Government Announcements
NIH Challenge Grant RFA—New Funding Opportunities
Posted March 6, 2009
Introducing the NIH Challenge Grant RFA OD-09-003
NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5. The NIH has designated at least $200 million in FYs 2009.
2010 for a new initiative called the NIH Challenge Grants in Health and Science Research. (http://grants1.nih.gov/grants/guide/rfa-files/RFA-OD-09-003.html)
This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.
The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.
In addition to the Challenge topics listed in the previous link, NIDA–specific Challenge Topics can be viewed at http://www.drugabuse.gov/Recovery.
NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: "a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients.
Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy." Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.
The application due date is April 27, 2009.
Air News Release (HQ): Jackson Announces EPA Schools Monitoring Initiative
Posted March 2, 2009
U.S. Environmental Protection Agency (EPA)
Jackson Announces EPA Schools Monitoring Initiative
Administrator Jackson: "Our job is to protect the American public where they live, work and play—and that certainly includes protecting schoolchildren where they learn.'
Contact: Cathy Milbourn, (202) 564-4355 / milbourn.cathy@epa.gov
(Washington, D.C.—March 2, 2009) Lisa Jackson, administrator of the U.S. Environmental Protection Agency, announced today a new initiative to further measure levels of toxic air pollution near many schools across the country for better protection. EPA and its state partners will prioritize and monitor schools for more extensive air quality analysis, looking closely at schools located near large industries and in urban areas.
"I'm a mother first, and like all parents, I want to be sure my children are breathing healthy air at school," said EPA Administrator Lisa P. Jackson. "Questions have been raised about air quality around some U.S. schools, and those questions merit investigation. EPA will work quickly to make assessments and take swift action where necessary. Our job is to protect the American public where they live, work and play—and that certainly includes protecting schoolchildren where they learn."
Administrator Jackson has outlined an aggressive timeline for prioritizing and monitoring schools to determine any which are exposed to high levels of toxic air pollution. EPA anticipates monitoring at some schools will begin within the next 30 days. Directed by EPA, the monitoring will be conducted primarily by state and local governments. Some states have already begun monitoring.
Recent media reports have raised critical questions about air quality outside schools near large industrial facilities. At Administrator Jackson’s confirmation hearings, she was asked about this issue by Congress and pledged to take swift action to investigate and remediate if necessary any potential high-risk exposure for our nation’s school children.
EPA will work with states, tribes, and local communities to ensure that monitors are deployed quickly to get high-quality data and to share results with American families. This partnership will help EPA maximize its monitoring and analytical capabilities to develop a clearer picture of any potential risks to children from toxic air pollution. This action is particularly critical in some low-income areas, which are sometimes disproportionately impacted by environmental degradation.
From 1990 to 2005, emissions of air toxics in the United States declined 41 percent. Levels of air toxics, however, can vary widely from place to place depending upon a number of factors including the amount and types of industry nearby, proximity to heavily traveled or congested roadways, and weather patterns.
More information: http://www.epa.gov/air/toxicair/newtoxics.html
NTP UPDATE: NICEATM Announces LLNA Peer Review Panel Meeting; availability of draft documents and requests comments
Posted March 2, 2009
In the 27 February 2009 Federal Register: NICEATM Announces Peer Review Panel Meeting on the Murine Local Lymph Node Assay; Availability of Draft Documents—view the notice.
The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), will convene an independent scientific peer review panel (Panel) meeting to evaluate updated information on three non-radioactive versions and an expanded applicability domain for the Murine Local Lymph Node Assay (LLNA). The Panel meeting will take place April 28–29, 2009, at the Natcher Conference Center, National Institutes of Health, Bethesda, MD, and is open to the public at no charge. NICEATM invites public comments on draft ICCVAM test recommendations and draft Background Review Documents (BRD) that will be considered by the Panel. The documents will soon be available on the NICEATM-ICCVAM Web site (see below).
NICEATM and ICCVAM convened the peer review panel in March 2008 to review the new versions and applications of the LLNA. However, the Panel concluded that more information and data were required for the revised test methods and the proposed expanded applicability domain before recommendations could be made regarding their use for regulatory safety testing. NICEATM has received additional information and revised the BRDs. ICCVAM has also revised its draft test method recommendations regarding proposed usefulness and limitations, standardized protocol, and future studies. The Panel will consider the additional information and revised recommendations.
The LLNA is a test method that can be used to determine the allergic contact dermatitis potential of chemicals and products for regulatory hazard classification and labeling purposes. As an accepted alternative to traditional guinea pig tests, it uses fewer animals and eliminates pain and distress. ICCVAM is evaluating the new versions and applications of the LLNA in response to a request from the U.S. Consumer Product Safety Commission. The new versions and applications, if recommended by ICCVAM and accepted by regulatory agencies, could expand the range of substances and products that can be tested in the LLNA.The new versions could also be used more widely because they do not require the use of radioactive markers.
If you wish to attend the meeting, please register by April 14, 2009.
Registration for the meeting will begin March 3. This page will also have links to more information about the meeting.
The draft ICCVAM test method recommendations and draft background review documents will be available on March 3.
If you wish to submit a comment to be considered by the Panel, please use the comment form on the NICEATM-ICCVAM Web site. Comments may also be submitted by e-mail at niceatm@niehs.nih.gov. The deadline to submit comments to NICEATM is April 14, 2009.
ICCVAM has contributed to the approval or endorsement of 18 alternative safety testing methods by Federal regulatory agencies since its establishment in 1997. These test methods have significantly reduced animal use and improved animal welfare. ICCVAM has also identified critical research, development, and validation efforts needed to further advance numerous other alternative methods.
Stimulus Plan Will Create Sustainable Jobs That Will Protect Public Health
Posted February 27, 2009
Release date: 02/19/2009
Contact Information: Contact: Enesta Jones, (202) 564-7873/4355/jones.enesta@epa.gov
(Washington, D.C.—Feb. 19, 2009) The economic recovery plan signed by President Obama will create 3 to 4 million quality, sustainable jobs with many protecting our country’s public health and our environment.
"Through the President's stimulus package, green initiatives will play a significant role in powering economic recovery," said EPA Administrator Lisa P. Jackson. "EPA's portion of the plan will create good, sustainable jobs that help produce cleaner drinking water, purer air, environmentally friendly urban and rural re-development, and reduced greenhouse gases. This is a perfect example of economic growth and environmental protection working hand in hand to the benefit of all Americans."
The American Recovery and Reinvestment Act of 2009 specifically includes $7.22 billion for projects and programs administered by EPA. These programs will protect and promote both green jobs and a healthier environment. These environmental areas include:
- Clean Water State Revolving Fund and Drinking Water State Revolving Fund: $4 billion for assistance to help communities with water quality and wastewater infrastructure needs and $2 billion for drinking water infrastructure needs. A portion of the funding will be targeted toward green infrastructure, water and energy efficiency, and environmentally innovative projects.
- Brownfields: $100 million for competitive grants to evaluate and clean up former industrial and commercial sites.
- Diesel Emissions Reduction: $300 million for grants and loans to help regional, state and local governments, tribal agencies, and non-profit organizations with projects that reduce diesel emissions.
- Superfund Hazardous Waste Cleanup: $600 million for the cleanup of hazardous sites.
- Leaking Underground Storage Tanks: $200 million for cleanup of petroleum leaks from underground storage tanks.
The new law is geared for performance and unprecedented transparency: preference will be given to projects that can be started and completed expeditiously, and EPA intends to move designated funds to states as quickly as possible. All funding will be monitored by EPA’s Inspector General, which will receive $20 million for oversight and review. Announcements of grants will be posted on the Web to ensure transparency. The state-by-state distributions for clean water and drinking water state revolving funds are also available on the Web.
For new information on the state-by-state distributions for clean water and drinking water state revolving funds: http://www.epa.gov/recovery
FDA Issues Draft Guidance for Industry on Animal Models
Posted February 20, 2009
The Food and Drug Administration (FDA) has announced the availability of a draft guidance entitled "Animal Models—Essential Elements to Address Efficacy Under the Animal Rule.'' This guidance identifies and discusses the critical characteristics of an animal model that should be addressed when developing products for approval under the "Animal Rule." When finalized, the guidance will represent the agency's current thinking on animal models when addressing efficacy under this rule. It is important that the FDA hear from research professionals who conduct research using animal models to support approval or licensure of a drug or biological product in cases when human efficacy studies are neither ethical nor feasible, as supported under the "Animal Rule." The FDA will accept electronic comments on the draft guidance through March 23, 2009.
To read the notice, see: http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-936.pdf
Electronic comments can be submitted at:
http://www.regulations.gov
EPA Press Release—Statement by Administrator Designate Lisa Jackson
Posted January 23, 2009
Contact: Roxanne Smith, (202) 564-4355 / smith.roxanne@epa.gov
"I am honored by the confidence and faith President Obama and the Senate have reposed in me to lead the EPA in confronting the environmental challenges currently before us. As Administrator, I will ensure EPA's efforts to address the environmental crises of today are rooted in three fundamental values: science-based policies and programs, adherence to the rule of law, and overwhelming transparency. By keeping faith with these values and unleashing innovative, forward-thinking approaches—we can further protect neighborhoods and communities throughout the country."
More information: http://www.epa.gov/administrator/memotoemployees.html
Year of Science 2009: EPA Joins Grassroots Effort to Celebrate Science
Posted January 8, 2009
Contact: Suzanne Ackerman (202) 564-4355 / ackerman.suzanne@epa.gov
(Washington, D.C., Jan. 7, 2009) Science is an integral part of everything EPA does to protect human health and the environment. In setting health protective regulations, EPA must use scientific research on the health and ecological effects of pollutants. Therefore, EPA has joined with the Coalition on the Public Understanding of Science (COPUS)—a grassroots network of more than 400 universities, scientific societies, and organizations—to celebrate The Year of Science 2009. COPUS was established to engage the public in science by showcasing how science works, who scientists are, and why science matters in our communities and everyday lives.
"The Year of Science 2009 presents an ideal opportunity for EPA scientists to share their passion for the science of environmental protection with the public," said Kevin Teichman, deputy assistant administrator for science in EPA’s Office of Research and Development. "We're looking forward to actively participating in the kick-off events and throughout the year to demonstrate how EPA puts science to work for the American people."
Throughout the year, EPA will be blogging, hosting activities, inviting public participation and providing special content on a new Web site. On the first Wednesday of each month EPA staff and grantees will highlight the COPUS theme of the month in EPA’s science blog, Science Wednesday. The EPA Web site will complement the COPUS Year of Science Web site, which allows visitors to search for science events such as science festivals and science cafes in their communities, and provides access to scientific resources and educational materials.
More information on the EPA Year of Science: http://www.epa.gov/yearofscience
More information on COPUS and The Year of Science 2009:http://www.yearofscience2009.org
USDA Extends Comment Period on Proposed Contingency Plan Requirement for Animals Regulated Under the Animal Welfare Act
Posted December 19, 2008
The U.S. Department of Agriculture announced it is extending the comment period for our proposed rule that would amend the Animal Welfare Act regulations to add requirements for contingency planning and training of personnel by research facilities and by dealers, exhibitors, intermediate handlers, and carriers. This action will allow interested persons additional time to prepare and submit comments (http://www.aphis.usda.gov/newsroom/notices/content/2008/12/awacontn.shtml).
Notice of this extension is published in the December 19 Federal Register.
Consideration will be given to all comments that we receive on or before February 20, 2009. You may submit comments by either of the following methods:
- Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0159 to submit or view comments and to view supporting and related materials available electronically.
- Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS-2006-0159, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0159.
Linda S. Birnbaum, Ph.D., DABT, ATS, Named New Director of the National Institute of Environmental Health Sciences
Posted December 3, 2008
Dr. Raynard S. Kington, acting director of the National Institutes of Health (NIH), today announced the appointment of Linda S. Birnbaum, Ph.D., DABT, ATS, as director of the National Institute of Environmental Health Sciences (NIEHS). Dr. Birnbaum, who is currently a senior advisor at the Environmental Protection Agency (EPA), where she served for 16 years as director of the Experimental Toxicology Division, will begin her appointment in January 2009.
“I look forward to Dr. Birnbaum joining us,” Dr. Kington said. “She has a long and distinguished career conducting research into the health effects of environmental pollutants, and the cause and effects relationships at pollutant concentrations which mimic those occurring in the environment.”
As NIEHS director, Dr. Birnbaum will oversee a $730 million budget that funds multidisciplinary biomedical research programs, prevention, and intervention efforts that encompass training, education, technology transfer, and community outreach. NIEHS is located in Research Triangle Park, near Durham, Raleigh, and Chapel Hill, North Carolina. NIEHS currently supports more than 1,240 research grants.
“I am excited about serving as the director of NIEHS at a time when integration across disciplines is essential, from molecular biology to pharmacology and physiology to epidemiology. Complex environmental issues require individual and team efforts to address the interactions between the environment and human health,” said Dr. Birnbaum. "Chronic exposures and chronic diseases can have multiple causative factors. A broad array of scientific expertise is needed to understand such problems in order to prevent disease. I am eager to translate the work of the basic scientist and epidemiologist into improvements for the health of our citizens and communities."
A native of New Jersey, Dr. Birnbaum received her M.S. and Ph.D. in microbiology from the University of Illinois, Urbana. A board certified toxicologist, Dr. Birnbaum has served as a federal scientist for nearly 29 years—the first ten of those at NIEHS—first as a senior staff fellow at the National Toxicology Program, then as a principal investigator and research microbiologist, and finally as a group leader for the Institute’s Chemical Disposition Group.
Dr. Birnbaum has received numerous awards, including the Women in Toxicology Elsevier Mentoring Award, the Society of Toxicology Public Communications Award, EPA’s Health Science Achievement Award and Diversity Leadership Award, and 12 Science and Technology Achievement Awards, which reflect the recommendations of EPA’s external Science Advisory Board, for specific publications. She is the author of more than 600 peer-reviewed publications, book chapters, abstracts, and reports. Dr. Birnbaum’s research focuses on the pharmacokinetic behavior of environmental chemicals; mechanisms of actions of toxicants, including endocrine disruption; and linking of real-world exposures to effects. She is also an adjunct professor in the School of Public Health, the Toxicology Curriculum, and the Department of Environmental Sciences and Engineering at the University of North Carolina, Chapel Hill, as well as in the Integrated Toxicology Program at Duke University.
Dr. Birnbaum is also an active member of the scientific community. She is currently president-elect of the International Union of Toxicology, the umbrella organization for toxicology societies in more than 50 countries; former president of the Society of Toxicology, the largest professional organization of toxicologists in the world; former chair of the Division of Toxicology at the American Society of Pharmacology and Therapeutics; and former vice president of the American Aging Association.
NIEHS supports research to understand the effects of the environment on human health and is part of NIH. For more information on environmental health topics, please visit our website at www.niehs.nih.gov.
The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NTP UPDATE: ICCVAM Releases 2006–2007 Biennial Report
Posted October 24, 2008
The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), announces the availability of the Biennial Progress Report: Interagency Coordinating Committee on the Validation of Alternative Methods: 2006–2007. Availability of the report was announced today in the Federal Register (Vol. 73, No. 206, p. 63150).
The report describes ICCVAM activities, test method recommendations, and other progress made during the 2006–07 reporting period. Selected highlights include:
- ICCVAM recommended the first non-animal ocular safety testing methods to Federal agencies that can identify substances causing severe eye damage, such as blindness, without the use of animals.
- ICCVAM determined that two non-animal cell-based assays can reduce animal use for testing required to determine if chemicals and products can cause acute poisoning, the most common product safety test performed.
- ICCVAM completed evaluation of five non-animal test methods for assessing the fever-inducing, or pyrogenicity, potential of injectable pharmaceuticals and other products.
- NICEATM initiated an international validation study of a cell-based test method to determine if it can identify substances that may disrupt normal hormonal function.
- NICEATM and ICCVAM strengthened collaborations with European and Japanese counterparts in the areas of validation studies and review activities.
ICCVAM has contributed to the approval or endorsement of 18 alternative safety testing methods by Federal regulatory agencies since its establishment in 1997. These test methods have significantly reduced animal use and improved animal welfare. ICCVAM has also identified critical research, development, and validation efforts needed to further advance numerous other alternative methods.
The 2006–2007 Biennial Report describes how NICEATM and ICCVAM continue to promote the development, validation and regulatory acceptance of new test methods that will reduce, refine, and replace the use of animals in testing while maintaining and promoting scientific quality and the protection of people, animals, and the environment.
The ICCVAM 2006–2007 Biennial Report (NIH Publication Number 08-6529) can be found at: http://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm
There is also a link to the report on the home page of the NICEATM-ICCVAM Web site.
If you would like a print copy of the report, please contact NICEATM at niceatm@niehs.nih.gov.
Thank you for your interest and your support of NICEATM and ICCVAM.
Zerhouni Ends Tenure as NIH Director
Posted September 24, 2008
Dear Friends and Colleagues in the extramural community,
Today, I informed my NIH colleagues, including staff, scientists, administrators, contractors, and trainees that at the end of October, I will be leaving my position as NIH Director to explore new opportunities and to devote much of my attention to writing.
I have said repeatedly that NIH is one of the true “wonders of the world.” For over six years, I have had the unparalleled privilege of leading one of the great institutions in history. Whenever an individual participates in a clinical trial or prevention effort, visits the doctor, stays in the hospital, has a medical test, or undergoes a procedure or treatment, they are benefiting from the extraordinary contribution you make to NIH’s single, great mission: improving the public’s health.
NIH has also been in the spotlight during a revolution in the biomedical sciences, one that continues to have broad and profound implications for academic institutions, industry, nonprofits, professional and scientific organizations, the health care profession, Government, and most important, for the health of the world. I am extremely fortunate to have led NIH during these unique times, which have brought with them complex challenges and amazing opportunities.
Your work will continue to transform the future of the agency and to play a key role in that revolution. Every day, people benefit from new treatments and potential cures for disabling and fatal conditions that result from your commitment and tireless dedication, even in the presence of complex problems and unprecedented challenges.
As recipients of NIH funding, you are among the world’s best, brightest, and most innovative scientists in a most competitive and challenging era for all of us. It is because of you and your contributions to science and health that NIH is known as the “crown jewel” agency of the federal government and you have every right to claim a stake in the agency’s success.
I also want to take this occasion to express my deep personal appreciation to the countless grantees who selflessly serve the NIH as volunteers on study sections, advisory councils and the many other activities the agency often calls upon you to join.
I know that my sentiments are shared by my colleagues at the NIH, and our gratitude runs deep. We are grateful for your support and the contributions you make every day.
Please feel free to distribute this message to your colleagues.
Sincerely,
Elias A. Zerhouni, M.D.
News Brief: EPA Appoints New Head of Panel Providing Independent Scientific Advice on Regulations
Posted September 17, 2008
If you need more information on this subject, call the Press Officer, Dave Ryan
Administrator Stephen L. Johnson today announced the appointment of Dr. Deborah Swackhamer, an internationally recognized expert on toxic chemicals in freshwater lakes and rivers, as chair of the EPA Science Advisory Board (SAB).
Dr. Swackhamer, Professor of Environmental Health Sciences and Co-Director of the Water Resources Center at the University of Minnesota in Minneapolis-St. Paul, brings to the job extensive research and experience applying science to environmental protection. Her research interests focus on chemical and biological processes affecting the behavior and fate of toxic organic contaminants such as PCBs, dioxins, and pesticides in the aquatic environment, particularly bioaccumulation of persistent compounds in fish in the Great Lakes.
Johnson also thanked Dr. M. Granger Morgan, Lord Chair Professor in Engineering at Carnegie Mellon University in Pittsburgh, for his public service in the past four years as chair of the SAB.
The SAB is an independently chartered federal advisory committee composed of external scientists and engineers. The SAB's principal mission includes reviewing the quality and relevance of the scientific and technical information being used or proposed as the basis for EPA regulations. Every year, EPA solicits nominations for members to serve on the SAB. The chair will serve a two-year term beginning Oct. 1.
Information about the SAB, visit the Web site.
EPA Calls for Comments on Regulating Greenhouse Gases Under the Clean Air Act
Posted July 30, 2008
Today's Federation Register (Vol. 73, No. 147: 44354) includes an Environmental Protection Agency (EPA) announcement of a proposed ruling making on regulating greenhouse gases (GHGs) under the Clean Air Act (CAA). The EPA seeks comments on analyses and policy alternatives regarding GHG effects and regulation under the CAA. This notice responds to the U.S. Supreme Court's decision in Massachusetts v. EPA and numerous petitions related to the potential regulation of GHGs under the CAA. The comment period extends until November 28, 2008. To access this Federal Register notice go to http://edocket.access.gpo.gov/2008/pdf/E8-16432.pdf
NIEHS—Newly Approved Ocular Safety Methods Reduce Animal Testing
Posted July 9, 2008
Federal regulatory agencies have accepted recommendations of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) for two methods that can reduce live animal use for ocular safety testing, the committee announced today. ICCVAM is a permanent interagency committee composed of representatives from 15 federal regulatory and research agencies, including the National Institutes of Health (NIH) that use, generate or disseminate toxicology testing information. More on Approved Ocular Safety Methods.
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