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

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.

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.

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.

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).

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).

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.

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 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 ``Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.'' This draft guidance addresses the definition and regulatory status of a class of in vitro diagnostic devices referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). The guidance also addresses premarket and postmarket requirements with respect to IVDMIAs. An IVDMIA employs data, derived in part from one or more in vitro assays, and an algorithm that usually, but not necessarily, runs on software, to generate a result that diagnoses a disease or condition or is used in the cure, mitigation, treatment, or prevention of disease.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Ames Laboratory, in Ames, Iowa as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 8, 2006, the Secretary of HHS designated the following class of employees as an addition to the SEC:

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

The Health Resources and Services Administration published a document in the Federal Register on August 11, 2006, concerning changes to the organization and functions of the Office of the Administrator (RA) and the HIV/AIDS Bureau (RV). The document omitted information regarding movement of the Center for Quality and also erroneously included the Telehealth function within the HIV/AIDS Bureau, which was moved to the Office of Health Information Technology (RT) on 12/27/05 (70 FR 76463-76465).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 13, 2006, page 34142, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This notice announces the ninth meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the first meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.). The Quality Workgroup was created to make recommendations to the American Health Information Community on how HIT can: Provide data for the development of quality measures that are useful to patients and others in the health care industry; automate the measurement and reporting of a comprehensive current and future set of quality measures; and accelerate the use of clinical decision support that will improve performance using quality measures. The workgroup's initial charge will be to make recommendations to the American Health Information Community that specify how certified health information technology should capture, aggregate, and report data for a core set of ambulatory and in-patient quality measures. Date/Time: September 22, 2006, 11 a.m. to 2 p.m.

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.