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

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.