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.     

Department of Health and Human Services--Grants and subgrants to for-profit organizations. Proposed rules

This rule proposed to remove regulatory bars to grants to for-profit organizations under three HHS grant programs in which the for-profit organizations are not barred by statute from receiving grants. It also proposes (1) to make HHS's Department-wide grants administration regulations, 45 CFR Part 74, apply automatically to grants and subgrants to for-profit organizations and (2) to add to those regulations additional provisions for grants and subgrants to for-profit organizations. These actions reflect a reversal of the Department's generally policy of not making for-profit organizations eligible for grants in those few programs where they are not statutorily barred from receiving grants.     

Sanctions applicable to letter of credit administration--Office of the Secretary, HHS. Proposed rule

We are proposing regulations that would govern the imposition of sanctions against recipient organizations holding letters of credit under programs administered by the Department of Health and Human Services. The regulations would describe the conditions which may prompt the imposition of sanctions and would establish uniform procedures for providing affected recipient organizations: (1) Adequate notice of the grounds upon which proposed sanctions are based, (2) an opportunity to respond to the factual and legal bases of the proposed sanctions, and (3) a reasoned decision that articulates the factual and legal bases of the Department's final decision. We believe that these uniform procedures would be useful both as a sound management tool for the Department and as a guide to grantees and contractors.     

Hazardous waste management system: standards applicable to generators of hazardous waste and standards applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities--Environmental Protection Agency. Proposed rule

The Environmental Protection Agency (EPA) is today proposing amendments to its hazardous waste regulations under Subtitle C of the Resource Conservation and Recovery Act (RCRA). These amendments would replace the annual reporting requirements for hazardous waste generators and owners and operators of hazardous waste treatment, storage, ad disposal (TSD) facilities with a biennial survey of representative samples of those populations. This approach will provide verifiable data on a wider range of topics, better serve EPA's long term regulatory needs under RCRA, and reduce significantly the information burden on the regulated community.     

Revisions to the requirements applicable to blood, blood components, and source plasma. 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 the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment sufficient to terminate the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule. FDA is issuing this rule as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood, blood components, and Source Plasma.     

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).     

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.     

Miscellaneous amendments to the HHS procurement regulations--Department of Health and Human Services. Proposed rule

The Office of the Secretary, Department of Health and Human Services is proposing to amend 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.     

Assistance to States for the Education of Children with Disabilities. Office of Special Education and Rehabilitative Services, Department of Education. Final regulations

The Secretary amends the regulations for the Assistance to States for the Education of Children with Disabilities program under Part B of the Individuals with Disabilities Education Act (IDEA; Part B). This amendment is needed to implement the statutory provision that for any fiscal year in which the appropriation for section 611 of the IDEA exceeds $4.1 billion, a local educational agency (LEA) may treat as local funds up to 20 percent of the amount it receives that exceeds the amount it received during the prior fiscal year. The amendment is intended to ensure effective implementation of the 20 percent rule by clarifying which funds under Part B of IDEA can be included in the 20 percent calculation, and, as a result, to reduce the potential for audit exceptions.     

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.     

Federal Old-Age, Survivors, and Disability insurance benefits; limitations on benefit payments to prisoners; restrictions on disability determinations for felony-related and prison-related impairments--Social Security Administration. Proposed rules

These proposed regulations, which are based on Pub. L. 96-473, place certain restrictions on the payment of benefits based on disability and student status to persons who have been convicted of a felony and are imprisoned and restrict the use of certain impairments in determining disability. These proposed rules specify the conditions under which benefits will not be paid to these individuals and how a finding of disability may be affected when an impairment, or the aggravation of a preexisting impairment, arises during the commission of a felony or imprisonment. Before the enactment of Pub. L. 96-473, there were no restrictions upon the payment of benefits or the making of disability determinations for these persons.     

Claims procedures for employee benefit plans--Pension and Welfare Benefits Administration, Department of Labor. Request for information

This document requests information from the public concerning the advisability of amending the existing regulation under the Employee Retirement Income Security Act of 1974 (ERISA) that establishes minimum requirements for employee benefit plan claims procedures. The term "claims procedure" refers to the process that employee benefit plans must provide for participants and beneficiaries who seek to obtain pension or welfare plan benefits, including requests for medical treatment or services, consideration of claims, and review of denials of claims by plans. The primary purpose of this notice is to obtain information to assist the Department of Labor (the Department) in evaluating (1) the extent to which the current claims procedure regulation assures that group health plan participants and beneficiaries are provided with effective and timely means to file and resolve claims for health care benefits, and (1) whether and in what way the existing minimum requirements should be amended with respect to group health plans covered by ERISA. The furnished information also will assist the Department in determining whether the regulation should be amended with respect to pension plans covered by ERISA and in developing legislative proposals to address any identified deficiencies relating to the claims procedures that cannot be addressed by amending the current regulation.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); revisions to the eligibility requirements--DoD. Proposed rule

This proposed rule revises the comprehensive CHAMPUS regulation pertaining to basic CHAMPUS benefits in accordance with several statutory changes. This proposed rule: sets forth the requirements for reinstatement of CHAMPUS eligibility for beneficiaries under age 65 who would otherwise have lost eligibility for CHAMPUS due to eligibility for Medicare as a result of disability or end-stage renal disease (ESRD); establishes new classes of CHAMPUS eligibles; establishes the Transitional Assistance Management Program which provides transitional health care for members (and their dependents) who served on active duty in support of a contingency operation and for members (and their dependents) who are involuntarily separated from active duty; allows former spouses who buy a conversion health policy to keep CHAMPUS eligibility for twenty-four (24) months for preexisting conditions that are not covered by the conversion policy; and makes minor technical revisions to the double coverage provisions. This proposed rule also adds a new category of eligible beneficiary under the Continued Health Care Benefit Program.