NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING MINUTES
February 1, 2001

I.  CALL TO ORDER AND OPENING REMARKS– Dr. Claude Lenfant

Dr. Claude Lenfant opened the meeting and welcomed the Council to the 201st meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC). He noted that a booklet had been produced to celebrate the prior meeting, the 200th meeting of the NHLBAC. The booklet depicts some of the history and accomplishments of the Council.

February was noted as American Heart Month with the theme "Be Prepared for Cardiac Emergencies."

New Council Members

Dr. Lenfant reintroduced two new Council members, Dr. Pearl Toy from San Francisco, and Dr. Robert Roberts from Houston who were present at the last Council meeting and introduced the other new members.

Ms. Sue Byrnes, the founding and the current Executive Director of the Lymphangioleiomyomatosis (LAM) Foundation. The Foundation was established in 1995 through the efforts and energy of Ms. Byrnes. LAM is a very rare lung disorder that almost exclusively affects women. There currently is no known cause, cure, or treatment of that condition.

Dr. Melissa Austin is Professor of Epidemiology at the School of Public Health and Community Medicine at the University of Washington. She is involved in many aspects of genetics related to public health. Dr. Austin has been active in many NHLBI programs including the cooperative program with Japan. Her major interest is in the genetic epidemiology of cardiovascular diseases.

Dr. Jeffrey Drazen is Editor-in-Chief of the New England Journal of Medicine, and is also Parker B. Francis Professor of Medicine at the Harvard Medical School and the Sue Perlmutter Laboratory at the Brigham Women's Hospital. Dr. Drazen has been a grantee of the Institute for many years and has served on several Institute advisory committees. He returned to the U.S. only the previous day from receiving the Doctor Honorus degree from the University of Friuli in Italy, one of the oldest universities in the Western world.

Guests

Members of the Public Interest Organizations group, which had met the previous day, had been invited to attend the open session of the Council meeting. Dr. Lenfant welcomed those present.

Personnel changes

NIH-wide

Dr. Lenfant noted that with the change of administration, Secretary of the Department of Health and Human Services Donna Shalala had been replaced by Secretary Tommy G. Thompson, the former Governor of Wisconsin. Secretary Thompson has met with Dr. Ruth Kirschstein, the current Acting Director of the NIH. There is no news concerning the vacant Director of NIH position. When Dr. Harold Varmus was appointed Director of the NIH by the preceding administration, his appointment was not confirmed until the fall of the year that the new administration was installed. This suggests that there may not be a permanent Director for several months.

Dr. John Ruffin has accepted the position of the Director of the Center on Minority Health and Health Disparities. He was formerly the NIH Associate Director for Research and Minority Health, a post that he had held since 1990. One of the main features of this new Center is that it has the authority to issue grant awards.

Within NHLBI

Dr. Carol Letendre, who was Deputy Director of the Division of Blood Diseases and Resources, retired after many years of distinguished service to the Institute.

Dr. Carl Hunt has been appointed as the Director of the National Center for Sleep Disorders Research. Dr. Hunt was Professor and Chair at the Department of Pediatrics at the Medical College of Ohio in Toledo. Dr. Hunt has worked in the area of Sudden Infant Death Syndrome and has been honored by a number of organizations for his work in that area. Dr. Lenfant acknowledged the excellent work of Dr. Michael Twery as the Acting Director of the Center.

Other announcements

Dr. Lenfant noted the inclusion of the language for the Cardiac Arrest Survival Act in the Council book. One recommendation deals with the placement of automated external defibrillators in federal buildings, community facilities, and similar places. He then distributed an article that appeared in The Washington Post at the time of the Presidential Inauguration. At one of the Inauguration balls, a guest had a cardiac arrest, and that person was resuscitated with a cardiac defibrillator that was available on site. The cardiac defibrillator was available as part of a clinical trial sponsored by the NHLBI.

II.  REVIEW OF CONFIDENTIALITY & CONFLICT OF INTEREST – Dr. Claude Lenfant

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Dr. Lenfant reminded the Council that according to Public Law 92-463, the Federal Advisory Committee Act, the meeting of the NHLBAC would be open to the public except during consideration of grant applications. A notice of this meeting was published in the Federal Register indicating that it would start at 8:30 a.m. and remain open until approximately 2:00 p.m. He also reminded the Council members that they are Special Government Employees and are subject to departmental conduct regulations.

III.  REPORT OF THE DIRECTOR - Dr. Claude Lenfant

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Dr. Lenfant presented a series of slides showing the current NHLBI budget and contrasting it with prior year budgets. The slides showed various breakdowns into budget categories. The FY01 budget provides an increase of $275 million or 13.6 percent. That total includes, however, a recision of $875,000 and various NIH taps. He pointed out that although the increase for the total budget is 13.6 percent, the Institute plans to increase spending for extramural activities by 13.8 percent. When applied to a budget of $2 billion, 0.2 percent is a large dollar increase.

It was noted that the Institute carries a large base of noncompeting awards. That is money owed from previously-awarded grants. As a consequence, the amount for new and competing grants is approximately the same as last year, an increase of $2 million. Because of the number of awards made last year the noncompeting base increased from 2,566 to 2,810.

This year, the Institute proposes to fund 983 new grants. This is 20 fewer than last year due to the taps on the Institute, the large commitment base, and the increase in the average size of grants.

All of the budget increases for extramural research have occurred because of the commitment of the Congress to double the budget of NIH in five years. This process is now in its third year. The budget increases mean an increase in the commitment base. The new administration has at the very outset reaffirmed the commitment to doubling the budget of NIH, but the final outcome is difficult to predict at this time.

The dates for Congressional testimony by the NIH and the NHLBI have not yet been set. This is usual for a new administration but there are also changes in key legislative committees.

Mr. John Porter has left the Congress and his position as Chair of the Subcommittee on Appropriations in the House has not yet been filled. It appears that Senator Arlen Specter, will remain as Chair on the Senate Subcommittee on Appropriations. He has been a strong supporter of the doubling of the budget of NIH.

There were no comments from the Council concerning the Report of the Director.

  IV.  GENERAL RECOMMENDATIONS OF THE NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL – Mr. Robert Carlsen

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Mr. Robert Carlsen, Director, Division of Extramural Affairs presented the General Recommendations to the Council. The proposal was to reaffirm the current recommendations and to add an exclusion from required Council discussion of training grant applications exceeding $500,000. The rationale for the training-grant exclusion was that these were different from the usual research grants, and that the $500,000 threshold would mean that some, but not all training grants would be presented to Council.

Council expressed concerns about the exclusion of training grants exceeding $500,000 from the usual Council discussion. A variety of issues were raised including limited information in summary statements about current position of trainees. These concerns centered on whether the review group was appropriately considering all of the information potentially available, such as individuals who have gone on to careers in preventive medicine and have obtained grants.

The importance of the training function of the Institute was emphasized, and a concern expressed that not looking explicitly at large training grants would distance the Council from looking at the Institute training function. Council members who had served on the training committee noted that substantial data concerning training programs and outcomes are available to reviewers and that reviewers consider them seriously. It is important, especially for long-standing training grants, to judge outcomes.

Other Council members noted that the figure of $500,000 is arbitrary, and that the real issue is examining applications on the margin of fundability or those which are troublesome. Neither very good nor very poor applications normally need substantial consideration. It was reiterated that no one was suggesting the Council should repeat what a study section has done.

The Institute noted that there is a review group which reviews solely T32 grants. While it is not a standing review committee, there is continuity with some members serving on a repeated basis. The committee is provided information concerning the productivity of the training grant, including whether trainees become researchers or go into private practice. The possibility of identifying potentially problematic grants is reasonable, and would not cause any difficulty within the review group. One would need to define what is a problematic grant. It was also noted that any member who would like any information regarding a grant could have complete access to it. Thus if a Council member would identify a problem from reading the review, they could request further information.

Other Council members pointed out that the Council should help devise and improve criteria for these grants, but they should not normally be put themselves in the position of second guessing the initial peer review. What is important is that the relevant criteria are being uniformly applied to all applications being reviewed.

Dr. Lenfant summarized the discussion of the Council by noting that the Institute will develop a working paper on its view of the critical features of training grants. These features will be sent to the Council for discussion at the next Council meeting.

Council then voted to accept the Delegated Authorities as currently in force, but to table the exception for the T32 grants.

V.  LOAN REPAYMENT – Dr. Claude Lenfant

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Before adjournment, the last Congress passed legislation which established new loan repayment programs.

One program is for minorities, and is part of the legislation that establishes the Center on Minorities and Health Disparities. This Loan Repayment Program will be developed and administered by that Center.

A second loan repayment program is for individuals engaged in clinical research. The legislation does not specify whether the recipients must hold clinical degrees. Therefore, some Ph.D.s, veterinarians, pathologists, or similar researchers might be eligible for the program if what they do is consistent with the definition of clinical research. This program may be very large dependent on the criteria for eligibility, which are still to be developed.

The third loan repayment program is for pediatric research, but does not specify clinical pediatric research. It is assumed that the intent of the Congress is to include researchers who do either basic or clinical research related to pediatrics. This is the only one of the new programs where basic research is within the scope of the loan repayment.

NIH has established a committee to develop implementation guidelines. A report will be submitted to the Acting Director, NIH for review and approval of the guidelines. Then the guidelines will be sent to the Office of Management and Budget (OMB) for concurrence. Once OMB has developed the rules they will be published in the Federal Register for public comment. The process will probably take from six to eight months. This is an unfunded mandate. NIH intends to put an appropriation for the loan repayment program in the 2002 request. The size of the request will depend in part on the eligibility criteria. Furthermore, safeguards need to be put in place to ensure that people who receive loan repayment actually stay in research. This will be a complex program to administer.

Council felt that the loan repayment programs were an important part of the translational and clinical science area. It was suggested that a Council working group be formed to suggest approaches for implementation.

In a discussion of the pediatric loan repayment program, there was some concern that since this is the only program which will support basic research, a two-tiered system will develop between basic researchers in the pediatric area and in other areas of science. Other members of the Council pointed out that the genesis was the grave concern that, in the field of pediatrics, both the number of funded scientists and the number of subspecialists is very small. It was felt by the pediatric community that drastic action was necessary, which led to lobbying the Congress. The numbers of individuals likely to be affected are small and unlikely to cause a budget problem.

Dr. Lenfant noted that the goal is to have an implementation plan prepared at the time of the 2001/2002 final appropriation. As currently conceived, the law provides pay up to $35,000 a year, for a minimum of two years. In addition, because this would be viewed as compensation, the tax obligation would also be paid. It is not clear at the moment how the program will be implemented, but it is the intent of the Congress to activate this program in 2002. The major effort is to unite scientists behind whatever plan is launched, in order to have an appropriation for this program in place when the implementation must begin. With a price tag of $70 or $80 million a year, it is important that this mandate be funded.

VI.  ESTABLISHMENT OF A NEW INSTITUTE ON BIOMAGING AND BIOENGINEERING -Dr. Claude Lenfant

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The National Institute on Bioimaging and Bioengineering has now been established in law. At the moment, there are few details of what it will look like. Neither bioimaging nor bioengineering is new at NIH; in fact, the NHLBI was a pioneer in the area of bioengineering. The scope of the new Institute is the object of intense discussion by an NIH task force working with various professional societies. The product of this discussion will be the specific mission of the Institute. Currently, the thought seems to be that the new Institute would focus on developing technologies and approaches, but not work on the applications of these technologies and approaches. That task would remain with the categorical Institutes.

VII.  INCLUSION OF WOMEN AND MINORITIES IN CLINICAL STUDIES - Dr. Carl Roth

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The purpose of this discussion was to review with Council NHLBI inclusion of women and minorities in study populations, as mandated by the NIH Revitalization Act of 1993. This act requires that the Advisory Council of each Institute prepare biennial reports describing the manner in which the institute has complied with the mandate that women and minorities be included in all clinical studies supported by the NIH. The approach the NIH has taken is that a summary report will be prepared by the NIH, Office of Research on Women's Health. This report will include a statement that the National Heart, Lung, and Blood Advisory Council has reviewed the NHLBI procedures and results of the implementation of the NIH policy for inclusion of women and minorities in clinical studies and has determined that NHLBI is in compliance.

The NHLBI procedure has been in place since the inception of the policy. Each Health Scientist Administrator evaluates every project that includes patients for appropriate representation of women and minorities. Excluded from rigorous target data, but still tracked, are studies which have nine or fewer patients. The Health Scientist Administrator discusses any concerns with senior staff, then discusses those concerns and possible solutions with the applicant, and only if there is a satisfactory solution and appropriate inclusion does the project come to the Council. NHLBI is one of the few institutes of the NIH that mandates target data for all populations. Thus the Institute has established goals, so that they and the investigator are clear on expectations a priori.

Dr. Roth then presented a series of slides showing target and actual data for the latest reporting year, FY1999. He pointed out the distribution of recruitment by ethnic group as compared with U.S. population groups. There was a high degree of correspondence among the target figures, the population figures, and the actual enrollment figures. The essence of the report is that the Institute has shown a strong commitment to implement the law and to adhere to the requirement to include women and minorities as they are represented in the population and to address specific minority and women's health needs as they are appropriate.

Council commented that the report was thorough and appropriate. The question was raised about the requirement to include children in clinical studies and the potential tracking of their enrollment. Dr. Roth pointed out that the NIH has decided not to track the data, but there is a requirement in the peer review process that representation of children must be appropriate.

The difficulty of implementing the inclusion criteria for some studies was noted, particularly in the area of molecular genetics. Here homogeneous populations are more scientifically productive than mixed populations. It was noted that study sections have the latitude to conclude that any lack of inclusion may be scientifically justified. Council also noted the somewhat disparate requirements, citing the mandate to include children, but finding genetic testing of children is unacceptable.

Council voted that the NHLBI is in full compliance with the law.

VIII.  SKILLS DEVELOPMENT CORE IN LARGE GRANT PROGRAMS - Dr. Carl Roth

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The purpose of this proposal is to capitalize on the rich multidisciplinary research environments of our Program Project Grants (PPG) and Specialized Centers of Research (SCOR) to develop new investigators in research areas related to the mandate of the NHLBI. The concept came from a workshop on training and career development held by the Institute in November 1999. Since the Institute has these established resources, and much of the new research is multidisciplinary, and there is a need to train new people, these grants represent a resource which could be used to develop the scientific talent needed to do the research of the future. The concept was reviewed and endorsed by the Board of Extramural Advisors (BEA), and then discussed with a working group of the Council. The draft was revised following review by the Council working group.

The concept has several features. The first is that this core is optional. Someone can get a PPG or SCOR as they have in the past, and the absence of a skill development core would not be a disadvantage in review. Both PPGs and SCORs have their requested dollars capped. The funds for the skill development core would be $100,000 in addition to the current cap. The core provides salary support for the core leader or other senior investigators, as appropriate, and for the new investigators. The cores would be encouraged to address the new technologies and skills such as genomics, bioinformatics, and translational research. These areas are inherently multidisciplinary and are of increasing importance in research.

The intent is primarily to support new investigators; that is, graduate students, medical students, and postdoctoral research fellows. However, it is possible for established investigators to qualify, if the need for the development of new skills is strongly justified, such as in learning a new scientific technique or approach.

Inclusion of under-represented minorities and women will be strongly encouraged. The core leader must have strong educational mentoring skills and is required to devote at least five percent of his or her effort to the core. A detailed development plan would be required for each new investigator. The plan must address, in addition to required course work, other scientific or enrichment activities planned as part of the core. Finally, the new investigator must devote full-time effort during the skill development experience. There is an allowance, however, for the fact that those people who are clinically trained need time to maintain their clinical skills.

Council asked whether this core could be added as a supplement to an ongoing grant, or could only be part of a new award. As currently structured it would be reviewed at the time of a new or competing grant. Budget considerations suggest the program be implemented over time. 

Council suggested that there might be priorities in the implementation. The lowest priority might be new grants where the Center is newly established and people are focused on work rather than training. A better use of the money may be to supplement established programs. 

Council also suggested that Master’s level students might be eligible for this award, with specific reference to Public Health students. There is nothing to preclude such students from the award. It would simply need to be well justified. As currently written, a student is allowed to pursue a degree under this program.

A question was raised concerning the $100,000 figure, noting that this is not much money for the program as stated. It was noted that, fiscal constraints notwithstanding, the program might fail if inadequate resources are available, independent of the theoretical value of the program. The suggestion was to remove the cap and allow investigators to justify requests. It was clarified that these cores would be reviewed for merit by review groups.

There was substantial discussion on raising the cap, or letting it float. There was some consensus, but it was also noted that there are fiscal constraints for the Institute, and that nothing precludes institutions from supplementing these funds. 

Overall there was strong support for the program, but varied ideas as to how is should be implemented.

IX.  FY 2001 SALARY CAP- Mr. Edward Donohue

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Mr. Edward Donohue, Chief, Grants Operations Branch, provided some background information on the increased salary cap that may be charged to both grants and contracts with awards made with Fiscal Year 2001 funds. He also discussed how NIH and NHLBI will be implementing these new caps.

There is an increase in the salary cap for Fiscal Year 2001. This cap applies to those awards made with FY 2001 funds. Thus, if an award was made prior to October 1, the old salary of $143,100 would apply. This cap, which is legislatively mandated, applies to grants, to cooperative agreements, and to contracts, and it is uniform for all of the Institutes at NIH.

The previous cap of $143,100 applied to awards made with Fiscal Year 2000 money. The previous year the cap had been $125,900. The new cap was $157,000 from October 1, 2000 until December 31, 2000. Then, as of January 1, 2001 that level increased to $161,200. This cap applies to an individual's base salary, what an investigator receives based on his or her appointment. The base salary is exclusive of any earned income beyond that salary related to the appointment. In addition to the base salary, the Institute will also provide the related fringe benefits and the associated overhead. The base salary does not restrain the institution from providing a higher salary than the cap.

Additional funds for submitted application can only be provided if the application had been submitted in accordance with the application instructions, and reflected an institutional-based salary for an individual that exceeds the old cap of $143,100, or if in the budget justification there is a specific explanation that says that the individual's salary exceeds the old cap. Under either of those scenarios, the Institute will increase the grant up to the level of the new cap, or to the institutional-based salary if that is less. Because we have limited funds available, institutions are not allowed to now revise their budgets to indicate that the salary is higher than indicated in the application.

X.  UPDATE OF THE PUBLIC INTEREST ORGANIZATION MEETING- Dr. Claude Lenfant

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Dr. Lenfant asked Ms. Paula Polite to reflect on the meeting of the Public Interest Organizations (PIO) held the prior day. Ms. Polite noted that a common theme heard throughout the meeting was collaboration. She suggested that ways to address this be explored at the next PIO meeting. She also commented that this session complemented last year's session. She indicated satisfaction with the meeting.

Dr. Lenfant commented that collaboration can take many aspects. He reported that earlier in the day, 
Dr. David Satcher, the Surgeon General of the United States, signed a memorandum of understanding along with a number of agencies involved with the Healthy People 2010. The American Heart Association (AHA) was also part of this agreement. The previous day, the President of the AHA had indicated that she met with a number of the groups interested in various aspects of heart disease and had initiated discussion on how these smaller groups can work with the Heart Association. This kind of collaboration is what the Institute has hoped to accomplish with the PIO.

A topic resulting from several small groups was partnering with NHLBI for various initiatives. Dr. Lenfant responded that this Institute would be willing to explore ways to work with the groups, but the response would depend on the specifics of the proposal.

Council felt that the participants greatly valued the opportunity to get together, not just with NHLBI but with each other. It was suggested that next year workshop sessions be structured so the representatives could work with and learn from each other on a particular topic. The topics might be solicited in advance to get suggestions from them. It seemed clear that the group valued the breakout sessions more than the plenary sessions, and it was suggested that more time be devoted to breakout sessions next year.

It was noted that a number of these organization, especially the smaller ones, are floundering, and are looking for help in how to run their organizations and how to be more effective. Could the Institute serve as a facilitator for more frequent meetings? A Council member noted that there is an organization, the National Organization of Rare Diseases (NORD), that was not represented at the meeting. NORD does help the smaller organizations get their feet on the ground. Others thought that NORD was not particularly helpful because it spanned such a large range of organizations so that there is a limit to the kinds of services they can provide, but NORD does provide training in how to organize an organization, business-type skills that many of the organizations need.

Closed Portion

This portion of the meeting was closed to the public in accordance with the determination that it was concerned with 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).

There was 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.

REVIEW OF APPLICATIONS

The Council considered 1,100 applications requesting $1,109,403,011 in total direct costs. The Council recommended 747 applications with total direct costs of $827,264,031. A summary of applications by activity code may be found in Attachment B.

INTRAMURAL REVIEW

The Council then reviewed reports prepared by the Board of Scientific Counselors, NHLBI, which reviewed NHLBI intramural laboratories during FY2000.

ADJOURNMENT

The meeting was adjourned at 4:30 p.m. on February 1, 2001.

CERTIFICATION

I hereby certify that the foregoing minutes are accurate and complete.

Claude Lenfant, M.D.
Chairperson
National Heart, Lung, and Blood Advisory Council
on 5/24/01

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