Department of Health and Human Services July 21, 2005 – Federal Register Recent Federal Regulation Documents

The CERHR announces the availability of the expert panel report on styrene on July 18, 2005 from the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from the CERHR (see ADDRESSES below). The expert panel report is an evaluation of the reproductive and developmental toxicity of styrene conducted by a 13-member expert panel composed of scientists from the federal government, universities, and private organizations. The CERHR invites the submission of public comments on this expert panel report (see SUPPLEMENTARY INFORMATION below). The CERHR previously solicited public comment on the draft version of this expert panel report (Federal Register Vol. 70, No. 45 pp. 11680-11681). Public deliberations by the panel took place on June 1-3, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to styrene is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, Office of Science Policy, Office of Science Education, National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection has not been previously published in the Federal Register. The purpose of this notice is to allow 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number. Proposed Collection: Title: The Effectiveness of the NIH Curriculum Supplements and Workshops Survey. Information Collection Request: NEW. New and Use of Information Collection: The survey will attempt to assess the effectiveness of the NIH curriculum supplements in aiding teachers to teach science in a more engaging and interactive way. The supplements help k-12 educators teach science in more engaging and effective ways by featuring the latest NIH research. A typical supplement contains two weeks of student activities on the science behind a health topic, such as cancer, sleep or obesity. Web-based simulations, animations and experiments enhance the ``pencil and paper'' activities. In addition to developing and distributing the supplements, OSE conducts professional workshops to help teachers successfully implement these lessons with their students. Since January 2000, over 3,000 teachers have attended an OSE workshop. Assessing the effectiveness of the NIH Curriculum Supplements and teacher workshops is critical to determining if OSE is successfully fulfilling its mission. OSE has the database infrastructure in place to easily collect customer satisfaction data from supplement requests and workshops attendees. At present, we do not have clearance to contact our customers to determine how NIH resources are meeting their educational needs.

The Food and Drug Administration (FDA) is correcting the single-ingredient roxarsone Type A medicated article that may be used to formulate three-way, combination drug Type C medicated broiler chicken feeds containing semduramicin, virginiamycin, and roxarsone under a new animal drug application (NADA) recently approved for Phibro Animal Health. FDA is also amending the animal drug regulations to reflect two roxarsone Type A medicated articles approved under separate new animal drug applications (NADAs) for different conditions of use. This action is being taken to improve the accuracy of the agency's regulations.

The Food and Drug Administration (FDA) is announcing the availability of two draft manuals entitled ``Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments'' (the ``Operator's Manual'') and ``Managing Food Safety: A Regulator's Manual for Applying HACCP Principles to Risk-Based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems'' (the ``Regulator's Manual''). The Operator's Manual presents FDA's best advice to retail and foodservice operators for voluntarily implementing food safety management systems based on hazard analysis and critical control point (HACCP) principles to reduce the occurrence of foodborne illness risk factors. The Regulator's Manual is intended to assist State, local, and tribal regulatory authorities in identifying and assessing control of foodborne illness risk factors during routine inspections of retail and foodservice establishments by providing a risk-based inspection methodology.