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

Results 201 - 250 of 261
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting
Document Number: E8-15471
Type: Notice
Date: 2008-07-08
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-15470
Type: Notice
Date: 2008-07-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-15464
Type: Notice
Date: 2008-07-08
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Injury Prevention and Control Initial Review Group
Document Number: E8-15399
Type: Notice
Date: 2008-07-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Library of Medicine; Notice of Meetings
Document Number: E8-15192
Type: Notice
Date: 2008-07-08
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: E8-15191
Type: Notice
Date: 2008-07-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-15189
Type: Notice
Date: 2008-07-08
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: E8-15188
Type: Notice
Date: 2008-07-08
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Cells, Tissues, and Cellular and Tissue-Based Products; Request for Data
Document Number: E8-15368
Type: Notice
Date: 2008-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting submission of data related to certain recommendations in the draft guidance entitled, ``Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' that published April 28, 2008. The agency is taking this action to allow interested persons to submit complete data from the 2008 West Nile Virus season concerning the criteria for converting from minipool nucleic acid tests (NAT) to individual donation NAT for donations of Whole Blood and blood components for transfusion.
Grant Award to the University of Northern Colorado
Document Number: E8-15297
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services
This notice is to inform the public that the Office of Population Affairs (OPA) is awarding, in fiscal year 2008, $50,000 to the University of Northern Colorado, under Title X of the PHS Act (42 U.S.C. 300, et seq.). This institution proposes to conduct research activities, authorized under section 1004 of the Act, which are relevant to the purposes of the statue. These purposes include research in the behavioral and program implementation fields related to family planning and population. The Title X research program is described in the Catalog of Federal Domestic Assistance Number 93.974.
Meeting of the Advisory Committee on Minority Health
Document Number: E8-15264
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) 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.
Board of Scientific Counselors, Coordinating Office for Terrorism Preparedness and Emergency Response (BSC, COTPER)
Document Number: E8-15247
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
National Library of Medicine; Notice of Closed Meeting
Document Number: E8-15080
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: E8-15079
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-15078
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Center on Minority Health and Health Disparities; Notice of Closed Meetings
Document Number: E8-15077
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-15076
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Amended Notice of Meeting
Document Number: E8-15074
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: E8-15073
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; and Revisions to the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; Proposed Rule
Document Number: E8-14949
Type: Proposed Rule
Date: 2008-07-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would address proposed changes to Medicare Part B payment policy. 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 refinements to resource-based practice expense (PE) relative value units (RVUs); geographic practice cost indices (GPCI) changes; malpractice RVUs; requests for additions to the list of telehealth services; several coding issues; payment for covered outpatient drugs and biologicals; the competitive acquisition program (CAP); application of health professional shortage area (HPSA) bonus payments; payment for renal dialysis services; performance standards for mobile independent diagnostic testing facilities; and physician and nonphysician practitioners furnishing diagnostic testing services; a solicitation for comments regarding the use of the Federal Payment Levy Program to recover delinquent Federal tax debts; a proposed amendment to the exemption for computer-generated facsimile transmissions from the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for transmitting prescription and certain prescription-related information for Part D covered drugs prescribed for Part D eligible individuals; conforming and clarifying changes for comprehensive outpatient rehabilitation facilities (CORFs); revisions for rehabilitation agencies; therapy-related technical corrections; the physician quality reporting initiative; physician self-referral issues and anti-markup; beneficiary signature for nonemergency ambulance transport; the chiropractic services demonstration; educational requirements for nurse practitioners and clinical nurse specialists; qualifications of portable x-ray supplier personnel; the expiration of provisions of the Medicare, Medicaid, and SCHIP Extension Act of 2007; bonus payments for long ambulance transports; the annual update for clinical laboratory fees under the clinical laboratory fee schedule; physician certification/recertification for home health services; a prohibition concerning providers of sleep tests; organ retrieval; a revision to the ``Appeals of CMS or CMS contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges'' final rule; and, potentially misvalued services under the physician fee schedule.
Agency Information Collection Request; 30-Day Public Comment Request, Grants
Document Number: E8-14427
Type: Notice
Date: 2008-07-07
Agency: Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E8-15203
Type: Notice
Date: 2008-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: E8-15201
Type: Notice
Date: 2008-07-03
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.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-15183
Type: Notice
Date: 2008-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-15180
Type: Notice
Date: 2008-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-15179
Type: Notice
Date: 2008-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E8-15178
Type: Notice
Date: 2008-07-03
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-15152
Type: Notice
Date: 2008-07-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-15150
Type: Notice
Date: 2008-07-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Training of Latin American Health-Care Workers Through the Gorgas Memorial Institute, Republic of Panama
Document Number: E8-15120
Type: Notice
Date: 2008-07-03
Agency: Department of Health and Human Services
This project will support the Gorgas Memorial Institute (GMI) to: (a) Develop a regional training center in Panama and (b) train community health workers, clinicians (physicians, nurses, and auxiliary medical workers) and select public-health professionals from Central and South America (i.e., Latin America), (c) facilitate partnerships between U.S. universities and their Latin American counterparts to develop human resources for health in Latin America, and (d) harness the energies of U.S. and other non-governmental organizations by partnering with them to advance community health-training and program efforts in Latin America. These efforts will help engage significantly more areas of these countries to prepare for and respond to public-health emergencies, such as pandemic influenza, and they will contribute to the improved and expanded provision of prevention and primary health care. This training of nurses, community health workers and physicians will focus on improving and expanding coverage and access to both public-health emergency care and preventive and primary health care in underserved parts of Latin America (i.e., both underserved rural and poor urban communities). A result of this project, the health-care work force in Central America should be better prepared to respond to public-health emergencies, including pandemic influenza. Key to the selection of recipients for this training will be their availability and willingness to provide their health and medical care skills in underserved areas within the region, especially rural and indigenous communities and those visited by U.S. Government humanitarian missions in the past year. In addition to all appropriate subjects in the fields of medical care and health education or communication, training supported by this project will emphasize infectious diseases, epidemiology, disease surveillance and outbreak response, so graduates of training programs will be prepared to play contributing roles in any pandemic preparation and response.
Study Team for the Los Alamos Historical Document Retrieval and Assessment (LAHDRA) Project
Document Number: E8-15109
Type: Notice
Date: 2008-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: E8-15108
Type: Notice
Date: 2008-07-03
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:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Closed-Circuit Self-Contained Breathing Apparatus-NIOSH Docket # 039; Supplied Air Respirators-NIOSH Docket # 083; Reevaluation of NIOSH Limitations on and Precaution for Safe Use of Positive-Pressure Closed-Circuit Self-Contained Breathing Apparatus-NIOSH Docket # 123; CBRN APR Mechanical Connector Design-NIOSH Docket # 139
Document Number: E8-15107
Type: Notice
Date: 2008-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following public meeting to discuss current respirator standards development projects for Closed-Circuit Self-Contained Breathing Apparatus; Supplied Air Respirators; Reevaluation of NIOSH Limitations on and Precaution for Safe Use of Positive-Pressure Closed-Circuit Self-Contained Breathing Apparatus; and the Mechanical Connector Design Used in the Chemical Biological Radiological and Nuclear (CBRN) Air-Purifying Respirator (APR).
Submission for OMB Review; Comment Request; The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI)
Document Number: E8-15072
Type: Notice
Date: 2008-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 30, 2008 (Vol. 73, No. 84, p. 23473), and allowed 60 days for public comment. No public comments or questions 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 Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI) (OMB: 0925-0406). Type of Information Collection Request: Renewal. Need and Use of Information Collection: The purpose of this information collection is to continue and complete updating the occupational and environmental exposure information as well as medical history information for respondents enrolled in the Agriculture Health Study. This represents a request to continue and complete phase III (2005-2008) of the study. Due to reduced annual budgets for research, a delay in data collection has resulted and there has not been enough time to complete the data collection on the number of respondents that had been originally requested in the 2005 OMB submission. The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environment. The data will be collected by using a computer assisted telephone interview (CATI) system. A small percentage of the respondents will also be asked to participate in a buccal cell collection which is a sample of loose cells from the respondent's mouth. The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. Frequency of Response: Once. Affected Public: Private sector, farms. Type of Respondents: Licensed pesticide applicators and their spouses. The annual reporting burden is as follows:
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E8-15068
Type: Notice
Date: 2008-07-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: E8-15062
Type: Notice
Date: 2008-07-03
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition
Document Number: E8-15052
Type: Rule
Date: 2008-07-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. We are issuing this order based on evidence that extralabel use of these drugs in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to the public health.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-14924
Type: Notice
Date: 2008-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
Document Number: E8-15007
Type: Notice
Date: 2008-07-02
Agency: Department of Health and Human Services
This notice announces the meeting date for the 23rd meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT). Meeting Date: July 29, 2008, from 8:30 a.m. to 2 p.m. (Eastern).
Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program
Document Number: E8-14999
Type: Notice
Date: 2008-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is seeking volunteers from pharmaceutical companies to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, consistent with the principles of quality by design and risk management in pharmaceutical manufacturing. The purpose of the pilot program is to gain more information on and facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology products. This pilot will focus on products reviewed by FDA's Office of Biotechnology Products (OBP), in the Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER). This pilot program will assist FDA in developing guidance for industry on quality by design and risk management in pharmaceutical manufacturing. The pilot is open to original submissions of and supplements to biologic license applications (BLA) or new drug applications (NDA) reviewed by OBP.
Danisco USA, Inc.; Withdrawal of Food Additive Petition; Correction
Document Number: E8-14998
Type: Notice
Date: 2008-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6A3958) that appeared in the Federal Register of June 20, 2008. FDA is correcting the addresses of both Pfizer, Inc., and Danisco USA, Inc.
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-14938
Type: Notice
Date: 2008-07-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-14925
Type: Notice
Date: 2008-07-02
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Partner and Customer Satisfaction Surveys
Document Number: E8-14920
Type: Notice
Date: 2008-07-02
Agency: Department of Health and Human Services
Under the provisions of Section 3507(a)(l)(D) of the Paperwork Reduction Act of 1995 for the opportunity for public comment on the proposed data collection projects, the Center for Scientific Review (CSR), National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. The purpose of this notice is to allow 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: Reinstatement of Generic Clearance for Voluntary Partner and Customer Satisfaction Surveys. Type of Information Collection Request: Reinstatement. Need and Use of Information Collection: The information collected in these surveys will be used by the Center for Scientific Review management and personnel: (1) To assess the quality of the modified operations and processes now used by CSR to review grant applications; (2) To assess the quality of service provided by CSR to our customers; (3) To enable identification of the most promising biomedical research that will have the greatest impact on improving public health by using a peer review process that is fair, unbiased from outside influence, timely, and (4) To develop new modes of operation based on customer need and customer feedback about the efficacy of implemented modifications. These surveys will almost certainly lead to quality improvement activities to enhance and/or streamline CSR's operations. The major mechanism by which CSR will request input is through surveys. The major initiatives ongoing at the present time include: shortening the review and application process, shortening the grant application, recruiting the best reviewers by developing additional review modes, improving study section alignment to ensure the best reviews, and others. Surveys will be collected via Internet. Information gathered from these surveys will be presented to, and used directly by, CSR management to enhance the operations, processes, organization of, and services provided by the Center. Frequency of Response: The participants will respond once, unless there is a compelling reason for a subsequent survey. Affected public: Universities, not-for-profit institutions, business or other for-profit, small businesses and organizations, and individuals. Type of Respondents: Adult scientific professionals.
Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs
Document Number: E8-14917
Type: Notice
Date: 2008-07-01
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments from affected entities and individuals about (a) Whether OHRP should issue additional guidance recommending that institutions engaged in human subjects research conducted or supported by the Department of Health and Human Services (HHS) implement training and education programs for certain individuals involved in the conduct, review, or oversight of human subjects research, or (b) whether HHS should develop a regulation requiring the implementation of such training and education programs. This request for information and comment stems from the 1998 report from the HHS Office of Inspector General (OIG) recommending that Federal requirements be enacted to help ensure that investigators and institutional review board (IRB) members be adequately educated about, and sensitized to, human subjects protections. More recently, the Secretary's Advisory Committee on Human Research Protections (SACHRP) recommended that OHRP require institutions to ensure that initial and continuing training is provided for IRB members and staff, investigators, and certain institutional officials. The implementation of such training and education programs might help to ensure that individuals involved in the conduct or review of human subjects research at institutions holding OHRP-approved Federalwide Assurances (FWAs) understand and meet their regulatory responsibilities for protecting human subjects.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension of Certification on Maintenance of Effort for the Title III and Certification of Long-Term Care Ombudsman Program Expenditures
Document Number: E8-14898
Type: Notice
Date: 2008-07-01
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Statement of Organization, Functions, and Delegations of Authority
Document Number: E8-14896
Type: Notice
Date: 2008-07-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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