Department of Health and Human Services March 6, 2008 – Federal Register Recent Federal Regulation Documents
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Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL (risperidone), and TIMOLOL (timolol). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Draft Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Reopening of Comment Period; Public Conference
The Food and Drug Administration (FDA) is reopening until June 30, 2008, the comment period for the draft guidance for industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation,'' published in the Federal Register of October 25, 2007 (72 FR 60681). FDA is also announcing a public conference entitled ``Detecting and Investigating Drug-Induced Liver Injury During Clinical Trials.'' FDA is cosponsoring the conference with the American Association for the Study of Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America. The purpose of the conference is to discuss the draft guidance and to solicit additional input on the issues and questions presented in this document.
Notice of the Revised Priority List of Hazardous Substances That Will Be the Subject of Toxicological Profiles
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires that ATSDR and the Environmental Protection Agency(EPA) prepare a Priority List of Hazardous Substances commonly found at facilities on the CERCLA National Priority List (NPL). The Priority List of Hazardous Substances includes substances that have been determined to be of greatest public health concern to persons at or near NPL sites. CERCLA as amended also requires that ATSDR and EPA periodically revise the Priority List of Hazardous Substances. Pursuant to these CERCLA mandates, the agencies announce that based on the most recent information available, they have developed and now make available a revised CERCLA Priority List of 275 Hazardous Substances. Because CERCLA as amended also requires ATSDR to prepare and to periodically revise toxicological profiles on hazardous substances included in the priority list, each priority list substance is a potential toxicological profile subject, as well as a candidate for identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events at which ATSDR is involved and wherein a substance has been found in a completed exposure pathway (CEP). This report is included in the Support Document of the Priority List.
Notice of Public Meeting
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 NIOSH Research Project entitled ``Effectiveness of Extension Ladder Safety Innovations''. The meeting will include a presentation/overview of the project that will be followed by comments on the technical and scientific aspects of the planned research. Viewpoints and suggestions from industry, labor, academia, other government agencies, and the public are invited. Written comments also will be considered. Written comments should be sent to Dr. Peter Simeonov, NIOSH, Division of Safety Research, Mailstop G800, 1095 Willowdale Road, Morgantown, West Virginia 26505-2888 or via E-mail at psimeonov@cdc.gov, and should be received on or before March 31, 2008. Public Meeting Time and Date: 9 a.m.-12 p.m., April 9, 2008. Place: NIOSH, 1095 Willowdale Road, Conference Room L-1BCD, Morgantown, West Virginia 26505-2888. Purpose of Meeting: To provide individual comments on the technical and scientific aspects of the research proposal directed to the prevention of fall injuries associated with the use of extension ladders among construction workers. The proposed research seeks to establish engineering solutions, with human factors considerations beyond the traditional regulation and training approaches, to minimize the possibility of workers making unsafe choices or actions, and thus reduce fall-from-ladder incidents. Status: The meeting is open to the public, limited only by the space available (the room accommodates approximately 50 people). Due to limited space, notification of intent to attend the meeting must be made to Peter Simeonov, Ph.D., no later than March 31. Dr. Simeonov can be reached at (304) 285-6268 or by E-mail at psimeonov@cdc.gov. Requests to attend the meeting will be accommodated on a first-come basis. Contact Persons for Technical Information: Hongwei Hsiao and Dr. Simeonov, Project Officers, Division of Safety Research, NIOSH, CDC, Mailstop G800, 1095 Willowdale Road, Morgantown, West Virginia 26505- 2888, (304) 285-5910 and (304) 285-6268, E-mail hhsiao@cdc.gov & psimeonov@cdc.gov. Copies of the research proposal may be obtained by contacting Dr. Simeonov.
Notice of Public Meeting
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following meeting and request for information: Opportunity To Provide Input regarding a protocol for the following: (1) An industry wide research study to evaluate occupational exposure to flavorings in the flavorings and food production industries; (2) an industry wide study of engineering controls for protection against exposure to flavorings in the flavorings and food manufacturing industries; and (3) research concerning improved analytical laboratory methods for use in flavorings and food production exposure assessment. Public Meeting Time and Date: 9 a.m.-4 p.m., April 2, 2008. Place: NIOSH Hamilton Laboratory, 5555 Ridge Ave, Cincinnati, OH, 45213, telephone (513) 841-4366, fax (513) 841-4483. Status: Meeting is open to the public, limited only by the space available (the room accommodates approximately 80 people). Persons who are not U.S. citizens will need approval to enter the NIOSH building and should contact Douglas Trout, MD, MHS, by March 5, 2008, to arrange for this. Those who cannot attend in person are encouraged to email comments. Deadline for e-mailed comments is April 16, 2008. Background: According to 2002 U.S. Census data, there were approximately 21,000 employees working in flavoring production and about 1.5 million workers in food manufacturing nationwide. Employees have complex exposures in terms of the physical form of the agents (solid, liquid, and gas) and the number of different chemicals used. Severe respiratory health effects have been identified among workers after exposure to flavoring chemicals such as diacetyl (a component of butter flavoring). NIOSH investigators have begun a research effort evaluating analytical methods, exposure assessment, and engineering controls in the flavoring and food production industries. This research is intended to provide information necessary to reduce occupational exposures and prevent health effects among workers in these industries. The meeting will consist of two parts: (1) External peer review of the research protocol. Peer reviewers external to CDC will be present to provide technical (scientific) review comments for the project officers to maximize the relevance and quality of the proposed research; and (2) Stakeholder meeting. The latter part of the meeting will be structured to hear stakeholder comments on important occupational safety and health issues related to this research. Participants wishing to provide stakeholder comments may do so via E-mail or may request an opportunity to make a five minute presentation. Participants making a presentation at the meeting must submit their comments in writing at the time of the meeting. All participants (whether making a presentation or not) are requested to register for the free meeting by sending an E-mail to DTrout@cdc.gov with their name, affiliation, 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 meeting is open to everyone, including all workers, representatives of professional societies, organized labor, employers, researchers, health professionals, government officials and elected officials. Broad participation is desired. Contact Person For Technical Information: Dr. Douglas Trout, MD, MHS, Associate Director for Science, Division of Surveillance, Hazard Evaluations, and Field Studies, NIOSH, telephone (513) 841-4428. Comments and meeting registrations may also be E-mailed to DTrout@cdc.gov, or sent via mail to: Dr. Douglas Trout, NIOSH, 4676 Columbia Parkway, R-12, Cincinnati, OH 45226.
Notice of Draft Document Available for Public Comment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document available for public comment entitled ``NIOSH Alert: Preventing Chronic Beryllium Disease and Beryllium Sensitization.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/ review/public/120/. Public Comment Period: March 6, 2008 through May 12, 2008. Status: Written comments may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, Mailstop C- 34, Cincinnati, Ohio 45226, (513) 533-8611. All material submitted to the Agency should reference NIOSH Docket number 120 and must be submitted by May 12, 2008, to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copies available at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Background: Beryllium is a lightweight metal with many remarkable properties, including heat resistance and conductance, electrical conductance, flexibility, formability, neutron moderation, x-ray transparency, and lubricity. Exposure to beryllium can lead to sensitization, a cell-mediated allergic-type response, and cause a granulomatous lung disease called chronic beryllium disease. The Alert describes the nature of the lung disease and other health effects that can occur from exposure to beryllium and beryllium- containing materials and recommends steps companies and workers should take to minimize the health risk to workers. This guidance document does not have the force and effect of law. Contact Person for Technical Information: Christine R. Schuler, PhD, Research Epidemiologist, Division of Respiratory Disease Studies, NIOSH. To ask technical questions, please call (304) 285-6369 or send e-mail to BeAlert@cdc.gov. All comments on the Alert must be submitted as stated in the Status section. Reference: NIOSH Alert: Preventing Chronic Beryllium Disease and Beryllium Sensitization https://www.cdc.gov/niosh/review/public/120/.
Canned Pacific Salmon Deviating From Identity Standard; Temporary Permit for Market Testing
The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Yardarm Knot Fisheries, LLC, 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.
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