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NCI Nealon DigestFEDERAL CANCER NEWS AND EVENTS FROM THE NCI OFFICE OF ADVOCACY RELATIONSSeptember 28, 2011 |
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National Cancer Institute Highlight Fact Sheets, Websites, & Publications |
Prescription Drug Shortages – FDA Webinar (September 30th)The FDA Center for Drug Evaluation and Research is hosting a 30-minute webinar on Friday, September 30 at 11 a.m. ET about prescription drug shortages. Webinar participants will learn how FDA helps reduce the impact of drug shortages for patients and our nation’s health care system. An FDA expert will discuss the extent of the current drug shortage and the importance of communication among FDA, drug manufacturers, health professionals, and the public in helping to reduce the shortages’ impact on public health. Read more… Final Issue of the NCI Nealon DigestAs announced in the September 14th issue, this will be the final issue of the NCI Nealon Digest. The National Cancer Institute (NCI) is developing new communication tools which will be unveiled during the winter 2011/12. Some downtime will occur as we transition resources to develop and implement these new and exciting communication tools. The NCI Office of Advocacy Relations (OAR) will continue to use this listserv to share important information about these new developments and other announcements from across the NCI. OAR will also continue to make information on relevant conferences, meetings, public comment opportunities, and applications available on its website. OAR would like to thank you for being a loyal reader of the NCI Nealon Digest. As many of you know, the Digest was named after Eleanor O’Donoghue Nealon who boldly led the NCI effort to communicate more effectively with the cancer advocacy community. She established the Office of Liaison Activities, now known as OAR, as well as the NCI Director’s Consumer Liaison Group (DCLG). Ms. Nealon will always be remembered as champion for the advocate role within the cancer research enterprise.
California Researchers Identify Enzyme that Regulates Degradation of Damaged Protein (9/28/11)A study by scientists at the University of California, San Diego and UC Irvine has identified an enzyme called a proteasome phosphatase that appears to regulate removal of damaged proteins from a cell. The understanding of how this process works could have important implications for numerous diseases, including cancer and Parkinson’s disease. Read more… Seattle Researchers Map Genome of Advanced, Lethal Prostate Cancers and Discover "Hypermutations" (9/27/11)A team of researchers at Fred Hutchinson Cancer Research Center and the University of Washington has conducted the first comprehensive assessment of every gene in the genome of advanced, lethal prostate cancer. Until now, the genetic composition of such tumors had been poorly defined... Read more… Washington University in St. Louis Study Finds IMRT Has Less Harmful Rectal Side Effects than 3D-CRT for Prostate Cancer Patients (9/27/11)Men with localized prostate cancer treated with a newer technology, intensity modulated radiation therapy (IMRT), have more than a quarter (26 percent) fewer late bowel and rectal side effects and a statistically improved lower dose of radiation to the bladder and rectum, compared to those who undergo 3D-CRT, according to a randomized study to be presented at the plenary session October 3, 2011, at the 53rd Annual Meeting of the American Society for Radiation Oncology (ASTRO). Read more… Scientists Find a New Function for Breast Cancer Gene BRCA1 (9/26/11)Scientists at the National Cancer Institute (NCI) have uncovered a new function for BRCA1, a gene most commonly associated with hereditary breast and ovarian cancer. Read more… Johns Hopkins Study Reveals Significant Rise in Prostate Biopsy Complications and High Post-Procedure Hospitalization Rate (9/23/11)In a study of complication rates following prostate biopsy among Medicare beneficiaries, Johns Hopkins researchers have found a significant rise in serious complications requiring hospitalization. Read more… UCLA Scientists Develop System to Find Prostate Cancer Metastases Earlier Than Conventional Imaging (9/23/11)Researchers at UCLA’s Jonsson Comprehensive Cancer Center have developed a way to image the spread of a particularly dangerous form of prostate cancer earlier than conventional imaging in use today, which may allow oncologists to find and treat these metastases more quickly and give patients a better chance at survival. Read more… Stanford Discovery of Gene Fusion in Ovarian Cancer Could Lead to Earlier Diagnoses (9/21/11)About 15 percent of cases of an aggressive, difficult-to-detect form of ovarian cancer contain a unique fusion between two neighboring, normally separate genes, say researchers at the Stanford University School of Medicine. Read more… UNC Scientist Proves Potential of New Nanoparticle Design for Cancer Therapy (9/21/11)[The scientists] developed and tested a new type of nanoparticle that can deliver larger amounts of a drug and will not leak the drug as the particle circulates through the blood stream on its way to the target. Read more… Ohio State Study Finds Blood Pressure Drugs May Lengthen Lives of Melanoma Patients (9/21/11)A review of thousands of medical records in the Danish Cancer Registry showed that patients with the skin cancer melanoma, and who also were taking a specific beta-blocker, had much lower mortality rates than did patients not taking the drug. Read more… Stanford Study Finds Death Rate Higher in Minorities with Acute Leukemia (9/20/11)Blacks and Hispanics have fewer cases of acute leukemia compared to whites but they die at a substantially higher rate, according to study results presented at the Fourth AACR Conference on The Science of Cancer Health Disparities... Read more… Study Led by St. Jude Finds Key Regulatory Genes Often Amplified in Aggressive Childhood Tumor of the Brainstem (9/20/11)The largest study ever of a rare childhood brain tumor found more than half the tumors carried extra copies of specific genes linked to cancer growth, according to research led by St. Jude Children’s Research Hospital investigators. The findings identify possible new targets for treatment of a tumor in the brainstem known as diffuse intrinsic pontine glioma (DIPG). Read more… Purdue Technology Used in First Fluorescence-Guided Ovarian Cancer Surgery (9/19/11)The first fluorescence-guided surgery on an ovarian cancer patient was performed using a cancer cell "homing device" and imaging agent created by a Purdue University researcher... The method illuminates cancer cells to help surgeons identify and remove smaller tumors that could otherwise be missed. Read more… NIH Research Matters – Insights Into Tumor-Associated Epilepsy (9/19/11)Glioma, one of the most deadly and common types of brain tumor, is often associated with seizures, but the origins of these seizures and effective treatments for them have been elusive. A new study sheds light on the cause and suggests potential therapies. Read more… NIH Scientists Find Approach to Enhance and Prolong Immune Attack Against Tumor Cells (9/19/11)Investigators have identified a new class of human immune cells that behave like stem cells. These cells, a subtype of T lymphocytes, which comprise a small fraction of white blood cells, may prove more effective than any previously reported type of T cell for treating tumors. Read more… Scientists Find that Blocking Cholesterol in Brain Cancer Cells Offer a New Strategy to Fight Deadly Glioblastomas (9/16/11)Blocking the uptake of large amounts of cholesterol into brain cancer cells could provide a new strategy to battle glioblastoma, one of the most deadly malignancies, researchers at UCLA's Jonsson Comprehensive Cancer Center and the Ohio State University Comprehensive Cancer Center have found. Read more… St. Jude Investigators Devise New Strategy Likely to Speed Drug Development for Rare Cancers (9/16/11)Research led by St. Jude Children’s Research Hospital investigators used a pioneering approach to drug development and identified dozens of potential new treatments of ependymoma, a rare tumor of the brain and spinal cord. Read more… Stem-Like Memory T Cells are Discovered (September 2011)T cells are the white blood cells that are the body’s first line of attack against foreign invaders. When designing immunotherapies to treat cancer the goal is to prolong the immune response of T cells a bit beyond what the body normally does when a bacterium or a virus is encountered. Read more… Interleukin-8 and Its Role During EMT (September 2011)The switch of cancer cells from an epithelial to a mesenchymal-like phenotype, designated as epithelial-to-mesenchymal transition or EMT, is known to induce cell motility and invasiveness and appears to be critical for the dissemination of solid tumors and drug resistance. An understanding of the signaling events that induce tumor EMT could lead to novel ways to prevent metastasis. Read more…
CDC Features – CDC Awards Community Transformation Grants (Updated: 9/27/11)On September 27, the Department of Health and Human Services announced approximately $103 million in Community Transformation Grants (CTG) to states and communities, serving approximately 120 million Americans throughout the country. These projects are part of a comprehensive HHS initiative to address the health and well-being of our communities, and will be administered by the Centers for Disease Control and Prevention. Read more… CDC Features – Hispanic/Latino Heritage (Updated: 9/26/11)Learn about the diverse demographics, see examples of health disparities, and find out what Federal plans, activities and programs address the health and well-being of Hispanic/Latino Populations. Read more… CDC Features – CDC Learning Connection (Updated: 9/26/11)Through collaboration with the Public Health Foundation, CDC TRAIN provides free access to learning products for the public health community. Read more… CDC Features – Share Your Community Success Stories (Updated: 9/26/11)Communities across the country are hard at work creating policies to reduce the risk factors related to chronic diseases. To share the impact of creating policies, the Centers for Disease Control and Prevention's (CDC) Healthy Communities Program is pleased to announce the new Success Stories Web Site. Read more… New Guides Compare Benefits and Risks of GERD Treatments (9/23/11)GERD, sometimes known as acid reflux disease, occurs when stomach contents frequently back up into the esophagus. GERD often causes heartburn, which occurs when stomach acid irritates the esophagus. Some patients with GERD develop a condition called Barrett's esophagus, a disorder in which the lining of the esophagus is damaged by stomach acid, which can increase the risk of esophageal cancer. Read more… Cancer Control and Global Health (9/21/11)In conjunction with a high-level United Nations meeting on non-communicable diseases in the developing world, NCI Director Harold Varmus, M.D., and Edward L. Trimble, M.D., NCI, have published a commentary in Science Translational Medicine on “Integrating Cancer Control into Global Health.” Read more… (en Español…) FDA's MedWatch Safety Alerts: August 2011 – Diflucan and Birth Defects (Updated: 9/21/11)Fluconazole is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant. Read more… Beth Israel-Led Study Shows Candid Discussion Regarding Sexuality Can Improve Quality of Life for Prostate Cancer Survivors (9/21/11)Physicians are now better able to predict a man's recovery of sexual function after prostate cancer treatment, making a conversation between doctor and patient an important part of pre-treatment planning, a Beth Israel Deaconess Medical Center-led research team suggests. Read more… Duke Study Finds MRI Screening for Breast Cancer Could Benefit High-Risk Women Who Lack Insurance (9/21/11)Although an MRI screening can be expensive, it has been shown to be beneficial and cost effective for women at high risk of breast cancer who have little or no insurance, researchers at Duke University Medical Center report... Read more… Duke Study Finds Understanding Aggressive Breast Cancers Could Ease Racial Disparities in Death Rates (9/21/11)Some aggressive breast cancer tumors that disproportionately strike African-American women are known to take up blood sugar very rapidly. Now researchers from the Women's Wellness Program at Duke University have found a similar tendency in premalignant breast cells from high-risk African-American women. Read more… FEEDBACK NIH – Confronting the Quiet Global Epidemic (9/20/11)Diseases neither know nor respect national boundaries. Consequently, our efforts to use the power of research to develop new ways of fighting disease must have a vision that extends beyond borders, sets aside traditional rivalries, and supersedes scientific egos. Read more… AHRQ Initiative Encourages Better Two-way Communication Between Clinicians and Patients (9/20/11)The U.S. Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) today launched an initiative with the Ad Council to encourage clinicians and patients to engage in effective two-way communication to ensure safer care and better health outcomes. Read more… HHS Announces Text4Health Task Force Recommendations and Global Partnership (9/19/11)Today, the U.S. Department of Health and Human Services (HHS) announced new recommendations to support health text messaging and mobile health (mHealth) programs. Read more… CDC Features – UN Summit to Address the World's Major Emerging Health Threat (Updated: 9/19/11)Noncommunicable diseases (NCDs) such as heart disease and stroke, cancer, diabetes, and chronic lung disease kill more people globally than infectious diseases. Read more… CDC Media Relations – Lung Cancer Rates Decline Nationwide (Updated: 9/19/11)The rates of new lung cancer cases in the United States dropped among men in 35 states and among women in 6 states between 1999 and 2008, according to a report by the Centers for Disease Control and Prevention. Among women, lung cancer incidence decreased nationwide between 2006 and 2008, after increasing steadily for decades. Read more… Jefferson Researchers Find That Cancer Information on Wikipedia is Accurate, But Not Very Readable (9/16/11)It is a commonly held that information on Wikipedia should not be trusted, since it is written and edited by non-experts without professional oversight. But researchers from the Kimmel Cancer Center at Jefferson have found differently, according to a study published online Sept. 15 in the Journal of Oncology Practice. Read more… MMWR – State-Specific Trends in Lung Cancer and Smoking – United States, 1999-2008 (9/15/11)The rate of new lung cancer cases in the U.S. dropped among women in 6 states and among men in 35 states between 1999 and 2008. The decrease in lung cancer cases corresponds closely with smoking patterns across the nation. Read more…
New Affordable Care Act Initiative Helps Create Healthier Communities, Fight Chronic Disease (9/27/11)The U.S. Department of Health and Human Services (HHS) announced today grants to 61 states and communities with over 120 million residents to fight chronic disease, which is the leading cause of death in Americans. Read more… New Innovation Winners Honored by Secretary Sebelius (9/26/11)HHS Secretary Kathleen Sebelius today announced six winners for Round 3 of the HHSinnovates program, and said the program is part of an HHS-wide initiative “to build a constant thrust of innovation into the everyday operations of our health and human services agencies.” Read more… 2012 Medicare Advantage Premiums Fall and Projected Enrollment Rises (Revised: 9/25/11)On average, Medicare Advantage premiums will be 4 percent lower in 2012 than in 2011, and plans project enrollment to increase by 10 percent, the Department of Health and Human Services (HHS) announced today. Read more… FEEDBACK NIH – A Great Week for NCATS (9/23/11)Their report describes the best ways that NCATS can speed the entire effort of getting effective medicines to patients. And these are the folks who know this world well; they come from pharma, biotech, universities, non-profits, and the venture capital world. Read more… Reducing Costs, Protecting Consumers: The Affordable Care Act on the One Year Anniversary of the Patient’s Bill of Rights (9/23/11)One year after the Affordable Care Act’s Patient’s Bill of Rights took effect, the U.S. Department of Health and Human Services (HHS) released a report summarizing some of the achievements of the health reform law. Read more… New Funding Opportunities to Assist Innovative Small Businesses Announced (9/22/11)The National Cancer Institute Small Business Innovation Research (SBIR) program recently announced $8 million in new contract funding opportunities to assist small businesses with cancer research and technology development. Read more… New Data: Affordable Care Act Helps One Million Additional Young Adults Get Health Insurance (9/21/11)Today, the National Center for Health Statistics at the Centers for Disease Control and Prevention (CDC) released data illustrating that the Affordable Care Act has helped increase the number of young adults who have health insurance. Read more… Over $100 Million in New Affordable Care Act Grants Help Fight Health Insurance Premium Hikes (Revised: 9/21/11)HHS Secretary Kathleen Sebelius today announced Affordable Care Act grant awards of $109 million to 28 states and the District of Columbia that will help fight unreasonable premium increases and protect consumers. Read more… Hospitals Seek to Improve Health Care Through Faith-Based and Community Partnerships (Revised: 9/21/11)The White House and the Department of Health and Human Services (HHS) today welcomed 16 hospital CEOs and senior leadership from across the country to discuss improving health outcomes through faith-based and community partnerships. Read more… HHS Awards Affordable Care Act Funds for Organizations to Become Community Health Centers (Revised: 9/20/11)U.S. Department of Health and Human Services Secretary Kathleen Sebelius today announced awards totaling $10 million to aid 129 organizations across the country that would like to become community health centers. Read more…
NCI FactSheet – Lasers in Cancer Treatment (Reviewed: 9/13/11)Laser light can be used to remove cancer or precancerous growths or to relieve symptoms of cancer. It is used most often to treat cancers on the surface of the body or the lining of internal organs. View factsheet… New NIH Website – Intramural Research Program (September 2011)We designed this new site to complement ongoing efforts at the NIH to reach a broad audience, but among the groups we most desire to reach are fellow scientists outside of the NIH. So, we have taken a trans-NIH approach in characterizing IRP research by focus area --- cell biology, immunology, clinical, and so on. View website… New NIH Website – The NIH Catalyst (September 2011)The NIH Catalyst showcases the scientific research conducted at the National Institutes of Health and contains feature stories, essays, breaking news on NIH research, profiles, and information about Scientific Interest Groups, as well as articles on new scientific methods, NIH history, the Clinical Center, and more. View website… NCI Lifelines – Cancer and the Elderly (July 2011)In many American families, including those from minority populations, people from a wide range of ages live together under the same roof. The elder folk in these homes face what are called the diseases of aging, including hypertension, diabetes, arthritis, and cancer. Read more… FDA – Viral Hepatitis Therapies (5/25/11)Approved therapies for treatment of Hepatitis B and C. Read more…
Editor’s Note: All of these events, and more, are updated daily on the Office of Advocacy Relations website where you can view upcoming meetings, conferences, and teleconferences. Prescription Drug Shortages (9/30/11) WebinarIn 2010, there were a record number of prescription drug shortages. In 2011, FDA continues to see an increasing number of shortages, especially those involving older "sterile injectables"—medicines given by injection or intravenously to patients in the hospital. Learn how FDA helps reduce the impact of drug shortages for patients and our nation's health care system in this 30-minute webinar. An FDA expert will discuss the extent of the current drug shortage and the importance of communication among FDA, drug manufacturers, health professionals, and the public in helping to reduce the shortages' impact on public health. More information… NIH Advisory Board for Clinical Research (10/3/11) Bethesda, MDThe agenda includes a discussion of intramural clinical research operational and funding issues. More information… Task Force on Community Preventive Services (10/3/11 – 10/4/11) Atlanta, GADuring this meeting, the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide). Matters to be discussed during this meeting include updates on tobacco, skin cancer, health equity and cardiovascular disease. More information… Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (10/3/11 – 10/4/11) Washington, DCThe Advisory Group has been established to provide recommendations and advice to the National Prevention, Health Promotion and Public Health Council (the "Council"). The Advisory Group shall provide assistance to the Council in carrying out its mission. More information… Secretary's Advisory Committee on Human Research Protections (SACHRP) (10/4/11 – 10/5/11) Washington, DCBoth days of this meeting will be devoted to SACHRP discussion of the recent Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 26 Federal Register. The meeting will open October 4 with remarks from SACHRP Chair Dr. Barbara Bierer and OHRP Director Dr. Jerry Menikoff, followed by presentation of joint recommendations on the ANPRM from the Subpart A Subcommittee (SAS) and the Subcommittee on Harmonization (SOH). More information… Health In the US – A Review of the First Decade in the 21st Century (10/6/11) WebcastAssistant Secretary of Health, Dr. Howard Koh, and the Director of the National Center for Health Statistics, Dr. Edward Sondik, will present key findings from the Healthy People 2010 Final Review. The Healthy People 2010 Final Review presents a quantitative end-of-decade assessment of progress in achieving the Healthy People 2010 objectives and goals. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (10/11/11) Research Triangle Park, NC and Conference CallThe purpose of the meeting is to continue the work of the Research Translation, Dissemination, and Policy Implications Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (10/12/11) Research Triangle Park, NC and Conference CallThe purpose of the meeting is to continue the work of the Research Process Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC. More information… HIT Policy Committee (10/12/11) Washington, DCThe committee will hear reports from its workgroups, including the Meaningful Use Workgroup, the Privacy & Security Tiger Team, the Enrollment Workgroup, and the Quality Measures Workgroup. More information… Immunology Devices Panel of the Medical Devices Advisory Committee (10/14/11) Gaithersburg, MDThe committee will discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay sponsored by Gen-Probe, Inc. The Progensa PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results. A lower PCA3 score is associated with a decreased likelihood of a positive biopsy. More information… Reaching Minority Populations: Cancer Control and Prevention for Latino Populations (10/18/11) WebcastThe burden of cancer is often greater for the poor, ethnic minorities, and the uninsured than for the general population. To overcome these disparities, there is a need to identify and understand the contributing factors to develop and disseminate culturally appropriate interventions. During October's NCI Research to Reality cyber-seminar, Dr. Patricia Miranda, Assistant Professor of Health Policy and Administration at Penn State University, will discuss her research on cancer disparities among Latinos and the need for targeted communications and intervention. Dr. Maria Fernandez, an associate professor of health promotion and behavioral sciences at The University of Texas-Houston, will also join us to share her collaborative work National Center for Farmworker Health and their adaptation and implementation of an evidence-based breast and cervical cancer program for a variety of settings in Texas. More information… Review and Qualification of Clinical Outcome Assessments Workshop (10/19/11) Silver Spring, MDThe Food and Drug Administration (FDA) is announcing a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for use in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer-reported outcome (ObsRO) measures. This public workshop is intended to provide information for and gain perspectives from patient advocates, health care providers, researchers, regulators, individuals from academia, industry, and other interested persons on various aspects of the development and implementation of COAs in the evaluation of treatment benefit. Regulatory review issues regarding context of use and documentation of the measurement properties of a COA will be covered during panel discussions. The input from this public workshop will be published in the form of a white paper or a series of manuscripts. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (10/20/11) Conference CallThe purpose of the meeting is to continue the work of the State of the Science Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC including: summarizing the state of the literature (both animal and human research) and identifying research gaps. More information… Advisory Committee on Research on Women's Health (10/20/11 – 10/21/11) Bethesda, MDThe purpose of the meeting will be for the Committee to provide advice to the Office of Research on Women's Health (ORWH) on appropriate research activities with respect to women's health and related studies to be undertaken by the national research institutes; to provide recommendations regarding ORWH activities; to meet the mandates of the office; and for discussion of scientific issues. More information… HIT Standards Committee Advisory Meeting (10/21/11) TeleconferenceThe committee will hear reports from its workgroups, including the Clinical Operations, Vocabulary Task Force, Clinical Quality, Implementation, and Enrollment Workgroups. More information… Prescription Drug User Fee Act (10/24/11) Silver Spring, MDThe Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary. Registration to attend the meeting must be received by October 10, 2011. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (10/26/11) Research Triangle Park, NC and Conference CallThe purpose of the meeting is to continue the work of the Research Process Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC. More information… Health Professional Organizations Conference (10/31/11) Silver Spring, MDThe Food and Drug Administration (FDA) is announcing a conference for representatives of Health Professional Organizations. Dr. Margaret Hamburg, Commissioner of the Food and Drugs, and Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research have been invited to speak about their visions of the relationship between the Agency and the health professional community. Other topics on the agenda include Risk Evaluation and Mitigation Strategies and the Unapproved Drugs Initiative. The topics of discussion for this conference will include three separate panels that will highlight examples where FDA and health professional organizations collaborate to further public health. The goal of the panel presentations is to exchange ideas, highlight the value of FDA and health professional organizations working together, and encourage collaboration to promote public health. A list of concurrent breakout session topics is included in the agenda to facilitate informal discussion on how FDA and health professional organizations can collaborate more effectively. More information… Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (11/2/11) Silver Spring, MDThe subcommittee will consider and discuss regulatory, academic, and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/pharmacodynamic studies to support a pediatric indication for anticoagulants. More information… Tobacco Products Scientific Advisory Committee (11/2/11 – 11/3/11) Rockville, MDThe committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC's required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (11/8/11) Research Triangle Park, NC and Conference CallThe purpose of the meeting is to continue the work of the Research Translation, Dissemination, and Policy Implications Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC. More information… Board of Scientific Counselors, National Center for Biotechnology Information (11/8/11) Bethesda, MDThe agenda includes a program discussion. More information… Clinical Trials and Translational Research Advisory Committee (11/9/11) Bethesda, MDThe agenda includes a strategic discussion of NCI’s clinical and translational research programs. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (11/10/11) Research Triangle Park, NC and Conference CallThe purpose of the meeting is to continue the work of the Research Process Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (11/10/11) Conference CallThe purpose of the meeting is to continue the work of the State of the Science Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC including: summarizing the state of the literature (both animal and human research) and identifying research gaps. More information… Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice (11/16/11 – 11/17/11) Philadelphia, PAThe public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. More information… Risk Communication Advisory Committee (11/17/11 – 11/18/11) Silver Spring, MDOn November 17, 2011, the committee will discuss results of a literature review (as required in the Patient Protection and Affordable Care Act (Pub. L. 111-148) about communicating quantitative risk and benefit information in prescription drug promotional labeling and print advertising, and will also receive a briefing on activities in FDA's Office of Special Health Issues. On November 18, 2011, the committee will discuss implications, for strategic communication, of recent theoretical developments on information use in decision making. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (11/29/11) Conference CallThe purpose of the meeting is to continue the work of the State of the Science Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC including: summarizing the state of the literature (both animal and human research) and identifying research gaps. More information… NIH State-of-the-Science Conference: Role of Active Surveillance in the Management of Men with Localized Prostate Cancer (12/5/11 – 12/7/11) Bethesda, MDTo better understand the benefits and risks of active surveillance and other observational management strategies for PSA-screening-detected, low-grade, localized prostate cancer, the National Institutes of Health has engaged in a rigorous assessment of the available scientific evidence. This process will culminate in a State-of-the-Science Conference on December 5–7, 2011, that focuses on key questions developed by a multidisciplinary planning committee, which will be addressed in an evidence report prepared through the Agency for Healthcare Research and Quality's Evidence-based Practice Centers program. During the conference, invited experts, including the authors of the report, will present scientific evidence. Attendees will have opportunities to ask questions and provide comments during open discussion periods. After weighing the evidence, an unbiased, independent panel will prepare and present a statement addressing the key questions. The statement will be widely disseminated to practitioners, policymakers, patients, researchers, the general public, and the media. More information… Interagency Breast Cancer and Environmental Research Coordinating Committee (IBCERC) (12/6/11) Research Triangle Park, NC and conference CallThe purpose of the meeting is to continue the work of the Research Translation, Dissemination, and Policy Implications Subcommittee as it addresses a broad set of objectives related to the overall mandate of the IBCERC. More information…
Editor’s Note: Upcoming opportunities for public comment are updated daily on the Office of Advocacy Relations website. Center for Devices and Radiological Health 510(k) Clearance Process – Institute of Medicine Report: "Medical Devices and the Public's Health, the FDA 510(k) Clearance Process at 35 Years" – Comments must be submitted by September 30, 2011The Food and Drug Administration (FDA) is requesting comments on the Institute of Medicine (IOM) report entitled: “Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years.” The establishment of this public docket does not signify FDA endorsement or concurrence with any of the conclusions or recommendations contained within the report. FDA may, in the future, take additional measures to solicit public input in the report and specific recommendations contained therein. FDA will not adopt any of the recommendations contained in the report before the close of this comment period. Submit comments online by September 30, 2011. More information… Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke – Comments must be submitted by October 11, 2011The Food and Drug Administration (FDA) is requesting comments, including scientific and other information, concerning the harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke. This information will assist the Agency in establishing a list of HPHCs in tobacco products and tobacco smoke (the HPHC list). Submit comments online by October 11, 2011. More information… Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices – Comments must be submitted by October 12, 2011The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “In Vitro Companion Diagnostic Devices.” This guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device for its safe and effective use or an in vitro diagnostic device that is intended for use with a corresponding therapeutic product and included in the instructions for use in the labeling of those products. This guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight of companion diagnostic devices; clarifies that, in most circumstances, if use of a companion diagnostic device is essential for the safe and effective use of a therapeutic product, the diagnostic device and therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling; provides guidance for industry and FDA staff on possible premarket regulatory pathways and FDA’s regulatory enforcement policy; and describes certain statutory and regulatory approval requirements relevant to therapeutic product labeling that stipulate concomitant use of a companion diagnostic device to ensure safety and effectiveness of the therapeutic product. This draft guidance is not final, nor is it in effect at this time. Submit comments online by October 12, 2011. More information… Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators – Comments must be submitted by October 26, 2011The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects. Submit comments online by October 26, 2011. More information… Draft Guidance on Exculpatory Language in Informed Consent – Comments must be submitted by November 7, 2011The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health and the Food and Drug Administration (FDA), are announcing the availability of a draft guidance entitled, "Guidance on Exculpatory Language in Informed Consent." The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic and will supersede OHRP’s November 15, 1996 guidance document entitled "'Exculpatory Language' in Informed Consent” and question number 52 in FDA's January 1998 guidance entitled, "Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators." The draft guidance is intended primarily for institutional review boards (IRBs), investigators, sponsors, and funding agencies that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS or regulated by FDA. Submit comments online by November 7, 2011. More information… Design Considerations for Pivotal Clinical Investigations for Medical Devices Food and Drug Administration – Comments must be submitted by November 14, 2011The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Design Considerations for Pivotal Clinical Investigations for Medical Devices." This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in effect at this time. Submit comments online by November 14, 2011. More information… CLIA Program and HIPAA Privacy Rule: Patients’ Access to Test Reports – Comments must be submitted by November 14, 2011This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the proposed rule would retain the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested the test. In addition, this proposed rule would also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. Submit comments online by November 14, 2011. More information… Federal Strategic Plan to Reduce Health IT DisparitiesFor the past few months, the Health IT Disparities Workgroup – comprised of staff from agencies of the U.S. Department of Health and Human Services (HHS): with strategic and operational programs in health IT and co-chaired by the Office of the National Coordinator for Health Information Technology (ONC) and the Office of Minority Health (OMH) – has led a focused effort to further define the federal government's strategies and tactics to reduce health IT disparities within underserved communities. The result of this process will reflect our commitment to do more to reduce health IT disparities. The Health IT Disparities Workgroup is developing a federal plan to reduce health IT disparities. A draft set of strategies/tactics – aligned with the five goals of the Federal Health IT Strategic Plan – is available. We hope you will assist us by providing comments on the following questions: What do you think of the draft strategies / tactics? What specific activities would you like to see the federal government take on to reduce health IT disparities? Submit comments online. More information…
Editor’s Note: Upcoming opportunities for advocates are updated daily on Applications page of the Office of Advocacy Relations website. Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC) – Nominations must be submitted by October 1, 2011The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the BCCEDCAC. The BCCEDCAC provides advice and guidance to the Secretary, the Assistant Secretary for Health, and the CDC on the early detection and control of breast and cervical cancer. The role of the BCCEDCAC is to provide advice and make recommendations regarding national program goals and objectives; implementation strategies; program priorities, including surveillance, epidemiologic investigations, education and training, information dissemination, professional interactions and collaborations, and policy. Nominations should be submitted via email by October 1, 2011. More information… Board of Scientific Counselors – Nominations must be submitted by October 31, 2011The Board of Scientific Counselors, NCEH/ATSDR provides advice and guidance to the Secretary, HHS; the Director, CDC; and the Director, NCEH/ATSDR, regarding program goals, objectives, strategies, and priorities in fulfillment of the agencies' mission to protect and promote people's health. The Board provides advice and guidance to help NCEH/ATSDR work more efficiently and effectively with its various constituents and to fulfill its mission in protecting America's health. Nominations should be sent, in writing, and postmarked by October 31, 2011 to: Sandra Malcom, Committee Management Specialist, NCEH/ATSDR, CDC, 4770 Buford Highway (MS-F61), Chamblee, Georgia 30341. (E-mail address: sym6@cdc.gov). More information… Tobacco Products Scientific Advisory Committee – Nominations must be submitted by November 1, 2011The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, Center for Tobacco Products. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. Members will be invited to serve for terms of up to 4 years. The Committee shall include nine technically qualified voting members, selected by the Commissioner or designee. The nine voting members shall be physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty. Nominations should be submitted via email by November 1, 2011. More information…
TRACO: Topoisomerases; LymphomaOriginal Air Date: September 26, 2011 NCI’s Center for Global HealthPosted Date: September 20, 2011 TRACO: Metastasis; AngiogenesisOriginal Air Date: September 19, 2011 NCI Director Discusses the Provocative Questions ProjectPosted Date: September 6, 2011 Doctor Harold Varmus, Director del NCI: Bienvenidos a Cancer.gov en EspañolPosted Date: August 31, 2011
Thyroid Cancer Clinical Trial Conducted at NCI’s Center for Cancer Research, NIH
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