Department of Health and Human Services April 21, 2006 – Federal Register Recent Federal Regulation Documents
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MicroArray Quality Control Project on the Evaluation of Analysis Protocols for Deoxyribonucleic Acid Microarray Data
The Food and Drug Administration (FDA) is soliciting gene expression datasets from deoxyribonucleic acid (DNA) microarray studies, as well as proposals to analyze these datasets in order to evaluate the impact of different analysis protocols on the selection of genes and their associated signatures for biomarker pattern development. This project is being coordinated by FDA as a followup to the MicroArray Quality Control (MAQC) Project. This evaluation process is open to the public.
Vaccine Adverse Event Reporting; Revised Form VAERS-2; Withdrawal of Proposed Revised Form
The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed revised form that was issued in the Federal Register on November 20, 2001.
State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP Funds From the Appropriation for Fiscal Year 2003; Additional Allotments To Eliminate SCHIP Fiscal Year 2006 Funding Shortfalls; and Provisions for Continued Authority for Qualifying States To Use a Portion of Certain SCHIP Funds for Medicaid Expenditures
This notice with comment period describes the procedure for redistribution of States' unexpended Federal fiscal year (FY) 2003 SCHIP allotments remaining at the end of FY 2005 to those States that fully expended such allotments. This notice also announces the application of the provisions of the Deficit Reduction Act of 2005 (DRA, Pub. L. 109-171, enacted on February 8, 2006) concerning the availability of additional allotments appropriated to eliminate States' funding shortfalls under the SCHIP in FY 2006. The redistributed FY 2003 allotments and the additional allotments to eliminate shortfalls in FY 2006 will be available through the end of FY 2006 (September 30, 2006). This notice also describes the DRA amendments to the SCHIP statute relating to the provisions for ``qualifying States'' to elect to receive a portion of their available SCHIP allotments as increased Federal matching funds for certain expenditures in their Medicaid programs.
New Animal Drugs for Use in Animal Feeds; Melengestrol and Monensin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and monensin to make two-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
Revocation of Status of Specific Products; Group A Streptococcus; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of June 2, 2006, for the direct final rule that appeared in the Federal Register of December 2, 2005 (70 FR 72197). The direct final rule removes the regulation applicable to the status of specific products; Group A streptococcus. FDA is removing the regulation because the existing requirement for Group A streptococcus organisms and derivatives is both obsolete and a perceived impediment to the development of Group A streptococcus vaccines. This document confirms the effective date of the direct final rule.
Medicare Program; Requirements for Providers and Suppliers To Establish and Maintain Medicare Enrollment
This final rule requires that all providers and suppliers (other than physicians or practitioners who have elected to ``opt-out'' of the Medicare program) complete an enrollment form and submit specific information to us. This final rule also requires that all providers and suppliers periodically update and certify the accuracy of their enrollment information to receive and maintain billing privileges in the Medicare program. In addition, this final rule implements provisions in the statute that require us to ensure that all Medicare providers and suppliers are qualified to provide the appropriate health care services. These statutory provisions include requirements meant to protect beneficiaries and the Medicare Trust Funds by preventing unqualified, fraudulent, or excluded providers and suppliers from providing items or services to Medicare beneficiaries or billing the Medicare program or its beneficiaries.
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