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

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0003, ``Medical Staff Credentials and Privileges Records.'' The amended and altered system of records makes only one administrative revision as necessary.

HHS invites all comments, suggestions, recommendations and creative ideas on the feasibility of establishing a system of Electronic Benefits Transfer (EBT) as a simple, comprehensive, and efficient means to deliver to disaster victims the Federal, State and local human services for which they qualify. This Request for Information (RFI) is intended to provide ideas for consideration, and may or may not result in a future procurement.

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), seeks to enter into a CRADA with a commercial partner to co-develop a suite of computer programs for modeling and simulating complex cellular biological processes. The existing suite of computer programs allows biologists to develop and test quantitative models of cell biological processes. The graphical interfaces of the programs make it possible to develop realistic models of molecular interactions and cellular processes that take into account the intracellular and extracellular spatial inhomogeneity of signaling components without the user having to deal with the partial differential equations and state automata that underlie the quantitative simulation of the models. The program suite offers graphical symbols and drag-and-drop mechanisms to define molecular interactions, molecular complexes, cellular stimulus-response mechanisms, and the structure of extracellular compartments. An intuitive graphical interface can be used to inspect and interact with running simulations; for example, molecules and cells can be placed into the simulated compartments, cells can be selected for detailed analysis of their behavior and intracellular, spatially-resolved biochemistry. One part of the program suite reads the molecular interaction network data that are generated by the program based on the user defined bimolecular interactions and displays them as interaction graphs, visualizing the reaction dynamics in the modeled cellular signaling pathways. It is anticipated that the collaboration will result in the commercialization of the software.

The Food and Drug Administration (FDA) has determined the regulatory review period for CUBICIN 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 Citizens' Health Care Working Group (the Working Group), authorized by section 1014 of the Medicare Modernization Act, is publishing interim recommendations and requesting public comment on them.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.

The Food and Drug Administration (FDA) has determined the regulatory review period for RESTYLANE 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 Administration for Native Americans (ANA) herein announces a Program Expansion Supplement to the Red Lake Band of Chippewa Indians, Red Lake, Minnesota. This supplement for $136,400 will extend funding for 11 youth volunteers through the second year of the project. In FY 2005, ANA provided an urgent grant award to the Tribe to assist in mitigating the effects of the tragic events of the school shooting in March 2005 that resulted in the death of students, faculty and staff. The shooting marked the highest death toll in U.S. school shootings since the Columbine High School massacre in April 1999. Due to the devastation created by the high school shooting, ANA is providing urgent financial assistance for minor renovations to the local community centers to support positive community development; funding to hire 11 volunteers to assist youth and members of the community in coping with this event; and building support systems, which will aid in preventing future tragedies.

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

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report on policy issues raised by the prospect of the U.S. undertaking a large population cohort project for the study of genes, environment, and disease. A copy of the report, ``Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease,'' is available electronically at https:// www4.od.nih.gov/oba/ sacghs/publiccomments.htm. A copy may also be obtained from the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) by e-mailing Ms. Amita Mehrotra at mehrotraa@od.nih.gov or calling 301-496-9838.

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

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

The Office of Global Health Affairs (OGHA) announces up to $600,000 in FY 2006 funds is available for a cooperative agreement to the Fundaci[oacute]n M[eacute]xico-Estados Unidos para la Ciencia, A. C. (FUMEC) (United States-Mexico Foundation for Science) to support the implementation, management, and administration of U.S.-Mexico Border Health Commission (USMBHC) programs and activities at the Mexican Outreach Offices. This initiative will support the development, administration, and evaluation of programs in specified health areas, including training for health personnel, development, and dissemination of educational materials and workshops, research, community outreach, health promotion, and improvement of information technology to enhance program support. HHS/OGHA will approve the budget period to be one year and the project period for up to a five-year period for a total of $600,000 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.

This announcement is made by the United States Department of Health and Human Services (HHS or Department), Medical Reserve Corps (MRC) program, located within the Office of the Secretary, Office of Public Health and Science (OPHS), Office of the Surgeon General (OSG), Office of Force Readiness and Deployment (OFRD). Background Information: During his January 2002 State of the Union address, President George W. Bush called on all Americans to dedicate at least two yearsthe equivalent of 4,000 hours of their timeto provide volunteer service to others. To help every American answer the call to service, the President created the USA Freedom Corps, and charged it with strengthening and expanding service opportunities for volunteers to protect our homeland, to support our communities, and to extend American compassion around the World. Simultaneously, the President also created the Citizen Corps, within the Department of Homeland Security (DHS), as a way to offer Americans new opportunities to get involved in their communities through emergency preparation and response activities. Along side Citizen Corps are several partner programs that share the common goal of helping communities prevent, prepare for, and respond to crime, natural disasters, and other emergencies. These partner programs include: Community Emergency Response Teams (CERT), also under DHS; Neighborhood Watch and Volunteers in Police Service, under the direction of the Department of Justice; Fire Corps; and the Medical Reserve Corps. The MRC is a nationwide network of community-based, citizen volunteer units, which have been initiated and established by local organizations for their communities. MRC units are local assets to meet locally determined needs. Medical and public health volunteers in the MRC can utilize their professional expertise to contribute to local public health initiatives, such as those meeting the Surgeon General's priorities for public health, on an ongoing basis and to supplement the existing response capabilities of the community in emergencies. Communities across the country are beginning to recognize that strengthening the everyday public health infrastructure will improve preparedness. The MRC was developed following the events of September 11, 2001, when many medical and public health professionals showed up at the disaster sites to support the response efforts and were mostly turned away due to identification, credentialing, and liability issues. One of the primary functions of the MRC is to resolve issues of pre- identifying and preparing volunteer health professionals for emergencies. The MRC brings volunteershealth professionals and otherstogether to supplement existing local resources in cities, towns, and counties throughout the United States. MRC volunteers include medical and public health professionals such as physicians, nurses, pharmacists, dentists, veterinarians, physician assistants, nurse practitioners, paramedics, EMTs, mental health workers, and epidemiologists. Many other community members interpreters, chaplains, office workers, legal advisors, etc.can fill key support positions. Many of these professionals have active practices in a variety of settings; others are in training; some are retired; and yet others are licensed but do not maintain an active practice. As this is a community-based program, each MRC is responsible for determining its own structure and developing its own policies and procedures. MRC units may be established and implemented by local government agencies, non-governmental organizations, or other non- profit entities. Partnerships with local medical, public health and emergency management entities are essential. The MRC Demonstration Project (started in FY 2002 and continued in FY 2003) provided start-up grants to 166 communities across the US. Other communities have been encouraged to establish MRC units without HHS funding support. As of May 19, 2006, there were 431 MRC units in 49 States, the District of Columbia, Guam, and the U.S. Virgin Islands, with more than 75,000 volunteers. The OSG has lead responsibility within HHS for the development of the MRC. OSG undertook this responsibility in March 2002 and subsequently created the MRC Program Office, with a mission to provide national and regional leadership, in partnership with key stakeholders, to facilitate local efforts to establish, implement, and sustain MRC units. The MRC program office facilitates the formation and implementation of MRC units in communities across the nation by coordinating mechanisms for information sharing and providing forums for discussions of promising practices and lessons learned. The major MRC program office activities include policy development, interagency coordination, program management, grants management, contract oversight, technical assistance, and outreach. Since its inception, the MRC program office has: Implemented the MRC Demonstration Project, which awarded small grants (of up to $50,000 per year for 3 years) to help jump start the establishment of local MRC units. Forty-two grants were awarded in September 2002 and an additional 124 grants were awarded in October 2003. Encouraged the development of MRC units in communities outside of the MRC Demonstration Project. As of May 19, 2006, over 260 additional communities have registered MRC units without receiving grant funding through the MRC program office. Developed a technical assistance contract to provide valuable expert advice to developing and established MRC units. A series of technical assistance documents were written to serve as a guide for local leaders to assist with establishment and implementation of MRC units. Established an MRC Web site (https://www.medicalreservecorps.gov) with resources for developing and established MRC units. The Web site includes an electronic message board and document clearinghouse to allow MRC communities to share information. Held consultation meetings with numerous governmental and non- governmental organizations at the local, State, regional, and national levels. Displayed the MRC exhibit booth at professional conferences to boost awareness of the program. Conducted leadership conferences at the national and regional levels to facilitate coordination, cooperation, and information sharing. Coordinated the MRC response following the 2005 Hurricanes. An estimated 6,000 MRC volunteers supported the response and recovery efforts in their local communities. In the hardest hit areas, and as the storm forced hundreds of thousands of Americans to flee the affected areas, MRC volunteers were ready and able to help when needed and were there to assist as evacuees were welcomed into their communities. These volunteers spent countless hours helping the many people whose lives were upended by these disastrous events. During the 2005 Hurricane Response, MRC volunteers throughout the nation served their local communities by: Establishing medical needs shelters to serve medically fragile and other displaced people; Staffing and providing medical support in evacuee shelters and clinics; Filling in locally at hospitals, clinics and health departments for others who were deployed to the disaster-affected regions; Immunizing responders prior to their deployment to the disaster affected regions; Staffing a variety of response hotlines created after the hurricanes hit; Raising funds for those affected by the hurricanes; Teaching emergency preparedness to community members; and Recruiting more public health and medical professionals who can be credentialed, trained and prepared for future disasters that may affect their hometowns or elsewhere. In addition to this local MRC activity, over 1,500 MRC members expressed a willingness to deploy outside their local jurisdiction on optional missions to the disaster-affected areas with their state agencies, the American Red Cross (ARC) and the U.S. Department of Health and Human Services (HHS). Of these, approximately 200 volunteers from 25 MRC units were hired by HHS as unpaid temporary Federal employees and more than 400 volunteers from over 80 local MRC units have been deployed to support ARC disaster operations in areas along the Gulf coast. Future Direction: Though the MRC was developed as a network of local, community-based assets established to meet locally determined needs, much national attention has been focused on the program in light of its astounding growth and its response following the 2005 Hurricanes. This attention has led to a call for an expansion of the MRC program. For example, in 2005 the White House Homeland Security Council charged HHS to establish systems to pre-enroll, credential, train, and deploy MRC members who are willing to provide emergency health and medical services after a catastrophic event. More recently, in the February 2006 Federal Response to Hurricane Katrina: Lessons Learned document, the White House recommended that ``HHS should organize, train, equip, and roster medical and public health professionals in preconfigured and deployable teams'' to include the PHS Commissioned Corps, members of the MRC, and other Federal partners. In support of the President's national strategies, in keeping with the National Response Plan and consistent with the charge from the Homeland Security Council, this single-eligibility cooperative agreement with the National Association of County and City Health Officials (NACCHO) will support HHS efforts to expand the capacity of MRC units throughout the nation. All work will be closely coordinated with OSG, the MRC program office, State coordinators, MRC regional coordinators, Regional Health Administrators and other Federal officials. NACCHO will begin by providing capacity-building support to all interested MRC units. NACCHO will also assist with the development of a comprehensive operational manual and support OSG efforts in credentialing, verifying backgrounds, badging, assessing levels of training, and utilizing MRC members who are willing and able to deploy with HHS as unpaid temporary Federal employees on national-level responses (keeping in mind that any employment of individuals is under the authority of HHS and will follow Federal employment standards). This subset of MRC members will be referred to as the ``Public Health Service Auxiliary.'' In addition, a Demonstration Project of the Public Health Service Auxiliary will be initiated, primarily targeting MRC units in geographic locations in the vicinity of the proposed PHS Rapid Deployment Force (RDF) teams: Washington DC/Baltimore; Georgia/North Carolina/South Carolina; Texas/ Oklahoma; and Arizona/New Mexico. Ultimately, this cooperative agreement with NACCHO will enhance the collaboration and coordination between OSG and community/state public health and emergency agencies to support and increase the MRC capacity to meet local, state and national needs.