Department of Health and Human Services October 2, 2006 – Federal Register Recent Federal Regulation Documents

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 Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations.'' This guidance explains FDA's current thinking regarding advances that have been made in the quality and manufacturing sciences since the current good manufacturing practice (CGMP) regulations were issued in 1978. The guidance describes the key elements of a robust quality systems model and shows how persons implementing such a model can achieve compliance with the CGMP regulations.

The Office of Public Health Emergency Preparedness (OPHEP) and the Office of Global Health Affairs (OGHA) within the U.S. Department of Health and Human Services (HHS) announces that up to $2,100,000 in fiscal year (FY) 2006 funds is available for a cooperative agreement to provide support to develop a cadre of in-country trainers who can improve their ongoing hospital infection-control programs to achieve better adherence by health-care workers to infection-control and case- management principles and practices. This effort is an undertaking by the Department of Health and Human Services (HHS). The project will be approved for up to a program period of three (3) years with a budget period of one-year for a total of $2,100,000. Under certain circumstances especially in support of HHS International efforts, OGHA and OPHEP are required to collaborate on programs, issues and initiatives regarding international public health (i.e. Avian Influenza, disease surveillance, etc.). Normally, OGHA is often tasked as to devise, award, and administer international Federal assistance actions (grants, cooperative agreements, IAA's, etc.). When emergency preparedness issues are to be addressed as part of the program plan, OGHA partners with OPHEP to provide assistance in ensuring risks mitigation and emergency preparedness elements are included. The Regional Emerging Diseases Intervention (REDI) Center in Singapore will design the program around mentorship principles so trainers can gain advice and support for their efforts in teaching infection-control and case-management practices in local languages. While there is no current pandemic influenza outbreak, there is still reason to be concerned about the spread of the H5N1 virus from Southeast Asia to countries in Europe, the Middle East, and Africa. In the last century, three influenza pandemics have affected the United States, and viruses from birds contributed to all of them. Medical practitioners have also discovered several other, new, avian viruses human beings can transmit among one another. Although the H5N1 virus has primarily infected domesticated birds and long-range migratory birds, the virus has demonstrated the ability to infect and produce fatal illness in humans. Influenza experts believe an avian virus could become efficiently transmissible between humans, and result in a worldwide outbreak, which would overwhelm health and medical capabilities. Furthermore, an influenza pandemic could result in hundreds of thousands of deaths, millions of hospitalizations, and hundreds of billions of dollars in direct costs in the United States alone. On November 1, 2005, President Bush announced the National Strategy on Pandemic Influenza, and the following day Secretary Michael O. Leavitt released the HHS Pandemic Influenza Plan. Building on these efforts, President Bush released the Implementation Plan for the National Strategy for Pandemic Influenza on May 3, 2006, which describes more than 300 critical actions to address the threat of pandemic influenza. All relevant Federal Departments and agencies must take steps to address the threat of avian and pandemic influenza. Drawing on the combined efforts of Government officials and the public- health, medical, veterinary, and law-enforcement communities, as well as the private sector, this strategy is designed to meet three critical goals: Detecting human or animal outbreaks that occur anywhere in the world; protecting the American people by stockpiling vaccines and antiviral drugs, while improving the capacity to produce new vaccines; and preparing to respond at the Federal, State, and local levels in the event an avian or pandemic influenza reaches the United States. HHS technical expertise in applied epidemiology, rapid laboratory diagnostics, infection control, virology research, vaccine delivery, and other areas is a critical component of both the domestic and the international response to the threat of pandemic influenza. One of the primary objectives of both the National Strategy and the HHS Pandemic Plan is to leverage global partnerships to increase preparedness and response capabilities around the world with the intent of stopping, slowing, or otherwise limiting the spread of a pandemic to the United States.\1\ The U.S. cannot mount an effective response to an influenza pandemic without effective worldwide partnerships. As such, we are working bilaterally with partner countries, with multilateral organizations, and with private, non-profit organizations, to amplify our efforts. Our international effort to contain and mitigate the effects of an outbreak of pandemic influenza is a central component of our overall strategy. In many ways, the character and quality of the U.S. response and that of our international partners could play a determining role in the severity of a pandemic. Pillars Two and Three of the National Strategy set out clear goals for ensuring the rapid reporting of outbreaks and containing outbreaks beyond the borders of the U.S. by taking the following actions:

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Rural Hospice Demonstration (RHD), System No. 09-70-0563.'' The program is mandated by Sec. 409 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173), which was enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). Section 409 authorizes the Secretary of HHS (the Secretary) to conduct a demonstration project for the delivery of hospice care to Medicare beneficiaries in rural areas. Under the demonstration, Medicare beneficiaries who are unable to receive hospice care at home for lack of an appropriate caregiver are provided such care in a facility of 20 or fewer beds that offers, within its walls, the full range of services provided by hospice programs. In order for a hospice organization or agency to participate in this demonstration, it must be Medicare certified and meet all of the Medicare Conditions of Participation as described in subparts C (General Provisions), D (Core Services), and E (Other Services) of 42 CFR 418, except it shall not be required to offer services outside the facility or meet the 20 percent inpatient cap requirements of section 1861(dd)(2) (A) (iii) of the Act. The purpose of this system is to collect and maintain a person- level view of identifiable data of Medicare beneficiaries who participate in the rural hospice demonstrations. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or grantee; (2) assist another Federal or State agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about this system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

In accordance with the Grants Policy Directive Part 1.03, the Office of Health Information Technology (OHIT) has been granted a class deviation from the competition requirements contained in the Grants Policy Directive Part 2.04 to provide an additional year of funding without competition for Health Center Controlled Network (HCCN) Initiatives funded under Section 330 of the Public Health Service Act, as amended.

The Food and Drug Administration (FDA) has determined the regulatory review period for BYETTA 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 that claims that human drug product.