Federal register
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This final rule implements provisions of the Immigration Act of 1990 (IMMACT). Public Law No. 101-649, November 29, 1990, and the Armed Forces Immigration Adjustment Act of 1991. Public Law No. 102-110, October 1, 1991, as they relate to temporary alien workers seeking nonimmigrant classification and admission to the United States under sections 101(a)(15) (H), (L), (O), and (P) of the Immigration and Nationality Act (Act), 8 U. ⋯ C. 1101. This rule also contains technical amendments which reflect the Service's operating experience under the H and L classifications. This rule will conform Service policy to the intent of Congress as it relates to these classifications, implement new nonimmigrant classifications and requirements established by Public Law 101-649 and Public Law No. 102-110, and clarify for businesses and the general public requirements for classification, admission, and maintenance of status.
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The Food and Drug Administration (FDA) is promulgating a new regulation to describe how the agency will determine which component within FDA will have primary jurisdiction for the premarket review and regulation of: (1) A combination drug, device, or biologic product or (2) any drug, device, or biologic product where the center with primary jurisdiction is unclear or in dispute. This rule describes how to identify the agency's assigned review component which will, in most cases, eliminate the need for a sponsor to obtain approval from more than one FDA component for a combination product.
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The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to redelegate the Commissioner's authority to designate primary jurisdiction over the premarket review and regulation of combination products under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U. S. C. 353(g)(1)) a provision of the Safe Medical Devices Act of 1990 to the ombudsman as the product jurisdiction officer, Office of the Commissioner. Under a regulation published elsewhere in this issue of the Federal Register, the FDA ombudsman is the designated product jurisdiction officer.
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The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to premarket approval of products that are or contain a biologic, a device, or a drug. The amendment grants directors, deputy directors, and certain other supervisory personnel in the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Drug Evaluation and Research (CDER) reciprocal premarket approval authority to approve such products.
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This rule sets forth the policy of the Department of Veterans Affairs (VA) for participation in the National Practitioner Data Bank (Data Bank). VA will request information from the Data Bank concerning physicians, dentists and other health care practitioners who provide or seek to provide health care services at VA facilities and will also report information to the Data Bank regarding malpractice payments and adverse clinical privileges actions. The intended effect of this policy is to participate in the Data Bank for the purpose of promoting better health care at VA and non-VA health care facilities.