Department of Health and Human Services April 10, 2006 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance that was issued on March 15, 2000.
Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path.'' FDA is issuing this guidance to inform industry and agency staff of steps that are needed to ensure the safe and effective use of in vitro diagnostic (IVD) devices intended for use in the detection of influenza A (or A/B) virus directly from human specimens. FDA is taking this action because of recent significant public health concerns associated with emergence of an avian influenza A virus strain as a human pathogen in Southeast Asia. This guidance document describes recommendations for fulfilling labeling requirements applicable to all IVDs intended to generally detect influenza A (or A/B) virus directly from human specimens, and outlines the premarket regulatory path for new or modified devices intended to generally detect influenza A virus, or to detect and differentiate, specific novel influenza A viruses infecting humans. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006
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.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
NIOSH Pilot Study of Truck Driver Anthropometric and Workspace Dimensions; Meeting
Purpose: The public meeting will explain and discuss issues related to the current NIOSH pilot project and a possible large-scale research project on U.S. truck driver anthropometric and workspace data. This possible large-scale study will establish an anthropometric and workspace database for U.S. truck drivers. The database will be used to formulate anthropometric guidelines, develop digital human models for cab designs, and upgrade current standards for new generation cabs that would accommodate all trucking populations. Updated anthropometric information for cab design will help to increase truck drivers' visibility, operational comfort, maneuverability, and post-crash survivability, thereby possibly reducing fatal and nonfatal injuries. The current NIOSH pilot study will (1) identify critical cab design criteria and related human body dimensions, (2) establish test procedures for the large-scale project, and (3) develop research partnerships with interested parties. The scope of this pilot and possible large-scale study will be limited to medium and heavy trucks and their operators in the continental U.S. Special emphasis will be placed on discussion of the following issues: (1) What are the key anthropometric and workspace dimensions for the design of an ergonomically sound cab? (2) What are the essential adjustment parameters and values of the truck buck that is to be constructed for data collection? (3) What are the essential postures to be scanned in three- dimensional anthropometry that are to be used in computer simulation? (4) What are the essential cab accommodation models to be developed once updated anthropometric and workspace data become available? The public is invited to attend and will have the opportunity to provide comments. NIOSH will use this information to assess the scientific basis for the current pilot project and the possible large- scale project on U.S. truck driver anthropometric and workspace data. Status: The consortium meeting will include scientists and representatives from various government agencies, industry and other stakeholders and is open to the public, limited only by the space available. The meeting room accommodates 40 people. Due to limited space, notification of intent to attend the meeting must be made to Jinhua Guan, PhD, not later than April 14, 2006. Dr. Guan can be reached by telephone at (304) 599-4676 or by e-mail at ezg6@cdc.gov. Requests to attend the meeting will be accommodated on a first-come basis. Non-U.S. Citizens: Because of CDC Security Regulations, non-U.S. citizens wishing to attend this meeting must provide the following information in writing to Barbara Phillips (telephone: 304-285-6325; fax: (304) 285-6039; e-mail: djp2@cdc.gov) no later than April 14, 2006: 1. Visitor's Full Name: 2. Gender: 3. Date of Birth: 4. Place of Birth (city, province, state, country): 5. Citizenship: 6. Passport Number: 7. Date of Passport Issue: 8. Date of Passport Expiration: 9. Type of Visa: 10. Visitor's Organization: 11. Organization Address: 12. Organization Telephone Number: 13. Visitor's Position/Title within the Organization: This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. A copy of the research protocol titled ''NIOSH Pilot Study of Truck Driver Anthropometric and Workspace Dimensions'' can be obtained from the CDC Internet at https://www.cdc.gov/niosh/docs or a hard copy may be requested from the Docket Officer, Karen Dragon (see contact information below).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reprocessed Single-Use Device Labeling
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Reprocessed Single-Use Device Labeling'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export Certificates for Food and Drug Administration-Regulated Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export Certificates for FDA- Regulated Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Blood Establishment Registration and Product Listing, Form FDA 2830
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Blood Establishment Registration and Product Listing, Form FDA 2830'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated in the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting is open to the public.
Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
The Food and Drug Administration (FDA) is proposing to amend its current good manufacturing practice (CGMP) regulations to include new requirements for the label, color, dedication, and design of medical gas containers and closures. These requirements are intended to do the following: Make the contents of medical gas containers more readily identifiable, reduce the likelihood that containers of industrial or other gases would be inappropriately connected to medical oxygen supply systems, and reduce the risk of contamination of medical gases. FDA is also proposing to include medical air, oxygen, and nitrogen among, and exclude cyclopropane and ethylene from, those gases intended for drug use that are exempt from certain labeling requirements.
Announcement of Availability of Funds for Cooperative Agreement to the Arizona Outreach Office to Strengthen Public Health Services at the Arizona-Sonora Border
The Office of Global Health Affairs (OGHA) announces that up to $267,500 in fiscal year (FY) 2006 funds is available for a cooperative agreement to the Arizona Department of Health Services, Arizona Outreach Office of the U.S.-Mexico Border Health Commission to strengthen the binational public health projects and programs along the Arizona-Sonora border. Working in collaboration with the Arizona Department of Health Services Office of Border Health, the Secretaria de Salud de Sonora, and the USMBHC Arizona and Sonora Delegation Offices, this initiative targets activities on the following areas: Data analysis; public information, promotion and communication; and Healthy Gente/Healthy Border 2010 activities. The project will be approved for up to a one-year period for a total of $267,500 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.
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