Department of Health and Human Services August 2, 2007 – Federal Register Recent Federal Regulation Documents
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Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Injection
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 Norbrook Laboratories, Ltd. The ANADA provides for use of an oxytetracycline hydrochloride injectable solution in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves for the treatment of various bacterial diseases.
Ophthalmic and Topical Dosage Form New Animal Drugs; Emodepside and Praziquantel
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Bayer HealthCare LLC. The NADA provides for veterinary prescription use of an emodepside and praziquantel topical solution on cats for the treatment and control of infections by several internal parasites.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2008
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2008 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA), authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2008. For FY 2008, the animal drug user fee rates are: $172,500 for an animal drug application; $86,250 for a supplemental animal drug application for which safety or effectiveness data is required; $4,125 for an annual product fee; $52,700 for an annual establishment fee; and $43,900 for an annual sponsor fee. FDA will issue invoices for FY 2008 product, establishment and sponsor fees by December 30, 2007, and these invoices will be due and payable by January 31, 2008. The application fee rates are effective for applications submitted on or after October 1, 2007, and will remain in effect through September 30, 2008. Applications will not be accepted to review until FDA has received full payment of application fees and any other animal drug user fees owed.
Office of the National Coordinator for Health Information Technology; American Health Information Community; Announcement of Public Comment Period About the Design and Implementation of the American Health Information Community Successor
This notice announces a public comment period, from August 6, 2007 to August 31, 2007, to collect input about ideas for the design and implementation of a successor entity for the American Health Information Community (AHIC) as described in the American Health Information Community Successor White paper, July 2007 (available on the Web at https://www.hhs.gov/healthit/community/background/ AHICsuccessor. html on or after July 31, 2007). The ANIC is a federally-chartered advisory committee that provides input and recommendations to the Department of Health and Human Services (HHS) on how to make health records digital and interoperable, and how to assure that the privacy and security of those records are protected. The charter of the AHIC requires that its responsibilities be transferred to a successor entity. Therefore, HHS and the AHIC are embarking upon a project that will take the AHIC to the next level. The successor entity will be an independent, sustainable public-private partnership that brings together the best of the public and private sectors. This new public-private partnership will develop a unified approach to realize an effective, interoperable nationwide health information system that supports the health and well-being of the people of this country. The input from this public comment period will be used to inform the plans for transitioning the locus of activity from a Federal advisory committee to a independent public-private partnership. HHS and the AHIC are eager to hear the thoughts of your organization with respect to the AHIC successor entity. To facilitate your participation in this process, you are encouraged to provide your comments organized by the following concepts:
Medicare Program: Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates; Proposed Changes to the Ambulatory Surgical Center Payment System and CY 2008 Payment Rates; Medicare and Medicaid Programs: Proposed Changes to Hospital Conditions of Participation; Proposed Changes Affecting Necessary Provider Designations of Critical Access Hospitals
This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2008. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). In this proposed rule, we propose the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which the final policies of the ASC payment system would apply, and other pertinent ratesetting information for the CY 2008 ASC payment system. These changes would be applicable to services furnished on or after January 1, 2008. In this proposed rule, we also are proposing changes to the policies relating to the necessary provider designations of critical access hospitals (CAHs) that are being recertified when a CAH enters into a new co-location arrangement with another hospital or CAH or when the CAH creates or acquires an off-campus location. Further, we are proposing changes to several of the current conditions of participation that hospitals must meet to participate in the Medicare and Medicaid programs to require the completion and documentation in the medical record of medical histories and physical examinations of patients conducted after admission and prior to surgery or a procedure requiring anesthesia services and for postanesthesia evaluations of patients before discharge or transfer from the postanesthesia recovery area.
Medicare Program; Revised Payment System Policies for Services Furnished in Ambulatory Surgical Centers (ASCs) Beginning in CY 2008
This final rule revises the Medicare ambulatory surgical center (ASC) payment system to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). This final rule establishes the ASC list of covered surgical procedures, identifies covered ancillary services under the revised ASC payment system, and sets forth the amounts and factors that will be used to determine the ASC payment rates for calendar year (CY) 2008. The changes to the ASC payment system and ratesetting methodology in this final rule are applicable to services furnished on or after January 1, 2008.
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