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

Results 101 - 150 of 246
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-19060
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-19052
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Center for Environmental Health (NCEH)
Document Number: E8-19044
Type: Notice
Date: 2008-08-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Eye Institute; Notice of Meeting
Document Number: E8-18986
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-18985
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: E8-18984
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-18983
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
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.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-18982
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
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.
Submission for OMB Review; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI)
Document Number: E8-18981
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 6, 2008, Volume 73, Number 110, Page 32338 and allowed 60 days for public comment. In response to the notice, there were no public comments 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: 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.
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition; Extension of Comment Period; Delay of Effective Date of Final Rule
Document Number: E8-18967
Type: Rule
Date: 2008-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending to November 1, 2008, the comment period for the order of prohibition. FDA is also delaying the effective date of this final rule to November 30, 2008. In the final rule, FDA requested comments on the document. The agency is taking this action in response to requests for an extension to allow additional time to submit comments.
Service of Process
Document Number: E8-18917
Type: Rule
Date: 2008-08-18
Agency: Department of Health and Human Services
This rule amends our regulations, which provide for service of process on the Department of Health and Human Services, the Secretary of Health and Human Services, or other employees of the Department in their official capacities. The purpose of this amendment is to expand the number of people who can be served process on behalf of the Department.
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-18878
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-18876
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: E8-18875
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: E8-18874
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Amended Notice of Meeting
Document Number: E8-18873
Type: Notice
Date: 2008-08-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-18958
Type: Notice
Date: 2008-08-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-18957
Type: Notice
Date: 2008-08-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees for the Connecticut Aircraft Nuclear Engine Laboratory, Middletown, CT, To Be Included in the Special Exposure Cohort
Document Number: E8-18915
Type: Notice
Date: 2008-08-15
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Connecticut Aircraft Nuclear Engine Laboratory, Middletown, Connecticut, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Connecticut Aircraft Nuclear Engine Laboratory. Location: Middletown, Connecticut. Job Titles and/or Job Duties: All employees. Period of Employment: January 1958 through December 1960.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees for the Tyson Valley Powder Farm, St. Louis, MO, to be included in the Special Exposure Cohort
Document Number: E8-18909
Type: Notice
Date: 2008-08-15
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Tyson Valley Powder Farm, St. Louis, Missouri, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Tyson Valley Powder Farm. Location: St. Louis, Missouri. Job Titles and/or Job Duties: All employees. Period of Employment: January 1, 1942 through December 31, 1949.
The National Center for Chronic Disease Prevention and Health Promotion
Document Number: E8-18899
Type: Notice
Date: 2008-08-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-18889
Type: Notice
Date: 2008-08-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: E8-18888
Type: Notice
Date: 2008-08-15
Agency: Department of Health and Human Services, National Institutes of Health
Bisphenol A Subcommittee of the Science Board to the Food and Drug Administration; Notice of Meeting
Document Number: E8-18864
Type: Notice
Date: 2008-08-15
Agency: Food and Drug Administration, Department of Health and Human Services
Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Risk of Coronary Heart Disease
Document Number: E8-18863
Type: Rule
Date: 2008-08-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule (IFR) that amended the regulation authorizing a health claim on soluble fiber from certain foods and risk of coronary heart disease (CHD), to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. FDA is taking this action to complete the rulemaking initiated with the IFR.
Proposed Information Collection Activity; Comment Request
Document Number: E8-18790
Type: Notice
Date: 2008-08-15
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: E8-18788
Type: Notice
Date: 2008-08-15
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Request for Planning Ideas for Development of an AHRQ Innovations Research Portfolio
Document Number: E8-18671
Type: Notice
Date: 2008-08-15
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
AHRQ is establishing a new research portfolio, the Innovations Portfolio. The Portfolio goal is to identify and support research that has the potential to accelerate improvements in the organization, delivery, and management of healthcare. AHRQ seeks ideas on priority topics and activities that should be addressed as components of the Innovations Portfolio.
Meeting of the President's Council on Bioethics
Document Number: E8-18830
Type: Notice
Date: 2008-08-14
Agency: Department of Health and Human Services
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-fourth meeting, at which it will discuss its projected white paper on ethical questions in medical care reform as well as hear and discuss presentations on two additional topics, i.e., exercises of conscience in the practice of the health professions and futility in clinical judgments at the end of life. Subjects discussed at past Council meetings (although not on the agenda for the September 2008 meeting) include: Therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), Taking Care: Ethical Caregiving in Our Aging Society (September 2005), and Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008). Reports are forthcoming on three topics: Controversies in the determination of death; organ donation, procurement, allocation, and transplantation; and newborn screening.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-18820
Type: Notice
Date: 2008-08-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-18819
Type: Notice
Date: 2008-08-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-18817
Type: Notice
Date: 2008-08-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Meeting
Document Number: E8-18795
Type: Notice
Date: 2008-08-14
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
Document Number: E8-18792
Type: Rule
Date: 2008-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of July 17, 2008 (73 FR 40967). The final rule reclassified bone sonometer devices from class III into class II, subject to special controls. The document contained an inadvertent error regarding the impact of the final rule on small businesses. This document corrects that error.
Submission for OMB Review; Comment Request
Document Number: E8-18629
Type: Notice
Date: 2008-08-14
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Biodefense Science Board; Notification of a Public Teleconference
Document Number: E8-18762
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public teleconference. The meeting is open to the public.
National Center for Research Resources; Notice of Closed Meeting
Document Number: E8-18749
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-18746
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2008 Performance Review Board
Document Number: E8-18745
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Cancellation of Meeting
Document Number: E8-18744
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-18742
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program: Request for Cosponsors for E-prescribing Educational Conference
Document Number: E8-18678
Type: Notice
Date: 2008-08-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the opportunity for public and private- sector organizations to act as potential cosponsors for a 2-day conference that we are sponsoring to educate stakeholders about the new e-prescribing initiative as described in section 132 of the Medicare Improvements for Patients and Providers Act of 2008.
Medicare and Medicaid Programs; Fire Safety Requirements for Long Term Care Facilities, Automatic Sprinkler Systems
Document Number: E8-18670
Type: Rule
Date: 2008-08-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule requires all long term care facilities to be equipped with sprinkler systems by August 13, 2013. Additionally, this final rule requires affected facilities to maintain their automatic sprinkler systems once they are installed.
National Library of Medicine; Notice of Closed Meeting
Document Number: E8-18660
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Center; Notice of Meeting
Document Number: E8-18659
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: E8-18657
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
NIH Consensus Development Conference: Management of Hepatitis B; Notice
Document Number: E8-18656
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: E8-18557
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institutes of Health
Document Number: E8-18514
Type: Notice
Date: 2008-08-13
Agency: Department of Health and Human Services