HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
The Health Resources and Services Administration (HRSA) is amending the uniform waiver standards for Ryan White HIV/AIDS Program grantees requesting a core medical services waiver for fiscal year (FY) 2009 and beyond. Title XXVI of the Public Health Service (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation. HRSA has issued waiver standards for grantees under Parts A, B, and C of Title XXVI of the PHS Act. This Federal Register notice seeks to make public the final notice of Uniform Standard for Waiver of Core Medical Services Requirements for Grantees Under Parts A, B, and C effective FY 2009.
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ABILIFY (aripiprazole), ANDROGEL (testosterone), and DIOVAN (valsartan). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act, enacted in 2002, (the 2002 BPCA). For all pediatric supplements submitted under the 2002 BPCA, the 2002 BPCA required FDA to make available to the public, including by publication in the Federal Register, a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Computerized Tribal IV-D Systems and Office Automation
This proposed rule would enable Tribes and Tribal organizations currently operating a comprehensive Tribal Child Support Enforcement program under Title IV-D of the Social Security Act (the Act) to apply for and receive direct Federal funding for the costs of automated data processing. This proposed rule addresses the Secretary's commitment to provide instructions and guidance to Tribes and Tribal organizations on requirements for applying for, and upon approval, securing Federal Financial Participation (FFP) in the costs of installing, operating, maintaining, and enhancing automated data processing systems.
Tribal Child Support Enforcement Program
Notice is hereby given for the dates and locations for one informational meeting and three Tribal consultations on the Computerized Tribal IV-D Systems and Office Automation Notice of Proposed Rulemaking (NPRM). On June 11, 2008, the Federal Register will publish an NPRM that would enable Tribes and Tribal organizations currently operating a comprehensive Tribal Child Support Enforcement program under Title IV-D of the Social Security Act (the Act) to apply for and receive direct Federal funding for the costs of child support automated data processing. This proposed rule addresses the Secretary's commitment to provide instructions and guidance to Tribes and Tribal organizations on requirements for applying for, and upon approval, securing Federal Financial Participation (FFP) under the Tribal IV-D program in the costs of installing, operating, maintaining, and enhancing child support automated data processing systems. The public comment period for this regulation will be 60 days from the date of the publication of the NPRM. The Federal Office of Child Support Enforcement (OCSE) will host one meeting to introduce the proposed rule and three consultations to receive public comment on the proposed rule. This notification provides specific information for the informational meeting and consultations.
Food Protection Task Force Conference
The Food and Drug Administration (FDA) is announcing the availability of conference grant funding for meetings of State Food Protection Task Forces. The original announcement of availability of funding for State Food Safety Task Force Meetings, published in the Federal Register June 25, 2004 (69 FR 35651) and February 4, 2005 (70 FR 6015) as revised on May 3, 2005 (70 FR 22889). This revised announcement provides for a change in the name of the grant program to align with the FDA Food Protection Plan and new policies that apply to the State Food Protection Task Force Meetings conference Grant Program. FDA anticipates providing approximately $160,000 in direct costs only in support of this program in fiscal year (FY) 2008. It is anticipated that 32 awards will be made for up to $5,000 per award.
Prospective Grant of Exclusive License: Use of the Licensed Patent Rights To Develop Fully Human and/or Humanized Monoclonal Antibodies Against IGF-I and/or IGF-II for the Treatment of Human Cancers
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 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 the following U.S. Patent Applications to Systems Medicine, Inc., which is located in Tucson, Arizona. 1. PCT Patent Application No. PCT/US2006/031814 entitled ``Human Monoclonal Antibodies that Specifically Bind IGF-II'' [HHS Ref. Nos. E- 217-2005/0, 1, and 2]; and 2. PCT Application Serial No. PCT/US2007/66180 entitled ``Human IGF-I-Specific and IGF-I and IGF-II Cross-Reactive Human Monoclonal Antibodies'' [HHS Ref. No. E-336-2005/0]. 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 the use of the antibodies and their method of use in the Licensed Patent Rights for the treatment of human cancers
Office of the Director, Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
Proposal to conduct research involving the deliberate transfer of a drug resistance trait to a microorganism that causes disease in humans has been reviewed by the Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director.
Proposed Collection; Comment Request; NIH-American Association for Retired Persons (AARP) Comprehensive Lifestyle Interview by Computer (CLIC) Study (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: NIH-American Association for Retired Persons (AARP) Comprehensive Lifestyle Interview by Computer (CLIC) Study. Type of Information Collection Request: New. Need and Use of Information Collection: The Nutritional Epidemiology Branch of the Division of Cancer Epidemiology and Genetics of the National Cancer Institute has planned this study to evaluate the feasibility of using these three new computerized questionnaires as well as the Diet and Health Questionnaire (DHQ), a well-established food frequency questionnaire in a population of early-to-late-middle-aged men and women. Participants will be asked to complete one of four different series (pathways) of computerized questionnaires over a 90 day period, with some questionnaires in a series being completed twice. This evaluation study comprises the necessary performance and feasibility tests for the new computerized questionnaires, which will provide an opportunity to assess the possibility of administering computerized questionnaires in future large prospective cohort studies. The computerized questionnaires will support the ongoing examination between cancer and other health outcomes with nutritional, physical activity, and lifestyle exposures. The computerized questionnaires adhere to The Public Health Service Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Either 2 or 4 times, depending on the pathway. Affected Public: Individuals. Type of Respondents: U.S. adults (aged 50 and over). The annual reporting burden is displayed in the table below. The estimated total annualized burden hours being requested is 2616. The annualized cost to respondents is estimated at: $46,242. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project, ``Reducing Healthcare Associated Infections (HAI): Improving patient safety through implementing multidisciplinary training.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 3rd, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project: ``Overcoming Barriers to Expanded Health Information Exchange (HIE) Participation in Indiana.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Notice of Approval of Supplemental New Animal Drug Application; Moxidectin
The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The approved NADA provides for the veterinary prescription use of a sustained-release injectable moxidectin formulation for prevention of heartworm disease and treatment of existing hookworm infections in dogs. The supplemental NADA adds animal safety information to product labeling.
Compliance Policy Guide Sec. 560.700 Processing of Imported Frozen Products of Multiple Sizes (e.g., Shrimp, Prawns, Etc.) (CPG 7119.10); Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 560.700 Processing of Imported Frozen Products of Multiple Sizes (e.g., Shrimp, Prawns, Etc.) (CPG 7119.10) (CPG Sec. 560.700). CPG Sec. 560.700 is included in FDA's Compliance Policy Guides Manual, which was listed in the Annual Comprehensive List of Guidance Documents that published on March 28, 2006.
Call for Collaborating Partners for the National Bone Health Campaign
The U.S. Department of Health and Human Services (HHS), Office on Women's Health (OWH) announces its new leadership of the National Bone Health Campaign and invites public and private sector bone health- and girls' health-related organizations to participate as collaborating partners to provide advice on the development and dissemination of the campaign materials and messages.
Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (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: Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO). Type of Information Collection Request: REVISION (OMB : 0925-0407, current expiry date 10/31/2008). Need and Use of Information Collection: This trial is designed to determine if screening for prostate, lung, colorectal and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 254,900 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then through 2008. During the first approval period a pilot study was conducted to evaluate recruitment methods and data collection procedures. Recruitment was completed in 2001 and data collection continues through 2008. When participants enrolled in the trial they agreed to be followed for at least 13 years from the time of enrollment. The current number of respondents in the study is 136, 341; this is down from the total initially due to deaths. The primary endpoint of the trial is cancer-specific mortality for each of the four cancer sites (prostate, lung, colorectum, and ovary). In addition, cancer incidence, stage shift, and case survival are to be monitored to help understand and explain results. Biologic prognostic characteristics of the cancers will be measured and correlated with mortality to determine the mortality predictive value of these intermediate endpoints. Basic demographic data, risk factor data for the four cancer sites and screening history data, as collected from all subjects at baseline, will be used to assure comparability between the screening and control groups and make appropriate adjustments in analysis. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals. Frequency of Response: Annually. Affected Public: Individuals. Type of Respondents: Adult men and women. The estimated total annual burden hours requested is 11,401. The annualized cost to respondents is estimated at $219,919 per year, for a total of $659,756 over the proposed three year renewal. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.