Department of Health and Human Services September 8, 2006 – Federal Register Recent Federal Regulation Documents
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Office of Public Health Emergency Preparedness; Draft HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy for Chemical, Biological, Radiological and Nuclear (CBRN) Threats 1
The United States faces serious public health threats from the deliberate use of weapons of mass destruction (WMD)chemical, biological, radiological, or nuclear (CBRN)by hostile States or terrorists, and from naturally emerging infectious diseases that have a potential to cause illness on a scale that could adversely impact national security. Effective strategies to prevent, mitigate, and treat the consequences of CBRN threats is an integral component of our national security strategy. To that end, the United States must be able to rapidly develop, stockpile, and deploy effective medical countermeasures to protect the American people. The ultimate goal of this HHS Public Health Emergency Medical Countermeasures Enterprise Strategy (PHEMCE Strategy) is to establish the foundational elements and guiding principles that will support medical countermeasure availability and utilization for the highest priority CBRN threats facing our nation.
New Animal Drugs; Zilpaterol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of a zilpaterol hydrochloride Type A medicated article to formulate Type B and Type C medicated feeds for cattle fed in confinement for slaughter.
New Animal Drugs For Use in Animal Feed; Oxytetracycline
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 Phibro Animal Health. The supplemental NADA revises labeling of oxytetracycline Type A medicated article with the current genus for the causative bacteria for American foulbrood of honeybees.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Prospective Grant of Exclusive License: Diagnostics of Fungal Infections
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, limited field of use, co-exclusive license to practice the inventions embodied in the patent and patent applications referred to below to Myconostica, Inc. (Myconostica) having a place of business in Manchester, United Kingdom. CDC intends to grant no more than three licenses to these inventions. The patent rights in these inventions have been assigned to the government of the United States of America. The patent and patent applications to be licensed are: Title: Nucleic Acids for Detecting Aspergillus Species and Other Filamentous Fungi. U.S. Patent Application Serial No.: 09/423,233. Filing Date: 6/27/2000. Domestic Status: 6,372,430. Issue Date: 4/16/2002.
Prospective Grant of Exclusive License: Insecticide-Impregnated Bednet
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a limited field of use, exclusive license in India to practice the inventions embodied in the patent referred to below to Molecular Diagnostic Laboratory, having a place of business in Lucknow, India. The patent rights in these inventions have been assigned to the government of the United States of America. The patent(s) to be licensed are: US 6,896,892 B2 entitled ``Insecticide-Impregnated Fabric and Method of Production,'' issue date 05.24.2005. CDC Technology ID No. I- 008-99. Status: Issued. Issue Date: 05.24.2005 The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. Technology: This technology provides a new insecticide-impregnated fabric and method of production for bednets.
Identification of Priority Data Needs for Two Priority Hazardous Substances
This notice makes available for public comment the priority data needs for two priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). The notice also serves as a continuous call for voluntary research proposals. The SSARP is authorized by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (Superfund) or CERCLA, as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)]. This research program was initiated in 1991. At that time, a list of priority data needs for 38 priority hazardous substances was announced in the Federal Register on October 17, 1991 (56 FR 52178). The list was subsequently revised, based on public comments, and published in final form on November 16, 1992 (57 FR 54150). In 1997, ATSDR finalized the priority data needs for a second list of 12 substances; that priority data needs list was subsequently announced in the Federal Register on July 30, 1997 (62 FR 40820). Ten substances constitute the third list of hazardous substances for which priority data needs were identified by ATSDR. The final list of the 10 substances was published on April 29, 2003 (68 FR 22704), after it was subjected to public comment. The exposure and toxicity priority data needs in this notice were distilled from data needs identified in the Agency's toxicological profiles via a logical scientific approach described in a ``Decision Guide'' published in the Federal Register on September 11, 1989 (54 FR 37618). The priority data needs represent essential information to improve the database for conducting public health assessments. Research to address these priority data needs will help determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the hazardous substances. The priority data needs identified in this notice reflect the opinion of the Agency, in consultation with other Federal programs, of the research needed pursuant to ATSDR's authority under CERCLA. They do not represent the priority data needs for any other agency or program. Consistent with Section 104(i)(12) of CERCLA as amended [42 U.S.C. 9604(i)(12)], nothing in this research program shall be construed to delay or otherwise affect or impair the authority of the President, the Administrator of ATSDR, or the Administrator of EPA to exercise any authority regarding any other provision of law, including the Toxic Substances Control Act of 1976 (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act of 1972 (FIFRA), or the response and abatement authorities of CERCLA. In developing this research program, ATSDR has worked with other federal programs to determine common substance-specific data needs, as well as mechanisms to implement research that may include authorities under TSCA and FIFRA, private-sector voluntarism, or the direct use of CERCLA funds. When deciding the type of research that should be done, ATSDR considers the recommendations of the Interagency Testing Committee established under Section 4(e) of TSCA. Federally funded projects that collect information from 10 or more respondents and that are funded by cooperative agreements are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. If the proposed project involves research on human subjects, the applicants must comply with Department of Health and Human Services regulations (45 CFR part 46) regarding the protection of human subjects. Assurance must be provided that the project will be subject to initial and continuing review by the appropriate institutional review committees. Overall, data generated from this research program will lend support to others conducting human health assessments involving these two substances by providing additional scientific information for the risk assessment process. The two substances that are included in the ATSDR Priority List of Hazardous Substances established by ATSDR and EPA (70 FR 72840, December 7, 2005) are: Acrolein Barium The priority data needs for these two substances are presented in Table 1. We invite comments from the public on individual priority data needs. After considering the comments, ATSDR will publish the final priority data needs for each substance. These priority data needs will be addressed by the mechanisms described in the ``Implementation of Substance-Specific Applied Research Program'' section of this Federal Register notice. This notice also serves as a continuous call for voluntary research proposals. Private-sector organizations may volunteer to conduct research to address specific priority data needs in this notice by indicating their interest through submission of a letter of intent to ATSDR (see ADDRESSES section of this notice). A Tri-Agency Superfund Applied Research Committee (TASARC) comprised of scientists from ATSDR, the National Toxicology Program (NTP), and EPA, will review all proposals. The substance-specific priority data needs were based on, and determined from, information in corresponding ATSDR toxicological profiles. Background technical information and justification for the priority data needs in this notice are in the priority data needs documents. These documents are available for review by requesting them in writing from ATSDR (see ADDRESSES section of this notice).
Risk Communication on Medical Devices: Sharing Perspectives
The Food and Drug Administration (FDA), in cooperation with the Advanced Medical Technology Association (AdvaMed), is announcing a public meeting entitled ``Risk Communication on Medical Devices: Sharing Perspectives.'' This 1-day workshop is intended to bring together various creators and recipients of medical device risk/benefit information to discuss how this information is developed, disseminated, and perceived; and to explore ways in which the process might be improved. Dates and Times: The public meeting will be held on September 26, 2006, from 7:30 a.m. to 5 p.m. Online registration is available until 5 p.m. on September 25, 2006; however, onsite registration will be permitted if space remains (see the Registration section of this document for details).
Request for Public Comment: 30-day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges File
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 (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. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval. The IHS received no comments in response to the 60-day Federal Register notice (71 FR 35921) published on June 22, 2006. The purpose of this notice is to allow an additional 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0009, ``Indian Health Service Medical Staff Credentials and Privileges Files.'' Type of Information Collection Request: Extension of a currently approved information collection, 0917-0009, ``Indian Health Service Medical Staff Credentials and Privileges Files.'' Form Number: None. Need and Use of Information Collection: This collection of information is used to evaluate individual health care providers applying for medical staff privileges at IHS health care facilities. The IHS operates health care facilities that provide health care services to American Indians and Alaska Natives. To provide these service, the IHS employs (directly and under contract) several categories of health care providers including: physicians (M.D. and D.O.), dentists, psychologists, optometrists, podiatrists, audiologists, physicians assistants, certified registered nurse anesthetists, nurse practitioners, and certified nurse midwives. The IHS policy specifically requires physicians and dentists to be members of the health care facility medical staff where they practice. Health care providers become medical staff members, depending on the local health care facility's capabilities and medical staff bylaws. There are three types of IHS medical staff applicants: (1) Health care providers applying for direct employment with IHS; (2) contractors who will not seek to become IHS employees; and (3) employed IHS health care providers who seek to transfer between IHS health care facilities. National health care standards developed by the Center for Medicare and Medicaid Services (formerly the Health Care Financing Administration), the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and other accrediting organizations required health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. To meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: Former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves. In addition to the initial granting of medical staff membership and clinical privileges, JCAHO standards require that a review of the medical staff be conducted not less than every two years. This review evaluates the current competence of the medical staff and verifies whether they are maintaining the licensure or certification requirements of their specialty. The medical staff credentials and privileges records are maintained at the health care facility where the health care provider is a medical staff member. The establishment of these records at IHS health care facilities is not optional; such records must be established and maintained at all health care facilities in the United States that are accredited by JCAHO. Prior to the establishment of this JCAHO requirement, the degree to which medical staff applications were verified for completeness and accuracy varied greatly across America. Affected Public: Individuals and households. Type of Respondents: Health care providers requesting medical staff privileges at IHS health facilities. The table below provides the following: Types of data collection instruments, estimated number of respondents, number of responses per respondent, annual number of responses, average burden hour per response, and total annual burden hour.
Public Meeting on Patient and Physician Concerns in Access to Intravenous Immunoglobulin (IVIG)
This notice announces the date and location of a Town Hall meeting to be held on September 28, 2006 to obtain public comment on patient and physician concerns with access to IVIG. The Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation has contracted with Eastern Research Group, Inc. (ERG) to develop an analysis of supply, distribution, demand, and access issues associate with IVIG. This public meeting provides a forum for interested parties to make oral comments and to submit written comments about IVIG access for use in the analysis. In particular, comments are invited that will aid in the analysis of any physician or patient problems with access to IVIG, including the nature, size, and scope of any problems, as well as estimation of changes in health outcomes that may result from access problems.
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