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

Total Amount Awarded: $600,000. Total Number of Awards: One (1). Description of Opportunity: The Office of Disease Prevention and Health Promotion (ODPHP)/Office of Public Health and Science (OPHS), announces a competitive cooperative agreement project titled Disease Prevention and Health Promotion Scholarship Program for up to $600,000, in the fiscal year (FY) 2007 for a 5 year period, subject to available funding. This project seeks to provide disease prevention and health promotion educational and training opportunities for medical and public health students; preventive medicine and primary care residents; and practicing physicians and public health professionals. Eligibility: To qualify for funding, an applicant must be a professional non-profit organization, association, or institute of higher learning that focuses or has as its mission to educate one or more of the following groups: Medical and/or public health students, preventive medicine and primary care residents; and practicing physicians from communities across the country. Eligible applicants are also encouraged to apply in partnerships. Faith-based groups that meet the definition of professional non-profit organization or institution of higher learning as described above are also eligible to apply.

The Food and Drug Administration (FDA) is announcing the availability of several proposed and final documents that have been prepared by Study Groups 1 and 5 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on these documents.

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.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

This notice announces the 15th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

The DHHS Agency for Healthcare Research and Quality (AHRQ) invites nominations from interested organizations and knowledgeable individuals for a Stakeholder Group to support the work of the Effective Health Care Program, funded under Section 1013 of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003. The goals of this program are to develop evidence on the effectiveness and comparative effectiveness of different treatments and health care interventions of importance to the Medicare, Medicaid, and State Child Health Insurance. To achieve these goals, AHRQ is supporting projects to review, synthesize, generate and translate published and unpublished scientific evidence, as well as identify important issues for which existing scientific evidence is insufficient to inform decisions about health care. This evidence will be made readily available to all heath care decision-makers. The Stakeholder Group is critical to the success of this project, providing input to the program in collaboration with the Effective Health Care Scientific Resource Center (currently based at the Oregon Evidence-based Practice Center). The role of the Stakeholder Group will be to: Provide input on critical research information gaps for practice and policy and on identifying and developing the key research questions to address these gaps. Provide input on implementation issues for Effective Heath Care program reports and findings. Define information needs and identify types of projects that will be most useful. Provide feedback from report users. Provide guidance on the program as a whole for quality improvement. Provide guidance on how the program can have more of an impact with users. Members will serve as volunteers for a two-year period from October 2007 through September 2009. Stakeholder Group members will attend 3-4 meetings per year as part of this process. Meetings will be held in Rockville, MD and Portland, Oregon. Meetings will be 1-2 days in length. The Scientific Resource Center (SRC) will make the travel arrangements. The first meeting will be held on October 26, 2007, in Rockville, MD. Members are expected to actively participate in meetings and to engage in related activities by phone and e-mail between meetings. Between-meeting work may include assisting with agenda planning and session preparation for Stakeholder meetings, consulting with SRC or AHRQ staff on constituency issues, and serving as a resource to the Effective Health Care Program. It is anticipated that the Stakeholder Group member time commitment between meetings will not exceed 10 hours. The Stakeholder Group will be composed of up to 15 members. The group will represent several broad constituencies of stakeholders and decision-makers at the policy, system, and clinical levels, which will include: Third party healthcare payers (including, but not limited to public State or Federal Medicare or Medicaid programs, and private insurance health plans and Health maintenance Organizations). Employers and health-related business groups. Pharmacy and therapeutic committees. Healthcare providers. Patient/consumer organizations. Consumers of Federal and State beneficiary programs. Healthcare industry professional organizations. Academic researchers (including, but not limited to those with expertise in evidence-based methods and effectiveness and translational research). Self-nominations are encouraged. Materials to be submitted are a cover letter and curriculum vitae or similar supportive documentation. The cover letter will provide information on how the nominee's experience, skills and roles fit with the composition and goals of the Stakeholder Group as described above. Specific information on nominee experience in the constituency groups described above is required. Nominees chosen for the Stakeholder Group will be required to declare and submit conflict of interest documentation. This will not necessarily preclude service. Nominees may indicate their willingness to be considered in subsequent calls for nominations if not selected for this Stakeholder Group in their supporting documentation. All nominations received by submission deadline will be reviewed by a committee composed of representatives from AHRQ and the SRC. Nominees who best represent the broad constituencies described as the goal for composition of the Stakeholder Group will be selected and notified by September 28, 2007. In addition, AHRQ is interested in fostering diversity and including representatives of, or individuals with expertise regarding, populations experiencing health care disparities and in this case individuals with expertise regarding chronic conditions and health care needs of the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) populations.

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 Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 75-milligram size deracoxib tablet which is used for the control of pain and inflammation in dogs.

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on a proposed rule that would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove essential-use designations for certain oral pressurized metered-dose inhalers (MDIs). In the Federal Register of June 11, 2007 (72 FR 32030), the agency proposed to remove the essential use designation for MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Information from the public meeting, which is required by agency regulations, will be considered in finalizing the rulemaking.