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

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Importer's Entry Notice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to preventing the onset and reducing the progression of mental illness, substance abuse, and substance-related problems among all individuals, including youth. As part of this effort, SAMHSA has expanded and refined the agency's National Registry of Evidence-based Programs and Practices (NREPP). Two previous notices announcing these changes have been published in the Federal Register (70 FR 165, Aug. 26, 2005, 50381-50390; 71 FR 49, Mar. 14, 2006, 13133-13155). This notice explains how SAMHSA and its three Centers will prioritize interventions submitted for NREPP reviews during Fiscal Year 2007 and provides guidance on the submission process. This information can be helpful to individuals and organizations seeking to have an intervention reviewed and listed on the new NREPP Web site. For Further Information Contact: Kevin D. Hennessy, Ph.D., Science to Service Coordinator/SAMHSA, 1 Choke Cherry Road, Room 8-1017, Rockville, MD 20857, (240) 276-2234.

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 Food and Drug Administration (FDA) is requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year (FY) 2007. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This notice is being published to give the public an opportunity to provide input into the priority- setting process.

The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII and VIII of the Public Health Service (PHS) Act. The Department periodically publishes in the Federal Register low income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from ``low income families.''

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3601 entitled ``Medical Device User Fee Cover Sheet'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.

The Food and Drug Administration (FDA) is announcing the following public meeting: The Use of Bayesian Statistics in Medical Device Clinical Trials. The draft guidance entitled ``Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials'' provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (the Task Force). The Task Force, a standing, independent panel of private-sector experts in prevention and primary care, is composed of members appointed to serve for four year terms with an option for reappointment. New members are selected each year to replace (approximately) one fourth of the Task Force members, i.e., those who are completing their appointments. Individuals nominated but not appointed in previous years, as well as those newly nominated, are considered in the annual selection process. Task Force members meet three times a year for two days in the Washington, DC area. Member duties include reviewing and preparing comments (off site) on systematic evidence reviews prior to discussing and making recommendations on preventive services, drafting final recommendation documents, and participating in workgroups on specific topics or methods. AHRQ particularly encourages nominations of women, members of minority populations, and persons with disabilities. Interested individuals and organizations may nominate one or more persons qualified for membership on the Task Force. Qualification Requirements: The mission of the Task Force is to produce evidence-based recommendations on the appropriate screening, counseling, and provision of preventive medication for asymptomatic patients seen in the primary care setting. Therefore, in order to qualify for the Task Force, an applicant or nominee MUST demonstrate the following: 1. Knowledge and experience in the critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Understanding and experience in the application of synthesized evidence to clinical decision-making and/or policy; 3. Expertise in disease prevention and health promotion; 4. Ability to work collaboratively with peers; and, 5. Clinical expertise in the primary health care of children and/or adults, and/or expertise in counseling and behavioral interventions for primary care patients. Some Task Force members without primary health care clinical experience may be selected based on their expertise in methodological issues such as medical decision making, clinical epidemiology, behavioral medicine, and health economics. Strongest consideration will be given to individuals who are recognized nationally or internationally for scientific leadership within their field of expertise. Applicants must have no substantial conflicts of interest that would impair in the scientific integrity of the work of the Task Force including financial, intellectual, or other conflicts.

This proposed notice sets forth proposed revisions to work relative value units (RVUs) affecting payment for physicians' services. The statute requires that we review RVUs no less often than every 5 years. This is our third review of work RVUs since we implemented the physician fee schedule (PFS) on January 1, 1992. These revisions to work RVUs are proposed to be effective for services furnished beginning January 1, 2007. These revisions reflect changes in medical practice, coding changes, new data on relative value components, and the addition of new procedures that affect the relative amount of physician work required to perform each service as required by the statute. In addition, we are proposing revisions to our methodology for calculating practice expense (PE) RVUs, including changes based on supplemental survey data for PE. This revised methodology would be used to establish payment for services beginning January 1, 2007.

The Centers for Disease Control and Prevention (CDC), Coordinating Center for Infectious Disease (CCID), through its component Centers and Divisions has lead technical responsibility for a number of Category A, B and C bioterrorism agents and their associated toxins (Bacillus anthracis, Clostridium botulinum, Brucella sps., Burkholderia sps., Staphylococcus entertoxin B, other food- or waterborne bacterial pathogens, and other bacterial agents). CCID uses epidemiologic, laboratory, clinical, and biostatistical sciences to control and prevent bacterial and mycotic infectious disease. The Centers also conduct applied research in a variety of settings, and translate the findings of this research into public health practice. The purpose of this announcement is to make interested parties aware that CCID is currently engaged in a research activity to establish and evaluate an intravenous infusion rabbit model for delivery of therapeutic molecules for the treatment of inhalation anthrax. The activity is in the early stage of feasibility assessment. The protocols for these studies may be made available to interested parties upon request. The short term objective of making these protocols available is to promote standardization of the approach to in vivo model development for anthrax therapy evaluation to meet the Nation's bioterrorism defense needs. The longer term objective is to develop these or subsequent protocols into standardized in vivo models that may meet the Food and Drug Administration (FDA) acceptance criteria for product development and licensure. Interested organizations may request an electronic copy of the protocols by contacting CDC at the address below. To ensure a response, requests must be submitted within thirty days of publication of this notice. Responses are preferred in electronic format and can be e-mailed to the attention of Dr. Conrad Quinn at CQUINN@CDC.GOV. Mailed responses can be sent to the following address: Dr. Conrad Quinn, Division of Bacterial Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., NE., Mail Stop C-09, Atlanta, GA 30333.

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 Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) personnel (Corps Personnel, Corps members) for the period July 1, 2006 through June 30, 2007 is posted on the NHSC Web site at https://nhsc.bhpr.hrsa.gov/ resources/fedreg-hpol/. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the S-50 Oak Ridge Thermal Diffusion Plant, Oak Ridge, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: S-50 Oak Ridge Thermal Diffusion Plant. Location: Oak Ridge, Tennessee. Job Titles and/or Job Duties: All workers. Period of Employment: 1944 through 1951.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 015'' (Recognition List Number: 015), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

This final notice announces our decision to deny T[Uuml]V Healthcare Specialists' (T[Uuml]VHS) request for deeming authority for hospitals that wish to participate in the Medicare and Medicaid programs.

This interim final rule with comment period identifies the Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8.1 (hereafter referred to as ``Version 8.1 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard'') as a backward compatible update of the adopted Version 5.0. This interim final rule with comment period also permits the voluntary use of Version 8.1 of the NCPDP SCRIPT Standard for conducting certain e- prescribing transactions for the electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which an applicant may obtain an assignment or designation determination.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

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 announcing that a collection of information entitled ``Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for BONIVA 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 Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed new collection of information to be submitted to the Office of Management and Budget for review.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.'' The guidance provides recommendations to developers of new plant varieties, including bioengineered plant varieties, on the early food safety evaluation of new non-pesticidal proteins. The guidance describes procedures for submitting an early food safety evaluation of such proteins to the agency.

The Food and Drug Administration (FDA) San Francisco District, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a public workshop on FDA device regulations. This 2-day public workshop for start up and small device manufacturers and their suppliers will include both industry and FDA perspectives and a question and answer period. Date and Time: The public workshop will be held on July 12, 2006, from 8:30 a.m. to 5:30 p.m. and July 13, 2006, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at The Marriott Fremont, 46100 Landing Pkwy., Fremont, CA 94538, 510-413-3710, FAX: 510-413- 3710. For further hotel information and driving directions, go to https://Marriott.com/property/propertypage/sjcfm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: For FDA: Eric Anderson, Office of Regulatory Affairs (HFR- PA1530), Food and Drug Administration, 96 North Third St., San Jose, CA 95115, 408-291-7548, ext. 115, FAX: 408-291-7228, e-mail: eric.anderson@fda.hhs.gov. For AdvaMed: Krystine McGrath, 202-434-7237, FAX: 202-434-7850, e- mail: kmcgrath@advamed.org. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $495.00 per person to the AdvaMed contacts (see Contact). The registration fee for FDA employees is waived. To register via the Internet go to https://www.advamedmtli.org/mtli/fda.cfm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Payment forms accepted are major credit cards (MasterCard, Visa, or American Express) or company check. If you wish to pay by check, contact Krystine McGrath (see Contact). For more information on the meeting, or for questions on registration, contact Krystine McGrath (see Contact). Attendees are responsible for their own accommodations. The registration fee will be used to offset the expenses of hosting the workshop, including meals (breakfasts and lunches), refreshments, meeting rooms, and training materials. It also includes a networking reception on July 12, 2006. Space is limited; therefore, interested parties are encouraged to register early. There will be no onsite registration. If you need special accommodations due to a disability, please contact Eric Anderson (see Contact) at least 7 days in advance of the workshop.

On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird- derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/[H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 FR 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OlE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. Because of the documentation of highly pathogenic avian influenza H5N1 in poultry, HHS/CDC added the following countries to its embargo: Kazakhstan, Romania, Russia, Turkey, and Ukraine on December 29, 2005; Nigeria on February 8, 2006; India on February 22, 2006; Egypt on February 27, 2006; Niger on March 2, 2006; Albania, Azerbaijan, Cameroon, and Burma (Myanmar) on March 15, 2006; Israel on March 20, 2006; Afghanistan on March 21, 2006; Jordan on March 29, 2006; Burkina Faso on April 10, 2006; Pakistan on April 10, 2006; Gaza, the West Bank, and the Ivory Coast (C[ocirc]te d'Ivoire) on April 28, 2006; and Sudan on May 16, 2006. On May 27, 2006, OlE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Djibouti. At this time, HHS/CDC is adding Djibouti to its current embargo. USDA has also taken a similar action with respect to this region. This action is effective on June 2, 2006, and will remain in effect until further notice.

The Office on Women's Health (OWH) is the focal point for women's health within the Department of Health and Human Services (DHHS). Under the direction of the Deputy Assistant Secretary for Women's Health, OWH provides leadership to promote the health equity for women and girls through gender-specific approaches. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide. These include supporting collaborative efforts to provide accurate prevention education and programs for young women at risk for developing type II diabetes because they are overweight or obese. These awards focus on the HHS initiative Emphasize Healthy Living and Prevention of Disease, Illness, and Disability in the ``One Department. One Direction'' Department-wide Objectives. This program is authorized by 42 U.S.C. 300u-2(a).

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

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging will discuss items related to the final report of the Conference during a conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.

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

A notice was published in the Federal Register on January 23, 2006 (Vol. 71, No. 14, pages 3519-3520). The purpose of this notice was to solicit comments to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (176) entitled ``Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances'' (VICH GL-39). This guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to assist to the extent possible, in the establishment of a single set of recommended global specifications for new veterinary drug substances and medicinal products. It provides guidance through recommendations on the setting and justification of acceptance criteria and the selection of test procedures for new veterinary drug substances of synthetic chemical origin, and new medicinal products produced from them, which have not been registered previously in the United States, the European Union, or Japan.

The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) that appeared in the Federal Register of April 27, 2006 (71 FR 24814). FDA is correcting a paragraph designation in the table for lasalocid cattle feeds which was drafted in error. This correction is being made to improve the accuracy of the animal drug regulations.

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.