Department of Health and Human Services March 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined that LAMICTAL (lamotrigine) tablets, 50 milligrams (mg) and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for lamotrigine tablets, 50 mg and 250 mg, if all other legal and regulatory requirements are met.

This notice announces the eighth meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This proposed rule revises the Child Care and Development Fund (CCDF) regulations to provide for the reporting of error rates in the expenditure of CCDF grant funds by the fifty States, the District of Columbia and Puerto Rico. The error rate reports will serve to implement provisions of the Improper Payments Information Act of 2002 (IPIA) and the President's Management Agenda (PMA)'s goal of ``Eliminating Improper Payments.'' For reasons that will be explained in the preamble to the rule, the initial information collection under this proposed rule will require States, the District of Columbia, and Puerto Rico to review and report on a random sample of cases estimated to achieve the calculation of annual improper authorizations for payment (rather than improper payments made) with a 90 percent confidence interval of +/-5.0 percent.

The Secretary has authorized a total of $160 million in grant funds available to all three States. Based on each eligible IPPS hospital's and SNF's share of total Medicare inpatient payments in the FEMA designated counties in calendar year 2005 (the latest and most complete year of Medicare billing data available to us), this funding is being allocated for each State in the following proportions: 45 percent to Louisiana ($71,633,492), 38 percent to Mississippi ($60,556,425) and 17 percent to Alabama ($27,810,083). This grant program is to fund State payments to general, acute care hospitals, and skilled nursing facilities in impacted communities that may face financial pressures because of changing wage rates that are not yet reflected in Medicare PPS payment methodologies. The grant funds must be used by the States to make payments to all Medicare participating general hospitals, acute care hospitals, and SNFs that are currently paid under a Medicare PPS in the impacted communities. States have some flexibility in determining the methodology to determine the timing and amount of provider payments, but the methodology must reflect each provider's share of total Medicare payments during a specified period of time. Grant funds may not be distributed to hospitals and SNFs that are not in operation. States' payment methodologies should specify the relevant time periods and any other factors that will be considered in distributing available grant funds according to the principles specified above, and are subject to approval by CMS.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Monsanto Chemical Company in Dayton, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On February 16, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for the addition of tylosin tartrate to an approved subcutaneous implant containing trenbolone and estradiol used for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet Inc. The supplemental NADA provides for the removal of a caution statement against the formulation of pelleted feeds from labeling of zilpaterol hydrochloride Type A medicated article and Type B and Type C medicated feeds.

The Department of Health and Human Services (HHS or the Department) is issuing a new part 376 on nonprocurement debarment and suspension in Title 2 the Code of Federal Regulations (CFR). This new part is HHS's implementation of OMB's guidance provided at 2 CFR part 180. HHS is removing 45 CFR part 76, the part containing its implementation of the government-wide common rule on nonprocurement debarment and suspension. The new part in 2 CFR serves the same purpose as the common rule, but in a simpler way. This interim final rule is part of OMB's initiative to streamline and consolidate all federal regulations on nonprocurement debarment and suspension. It is an administrative simplification that would make no substantive change in HHS policy or procedures for nonprocurement debarment and suspension.