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

The Agency for Healthcare Research and Quality (AHRQ) and the Food and Drug Administration (FDA) are announcing a 2-day joint public workshop entitled ``Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges.'' This public workshop is intended to seek constructive input from a wide range of stakeholders, including clinicians, pharmacists, patients, third party payers of care, the pharmaceutical and biotechnology industries, researchers, and innovators in health information technology (HIT), to help in the development and implementation of mechanisms to minimize the risks of pharmaceuticals with unusual safety and patient monitoring concerns. This meeting is an initial step that is part of FDA's commitment to monitor the performance of RiskMAPs consistent with the goal articulated in the proposed PDUFA IV agreement to undertake regular follow up of these plans.

This is a notice to award a grant to the Medical Institute for Sexual Health, Austin, TX, in the amount of $207,400 to support the development of online medical accuracy training for abstinence education providers. Background: The Medical Institute for Sexual Health proposes to develop an online instructor-led workshop to train abstinence education providers in methods to access medically accurate sexual health information via the internet. Participants will learn to identify credible internet resources for sexual health information, efficiently and effectively search the internet, and answer most questions on sexual health topics. The proposal is within the scope of technical assistance activities that the Abstinence Education Division of the Family and Youth Services Bureau (FYSB) provides to grantees with regard to integrating medical and scientific information into abstinence education programming. The Congress, in appropriating funds for the program, has directed the Administration for Children and Families (ACF) to devote up to five percent of appropriated funds for technical assistance and capacity- building for abstinence education grantees. In addition, the proposed activities of this awardee are outside the scope of the ACF's previous or proposed abstinence education competitive program announcements and would not qualify for any other existing grant opportunities. For Further Information Contact: Stanley Koutstaal, Ph.D., Acting Director, Division of Abstinence Education, 1250 Maryland Ave., SW., Washington, DC 20024, (202) 401-9205, Nina.Degeorge@ACF.hhs.gov.

On March 1, 2007, this grant program was made available to the State of Louisiana to fund State payments for professional healthcare workforce fulfillment in Greater New Orleans, which has continued to face unique health professional shortages as a result of Hurricane Katrina and its subsequent floods. With nearly 4,500 doctors displaced and approximately 50 percent of the physicians who worked in Region 1 before Hurricane Katrina, no longer practicing there, Greater New Orleans is experiencing a shortage of primary care doctors to see Medicaid and uninsured patients. Funding recently awarded under this grant program must be used by the State to make payments for purposes of recruitment and retention of professional healthcare staff for the impacted communities. For purposes of this grant, impacted communities are those four parishes located in the State of Louisiana that comprise Region 1, as defined by the Louisiana Department of Health and Hospitals, namely, Orleans, Jefferson, St. Bernard, and Plaquemines. The grant funds must be used only for purposes of recruitment or retention of healthcare workforce professionals in Greater New Orleans. The State has been given flexibility in determining the payment methodology, the scope and type of activities, criteria for awarding payment, and the amount of payments to be made to such professionals. Payment recipients are limited to licensed healthcare professionals. Activities include those that were recommended by the Louisiana Health Care Redesign Collaborative (LHCRC) in their concept paper submitted to the Secretary on October 20, 2006. These activities include but are not limited to: Income guarantees, annual medical malpractice payment relief, loan repayments, and incentive payments (relocation expenses and sign-on bonuses). Grant funds may not be distributed to staff who are no longer providing professional healthcare services in the Greater New Orleans area at the time of the disbursement of grant funds. All payments must be made under this grant program by the end of federal fiscal year 2009. Payments to physicians and other professional healthcare workforce staff under this program are not allowed to be considered payments for Medicare, Medicaid or other specific services, and are not available as the non-Federal share of expenditures or for supplemental disproportionate share hospital payments. Payments cannot be made conditional on the provision of any particular items or services by the professionals. Grant applications requesting funds to be used for the non-Federal share of Medicaid or other federal grant expenditures or for supplemental Medicaid disproportionate share hospital payments will not be considered. This award was made based on the authority granted by section 6201 of the Deficit Reduction Act (DRA). In particular, section 6201(a)(4) of the DRA provides authority to the Secretary, Department of Health and Human Services (DHHS), to make payments to States to restore access to healthcare in communities impacted by Hurricane Katrina. Justification For Exception To Competition: The Secretary invoked his authority to restore healthcare in impacted communities affected by Hurricane Katrina by offering this unique funding opportunity which will give further incentive to the retention and recruitment of healthcare workforce professionals in Greater New Orleans. Louisiana is the only State with knowledge and ability to administer a grant designed to affect impacted Louisiana communities. For this reason, the Secretary has directed the Centers for Medicare & Medicaid Services to issue a single-source award to the State of Louisiana to increase access to healthcare services and to relieve economic pressures suffered by healthcare providers resulting from both the hurricane and its subsequent flooding.

The Food and Drug Administration (FDA) has determined the regulatory review period for FOSRENOL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for IRESSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 final rule revises the Child Care and Development Fund (CCDF) regulations to permit States to designate multiple public and/or private entities as eligible to receive private donations that may be certified as child care expenditures for purposes of receiving CCDF Federal matching funds. This final rule also raises from 20 to 30 percent the amount of each State's match requirement that may be met with public pre-kindergarten expenditures in order to implement a provision of the President's Good Start, Grow Smart initiative. These provisions are intended to give States increased flexibility in making the necessary State expenditures on child care to draw down their full allotment of CCDF Federal matching funds.