Submission for OMB Review; Comment Request; Brain Power! The NIDA Junior Scientist Program and the Companion Program, Brain Power! Challenge
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.
Proposed Collection; Comment Request; the Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI)
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI) (OMB: 0925-0406). Type of Information Collection Request: Renewal. Need and Use of Information Collection: The purpose of this information collection is to continue and complete updating the occupational and environmental exposure information as well as medical history information for respondents enrolled in the Agriculture Health Study. This represents a request to continue and complete phase III (2005-2008) of the study. Due to reduced annual budgets for research, a delay in data collection has resulted and there has not been enough time to complete the data collection on the number of respondents that had been originally requested in 2005 OMB submission. The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environment. The data will be collected by using a computer assisted telephone interview (CATI) system. A small percentage of the respondents will also be asked to participate in a buccal cell collection which is a sample of loose cells from the respondent's mouth. The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. Frequency of Response: Once. Affected Public: Private Sector, Farms. Type of Respondents: Licensed pesticide applicators and their spouses. The annual reporting burden is as follows:
Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Spinal Cord Injury, Traumatic Brain Injury, and Leukemia
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.
National Toxicology Program (NTP); Report on Carcinogens (RoC); Request for Public Comments on the RoC Expert Panel's Recommendations on Listing Status for Aristolochic Acids and Riddelliine in the 12th RoC and the Scientific Justifications for the Recommendations
The RoC Office invites public comments on the recommendations from an expert panel on listing status for aristolochic acids and riddelliine in the 12th RoC and the scientific justifications for the recommendations. The recommendation and scientific justification for each candidate substance are available electronically in Part B of the Expert Panel Report (http://ntp.niehs.nih.gov/go/29682, see Expert Panel Report Part B) or in printed text from the RoC Office (see FOR FURTHER INFORMATION CONTACT below). The RoC Office convened an eight- member expert panel of scientists from the public and private sectors on January 24-25, 2008, to review aristolochic acid related exposures and riddelliine. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make recommendations regarding listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for aristolochic acids and for riddelliine in the 12th RoC and (2) to provide the scientific justifications for the recommendations.
Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Submission for Office of Management and Budget Review; Health and Diet Survey; Pet Food Labeling Survey
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.
Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Proposed Changes to Disclosure of Physician Ownership in Hospitals and Physician Self-Referral Rules; Proposed Collection of Information Regarding Financial Relationships Between Hospitals and Physicians
We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the Deficit Reduction Act of 2005, the Medicare Improvements and Extension Act, Division B, Title I of the Tax Relief and Health Care Act of 2006, and the TMA, Abstinence Education, and QI Programs Extension Act of 2007. In addition, in the Addendum to this proposed rule, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These proposed changes would be applicable to discharges occurring on or after October 1, 2008. We also are setting forth the proposed update to the rate-of-increase limits for certain hospitals and hospital units excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The proposed updated rate-of-increase limits would be effective for cost reporting periods beginning on or after October 1, 2008. Among the other policy decisions and changes that we are proposing to make are changes related to: Limited proposed revisions of the classification of cases to Medicare severity diagnosis-related groups (MS-DRGs), proposals to address charge compression issues in the calculation of MS-DRG relative weights, the proposed revisions to the classifications and relative weights for the Medicare severity long- term care diagnosis-related groups (MS-LTC-DRGs); applications for new medical services and technologies add-on payments; wage index reform changes and the wage data, including the occupational mix data, used to compute the proposed FY 2009 wage indices; submission of hospital quality data; proposed changes to the postacute care transfer policy relating to transfers to home for the furnishing of home health services; and proposed policy changes relating to the requirements for furnishing hospital emergency services under the Emergency Medical Treatment and Labor Act of 1986 (EMTALA). In addition, we are proposing policy changes relating to disclosure to patients of physician ownership or investment interests in hospitals and soliciting public comments on a proposed collection of information regarding financial relationships between hospitals and physicians. We are also proposing changes or soliciting comments on issues relating to policies on physician self-referrals.
National Advisory Council on Migrant Health
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
New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Halocarbon Laboratories, Division of Halocarbon Products Corp., to Halocarbon Products Corp.
Prospective Grant of Exclusive License: Development of Cancer Therapeutics in Humans
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.
Request for Public Comment: 60-Day Proposed Information Collection: Behavioral Health Preventive Care Assessment Focus Group Guide
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-NEW, ``Behavioral Health Preventive Care Assessment Focus Group Guide.'' Type of Information Collection Request: Three-year approval of this new information collection, 0917-NEW, ``Behavioral Health Preventive Care Assessment Focus Group Guide.'' Form(s): None. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission, IHS uses the Government Performance Act (GPRA) to assess quality of care among its Federal, Urban, and Tribal health programs. The IHS has been largely successful in meeting GPRA targets for selected clinical performance measures at the national level. However, there is significant variability in performance among IHS and Tribal service units. Until this time, IHS has not undertaken any comprehensive studies to evaluate the reasons for that variability or the factors that contribute to high quality care at the local level. The IHS has three GPRA measures relating to behavioral health, a high priority for the Agency and one of the IHS Director's Initiatives. This study will focus on these three GPRA behavioral health measures: Depression Screening in adults age 18 and over, Domestic/Intimate Partner Violence screening in women ages 14-15, and Alcohol Screening (to prevent Fetal Alcohol Syndrome) in women ages 15-44. Tribal programs voluntarily report their GPRA results quarterly and annually for national reporting. GPRA data collected for these three behavioral health measures includes: the number of patients eligible for a screening (denominator), number of eligible patients who receive a screening (numerator), and the resulting screening rate (percentage). IHS has developed a methodology to identify superior and poor performers on these measures in both Tribal and Federal sites using fiscal year 2005, 2006, and 2007 GPRA performance results. IHS will convene focus groups with employees at 17 of these programs (7 IHS and 10 Tribal) in order to identify the factors contributing to (and when appropriate, the barriers preventing) the provision of high quality behavioral health care at the local level. These focus groups will allow employees to provide detailed data regarding program practices, screening and documentation procedures, initiatives, resources, and other factors relating to the provision of behavioral health preventive care at their health program. A total of two to three focus groups, organized by occupational specialty, will be convened at each program. Using the Chronic Care Model and Institute of Medicine recommendations, IHS will analyze the information collected during these site visits, along with background information that is publicly available (e.g., information found on clinic web pages), on other qualitative and quantitative features of individual programs, such as staffing and funding levels, community demographics, and organizational structure, to develop a behavioral health preventive care model relevant to the unique system of IHS delivery. Affected Public: Individuals. Type of Respondents: Tribal employees at Tribal health programs. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).
Government-Owned Inventions; Availability for Licensing
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.
Prospective Grant of Exclusive License: Method To Treat Psoriasis in Humans
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 U.S. Provisional Patent Application No. 60/855,422 and 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], to Lee's Pharmaceuticals, Ltd., which is located in Hong Kong, China. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be Asia and the field of use may be limited to the use of Licensee's proprietary delivery formulation for the treatment of psoriasis as claimed in the Licensed Patent Rights.
Tribal Self-Governance Program Negotiation Cooperative Agreement; Correction
The Indian Health Service published a document in the Federal Register (FR) on March 31, 2008. The document contained three errors.
Tribal Self-Governance Program Planning Cooperative Agreement; Correction
The Indian Health Service published a document in the Federal Register (FR) on March 31, 2008. The document contained four errors.
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated April 2008. This draft guidance is intended for establishments that collect Whole Blood and blood components intended for transfusion and establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The document provides recommendations for testing of donations of Whole Blood and blood components and HCT/P donor specimens for West Nile Virus (WNV) using an FDA-licensed donor screening assay. FDA believes that the use of a licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV, and therefore recommend use of a licensed NAT to screen donors of Whole Blood and blood components intended for transfusion and for testing donors of HCT/Ps for infection with WNV. FDA recommends the use of licensed NAT testing for WNV within 6 months after a final guidance is issued.
Meeting of the President's Council on Physical Fitness and Sports
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Physical Fitness and Sports will hold a meeting. This meeting is open to the public. A description of the Council's functions is included also with this notice.
Meeting of the Advisory Committee on Blood Safety and Availability
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.
Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
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.
Determination That TAPAZOLE Tablets and 18 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the 19 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
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 the information collection provisions of FDA's current good manufacturing practice (CGMPs) regulations for finished pharmaceuticals.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping and Records Access Requirements for Food Facilities
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.
Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening for 90 days, the comment period for the proposed rule, published in the Federal Register of February 20, 2002 (67 FR 7620), on the classification of encapsulated amalgam alloy and dental mercury, the reclassification of dental mercury, and the issuance of special controls for amalgam alloy. In the Federal Register of July 17, 2002 (67 FR 46941), the initial comment period was reopened for 60 days. The agency is taking this action to provide the public with an additional opportunity to comment and to request data and information that may have become available since publication of the proposed rule.