Department of Health and Human Services April 23, 2010 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253
The Food and Drug Administration (FDA) has determined the regulatory review period for VIMPAT based on new drug application (NDA) 22-253 for VIMPAT TABLETS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extensions of patents which claim the human drug product, VIMPAT. The regulatory review period determination for VIMPAT Injection is publishing in this issue of the Federal Register.
Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254
The Food and Drug Administration (FDA) has determined the regulatory review period for VIMPAT based on new drug application (NDA) 22-254 for VIMPAT injection and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim the human drug product, VIMPAT. The regulatory review period determination for VIMPAT Tablets is publishing in this issue of the Federal Register.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Fiscal Year (FY) 2010 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $1,000,000 (total costs) for up to one year to the current grantee for the National Center for Child Traumatic Stress (NCCTS). This is not a formal request for applications. Assistance will be provided only to the current grantee for the National Center for Child Traumatic Stress based on the receipt of a satisfactory application that is approved by an independent review group.
North American Bioproducts Corp.; Filing of Food Additive Petition (Animal Use); Erythromycin Thiocyanate
The Food and Drug Administration (FDA) is announcing that North American Bioproducts Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of erythromycin thiocyanate as an antimicrobial processing aid in fuel- ethanol fermentations with respect to its consequent presence in by- product distiller grains used as an animal feed or feed ingredient.
Certain Other Dosage Form New Animal Drugs; Detomidine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation and restraint of horses.
Medicare Program; Ambulatory Surgical Centers, Conditions for Coverage
This proposed rule would revise one of the existing conditions for coverage (CfC) that ambulatory surgical centers (ASCs) must meet in order to participate in the Medicare program. The proposed revision would modify the current CfC for patient rights to include an exception that would allow an ASC to provide patients or the patients' representative or surrogate with required patient rights information on the day of the procedure when the procedure must, to safeguard the health of the patient, be performed on the same day as the physician's referral. In addition, we are proposing some other minor changes to the CfC for patient right requirements.
Medicare and Medicaid Programs; Waiver of Disapproval of Nurse Aide Training Program in Certain Cases
This final rule will permit a waiver of a nurse aide training disapproval as it applies to skilled nursing facilities, in the Medicare program, and nursing facilities, in the Medicaid program, that are assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. This is a statutory provision enacted by section 932 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003).
Medicaid Program; Final FY 2008, Revised Preliminary FY 2009, and Preliminary FY 2010 Disproportionate Share Hospital Allotments and Final FY 2008, Revised Preliminary FY 2009, and Preliminary FY 2010 Disproportionate Share Hospital Institutions for Mental Disease Limits
This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal FY (FY) 2008 and the preliminary Federal share DSH allotments for FY 2010. This notice also announces the final FY 2008 and the preliminary FY 2010 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. This notice also announces the revised preliminary Federal share DSH allotments for FY 2009 and the revised preliminary FY limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities to reflect the provisions of the American Reinvestment and Recovery Act of 2009 (the Recovery Act), enacted on February 17, 2009. This notice also includes background information describing the methodology for determining the amounts of States' FY DSH allotments.
Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2009 and Federal Fiscal Year 2010
This notice sets forth final allotments available to States to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the Federal fiscal year (FY) 2009 and the preliminary QI allotments for FY 2010. The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations, as amended in the Federal Register published on November 24, 2008, and reflect funding for the QI program made available under recent legislation.
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