Federal register
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In this document, EPA is finalizing the Long Term 1 Enhanced Surface Water Treatment Rule (LT1ESWTR). The purposes of the LT1ESWTR are to improve control of microbial pathogens, specifically the protozoan Cryptosporidium, in drinking water and address risk trade- offs with disinfection byproducts. ⋯ The LT1ESWTR builds upon the framework established for systems serving a population of 10,000 or more in the Interim Enhanced Surface Water Treatment Rule (IESWTR). This rule was proposed in combination with the Filter Backwash Recycling Rule (FBRR) in April 2000.
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The Food and Drug Administration (FDA) is issuing a final rule to amend its regulations pertaining to the registration of foreign establishments and the listing of human drugs, animal drugs, biological products, and devices. The final rule requires foreign establishments whose products are imported or offered for import into the United States to register with FDA and to identify a United States agent. The final rule implements section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) as it pertains to foreign establishment registration.
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Section 3102 of the Children's Health Act of 2000, Pub. L. 106-310, amends section 501 of the Public Health Service (PHS) Act (42 U. S. ⋯ Pursuant to Public Law 106-310, the Secretary is required to establish, and publish in the Federal Register, criteria for determining when a mental health or substance abuse emergency exists. In this interim final rule, the Secretary sets out these criteria, as well as the intended approach for implementing this new mental health and substance abuse emergency response authority. The Secretary invites public comments on both the criteria and the approach described in this interim final rule.
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients." 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 describes current good manufacturing practice (CGMP) for manufacturing of active pharmaceutical ingredients (APIs). The guidance is intended to help ensure that all APIs meet the standards for quality and purity they purport or are represented to possess.
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We are revising the Medicare hospital inpatient prospective payment systems for operating and capital costs to: implement applicable statutory requirements, including a number of provisions of the Medicare, Medicaid, and SCHIP [State Children's Health Insurance Program] Benefits Improvement and Protection Act of 2000 (Public Law 106-554); and implement changes arising from our continuing experience with these systems. In addition, in the Addendum to this final rule, we describe changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes apply to discharges occurring on or after October 1, 2001. ⋯ These provisions related to reclassification of hospitals from urban to rural status, reclassification of certain hospitals for purposes of payment during fiscal year 2000, critical access hospitals, payments to hospitals excluded from the prospective payment system, and payments for indirect and direct graduate medical education costs. A June 13, 2001 interim final rule with comment period (66 FR 32172, HCFA-1178-IFC) that implemented, or conformed the regulations to, certain statutory provisions relating to Medicare payments to hospitals for inpatient services that were contained in Public Law 106- 554, and that were effective prior to passage of Public Law 106-554 on December 21, 2000; on April 1, 2001; or on July 1, 2001. Many of the provisions of Public Law 106-554 modified changes to the Social Security Act made by Public Law 106-113 or the Balanced Budget Act of 1997 (Public Law 105-33), or both.