The State Vocational Rehabilitation Services Program. Office of Special Education and Rehabilitative Services, Department of Education. Final regulations

The Secretary amends the regulations governing The State Vocational Rehabilitation Services Program (VR program). These amendments are needed to implement changes in the Rehabilitation Act of 1973, as amended (Act). These changes establish evaluation standards and performance indicators for the VR program.     

Special demonstration programs. Office of Special Education and Rehabilitative Services, Department of Education. Final regulations

The Secretary issues regulations governing the Special Demonstration Programs. These regulations are needed to implement changes in the Rehabilitation Act Amendments of 1998. The regulations provide definitions and requirements for grants and contracts under the expanded authority of the Special Demonstration Programs.     

State Vocational Rehabilitation Services Program. Office of Special Education and Rehabilitative Services, Department of Education. Final regulations

The Secretary amends the regulations governing the State Vocational Rehabilitation Services Program (VR program) by revising the scope of employment outcomes under the VR program. These regulations redefine the term "employment outcome" (as it applies to the VR program) to mean outcomes in which an individual with a disability works in an integrated setting. This action is necessary to reflect the purpose of Title I of the Rehabilitation Act of 1973, as amended (Act), which is to enable individuals with disabilities who participate in the VR program to achieve an employment outcome in an integrated setting.     

Limitation on federal participation for capital expenditures--PHS. Notice of proposed rulemaking

Section 1122 of the Social Security Act, "Limitation on Federal Participation for Capital Expenditures," establishes under which the Secretary may deny Federal reimbursement under titles XVIII and XIX of the Act for expenses related to capital expenditures by or on behalf of health care facilities (1) which the health planning agency designated for a State has found to be inconsistent with standards, criteria, or plans developed under the Public Health Service Act, or (2) for which the designated planning agency was not provided notification as required. These proposed regulations include changes in the regulations now codified at 42 CFR Part 100 based on (1) the proposed amendments to the regulations published in the Federal Register on March 19, 1976, and comments submitted in response to that Notice, (2) the amendments to Title XV of the Public Health Service Act enacted by the Health Planning and Resources Development Amendments of 1979 (Pub. L. 96-79), the Health Programs Extension Act of 1980 (Pub. L. 96-538), and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and (3) the amendments to section 1122 enacted by the Health Maintenance Organization Amendments of 1978 (Pub. L. 95-559), the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and the Social Security Amendments of 1983 (Pub. L. 98-21). Interested persons are invited to submit written comments and suggestions concerning this Notice of Proposed Rulemaking (NPRM).     

Federal sector equal employment opportunity. Final rule

The Equal Employment Opportunity Commission is publishing this final rule to implement the amendment of section 501 of the Rehabilitation Act, under the Rehabilitation Act Amendments of 1992. This rule continues the movement towards full integration of individuals with disabilities into the Federal workforce.     

Grants for the establishment of Departments of Family Medicine--HRSA. Final rule

This final regulation amends the existing regulations governing the program for Grants for the Establishment of Departments of Family Medicine authorized by section 747(b) of the Public Health Service Act (the Act), to bring the regulations into conformity with technical amendments made by the Health Professions Extension Amendments of 1992 and to include other changes for consistency with current grant program policies.     

Procedures for disclosure or production of information under the Freedom of Information Act; amendments--Consumer Product Safety Commission. Final Rule

The Electronic Freedom of Information Act Amendments of 1996, which amend the Freedom of Information Act, are designed to make government documents more accessible to the public in electronic form. The amendments are also intended to expedite and streamline the process by which agencies disclose information generally. In this notice, the Commission amends its Freedom of Information Act regulations to comply with the requirements of the new statute.     

General and plastic surgery devices; classification of silicone sheeting. Final rule

The Food and Drug Administration (FDA) is classifying silicone sheeting intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars into class I (general controls). As a class I device, the device will be exempt from premarket notification requirements. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Devices User Fee Modernization Act of 2002 (MDUFMA).     

Ear, nose, and throat devices; classification of the nasal dilator, the intranasal splint, and the bone particle collector. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the nasal dilator, intranasal splint, and the bone particle collector into class I (general controls). FDA is also exempting the devices from the requirements of premarket notification. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Medical devices; classification of temporomandibular joint implants--FDA. Final rule

The Food and Drug Administration (FDA) is classifying four temporomandibular joint (TMJ) implants, the total temporomandibular joint prosthesis, the glenoid fossa prosthesis, the mandibular condyle prosthesis, and the interarticular disc prosthesis (interpositional implant), into class III (premarket approval). These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA).     

Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997.     

Medical devices; laser fluorescence caries detection device. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.     

General and plastic surgery devices; classification of the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into class I (general controls). FDA is also exempting these devices from premarket notification procedures. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Orthopedic devices: classification and reclassification of pedicle screw spinal systems--FDA. Final rule

The Food and Drug Administration (FDA) is classifying certain previously unclassified preamendments pedicle screw spinal systems into class II (special controls) and reclassifying certain postamendments pedicle screw spinal systems from class III (premarket approval) to class II. FDA is taking this action because it believes that special controls would provide reasonable assurance of safety and effectiveness. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Medical devices; anesthesiology devices; classification of nitric oxide administration apparatus, nitric oxide analyzer, and nitrogen dioxide analyzer. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the nitric oxide administration apparatus, nitric oxide analyzer, and nitrogen dioxide analyzer into class II (special controls). The special control that will apply to these devices is a guidance document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices.     

Release of information from Department of Veterans Affairs records--VA. Proposed rule

This document proposes to amend Department of Veterans Affairs (VA) regulations governing the confidentiality and release of VA records subject to the Privacy Act, the Freedom of Information Act (FOIA) (including the Electronic Freedom of Information Act Amendments of 1996), and the veterans' records confidentiality statute. The proposed rule sets forth a mechanism for the public to obtain information from the VA. The proposed rule is intended to maximize public availability of VA records to the extent permitted by law and considerations such a personal privacy or law enforcement. Essentially these provisions consist of restatements of statute, interpretations of statute, interpretations of case law, interpretations of Executive Orders, and clarification. The proposed amendments also would implement the Electronic Freedom of Information Act Amendments of 1996, court decisions and Executive Branch guidance issued since the regulations were originally published. Further, this document proposes to delegate authority to the Assistant General Counsel for Professional Staff Group IV for making final Departmental decisions on appeals under the Freedom of Information Act, the Privacy Act, and 38 U.S.C. 5701 and 5705. This would simplify decision making by allowing the highest level individual with direct responsibility for decision making to issue decisions.     

Medical devices; gastroenterology-urology devices; classification of the ingestible telemetric gastrointestinal capsule imaging system. Final rule

The Food and Drug Administration (FDA) is classifying the ingestible telemetric gastrointestinal capsule imaging system device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.     

Medical devices; immunology and microbiology devices; classification of the endotoxin assay. Final rule

The Food and Drug Administration (FDA) is classifying the endotoxin assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.     

Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.     

Medical devices; immunology and microbiology devices; classification of the West Nile Virus IgM capture Elisa assay. Final rule

The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.