Department of Health and Human Services December 17, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 192 entitled ``Anesthetics for Companion Animals.'' This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals. The guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of a new animal drug application (NADA) for general anesthetics.

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.

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 was previously published in the Federal Register on September 23, 2008 (Volume 73, Number 185, page 54840) and allowed 60-days for public comment. One comment was received. 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 Programs and Career Resources. Information Collection Request: Reinstatement. Need and Use of Information Collection: The survey will attempt to assess customer demographics and their satisfaction with the NIH curriculum supplements in presenting science in a more engaging and interactive way. The supplements help K-12 educators teach science by featuring the latest NIH research and utilized research-based instructional methods. 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 6,000 teachers have attended an OSE workshop. OSE also develops a series of videos, Women Are Scientists, that aim to excite middle school students on careers in the health sciences. Assessing the effectiveness of the NIH curriculum supplements, teacher workshops, and career resources is critical to determining if OSE is successfully fulfilling its mission. OSE has the database infrastructure in place to easily collect data from supplement and career video requesters and workshop attendees. At present, we do not have clearance to contact our customers to determine how NIH resources are meeting their educational needs.