Department of Health and Human Services November 21, 2005 – Federal Register Recent Federal Regulation Documents

Public Meeting of the President's Council on Bioethics on December 8-9, 2005
Document Number: 05-22990
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-second meeting, at which, among other things, it will discuss ethical issues relating to children. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, lifespan-extension, and organ procurement for transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).
Fees for Sanitation Inspections of Cruise Ships
Document Number: 05-22967
Type: Notice
Date: 2005-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This notice announces an increase in the fees for vessel sanitation inspections for the remainder of fiscal year 2006 (January 1, 2006, through September 30, 2006).
Notice of Approval of Supplemental New Animal Drug Application; Ivermectin and Praziquantel Paste
Document Number: 05-22941
Type: Notice
Date: 2005-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for oral use of an ivermectin and praziquantel paste as an over-the-counter product for the treatment and control of various parasitic conditions of horses. This supplemental NADA reduces the minimum age for administration from 5 months to 2 months of age.
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-22940
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 05-22939
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 05-22938
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 05-22937
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-22936
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Florfenicol
Document Number: 05-22935
Type: Rule
Date: 2005-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the use of florfenicol by veterinary feed directive in catfish feed for the control of mortality due to enteric septicemia of catfish.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 05-22934
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 05-22933
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 05-22932
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 05-22931
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 05-22930
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 05-22929
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-22928
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Exclusion of Vendor Purchases Made Under the Competitive Acquisition Program (CAP) for Outpatient Drugs and Biologicals Under Part B for the Purpose of Calculating the Average Sales Price (ASP)
Document Number: 05-22175
Type: Rule
Date: 2005-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period provides clarification and solicits comments on the relationship between drugs supplied under the Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals and the calculation of Average Sales Price (ASP). (For purposes of this interim final rule, the term ``drug'' refers to drugs and biologicals.) This interim final rule with comment period also will exclude units of drugs supplied under the CAP from ASP calculations for a period of up to 3 years, at which time the policy will be re-evaluated. In addition, this rule revises the definition of unit to reflect the exclusion of units of CAP drugs administered to beneficiaries by participating CAP physicians.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 and Certain Provisions Related to the Competitive Acquisition Program of Outpatient Drugs and Biologicals Under Part B
Document Number: 05-22160
Type: Rule
Date: 2005-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule addresses Medicare Part B payment policy, including the physician fee schedule that are applicable for calendar year (CY) 2006; and finalizes certain provisions of the interim final rule to implement the Competitive Acquisition Program (CAP) for Part B Drugs. It also revises Medicare Part B payment and related policies regarding: Physician work; practice expense (PE) and malpractice relative value units (RVUs); Medicare telehealth services; multiple diagnostic imaging procedures; covered outpatient drugs and biologicals; supplemental payments to Federally Qualified Health Centers (FQHCs); renal dialysis services; coverage for glaucoma screening services; National Coverage Decision (NCD) timeframes; and physician referrals for nuclear medicine services and supplies to health care entities with which they have financial relationships. In addition, the rule finalizes the interim RVUs for CY 2005 and issues interim RVUs for new and revised procedure codes for CY 2006. This rule also updates the codes subject to the physician self-referral prohibition and discusses payment policies relating to teaching anesthesia services, therapy caps, private contracts and opt-out, and chiropractic and oncology demonstrations. As required by the statute, it also announces that the physician fee schedule update for CY 2006 is -4.4 percent, the initial estimate for the sustainable growth rate for CY 2006 is 1.7 percent and the conversion factor for CY 2006 is $36.1770.
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