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

Results 151 - 200 of 285
Public Meeting of the President's Council on Bioethics
Document Number: E8-2779
Type: Notice
Date: 2008-02-14
Agency: Department of Health and Human Services
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-second meeting, at which it will discuss and hear presentations on (1) newborn screening and (2) the problems of cost, access, and quality in American health care. The Council will also unveil its most recent publication, Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics. Subjects discussed at past Council meetings (although not on the agenda for the March 2008 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, personalized medicine, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), Taking Care: Ethical Caregiving in Our Aging Society (September 2005), and Human Dignity and Bioethics: Essays Commissioned by the President's Council on Bioethics (March 2008). Reports on (a) controversies in the determination of death, and (b) organ procurement, transplantation, and allocation are forthcoming.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-2752
Type: Notice
Date: 2008-02-14
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.
Cooperative Research and Development Agreement (CRADA) Opportunity With the National Heart Lung and Blood Institute and Licensing Opportunity for Development of Multi-Domain Amphipathic Helical Peptides for the Treatment of Cardiovascular Disease
Document Number: E8-2750
Type: Notice
Date: 2008-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. 3710; and Executive Order 12591 of April 10, 1987, as amended, and in accordance with 35 U.S.C. 207 and 37 CFR Part 404, the National Institutes of Health (NIH) of the Public Health Service (PHS) of the Department of Health and Human Services (HHS) seeks a Cooperative Research and Development Agreement (CRADA) and/or license(s) with a pharmaceutical or biotechnology company to develop and commercialize amphipathic helical peptides potentially useful for the treatment and prevention of cardiovascular disease. The CRADA would have an expected duration of one (1) to five (5) years. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, methods of treatment or prevention that may result from the research. The CRADA Collaborator will have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA defined by the CRADA Research Plan, subject to any pre-existing licenses already issued for other fields of use, and can apply for background licenses to the existing patent applications encompassed within HHS Reference Nos. E-114-2004/0-US-01 (United States Patent Application Serial No. 11/577,259), E-114-2004/0-AU-03 (Australian Patent Application Serial No. 2005295640), E-114-2004/0-CA-04 (Canadian Patent Application No. 2584048), E-114-2004/0-EP-05 (European Patent Application No. 05815961.7) and E-114-2004/0-JP-06 (Japanese Patent Application No. 2007-536912) titled: Multi-Domain Amphipathic Helical Peptides and Methods of Their Use.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-2749
Type: Notice
Date: 2008-02-14
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 Collection; comment request; The REDS-II Donor Iron Status Evaluation (RISE) Study
Document Number: E8-2748
Type: Notice
Date: 2008-02-14
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c) (2) (A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: E8-2715
Type: Notice
Date: 2008-02-14
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice of Public Meeting and Availability for Public Comment
Document Number: E8-2743
Type: Notice
Date: 2008-02-13
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 following meeting and request for public comment on the Emergency Preparedness and Response Research Portfolio. The document and instructions for submitting comments can be found at http:// www.cdc.gov/niosh/review/public/126/. Comments may be given orally at the following meeting, as well as provided to the NIOSH Docket Office. Public Meeting Time and Date: 8:30 a.m.-5 p.m., March 25, 2008. Place: Hyatt Regency Crystal City, 2799 Jefferson Davis HWY, Arlington, Virginia 22202. Purpose of Meeting: NIOSH has developed strategic goals to address important issues surrounding the health and safety of emergency responders. The full list of goals can be accessed through the NIOSH Web site at: http://www.cdc.gov/niosh/programs/epr/goals.html. The eight overarching goals are: 1. SAFETY CLIMATE: Improve the organization of emergency response work to reduce exposure to risks and to enhance the health and safety of emergency responders. 2. PERSONAL PROTECTIVE EQUIPMENT (PPE): Improve PPE assortment, proper selection and wear, and decontamination. 3. ENGINEERING/TECHNOLOGICAL INTERVENTIONS AND CONTROLS: Improve engineering controls, technology, and tools to minimize responders' exposures to hazards associated with chemical, biological, radiation or nuclear (CBRN), toxic industrial compound (TIC), and other hazardous materials. 4. CHARACTERIZATION/ASSESSMENT OF POTENTIAL HAZARDS: Develop methods to evaluate the spatial and temporal distribution of gases, vapors, and aerosols, as well as liquids or particulates associated with surface contamination. 5. SUBGROUP-SPECIFIC STRATEGIES: Improve subgroup awareness, develop targeted messages, and expand subgroup-preferred channels. 6. SURVEILLANCE: Develop surveillance reporting systems to improve emergency responder safety and health through the systematic collection, analysis, and interpretation of exposure, hazard, injury, and illness data. 7. ENVIRONMENTAL MICROBIOLOGY: Improve the understanding of environmental microbiology of threat agents, including environmental factors that influence the introduction, spread, and control of these agents. 8. ENVIRONMENTAL AND BIOLOGICAL MONITORING OF TERRORISM AGENTS: Improve the identification and characterization of terror agents to reduce exposures to response and remediation workers. Stakeholders are encouraged to review the strategic goals on the NIOSH Web site (http://www.cdc.gov/niosh/programs/epr/goals.html ) in order to prepare their comments/feedback around the following topics to be discussed. Written responses can be submitted in person at the meeting or by emailing nioshdocket@cdc.gov. Please reference Docket Number NIOSH-126 in your response. Give your opinion about the top three goals needed to improve the safety and health of emergency responders. Discuss why these are the top goals. Address any obstacles in achieving these goals. Talk about how research can help the nation address the top goals that you have identified. Provide a couple of examples of research ideas for each of your top goals identified. Discuss opportunities you see on the horizon that could lead to improvements in emergency responder safety and health. Please include as much information as might be useful for understanding the safety or health research priority you identify. Such information could include characterization of the frequency and severity with which the injury, illness, or hazardous exposure is occurring and of the factors you believe might be causing the health or safety issue. Input is also requested on the types of research that you believe might make a difference and which partners (e.g., specific industry associations, labor organizations, research organizations, government agencies) should be involved in informing research efforts and solutions. Status: The public meeting is open to everyone, including all workers, professional societies, organized labor, employers, researchers, health professionals, government officials, and elected officials. The public meeting will address priorities for emergency preparedness and response research during both morning and afternoon public comment periods. Participants are invited to speak for 5 minutes about the discussion topics listed above. Participants may register to speak during either the morning or afternoon session, though they are encouraged to stay for both sessions. Broad participation is desired. All participants are requested to register for the free meeting by e-mailing nioshdocket@cdc.gov or on site the day of the meeting, space permitting. Participants wishing to speak are encouraged to register early. This meeting is open to the public, limited only by the space available. Background: The mission of the NIOSH Emergency Preparedness and Response (EPR) Program portfolio is to advance research and collaborations to protect the health and safety of emergency response providers and recovery workers by preventing diseases, injuries, and fatalities in anticipation of and during responses to natural and man- made disasters and novel emergent events. The EPR Program research portfolio cuts across the eight sectors that are the focus of the National Occupational Research Agenda (NORA). NORA is a partnership program to stimulate innovative research and improved workplace practices. Unveiled in 1996, NORA has become a research framework for NIOSH and the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Public Comment Period: Those unable to attend the public meeting may submit input to the NIOSH Docket Office within 60 days after the date of publication of this notice in the Federal Register. Reference NIOSH Docket 126 in comments. Contact Person for Technical Information: Dr. Renee Funk, EPR Portfolio Coordinator at (404) 498-2499 or e-mail rfunk@cdc.gov. Comments may be e-mailed to nioshdocket@cdc.gov or sent via postal mail to: Centers for Disease Control and Prevention, NIOSH Docket-126, Robert A. Taft Laboratories (C-34), 4676 Columbia Parkway, Cincinnati, OH 45226. Additional Information: A limited number of rooms have been reserved in the same hotel as the meeting for participants who require lodging for the night of March 24th. Please contact the hotel reservations desk for rooms under ``NIOSH Town Hall Meeting'' by the March 3rd deadline at (703) 418-7233. Reference: More information about NIOSH/EPR can be found on the NIOSH Web page at: http://www.cdc.gov/niosh/programs/epr/.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-2740
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: E8-2737
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets
Document Number: E8-2608
Type: Rule
Date: 2008-02-13
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 two supplemental new animal drug applications (NADAs) filed by IVX Animal Health, Inc. The supplemental NADAs provide revised labeling for phenylbutazone tablets used in horses and dogs.
New Animal Drugs; Change of Sponsor; Ketamine
Document Number: E8-2607
Type: Rule
Date: 2008-02-13
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 ketamine hydrochloride injectable solution from Veterinary Research Associates, Inc., to Putney, Inc.
National Institutes of Health/National Institute of Environmental Health Sciences; Proposed Collection; Comment Request
Document Number: E8-2606
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Parkinson's, Genes and Environment (PAGE) Study II. Type of Information Collection Request: NEW. Need and Use of Information Collection: We propose a large case-control study to evaluate roles of environmental exposures, genes, and gene-environment interactions in the etiology of late-onset sporadic Parkinson's disease (PD). This project, the Parkinson's, Genes and Environment Study II (PAGE II), will be developed based on the infrastructure that was set up for the ongoing PAGE I project. PAGE I was designed to prospectively evaluate diet and lifestyle exposures in relation to PD risk. In PAGE I, we expect to recruit approximately 1,200 incident PD cases and 2,800 controls from the NIH-AARP Diet and Health (DH) cohort. The dietary and lifestyle data were collected as part of the NIH-AARP DH baseline surveys in the mid-1990s by investigators from the National Institute of Cancer. The cases in PAGE I were PD cases who reported a physician diagnosed PD during the 10 year follow-up of NIH-AARP DH cohort and controls were appropriately selected by frequency matching from participants without PD in the same cohort. As part of PAGE I, we are confirming PD diagnoses for self-identified PD cases by contacting their neurologists and reviewing medical records and are collecting saliva samples for genetic testing from both cases and appropriately selected controls. As the NIH-AARP DH study was designed to examine dietary and lifestyle exposures important in the etiology of cancer, many environmental exposures key to PD research were not collected. Examples include pesticide use, occupational history, history of infections, and use of statins. Therefore the primary aim of the PAGE II project is to retrospectively collect these important environmental exposures from PD cases and appropriately selected controls. Cases and controls identified from PAGE I will be re-contacted and interviewed for data collection in PAGE II. Assuming a 70% response rate from cases and controls, we expect to obtain this information from approximately 850 PD cases and 1960 controls. This data collection, together with the dietary and lifestyle data and genetic samples obtained in PAGE I, will make the PAGE study one of the largest and most comprehensive studies to date to examine environmental and genetic causes of PD. Frequency of Response: One 90 minute long telephone interview. Affected Public: Individuals. Type of Respondents: We will enroll men and women who participated in the PAGE I study. The annual reporting burden is as follows: Estimated Number of Respondents: 2810. Estimated Number of Responses per Respondent: 1 computer assisted telephone interview (CATI). Average Burden Hours per Response: 1.5. Estimated Total Burden Hours Requested: 4215. The annualized cost to respondents is estimated at $30 (assuming $20 hourly wage x 1.50 hours) for the interview. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. For Further Information: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Honglei Chen, Epidemiology Branch, NIEHS, Building 101, A3-05, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541-3782 or E-mail your request, including your address to: chenh2@a_niehs.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-2585
Type: Notice
Date: 2008-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 08-639
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 08-638
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 08-637
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 08-636
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Document Number: 08-635
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 08-634
Type: Notice
Date: 2008-02-13
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: 08-633
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 08-632
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 08-631
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 08-630
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Office of Clinical and Preventive Services; Demonstration Project for Healthy Lifestyles in Youth
Document Number: 08-626
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, Indian Health Service
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
Document Number: 08-625
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services
This notice announces the 24th 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 Personalized Healthcare Workgroup Meeting
Document Number: 08-624
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services
This notice announces the 13th 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 Quality Workgroup Meeting
Document Number: 08-623
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services
This notice announces the 16th 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 Chronic Care Workgroup Meeting
Document Number: 08-622
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services
This notice announces the 23rd 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.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
Document Number: 08-621
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services
This notice announces the 24th 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 Confidentiality, Privacy, and Security Workgroup Meeting
Document Number: 08-620
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services
This notice announces the 18th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92- 463, U.S.C., App.).
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 08-604
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 08-603
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging, Notice of Closed Meetings
Document Number: 08-602
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Amended Notice of Meeting
Document Number: 08-601
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Workgroup Meeting
Document Number: 08-600
Type: Notice
Date: 2008-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Task Force on Community Preventive Services
Document Number: E8-2548
Type: Notice
Date: 2008-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting
Document Number: E8-2540
Type: Notice
Date: 2008-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-2508
Type: Notice
Date: 2008-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Patient Safety and Quality Improvement
Document Number: E8-2375
Type: Proposed Rule
Date: 2008-02-12
Agency: Department of Health and Human Services
This document proposes regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The proposed regulations establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for analysis of patient safety events. The proposed regulations also outline the requirements that entities must meet to become PSOs and the processes for the Secretary to review and accept certifications and to list PSOs. In addition, the proposed regulation establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, termed ``patient safety work product'' by the Patient Safety Act, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.
Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Extension of the Comment Period
Document Number: E8-2454
Type: Proposed Rule
Date: 2008-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period until April 11, 2008, for a proposed rule that was published in the Federal Register of October 19, 2005 (70 FR 60751). FDA issued a Federal Register notice to reopen the comment period on this proposal on December 11, 2007 (72 FR 70251), to seek further comment on only two specific issues raised by the comments concerning the proposed ingredient declaration. The agency is extending this comment period in response to a request to give interested parties additional time to provide the information requested by FDA in that notice.
Announcement of the Third Meeting of the Physical Activity Guidelines Advisory Committee
Document Number: E8-2453
Type: Notice
Date: 2008-02-11
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the final in a series of three federal advisory committee meetings on the Physical Activity Guidelines for Americans, to be held in Washington, DC. This meeting will be open to the public. The Physical Activity Guidelines Advisory Committee has been charged with reviewing existing scientific literature to identify where there is sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The Committee will prepare a report to the Secretary of HHS that documents the scientific background and rationale for the issuance of Physical Activity Guidelines for Americans. The report will also identify areas where further scientific research is needed. The Committee's recommendations will be utilized by the Department to prepare the final Physical Activity Guidelines. The intent is to issue physical activity recommendations for all Americans that will be tailored as necessary for specific subgroups of the population.
Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products; Availability
Document Number: E8-2398
Type: Notice
Date: 2008-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products,'' dated February 2008. The draft guidance document provides manufacturers of cellular and gene therapy products with recommendations on the validation of growth-based Rapid Microbiological Methods (RMMs) for sterility testing of their products. This draft guidance addresses considerations for method validation and determining equivalence of an RMM to sterility assays. This draft guidance applies to somatic cellular therapy and gene therapy products.
Hemoglobin Based Oxygen Carriers: Current Status and Future Directions; Public Workshop
Document Number: E8-2397
Type: Notice
Date: 2008-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
Document Number: E8-2396
Type: Notice
Date: 2008-02-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill five (5) upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). Authority: 42 U.S.C. 294f, section 756 of the PHS Act, as amended. The Advisory Committee is governed by provisions of Public Law (Pub. L.) 92-463, as amended (5 U.S.C. Appendix 2) which sets forth standards for the formation and use of advisory committees.
Proposed Information Collection Activity; Comment Request
Document Number: 08-599
Type: Notice
Date: 2008-02-11
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 08-587
Type: Notice
Date: 2008-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 08-586
Type: Notice
Date: 2008-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 08-585
Type: Notice
Date: 2008-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 08-584
Type: Notice
Date: 2008-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 08-583
Type: Notice
Date: 2008-02-11
Agency: Department of Health and Human Services, National Institutes of Health