Federal register
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We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the TMA, Abstinence Education, and QI Program Extension Act of 2007, the Medicare Improvements for Patients and Providers Act of 2008, and the American Recovery and Reinvestment Act of 2009. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 2009. ⋯ Third, in this final rule, we are responding to public comments we received on, and finalizing, two May 2008 interim final rules with comment period that implemented certain provisions of section 114 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA, Pub. L. 110-173) relating to payments to LTCHs and LTCH satellite facilities, the establishment of LTCHs and LTCH satellite facilities, and increases in beds in existing LTCHs and LTCH satellite facilities under the LTCH PPS. Fourth, through an interim final rule with comment period as part of this document, we are implementing those provisions of the ARRA that amended certain provisions of section 114 of the MMSEA relating to payments to LTCHs and LTCH satellite facilities and increases in beds in existing LTCHs and LTCH satellite facilities under the LTCH PPS.
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The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. ⋯ The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.
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The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency's final rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted previously.
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With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance tapentadol, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, into schedule II of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of schedule II will be applicable to the manufacture, distribution, dispensing, importation, and exportation of tapentadol and products containing tapentadol.
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." 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 a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."