Federal register
-
The Food and Drug Administration (FDA) is issuing a final rule amending the regulations governing humanitarian use devices (HUD's). These amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
-
The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).
-
This interim rule, which has been drafted in consultation with the U. S. Department of Health and Human Services (HHS), amends regulations of the Immigration and Naturalization Service (Service or INS) in order to implement, on a temporary basis, certain portions of section 343 of the Illegal Immigration Reform and Immigrant Responsibility act of 1996 (IIRIRA) as they relate to prospective immigrants. ⋯ This requirement is intended to ensure that aliens possess proficiency in the skills that affect the provision of health care services in the United States. This rule establishes a temporary mechanism to allow applicants for immigrant visas or adjustment of status in the fields of nursing and occupational therapy of satisfy the requirements of section 343 on a provisional basis. The Service expects to publish a proposed rule in the near future which will implement in full the provisions of section 343.
-
The Food and Drug Administration (FDA) is amending certain regulations governing establishment registration and device listing by domestic distributors. These amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.
-
The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of June 16, 1998 (63 FR 32772). The document proposed to amend the FDA regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The document was published with an error. This document corrects that error.