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DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCILMEETING SUMMARY OF THE NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCILJune 13, 2012The 246th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Wednesday, June 13, 2012, in Conference Room 10, C Wing, Building 31, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:05 a.m. until 12:40 p.m. The meeting was closed to the public from 1:15 p.m. until adjournment at 3:00 p.m. Dr. Susan B. Shurin, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair. COUNCIL MEMBERS PRESENT:Mr. Jonathan R. Alger COUNCIL MEMBERS ABSENT:Ms. Beverly W. Hogan
VIDEO CONFERENCE:Dr. Ron G. King
TELECONFERENCE:Dr. Polly E. Parsons (via telephone) INVITED GUESTS:Dr. George Buchanan
MEMBERS OF THE PUBLIC PRESENT:Ms. Janet Choy
CSR EMPLOYEES PRESENT:Dr. Julia Krushkal Adkins
NHLBI EMPLOYEES PRESENT:Numerous NHLBI staff members were in attendance or were able to view the meeting via closed circuit broad cast. I. CALL TO ORDER AND REPORT OF THE ACTING DIRECTOR, NHLBIDr. Susan B. Shurin, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 246th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). Dr. Shurin updated the Council on NHLBI and NIH leadership appointments:
Dr. Shurin updated the Council on member news:
Dr. Shurin discussed the new policy at NIH for Special Council Review for well funded investigators. Accordingly, the NHLBI will provide information to Council on investigators with 1.5 million or more in annual direct costs in NIH research support. This policy will be a requirement of the FY 2013 budget. The FY 2012 funding payline will remain at the 10th percentile for established investigator R01s and R21s. Pending availability of funds, the Institute intends to make use of the select pay option to fund some additional grants. Dr. Shurin discussed the SBIR/STTR programs. Their reauthorization mandated increasing the set-aside percentages over the course of the next 6 years. Currently, a Scientific Management Review Board (SMRB) subcommittee is analyzing the SBIR/STTR program at the NIH. Its charge is to recommend strategies for how the NIH can optimize its use of the SBIR/STTR programs in keeping with the NIH mission. The NHLBI convenes a Topic Review Advisory Committee with a charge to assist NHLBI staff in identifying, assessing, and developing SBIR/STTR ideas for commercial development. Dr. Shurin updated the Council on two other SMRB recommendations--(1) translational medicine and therapeutics, and (2) substance use, abuse, and addiction research at NIH.
II. BIOMEDICAL RESEARCH: HOW DO WE KNOW WE ARE ON TRACK?Dr. Michael Lauer, Director, Division of Cardiovascular Sciences, NHLBI presented an update of ongoing activities in the Institute's program divisions on assessing impact and productivity of research investments. He also discussed developing Results Based Accountability as a part of the NHLBI culture. III. NHLBI AIDS PROGRAM OVERVIEWDr. Monica Shah, NHLBI AIDS Coordinator, discussed the NHLBI AIDS program. It has an independent budget ($68 million in FY 2012), a separate payline that is approximately 10 percentile points higher than the regular payline, specific receipt dates, and specific review. Success rates of AIDS applications are much higher than those of non-AIDS applications--42% versus 18% in FY 2011. The NHLBI hopes to encourage more submissions of AIDS projects and hopes to understand the barriers to submission. IV. REPORT FROM THE PUBLIC INTEREST ORGANIZATION (PIO) MEETINGDr. Lanetta Jordan, Assistant Professor, Department of Epidemiology and Public Health, University of Miami, Miller School of Medicine, and Council member, reported on the 13th annual NHLBI PIO meeting held June 11-12, 2012. Four Council members attended the meeting in addition to representatives from PIOs and professional societies, and NHLBI staff. V. BACKGROUND AND SUMMARY OF THE EXPERT PANEL REPORT ON MANAGMENT OF SICKLE CELL DISEASEDr. Joylene John-Sowah, Medical Officer, NHLBI, and Dr. George Buchanan, Professor of Pediatrics, University of Texas Southwestern Medical Center, and Co-Chair, Sickle Cell Guidelines Expert Panel, presented background and a summary of the Panel's report on the management of sickle cell disease. Dr. John-Sowah discussed the reasons why sickle cell disease management guidelines are needed:
At the request of the NHLBAC, the NHLBI convened a multi-disciplinary panel to develop evidence-based sickle cell disease guidelines for children and adults, targeting primary care providers, to enhance sickle cell disease management. Dr. John-Sowah outlined the guideline development steps and the review and approval process. Release of the guidelines is expected in December 2012. Dr. Buchanan discussed the goals of the panel--to generate implementable evidence-based recommendations on managing sickle cell disease in clinical practice and to identify gaps in knowledge for additional research. The guidelines' four major topic areas are:
VI. REPORT OF THE COUNCIL WORKING GROUP ON CLINICAL PRACTICE GUIDELINESDr. Pamela Douglas, Ursula Geller Professor or Research in Cardiovascular Diseases and Director, Cardiovascular Imaging Program, Duke University School of Medicine, and Council member, presented a report of the Council Working Group on Clinical Practice Guidelines. The working group was asked whether the NHLBI should create guidelines. Dr. Douglas noted that part of the NHLBI strategic plan is, "To promote the development and implementation of evidence-based guidelines." She offered a snapshot of the cost of guideline creation and dissemination and presented pros and cons for creation of guidelines by the NHLBI. Pros:
Cons :
The working group recommended that the NHLBI:
VII. RECOGNITION OF DR. SHURINDr. Shurin was recognized for her outstanding service as Acting Director since November 2009, by Dr. Lawrence A. Tabak, Principal Deputy Director, NIH, Incoming Director Dr. Gary H. Gibbons, and the entire Council. Dr. Carl A. Roth was also applauded for his leadership efforts as Acting Deputy Director for the past two-and-a-half years. VIII. REPORT OF THE BOARD OF EXTERNAL EXPERTS AND INITIATIVE CONCEPTSNHLBI staff presented 7 new initiatives and 5 renewals, all of which had been reviewed in May by the Board of External Experts (BEE). Initiative development at the NHLBI is a two-cycle process. First, staff within each extramural division develop ideas and potential initiatives, which they present to the trans-NHLBI Idea Forum. Sufficiently developed initiatives are subsequently considered by the BEE, which ranks each and provides accompanying advice to the Council. The Council was mostly supportive of the initiatives presented, but made a number of specific recommendations for consideration prior to their release. The Acting Director, NHLBI, will consider the recommendations of the BEE and the Council and other budgetary and programmatic issues in determining which of the proposed initiatives, if any, to implement. Strategic Plan Goal I: To improve understanding of the molecular and physiological basis of health and disease, and to use that understanding to develop improved approaches to disease diagnosis, treatment, and prevention.
Strategic Plan Goal II: To improve understanding of the clinical mechanisms of disease and thereby enable better prevention, diagnosis, and treatment.
IX. CLOSED PORTIONThis portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2). REVIEW OF APPLICATIONSThe session included a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect. The Council considered and recommended 1,284 applications requesting $1,975,121,550 in total direct costs. ADJOURNMENTThe meeting was adjourned at 3:00 p.m. Last Updated September 2012 | ||||||||||||||||||||||||||||