Department of Health and Human Services August 17, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mixups at Health Care Facilities-Survey
The Food and Drug Administration (FDA) is announcing that a collection of information entitled Requirements for Collection of Data Relating to the Prevention of Medical Gas Mixups at Health Care FacilitiesSurvey has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): Scientific Workshop on Alternative Methods To Refine, Reduce, or Replace the Mouse LD50
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM announce an upcoming ``ICCVAM/ NICEATM/ECVAM Scientific Workshop on Alternative Methods to Refine, Reduce, or Replace the Mouse LD50 Assay for Botulinum Toxin Testing.'' The workshop is being co-organized by ICCVAM, NICEATM, and the European Centre for the Validation of Alternative Methods (ECVAM). This workshop is open to the public with attendance limited only by the space available. ICCVAM and NICEATM also invite the submission of (1) data from botulinum toxin test methods and (2) abstracts for scientific posters for display at the workshop (discussed more under ``Supplemental Information'').
National Toxicology Program (NTP); Report on Carcinogens; Proposed Review Process for the 12th Report on Carcinogens (RoC): Request for Public Comment
The NTP invites public comments on the proposed review process for the 12th RoC. The proposed review process for the 12th RoC is available on the NTP Web site https://ntp.niehs.nih.gov (select ``Report on Carcinogens'') or by contacting Dr. C.W. Jameson at the address provided below.
Heparin Catheter Lock-Flush Solutions; Transfer of Primary Responsibility from Center for Drug Evaluation and Research to Center for Devices and Radiological Health
The Food and Drug Administration (FDA) is announcing the transfer of primary responsibility for the regulation of heparin catheter lock-flush solution products from the Center for Drug Evaluation and Research (CDER) to the Center for Devices and Radiological Health (CDRH). These products are combination drug-device products. The transfer of lead review responsibility to CDRH is based on FDA's determination that the primary mode of action for these heparin catheter lock-flush solution products is that of the device part of the combination. The transfer provides consistency and efficiency in the regulation of these combination products by treating like products similarly.
Draft Guidance for Industry; Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry (183) entitled ``Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions.'' The draft guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of the Animal Drug User Fee Act of 2003.
Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Chicago, Illinois'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Chicago, IL. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Chicago, IL, October 23 through 26, 2006, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Monday, October 2, 2006, from 1:30 p.m. to 4 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3d Fl., Conference Room G, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 1:25 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room G. Contact Person: Tammie Bell, Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0919, e-mail: Tammie.Bell2@fda.hhs.gov, FAX: 301-480-0716. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by September 25, 2006. If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch-The Food and Drug Administration Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``MedWatchThe Food and Drug Administration Safety Information and Adverse event Reporting Program; Proposal to Survey MedWatch Partners Organizations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Decision To Evaluate a Petition To Designate a Class of Employees at Los Alamos National Laboratory, Los Alamos, NM, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Los Alamos National Laboratory, Los Alamos, New Mexico, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Los Alamos National Laboratory. Location: Los Alamos, New Mexico. Job Titles and/or Job Duties: All Department of Energy employees, contractors, and subcontractors employed in all Tech areas. Period of Employment: 1943-1975.
Decision To Evaluate a Petition To Designate a Class of Employees at Blockson Chemical Company (Also Known As Olin Mathieson), Joliet, IL, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Blockson Chemical Company (also known as Olin Mathieson), Jolit, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to a revision as warranted by the evaluation, is as follows: Facility: Blockson Chemical Company (also known as Olin Mathieson). Location: Joliet, Illinois. Job Titles and/or Job Duties: All workers who worked in Building 55 at the Blockson Chemical Company. Period of Employment: January 1, 1951 to December 31, 1962.
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
This notice announces the eighth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality and Security Workgroup Meeting
This notice announces the cancellation of the eighth meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.). Canceled Date/Time: August 14, 2006, 1 p.m. to 5 p.m.
Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of July 25, 2006 (71 FR 42031). The document amended the voluntary nutrition labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. The document published with incorrect units of measures for nutrients and an incorrect number in the Final Regulatory Impact Analysis section. This document corrects those errors.
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