Department of Health and Human Services April 2008 – 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 of Dental and Craniofacial Research (NIDCR), 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. This proposed information collection was previously published in the Federal Register on February 26, 2008 (Volume 73, Number 38, Page 10262) and allowed 60- days for public comment. One public comment was received. 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 on or after October 1, 1995, unless it displays a currently valid OMB control number. 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: This information collection request is for an extension of a previously approved OMB clearance (OMB Control number 0925-0542 that was obtained in 2005, and is requested until April 30, 2010. Need and Use of Information Collection: This is a request to evaluate the effectiveness of the Brain Power! Program's ability (1) increase children's knowledge about the biology of the brain and the neurobiology of drug addiction, (2) increase positive attitudes toward science, careers in science, science as an enjoyable endeavor, and the use of animals in research; and stimulate interest in scientific careers; and (3) engender more realistic perceptions of scientists as being from many races, ages, and genders. The secondary goals of the evaluation are to determine the Program's impact on attitudes and intentions toward drug use. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. There are 2 critical components to this mission: 1. the strategic support and conduct of research across a broad range of disciplines; 2. ensuring the rapid and effective dissemination and use of the results of that research to significantly improve the prevention of drug abuse and addiction, its treatment, and policy. The Brainpower! Challenge project is one of NIDA's many dissemination projects that is anticipated to improve the prevention of drug abuse and addiction among children and youth. These dissemination and diffusion projects complement NIDA's research projects to identify, develop, and refine effective efficient methods, structures, and strategies that test models to disseminate and implement research- tested health behavior change interventions and evidence-based interventions in prevention and treatment. Secondly, from its research NIDA knows that in order for prevention efforts to be effective educational programs must involve teachers, peers, parents, and the entire community. In 1996 NIDA convened a national prevention research conference on preventing drug use among children and adolescents. From it a research-base guide was prepared to provide prevention principles that a school or community can use to implement a prevention program specifically tailored to meet each community's particular needs. And the public response to the guide is evident from the continued requests for the guidean average of about 20,000 per month, and more than 200,000 copies distributed to date. The Brainpower! Challenge project provides a tool for science education that involves teachers, peers, parents and the entire community, and adds to any prevention programs implemented in the community. Thirdly, while education for the prevention of drug abuse may be a worthy function for the Department of Education to conduct, Executive Order 12862 directs federal agencies to provide significant services directly to the public. To provide services from NIDA's research findings, the 1993 the Science Education Abuse Partnership Award Program was conceptualized to ``* * *encourage the development and evaluation of programs that foster an understanding of neuroscience and the biology of drug abuse and addiction among K-12 students * * *.'' NIDA's current Science Education Program to increase scientific literacy and interest in science careers, continues this purpose. The Brainpower! Challenge project will bring a service to the schools and to parents, for laying the foundation for drug prevention among children and youth, and to educate them in the biology and neurobiology of the brain and addiction. Its anticipated achievement will be three- foldprevention of drug abuse among youth, fostering positive attitudes towards science careers, and service provision that translates research findings into practice among a vital population group. 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 will also 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: 1,337; Estimated Number of Responses per Respondent: 2; Average Burden Hours Per Response: .25; Estimated Total Annual Burden Hours Requested: 640.5. 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 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.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in 1. E-073- 1999/0-US-02, patent 6,737,511, issued May 15, 2004, entitled Receptor- Mediated Uptake of an Extracellular BCL-XL Fusion Protein Inhibits Apoptosis and 2. E-073-1999/0-US-05, patent application number 11/ 692,112 filed March 27, 2007, entitled Receptor-Mediated Uptake of an Extracellular BCL-XL Fusion Protein Inhibits Apoptosis, to Protox Therapeutics Incorporated (Protox), having a place of business in Vancouver and Victoria, Canada. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to therapeutics for the treatment of spinal cord injury, traumatic brain injury and leukemia.

The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), is holding a public workshop focused upon the state of the art in the research and development of an artificial pancreas. The public workshop entitled ``Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, and Juvenile Diabetes Research Foundation Workshop'' will provide a public forum for discussing the progress and remaining challenges in the development of closed-loop systems designed to regulate glycemic control, as an aid in the management of diabetes mellitus. It is intended to provide stakeholders with information that will accelerate the development of an artificial pancreas.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information for public comment in response to the notice. This notice solicits comments on FDA's Pet Food Labeling Survey.

The Health Resources and Services Administration published a meeting notice for the National Advisory Council on Migrant in the Federal Register of April 2, 2008 (73 FR 17991). The meeting place has changed. Correction

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Application Serial No. PCT/US07/083027 and foreign equivalents thereof, entitled ``Smoothened Polypeptides and Methods of Use'' [HHS Ref. No. E-014-2007/0]; PCT Application Serial No. PCT/US07/083772 and foreign equivalents thereof, entitled ``Self-Assembling Nanoparticles Composed of Transmembrane Peptides and Their Application for Specific Intra- Tumor Delivery of Anti-Cancer Drugs'' [HHS Ref. No: E-256-2006/0]; and U.S. Patent No. 7,105,488, and foreign equivalents thereof, entitled ``G Protein-Coupled Receptor Antagonists'' [HHS Ref. No: E-290-1997/0] to Calidris Therapeutics which is registered in Japan. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be worldwide and the field of use may be limited to peptidomimetic drugs for the treatment of cancer as claimed in the Licensed Patent Rights. These cancers may be limited to multiple myeloma, colon, lung, melanoma, liver, breast, prostate, ovarian, pancreatic cancers, ALL, AML, NHL, rhabdomyosarcoma, neuroblastoma, osteosarcoma and medulloblastoma. With respect to the GPCR technology, the exclusive license field of use may be limited to antagonists of the GPCR CXCR4.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Indian Health Service published a document in the Federal Register (FR) on March 31, 2008. The document contained three errors.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public on both Thursday, May 29 and Friday, May 30, 2008.

The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping and Records Access Requirements for Food Facilities'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.