Department of Health and Human Services July 22, 2005 – Federal Register Recent Federal Regulation Documents

National Committee on Vital and Health Statistics: Meeting
Document Number: 05-14509
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services
National Committee on Vital and Health Statistics: Meeting
Document Number: 05-14507
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services
Office of Budget, Technology and Finance; Statement of Organization, Functions, and Delegations of Authority
Document Number: 05-14506
Type: Notice
Date: 2005-07-22
Agency: Office of the Secretary, Department of Health and Human Services
Medicare Program; Evaluation Criteria and Standards for Quality Improvement Program Contracts
Document Number: 05-14505
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice describes the evaluation criteria we will use to evaluate the Quality Improvement Organizations (QIOs) under their contracts with us, for efficiency and effectiveness in accordance with the Social Security Act. These evaluation criteria are based on the tasks and related subtasks set forth in the QIO's Scope of Work (SOW). The current 7th SOW includes Tasks 1 through 4, with subtasks included under all tasks, excluding Task 4. QIOs were awarded contracts for the 7th SOW, or 7th Round, for 3 years, with staggered starting dates beginning August 2002, November 2002, and February 2003. This final notice also responds to the public comments received regarding the evaluation criteria published in July 2004.
Amendment to the Interim Final Regulation for Mental Health Parity
Document Number: 05-14504
Type: Rule
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document contains an amendment to the interim final regulation that implements the Mental Health Parity Act (MHPA) to conform the sunset date of the regulation to the sunset date of the statute under legislation passed by the 108th Congress.
Prospective Grant of Exclusive License: Use of HIV-Dependent Expression Constructs and Uses Therefor for the Development of FDA-Approvable HIV Diagnostic Kits
Document Number: 05-14502
Type: Notice
Date: 2005-07-22
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 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in PCT/US04/ 31967 filed September 28, 2004 from U.S. provisional application 60/ 507,034 (E-276-2003/0-US-01), entitled ``HIV-Dependent Expression Constructs and Uses Therefor'' (E-276-2003/0-PCT-02), (Inventors: Yuntao Wu and Jon Marsh), to Revix Technology LLC (hereafter Revix), having a place of business in Manassas, Virginia. The patent rights in these inventions have been assigned to the United States of America.
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-14501
Type: Notice
Date: 2005-07-22
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: 05-14500
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 05-14499
Type: Notice
Date: 2005-07-22
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: 05-14498
Type: Notice
Date: 2005-07-22
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: 05-14497
Type: Notice
Date: 2005-07-22
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 Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-14496
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing and Cooperative Research and Development Agreement (CRADA): Aminoflavone Prodrug
Document Number: 05-14495
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, National Institutes of Health
The inventions described 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 in association with collaborative research via a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) of the National Institutes of Health. This opportunity is being offered 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 05-14494
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 05-14493
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Meeting
Document Number: 05-14492
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; Comment Request; The National Diabetes Education Program Survey of the Public
Document Number: 05-14491
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, National Institutes of Health
Under provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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 September 9, 2003, pages 53176-53177, and allowed 60 days for public comment. No public comments were 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: The National Diabetes Educations Program Survey of the Public. Type of Information Collection Request: New. Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goals of the NDEP are to improve the treatment and health outcomes of people with diabetes, to promote early diagnosis, and, ultimately, to prevent the onset of diabetes. The NDEP objectives are: (1) To increase awareness of the seriousness of diabetes, its risk factors, and strategies for preventing diabetes and its complications among people at risk for diabetes; (2) to improve understanding about diabetes and its control and to promote better self-management behaviors among people with diabetes; (3) to improve health care providers' understanding of diabetes and its control and to promote an integrated approach to care; (4) to promote health care policies that improve the quality of and access to diabetes care. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Creating partnerships with other organizations concerned about diabetes; (2) developing and implementing awareness and education activities with special emphasis on reaching the racial and ethnic populations disproportionately affected by diabetes; (3) identifying, developing, and disseminating educational tools and resources for the program's diverse audiences; (4) promoting policies and activities to improve the quality of and access to diabetes care. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This clearance request is for the collection of additional primary data from NDEP target audiences on some key process and impact measures that are necessary to effectively evaluate the program. Approval is requested for survey of the public including people at risk for diabetes, people with diabetes and their families. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 1600; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .25; and Estimated Total Annual Burden Hours Requested: 400. The annualized cost to respondents is estimated at: $8,000.00. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Statement of Organization, Functions and Delegations of Authority
Document Number: 05-14485
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 05-14484
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 05-14476
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-14475
Type: Notice
Date: 2005-07-22
Agency: Office of the Secretary, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 05-14474
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Administration on Children, Youth and Families; Family and Youth Services Bureau; Notice of the Availability of Financial Assistance and Request for Applications To Establish and Operate the National Domestic Violence Hotline
Document Number: 05-14459
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF) announces the availability of funds in fiscal year 2005 for the award of one grant on a competitive basis to operate a national, toll-free telephone hotline to provide information and assistance to victims of domestic violence.
Listing of Color Additives Exempt from Certification; Mica-Based Pearlescent Pigments
Document Number: 05-14457
Type: Rule
Date: 2005-07-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs. This action is in response to a petition filed by EM Industries, Inc.
Guidance for Industry on Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability
Document Number: 05-14456
Type: Notice
Date: 2005-07-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.'' This guidance provides a description and basis for a process by which to select a maximum recommended starting dose (MRSD) for a first-in-human clinical trial of a therapeutic in adult healthy volunteers.
General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 05-14455
Type: Notice
Date: 2005-07-22
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-14156
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-14155
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program; August 22, 2005, Meeting of the Practicing Physicians Advisory Council and Request for Nominations
Document Number: 05-14154
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will be meeting to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of the Department of Health and Human Services (the Secretary). This meeting is open to the public. In addition, this notice invites all organizations representing physicians to submit nominations for consideration to fill four seats that will be vacated by current Council members in 2006.
Medicare Program; Request for Nominations for the Advisory Panel on Medicare Education
Document Number: 05-14153
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on opportunities for CMS to optimize the effectiveness of the National Medicare Education Program and other CMS programs that help Medicare beneficiaries understand the Medicare program and the range of health plan options available. Nominees must be knowledgeable in the field of labor and retirement benefits.
Medicare Program; Meeting of the Medicare Coverage Advisory Committee-October 6, 2005
Document Number: 05-14152
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting concerns the treatments for bone fractures that fail to progress to union. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Request for Nominations for Members for the Medicare Coverage Advisory Committee
Document Number: 05-14150
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice requests nominations for consideration for membership on the Medicare Coverage Advisory Committee (MCAC).
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 05-14149
Type: Notice
Date: 2005-07-22
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 05-14148
Type: Notice
Date: 2005-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services