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

The Food and Drug Administration (FDA) is confirming the effective date of April 23, 2007, for the direct final rule that appeared in the Federal Register of December 7, 2006 (71 FR 70870). The direct final rule amends the regulation to remove beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide, used in oral pressurized metered- dose inhalers, from the list of essential uses of ozone-depleting substances. None of these products is currently being marketed. This document confirms the effective date of the direct final rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the veterinary prescription use of diclazuril oral pellets in horses for the treatment of equine protozoal myeloencephalitis.

The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Peter Pan Seafoods, Inc., to market test canned Pacific salmon that deviates from the U.S. standard of identity for canned Pacific salmon. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product and assess commercial feasibility.

This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.

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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the following draft document: ``Asbestos and Other Mineral Fibers: A Roadmap for Scientific Research.'' The document can be found at https:// www.cdc.gov/niosh/review/public/099/. Instructions are provided for submitting comments. Public Comment Period: February 28 through May 31, 2007. Public Meeting Date and Time: May 4, 2007, 9 a.m.-4 p.m. Place: Holiday Inn Capitol, 550 C Street SW., Washington, DC 20024. Purpose of Meeting: To discuss and obtain comments on the draft document, ``Asbestos and Other Mineral Fibers: A Roadmap for Scientific Research''. Special emphasis will be placed on discussion of the following: (1) Whether the hazard identification and discussion of health effects for asbestos and mineral fibers are a reasonable reflection of the current understanding of the evidence in the scientific literature, (2) The appropriateness and relevancy of the discussion of the current understanding of the analytical issues and the research needs for analysis of asbestos and mineral fibers, (3) The appropriateness and relevancy of the discussion of the current understanding of the epidemiological issues and the research needs for understanding the health effects of asbestos and mineral fibers, (4) The appropriateness and relevancy of the discussion of the current understanding of the toxicological issues and the research needs for understanding the health effects of asbestos and mineral fibers, and (5) The appropriateness and relevancy of the discussion of the path forward and whether the ultimate vision is a reasonable outcome for the proposed research strategy for asbestos and mineral fibers. Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. Persons wanting to attend and provide oral comments at the meeting are requested to notify Diane Miller no later than May 1, 2007 to reserve time for their comments. Those interested in attending without providing oral comments at the meeting also are requested to notify Ms. Miller by May 1, 2007 to reserve a seat. Ms. Miller can be reached by telephone at 513/533-8450 or by e-mail at niocindocket@cdc.gov. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come basis. Unreserved walk-in attendees will be accommodated on the day of the meeting if space is available. Persons wanting to provide oral comments will be permitted up to 15 minutes. If additional time becomes available, presenters will be notified. Oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8450. All material submitted to the Agency should reference docket number NIOSH-099 and must be submitted by May 31, 2007 (public review closing date) to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-099. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, relevant to the characterization of exposures and possible health risks of occupational exposure to asbestos and other mineral fibers. Examples of requested information include, but are not limited to, the following: (1) Identification of industries, occupations, and processes where exposure to mineral fibers may occur, including exposure to fiber-like cleavage fragments and thoracic-sized fibers (as defined in the draft NIOSH document). (2) Current and historical mineral fibers exposure measurement data, including exposure to fiber-like cleavage fragments and thoracic- sized fibers at various types of industries and jobs. (3) Case reports or other health information demonstrating health effects in workers exposed to mineral fibers, including exposure to fiber-like cleavage fragments and thoracic-sized fibers. (4) Reports of experimental in vivo, in vitro, and inhalation studies with rodents that provide evidence of biopersistence and/or of a dose-relationship between the particle dimension (e.g., fiber) of the mineral and its biological activity. (5) Information on sampling and analytical methods that could be used to improve the identification and differentiation of ``fibers'' of different dimensions and composition. (6) Information on technologies that could be used to separate thoracic-sized fibers, including fiber-like cleavage fragments, into discrete size dimensions in quantities sufficient for conducting chronic rodent inhalation studies. NIOSH will use this information to assess the scientific basis for the draft document and the need to revise research recommendations. Contact Person for Technical Information: Paul Middendorf, telephone (513) 533-8606, M/S C-9, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Contact Person for Submitting Comments/Meeting Attendance: Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C-34, Cincinnati, Ohio 45226, telephone (513) 533-8450. All material submitted to the Agency should reference Docket Number NIOSH-099. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting and request for information: NIOSH Availability of Opportunity to Provide Input regarding the National Occupational Research Agenda (NORA) for the Mining Sector. Status: Meeting is open to the public, limited only by the space available. Participation is encouraged through the Web for those who cannot attend in person. Background: A large part of our lives is shaped by the work we do. NORA is a framework to guide occupational safety and health research for the nation. It is an ongoing endeavor to focus research to reduce work-related injury and illness. As the program entered its second decade, it was structured according to eight industry sector groups in order to encourage widespread adoption of effective practices developed through research. Each sector will have a NORA Sector Council consisting of NIOSH and stakeholder representatives. The initial task of the NORA Mining Council will be to draft a strategic plan for the nation addressing high priority needs in the sector. Following revisions based on public comment, the ongoing task of the Council will then be to encourage implementation of the plan by research and industry organizations in order to reduce occupational illnesses, injuries and fatalities in the sector. Given that NORA represents a broad-based partnership involving government, business, the worker community, academia, and others, public input is essential for planning future directions for the initiative. Some of the considerations for the Mining Sector are that NIOSH as the federal organization charged with conducting occupational safety and health research has established strategic goals in mining research. They are available for viewing: https://www.cdc.gov/niosh/ programs/mining/goals.html. Since development of these goals, the NIOSH research program has been enhanced according to the requirements of the MINER Act of 2006: https://www.cdc.gov/niosh/mining/mineract/ mineract.htm. Unlike other sectors, NIOSH can request advice from an Advisory Committee for mining: Mine Safety and Health Research Advisory Committee (MSHRAC). Besides these ongoing NIOSH activities, NORA provides the opportunity for NIOSH to work with partners and for partners to work with each other to effectively conduct additional research in mining safety and health and to move those research results into more effective workplace practice. The first meeting of the NORA Mining Sector Council will be held May 3, 2007, 1:30 p.m.-5 p.m. From 2:30 p.m.-4 p.m., the meeting will be structured to hear stakeholder comments on important occupational safety and health issues in the industry, especially those not adequately covered by NIOSH or other ongoing research; organizations that should participate in the research or in NORA activities; individuals who are willing to participate in NORA Mining Sector Council activities; and efficient ways to accomplish the NORA activities in light of ongoing organizational activities in the sector. Participants wishing to provide comments may do so via E-mail or may request an opportunity to make a five minute presentation. All participants are requested to register for the free meeting by sending an E-mail to MWerner@cdc.gov with their name, affiliation, whether they wish to attend in person or through the Web, whether they are requesting time to speak briefly, and, if so, the general topic(s) on which they wish to speak. Participants wishing to speak are encouraged to register early. The public meetings are open to everyone, including all workers, professional societies, organized labor, employers, researchers, health professionals, government officials and elected officials. Broad participation is desired. Summary: The NORA Mining Sector Council will accept public comments on the range of occupational safety and health issues that should be considered and the individuals and organizations who should be involved for the purpose of enhancing the effectiveness of the Council. Types of occupational safety and health issues might include diseases, injuries, exposures, populations at risk, and needs of occupational safety and health systems. For example, occupational musculoskeletal disorders in workers at small operations might be seen as important for a segment of the mining sector. If possible, please include as much information as necessary for understanding the safety or health research priority you identify. Such information could include characterization of the frequency and severity with which the injury, illness, or hazardous exposure is occurring and of the factors you believe might be causing the health or safety issue. Input is also requested on the types of research that you believe might make a difference and the partners (e.g., specific industry associations, labor organizations, research organizations, governmental agencies) who should be involved in forming research efforts and in solving the problem. All presentation text and other comments provided by e-mail will be entered into the searchable database of NORA comments, which will be publicly available and will be consulted by the NORA Mining Sector Council when drafting the strategic plan for the nation. The current version of the searchable database of NORA comments is available at: https://www2a.cdc.gov/niosh-comments/nora-comments/commentsrch .asp. For Technical Information Contact: Dr. Michael A. Werner, Senior ScientistMining, NIOSH, telephone 509-354-8014, Co-Chair, NORA Mining Sector Council.

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.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill 11 vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).

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.

The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems,'' which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.