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

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV.'' The guidance is intended to encourage sponsors to submit to FDA applications for fixed dose combination (FDC), co-packaged, and single- entity versions of antiretroviral drugs for the treatment of human immunodeficiency virus (HIV). The availability of a wide range of safe and effective antiretroviral products may help facilitate a wider distribution of anti-HIV drugs to better meet the demands of the global HIV/AIDS pandemic.

The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ALTACE (ramipril), GEMZAR (gemcitabine), LESCOL (fluvastatin), SANDOSTATIN LAR (octreotide), and SEREVENT (salmeterol). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.

This notice announces the eleventh meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the fourth meeting of the American Health Information Community Confidentiality, Privacy and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the eleventh meeting the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Ms. Anne L. Butkovitz from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Ms. Butkovitz was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the act. After being given notice of the proposed permanent debarment and her opportunity to request a hearing within the timeframe prescribed by regulation, Ms. Butkovitz failed to request a hearing. Ms. Butkovitz's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.

In January 2006, the Interagency Coordinating Committee on Alternative Methods (ICCVAM) received a test method nomination for the validation of a cell-based estrogen receptor (ER) transcriptional activation (TA) test method from CertiChem, Inc. CertiChem, Inc. submitted a background review document (BRD) containing information on historical development of the test method, the rationale for the test method, and supporting materials. In accordance with the ICCVAM nomination process, NICEATM conducted a pre-screen evaluation of the BRD to determine the extent that it addressed ICCVAM prioritization criteria, submission guidelines, and recommendations for standardization and validation of in vitro endocrine disruptor test methods. NICEATM also reviewed the performance of the test method based on pre-validation data to determine if it warranted consideration for further validation. ICCVAM requests public comments on the pre-screen evaluation titled, ``Pre-Screen Evaluation of the CertiChem, Inc. In Vitro Endocrine Disruptor Assay (Robotic MCF-7 Cell Proliferation Assay of Estrogenic Activity.)'' The pre-screen evaluation is available with supporting documents at (https://iccvam.niehs.nih.gov/methods/ endocrine.htm). ICCVAM also invites public comments on whether this test method should be considered for additional validation studies. In addition, ICCVAM again invites the nomination of other in vitro ER and androgen receptor (AR) binding and TA test methods for which there are standardized test method protocols, pre-validation data, and proposed validation study designs.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Current Beneficiary Survey (MCBS),'' System No. 09-70-6002, last published at 66 Federal Register 15496 (March 19, 2001). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center of the Health Care Financing Administration that maintained the system of records. The new assigned identifying number for this system should read: System No. 09-70-0519. We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will be renumbered as routine use number 1. We will delete routine use number 4 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain a research database for CMS and other researchers that is capable of producing data sets suitable for both longitudinal and cross-sectional analysis to be used to: (1) Produce projections for current programs and proposed program changes, (2) produce national level estimates of health care expenditures by the aged and disabled, and (3) provide a research database that can be used to provide guidance to program management and policies. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or a CMS 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) assist 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; and (4) support litigation involving the agency. We have provided background information about the modified 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATE section for comment period.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Competitive Bidding for Clinical Laboratory Services (CBCLS), System No. 09-70- 0589.'' The demonstration project is mandated by section 302(b) 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). The CBCLS demonstration and evaluation seek to determine whether competitive bidding can be used to provide quality laboratory services at prices below current Medicare reimbursement rates. Independent, hospital, and physician office laboratories providing non- patient Medicare Part B laboratory services will be required to participate in the demonstration. The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who reside in the demonstration area and providers and/or suppliers that are potential participants in the demonstration who provide Medicare Part B clinical laboratory services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant; (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 the new 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.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Duke University, on behalf of its Duke Clinical Research Institute (DCRI). FDA and Duke University agree to collaborate under the terms and conditions of this MOU, through steering committees and technical working groups, to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goals of identifying indicators of cardiovascular risk, predicting adverse cardiovascular events associated with therapeutic interventions, improving the clinical utility of biomarker technologies as diagnostic and assessment tolls that facilitate the development of safer and more effective cardiovascular therapies, diagnostic, and assessment tools. This collaboration between the Parties shall be known as the Cardiac Safety Research Consortium.

The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or items that measure patient perspectives on the cultural awareness of the healthcare professionals providing care to those patients. This initiative is in response to the need to develop a new CAHPS[supreg] cultural competency survey. AHRQ is interested in incorporating this survey into an integrated set of carefully tested, standardized survey questionnaires and accompanying reports. The addition of the CAHPS[supreg] cultural competency component to the set is intended to empower consumers with quality of care information while also encouraging healthcare professionals to provide culturally competent care. The survey will be designed to assess the quality of care and services provided by healthcare professional in the context of cultural competency. Based on prior work, there are several functional areas that the planned instrument could assess such as: (1) Patient-provider communication (e.g., providers give clear explanations, patients feel that they get all the information they need,), (2) respect for patient preferences/shared decision-making (e.g., providers discuss pros and cons of treatment options, providers understand and takes into account patient's environment, family members are appropriately included in decisions), (3) experiences leading to trust or distrust (e.g., providers treat patients in a culturally sensitive or insensitive manner that led to trust or distrust), (4) experiences of discrimination (e.g., providers or staff treat patients with disrespect because of a patients' racial/ethnic backgrounds, insurance type/ status, lack of proficiency in English), (5) language access (e.g., availability of interpreter services and translated materials), and (6) alternative treatment (e.g., providers are open to discussion about traditional healers and remedies).

The Secretary of Health and Human Services, by authority of 42 U.S.C. 9836A, section 641A(b) of the Head Start Act, as amended (5 U.S.C. Appendix 2), has formed the Advisory Committee on Head Start Accountability and Educational Performance Measures (the Committee). The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2). The function of the Committee is to help assess the progress of HHS in developing and implementing educational measures in the Head Start Program. This includes the Head Start National Reporting System (NRS). The Committee is to provide recommendations for integrating NRS with other ongoing assessments of the effectiveness of the program. The Committee will make recommendations as to how NRS and other assessment data can be included in the broader Head Start measurement efforts found in the Family and Child Experiences Survey (FACES), the National Head Start Impact Study, Head Start's Performance-Based Outcome System, and the ongoing evaluation of the Early Head Start program.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Evaluations of the Medicaid Reform Demonstrations (EMRD),'' System No. 09-70-0068, last published at 67 Federal Register 2216 (January 16, 2002). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system of records. The new assigned identifying number for this system should read: System No. 09- 70-0523. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractor and/or consultants. The modified routine use will remain as routine use number 1. We propose to combine routine uses 2 and 3 to 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. As they were duplicative of each other. We will delete routine use number 4, authorizing disclosure to support constituent requests made to a Congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 6 and 7, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We are modifying the language in the routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or MMA provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and provide data necessary to evaluate a series of Medicaid Reform Demonstrations that rely on waivers of section 1115 of the Social Security Act (the Act). This system will allow measurement of the effects of the demonstration on beneficiaries' eligibility, access to care, utilization, health care costs, satisfaction with care, quality of care and health status. The information retrieved from this system of records will also be disclosed to: (1) Support program administration, reporting, and regulator, reimbursement, and policy functions performed within the CMS 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 a Federally-funded health benefits programs. We have provided background information about the modified 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

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.

An Application Information Meeting, hosted by the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute on Drug Abuse (NIDA), will be held on October 20, 2006, on the NIEHS campus in Research Triangle Park, North Carolina. The meeting will include an overview of the Exposure Biology Program, presentations on the five funding opportunities, an overview of the cooperative agreement mechanism and Grants Management and Review issues, and a question and answer session addressing RFA-related questions.

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 requiring that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. These recordkeeping requirements provide documentation for the provisions in FDA's interim final rule entitled ``Use of Materials Derived From Cattle in Human Food and Cosmetics.'' FDA is requiring recordkeeping because manufacturers and processors of human food and cosmetics need records to ensure that their products do not contain prohibited cattle materials, and records are necessary to help FDA ensure compliance with the requirements of the interim final rule.

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:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2007. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmb@osophs.dhhs.gov.

This notice announces an administrative hearing to be held on December 8, 2006, at 2201 6th Street, Suite 1101, Seattle, Washington 98121, to reconsider CMS' decision to disapprove Oregon State plan amendment 05-003. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by October 23, 2006.

The FIC is initiating a strategic planning process to culminate in the FIC Strategic Plan 2007-2011. To anticipate and set priorities for global health research and research training, FIC requests input from scientists, the general public, and interested parties. The goal of this strategic planning process is to identify current and future needs and directions for global health research. The existing FIC strategic plan can be viewed at https://www.fic/nih.gov/ about/plan/StrategicPlan.pdf.

The Food and Drug Administration (FDA) is announcing the availability of additional questions and answers that are being incorporated into the final guidance document entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers.'' This final guidance is dated October 2006. The additional questions and answers relate to blood and blood components intended for transfusion and requirements that their container labels bear certain machine- readable information. These requirements were part of the final rule on bar code label requirements for human drugs published on February 26, 2004.

This rule finalizes the provisions of the proposed rule published on May 30, 2006 and responds to public comments received as a result of the proposed rule. This final rule authorizes approval of annual waivers, under certain circumstances, from two provisions in the current Head Start transportation regulation (45 CFR part 1310): the requirement that each child be seated in a child restraint system while the vehicle is in motion, and the requirement that each bus have at least one bus monitor on board at all times. Waivers would be granted when the Head Start or Early Head Start grantee demonstrates that compliance with the requirement(s) for which the waiver is being sought will result in a significant disruption to the Head Start program or the Early Head Start program and that waiving the requirement(s) is in the best interest of the children involved. The rule also revises the definition of child restraint system in the regulation to remove the reference to weight which now conflicts with Federal Motor Vehicle Safety Standards. The regulation also reflects new effective dates for Sec. 1310.12(a) and 1310.22(a) on the required use of school buses or allowable alternate vehicles and the required availability of such vehicles adapted for use of children with disabilities, as the result of enactment of Section 224 of Public Law 109-149 and Section 7012 of Public Law 109-234.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled ``Low Vision Rehabilitation Demonstration (LVRD),'' System No. 09-70-0582. The program is mandated by Section 641 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173), enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The LVRD program seeks to establish a new demonstration project to examine Medicare beneficiaries who are diagnosed with moderate to severe visual impairment and who may be eligible to receive covered vision rehabilitating services. Rehabilitation may be conducted under general supervision of a qualified physician in an appropriate setting including in the home of the beneficiary receiving the services. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the performance payments. The primary purpose of the system is to collect and maintain identifiable information on Medicare beneficiaries who participate in Medicare Part B fee-for-service coverage, qualified physicians, such as ophthalmologists or optometrists, qualified occupational therapists, and vision rehabilitation therapists who are certified by the Academy for Certification of Vision Rehabilitation Professionals. Information retrieved from this system will also 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 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) assist 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 health benefits programs. We have provided background information about the new 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.

This notice announces the second meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 18, 2006 entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates.''

The Centers for Medicare & Medicaid Services has awarded a supplemental grant entitled ``Increasing Access to Health Care for Bucks County Residents'' to the Bucks County Health Improvement Project, Inc., 1201 Langhorne-Newton Road, Langhorne, PA 19047. The project period is September 10, 2002 through September 9, 2008. The Bucks County Health Improvement Project (BCHIP) proposes to provide 3 ongoing major programs, which were initiated under the parent grant. These include continuation and expansion of: The adult health clinic which has served over 3,274 patients having 9,200 visits; the dental program for needy children and adults; and the Cardiovascular Risk Reduction program. Through these programs, BCHIP provides health and dental services for vulnerable populations, including under-insured and recent immigrants. These BCHIP health services for the indigent and uninsured have helped meet fundamental physical, dental, and mental health needs for residents, including immigrant groups, who are otherwise without resources for needed care. There is concern that without additional supplemental funding, provision of these vital health care services in Bucks County would be at risk. An additional 2 years of funding will permit BCHIP to follow-on with several of their major, demonstrated successful programs delivering community care and outreach to targeted groups with serious unmet needs. Furthermore, the BCHIP consortium of public and private hospitals and outpatient health and dental providers has collaborated over the past 15 years to develop an impressively efficient administrative framework for the donation, provision and coverage of a wide array of health services for the medically indigent. Additional funding will further foster the improvement and expansion of their model for administering health care through multiple programs to the needy. Over the past 2 years, BCHIP leaders have been sharing their administrative model and experience with other health U.S. organizations and communities, including a ``Communities Joined in Action'' conference in New Orleans and quarterly Pennsylvania State Health Improvement Plan (SHIP) meetings. They plan to continue to offer guidance to providers and health organizations gleaned from their expanding, ongoing service programs under requested supplemental funding. This award is made based on the authority granted by section 1110 of the Social Security Act, which authorizes appropriations each fiscal year for grants to pay for part of the cost of research or demonstration projects that will improve the administration and effectiveness of programs.

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.

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the fifth meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the fifth meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings. The public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.

This general notice with comment period describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries (FIs) and carriers in the administration of the Medicare program. The results of these evaluations are considered whenever we enter into, renew, or terminate an intermediary agreement, carrier contract, or take other contract actions, for example, assigning or reassigning providers or services to an intermediary or designating regional or national intermediaries. We are requesting public comment on these criteria and standards.

This document corrects technical errors that appeared in the July 31, 2006 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing FacilitiesUpdateNotice.'' Effective Date: This correction is effective October 1, 2006.

The Food and Drug Administration (FDA) has determined the regulatory review period for PLENAXIS 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.

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 Pfizer, Inc. The supplemental NADA provides for the addition of a pathogen to the indication for use of tulathromycin in cattle, by injection, for the treatment of respiratory disease.

The Food and Drug Administration (FDA) has determined the regulatory review period for LYRICA (new drug application (NDA) 21-723) 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 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 Federal Food, Drug, and Cosmetic Act (the act) requires the Food and Drug Administration (FDA) to review each agreement, guidance, or practice that is specific to the assignment of combination products to agency centers and to determine whether the agreement, guidance, or practice is consistent with the requirements of the act. In carrying out the review, the agency is to consult with stakeholders and directors of the agency centers, and then determine whether to continue in effect, modify, revise, or eliminate such an agreement, guidance, or practice. The agency has completed its initial review of relevant agreements, guidances, and practices, and has consulted with directors of the agency centers. This document provides the preliminary results of the agency's review and requests stakeholder comments to fulfill the act's requirement for stakeholder consultation prior to the agency's final determination whether to continue the agreements, guidance, or practices in effect, or to modify, revise, or eliminate them.

As stipulated in the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting is open to the public.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides for a new container size, a 40-gram dropper bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be administered for the treatment of acute and chronic canine otitis externa.

The Administration for Children and Families proposes to regulate the cost allocation methodology to be used in the Temporary Assistance for Needy Families (TANF) program. The proposed rule would require States to use the ``benefiting program'' cost allocation methodology required by OMB Circular A-87 (2 CFR Part 225) and previously required under HHS' Office of Grants and Acquisition Management (OGAM) Action Transmittal (AT) 98-2.

This notice announces an administrative hearing to be held on December 6, 2006, at 26 Federal Plaza, New York, NY 10278, Room 38- 110a, to reconsider CMS' decision to disapprove New York State plan amendment 05-50. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by October 12, 2006.