Department of Health and Human Services March 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This draft guidance is one of a series of guidance documents intended to assist applicants in complying with new FDA regulations on the content and format of labeling for human prescription drug and biological products. The draft guidance describes the recommended information to include in the Clinical pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA).'' Public Meeting Time and Date: 10 a.m.-4 p.m. EDT, June 17, 2009. Place: Patriots Plaza, 395 E Street, SW., Conference Room 9000, Washington, DC 20201. Purpose of Meeting: The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA as well as updates from approximately half of the Sector Councils on their progress, priorities, and implementation plans to date, including the Construction Sector; Manufacturing Sector; Services Sector; Public Safety Sub-Sector; and Wholesale and Retail Trade Sector. Updates will also be given on cross-council coordination activities in the areas of surveillance and safety culture. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an e-mail to noracoordinator@cdc.gov containing the participant's name, organization name, contact telephone number on the day of the meeting, and preference for participation by web meeting (requirements include: computer, internet connection, and telephone, preferably with ``mute'' capability) or in person. An e-mail confirming registration will include the details needed to participate in the web meeting. Non-US citizens are encouraged to participate in the web meeting. Non-US citizens registering to attend in person after June 3 will not have time to comply with security procedures. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Eight sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the web and town hall meetings, NORA Sector Councils have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008- 09, most of these Councils have posted draft strategic plans for public comment. Two have posted finalized National Sector Agendas after considering comments on the drafts. For more information, see the link above and choose ``Sector-based Approach,'' ``NORA Sector Councils,'' ``Sector Agendas'' and ``Comment on Draft Sector Agendas'' from the right-side menu. Contact Person for Technical Information: Sidney C. Soderholm, PhD, NORA Coordinator, e-mail noracoordinator@cdc.gov, telephone (202) 245- 0665.

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 collection of information concerning class II special controls for automated blood cell separator device operating by centrifugal or filtration separation principle.

The Health Resources and Services Administration (HRSA) will be providing temporary critical HIV medical care and treatment services through the Greenwood Leflore Hospital (GLH) Magnolia Medical Clinic to avoid a disruption of HIV clinical care to clients in Bolivar, Sunflower and Washington Counties in Mississippi.