Federal register
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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.
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This notice provides guidelines for complying with 42 CFR 411.25, which provides that certain third party payers for health services furnished to Medicare beneficiaries must furnish certain information to Medicare intermediaries and carriers when they learn that Medicare made primary payment for services for which the third party payer has made or should have made primary payment. The notice also informs third party payers that they should contact HCFA if they wish to discuss arrangements for exchanging, on a voluntary basis, data about beneficiaries for whom the third party payer has a primary payment obligation under the Medicare Secondary Payer (MSP) provisions of the Medicare law. ⋯ If the group health plan, or workers' compensation plan is self-insured and self-administered, the employer must provide the notice; otherwise the insurer, underwriter or third party administrator must give the notice. This description of information third party payers must furnish is intended to help ensure that, in accordance with the Medicare law, Medicare pays only secondary to primary coverage of third party payers.
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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. ⋯ 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.
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The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. ⋯ In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA.
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The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.