Health and Human Services policy for protection of human subjects research--HHS. Final rule

The Department of Health and Human Services (HHS) is amending its Human Subjects Protection regulations to rescind the provision requiring prior review and advice from an Ethical Advisory Board for research applications and proposals involving in vitro fertilization (IVF) of human ova as a prerequisite to funding by HHS and its components. The provision was nullified by the National Institutes of Health Revitalization Act of 1993. The regulations are being amended to reflect this statutory nullification. Institutional Review Board (IRB) review and approval of applications and proposals involving in vitro fertilization (IVF) of human ova continues to be required in accordance with other provisions of the Human Subjects Protection regulations. Furthermore, the Secretary may still exercise the option of seeking advice from an Ethical Advisory Board on ethical issues, including IVF, raised by research applications and proposals.     

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.     

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.     

Protection for subjects in human research. Final rule

With this final rule, EPA bans research for pesticides involving intentional exposure of human subjects, when the subjects are pregnant women or children. The rule further strengthens existing protections for subjects in research conducted or supported by EPA, by prohibiting such research if it would involve intentional exposure of human subjects who are pregnant women or children. The rule also extends new protections to adult subjects in research for pesticides conducted by others who intend to submit the research to EPA, when it involves intentional exposure of human subjects who are non-pregnant adults, and creates a new, independent Human Studies Review Board to advise the Agency on the ethical and scientific issues arising in such research. This final rule focuses on third-party intentional dosing human studies for pesticides and sets the stage for further Agency actions. In addition, in order to display the OMB control number for the information collection requirements contained in this final rule, EPA is amending the table of OMB approval numbers for EPA regulations that appears in 40 CFR part 9.     

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.     

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.     

Child abuse and neglect prevention and treatment program--Office of Human Development Services. Final rule

The Department of Health and Human Services is issuing final regulations to implement the amendments to the Child Abuse Prevention and Treatment Act contained in Title 1 of the Child Abuse Prevention and Treatment and Adoption Reform Act of 1978, Pub. L. 95-266, as amended. The regulations also clarify, simplify and eliminate where repetitive of the statute, the rules governing the Child Abuse and Neglect Prevention and Treatment Program and those related to the coordination of Federal activities related to child abuse and neglect.     

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.     

Federal policy for the protection of human subjects. Final rule

This document sets forth a common Federal Policy for the Protection of Human Subjects (Model Policy) accepted by the Office of Science and Technology Policy and promulgated in regulation by each of the listed Departments and Agencies. A Proposed Federal Policy for the Protection of Human Subjects published November 10, 1988 (53 FR 45661) has been revised in response to public comments. The Policy as revised is now set forth as a common final rule. For related documents, see other sections of this Federal Register part.     

Assistant Secretary of Defense for Health Affairs--DoD. Final rule

This document revises the responsibilities, functions, relationships, and authorities of the Assistant Secretary of Defense for Health Affairs ASD(HA). The principal revision, the assignment of the Health Affairs functions under the Under Secretary of Defense for Personnel and Readiness is consistent with Section 903 of the FY 1994 Defense Authorization Act.     

Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing additional criteria and procedures by which over-the- counter (OTC) conditions may become eligible for consideration in the OTC drug monograph system. The criteria and procedures address how OTC drugs initially marketed in the United States after the OTC drug review began in 1972, and OTC drugs without any U.S. marketing experience, can meet the statutory definition of marketing to a "material extent" and "for a material time" and become eligible. If found eligible, the condition would be evaluated for general recognition of safety and effectiveness in accordance with FDA's OTC drug monograph regulations. FDA is also changing the current OTC drug monograph procedures to streamline the process and provide additional information in the review.     

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.     

Public Health Service--Grants for allied health projects. Final rule

These regulations set forth requirements for grants to: (a) Establish regional or State systems to assure that allied health and nursing personnel needs in the area are met by coordinating and managing allied health professions and nursing education and training within and among educational institutions and their clinical affiliates; (b) Establish or improve recruitment, training, and retraining programs for allied health personnel; and (c) Establish career ladders and advancement programs for practicing allied health personnel. These regulations implement section 796 of the Public Health Service Act.     

Standard setting requirements for medical and nonmedical facilities where SSI recipients reside--Office of Human Development Services. Final rule

On March 1, 1983, the Office of Human Development Services (HDS) published in the Federal Register (48 FR 8453) a final rule with a 60 day comment period to amend 45 CFR Part 1397, Standard Setting Requirements for Medical and Nonmedical Facilities Where SSI Recipients Reside. (These requirements are known as the "Keys amendment" regulations). In response to comments, we have made one change in this final rule to allow States the option of charging a fee for providing copies of standards, procedures or other information on these facilities.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); partial hospitalization--DoD. Final rule

This final rule establishes a CHAMPUS benefit for partial hospitalization and makes corrections and clarifications on other mental health issues resulting from implementation of recent legislative changes. The partial hospitalization benefit is being added at the request of Congress to improve the availability of mental health services under CHAMPUS. The intent is to provide a needed service at a lower cost than the full hospitalization rate, and allow more efficient use of resources for needed mental health care. Facilities must be certified and enter into a participation agreement with CHAMPUS and obtain the required preauthorization prior to admitting CHAMPUS patients. Applications for facility approval may be obtained from the Director, OCHAMPUS, or a designee.     

Protection of human subjects; informed consent--FDA. Final rule

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.     

Availability of information to the public--Department of Health and Human Services. Proposed rule

The Department of Health and Human Services is proposing to amend its regulations implementing the Freedom of Information Act (FOIA). This proposal would increase fees for FOIA searches and copying, to reflect increased costs to the Department. It also proposes guidelines for the waiver or reduction of fees.     

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.