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

Section 6034 of the Deficit Reduction Act of 2005 established the Medicaid Integrity Program to promote the integrity of the Medicaid program by authorizing the Centers for Medicare and Medicaid Services (CMS) to enter into contracts with contractors that will review the actions of individuals or entities furnishing items or services (whether fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act; audit claims for payment of items or services furnished, or administrative services furnished, under a State plan; identify overpayments of individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This proposed rule would set forth limitations on a contractor's liability while performing these services under the Medicaid Integrity Program. This proposed rule would provide for limitation of a contractor's liability for actions taken to carry out a contract under the Medicaid Integrity Program. The proposed rule would, to the extent possible, employ the same or comparable standards and other substantive and procedural provisions as are contained in section 1157 (Limitation on Liability) of the Social Security Act.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Atlanta District and Southeast Regional Office (SER), in collaboration with Georgia Food Safety and Defense Task Force, and the Metro Environmental Health Directors Food Service Advisory Committee, is announcing a public workshop entitled ``Food Safety and Defense . . . Be ALERT!'' This public workshop will provide information about how to control foodborne illness risk factors and how to secure food from intentional contamination (food defense awareness). The target audience will be operators of small, independent (non-chain) retail and food service establishments. Date and Time: This public workshop will be held on Wednesday, August 15, 2007, from 9 a.m. to 3 p.m. Location: The public workshop will be held at the Hilton Atlanta Northeast Hotel, 5993 Peachtree Industrial Blvd., Norcross, GA. Contact: JoAnn Pittman, Food and Drug Administration, Atlanta District, Southeast Region, 60 8th St., NE., Atlanta, GA 30309, 404- 253-1272, FAX: 404-253-1202, or e-mail: JoAnn.Pittman@fda.hhs.gov. Registration is at no charge: The registration deadline is August 1, 2007; please see instructions in this document. Those accepted into the workshop will receive confirmation. Registration at the site is not guaranteed but, may be possible on a space available basis (100 maximum) on the day of the public workshop beginning at 9 a.m. If you need special accommodations due to a disability, please contact JoAnn Pittman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the registration form in this document and submit to `` Food and Drug Administration, Attn: Dan Redditt, 60 8th St., NE.. Atlanta, GA 30309.'' We encourage you to fax the completed registration form to: 404-253-2257 or 404-253-1202. To obtain a copy of the registration form, please contact: Dan Redditt at 404-253-1265 or via e-mail at joseph.redditt@fda.hhs.gov.

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 announcing that a collection of information entitled ``Threshold of Regulation for Substances Used in Food-Contact Articles'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Pulse Oximeters Premarket Notification Submissions [510(k)s].'' The draft guidance describes FDA's recommendations about the content of premarket notification submissions (510(k)s) for pulse oximeter devices.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Trans Fat Claims on Foods'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 announcing the availability of the draft guidance entitled ``Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents.'' This draft guidance is intended to assist device manufacturers interested in preparing premarket notification (510(k)) submissions for their medical devices that include antimicrobial agents. This guidance recommends testing and labeling for 510(k) submissions for devices that include antimicrobial agents. It is intended as a supplement to other device-specific guidance issued by the Center for Devices and Radiological Health (CDRH).

The Food and Drug Administration (FDA) is announcing its determination that Brethine (Terbutaline Sulfate) Injection was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for terbutaline sulfate injection if all other legal and regulatory requirements are met.

This final rule with comment period will implement the provisions of the Deficit Reduction Act of 2005 (DRA) pertaining to prescription drugs under the Medicaid Program. The DRA requires the Secretary of HHS to promulgate a final regulation no later than July 1, 2007. In addition, we are adding to existing regulations certain established Medicaid rebate policies that are currently set forth in CMS guidance. This rule will bring together existing and new regulatory requirements in one, cohesive subpart. Finally, this final rule with comment period allows for further public comment on the Average Manufacturer Price and Federal upper limit (FUL) outlier section of the rule.

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

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

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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

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

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

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 75-milligram size deracoxib tablet which is used for the control of pain and inflammation in dogs.

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

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 FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with ``due diligence.''

Section 340B of the Public Health Service Act (section 340B) and section 1927(a) of the Social Security Act (section 1927(a)) implement a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. Section 6004 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (section 6004) added children's hospitals to the list of covered entities eligible to access 340B discounted drugs. The purpose of this notice is to inform interested parties of proposed guidelines regarding the addition of children's hospitals that meet certain requirements, specifically: (1) The process for the addition of children's hospitals to the 340B Program; and (2) the obligation of manufacturers to provide the statutorily mandated discount to children's hospitals. These proposed guidelines will not take effect until final guidelines are issued.

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 paperwork associated with applications for new animal drugs.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage'' dated July 2007. The draft guidance provides to sponsors recommendations about certain information that should be included in an investigational device exemption (IDE) or investigational new drug application (IND) for a product intended to repair or replace knee cartilage. The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 14, 2007 (72 FR 32852). The agency issued a withdrawal of a new drug application (NDA) for RAXAR (grepafloxacin hydrochloride (HCl)) Tablets held by Otsuka Pharmaceutical Co., Ltd. (Otsuka), c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 20850. The document published with typographical errors and cited a section of the Code of Federal Regulations that no longer exists. This document corrects those errors. The agency is also announcing the removal of RAXAR Tablets from the list of approved drug products in FDA's ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (the Orange Book).

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 information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on recordkeeping requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).

This project will support the Gorgas Memorial Institute (GMI) to: (a) Develop a regional training center in Panama and (b) train community health workers, clinicians (physicians, nurses, and auxiliary medical workers) and select public-health professionals from Central and South America (i.e. Latin America), (c) facilitate partnerships between U.S. universities and their Latin American counterparts to develop human resources for health in Latin America, and (d) harness the energies of U.S. and other non-governmental organizations by partnering with them to advance community health training and program efforts in Latin America. These efforts will help engage significantly more areas of these countries to prepare for and respond to public health emergencies such as pandemic influenza, and they will contribute to improved and expanded provision of prevention and primary health care. This training of nurses, community health workers and physicians will focus on improving and expanding coverage and access to both public health emergency care and preventive and primary health care in underserved parts of Latin America (i.e., both underserved rural and poor urban communities). It is anticipated that as a result of this project, the healthcare work force will be better prepared to respond to public health emergencies such as pandemic influenza. Key to the selection of recipients for this training will be their availability and willingness to provide their health and medical care skills in underserved areas within the region. In addition to all appropriate medical care and health education or communication subjects, training supported by this project will emphasize infectious diseases, epidemiology, disease surveillance and outbreak response, among other subjects so graduates of training programs will be prepared to play contributing roles to any pandemic preparation and response.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

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.

This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and programs (entities). As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces availability of FY 2007 funding for the American Indian/Alaska Native Health Disparities Program (hereafter referred to as the AI/AN Health Disparities Program). OMH is authorized to conduct this program under 42 U.S.C. 300 u-6, section 1707 of the Public Health Service Act, as amended. The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point in the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health needs of racial and ethnic minorities. OMH activities are implemented in an effort to address Healthy People 2010, a comprehensive set of disease prevention and health promotion objectives for the Nation to achieve over the first decade of the 21st century (https://www.healthypeople.gov). This funding announcement is also made in support of the OMH National Partnership for Action initiative. The mission of the National Partnership for Action is to work with individuals and organizations across the country to create a Nation free of health disparities with quality health outcomes for all by achieving the following five objectives: Increasing awareness of health disparities; strengthening leadership at all levels for addressing health disparities; enhancing patient-provider communication; improving cultural and linguistic competency in delivering health services; and better coordinating and utilizing research and outcome evaluations. The AI/AN Health Disparities Program is intended to strengthen the capacity of Tribal Epidemiology Centers (TECs) to collect and manage data more effectively and to better understand and develop the link between public health problems and behavior, socioeconomic conditions, and geography. The establishment of the TECs was authorized by Congress to provide support to tribes in the areas of health data acquisition, analysis, and interpretation. The TECs were identified for this program because they are uniquely positioned to be effective in disease surveillance and control programs, assessing the effectiveness of public health programs and recognizing the significance and complexities of tribal communities, and understand their distinct operating systems. TECs recognize the challenge of adapting their services to geographically isolated communities, whose access to information, technology, data, and manpower varies considerably by tribe. TECs must possess a breadth of knowledge about a multitude of health topics, housing, social and economic issues, and evidence-based methodologies to better inform decision-making and planning. TECs recognize the importance of providing services in a culturally sensitive manner, and understand and appreciate tribal history and customs. Health disparities continue to plague the American Indian and Alaska Native communities. Tribal leaders have discussed with HHS the numerous health issues that affect their communities and the dearth of American Indian and Alaska Native health professionals. According to the Centers for Disease Control and Prevention: Heart disease and cancer are the leading causes of death among American Indians and Alaska Natives; American Indian and Alaska Native adults are 60% more likely to have a stroke than white adults are; American Indians and Alaska Natives have a 40% higher AIDS rate than their non-Hispanic counterparts do; The age-adjusted prevalence of diabetes for American Indians and Alaska Natives is over twice that for all U.S. adults; The infant mortality rate for the American Indian and Alaska Native populations is 1.7 times higher than the non-Hispanic white population; and The sudden infant death syndrome (SIDS) rate is the highest of any population group, more than double that of whites in 1999. However, unlike other ethnic minority groups, American Indians and Alaska Natives frequently contend with issues such as: geographic isolation, inadequate sewage disposal, and occasional conflicts between western medical practices and traditional spiritual beliefs, which prevent them from receiving quality medical care. The American Indian/Alaska Native Health Disparities Program is designed to address these barriers to healthcare as well as concerns raised by Tribal Leaders regarding the lack of American Indian and Alaska Native healthcare professionals, paraprofessionals, and researchers by funding tribal epidemiology centers (TECs). TEC activities include: Data collection; Evaluating existing delivery systems, data systems, and other systems that impact the improvement of American Indian and Alaska Native health; Assisting tribes and urban American Indian and Alaska Native communities in identifying their highest priority health status objectives and the services needed to achieve such objectives, based on epidemiological data; Making recommendations for the targeting of services needed by tribal, urban, and other American Indian and Alaska Native communities; and Making recommendations to improve healthcare delivery systems for American Indians and Alaska Natives. However, the mission of TECs is not limited to epidemiological research. TECs are also responsible for the development and implementation of disease control and prevention programs in addition to the coordination of activities with other public health authorities in the region. Different from other potential grant applicants, TECs are ideally situated to work locally and be responsive to the needs and sensitivities of tribal communities while cultivating close collaborative relationships with State and Federal agencies and academic departments. Because of this potential to serve as a bridge between the American Indian and Alaska Native communities and institutions of higher learning, TECs are excellent vehicles for: Providing research internships and opportunities to current and future American Indian and Alaska Native health professionals; Increasing awareness within the American Indian and Alaska Native populations of the need for healthcare professionals; Disseminating information about educational opportunities in the healthcare field; and Working cooperatively with tribal providers of health and social services in order to avoid duplication of existing services. In FY 2007 the AI/AN Health Disparities Program will support projects that enhance the TECs' capacity to carry out disease surveillance, including the interpretation and dissemination of surveillance data; address vital statistics needs; conduct epidemiologic analysis; investigate disease outbreaks; develop disease control and prevention strategies and programs; and/or coordinate with other health agencies in the region. In addition, to building their data capacity, TECs may form collaborative partnerships and alliances to improve access to quality health and human services, and/or design programs to increase the number of American Indians and Alaska Natives serving as health professionals, para-professionals, and researchers. OMH recognizes the importance of optimizing the use of Federal resources and makes this announcement with the expectation of coordinating its efforts under this program with other HHS agencies that support the TECs (e.g., AHRQ, CDC, IHS, NIH) to ensure that activities are complementary and not duplicative.

The Food and Drug Administration (FDA) is announcing the increased fees the agency will assess for inspections of mammography facilities starting October 1, 2007. The Mammography Quality Standards Act of 1992 (the MQSA) requires FDA to assess and collect fees from mammography facilities to cover the costs of annual inspections required by the MQSA. Because these costs have increased, FDA is raising the fees to ensure the program is able to meet its objective of ensuring that high quality mammography remains available to women. This document explains which facilities are subject to payment of inspection fees, provides information on the costs included in developing inspection fees, and provides information on the inspection billing and collection processes.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Mylan Bertek Pharmaceuticals, Inc., to UDL Laboratories, Inc.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application 60/870,050, entitled ``Human Cancer Therapy Using Anthrax Lethal Toxin Activated by Tumor Associated Proteases'' [HHS Reference E-070-2007/0-US-01], including background patent rights to U.S. Patent Application 10/088,952, entitled ``Mutated Anthrax Toxin Protective Antigen Proteins that Specifically Target Cells Containing High Amounts of Cell-Surface Metalloproteinases or Plasminogen Activator Receptors'' [HHS Reference E-293-1999/0-US-03] and foreign counterparts thereto, and U.S. Patents 5,591,631 and 5,677,274, entitled ``Anthrax Toxin Fusion Proteins and Uses Thereof'' [HHS References E-064-1993/0-US-01 and E-064-1993/1-US-01, respectively] and foreign counterparts thereto, to FP BioPharma, LLC, which has offices in Fort Mill, South Carolina. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

This notice is to inform rural inpatient hospitals of an opportunity to apply to participate in the Medicare Hospital Gainsharing Demonstration being implemented by CMS. The Medicare Hospital Gainsharing Demonstration authorized under section 5007 of the Deficit Reduction Act (DRA) of 2005 was established to test and evaluate methodologies and arrangements between hospitals and physicians designed to govern the utilization of inpatient hospital resources and physician work. The purpose of this demonstration is to improve the quality and efficiency of care provided to Medicare beneficiaries and to develop improved operational and financial hospital performance with the sharing of remuneration payments between hospitals and physicians in six projects, each project consisting of one hospital. Two projects must be rural. Because we received a limited response from rural hospitals to our original solicitation in September 2006, we are re-issuing our solicitation for proposals from rural hospitals only. Rural hospitals that submitted proposals previously are eligible to reapply. The goals and objectives of the demonstration remain unaltered. This demonstration will be limited in scope: we intend to focus on the short-term impacts of gainsharing programs.

This notice clarifies the availability of certain physician salary proxy data for purposes of the hospital direct and indirect graduate medical education policy adopted in the ``Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate Updates, and Policy Changes; and Hospital Direct and Indirect Graduate Medical Education Policy Changes'' final rule that appeared in the May 11, 2007 Federal Register.

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) 2008. 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 Food and Drug Administration (FDA) is denying the petition submitted by Scientific Laboratory Products LTD., to reclassify electroencephalogram (EEG) electrodes from class II to class I. The agency is denying the petition because the Scientific Laboratory Products LTD., failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices. This document also summarizes the basis for the agency's decision.

This notice announces the intent of ATSDR to develop two interaction profiles.

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, 2008. 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.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.'' This draft guidance document describes a means by which the tissue adhesive for the topical approximation of skin may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify tissue adhesive for the topical approximation of skin from class III into class II (special controls). This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies.'' This guidance document describes a means by which filtering facepiece respirators for use by the general public in public health medical emergencies may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). This guidance document is immediately in effect as a special control for the filtering facepiece respirator for use by the general public in public health medical emergencies, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention (CDC) is proposing to establish a new system of records (SOR), 09-20-0170, ``National Select Agent Registry (NSAR)/Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER.'' The purpose of the system is to limit access to those biological agents and toxins listed in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331, to those individuals who have a legitimate need to handle or use such agents or toxins, and who are not identified as restricted persons by the U.S. Attorney General. NSAR is a single web-based information management system shared by CDC and the U.S. Department of Agriculture (USDA)/ Animal and Plant Health Inspection Service (APHIS) that tracks the possession, use and transfer of select agents and toxins that could pose a severe threat to public health and safety, to the health and safety of animals, and to the safety of plants or animal and plant products. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Supplemental Medical Insurance (SMI) and Hospital Insurance (HI) Premium Accounting Collection and Enrollment (SPACE) System,'' System No. 09-70-0505, last published at 67 Federal Register 40933 (June 14, 2002). The third party premium collection system bills and collects Part A and/or Part B Medicare premiums paid by third party payers on behalf of beneficiaries represented by that entity. In September, 2003, the third party premium collection system known as ``SPACE'' was replaced by a redesigned system referred to as the ``Third Party System (TPS).'' The new system was designed to: (1) Integrate beneficiary third party data onto the EDB with Direct Billing and Enrollment/Entitlement data; (2) eliminate redundant and discrepant data; (3) reduce the number of exception cases requiring processing; (4) provide daily update of third party data at CMS and Social Security Administration; (5) implement several legislative provisions affecting premium collection; and (6) provide integrated online access to Medicare enrollment data. To more accurately reflect the changes proposed for this system, we will modify the name of this system to read: ``Third Party System (TPS).'' TPS will retain its current system identification number: CMS No. 09-70-0505. We propose to modify existing routine use number 3 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 5 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 published routine uses number 7 and 8, 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 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) (Public Law 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 process beneficiary premium billing accretions and deletions to third party premium payer accounts (state Medicaid agencies, Office of Personnel Management (OPM), and formal third party groups and surcharge only group payers (latter as defined in 42 Code of Federal Regulations (CFR) 408.80 through 408.92 and 408.200 through 408.210)) for the payment of Part B (SMI) and/or Part A (HI) premiums on behalf of Medicare beneficiaries, the payment of the surcharge portion of the Part B premium on behalf of Medicare beneficiaries by a State or local government entity, and for enrolling individuals for Part A or Part B coverage under state buy-in agreements. 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, agency of a State government, an agency established by State law, or its fiscal agent; (3) support formal third party groups and surcharge only group payers pursuant to an agreement with CMS; (4) assist an individual or research organization to support research evaluation of epidemiological projects; (5) support litigation involving the agency; and (6) combat fraud, waste, and abuse in certain Federally-funded health care 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 Indian Health Service published a document Federal Register on June 20, 2007, concerning rates for inpatient and outpatient medical care provided by Indian Health Service facilities for Calendar Year 2007 for Medicare and Medicaid beneficiaries of other Federal Programs. The document contained five incorrect rates.

In compliance with the provisions of Section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Physician Survey of Practices on Diet, Physical Activity, and Weight Control. Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will obtain current, national data on primary care physicians' knowledge, attitudes, and practices related to diet, physical activity, and weight control. Obesity, poor diet, and lack of physical activity are becoming recognized as major public health problems in the United States, and have been linked to increased risk, adverse prognosis, and poor quality of life for cancer and many other chronic diseases. The data collected in this study will support and further NCI work in monitoring and evaluating providers' cancer prevention knowledge, attitudes, and practices and their impact on population health, as well as enable monitoring of progress toward major cancer control goals. Data from the survey will be used to profile existing physician practice, understand barriers to counseling and referral, and to inform methods for improving the utilization of these services for adults and children. Two questionnaires, one sent to physicians and one sent to their practice administrators, will be administered by mail or telephone to a randomly-selected national sample of 2,000 physicians belonging to primary care specialties. Study participants will be 2,000 practicing physicians who are family practitioners, general internists, pediatricians, and obstetrician/gynecologists and 2,000 practice administrators. The annual reporting burden is as follows: Estimated Number of Respondents: 4,000; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .333; and Estimated Total Annual Burden Hours Requested: 1,332. The annualized cost to respondents is estimated at: $65,048. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and programs (entities). As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces availability of FY 2007 funding for the HIV/AIDS Health Promotion and Education Program (hereafter referred to as the HIV/AIDS Program). OMH is authorized to conduct this program under 42 U.S.C. 300 u-6, section 1707 of the Public Health Service Act, as amended. The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point within the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health of racial and ethnic minorities. OMH activities are implemented in an effort to address Healthy People 2010, a comprehensive set of disease prevention and health promotion objectives for the Nation to achieve over the first decade of the 21st century (https://www.healthypeople.gov). This funding announcement is also made in support of the OMH National Partnership for Action initiative. The mission of the National Partnership for Action is to work with individuals and organizations across the country to create a Nation free of health disparities with quality health outcomes for all by achieving the following five objectives: Increasing awareness of health disparities, strengthening leadership at all levels for addressing health disparities; enhancing patient-provider communication; improving cultural and linguistic competency in delivering health services; and better coordinating and utilizing research and outcome evaluations. Minority communities are currently at the center of the HIV/AIDS epidemic in this country. The Centers for Disease Control and Prevention (CDC) estimates that more than 1.1 million Americans were living with HIV/AIDS at the end of 2005.\1\ The CDC also states that young people in the U.S. are at persistent risk for HIV infection. ``This risk is especially notable for youth of minority races and ethnicities.'' \2\ Multifaceted approaches to HIV/AIDS prevention which involve peers, school, faith-based, and community components are necessary to reduce the incidence of HIV/AIDS among young people.\3\ Background information on racial/ethnic disparities in HIV/AIDS can be found in Section VIII of this announcement.

This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and program (entities). OMH is authorized to conduct the Bilingual/Bicultural Demonstration Grant Program (hereafter referred to as the Bilingual/Bicultural Program) under 42 U.S.C. 300u-6, section 1707 of the Public Health Service Act, as amended. The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point within the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health of racial and ethnic minorities. OMH activities are implemented in an effort to address Healthy People 2010, a comprehensive set of disease prevention and health promotion objectives for the Nation to achieve over the first decade of the 21st century (https:// www.healthypeople.gov). This funding announcement is also made in support of the OMH National Partnership for Action initiative. The mission of the National Partnership for Action is to work with individuals and organizations across the country to create a Nation free of health disparities with quality health outcomes for all by achieving the following five objectives: increasing awareness of health disparities; strengthening leadership at all levels for addressing health disparities; enhancing patient-provider communication; improving cultural and linguistic competency in delivering health services; and better coordinating and utilizing research and outcome evaluations. The Bilingual/Bicultural Program was developed in response to a congressional mandate to develop the capacity of health care professionals to address the cultural and linguistic barriers to health delivery and increase access to health care for limited English- proficient (LEP) populations, particularly those who are racial ethnic minorities. OMH is committed to working with faith- and community-based organizations to improve and enhance access to quality and comprehensive health services for LEP, particularly racial/ethnic minority, populations. The OMH intends to demonstrate the merit of projects partnering community-based, minority-serving organizations and health care facilities in a collaborative effort to address cultural and linguistic barriers to effective health care service delivery, and to increase access to quality and comprehensive health care for LEP and racial/ethnic minority populations living in the United States. The Bilingual/Bicultural Program seeks to improve the health status of LEP populations, particularly racial and ethnic minorities who face cultural and linguistic barriers to health services by: reducing barriers to care; increasing access to quality care; supporting and increasing national, state and local efforts to expand the pool of health care professionals, paraprofessionals, and students who are from diverse communities to provide linguistically and culturally competent services; conducting and disseminating research to connect cultural competency behaviors to specific health outcomes; and assessing the impact of cultural and linguistic training models. As cited in the National Healthcare Disparities Report, clear communication is an important component of effective health care delivery. It is vital for providers to understand patients' health care needs and for patients to understand providers' diagnoses and treatment recommendations. Communication barriers can relate to language, culture, and health literacy.\1\About 47 million Americans, or 18 percent of the population, spoke a language other than English at home in 2000, up from 32 million in 1990.\2\ Census data convey a sense of the growing portion of the United States population that is likely to experience LEP.\3\ The 2000 Census reported that 4.4 million households are linguistically isolated, meaning that no person in the household speaks English ``very well.'' This is a significant increase from 1990, when 2.9 million households were linguistically isolated.\4\ In responding to the need to ensure that all people entering the health care system receive equitable and effective treatment in a culturally and linguistically appropriate manner, the OMH published the National Standards on Culturally and Linguistically Appropriate Services (CLAS) in Health Care for voluntary adoption by health care organizations.\5\ CLAS consists of 14 standards that are organized by three themesCulturally Competent Care (Standards 1-3), Language Access Services (Standards 4-7), and Organizational Supports for Cultural Competence (Standards 8-14). The standards are intended to be inclusive of all cultures and not limited to any particular population group or sets of groups, to contribute to the elimination of racial and ethnic health disparities, and to improve the health of all Americans.

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 information collection requirements for premarket approval of medical devices.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adoption of FDA Food Code by Local, State and Tribal Governments'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 recordkeeping requirements for institutional review boards (IRBs).

The Department of Health and Human Services (``HHS'' or the ``Department'') adopted, by an interim final rule, the Office of Management and Budget (OMB) guidance at 2 CFR part 180 on nonprocurement debarment and suspension including some provisions specific to HHS. Public comment on this action was solicited in a Federal Register notice dated March 1, 2007. No comments were received; therefore, the Department makes no changes to its interim final rule and it remains in effect as of March 1, 2007. Pursuant to the requirements in OMB guidance, HHS makes final the following regulatory actions: Removes its existing regulation on nonprocurement debarment at 45 CFR part 76, establishes a new part 376 in title 2 Code of Federal Regulations (CFR) adopting OMB's guidance and adding provisions specific to HHS, and revises the reference in 45 CFR 74.13 to reflect the new citation to 2 CFR part 376.

This notice announces the 17th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 10th 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.).