- I. CALL TO ORDER
- II. NOTICE OF PROPOSED RULE MAKING
- III. REPORT OF THE ACTING DIRECTOR
- IV. OFFICE OF GLOBAL HEALTH STRATEGIC PLAN
- V. OVERVIEW OF NHLBI-SPONSORED CLINICAL PRACTICE GUIDELINES
- VI. INTEGRATED GUIDELINES FOR CARDIOVASCULAR HEALTH AND RISK REDUCTION IN CHILDREN AND ADOLESCENTS
- VII. DELEGATED AUTHORITIES FROM THE NHLBAC
- VIII. REVIEW OF APPLICATIONS
The 245th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Thursday, February 15, 2012, in Conference Room 10, C Wing, Building 31, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:30 a.m. to 11:45 a.m. The meeting was closed to the public from 12:35 p.m. to adjournment at 2:15 p.m. Dr. Susan B. Shurin, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.
COUNCIL MEMBERS PRESENT:
Ms. Coletta C. Barrett
Dr. Ivor J. Benjamin
Dr. Ingrid B. Borecki
Dr. Barry S. Coller
Dr. Pamela S. Douglas
Dr. Jack A. Elias
Dr. Gary H. Gibbons
Ms. Beverly W. Hogan
Dr. Lanetta B. Jordan
Dr. Ron G. King
Dr. Barbara A. Konkle
Dr. Naomi L.C. Luban
Dr. Polly E. Parsons
Dr. Leslee J. Shaw
Dr. Gilbert C. White
COUNCIL MEMBERS ABSENT:
Mr. Jonathan R. Alger
Dr. Robert L. Jesse (Ex Officio)
Dr. Talmadge E. King, Jr.
Dr. Michael S. Parmacek
Dr. Arun Chockalingam
Director, NHLBI Office of Global Health
Dr. Stephen Daniels
Chairman, Department of Pediatrics, University of Colorado School of Medicine
Dr. Kathy Hudson
Deputy Director for Science, Outreach, and Policy, NIH
Acting Deputy Director, NIH National Center for Advancing Translational Sciences
Dr. Denise Simons-Morton
Director, Division for the Application of Research Discoveries, NHLBI
MEMBERS OF THE PUBLIC PRESENT:
Dr. Diane Catellier, RTI International
Ms. Claudia Louis, American Heart Association
Ms. Jackie Nelson, Cure CMD
Dr. Anne Rutkowski, Cure CMD
Mr. Ted Shoneck, Tunnell Consulting
Ms. Susan Sepelak, Social & Scientific Systems, Inc.
Ms. Alison Thompson, Lewis-Burke Associates
Mr. Robert Yates, Social & Scientific Systems, Inc.
NIH EMPLOYEES PRESENT:
Mr. Brian Thompson,
Office of the Director, NIH
CSR EMPLOYEES PRESENT:
Dr. George Barnas
Dr. Lawrence Boerboom
Dr. Cheryl Corsaro
Dr. Luis Espinoza
Dr. Katherine Malinda
Dr. Bukhtiar Shah
NHLBI EMPLOYEES PRESENT:
Numerous NHLBI staff members were in attendance or were able to view the meeting via closed circuit broadcast.
Dr. Susan B. Shurin, Acting Director of the National Heart, Lung, and Blood Institute (NHLBI), welcomed members to the 245th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC).
Dr. Shurin welcomed three new Council members:
- Dr. Pamela Douglas, Ursula Geller Professor of Research in Cardiovascular Diseases, Duke University School of Medicine
- Dr. Ron King, Chief Science and Business Officer and Co-Founder, Bio-Accel
- Dr. Barbara Konkle, Director, Translational Research, Puget Sound Blood Center
Dr. Shurin updated the Council on NHLBI leadership appointments:
- Mr. Ariel Herman is the new Deputy Executive Officer for the Institute.
- Dr. Jamie Siegel is the new Chief of the Hemostasis and Thrombosis Branch in the Division of Blood Diseases and Resources.
- The search for the new Director of the NHLBI is ongoing. Dr. Shurin announced that beginning next year, the February meeting will join September Council as a virtual meeting.
Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the NIH, and Acting Deputy Director of the National Center for Advancing Translational Sciences updated the Council on revising the Common Rule on human subjects protections. The Common Rule was adopted by many federal agencies in 1991, but since then, the human subjects research landscape has changed, and human subjects regulations have not kept up with the changes.
The regulations are being revised, and an Advanced Notice of Proposed Rulemaking (ANPRM) was issued in July 2011, that emphasized two overarching goals:
- To enhance protection of research subjects
- To improve the efficiency of the review process
To achieve the goals, the ANPRM proposed seven regulatory reforms. Approximately 1,100 public comments were received and are being analyzed. The next steps in revising the Common Rule are: publications of a Notice of Proposed Rulemaking (NPRM), analysis of public comments on the NPRM, and promulgation of a Final Rule.
As a related issue, Dr. Hudson noted that the NIH will devote $1 million in bioethics research funding to the development of an evolving, evidence-based approach to ensuring the effectiveness of human subjects protections.
Dr. Shurin updated the Council on NIH leadership appointments and searches:
- Dr. Thomas R. Insel, Director, National Institute of Mental Health, has been appointed Acting Director, National Center for Advancing Translational Sciences (NCATS). A search for the NCATS Director is ongoing.
- Dr. M. Roy Wilson has been appointed Deputy Director, Strategic Scientific Planning and Program Coordination, National Institute on Minority Health and Health Disparities.
Dr. Shurin discussed the President's 2013 Budget. The proposed NHLBI budget remains relatively flat overall, with a total increase of 0.02%, or approximately $700 million. However, the Research Project Grant (RPG) line would decrease slightly, due in part to a mandated increase in SBIR/STTR funding (from 2.95% in FY 2012 to 3.05% in FY 2013--part of the SBIR/STTR reauthorization). Despite the RPG funding decrease, a slight increase in numbers of competing RPGs is expected because of variation in grant cycles. The Institute will continue to pay careful attention to where the dollars are going, because although biomedical research costs are increasing, the budget is not. The proposed FY 2013 funding is approximately equivalent to the FY 2000 funding in constant dollars.
The FY 2012 payline remains at the 10th percentile, with Early Stage Investigators receiving an advantage up to the 20th percentile. The Institute is very concerned about the low priority score cutoff, 19, for career development awards, whereas last year grants were funded up to a score of 30. As the fiscal year progresses and more money becomes available, it will be allocated to the RPG and training lines.
The NHLBI must continue to pay attention to protecting its core business, which is research and training. It will do so by:
- Managing resources as carefully as possible.
- Providing the resources needed to do the work.
- Maintaining support for training and new investigators.
- Partnering wherever possible.
- Maximizing return on investment.
The Institute believes that fully-funded strategic investments are more likely to thrive than investments receiving across-the-board cuts. The Institute will also continue to support three main scientific priorities: discovery research (including genomics, systems biology, and modeling), regenerative medicine, and translational research.
Dr. Shurin provided an update on the National Center for Advancing Translational Sciences (NCATS). Much effort is focused on the structuring of the new Center. NCATS will facilitate (not duplicate) other translational research activities supported by the NIH, complement efforts of the private sector, and reinforce the NIH's commitment to basic research. The NHLBI will work with NCATS when appropriate.
Dr. Shurin updated the Council on the Global Alliance for Chronic Disease, of which she is now the chair.
Dr. Shurin mentioned that the "Rock Talk" blog from Dr. Sally Rockey, the NIH Deputy Director for Extramural Research, contains valuable information and comments on a variety of issues of concern to the extramural community. She also reported on the primary issues received in response to the Biomedical Workforce Request for Information (RFI), and noted that opportunities to comment may be available soon.
Dr. Arun Chockalingam, Director of the NHLBI Office of Global Health (OGH), described the Office and its strategic plan. The Office, established in April 2010, primarily serves in an integration role, including:
- Facilitating and coordinating global health efforts across the NHLBI.
- Coordinating with other NIH Institutes and Centers, the Department of Health and Human Services, and the U.S. Department of State.
- Linking with other national and international organizations.
- Managing programs in partnership with NHLBI program divisions.
The OGH Strategic Plan consists of five strategies that align with the NHLBI strategic plan:
- Develop and facilitate access to scientific research resources.
- Develop new technologies, tools, and resources.
- Establish and expand collaborative resources for clinical research.
- Develop and retain human capital.
- Bridge the gap between research and practice through knowledge networks
Dr. Denise Simons-Morton, Director of the NHLBI Division for the Application of Research Discoveries, presented background and the current approach on development of NHLBI-sponsored clinical practice guidelines. NHLBI-sponsored guidelines date to the 1970s, when hypertension guidelines were first reported. The guidelines are published by the Government Printing Office and in journals. NHLBI-sponsored national education programs were integrated with clinical guidelines, and the programs released the guidelines.
The Institute realized that the process of guideline generation needed updating, and sought recommendations on how to do so beginning in June 2005. Additionally, the Institute of Medicine released new recommendations for standards for clinical guidelines in March 2011. The NHLBI is working to follow all of them. The Institute has adopted a new systematic review and guideline development process, and in addition to the National Asthma Education and Prevention Program, it has created two new programs: the now integrated National Program to Reduce Cardiovascular Risk, and the National Blood Disorders Program. Review and clearance of guideline reports now includes NHLBAC review. The Council was informed that it will review the Integrated Cardiovascular Risk Reduction in Children and Adolescents at the current meeting and will review the Sickle Cell Disease draft guidelines in June and the Cardiovascular Risk Reduction in Adults draft guidelines in October.
Dr. Stephen Daniels, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado; and Chair, Expert Panel on Integrated Guidelines for CV Risk Reduction in Children and Adolescents, discussed the guidelines that were released in December 2011. At the NHLBI National Thought Leaders meeting in 2005, attendees characterized useful guidelines as:
- Scientifically accurate
- Timely and up-to-date
- Created by an open process
- Outcome evaluated
Dr. Daniels mentioned that guidelines should not be considered a final product, but rather a continuously revised one that evolves along with their evidence base. The guidelines panel identified 14 critical questions to address, including a number of risk factors. The recommendations were based on grades by experts of both studies and the body of evidence. A full panel review of recommendations followed a pre-defined consensus process. The guidelines development process resulted in the first evidence-based guidelines with comprehensive systematic review of the literature, and the first integrated pediatric cardiovascular risk reduction guidelines that include all known risk factors, as well as diet and physical activity behaviors.
The guidelines were published in Pediatrics in December 2011. The report can also be found at the website for Pediatric Cardiovascular Risk Reduction Guidelines.
Delegated authorities allow NHLBI staff to perform specific functions without Council involvement, thereby adding flexibility and decreasing the burden on the Council. Dr. Stephen C. Mockrin, Director, Division of Extramural Research Activities, presented the delegated authorities to the Council. The Council was asked to continue the current policy of Delegated Authorities for another year and it agreed.
This 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).
The 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 2,046 applications requesting $2,839,347,174 in total direct costs. The Council recommended 2,046 applications with total direct costs of $2,839,347,174.
The meeting was adjourned at 2:15 p.m. on February 15, 2012.