Occupational exposure to ethylene oxide--Occupational Safety and Health Administration. Proposed rule and notice of hearing

By this notice, the Occupational Safety and Health Administration (OSHA) is proposing to amend its existing occupational standard that regulates employee exposure to ethylene oxide (EtO). The basis for this action is a determination by the Assistant Secretary, based on animal and human data, that exposure to EtO at OSHA's current permissible exposure limit (PEL) of 50 parts EtO per million parts of air (50 ppm) as an eight (8)-hour time-weighted average (TWA) is inadequate for employee health protection. OSHA proposes to reduce the PEL for EtO to a TWA of 1 ppm. An "action level" of 0.5 ppm as a TWA is included in the proposal as a mechanism for exempting an employer from the obligation to comply with certain requirements, such as employee exposure monitoring and medical surveillance, in instances where the employer can demonstrate that the employees exposures are at very low levels. The proposal would provide for among other requirements certain methods of exposure control, personal protective equipment, measurement of employee exposures, training, medical surveillance, signs and labels, regulated areas, emergency procedures and recordkeeping.     

Indian health--PHS. Proposed rule

The Department of Health and Human Services (HHS) is proposing to make technical amendments to Indian Health Service (IHS) grant regulations to make them conform to HHS regulations on grant administration, thereby eliminating duplication and conflict within the regulations.     

Quality mammography standards--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing mammography that published in a document entitled "Quality Mammography Standards." The purpose of these amendments is to eliminate a conflict between the mammography regulations, which must be followed by all facilities performing mammography, and FDA's Electronic Product Radiation Control (EPRC) performance standards, which establish radiation safety performance requirements for x-ray units, including mammographic systems.     

Blood and blood components; error and accident reports--Food and Drug Administration. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations concerning blood and blood components to require the submission of certain error and accident reports to the agency by licensed and unlicensed blood etablishments. These reports of error and accidents are being limited to those related to the issue of hepatitis-reactive blood and blood components and the accidental infusion of the wrong red blood cells to a donor during plasmapheresis. Certain other reports of error and accidents would no longer be required to be submitted to the Director, Bureau of Biologics, by these blood establishments. The agency is also proposing to amend the current good manufacturing practice (GMP) regulations for blood and blood components to provide a uniform procedure for reporting and maintaining these records.     

Reconsideration of denied claims--VA. Proposed rule

This document proposes to amend the Department of Veterans Affairs' "Medical" regulations by adding a new section to set forth reconsideration procedures available if requested by an individual or entity who made a claim for benefits administered by the Veterans Health Administration and who disagrees with the initial decision denying the claim. It is anticipated that these procedures would not only allow for more reflective decisions at the local level but would also allow some disputes to be resolved without the need for further appeal to the Board of Veterans Appeals.     

Program grants for black lung clinics--PHS. Final rule

The Public Health Service hereby revises the regulations governing the grants program for black lung clinics established under section 427(a) of the Federal Mine Safety and Health Act of 1977. The revision is in keeping with the Department of Health and Human Services' desire to remove as many programmatic burdens and restrictions from grantees as possible, while maintaining program integrity.     

Grants to states for construction or acquisition of state home facilities--VA. final rule

This document amends the "Medical" regulations regarding applications for grants to States for the construction or acquisition of State home facilities. VA awards grants based on a priority ranking system. Usually, the higher priority applications deplete the available funding to the extent that the lowest ranking application to be offered funding is offered only a partial grant. This final rule provides that if the lowest ranking grant application receives only a partial grant in a fiscal year and if such grant award is partial solely because VA has insufficient funds for a full grant, the application would be placed at the top of the list within its priority group for the next fiscal year. Often applicants are hesitant to accept a partial grant because of the uncertainty of receiving an additional grant the next fiscal year. This final rule will encourage States to accept a partial grant by creating the likelihood that the State would receive an additional grant in the subsequent fiscal year. Accordingly, this will help ensure that VA would be able to award grants to higher priority applicants that might otherwise reject partial funding. Also, this final rule provides that the applicant receiving partial funding and receiving priority as a proposed will not be required to submit a second application for additional funds in the subsequent fiscal year, but could be required to update information already submitted. The first application would normally be adequate because the grant award in the second fiscal year would be for the same project which received the partial grant award. Further, the final rule provides that the total amount awarded for the application may not exceed 65 percent of the total cost of the project as determined at the time of the second grant award for that grant application. This is consistent with the statutory requirement that limits grant awards to no more than 65 percent of the estimated cost construction or acquisition.     

Enrollment--provision of hospital and outpatient care to veterans--VA. Proposed rule

This document proposes to amend VA's medical regulations. The Veterans' Health Care Eligibility Reform Act of 1996 mandates that VA implement a national enrollment system to manage the delivery of healthcare services. Accordingly, the medical regulations are proposed to be amended to establish provisions consistent with this mandate. Starting October 1, 1998, most veterans must be enrolled in the VA healthcare system as a condition of receiving VA hospital and outpatient care. Veterans would be allowed to apply to be enrolled at any time. They would be eligible to be enrolled based on funding availability and their priority status. In accordance with statutory provisions, the proposed rule also states that some categories of veterans would be eligible for VA hospital and outpatient care even if not enrolled. This document further proposes to establish a "medical benefits package" setting forth, with certain exceptions, the hospital and outpatient care that would be provided to enrolled veterans and certain other veterans.     

Federal Old-Age, Survivors, and Disability Insurance benefits annual earnings test--Social Security Administration. Proposed rule

These proposed regulations reflect recent statutory amendments which delay for one year (from January 1982 until January 1983), for all except a very small number of individuals who file their tax returns on a fiscal year basis, full-implementation of section 302, Pub. L. 95-216, the Social Security Amendments of 1977. Section 302 reduced from 72 to 70 the age at which social security beneficiaries are no longer subject to an earnings test.     

Medical: advance healthcare planning--VA. Proposed rule

This document proposes to amend the VA medical regulations to codify VA policy regarding advance healthcare planning. The proposed rule sets forth a mechanism for the use of written advance directives, i.e., a VA Living Will, a VA durable power of attorney for health care, and a state-authorized advance directive. The proposed rule also sets forth a mechanism for honoring verbal or nonverbal instructions from a patient when the patient is admitted to care when critically ill and loss of capacity may be imminent and the patient is not physically able to sign an advance directive form, or the appropriate form is not readily available. This is intended to help ensure that VA acts in compliance with patients' wishes concerning future healthcare.     

New drug and antibiotic regulations--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to revise its regulations governing the approval for marketing of new drugs and antibiotic drugs for human use. FDA is taking this action to improve the efficiency of the agency's drug approval process and to improve the agency's dealings with applicants for marketing approval of new drugs and antibiotic drugs, while still maintaining the high level of public health protection the drug approval process now provides. The improvements will help applicants prepare and submit higher quality applications and permit FDA to review them more efficiently and with fewer delays. This will benefit consumers through earlier availability of drugs and benefit applicants by permitting earlier marketing of new drugs and antibiotics. This action is one part of a larger effort by FDA to review all facets of the agency's drug approval process.     

Security and electronic signature standards--HCFA. Proposed rule

This rule proposes standards for the security of individual health information and electronic signature use by health plans, health care clearinghouses, and health care providers would use the security standards to develop and maintain the security of all electronic individual health information. The electronic signature standard is applicable only with respect to use with the specific transactions defined in the Health Insurance Portability and Accountability Act of 1996, and when it has been determined that an electronic signature must be used. The use of these standards would 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. This rule would implement some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.     

Occupational exposure to tuberculosis--OSHA. Proposed rule and notice of public hearing

The Occupational Safety and Health Administration is proposing a health standard, to be promulgated under section 6(b) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 655, to control occupational exposure to tuberculosis (TB). TB is a communicable, potentially lethal disease that afflicts the most vulnerable members of our society: the poor, the sick, the aged, and the homeless. As many as 13 million U.S. adults are presently believed to be infected with TB; over time, more than 1 million of these individuals may develop active TB disease and transmit the infection to others. TB remains a major health problem with 22,813 active cases reported in the U.S. in 1995. A number of outbreaks of this disease have occurred among workers in health care settings, as well as other work settings, in recent years. To add to the seriousness of the problem, some of these outbreaks have involved the transmission of multidrug-resistant strains of Mycobacterium tuberculosis, which are often fatal. Although it is the responsibility of the U.S. Public Health Service to address the problem of tuberculosis in the general U.S. population, OSHA is solely responsible for protecting the health of workers exposed to TB as a result of their job. OSHA estimates that more than 5 million U.S. workers are exposed to TB in the course of their work: in hospitals, homeless shelters, nursing homes, and other work settings. Because active TB is endemic in many U.S. populations, including groups in both urban and rural areas, workers who come into contact with diseased individuals are at risk of contracting the disease themselves. The risk confronting these workers as a result of their contact with TB-infected individuals may be as high as 10 times the risk to the general population. Although the number of reported cases of active TB has slowly begun to decline after a resurgence between 1985-1992, 16 states reported an increase in the number of TB cases in 1995, compared with 1994. Based on a review of the data, OSHA has preliminarily concluded that workers in hospitals, nursing homes, hospices, correctional facilities, homeless shelters, and certain other work settings are at significant risk of incurring TB infection while caring for their patients and clients or performing certain procedures. To reduce this occupational risk, OSHA is proposing a standard that would require employers to protect TB-exposed employees by means of infection prevention and control measures that have been demonstrated to be highly effective in reducing or eliminating job-related TB infections. These measures include the use of respirators when performing certain high hazard procedures on infectious individuals, procedures for the early identification and treatment of TB infection, isolation of individuals with infectious TB in rooms designed to protect those in the vicinity of the room from contact with the microorganisms causing TB, and medical follow-up for occupationally exposed workers who become infected. OSHA has preliminarily determined that the engineering, work practice, and administrative controls, respiratory protection, training, medical surveillance, and other provisions of the proposed standard are technologically and economically feasible for facilities in all affected industries.     

Medicare program; ambulance services--HCFA. Proposed rule

This proposed rule would update and revise HCFA's policy on coverage of ambulance services. It would base Medicare coverage and payment for ambulance services on the level of medical services needed to treat the beneficiary's condition. It also clarifies Medicare policy on coverage of non-emergency ambulance services for Medicare beneficiaries.     

Procurement forms and administrative matters--HHS. Proposed rule

The Office of the Secretary, Department of Health and Human Services, is proposing to amend 41 CFR Part 3-50, Administrative matters, by adding a new subpart, 3-50.8, Determination of Adequacy of Contractors' Accounting and Billing Systems and Preparation of Invoices. This new subpart will establish uniform Departmental billing and financial reporting requirements for inclusion in cost-reimbursement type contracts. The objective of the new subpart are: (a) Streamlining the reporting of financial data; (b) establishing the requirements for determination of the adequacy of a contractor's accounting and billing system; and (c) establishing guidelines for the preparation of invoices for cost-reimbursement type contracts. Part 3-16, Procurement Forms, will be amended by the addition of three subsections to Subpart 3-16.9, Illustration of Forms. These subsections illustrate the financial reporting form and contain instructions for filling out the form and preparing invoices under cost reimbursement type contracts. When issued as a final rule, this regulation will supersede Procurement Circular HEW-78.1, Billing Instructions and Financial Reporting Requirements dated April 12, 1978, except for Section 3-50.803(b). Paragraph 3-50.803(b) has been superseded by Procurement Circular HHS 82.04, Prompt Payment, dated October 1, 1982.     

Protection of human subjects--Department of Energy. Proposed rule

Executive Order 12044 sets forth a program of regulatory reform to be followed by all executive departments. One element of that program is periodic review of existing regulations. The Department of Energy is committed to review all of its existing regulations within five years, on schedule set forth in the Federal Register for May 8, 1980, 45 FR 30448. As part of that commitment, the Department has reexmained the regulations contained in 10 CFR Part 745. These regulations deal with the protection of human subjects in research activities supported by the Department. In this notice, we are proposing regulations that will supersede the existing requirements. These proposed regulations are intended substantially to duplicate the policies and procedures proposed by the Department of Health and Human Services on August 14, 1979 (44 FR 47688). The primary responsibility for adequate review and approval to protect human subjects of research activities sponsored by the Department of Energy is placed on the institution that receives, or is accountable to the Department, for the funds awarded.