Privacy Act of 1974; new system of records--Department of Health and Human Services; Public Health Service. Notification of a new system of records: 09-25-0143

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new system of records, 09-25-0143, Biomedical Research: Records of Subjects in Clinical, Epidemiologic and Biometric Studies of the National Institute of Allergy and Infectious Diseases, HHS/NIH/NIAID. We are also proposing routine uses for this system. This system will be used to support (1) epidemiologic, clinical and biometric investigations into the causes, nature (morbidity and mortality), outcome, therapy and cost of infectious, immunologic and related diseases; (2) review and evaluation of the progress of these research projects, and identification and planning for improvements or for additional research. The population and statistical studies supported by this system may be conducted or managed by Institute staff as well as others outside the Institute. This system comprises records maintained in a number of distinct research projects. The number and specific nature of projects will change over time as new ones are started and as work on existing projects is completed.     

Privacy Act of 1974; new system of records--Department of Health and Human Services. Notification of new system of records. Mental Health Epidemiologic and Biometric Research Data

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing a notice of a proposal to initiate a new system of records in the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), National Institute of Mental Health (NIMH), entitled, "Mental Health Epidemiologic and Biometric Research Data, HHS/ADAMHA/NIMH." The purpose of the new system will be to maintain a data base for biometric and epidemiologic research in the area of mental health and mental illness. This system will allow the statistical analysis of research data to test hypotheses about relationships among the various items of information and generate new hypotheses to guide future research.     

Privacy Act of 1974; notification of new system of records--PHS. Notification of new system of records, "Health Resources and Services Administration Loan Repayment/Debt Management Records System

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new system of records entitled "Health Resources and Services Administration Loan Repayment/Debt Management Records System, HHS/HRSA/OA," 09-15-0045. PHS invites interested persons to submit comments on the proposed routine use established for the new system of records on or before August 10, 1983.     

Public Health Service--Privacy Act of 1974. Notification of new system of records: "clinical research; records of subjects in intramural research, epidemiology, demography, and biometry studies on aging."

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to adopt a new system of records. "Clinical Research: Records of Subjects in Intramural Research, Epidemiology, Demography, and Biometry Studies on Aging." DHHS/NIH/NIA, 09-25-0142. These records will be used to accomplish scientific research conducted by intramural scientists employed by the National Institute on Aging (NIA), and by hospitals, universities, research centers and research foundation under contract with NIA. These research activities aim at determining the health status of individuals and changes in health status over time, the incidence and prevalence of certain diseases and problems of the aged in certain populations, and changes that take place as the individuals age who are under study.     

Privacy Act of 1974; new system of records--Public Health Service. Notification of establishment of a new Privacy Act system of records, 09-25-0151

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new Privacy Act system of records, 09-25-0151, "Administration: Alert Records Concerning Investigations or Determinations of Misconduct by Current or Potential Recipients of Funds for Biomedical Research," HHS/NIH/OD. We are also proposing routine uses for this system. The National Institutes of Health (NIH) will use this system to make informed decisions on appropriate actions regarding awards of research funds to individuals who are or have been subjects of investigations or determinations of misconduct. PHS invites interested persons to submit comments on the proposed routine uses on or before June 11, 1982.     

Privacy Act of 1974; new routine use and system of records name change--HHS. Notification of a new routine use and system of records name change

The Public Health Service (PHS) is publishing notice of a new routine use, responding to comments, changing the system name, providing the contractor's address, and making editorial clarifications for system of records: 09-15-0054, "Health Care Practitioner Adverse Credentialing Data Bank, HHS/HRSA/BHPr", now titled "National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, HHS/HRSA/BHPr."     

Public health assessments completed. Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). Notice

This notice announces those sites for which ATSDR has completed public health assessments during the period April 1998 through September 1998. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL), and includes sites for which assessments were prepared in response to requests from the public.     

Privacy Act of 1974--PHS. Notification of establishment of a new Privacy Act system of records

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of intent to establish a new Privacy Act system of records 0937-0016, "Users of Health Statistics, HHS/ OASH / NCHS ." This system will be used to support the work of the National Center for Health Statistics ( NCHS ) by ascertaining from data users how NCHS can improve the usefulness of its health statistics to the public through changing content of data systems, statistical methodology used, or the nature or content of statistical publications. We are also proposing routine uses for this new system. PHS invites interested persons to submit comments on the proposed routine uses on or before June 29, 1984.     

Food and Drug Administration-Redesignation of the Department of Health, Education, and Welfare as the Department of Health and Human Services. Final rule

The agency is amending Chapter I of Title 21 of the Code of Federal Regulations to reflect the redesignation of the Department of Health, Education, and Welfare as the Department of Health and Human Services.     

Privacy Act of 1974; system of records--PHS. Notification of establishment of a new Privacy Act system of records

5n accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new Privacy Act system of records: 09-20-0162, "Records of Subjects in Agent Orange, Vietnam Experience, and Selected Cancers Studies, HHS/CDC/CEH." We are also proposing routine uses for this system. The Center for Environmental Health (CEH), Centers for Disease Control (CDC), will use this system of records to support studies of the health effects of human exposure to the herbicide Agent Orange and to other environmental factors associated with service in Vietnam, and to assess the risks for selected cancers among Vietnam veterans. PHS invites interested persons to submit comments on the proposed routine uses on or before July 30, 1984.     

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.     

Protection of human research subjects. Department of Health and Human Services (DHHS). Final rule

The Department of Health and Human Services (DHHS) is amending its human subjects protection regulations. These regulations provide additional protections for pregnant women and human fetuses involved in research and pertains to human in vitro fertilization. The rule continues the special protections for pregnant women and human fetuses that have existed since 1975. The rule enhances the opportunity for participation of pregnant women in research by promoting a policy of presumed inclusion, by permitting the pregnant woman to be the sole decision maker with regard to her participation in research, and by exempting from the regulations six categories of research. The rule also provides a mechanism for the Secretary of HHS to conduct or fund research not otherwise approvable after consultation with an expert panel and public review and comment.     

National Vaccine Injury Compensation Program: addition of vaccines against rotavirus to the program. Department of Health and Human Services (HHS), Public Health Service (PHS), Health Resources and Services Administration (HRSA). Final rule

This final rule amends the existing regulations governing the National Vaccine Injury Compensation Program (VICP) by adding vaccines against rotavirus to the Table of Injuries, which lists the vaccines covered under the VICP. This action is taken under section 2114(e) of the Public Health Service Act (the Act). The VICP provides a system of no-fault compensation for certain individuals who have been injured by specific childhood vaccines. The two prerequisites for adding vaccines against rotavirus to the VICP have been satisfied. An excise tax of 75 cents per dose was enacted on October 21, 1998, and took effect for sales of the vaccines after October 21, 1998. The Centers for Disease Control and Prevention (CDC) has recommended to the Secretary of HHS that this vaccine be routinely administered to children. Thus, vaccines against rotavirus are now included in the VICP.     

Quality mammography standards. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Direct final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments are intended to incorporate changes required by the Mammography Quality Standards Reauthorization Act (MQSRA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event that the agency withdraws the direct final rule.     

Essential medicolegal death investigation services: standardization of a survey instrument based on the Essential Public Health Services

The National Academy of Sciences recommends that states assess the performance of medicolegal death investigation agencies. To aid in performance assessment, we adapted an instrument based on the CDC's 10 Essential Public Health Services by translating the terminology to that of essential medicolegal death investigation services. This produced a survey that could be used to standardize reporting practices and services of agencies. To validate the instrument, a stratified random sample of 12 death investigation chiefs in 12 states was interviewed. This sample represented both medical examiner and coroner jurisdictions within the varying medicolegal structures. A cognitive testing process elicited how well participants could respond to and interpret the survey questions. The response was favorable in that the respondents agreed that given specific revisions toward question clarification, the instrument would be a useful and relevant tool for assessing system performance.     

Interim final rules for nondiscrimination in health coverage in the group market. Internal Revenue Service, Department of the Treasury; Pension and Welfare Benefits Administration, Department of Labor; Health Care Financing Administration, Department of Health and Human Services. Interim final rules with request for comments

This document contains interim final rules governing the provisions prohibiting discrimination based on a health factor for group health plans and issuers of health insurance coverage offered in connection with a group health plan. The rules contained in this document implement changes made to the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974 (ERISA), and the Public Health Service Act (PHS Act) enacted as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).     

Public Health Service--Privacy Act of 1974. Notification of establishment of a new Privacy Act System of Records 09-25-0148

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new Privacy Act System of Records 09-25-0148. Contracted and Contract-Related Research: Records of Subjects in Clinical, Epidemiological and Biomedical Studies of the National Institute of Neurological and Communicative Disorders and Stroke, HHS/NIH/NINCDS. We are also proposing routine uses for this system. This system will be used to support (1) epidemiological, clinical and biometric investigations into the causes, nature, outcome, therapy, prevention and cost of neurological and communicative disorders and stroke, and (2) review and evaluation of the progress of these research projects, and identification and planning for improvements or for additional research.