Department of Health and Human Services September 29, 2010 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. The purpose of this notice is to allow an additional 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. The proposed information collection was previously published in the Federal Register on June 28, 2010 Volume 75, No. 123, pages 36659-36660, and allowed 60-days for public comment. No comments were received on this notice. Proposed Collection: Title: Brain Power! The NIDA Junior Scientist Program, for grades K-5, and the companion program for Middle School, the Brain Power! Challenge. Type of Information Collection Request: NEW. The previous OMB approval was discontinued on March 31, 2009 (OMB Control number 0925- 0542 that was obtained in 2005), and the new submission is requested until July 31, 2011. Need and Use of Information Collection: This is a request for clearance to evaluate the effectiveness of the Brain Power! Program's ability to: Increase students' knowledge about the biology of the brain and the neurobiology of drug addiction; Increase positive attitudes toward science, careers in science, and science as an enjoyable endeavor, and stimulating interest in scientific careers; and Promote more balanced perceptions and attitudes of scientists as being of many races, ages, and genders The secondary goal is to determine the influence or change of attitudes toward and intentions about drug use. The findings will provide valuable information concerning the goals of NIDA's Science Education Program of increasing scientific literacy and stimulating interest in scientific careers. In order to test the effectiveness of the evaluation, information will be collected from students before and after exposure to the curriculum with pre- and post-test self-report measures. Surveys also will be administered to teachers after the completion of the program to examine ease and fidelity of implementation, as well as impact in knowledge and understanding of the neurobiology of addiction. Surveys will be administered to parents to obtain parental reaction and opinion on the materials and the degree to which parents find the curriculum informative and appropriate. Frequency of Response: On occasion. Affected Public: Elementary and middle school students, teachers, and parents. Type of Respondents: Students, Teachers, and Parents. The reporting burden is as follows: Estimated Number of Respondents: 1,260. Estimated Number of Responses per Respondent: Students 2, Parents and Teachers: 1. Average Burden Hours per Response: Students: .5, Parents: .5, and Teachers: .5. Estimated Total Annual Burden Hours Requested: 892.5. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.