Department of Health and Human Services August 12, 2005 – Federal Register Recent Federal Regulation Documents
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Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Meeting of the Advisory Committee on Blood Safety and Availability
The Advisory Committee on Blood Safety and Availability will meet to review progress and solicit additional comments from the Committee regarding numerous recommendations made over the past year. Specifically, the Committee will hear updates of previous recommendations. In addition, the Committee will be asked to continue its deliberation on strategies for vigilant detection and management of emerging or re-emerging infectious diseases, since it is a necessary first step toward the goal of reducing the risk of transfusion- transmitted diseases as well as disease transmission through other vital products such as bone marrow, progenitor cells, tissues, and organs.
Solicitation for Written Comments on the Proposed Changes to Healthy People 2010 Through the Midcourse Review
The Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science (OPHS), U.S. Department of Health and Human Services (HHS), acting on behalf of HHS and its lead agencies, as part of the process of conducting the Midcourse Review of Healthy People 2010, is soliciting written comments for consideration on changes and revisions proposed to the Healthy People 2010 objectives. Healthy People 2010, a set of national health objectives, was published by HHS in 2000. The Midcourse Review (MCR), conducted at the midpoint of the decade, is the process through which the Healthy People 2010 objectives are reviewed by HHS, the lead agencies, and other experts, to assess the data trends during the first half of the decade, consider new science and available data, and make changes that ensure that Healthy People 2010 remains current, accurate, and relevant. The proposed revisions take the form of: establishing baselines and targets for formerly developmental objectives (i.e., objectives that had no baseline data or target when Healthy People 2010 was released in 2000); changes to the language of objectives and subobjectives; deletions of objectives and subobjectives; new subobjectives; and baseline and target revisions.
Draft Guidance for Industry on Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance for industry entitled ``Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence.'' FDA is withdrawing the draft guidance because the published methodology limits the submission of scientifically valid information to the agency that may be based on different methodologies. FDA does not want to dictate the scientific approach for developing adequate methods.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2006 Rates
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. 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 hospital inpatient services for operating costs and capital- related costs. We also are setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. These changes are applicable to discharges occurring on or after October 1, 2005, with one exception: The changes relating to submittal of hospital wage data by a campus or campuses of a multicampus hospital system (that is, the changes to Sec. 412.230(d)(2) of the regulations) are effective on August 12, 2005. Among the policy changes that we are making are changes relating to: The classification of cases to the diagnosis-related groups (DRGs); the long-term care (LTC)-DRGs and relative weights; the wage data, including the occupational mix data, used to compute the wage index; rebasing and revision of the hospital market basket; applications for new technologies and medical services add-on payments; policies governing postacute care transfers, payments to hospitals for the direct and indirect costs of graduate medical education, submission of hospital quality data, payment adjustment for low-volume hospitals, changes in the requirements for provider-based facilities; and changes in the requirements for critical access hospitals (CAHs).
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