1984. The law contains several provisions affecting medical facilities which are assisted under the Hill-Burton Program and which transfer ownership or control or cease to be used as medical facility. These provisions include authority to waive the Federal right of recovery and methods of calculating interest when recovery is not waived.     

Chronic beryllium disease prevention program. Office of Environment, Safety and Health, Department of Energy. Final rule

The Department of Energy (DOE) is today publishing a final rule to establish a chronic beryllium disease prevention program (CBDPP) to reduce the number of workers currently exposed to beryllium in the course of their work at DOE facilities managed by DOE or its contractors, minimize the levels of, and potential for, exposure to beryllium, and establish medical surveillance requirements to ensure early detection of the disease. This program improves and codifies provisions of a temporary CBDPP established by DOE directive in 1997.     

Memorandum of understanding between the Food and Drug Administration and the Indian Health Service--FDA. Notice

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Indian Health Service (IHS). The purpose of the MOU is to develop a more cohesive relationship to mutually address American Indian and Alaska Native issues within the context of each organization's jurisdiction.     

Health maintenance organizations; amendments of 1981--Health Resources and Services Administration. Notice of proposed rulemaking

This notice proposes to amend the Public Health Service rules on health maintenance organizations (HMOs) to conform with 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, this notice proposes: (a) to remove provisions of the rules that are considered unnecessary or burdensome, such as the regulatory specification of contractual provisions, and (b) to increase one of the regulatory limits on copayments to permit HMOs to become more competitive with alternative forms of health insurance.     

HIPAA Newborns' and Mothers' Health Protection Act--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 minimum hospital length-of-stay requirements imposed on group health plans with respect to mothers and newborns. The hospital length-of-stay requirements were added to the Internal Revenue Code by section 1531 of the Taxpayer Relief Act of 1997. 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 hospital length-of-stay requirements added by the Newborns' and Mothers' Health Protection Act of 1996 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 new hospital length-of-stay requirements. The text of those temporary regulations also serves as the text of these proposed regulations.     

Availability of funds for Community Health Centers (CHCs)--Health Resources and Services Administration. Notice

Under the present Continuing Resolution, Pub. L. 97-377, providing funding for the Department of Health and Human Services, approximately $14 million are available for funding new CHCs and expanding existing CHCs. This notice contains information of interest to prospective applicants for such funding.     

Grants to State Health Planning and Development Agencies--HRSA. Notice regarding grants to State Health Planning and Development Agencies--determination of population of the States

This notice provides the population figures the Department will use when it determines the amount of grants to State Health Planning and Development Agencies (States Agencies).     

Health maintenance organizations: qualification determinations and compliance actions for calendar year 1992, fourth quarter--HCFA. Notice

This notice sets forth the names, addresses, service areas or modified service areas, and dates of qualification or expansion of entities determined to be Federally qualified health maintenance organizations (FQHMOs) during the period October 1, 1992 through December 31, 1992. Additionally, this notice sets forth compliance actions taken by the Office of Prepaid Health Care Operations and Oversight for the period October 1, 1992 through December 31, 1992. This notice is being published in accordance with our regulations set forth at 42 CFR 417.144 and 417.163, which require publication in the Federal Register of certain determinations relating to FQHMOs.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)--DoD. Notice of revised rates

This notice provides the updated adjusted standardized amounts, DRG relative weights, outlier thresholds, and beneficiary cost-share per diem rates to be used for FY 1993 under the CHAMPUS DRG-based payment system. It also describes the non-regulatory changes made to the CHAMPUS DRG-based payment system in order to conform to changes made to the Medicare Prospective Payment System (PPS).     

Solicitation of new safe harbors and special fraud alerts--Office of Inspector General, HHS. Notice of intent to develop regulations

In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal and State health care programs' anti-kickback statute, as well as developing new OIG Special Fraud Alerts. The purpose of developing these documents is to clarify OIG enforcement policy with regard to program fraud and abuse.