Department of Health and Human Services August 2005 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 311
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-15977
Type: Notice
Date: 2005-08-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 05-15975
Type: Notice
Date: 2005-08-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2006 Rates
Document Number: 05-15406
Type: Rule
Date: 2005-08-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are revising 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. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital- related costs. We also are setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. These changes are applicable to discharges occurring on or after October 1, 2005, with one exception: The changes relating to submittal of hospital wage data by a campus or campuses of a multicampus hospital system (that is, the changes to Sec. 412.230(d)(2) of the regulations) are effective on August 12, 2005. Among the policy changes that we are making are changes relating to: The classification of cases to the diagnosis-related groups (DRGs); the long-term care (LTC)-DRGs and relative weights; the wage data, including the occupational mix data, used to compute the wage index; rebasing and revision of the hospital market basket; applications for new technologies and medical services add-on payments; policies governing postacute care transfers, payments to hospitals for the direct and indirect costs of graduate medical education, submission of hospital quality data, payment adjustment for low-volume hospitals, changes in the requirements for provider-based facilities; and changes in the requirements for critical access hospitals (CAHs).
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 05-15949
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 05-15948
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases, Notice of Meeting
Document Number: 05-15947
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meeting
Document Number: 05-15946
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 05-15945
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Child Health and Human Development; Amended Notice of Meeting
Document Number: 05-15944
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging Bioengineering; Notice of Meeting
Document Number: 05-15943
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 05-15942
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 05-15941
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 05-15940
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 05-15939
Type: Notice
Date: 2005-08-11
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.
National Committee on Vital and Health Statistics: Meeting
Document Number: 05-15925
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services
Strengthen HIV/AIDS Prevention, Care, and Treatment Services for Infants of HIV Positive Mothers in the Republic of Haiti Through Provision of Improved Pediatric HIV/AIDS Laboratory Diagnosis
Document Number: 05-15893
Type: Notice
Date: 2005-08-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Provide a clear and concise summary of the proposed goals, major objectives and activities required for achievement of program goals, and amount of funding requested for budget year one of this cooperative agreement. Project Context and Background (Understanding and Need) Project StrategyDescription and Methodologies Project Goals Project Outputs Project Contribution to the Goals and Objectives of the Emergency Plan for AIDS Relief Work Plan and Description of Project Components and Activities Performance Measures Timeline (e.g., GANNT Chart) Management of Project Funds and Reporting. You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information includes the following: Budget Justification (only for Year 01) Curricula Vitae Organizational Charts Letters of Support You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access https://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the HHS/CDC web site at: https://www.cdc.gov/od/pgo/ funding/grantmain.htm. If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter. Additional requirements that could require you to submit additional documentation with your application are listed in section ``VI.2. Administrative and National Policy Requirements.''
Strengthening Management Support Services for HHS Global AIDS Program in the Republic of India
Document Number: 05-15891
Type: Notice
Date: 2005-08-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Enhancement of a Continuum of HIV/AIDS Prevention, Care and Treatment Through the Network Model in the United Republic of Tanzania
Document Number: 05-15890
Type: Notice
Date: 2005-08-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Program Exclusions: July 2005
Document Number: 05-15888
Type: Notice
Date: 2005-08-11
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
Capacity-Building Assistance for Global HIV/AIDS Microbiological Laboratory Program Development Through Technical Assistance Collaboration
Document Number: 05-15879
Type: Notice
Date: 2005-08-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Device User Fee Rates for Fiscal Year 2006
Document Number: 05-15863
Type: Notice
Date: 2005-08-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2006. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), authorizes FDA to collect user fees for certain medical device applications. The FY 2006 fee rates are provided in this notice. For all applications submitted on or after October 1, 2005, and through September 30, 2006, fees must be paid at the FY 2006 rates at the time the applications are submitted to FDA. The fee you must pay is the fee that is in effect on the date your application is received by FDA or on the date your check is received, whichever is later. This notice provides details on how fees for FY 2006 were determined and payment procedures for medical device applications subject to user fees.
Submission for OMB Review; Comment Request
Document Number: 05-15821
Type: Notice
Date: 2005-08-10
Agency: Department of Health and Human Services, Children and Families Administration
Office of Planning, Research and Evaluation; Grant Award to Urban Family Council
Document Number: 05-15820
Type: Notice
Date: 2005-08-10
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Notice is hereby given that a noncompetitive grant award is being made to Urban Family Council, Pennsylvania, to provide Abstinence-Only Education and related services for adolescents in public school, age 12-19 and their parents and guardians, in Philadelphia, Center, Cumberland, and Lycoming Counties of Pennsylvania. The amount of the grant is $229,152. This noncompetitive award was recommended by the Congress.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 05-15800
Type: Notice
Date: 2005-08-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 05-15799
Type: Notice
Date: 2005-08-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 05-15798
Type: Notice
Date: 2005-08-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 05-15797
Type: Notice
Date: 2005-08-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Findings of Scientific Misconduct
Document Number: 05-15777
Type: Notice
Date: 2005-08-10
Agency: Office of the Secretary, Department of Health and Human Services
Notice is hereby given that the Office of Research Integrity (ORI), the Acting Assistant Secretary for Health, and the Director, Office of Acquisition Management and Policy, have taken final agency action in the following case: Randall Luce, University at Buffalo, State University of New York: Based on the report of an investigation conducted by the University of Buffalo (UB), State University of New York (SUNY) (UB Report), and a conviction of the criminal offense of grand larceny, as defined in section 110-155.30 of the New York Penal Law, in the Buffalo City Court of Erie County, State of New York (Case 2004ER009612M), the Department of Health and Human Services (HHS) debarred Mr. Randall Luce, former research technician in the UB Research Institute for Addictions (RIA), for a period of three (3) years, beginning on July 26, 2005, and ending on July 25, 2008. Mr. Luce pled guilty to grand larceny and admitted to the misappropriation of funds and the fabrication of research subject interviews in the conduct of an RIA study supported by the United States Public Health Service (PHS), National Institutes of Health (NIH), National Institute on Alcoholism and Alcohol Abuse (NIAAA), grant RO1 AA12452, ``A harm reduction approach for reducing DWI recidivism.'' This action is taken pursuant to the HHS nonprocurement debarment and suspension regulation at 45 CFR part 76.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 05-15755
Type: Notice
Date: 2005-08-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 05-15754
Type: Notice
Date: 2005-08-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 05-15753
Type: Notice
Date: 2005-08-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Disease; Notice of Closed Meeting
Document Number: 05-15752
Type: Notice
Date: 2005-08-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 05-15751
Type: Notice
Date: 2005-08-10
Agency: Department of Health and Human Services, National Institutes of Health
Program To Reduce the Impact of HIV/AIDS Within the Correctional Services System of South Africa; Notice of Intent To Fund Single Eligibility Award
Document Number: 05-15714
Type: Notice
Date: 2005-08-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-15708
Type: Notice
Date: 2005-08-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Administration for Native Americans
Document Number: 05-15680
Type: Notice
Date: 2005-08-09
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Native Americans (ANA) herein announces an urgent grant award to the Red Lake Band of Chippewa Indians, Red Lake, Minnesota, in the amount of $311,400 for a project period of 24 months. This urgent grant award will assist the Tribe in mitigating the effects of the tragic events of the school shooting in March 2005 that resulted in the death of students, faculty and staff. The shooting marked the highest death toll in U.S. school shootings since the Columbine High School massacre in April 1999. Due to the devastation created by the high school shooting, ANA is providing urgent financial assistance for minor renovations to the local community centers to support positive community development; funding to hire eleven volunteers to assist youth and members of the community in coping with this event; and building support systems, which will aid in preventing future tragedies.
Office of Refugee Resettlement
Document Number: 05-15679
Type: Notice
Date: 2005-08-09
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Notice is hereby given that it has been proposed that a noncompetitive single-source program expansion supplement to an ongoing competitive award be made to the Hebrew Immigrant Aid Society (HIAS) in response to an unsolicited application. This application proposes to provide additional training and technical assistance to organizations implementing Refugee Marriage Enrichment projects. The application is not within the scope of any existing or expected to be issued program announcement for the Fiscal Year 2006. HIAS's application is expected to address issues critical to the development and implementation of marriage education programs for refugees by providing valuable on-site training and technical assistance to grantees and sub-grantees that offer marital communication training to refugee couples. In September of 2003, ORR awarded HIAS a grant of $200,000 to develop a Refugee Family Enrichment program which included technical assistance to subgrantees. Because of their success in the development of their marriage enrichment program, in 2004 HIAS was awarded a noncompetitive single source program expansion supplement to an ongoing competitive award to expand its Technical Assistance Services Program to Refugee Family Enrichment project sites specified by ORR. HIAS has since provided over 600 hours of technical assistance to project sites operated by organizations across the country. Their technical assistance primarily supports the work of small Mutual Assistance Associations, and without it, these agencies might struggle to provide refugee clients with the programs they need in order to achieve self sufficiency. The proposed project period is 9/30/2005-9/29/2006. Technical assistance to support grantees in developing better approaches to the delivery of services provided to refugees is authorized by section 412(c)(1)(A) of the Immigration and Nationality Act (8 U.S.C. 1522(c)(1)).
Proposed Information Collection Activity; Comment Request
Document Number: 05-15678
Type: Notice
Date: 2005-08-09
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 05-15693
Type: Notice
Date: 2005-08-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 05-15613
Type: Notice
Date: 2005-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities: Proposed Collection Comment Request
Document Number: 05-15612
Type: Notice
Date: 2005-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Council on Graduate Medical Education; Notice of Meeting
Document Number: 05-15611
Type: Notice
Date: 2005-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management; Availability
Document Number: 05-15546
Type: Notice
Date: 2005-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q9 Quality Risk Management.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The draft guidance is intended to enable regulators and industry to make more effective and consistent risk- based decisions.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient
Document Number: 05-15545
Type: Notice
Date: 2005-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Notification for a New Dietary Ingredient'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Records; Electronic Signatures
Document Number: 05-15544
Type: Notice
Date: 2005-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Electronic Records; Electronic Signatures'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006
Document Number: 05-15370
Type: Proposed Rule
Date: 2005-08-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would refine the resource-based practice expense relative value units (PE RVUs) and propose changes to payment based on supplemental survey data for practice expense and revisions to our methodology for calculating practice expense RVUs, as well as make other proposed changes to Medicare Part B payment policy. We are also proposing policy changes related to revisions to malpractice RVUs, in addition to revising the list of telehealth services. In this proposed rule, we also discuss multiple procedure payment reduction for diagnostic imaging, and several coding issues. We are proposing these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This proposed rule also discusses geographic locality changes; payment for covered outpatient drugs and biologicals; supplemental payments to federally qualified health centers (FQHCs); payment for renal dialysis services; the national coverage decision (NCD) process; coverage of screening for glaucoma; private contracts; and physician referrals for nuclear medicine services and supplies to health care entities with which they have financial relationships. In addition, we include discussions on payment for teaching anesthesiologists, the therapy cap, the chiropractic demonstration and the Sustainable Growth Rate (SGR).
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