Notice of attestations filed by facilities using nonimmigrant aliens as registered nurses--Employment and Training Administration, DOL. Notice

The Department of Labor (DOL) is publishing, for public information, a list of the following health care facilities that have submitted attestations (Form ETA 9029 and explanatory statements) to one of four Regional Offices of DOL (Boston, Chicago, Dallas and Seattle) for the purpose of employing nonimmigrant alien nurses. A decision has been made on these organizations' attestations and they are on file with DOL.     

Attestations by facilities using nonimmigrant aliens as registered nurses--DOL. Final rule

The Employment and Training Administration (ETA) and the Wage and Hour Division of the Employment Standards Administration (ESA) of the Department of Labor (DOL or Department) are publishing final regulations governing the filing and enforcement of attestations by facilities seeking to use nonimmigrant aliens as registered nurses under H-1A visas. The attestations, required under the Immigration and Nationality Act, pertain to substantial disruption in the delivery of health care services, absence of adverse effect on wages and working conditions of similarly employed registered nurses, payment of wages to nonimmigrant alien nurses employed by the facility at wage rates paid to other registered nurses similarly employed by the facility, taking timely and significant steps designed to recruit and retain U.S. nurses in order to reduce dependence on nonimmigrant alien nurses, absence of a strike or lockout, and giving appropriate notice of filing. Facilities are required to submit these attestations to DOL as a condition for being able to petition the Immigration and Naturalization Service (INS) for H-1A nurses. The attestation process is administered by ETA, while complaints and investigations regarding the attestations are handled by ESA.     

Attestations by facilities using nonimmigrant aliens as registered nurses--Employment and Training Administration and Employment Standards Administration, Labor--Final rule and amendment and announcement of effective date

On January 6, 1994, the Employment and Training Administration (ETA) and the Wage and Hour Division of the Employment Standards Administration of the Department of Labor published final regulations governing the filing and enforcement of attestations by health care facilities seeking to use the services of nonimmigrant aliens as registered nurses under H-1A visas. At that time, ETA submitted the information collection requirements to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1980. This document amends the January 6, 1994, Federal Register document to display the OMB control numbers and announces the effective date for the sections containing information collection requirements for which OMB approval has been received.     

Immunotoxicity testing guidance; availability. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Immunotoxicity Testing Guidance." This guidance is intended to provide FDA reviewers and manufacturers with a coherent strategy for assessing whether testing for potential adverse effects involving medical devices or constituent materials and the immune system is needed. The guidance is also intended to aid in developing a systematic approach to such testing.     

Medical device warning letter pilot. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is initiating a pilot program involving the medical device industry that is a continuation of the "medical device industry initiatives." This pilot concerns the issuance of warning letters for quality system, premarket notification submission (510(k)), and labeling violations. This pilot is intended to optimize resource utilization, enhance communication between industry and FDA, and provide firms with incentives to promptly correct violations or deficiencies. The pilot includes eligibility criteria and procedures for the issuance of warning letters.     

National Medical Support Notice. Pension and Welfare Benefits Administration, Labor. Final rule

This document contains a final rule that promulgates a National Medical Support Notice to be issued by State agencies as a means of enforcing the health care coverage provisions in a child support order, and to be treated by plan administrators of group health plans as a qualified medical child support order under section 609(a) of Title I of the Employee Retirement Income Security Act (ERISA). Through this regulation, the Department of Labor (the Department) is implementing an amendment to section 609(a) of ERISA, made by section 401 of the Child Support Performance and Incentive Act of 1998 (CSPIA), Pub. L. 105-200. This rule will affect group health plans, participants in group health plans, noncustodial children of such participants, and State agencies that administer child support enforcement programs.     

Requests that certain areas be designated as medically underserved areas--Health Resources and Services Administration. Notice

This notice is to advise all interested individuals and organizations particularly Health Systems Agencies and State Health Planning and Development Agencies, that the Department is reviewing a number of requests that certain areas be added to the current listing of areas designated as Medically Underserved Areas (MUAs). Governors of affected States will be consulted by letter regarding the proposed designations in their States. These areas are being reviewed as the result of requests for designation submitted by Health Systems Agencies.     

Guidance for industry on Population Pharmacokinetics; availability. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Population Pharmacokinetics." This guidance provides recommendations to pharmaceutical industry scientists, who have long been interested in the application of population pharmacokinetics, during the new drug development, safety and efficacy evaluation, and approval processes.     

Agreed minutes; meeting between the Food and Drug Administration and the Health Authorities of Switzerland. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is providing notice of agreed minutes between FDA and health authorities of Switzerland. The purpose of the agreed minutes is to continue and enhance cooperation in the fields of drugs, medical devices, and biological products consistent with FDA's framework for achieving mutual recognition of good manufacturing practices inspections.     

Memorandum of understanding between the Food and Drug Administration and the U.S. Army Medical Research and Material Command. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the U.S. Army Medical Research and Material Command. The purpose of the MOU is to define responsibilities during the research, development, and pre-marketing acquisition of medical material for military applications.     

National Medical Support Notice. Office of Child Support Enforcement, Administration for Children and Families, HHS. Final rule

This rule implements provisions of the Child Support Performance and Incentives Act of 1998 (CSPIA), Public Law 105-200, that require State child support enforcement agencies, under title IV-D of the Social Security Act (the Act), to enforce the health care coverage provision in a child support order through the use of the National Medical Support Notice (NMSN). A proposed rule was published in the Federal Register on November 15, 1999 (64 FR 62074). After consideration of the written comments received, changes have been made in this final regulation, including changes to the NMSN found in the Appendix.     

Health Care Financing Administration: adoption of the National Bureau of Standards fire safety evaluation system for health care facilities. Notice of comment period

The Department of Health, Education, and Welfare is proposing to extend use of the new Fire Safety Evaluation System (FSES) to all hospitals participating in the Medicare and Medicaid programs. We are seeking public comment on this proposal and on whether to apply the FSES to intermediate care and skilled nursing facilities. The Fire Safety Evaluation System (FSES) was designed by the National Bureau of Standards. It defines the combinations of widely accepted fire safety systems and structural arrangements which can be used by health care facilities to meet safety standards equal to or exceeding those in the Life Safety Code. The FSES provides a framework which guarantees that the high standards of fire safety necessary to protect patients will be met and which is flexible enough to allow for new advances in safety technology and practice. It is based on our experience, which clearly demonstrates that the Life Safety Code can be implemented more effectively and without waste if certain changes are made in the procedures for achieving these mandated levels of safety.     

Availability of additional HRSA competitive grants. Health Resources and Services Administration, HHS. Notice of availability of funds

The Health Resources and Services Administration (HRSA) announces the availability of funds for several HRSA programs. This Notice lists several programs that are announcing competitions for fiscal year (FY) 1999 funds but were not published in the fall 1998 HRSA Preview. This Notice includes funding for HRSA discretionary authorities and programs as follows: (1) Special Projects of National Significance, HIV/AIDS Bureau; (2) Extramural Support Program for Projects to Increase Organ and Tissue Donation, HIV/AIDS Bureau; (3) Cooperative Agreement for Emergency Medical Services for Children and Quality Improvement Center, Maternal and Child Health Bureau; and (4) Basic Nurse Education and Practice: Baccalaureate Nursing Education Using Distance Learning Methodologies for Rural RNs, Bureau of Health Professions. These programs were not published in the fall 1998 HRSA Preview and will only appear in the Federal Register and on the HRSA Home Page at: http://www.hrsa.dhhs.gov/. The next edition of the HRSA Preview is scheduled to be published by early summer 1999. The purpose of the HRSA Preview is to provide the general public with a single source of program and application information related to the Agency's competitive grant reviews. The HRSA Preview is designed to replace multiple Federal Register notices which traditionally advertised the availability of HRSA's discretionary funds for its various programs.     

Food and Drug Administration Modernization Act of 1997; list of documents issued by the Food and Drug Administration that apply to medical devices regulated by the Center for Biologics Evaluation and Research. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is publishing a list of documents issued in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA), and clarifying their applicability to medical devices regulated by the Center for Biologics Evaluation and Research (CBER). This notice is intended to inform the public of the availability of these documents, clarify their scope of applicability, and to provide instructions on ways to access them.     

International Conference on Harmonisation: guidance on testing for carcinogenicity of pharmaceuticals. Notice. Food and Drug Administration,HHS

The Food and Drug Administration (FDA) is publishing a guidance entitled "S1B Testing for Carcinogenicity of Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance outlines experimental approaches to evaluating the carcinogenic potential of pharmaceuticals to humans that may obviate the necessity for the routine conduct of two long-term rodent carcinogenicity studies     

Revocation of Office of Generic Drug's interim policy statement on inactive ingredients. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is revoking an interim policy statement on inactive ingredients in parenteral, ophthalmic, otic, and topical generic drug products (Interim Inactive Ingredient Policy). These generic drug products are the subjects of abbreviated new drug applications (ANDA's). The Interim Inactive Ingredient Policy was issued as a memorandum from the Acting Director of the Center for Drug Evaluation and Research's (CDER's) Office of Generic Drugs, FDA, to CDER's Associate Director for Science and Medical Affairs, FDA. FDA is taking this action because the Interim Inactive Ingredient Policy no longer represents current agency policy.     

Foods--adulteration involving hard or sharp foreign objects; compliance policy guide; availability. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) entitled "Foods--Adulteration Involving Hard or Sharp Foreign Objects." This CPG is intended to help FDA components and industry comply with FDA's internal enforcement process concerning foods that contain hard or sharp foreign objects.     

Notice of specific list for categorization of laboratory test systems, assays, and examinations by complexity--CDC. Notice with comment period

Regulations codified at 42 CFR 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. This Notice announces the addition of approximately 1,300 test systems, assays, and examinations that have been categorized and notified between June 7, 1996 and December 31, 1996. These categorizations were effective on the issue date of the notification letter sent to the manufacturer and are subject to the 30 day comment period for this Notice.