Department of Health and Human Services May 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for fomepizole solution for injection from Orphan Medical, Inc., to Jazz Pharmaceuticals, Inc. The regulations are also being amended to reflect approval of a supplemental NADA to remove a vial of saline diluent from this product.

This is a project to enhance the surveillance, epidemiological investigation, and laboratory diagnostic capabilities in Panama and other selected countries in Latin America that are at risk for an avian influenza (H5N1) outbreak. Such enhancements will help establish an early-warning system that could prevent and contain the spread of a highly pathogenic avian influenza to the United States and enhance our nation's preparedness for a possible human influenza pandemic.

The revised Federal Medical Assistance Percentages and Enhanced Federal Medical Assistance Percentages for Alaska for Fiscal Years 2006 and 2007 have been calculated pursuant to section 6053(a) of the Deficit Reduction Act. These percentages will be effective from October 1, 2005 through September 30, 2006 and October 1, 2006 through September 30, 2007. These revised Federal Medical Assistance Percentages for Alaska replace the percentages previously published for Fiscal Year 2006 (published November 24, 2004) and Fiscal Year 2007 (published November 30, 2005). This notice announces the revised ``Federal Medical Assistance Percentages'' and ``Enhanced Federal Medical Assistance Percentages'' that we will use in determining the amount of Federal matching for State medical assistance (Medicaid) and State Children's Health Insurance Program (SCHIP) expenditures for Alaska. The table gives the figure for Alaska, which is the only state affected by section 6053(a) of the Deficit Reduction Act. Section 6053(a) of the Deficit Reduction Act of 2005 provides for a modification of Alaska's Medicaid FMAP for Fiscal Years 2006 and 2007. The provision permits a maintenance of the Fiscal Year 2005 FMAP for Fiscal Year 2006 and Fiscal Year 2007 if the 2006 or 2007 FMAPs as calculated pursuant to section 1905(b) of the Act are less than the 2005 FMAP. Since the calculated Fiscal Year 2006 and 2007 FMAPs for Alaska are less than the 2005 FMAP, Alaska's 2005 FMAP will apply for Fiscal Years 2006 and 2007. Section 6053(a) applies to expenditures under Title XIX and Title XXI. Therefore, the Enhanced Federal Medical Assistance Percentages for Alaska for 2006 and 2007 will be calculated from Alaska's revised Federal Medical Assistance Percentages for 2006 and 2007. Federal Medical Assistance Percentages are used to determine the amount of Federal matching for State expenditures for assistance payments for certain social services such as Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Care Mandatory and Matching Funds for the Child Care and Development Fund, Title IV-E Foster Care Maintenance payments, Adoption Assistance payments, and State medical and medical insurance expenditures for Medicaid and the State Children's Health Insurance Program (SCHIP). However, the modification of the Federal Medical Assistance Percentages and the Enhanced Federal Medical Assistance Percentages under the Deficit Reduction Act of 2005 affect only medical expenditure payments under Title XIX and all expenditure payments for the State Children's Health Insurance Program under Title XXI. The Department believes that the percentages in this notice do not apply to payments under Title IV of the Act. In addition, the Title XIX statute provides separately for Federal matching of administrative costs, which is not affected by the Deficit Reduction Act of 2005. The Deficit Reduction Act of 2005, section 6053(b) also instructs the Secretary of HHS to disregard Katrina evacuees and income attributable to them in calculating the FMAPs for states with a significant number of evacuees. This provision would affect the calculation of the Federal Medical Assistance Percentages for Fiscal Year 2008, which HHS will publish in Fall 2006.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 25 approved new animal drug applications (NADAs) and 16 approved abbreviated new animal drug applications (ANADAs) for Type A medicated articles and feed use combinations from Intervet, Inc., to Huvepharma AD.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2007 (for discharges occurring on or after October 1, 2006 and on or before September 30, 2007) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the inpatient rehabilitation facility prospective payment system's case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are proposing to revise existing policies regarding the prospective payment system within the authority granted under section 1886(j) of the Act. In addition, we are proposing to revise the current regulation text at 42 CFR 412.23(b)(2)(i) and (b)(2)(ii) to reflect the changes enacted under section 5005 of the Deficit Reduction Act of 2005.

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given of the ninth Policy Committee meeting concerning adoption of the final report. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting. This notice is being published less than 15 days prior to the meeting due to scheduling problems.