Department of Health and Human Services June 2008 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 304
HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
Document Number: E8-13102
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
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
Document Number: E8-13099
Type: Notice
Date: 2008-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Statement of Organization, Functions and Delegations of Authority
Document Number: E8-13098
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
President's Committee for People With Intellectual Disabilities Notice of Meeting
Document Number: E8-13091
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: E8-13043
Type: Notice
Date: 2008-06-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Computerized Tribal IV-D Systems and Office Automation
Document Number: E8-13042
Type: Proposed Rule
Date: 2008-06-11
Agency: Department of Health and Human Services, Office of Child Support Enforcement, Child Support Enforcement Office, Family Support Administration, Agencies and Commissions
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.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-12914
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-12913
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: E8-12911
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E8-12910
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-12908
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-12907
Type: Notice
Date: 2008-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Tribal Child Support Enforcement Program
Document Number: E8-13073
Type: Proposed Rule
Date: 2008-06-10
Agency: Department of Health and Human Services, Office of Child Support Enforcement, Child Support Enforcement Office, Family Support Administration, Agencies and Commissions
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
Document Number: E8-13015
Type: Notice
Date: 2008-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Ethics Subcommittee, Advisory Committee to the Director, Centers for Disease Control and Prevention (CDC)
Document Number: E8-12960
Type: Notice
Date: 2008-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Establishment of a Community-Clinical Project 2008-R-09
Document Number: E8-12958
Type: Notice
Date: 2008-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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
Document Number: E8-12925
Type: Notice
Date: 2008-06-10
Agency: Department of Health and Human Services, National Institutes of Health
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)
Document Number: E8-12924
Type: Notice
Date: 2008-06-10
Agency: Department of Health and Human Services, National Institutes of Health
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)
Document Number: E8-12920
Type: Notice
Date: 2008-06-10
Agency: Department of Health and Human Services, National Institutes of Health
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
Document Number: E8-12768
Type: Notice
Date: 2008-06-10
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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
Document Number: E8-12765
Type: Notice
Date: 2008-06-10
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
National Center for Injury Prevention and Control (NCIPC) Advisory Committee for Injury Prevention and Control (ACIPC)
Document Number: E8-12892
Type: Notice
Date: 2008-06-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: E8-12868
Type: Notice
Date: 2008-06-09
Agency: Food and Drug Administration, Department of Health and Human Services
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E8-12866
Type: Notice
Date: 2008-06-09
Agency: Food and Drug Administration, Department of Health and Human Services
Notice To Award a Program Expansion Supplement
Document Number: E8-12806
Type: Notice
Date: 2008-06-09
Agency: Department of Health and Human Services, Office of Community Services
Agency Information Collection Request: 60-Day Public Comment Request
Document Number: E8-12794
Type: Notice
Date: 2008-06-09
Agency: Department of Health and Human Services
Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health, (NIOSH)
Document Number: E8-12793
Type: Notice
Date: 2008-06-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request: 60-Day Public Comment Request
Document Number: E8-12791
Type: Notice
Date: 2008-06-09
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-12655
Type: Notice
Date: 2008-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-12654
Type: Notice
Date: 2008-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-12653
Type: Notice
Date: 2008-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-12652
Type: Notice
Date: 2008-06-09
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Approval of Supplemental New Animal Drug Application; Moxidectin
Document Number: 08-1329
Type: Notice
Date: 2008-06-09
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: E8-12766
Type: Notice
Date: 2008-06-06
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: E8-12756
Type: Notice
Date: 2008-06-06
Agency: Department of Health and Human Services
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.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: E8-12681
Type: Notice
Date: 2008-06-06
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-12645
Type: Notice
Date: 2008-06-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E8-12644
Type: Notice
Date: 2008-06-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-12642
Type: Notice
Date: 2008-06-06
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI)
Document Number: E8-12641
Type: Notice
Date: 2008-06-06
Agency: Department of Health and Human Services, National Institutes of Health
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.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-12640
Type: Notice
Date: 2008-06-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-12574
Type: Notice
Date: 2008-06-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-12573
Type: Notice
Date: 2008-06-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services