Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents

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Draft Guidance for Industry on Tobacco Health Document Submission; Availability
Document Number: E9-30657
Type: Notice
Date: 2009-12-28
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Tobacco Health Document Submission.'' The draft guidance is intended to assist persons making certain document submissions to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Opportunity for Co-Sponsorship of the President's Challenge Physical Activity and Fitness Awards Program
Document Number: E9-30653
Type: Notice
Date: 2009-12-28
Agency: Office of the Secretary, Department of Health and Human Services
The Office of the President's Council on Physical Fitness and Sports (PCPFS) announces the opportunity for non-Federal public and private sector entities to co-sponsor and administer a series of financially self-sustaining activities related to the President's Challenge Physical Activity and Fitness Awards Program (President's Challenge). Potential co-sponsors must have a demonstrated interest in and be capable of managing the day to day operations associated with the program and be willing to participate substantively in the co- sponsored activity.
Office of Community Services; Award a Single Source Replacement Grant
Document Number: E9-30644
Type: Notice
Date: 2009-12-28
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Office of Community Services (OCS) awarded a single source replacement grant of $50,000 under the Community Services Block Grant (CSBG) Training and Technical Assistance and Capacity Building ProgramEarned Income Tax Credit (EITC) and Other Asset Formation Opportunities program to Maryland Volunteer Lawyers Service (MVLS) in Baltimore, Maryland on September 30, 2007. On September 16, 2009, MVLS submitted a letter relinquishing their grant. Job Opportunities Task Force (JOTF) of Baltimore, Maryland, an eligible entity, submitted a letter and grant application on September 16, 2009, requesting approval as a single source replacement grantee for the CSBG EITC project as of September 30, 2009. The Administration for Children and Families (ACF) approved Job Opportunities Task Force as the permanent successor grantee for the award.
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-30642
Type: Notice
Date: 2009-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E9-30606
Type: Notice
Date: 2009-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E9-30593
Type: Notice
Date: 2009-12-28
Agency: Department of Health and Human Services
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: E9-30592
Type: Notice
Date: 2009-12-28
Agency: Department of Health and Human Services
New Animal Drugs; Change of Sponsor; Isoflurane
Document Number: E9-30590
Type: Rule
Date: 2009-12-28
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 a change of sponsor for an abbreviated new animal drug application (ANADA) for isoflurane, USP, from Nicholas Piramal India Ltd. UK, to Piramal Healthcare Ltd.
Meeting of the Advisory Committee on Minority Health
Document Number: E9-30278
Type: Notice
Date: 2009-12-28
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DI-IHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
Agency Information Collection Activities: Proposed Collection Comment Request
Document Number: E9-30538
Type: Notice
Date: 2009-12-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
Gastrointestinal Drugs Advisory Committee; Notice of Meeting
Document Number: E9-30442
Type: Notice
Date: 2009-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 5 on Disintegration Test General Chapter; Availability
Document Number: E9-30441
Type: Notice
Date: 2009-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 5: Disintegration Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Disintegration Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''
National Library of Medicine; Notice of Meeting
Document Number: E9-30311
Type: Notice
Date: 2009-12-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E9-30395
Type: Notice
Date: 2009-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: E9-30394
Type: Notice
Date: 2009-12-22
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: E9-30393
Type: Notice
Date: 2009-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: E9-30392
Type: Notice
Date: 2009-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meeting
Document Number: E9-30391
Type: Notice
Date: 2009-12-22
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI)
Document Number: E9-30390
Type: Notice
Date: 2009-12-22
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Cancer Institute (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collected below. This proposed information collection was previously published in the Federal Register on June 10, 2009 (74 FR 27552), and allowed 60-days for public comment. One public comment was received regarding pharmaceutical testing. The submitter responded to the e-mail. 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 valid OMB control number.
Submission for OMB Review; Comment Request
Document Number: E9-30369
Type: Notice
Date: 2009-12-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E9-30339
Type: Notice
Date: 2009-12-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8 on Sterility Test General Chapter; Availability
Document Number: E9-30326
Type: Notice
Date: 2009-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''
Clinical Center; Notice of Meeting
Document Number: E9-30303
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Document Number: E9-30302
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-30301
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program (NTP); Report on Carcinogens (RoC) Center: Request for Public Comments on the RoC Expert Panel's Recommendation on Listing Status for Formaldehyde and the Scientific Justification for the Recommendation
Document Number: E9-30300
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
The NTP invites public comment on the recommendation from an expert panel on the listing status for formaldehyde in the 12th RoC and the scientific justification for the recommendation. The recommendation and scientific justification for formaldehyde are available electronically in Part B of the Expert Panel Report (http:// ntp.niehs.nih.gov/go/29682 Formaldehyde, Expert Panel Report Part B) or in printed text from the RoC Center (see FOR FURTHER INFORMATION CONTACT below). The RoC Center convened a ten-member expert panel of scientists, plus four technical scientific experts, from the public and private sectors on November 2-4, 2009, in Research Triangle Park, NC. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make a recommendation regarding listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for formaldehyde in the 12th RoC and (2) to provide the scientific justification for their recommendation.
National Institute of Environmental Health Sciences: Superfund Research Program; Request for Information (NOT-ES-10-003): Superfund Research Program Strategic Planning
Document Number: E9-30299
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
The NIEHS Superfund Research Program (SRP), in response to recommendations of the NIEHS Superfund Research Program External Advisory Panel convened in 2009, is seeking input to develop a strategic plan to provide direction to achieve its mandates described in SARA Section 311(a). Information provided will be used to develop a 5-year strategic plan to direct programmatic focus and enhance the impact of the SRP program. SRP welcomes input from sister Superfund agency representatives (i.e. United States Environmental Protection Agency, US EPA; and Agency for Toxic Substances and Disease Registry, ATSDR), other government officials, environmental health researchers, academics, members of the private sector, policy makers, the lay public, and others with an interest in the effects of hazardous substances on public health. SRP is using an online questionnaire and public meetings to receive input.
Guidance for Industry on the Timeframe for Submission of Tobacco Health Documents; Availability
Document Number: E9-30297
Type: Notice
Date: 2009-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Timeframe for Submission of Tobacco Health Documents.'' This document provides written guidance to tobacco product manufacturers and importers on enforcement of the requirement to submit certain documents to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Implantation or Injectable Dosage Form New Animal Drugs; Polysulfated Glycosaminoglycan
Document Number: E9-30222
Type: Rule
Date: 2009-12-21
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 supplemental new animal drug application (NADA) filed by Luitpold Pharmaceuticals, Inc. The supplemental NADA provides for additional vial sizes for an injectable solution of polysulfated glycosaminoglycan.
Notice of Re-Designation of the Service Delivery Area for the Cowlitz Indian Tribe
Document Number: E9-30213
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, Indian Health Service
This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Service Delivery Area (SDA) for the Cowlitz Indian Tribe. The Cowlitz SDA currently is comprised of Clark, Cowlitz, King, Lewis, Pierce, Skamania, and Thurston in the State of Washington. These counties were designated as the Tribe's SDA in 67 FR 46329. It is proposed that Columbia County, Oregon, and Wahkiakum and Kittitas Counties, Washington be added to the existing SDA.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E9-30112
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E9-30110
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E9-30108
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E9-30107
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E9-30106
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: E9-30104
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism: Notice of Closed Meeting
Document Number: E9-30066
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: E9-30065
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: E9-30061
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E9-30060
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: E9-30059
Type: Notice
Date: 2009-12-21
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E9-30176
Type: Notice
Date: 2009-12-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E9-30143
Type: Notice
Date: 2009-12-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program; Meeting of the Advisory Panel on Medicare Education, February 3, 2010
Document Number: E9-30136
Type: Notice
Date: 2009-12-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Medicare Program; First Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-February 17-19, 2010
Document Number: E9-30123
Type: Notice
Date: 2009-12-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the first semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2010. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the proposed and final rules that would update the hospital Outpatient Prospective Payment System (OPPS) for CY 2011.
Medicare Program; Physician Quality Reporting Initiative (PQRI): Listening Session-February 2, 2010.
Document Number: E9-30122
Type: Notice
Date: 2009-12-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a listening session to discuss the Physician Quality Reporting Initiative (PQRI). The purpose of the listening session is to solicit input from participating stakeholders on
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Contract Health Services Report
Document Number: E9-30115
Type: Notice
Date: 2009-12-18
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires a 30-day advance opportunity for public comment on the proposed information collection project, Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E9-30111
Type: Notice
Date: 2009-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E9-30101
Type: Notice
Date: 2009-12-18
Agency: Department of Health and Human Services, National Institutes of Health