Department of Health and Human Services
Public Health Service
National Arthritis and Musculoskeletal and Skin Diseases Advisory Council

Minutes of the 78th Meeting
8:30 a.m. to 2:40 p.m.

1. CALL TO ORDER

   The 78th meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC) was held on September 11, 2012, at the National Institutes of Health (NIH) Campus, Building 31, Conference Room 6. The meeting was chaired by Dr. Stephen I. Katz, Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). (Dr. Katz was unable to attend the beginning of the meeting, which was led by Dr. Robert Carter, NIAMS Deputy Director, until Dr. Katz’s arrival.)

   Attendance

   Council members present

   Dr. Lynda F. Bonewald
   Dr. Leslie J. Crofford
   Dr. Harry C. Dietz III
   Dr. David R. Eyre
   Dr. Gary Firestein
   Dr. Linda Griffith
   Ms. Michelle Hofhine
   Dr. Henry M. Kronenberg
   Dr. Ted Mala
   Dr. Regis J. O’Keefe
   Dr. Alice P. Pentland
   Ms. Jean Pickford
   Ms. Elizabeth Smith
   Mr. Bradley R. Stephenson
   Dr. Julio Vergara
   Dr. Xiao-Jing Wang

   Staff and Guests

   Staff

   The following NIAMS staff and guests attended:

   Mr. Steven Austin Dr. Carl Baker Ms. Susan Bettendorf Dr. Amanda Boyce Dr. Branden Brough Dr. Eric Brown Ms. Justine Buschman Dr. Robert Carter Dr. Faye Chen Dr. Ricardo Cibotti Ms. Barbara Cohn Mr. Richard Clark Ms. Stephanie Craver Ms. Robin DiLiello Ms. Theresa Do Dr. Jonelle Drugan Mr. Erik Edgerton Ms. Elizabeth Elliott Ms. Sharon Fair Ms. Barbara Footer Ms. Gerda Gallop-Goodman Dr. Nancy Garrick Ms. Gail Hamilton Mr. Arthur Hudson Ms. Katie Joffee Mr. Andrew Jones Dr. Stephen I. Katz Ms. Mary Beth Kester Ms. Shahnaz Khan Ms. Stephanie Kreider Dr. Gayle Lester Dr. Helen Lin Ms. Anita Linde Ms. Mimi Lising

   Ms. Leslie Littlejohn Dr. Kan Ma Dr. Marie Mancini Dr. Kathryn Marron Dr. Joan McGowa Dr. Laura K. Moen Ms. Melinda Nelson Ms. Anna Nicholson Dr. Glen Nuckolls Dr. John O‘Shea Dr. James Panagis Ms. Vivian Pham Dr. Charles Rafferty Ms. Trish Reynolds Dr. Louise Rosenbaum Dr. Susana Serrate-Sztein Dr. William Sharrock Dr. Richard Siegel Ms. Allisen Stewart Ms. Robyn Strachan Ms. Yen Thach Ms. Jamie Thompson Dr. Phil Tonkins Dr. Hung Tseng Dr. Bernadette Tyree Dr. Robert Walker Dr. Fei Wang Dr. Xibin Wang Dr. Yan Wang Dr. Chuck Washabaugh Ms. Sara Wilson Dr. James Witter Dr. Xincheng Zheng

   Guests

   Dr. Andrea Baruchin, Foundation for the National Institutes of Health (NIH)
   Mr. Michael Bykowski, Consolidated Solutions and Innovations
   Ms. Kim Cantor, Lupus Foundation of America
   Ms. Celeste Crouse, KAI Research, Inc.
   Dr. John Gallin, Clinical Center, NIH
   Ms. Petra Harvey, Osteogenesis Imperfecta Foundation
   Ms. Mary Beth Huber, Osteogenesis Imperfecta Foundation
   Dr. John Holden, Department of Veterans Affairs
   Ms. Kim Holmes, IQ Solutions
   Ms. Annie Joseph, National Heart, Lung, and Blood Institute, NIH
   Dr. Marjorie Mau, University of Hawaii
   Ms. Kimberly McGraw, IQ Solutions
   Ms. Amy Mhatre, KAI Research, Inc.
   Ms. Judith Mun, American Association of Colleges of Osteopathic Medicine
   Ms. Denise Peterson, Office of the Director, NIH
   Ms. Michelle Rodrigues, SRI International
   Dr. Martha Somerman, National Institute of Dental and Craniofacial Research, NIH
   Ms. Maria Spencer, Arthritis Foundation
   Mr. Richie Taffet, Ehlers-Danlos National Foundation

2. CONSIDERATION OF MINUTES

   A motion was made, seconded, and passed to accept with no changes the minutes of the 77th NAMSAC meeting, held on June 5, 2012.

3. FUTURE COUNCIL MEETING DATES

   Future Council meetings are currently planned for the following dates:

   February 5, 2013
   June 4, 2013
   September 10, 2013
   February 11, 2014
   June 3, 2014
   September 8, 2014

4. THE OSTEOARTHRITIS INITIATIVE: CREATION OF A RESEARCH RESOURCE

   Dr. Gayle Lester, Program Director in the NIAMS Division of Musculoskeletal Diseases, presented an update on the Osteoarthritis Initiative (OAI), an ongoing multicenter observational cohort study of knee osteoarthritis (OA) jointly sponsored by the NIH and the pharmaceutical industry. The goal of the OAI is to create research resources to aid in the identification, evaluation, and validation of biomarkers as: (1) risk factors for disease onset and progression, (2) measurements of disease onset and progression, and (3) surrogate outcome measures for OA clinical trials.

   Through the issue and support of five competitive contracts, a prospective OA cohort of 4,796 men and women over age 45 years with knee OA (roughly 25% of the cohort) or risk factors for knee OA was developed. More women than men are participating (58% versus 42%), most OAI participants are aged 56-69 years, and about 20% are of a race other than Caucasian. Slightly more than one-third of the study population has a body mass index (BMI) of more than 30. The cohort originally was to be followed for 4 years; follow-up was extended to 8 years. Retention has remained relatively high (approximately 85% of the starting cohort) despite allowing participants to opt out after the first 4 years. Clinical and imaging data as well as biospecimens have been collected from subjects. A public database has been created that provides Web-based access to the clinical and functional data by request.

   The OAI Clinical Centers will complete participant assessments in 2014 and the Data Coordinating Center will release the last of the data in 2015 (the Clinical Centers are currently in the last phases of the seventh year of follow-up). Dr. Lester reported that data from nine clinic visits will be available for most participants.

   Biospecimens (e.g., serum, plasma, DNA, urine, etc.) have been collected from baseline through the first 48 months of participation. Applications for access to biospecimens are accepted 3 times per year, and access to biospecimens has been open for more than 3.5 years. Requests for access are peer-reviewed and must be accompanied by proof of funding. Clinical data from baseline and 5 years of follow-up are currently available for the entire cohort and include questionnaire, exam, and functional data. Images from baseline and 4 years of follow-up are available upon request from the Coordinating Center. The data and images are widely used by the OA community, with more than 113 publications based on the OAI resource to date. In addition, numerous abstracts and presentations at national and international meetings have been based on analyses of OAI data. As of August 29, 2012, there were almost 2,500 registered OAI users from 93 countries. A total of 12,649 datasets have been downloaded and 340 image sets have been distributed.

   Some of the current research findings include:

   • Between 40-60% of OAI individuals with knee OA were classified as inactive based on accelerometer data.
   • Increased heterogeneity of cartilage (on MRI) at baseline is associated with degeneration of joint tissues at 3-year follow up.
   • Baseline and longitudinal increases in periarticular bone predict structural progression of knee OA.
   • Very high and very low levels of physical activity were associated with MRI changes in cartilage, reflective of cartilage degradation.

   In 2010, the NIAMS funded three research contracts using the OAI data (Hip Morphology and Limb-Specific Risk Factors for Radiographic Hip Osteoarthritis; Pivotal Osteoarthritis Initiative Magnetic Resonance Imaging Analyses; and Osteoarthritis, Patient Centered Outcomes and Complementary and Alternative Therapy). These projects are starting their third year.

   The Foundation for the NIH (FNIH)-supported Biomarker Consortium has recently funded a project that will use OAI data to establish the predictive validity of disease progression biomarkers for OA and to assess the responsiveness of imaging and biochemical markers in knee OA. The proposed outcome is to identify and qualify imaging biomarkers within the next two years that can be applied in therapeutic trials to demonstrate usefulness in early decision making and for use in obtaining regulatory approval for the efficacy of structure-modifying or disease-modifying therapy. This effort is entirely funded by the pharmaceutical industry and is of great interest because therapeutic trials have almost stopped for the development of treatments for OA (this is one of the main reasons the OAI was developed in the first place).

   The OAI continues to contribute to research by making data, images, and biospecimens available and enabling investigators to: (1) improve understanding of the natural course of OA, (2) explore novel biomarkers that may be associated with OA onset and progression, (3) examine the relative roles of extant risk factors, (4) elucidate new risk factors, and (5) examine changes in joint structure over time with and without disease. Current priorities for the OAI include enriching the OAI online data set with analysis data (e.g., readings of x-rays from six- and eight-year follow-up measures, readings of all hip and hand x-rays, etc.) and encouraging further use of OAI data.

   The OAI team is exploring a partnership with the National Cancer Institute (NCI) to provide the wider scientific community with Web access to images. Additional dissemination opportunities include sessions at national and international meetings, future presentations scheduled at radiology and MRI meetings, and future initiatives supporting the use of OAI resources in grant applications submitted to the NIH.

   Discussion

   Council members had questions about potential new therapeutics for knee OA under development, the use of complementary and alternative medicines such as glucosamine, why biospecimen collection was not continued during the follow-up years, and if there is a central repository for OAI data.

   In the discussion which followed, Dr. Lester explained that some of the treatments that have been tried most recently involve repurposed therapies for osteoporosis. These have not been successful to date in terms of change in pain or change in joint space width outcomes, although there is a great deal of interest in using some of the agents related to joint lubrication as early treatments to improve outcomes. Dr. Katz commented that one area of interest is early inflammation in OA. There is some new information in terms of early OA suggesting that inflammatory mechanisms may play a role. Dr. Lester agreed, adding that the use of anti-inflammatory medications in late-stage OA can alleviate pain in some cases, but has not been shown to have disease-modifying effects.

   While the OAI includes some dietary intake information, mostly in terms of the diet itself, the data are poor and somewhat limited. Dr. Katz noted that the National Center for Complementary and Alternative Medicine (NCCAM) has provided some funding to examine the effects of dietary supplements such as glucosamine.

   Dr. Lester noted that OAI subjects are volunteers and for the most part collectively wanted to stop biospecimen collection. Blood draws were taken from a subset of the cohort at 18 and 36 months. There was concern that up to 50% of the cohort would be lost if biospecimen collection continued. There was a suggestion that optional continued biospecimen collection (including saliva) could be a possibility and has shown to be successful in other initiatives. Dr. Lester agreed to bring this issue to the attention of the OAI Principal Investigators (PIs).

   Dr. Katz explained that there was an American Recovery and Reinvestment Act (ARRA) award intended to create a central repository type of database for OA, including genome-wide association study data.

5. DIRECTOR’S REPORT AND DISCUSSION

   Before starting his Director’s Report, Dr. Katz reminded Council members and others present that this meeting was being held on the anniversary of the September 11, 2001, terrorist attacks and asked everyone present to reflect on those who lost their lives and how the country has changed since that day.

   Dr. Katz then welcomed Council members, NIAMS staff, and guests, and opened his Director’s Report by inviting Council members to review the NIAMS ShortTakes online, a resource that contains information about NIH initiatives, highlights of Capitol Hill/Department of Health and Human Services/NIH activities, news about personnel changes at the NIH and NIAMS, updates on NIAMS communications and outreach efforts, and Dr. Katz’s "Director’s Column." In the current ShortTakes, Dr. Katz’s "Director’s Column" focuses on data from the NIAMS Web site that highlights the number of applications that the Institute receives and funds as a function of the scores these applications received during peer review. He encouraged Council members to share this information within their colleagues.

   Council members Dr. Katherine Mathews, Professor in the Departments of Pediatrics and Neurology at the University of Iowa, and Ms. Karen Evans, Chair of the Lupus Foundation of America, were unable to attend this Council meeting. This was the last Council meeting for Ms. Evans, Dr. Linda Griffith of the Department of Biological and Mechanical Engineering at Massachusetts Institute of Technology’s Biological Process Engineering Center, Dr. Leslie Crofford, Chief of the Division of Rheumatology in the Department of Internal Medicine at the University of Kentucky, and Dr. Henry Kronenberg, Chief of the Endocrine Unit at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. Dr. Katz thanked the outgoing Council members for their years of service and many contributions to the group.

   There were noteworthy awards and honors for NIH grantees and staff. Council member Dr. Harry Dietz, the Victor A. McKusick Professor of Medicine and Genetics in the McKusick-Nathans Institute of Genetic Medicine at Johns Hopkins University School of Medicine was recently awarded the Taubman Prize for Excellence in Translational Medical Science by the University of Michigan’s A. Alfred Taubman Medical Research Institute. The Taubman Prize was established to annually recognize a clinician-researcher who is transforming laboratory discoveries into clinical applications for patients suffering from disease. NIAMS grantee Dr. Valerie Horsley received a 2011 Presidential Early Career Award for Scientists and Engineers (PECASE). The PECASE is the highest honor bestowed by the U.S. government to outstanding scientists and engineers beginning their independent careers. In addition, 18 NIAMS staff members were selected for special recognition at the annual NIH Director’s Award Ceremony. These NIH Director’s Awards recognize employees who exhibited superior performance or special efforts that are significantly beyond their regular duty requirements, but relate directly to fulfilling the NIH mission.

   Personnel Changes in the NIH Community

   At the NIH level, Dr. Katz reported that Dr. David Murray has been named as the Associate Director for Disease Prevention and Director of the Office of Disease Prevention. Dr. Murray comes to the NIH from the Ohio State University, where he was Chair and Professor of the Division of Epidemiology in the College of Public Health.

   Dr. Janine Clayton has been named as the Associate Director for Research on Women’s Health and Director of the NIH Office of Research on Women’s Health (ORWH). Dr. Clayton has been the ORWH Deputy Director since 2008 and has been serving as the Office’s Acting Director since Dr. Vivian Pinn’s retirement last September.

   As part of NCCAM’s effort to expand its focus on pain research, that Institute has recruited Dr. Catherine Bushnell as the Scientific Director of a new intramural program focusing on the role of the brain in perceiving, modifying, and managing pain. Dr. Katz led the search committee that recruited Dr. Bushnell, who comes to the NIH from McGill University in Montreal.

   Dr. Katz noted that the NIH recently created the Office of Emergency Care Research as a focal point for basic, clinical, and translational emergency care research and training across the NIH. The Office, which is housed in NIH’s National Institute of General Medical Sciences, will foster innovation, emergency care research, and the training of future researchers. Dr. James Panagis (Medical Officer within the NIAMS Division of Musculoskeletal Diseases) serves as NIAMS’ representative to the Emergency Care Research Working Group, which includes representatives from most NIH institutes and centers (ICs). While NIH conducts a search for a permanent Director, the Office is being led on an acting basis by Dr. Walter Koroshetz, Deputy Director of the National Institute of Neurological Disorders and Stroke.

   Dr. Maria Freire has been named as the new FNIH President, effective November 1, 2012. Dr. Freire comes to the Foundation from her position as President of the Albert and Mary Lasker Foundation.

   Update on Budget and Congressional Activities

   Before the August Congressional recess, the Senate Appropriations Committee reported on the fiscal year (FY) 2013 Senate Labor-HHS-Education appropriations bill, and the House Appropriations Subcommittee on Labor, HHS, and Education held their markup on the FY 2013 appropriations bill. Once the House and Senate pass their respective appropriations bills, the Conference Committee will have to reconcile the differences between the two bills. However, in anticipation of contentious funding deliberations this fall, the House and Senate leaders have publically stated that beginning October 1, 2012, most of the government (including the NIH) will likely be operating under a six-month Continuing Resolution.

   As per its usual practice, the NIAMS will post its projected budget and funding plans on the Institute’s Web site as information becomes available.

   Dr. Katz noted that on August 7, 2012, President Obama signed H.R. 5872, the Sequestration Transparency Act of 2012 (P. L. 112-155), to require the Administration in 30 days to describe its plans for implementing the $1.2 trillion in automatic spending cuts scheduled to go into effect beginning in January 2013.

   Dr. Katz reminded the group that during the closed session portion of the June Council meeting, the Special Council Review process that was published in the NIH Guide to Grants and Contracts last May was piloted. In follow-up to feedback from this body and from other Advisory Councils and interested groups, the threshold for additional scrutiny of PI funding has been changed from $1.5 million in total costs to $1 million direct costs. The NIAMS also has developed some standard operating procedures based on the Council’s June discussion. Dr. Katz emphasized that the policy is not a cap, but rather a trigger to take a second look in the interest of good fiscal management (he commented that some of the most productive NIH investigators lead significant research teams and programs that may require annual budgets of more than $1 million).

   On July 26, 2012, Representative Ann Marie Buerkle (R-NY) introduced H.R. 6218, the Mary Colella Autoimmune Disease Awareness Act of 2012. If enacted, the bill would require the Secretary, HHS, to establish and maintain an Autoimmune Diseases Interdepartmental Coordinating Committee to coordinate governmental and private programs and activities relating to autoimmune diseases. Dr. Katz noted that the NIAMS has a long history of working with the autoimmune diseases research and advocacy community. The Institute participates in the NIAID-led NIH Autoimmune Diseases Coordinating Committee and chairs the Lupus Federal Working Group.

   In July, the first-ever Congressional Lupus Caucus held its inaugural briefing. The event followed closely behind the Lupus Foundation of America’s (LFA) annual Butterfly Gala, during which Dr. Katz and Olympic gold medalist Shannon Boxx presented LFA’s National Policy Leadership Award to the caucus Co-Chairs. Approximately 75 individuals from Congressional offices and advocacy groups attended the briefing, which focused on awareness, communication, research and collaboration.

   Representative Edward Markey (D-MA) introduced H.R. 6272, the Trial and Experimental Studies Transparency (TEST) Act of 2012. The TEST Act would expand upon the Food and Drug Administration Amendments Act of 2007 as they relate to clinical trials registration and results reporting on clinicaltrials.gov. The bill’s provisions include requirements that all interventional biomedical studies on humans be registered with the clinical trial registry database before the first participants are enrolled in the trial and that results from all covered trials are posted on the database within one year of completion of the trial, with some exceptions for new interventions.

   Dr. Katz also reported that the U.S. Court of Appeals recently upheld Executive Order 13505, Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, which President Obama issued in 2009. This ruling is important news for patients, as it affirms the administration’s commitment to the patients who are afflicted by diseases that may one day be treatable using results of this research.

   Highlights of Selected Recent Scientific Advances

   • When a muscle is damaged, satellite cells residing in the niche between muscle fibers divide into two cells: one that reverts to a quiescent (hibernating) satellite cell and one that continues to divide into cells that will mature into muscle cells. Dr. Shihuan Kuang and colleagues at Purdue University examined the role of a low-oxygen environment on muscle satellite cells in a mouse model and, in the process, identified some laboratory techniques that make transplanted cells more likely to establish themselves in muscle tissue. Theoretically, this is translatable to humans using hypoxic conditions (Development. 2012 Jul 4. [Epub ahead of print] PMID: 22764051).
   • Through mouse studies, it has been found that hair follicle stem cells go through periods of quiescence and activation during hair follicle regeneration. Much of this knowledge comes from analysis of static images of mouse skin, and the process is inferred by observing multiple, separate tissue samples. Dr. Valentina Greco and colleagues at Yale University have utilized a non-invasive imaging technology through which entire hair follicles can be visualized at the cellular level in a living adult mouse over a period of hours to days. Dr. Katz presented a video to demonstrate how researchers can follow the regeneration of individual hair follicles over time and directly observe individual cells and cell populations, such as stem cells and their progeny. This imaging technology could revolutionize the study of hair follicle regeneration and may have applications to the study of other dynamic processes in the skin (Nature. 2012 Jul 1. doi: 10.1038/nature11218. PMID: 22763436).
   • A newly identified immune system protein reduces defense against bacteria. Part of the immune system serves as the first line of defense against pathogens, by detecting invading microorganisms and releasing a burst of pro-inflammatory mediators, that triggers further steps in the immune response. Nod-like receptors (NLRs) are a component of this pathogen detection system. Dr. Thiru Kanneganti of St. Jude Children’s Research Hospital in Memphis and colleagues found that mice lacking one of these NLRs, NLRP6, fared better than their normal counterparts when infected with lethal doses of three different bacteria. These mice also had higher than normal levels of circulating inflammatory immune cells and they mounted a more effective immune response, indicating that NLRP6 might usually act to dampen the immune response (Nature. 2012 Jul 1. doi: 10.1038/nature11250 PMID: 22763455).
   • NIH scientists have shed light on the generation of antibody-mediated immunity. Interleukin (IL)-27 is a key immunosuppressive cytokine that counters the immune response of pro-inflammatory IL-17-producing T lymphocytes (Th17 cells). Th17 cells are involved in the initiation and facilitation of human autoimmune disorders including inflammatory bowel disease, rheumatoid arthritis, multiple sclerosis, type 1 diabetes, eczema and psoriasis. However, the mechanism of IL-27 to inhibit the development of Th17 cells is not known. Intramural Research Program (IRP) scientists led by NIAMS Scientific Director, Dr. John O’Shea, collaborated with a group of investigators from the University of Pennsylvania and Harvard Medical School to describe a new way of suppressing the immune response of T lymphocytes with IL-27. They found that when mature T cells (CD4+ T cells) were treated with IL-27, they acquire their immunosuppressive function by expressing a key immunosuppressive co-stimulatory molecule (PD-L1). This work demonstrates how IL-27 might be used as a potential drug to regulate autoimmune diseases, and significantly advances our understanding of how T cells regulate Th17 responses in humans (Immunity. 2012 Jun 29;36(6):1017-30. Epub 2012 Jun 21. PMID: 22726954).
   • Researchers also continue to make progress in understanding the interconnectedness of bone and other tissues or organ systems. A research team led by Dr. Bjorn Olsen at Harvard School of Dental Medicine has contributed another insight into the understanding of how bone and fat are connected. Previous observations noted that osteoporotic bones were spongy and had increased marrow fat in comparison with bones from healthy controls, and mesenchymal stem cells from osteoporosis patients were more likely to become adipocytes, rather than osteoblasts. The research team found that vascular endothelial growth factor (VEGF) is highly expressed by osteoblast precursor cells. A series of experiments targeting VEGF during post-natal development in mice prompted them to propose a model in which VEGF controls differentiation of mesenchymal stem cells. The reduction in bone mass and the increase in marrow fat that they saw in their mouse model are similar to changes associated with osteoporosis and age-related osteopenia (J Clin Invest. 2012 Aug 13. pii: 61209. doi: 10.1172/JCI61209. [Epub ahead of print] PMID: 22886301).
   • Five years ago, researchers discovered that the molecule serotonin influences bone mass. Serotonin comes from two sources—the brain and peripheral tissues, including the gut. Each has different biologic effects. Gut-derived serotonin is thought to inhibit the proliferation of bone-forming cells called osteoblasts. Recent mouse experiments by Dr. Stavroula Kousteni of Columbia University and colleagues have shown that gut-derived serotonin exerts these influences by affecting the behavior of the transcription factor FOXO1. At normal serotonin levels, FOXO1 maintains a balance between resting and dividing cells. However, high circulating serotonin levels tip the balance toward an excessive amount of ATF4-FOXO1 complexes, which suppress osteoblast proliferation. Much more remains to be discovered about this complicated and finely tuned process, and strategies to inhibit gut-derived serotonin synthesis are being considered as a potential treatment for conditions characterized by low bone mass (J Clin Invest. 2012 Sep 4. pii: 64906. doi: 10.1172/JCI64906. [Epub ahead of print] PMID: 22945629).

   NIH/NIAMS Activities and Plans for the Future

   Dr. Katz reported that the National Center for Advancing Translational Sciences (NCATS) recently launched a new effort, Discovering New Therapeutic Uses for Existing Molecules, to develop partnerships between pharmaceutical companies and the biomedical research community. As part of the effort, NCATS will provide up to $20 million to fund 2- to 3-year staged cooperative agreement research grants. Researchers will conduct pre-clinical validation and clinical feasibility studies in the first stage, and proof-of-concept clinical trials in the second stage, to test whether one of the compounds may be effective against a previously unexplored disease target.

   Another NCATS activity is the Tissue Chip for Drug Screening Initiative, which aims to develop three dimensional human tissue chips that accurately model the structure and function of human organs, such as the lung, liver, and heart. NIAMS Program Director Dr. Fei Wang has been part of the group that is leading this effort. The list of grantees includes a number of researchers who are familiar to the NIAMS. Drs. Linda Griffith and George Truskey are among those who are developing 3-D cellular microsystems that represent a number of human organ systems, while Drs. Angela Christiano and Rocky Tuan are exploring the potential of stem and progenitor cells to differentiate into multiple cell types that represent the cellular architecture within organ systems.

   Earlier this year at the January Council meeting, Dr. Katz noted that the National Defense Authorization Act for FY 2012 (P.L. 112-81) reauthorized the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs through FY 2017. Despite the prospect of flat budgets, the bill will gradually increase the SBIR set-aside to 3.2 percent (from 2.5 percent) and the STTR set-aside to 0.45 percent (from 0.3 percent) over the next 6 years. NIH Director Dr. Francis Collins charged the NIH Scientific Management Review Board (SMRB), a panel of NIH Institute and Center Directors and leaders from universities and other entities, with recommending strategies for how the NIH can better use the SBIR/STTR programs in keeping with the NIH mission. To this end, the SMRB formed a working group that reported back to the Board during its July meeting and will be reaching out to members of the extramural small business community for their perspectives on the program. Dr. Katz noted that the SMRB also will be discussing its assessment of the value of biomedical research, specifically: (1) current strategies for determining the value of biomedical research, examining both national and international methodologies; (2) the strengths and weaknesses of both extant and potential approaches for evaluating the value of biomedical research; and (3) the fundamental principles that should guide any comprehensive and rigorous approach for assessing the value of biomedical research.

   Another advisory group to the NIH, the Advisory Committee to the Director, recently heard recommendations from two working groups exploring workforce issues facing the biomedical research community. The Working Group on Biomedical Workforce Issues, chaired by Dr. Shirley Tilghman, President of Princeton University, and Dr. Sally Rockey, NIH Deputy Director for Extramural Research, was asked to make recommendations for actions that the NIH should take to support a future sustainable biomedical research infrastructure. The Working Group’s report, which the Co-Chairs submitted at the June Advisory Committee’s meeting, included a snapshot of the current biomedical research workforce, as well as advice about funding and training of graduate students and postdoctoral researchers as well as how to improve and maintain robust data collection on the biomedical research workforce to provide accurate information to those in the field and those thinking about joining it.

   In a parallel effort, the Working Group on Diversity in the Biomedical Research Workforce recently compiled data on the number of people from underrepresented groups who enter the biomedical educational pipeline and who receive Ph.D. degrees in the biological sciences, chemistry, and physics. This Working Group made recommendations regarding data collection and evaluation, mentoring and career preparation and retention, institutional support, bias-related research and intervention testing within the context of peer review, and an NIH diversity strategy and infrastructure.

   The National Institute on Minority Health and Health Disparities (NIMHD) will soon begin developing the NIH Health Disparities Strategic Plan and Budget for FY 2014-2018. Dr. Katz reminded the group that many of the conditions within the NIAMS mission disproportionately affect members of underserved groups, both in increased numbers and increased disease severity. The NIAMS will be working closely with the NIMHD to make sure that the plan for the NIH reflects the needs of its communities.

   Dr. Katz noted that the NIH Council of Councils met this summer. NAMSAC member Dr. Regis O’Keefe, Chair of the Department of Orthopaedics and Rehabilitation at the University of Rochester Medical Center, is a member of this body. One function of the Council of Councils is to provide advice on new and existing Common Fund programs. One Common Fund Initiative for FY 2013 will expand the NIH Undiagnosed Diseases Program (UDP) to provide a new network of medical research centers focused on the discovery, diagnosis, and ultimately care of undiagnosed patients by capitalizing on recent advances in genomics and the infusion of basic researchers in clinical projects. The NIH expects to provide approximately $145 million in Common Fund support over the next 7 years for the program, which will promote the use of genomic data in disease diagnosis and will engage basic researchers to identify the underlying mechanisms so that therapies may be rapidly identified. The program will also train clinicians in the use of contemporary genomic approaches so that these methods can be used to fight other diseases. Dr. Katz explained that the Common Fund is also launching an initiative to explore new ways in which cells communicate with each other using extracellular RNA.

   Like the NIH Office of the Director and other NIH components, the NIAMS continues to look forward and identify areas that are primed for exploration. Dr. Katz noted that later during this Council meeting, there would be a discussion about the initiatives that the Institute is considering pursuing in FY 2014 to promote research in arthritis and musculoskeletal and skin diseases. This Council meeting also featured an update on the NIAMS Centers Program, which is being evaluated under Dr. Carter’s leadership. The goal of this effort is not to examine the science that current NIAMS Centers are conducting, but rather to examine whether the existing structures are the best ways to support integrated, synergistic approaches to science. The Institute intends for its Centers to address challenges and opportunities that require teams, strategies, and infrastructure that may be difficult to establish through R01 or related mechanisms.

   Dr. Katz concluded his Director’s Report by providing highlights of selected information dissemination efforts. He called Council members’ attention to publications and other media efforts that have featured NIAMS’ work over the past few months and thanked NIAMS Office of Science Policy, Planning and Communications (OSPPC) staff for facilitating these interactions:

   • The new Alliance for Lupus Research podcast features Dr. Carter and highlights Federal support of lupus research.
   • Dr. Mahendra Rao of the NIH Center for Regenerative Medicine was interviewed for The Scientist and Drug Discovery and Development.
   • Dr. Joan McGowan, Director of the NIAMS Division of Musculoskeletal Diseases, contributed to an article about osteoporosis and bone health in Parents magazine.

   Dr. Katz also thanked Dr. Lisa Shulman, Professor of Neurology at the University of Maryland Medical Center, and NIAMS Program Director Dr. James Witter for participating in a video on the Patient Reported Outcomes Measurement Information System (PROMIS). Dr. Katz showed excerpts of the video to the Council. Supported by the trans-NIH Common Fund through 2013, PROMIS is managed administratively by the NIAMS. Dr. Katz acknowledged the considerable effort that has gone into this effort, particularly the leadership of Dr. Susana Serrate-Sztein (Director of the NIAMS Division of Skin and Rheumatic Diseases), the Lead Project Officer for PROMIS; Dr. James Witter, the program’s Chief Science Officer; and NIAMS Program Director Phil Tonkins.

   Discussion

   In the discussion which followed, Dr. O’Keefe noted that there is tremendous potential with the PROMIS initiative, commenting that it is not disease specific but health domain specific. PROMIS should be able to provide information on how the treatment of one disease compares with the treatment of another disease. The American Academy of Orthopaedic Surgeons in collaboration with other professional organizations is piloting a project with Dr. O’Keefe’s institution that implements PROMIS. Ultimately, it is hoped that all 200,000 patients seen annually at their clinic include PROMIS at every visit, with the goal of providing the structure and ability to understand how treatments impact musculoskeletal health.

6. OPPORTUNITIES FOR COLLABORATIONS AT THE NIH CLINICAL CENTER

   Dr. Gallin provided the Council with an overview of a new funding opportunity announcement (FOA) to foster extramural-intramural collaborations at the NIH Clinical Center. The Clinical Center’s mission is to provide the best science, patient care/safety, and training possible. As America’s research hospital, the Clinical Center’s vision is to lead the global effort in training today’s investigators and discovering tomorrow’s cures.

   When Congress created the NIH SMRB in 2010, one of the first activities this Board took on was to evaluate the Clinical Center. The Board made a recommendation for a major vision change: "The role of the NIH Clinical Center should be to serve as a state-of-the-art national resource, with resources optimally managed to enable both internal and external investigator use." In response to this recommendation, a new NIH FOA, "Opportunities for Collaborative Research at the NIH Clinical Center" has been announced. This new U01 FOA has the goal of supporting collaborative research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. The FOA requests applications with budgets of up to $500,000 per year in direct costs for 3 years. Teams must have one extramural and one intramural co-PI, and some of the work must be done at the Clinical Center. The intramural co-PI has to be either a senior investigator who is a tenured scientist or tenure-track scientist. (The U01 application can include additional team members.) The U01s will be awarded by the individual partnering ICs. The extramural component of the U01 will be funded as a U01 grant from the extramural pool. Intramural funds will be determined by each IC in two ways: some money will go to the collaborating PI in the intramural program and some will go to the Clinical Center to cover patient care costs.

   Key principles of the cost model for Clinical Center activity include: (1) maintaining services for the intramural research program (the Clinical Center and this new U01 mechanism are not intended to replace the intramural research program but rather to amplify its activities), (2) being simple and transparent, (3) having the Clinical Center determine costs for each proposed investigation based on standard templates completed by applicants, and (4) having an annual evaluation of the Clinical Center cost model to manage the risk of over/under charges to grantees in the future. It is estimated that inpatient days will represent approximately 30% of the total cost (based on the patient care unit to which the patient is assigned as determined by the diagnosis-related group). Similarly, outpatient visits are expected to represent roughly 30% of the total cost (traceable to the Clinical Center Service Master, direct costs only). Specialized services (e.g., fees for service items such as research positron emission tomography, etc.) are expected to be at full cost.

   In his overview of the planned U01 process, Dr. Gallin strongly recommended that all potential applicants submit a letter of intent, which will be considered by Dr. Gallin and the sponsoring IC leadership to determine resource availability and alignment with IC program goals. Applicants will submit their applications on a single receipt date. Peer review will be carried out at the discretion of the IC, either through an IC study section or through the Center for Scientific Review. Once the applications have been reviewed and awards have been made, the grants will be queued for implementation by the Clinical Center based on an assessment of current Clinical Center capacity.

   Dr. Gallin listed the 12 NIH ICs that have signed on to participate in the new U01 mechanism to date (including the NIAMS). A new Web site has been created to provide information on the U01 grants and collaborating with NIH intramural investigators at the Clinical Center (www.cc.nih.gov/translational-research-resources/). Next steps include publishing the FOA in late September/October 2012, receiving letters of intent in January 2013, a February 2013 application due date, and issuing the first round of awards in November/December 2013.

   Discussion

   Council members had questions about a variety of topics, including: the content of the information provided on the new Web site, clarification about IC participation, how the U01s will affect existing and new Clinical and Translational Science awards (CTSAs), and the role of NCATS in the process.

   In the discussion which followed, Dr. Katz noted that the NIAMS is enthusiastic about participating in this new initiative. Drs. Richard Siegel (NIAMS Clinical Director) and Serrate-Sztein are the NIAMS lead contacts for this initiative. The FOA includes a statement of NIAMS’ interest. Dr. Siegel invited Council members to contact him for additional information on the NIAMS Intramural Clinical Program.

   Dr. Gallin noted that a permanent NCATS Director has not yet been named and that there have been discussions about whether or not to include NCATS. The role of NCATS may be as an added resource to help enable the program projects that are put forward. The manner of the interaction between NCATS and the Clinical Center has yet to be fully defined. Dr. Katz added that the U01 will result in increased use of the Clinical Center as a resource, and without an intramural program, the NCATS may not be ready to fully participate in the U01 at this stage.

   Dr. Katz reminded the group that the U01 is a pilot. The outcomes are unclear, but the hope is that it results in enhanced Clinical Center utilization. The U01 is open to participation by all ICs, but some are waiting see how well the program works before signing on. The ICs with the largest budgets have agreed to participate, and there is still time for additional ICs to join. Dr. Katz noted that NIAMS’ reasoning for participating is based on enthusiasm that the science in areas of interest to the Institute can be enhanced with the U01.

   When asked if the requirement for an intramural collaborator is driven by practical considerations or whether it is an absolute prerequisite from a philosophical perspective, given that the overall goal is to have the Clinical Center emerge as a national resource and to increase its utilization, Dr. Gallin commented that the goal is to enrich the intellectual environment and enable projects that might not otherwise happen in the extramural community.

   He noted that the new Web site referenced during his presentation can be searched by research topic, clinical protocols can be reviewed, and there are contacts listed. The search feature utilizes all relevant NIH databases and includes all studies, IC annual reports, patient populations, Clinical Center department resources, etc.

7. NATIONAL MULTICULTURAL OUTREACH INITIATVE

   Dr. Carter explained that the NIAMS National Multicultural Outreach Initiative (NMOI) grew out of a need expressed by members of the NIAMS Coalition to reach underserved or minority populations and develop tools to help reach those groups. The goals of the NMOI are to: (1) raise awareness in multicultural communities about the availability and access to NIH, NIAMS, and other Federal resources to help people with conditions of the bones, joints, muscles, and skin; (2) emphasize that research is the foundation for progress; and (3) support and involve organizations in multicultural outreach. A series of NMOI materials were circulated among Council members. Target audiences include African Americans; Hispanics/Latinos; American Indians, Alaska Natives, and Native Hawaiians; and Asian Americans and Pacific Islanders.

   The NMOI timeline, which began with planning and strategy development in 2008, was followed by formative research and the development of health planners in 2010-2011 and a pilot study in 2012. National distribution of the health planners is planned for 2013.

   With regard to formative research and product development, 18 focus groups and 20 interviews were utilized across the populations of interest. It was found that a calendar format was most popular, while text message format was least popular. Themes of family and wisdom resonated best and photos of real people were most believable and motivational. Participants indicated that they did generally trust the government with regard to providing health information and suggested spelling out “NIAMS” and identifying it as part of the federal government. Participants also indicated the importance of highlighting information that is based on proven studies and free resources. As a result of this input, health planners in a calendar format were developed to reach target audiences. These planners include research-based health information; self-care tips; science-based facts; testimonials from real people about their conditions; references to information available at the NIAMS, NIH, and Federal government; and stickers that can be used to help with reminders. These planners are interactive tools that health care providers can use to communicate with their patients and include the NIAMS Web site and NIAMS Information Clearinghouse for obtaining additional information.

   Mimi Lising of the NIAMS OSPPC explained that as part of a pilot study, two planners—one for American Indians, one for Hispanics/Latinos—were developed and distributed in collaboration with the Indian Health Service, the Office of Minority Health, and two organizations affiliated with the NIAMS Coalition. The purpose of the pilot was to field test these planners for a 3-month period to assess how effective they were in raising awareness of the NIH and NIAMS as a reliable source of health information. Two community-based organizations were selected for each population. Out of 7,500 planners that were received by these community-based organizations, 91% were distributed (59% of the planners were distributed to American Indians, 41% were distributed to Hispanics/Latinos). The most common distribution venues were clinics, health fairs, and community facilities.

   Ms. Lising noted that the response from all sites was extremely positive. Field-site staff observed that there is great interest in culturally relevant materials, and community health workers reported using the planners as a teaching tool. Field-site staff also indicated that recipients shared information about the planners with their families and personal networks.

   User surveys were included with approximately one-third of the planners. A total of 62 surveys were received. Of the survey respondents, 66% reported using the planner in some way. Managing appointments was the most frequently mentioned use of the planner, followed by reading the information presented and using the reminder stickers to track doctor visits, prescription refills, physical activity, etc. Three percent reported using the planner as a calendar and nothing more. To help gain an understanding of new behaviors people may have after reading through the planner, survey responders were asked to list different actions that they took as a result of using the planner. Approximately 40% self-reported that they had taken a different action. The most frequently reported action was to exercise more or to make dietary changes, followed by managing appointments. Almost 75% of respondents indicated that they planned to make changes in the future. The most frequently reported planned actions were to be healthier in general, to exercise, and to make dietary changes. There were few differences in survey responses across the different sites and populations.

   Data were collected on Web site visits and calls to the NIAMS Information Clearinghouse (each of the four distribution sites were provided with unique URLs to accurately track Web site visits). The majority of inquiries came through the Web site. The 147 visitors to the Web site represent about 2.2% of those who received the planners. Although this number may appear to be low, it is well above the statistical norm (in general, when people are referred to an online source from a print source, the visit rate is roughly 1%). Direct distribution of the planners by community outreach workers, who are a trusted source of health information, may have helped reduce the number of Web visits. There was an average of 3 pages viewed per visit, suggesting a level of engagement with the target audience. Over the course of the 3-month study period, there were visitors from 7 states where the dissemination did not take place, indicating that people who received the planners spread information about the Web site to people in their personal networks. There were also 2 calls to the NIAMS Information Clearinghouse. The ratio is similar to patterns seen for calls to the Clearinghouse related to other NIAMS activities.

   Ms. Lising reviewed lessons learned from the pilot study, noting that multicultural audiences were: (1) appreciative and more interested in information targeted to their specific group, (2) engaged with information received via the planners, (3) attracted to information received from known and trusted sources like community health workers and local organizations, and (4) introduced to the NIH and NIAMS through the planners’ distribution.

   Moving forward to next year’s planned national distribution, modifications are being made to the 2 existing health planners based on lessons learned through the pilot study. Two additional health planners are being developed (for African Americans and Asian Americans/Pacific Islanders). These new planners will include a page listing Federal partners and their resources. A limited number of each planner will be printed—90 organizations have expressed an interest in disseminating almost 50,000 health planners to their communities. In addition to the planners, an electronic toolkit will be developed and made available online. The toolkit will include outreach strategies and tools, templates for the 4 multicultural health planners that can be customized with organization contact information, and an image gallery of multicultural photographs.

   Ms. Lising acknowledged NIAMS’ partners in this effort (including the Indian Health Service, Office of Minority Health, pilot study field sites, leadership and multicultural work groups, and the NIAMS Coalition). She noted that Council members Mr. Bradley R. Stephenson, an Attorney at Law and member of the Muscular Dystrophy Association’s Task Force on Public Awareness, Dr. Ted Mala (Director of the South Central Foundation’s Traditional Healing Clinic), and Ms. Jean Pickford (Executive Director of the Foundation for Ichthyosis and Related Skin Types) provided valuable insight to the project, as did Dr. Marjorie Mau of the University of Hawaii. Ms. Lising concluded the presentation by referring Council members to the Web site for additional information.

   Discussion

   Dr. Katz noted that this activity was recognized by HHS Secretary Kathleen Sebelius through a phone call made directly to Ms. Lising. Secretary Sebelius indicated that she very much appreciated this project.

   Dr. Mala noted that he and his colleagues are very excited about this outreach project. Very few other ICs have reached out to underserved and minority populations to this extent. He noted that the National Library of Medicine has been strong in the area of outreach to these populations as well. He characterized the NIAMS as serving as a leader at the NIH in terms of outreach to these populations and suggested that this outreach has heightened the Institute’s visibility to underserved and minority populations.

8. EVALUATION OF NIAMS CENTERS PROGRAMS

   Dr. Carter explained that there are important avenues of investigation in NIAMS mission areas that require integrated groups of investigators or infrastructure that would be difficult to form through research project grants (RPGs). The goal of the NIAMS Centers Program evaluation is to inform the design of the funding strategies to facilitate that type of research. The existing Centers include: (1) Research Core Centers (P30), (2) Centers of Research Translation (P50) and (3) Multidisciplinary Clinical Research Centers (P60). While the Centers have specifically different objectives, all are intended to promote or facilitate the interactions among a group of investigators.

   The alternative to the various Centers is to directly support research projects (e.g., through RPGs), or to use fee-for-service as a more efficient means of paying for the services of cores. The NIAMS recognizes that Centers provide other valuable functions, such as maintaining infrastructure that can support groups of investigators, leveraging local resources, providing space for technical development, supporting an institution’s education and outreach efforts, and recruiting new investigators or investigators from other fields into NIAMS research.

   The following questions will be used to facilitate the evaluation of the Centers Program:

   • Do the current Centers that promote translational and clinical research meet the goals for which they were intended? Do the current Centers that provide core support for research meet the goals for which they were intended?
   • What are the optimal Centers program structures to facilitate and support research in arthritis, musculoskeletal, and skin diseases that benefit from organizing synergistic, integrated groups of investigators?
   • How can NIAMS-supported Centers complement and integrate with CTSAs?
   • Should a portion of NIAMS funding for Centers be focused on the initiation of research groups for a limited period of time, after which the groups would be expected to sustain themselves through other mechanisms?

   Dr. Carter emphasized that the evaluation of the NIAMS Centers Program is not focusing on the performance of any one Center, but rather on how these programs as a whole function and what can be learned from them. Some trends and interesting new directions suggest that there is an evolution occurring naturally in the community. He expressed hope that the evaluation process will be seen as exciting and not threatening by the community. The objective is to determine what is needed in the field to make progress.

   This evaluation should not be seen as a judgment on the relative funding of Centers compared with RPGs; rather, it is about how Centers are designed. The NIAMS continues to believe that most research projects are best funded through R01s; research program project grants (P01s) are not on the table with regard to the Centers Program evaluation. Centers are geared to a different vision that involves research and infrastructure that requires integrated groups of investigators that cannot be done through RPGs.

   Discussion

   In the discussion which followed, many Council members voiced their opinions about the pros and cons of Centers programs and put them into the context of the current fiscal climate and the state of the science in their respective fields. Some of the points that were brought out are:

   • Institute review of all of its programs, including the Centers Program, is important to determine if the NIAMS is optimally supporting research. These evaluations should not be viewed as threatening by those outside of the Institute. It would be helpful to have a comparison with other ICs’ Centers programs to look at outputs and outcomes to determine the impact of the presence or absence of a Center.
   • It is important to make sure all Institute-supported programs are accountable for meeting their goals. There currently is not a fertile environment for young or new investigators and some traditional academic medical center departments are struggling now because they have not had a strong centers-based approach.
   • It could be important to look at how the Centers program affects academic medical centers and their strategic planning processes. There is a transition among academic medical centers to a more centers-based approach. Getting groups of investigators together has been part of the strategic planning at many of these institutions. A Council member also noted that at his institution, the NIAMS Centers Program has successfully fostered a sense of collaboration and a mentoring culture around research activities that may not have occurred otherwise.
   • Evaluation of the Centers Program is important. The process of investigating how these Centers succeed could be useful for educating groups that could form research networks in the future.
   • One of the first things Dr. Katz did when he assumed the role of NIAMS Director was to thoroughly evaluate the Centers Program. This was an important activity in terms of setting up the agenda for the Institute moving forward. The current evaluation is particularly important given the scrutiny under which money is spent in a time of shrinking budgets. When Centers are successful, they are doing things that the R01 mechanism alone does not allow for. Having grants that bring experts together, particularly those who would not necessarily collaborate otherwise, and having grants that explicitly provide infrastructure is tremendously important. However, supporting these programs decreases the funds available for other areas.
   • Examination of new Center grants versus the continued competitive renewal of existing Center grants might be a good approach; it may be that new Center grants might be further along in terms of forming new collaborations. If as a whole the NIAMS Centers Program does not show much progress in this area compared with other ICs that do not have Centers programs, the NIAMS will need to consider whether the money for the Centers Program is being spent in a way that justifies pulling these funds away from R01s. It was noted that shared infrastructure saves money and resources.

   Dr. Serrate-Sztein pointed to earlier comments from Council members suggesting that contributions of the Centers Program can be found in increased collaborations, mentoring, and overall culture changes. These aspects are not well captured in summary statements. She asked about other indicators or outputs that could be used to help evaluate the NIAMS Centers Program. Council members suggested looking at new collaborative publications and whether pilot projects lead to junior investigators obtaining funding for additional research projects (i.e., the ability of institutions to retain young investigators).

9. FY 2014 NIAMS EXTRAMURAL PROGRAM INITIATIVES

   Before concluding the open session of the Council meeting, Dr. Katz invited Council members to review the descriptions of the following proposed FY 2014 NIAMS extramural program initiatives:

   • Initiative To Encourage Small Businesses To Research and Develop Products for Diagnosis, Treatment, and Prevention of Rare Diseases Within the NIAMS Mission
   • Candidate Biomarker Platforms for Inflammatory Diseases of Interest to NIAMS
   • Immortalized Osteocyte Cell Lines for Bone Research
   • Support for Tracking Healthy People 2020 Goals in Arthritis
   • Differentiation of Induced Pluripotent Stem Cells (iPSCs) for In Vitro Models of Disease and Cell-Based Therapies
   • Advancing Basic Research on Tendons and Ligaments
   • Anabolic Therapies To Regenerate Bone and Joint for Osteoporosis and Osteoarthritis
   • Interactions Between Bone and Skeletal Muscle
   • Research Grants Using the Resources from the Osteoarthritis Initiative (OAI)
   • Reissue of Skin Diseases Research Core Centers (P30)
   • Reissue of Core Centers for Musculoskeletal Biology and Medicine (P30)
   • Reissue of Ancillary Studies to Large Ongoing Clinical Projects (R01) and (R21)
   • Reissue of Pilot and Feasibility Clinical Research Grants in Arthritis and Musculoskeletal and Skin Diseases (R21)

10. BOARD OF SCIENTIFIC COUNSELORS REPORT

    This report was given during closed session.

11. CONSIDERATION OF APPLICATIONS

    The Council reviewed a total of 1539 applications in closed session requesting $1,755,119,547 in total costs and recommended 1539 for $1,755,119,547 in total costs. Of these, 114 applications were considered and approved by early concurrence.

12. EMERGING TOPICS ON IMMUNE-MEDIATED SKIN DISEASES

    This portion of the meeting occurred during closed session.

13. ADJOURNMENT

    The 78th National Arthritis and Musculoskeletal and Skin Diseases Advisory Council Meeting was adjourned at 2:40 p.m. Proceedings of the public portion of this meeting are recorded in this summary.

    I hereby certify that, to the best of my knowledge, the foregoing summary and attachments are accurate and complete.