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

Results 201 - 250 of 337
Statement of Organization, Functions and Delegations of Authority
Document Number: E8-7855
Type: Notice
Date: 2008-04-15
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors
Document Number: E8-7831
Type: Notice
Date: 2008-04-15
Agency: Department of Health and Human Services
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Statement of Organization, Functions and Delegations of Authority
Document Number: E8-7823
Type: Notice
Date: 2008-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: E8-7817
Type: Notice
Date: 2008-04-15
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-7807
Type: Notice
Date: 2008-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-7803
Type: Notice
Date: 2008-04-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: E8-7799
Type: Notice
Date: 2008-04-15
Agency: Department of Health and Human Services, National Institutes of Health
Antimicrobial Resistance; Public Hearing; Request for Comments
Document Number: 08-1129
Type: Notice
Date: 2008-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public hearing on antimicrobial resistance. FDA is seeking general information about the problem of antimicrobial resistance, recommendations as to possible approaches to contain the problem of antimicrobial resistance, responses to specific questions (see section III of this document), and other pertinent information from interested parties. In addition, interested parties may provide views on which serious and life-threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antimicrobial- resistant bacteria, potentially qualify for available grants and contracts or other development incentives.
Medicare Program; Policy and Technical Changes to the Medicare Prescription Drug Benefit
Document Number: 08-1120
Type: Rule
Date: 2008-04-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule codifies clarifications of existing policies associated with the Medicare Prescription Drug Benefit (also known as Medicare Part D), including the following: guidance that certain supplies associated with the administration of insulin are included in the definition of a Part D drug; guidance regarding the statutory exclusion from the definition of a Part D drug of any drug when used for the treatment of sexual or erectile dysfunction, unless that drug is used for an FDA-approved purpose other than sexual or erectile dysfunction; a recent statutory change that allows for the payment of vaccine administration under Part D for Part D covered vaccines; and guidance on plan-to-plan reconciliation and reconciliation with a payer other than the Part D plan of record. This final rule also codifies clarifications of existing policies associated with the Retiree Drug Subsidy (RDS) program, including guidance on aggregating plan options for purposes of meeting the net test for actuarial equivalence and guidance on applying the Medicare supplemental adjustment when calculating actuarial equivalence. In addition, new clarifications and modifications in this final rule include establishing standards with respect to the timely delivery of infusible drugs covered under Part D and modifications to the retiree drug subsidy regulations. This final rule also codifies certain technical corrections to our regulations and clarifies our intent with respect to certain preamble discussions in a prior final rule implementing the Medicare prescription drug benefit.
Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities
Document Number: 08-1102
Type: Rule
Date: 2008-04-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule finalizes the February 4, 2005 proposed rule entitled ``Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities.'' It establishes new conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. This final rule focuses on the patient and the results of care provided to the patient, establishes performance expectations for facilities, encourages patients to participate in their plan of care and treatment, eliminates many procedural requirements from the previous conditions for coverage, preserves strong process measures when necessary to promote meaningful patient safety, well-being, and continuous quality improvement. This final rule reflects the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-7857
Type: Notice
Date: 2008-04-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-7845
Type: Notice
Date: 2008-04-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-7844
Type: Notice
Date: 2008-04-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Announcement of Second Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
Document Number: E8-7843
Type: Notice
Date: 2008-04-14
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the second in a series of federal advisory committee meetings regarding the national health promotion and disease prevention objectives for 2020, to be held online (via Webex software). This Committee meeting will be the equivalent of an in-person meeting of the Committee and will be open to the public. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will review the nation's health promotion and disease prevention objectives and efforts to develop goals and objectives to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
Document Number: E8-7722
Type: Notice
Date: 2008-04-14
Agency: Department of Health and Human Services
This notice announces the 15th meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92.463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
Document Number: E8-7720
Type: Notice
Date: 2008-04-14
Agency: Department of Health and Human Services
This notice announces the 26th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
Document Number: E8-7719
Type: Notice
Date: 2008-04-14
Agency: Department of Health and Human Services
This notice announces the 17th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
Document Number: E8-7718
Type: Notice
Date: 2008-04-14
Agency: Department of Health and Human Services
This notice announces the 26th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
Document Number: E8-7716
Type: Notice
Date: 2008-04-14
Agency: Department of Health and Human Services
This notice announces the 23rd meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, & Security Workgroup Meeting
Document Number: E8-7714
Type: Notice
Date: 2008-04-14
Agency: Department of Health and Human Services
This notice announces the 19th meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
Document Number: E8-7713
Type: Notice
Date: 2008-04-14
Agency: Department of Health and Human Services
This notice announces the 25th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Administration for Native Americans
Document Number: E8-7808
Type: Notice
Date: 2008-04-11
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This notice is to inform the public that the Administration for Native Americans (ANA) intends to announce six (6) urgent grant awards. The urgent grant awards will fund projects that are designed to mitigate the impact of the devastation created by the Southern California Wildfires of October 2007. As a result of the devastating wildfires that destroyed approximately 1,500 homes and 500,000 acres of land, ANA is providing urgent financial assistance to five Tribes and one Tribal Association to address a variety of restoration activities that include reforestation and revegetation, debris removal, erosion control and restoration, emergency planning and preparedness. Contained herein is a description of the projects to be funded: Rincon Band of Luiseno Indians ($114,977 for 6 months) This project will assist in the restoration of 4,250 acres of tribal lands with the planting of 6,750 cottonwood, sycamore, and oak seedlings to provide erosion control. Santa Ysabel Band of Diegueno Indians ($155,230 for 6 months) This project will protect existing properties, protect the health and safety of community members, and make 300 acres of the reservation less vulnerable to wildfires. La Jolla Band of Luiseno Indians ($150,353 for 6 months ) The goal of the project is to protect tribal residents from injury, death or displacement and reduce the possibility of damage or losses to existing assets, particularly critical facilities/infrastructures owned by the tribe. The project will clear four drainage channels of debris that currently present a fire/flooding threat. Mesa Grande Band of Mission Indians ($72,772 for 6 months) This project will insure the safety of tribal members and protect tribal assets through the thinning and clearing of fire prone debris on 280 acres of tribal land. Pauma Band of Mission Indians ($29,949 for 3 months) This project will stabilize the banks of Pauma Creek to protect lives and property on the Pauma Reservation by placing cut rock along the Pauma Creek banks to prevent flooding. Southern California Tribal Chairman's Association ($126,123 for 6 months) This project will restore connectivity to the rural Tribes in Southern California by reestablishing access of high speed internet services with the reconstruction of one tower, repair of a second tower, and the repair and replacement of power sources and radio equipment for three towers. It will also develop, print, and disseminate disaster prevention brochures to all tribal members of the Southern California Tribes to provide information and inform them of the real-time access to information through the Internet.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-7709
Type: Notice
Date: 2008-04-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-7706
Type: Notice
Date: 2008-04-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-7691
Type: Notice
Date: 2008-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys
Document Number: E8-7640
Type: Notice
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reports of Corrections and Removals
Document Number: E8-7638
Type: Notice
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A
Document Number: E8-7637
Type: Notice
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
Document Number: E8-7634
Type: Notice
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services, Health Resources and Services Administration
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (181) entitled ``Blue Bird Medicated Feed Labels.'' This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
Privacy Act of 1974; System of Records
Document Number: E8-7632
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System. This system of records is required to comply with the implementation directives of Public Law 109-129. HRSA published in the Federal Register of September 8, 2003, a document concerning notice of a new system of records, 09-15-0055, Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, 68 FR 52950. This document more fully explains the routine uses of records maintained in the system and amends the records' purpose and routine uses of records maintained in the system. Accordingly, the notice is published below in its entirety, as amended.
Announcement of Intent To Establish the 2010 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Membership
Document Number: E8-7614
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Department of Agriculture
The Department of Agriculture and the Department of Health and Human Services announce the intent to establish a Dietary Guidelines Advisory Committee and invite nominations for the Committee.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E8-7611
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services
National Advisory Council on Nurse Education and Practice; Notice of Meeting
Document Number: E8-7591
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting
Document Number: E8-7590
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Somatic Cell Therapy Investigational New Drug Applications; Availability
Document Number: E8-7588-2
Type: Notice
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human somatic cell therapy. In addition, the guidance provides instructions to FDA reviewers about information to record and assess as part of the IND review. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications'' dated August 2003.
Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Somatic Cell Therapy Investigational New Drug Applications; Availability
Document Number: E8-7588
Type: Notice
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human somatic cell therapy. In addition, the guidance provides instructions to FDA reviewers about information to record and assess as part of the IND review. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications'' dated August 2003.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting
Document Number: E8-7586
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Service Administration, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E8-7585-2
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004.
Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Availability
Document Number: E8-7585
Type: Notice
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services, Health Resources and Services Administration
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004.
New Animal Drugs For Use in Animal Feed; Zilpaterol
Document Number: E8-7583
Type: Rule
Date: 2008-04-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of approved, single-ingredient Type A medicated articles containing zilpaterol hydrochloride, monensin USP, and melengestrol acetate in three-way combination Type B and Type C medicated feeds for heifers fed in confinement for slaughter.
Statement of Organization, Functions and Delegations of Authority
Document Number: E8-7581
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a Statement of Organization, Functions and Delegations of Authority document in the Federal Register of March 10, 2008 (73 FR 12742), regarding the Bureau of Health Professions. In section heading RP, Office of the Administrator, the title was incorrect. Correction
''Low Income Levels'' Used for Various Health Professions and Nursing Programs Included in Titles III, VII, and VIII of the Public Health Service Act
Document Number: E8-7579
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) Disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from ``low income '' families.
Bureau of Health Professions; All Advisory Committee Meeting; Notice of Meeting
Document Number: E8-7576
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-7575
Type: Notice
Date: 2008-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Council on Graduate Medical Education; Notice of Meeting
Document Number: E8-7573
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-7571
Type: Notice
Date: 2008-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-7566
Type: Notice
Date: 2008-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-7560
Type: Notice
Date: 2008-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: E8-7556
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: E8-7554
Type: Notice
Date: 2008-04-10
Agency: Department of Health and Human Services, National Institutes of Health