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NAEC Meeting Minutes - September 17, 1998

Department of Health and Human Services
National Institutes of Health

National Eye Institute

September 17, 1998

The National Advisory Eye Council (NAEC) convened for its ninetieth meeting at 8:30 a.m. on Thursday, September 17, 1998, in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Director of the National Eye Institute (NEI), Carl Kupfer, M.D., presided as Chair of the Council. The meeting was open to the public from 8:30 a.m. until 12 noon, followed by the closed session for the review of the intramural research program and grant applications until adjournment at 3:15 p.m. Attachment A provides a roster of Council members.

Council members present:

  • Dr. Anthony J. Adams
  • Mr. Richard T. Hellner
  • Dr. David C. Beebe
  • Dr. Eve J. Higginbotham
  • Dr. Constance Cepko
  • Dr. David H. Hubel
  • Mr. Sanford Cloud, Jr.
  • Dr. Millicent L. Knight
  • Dr. Marian R. Fisher
  • Dr. Carl Kupfer (Ex Officio)
  • Lt. Col. William J. Flynn (Ex Officio)
  • Dr. Anthony B. Nesburn
  • Dr. Diane L. Hatchell (Ex Officio)

Council members absent: Dr. David S. Zee

Special Council Consultant: Dr. Dean Bok

NEI Staff Present:

Ms. Margie Baritz
Dr. Mary Frances Cotch
Ms. Olive Childers
Mr. Michael Davis
Ms. Lois DeNinno
Ms. Linda Dingle
Ms Judith A. Duff
Ms. Lois Eggers
Mr. Donald F. Everett
Dr. Frederick Ferris
Ms. Carol Fivozinsky
Dr. Maria Y. Giovanni
Ms. Carolyn E. Grimes
Dr. Ralph J. Helmsen
Dr. Richard Hertle
Ms. Tina E. Jones
Dr. Carl Kupfer
Dr. Natalie Kurinij
Dr. Ellen Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Lore’ Anne McNicol
Ms. Kathleen Moy
Dr. Michael Oberdorfer
Ms. Jane B. Schriver
Ms. Karen Robinson Smith
Ms. Judy Stein
Mr. John Whitaker
Ms. Cheryl E. Wild
Mr. Terry L. Williams
Dr. Robert H. Wurtz

Other NIH Staff Present:

Dr. Ellie Ehrenfeld, Director, CSR
Dr. Luigi Giacometti, CSR
Dr. Len Jakubczak, CSR
Dr. Carole Jelsema, CSR
Dr. L. R. Stanford, CSR

Food and Drug Administration Staff Present: Dr. Ralph Rosenthal

General Public present at the open session:

Ms. Joanne Angle, Association for Research in Vision and Ophthalmology
Ms. Carrie Kovar, American Academy of Ophthalmology
Dr. Israel A. Goldberg, Health Research Associates
Dr. John Whitener, American Optometric Association
Dr. Elaine Young, Juvenile Diabetes Foundation International

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Jack A. McLaughlin, Deputy Director, NEI, and Executive Secretary of the Council called the meeting to order and welcomed the Council members and guests. He introduced Mr. Sanford Cloud, Jr., a new Council member. Mr. Cloud is a graduate of Howard University and the Howard University Law School. He worked for Aetna Inc. for many years as Vice President for Corporate Public Involvement and as Executive Director of the Aetna Foundation. Mr. Cloud served two terms as Connecticut State Senator. He is currently the President and Chief Executive Officer of The National Conference for Community and Justice. He is the first African-American to lead The National Conference since it was established in 1927 as The National Conference of Christians and Jews. Throughout his distinguished career, Mr. Cloud has been active in encouraging private and public sector investments and philanthropic initiatives that aid people of color and the economically disadvantaged. He has taken a particular interest in the special health problems of individuals with diabetes and its complications, including diabetic retinopathy. Mr. Cloud is a member of the Board of Directors of the Juvenile Diabetes Foundation International.

Dr. McLaughlin next thanked Dr. Dean Bok who had agreed to participate in the meeting as a Special Council Consultant. Dr. Bok is the Dolly Green Professor of Ophthalmology, Jules Stein Eye Institute, and Professor of Neurobiology, Anatomy, and Cell Biology, University of California, Los Angeles.

Dr. McLaughlin said that this would be the final Council meeting for three the retiring members: Dr. Beebe, Dr. Fisher and Dr. Higginbotham, and indicated that they would be honored later in the day with a special presentation ceremony.

II. Confidentiality / Avoidance of Conflict of Interest

Dr. McLaughlin reviewed the policies and procedures regarding confidentiality and avoidance of conflict of interest situations. To avoid conflict of interest, members of federal advisory committees must not participate in the discussion of any application or proposal in which they, their spouse, minor child, close professional associate, or organization has a financial interest or affiliation. The Council members were later asked to sign a statement certifying that they were absent during such discussions.

III. Consideration of Minutes of Previous Meeting

The minutes of the June 11, 1998 Council meeting were considered and approved as submitted.

IV. Future Meeting Dates

The following dates were agreed upon for future Council meetings:

February 4-5, 1999
June 10-11, 1999
September 16-17, 1999

V. Fiscal Year 1999 Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the budget situation for Fiscal Years 1998 and 1999. She said that NEI had received a Fiscal Year (FY) 1998 budget of $355.7 million, an increase of 7.3% over the FY 1997 budget. Within this total, funding for research grants increased by 7.5% over the FY 1997 budget. The percentage increase received by NEI was in line with the increases received by most of the other Institutes. The NIH received a percentage increase of about 7.1% overall.

Ms. Fivozinsky next reviewed the FY 1999 President’s Budget Request (PB) for NIH and for NEI. The Administration requested $384.1 million for NEI, representing a 7.7% increase over FY 1998, compared to an 8.4% increase requested for NIH overall. She stated that although the Labor/HHS/Education appropriation bills (which include funding for NIH) had cleared both the House and Senate Appropriations Committees, the bills had not been brought to a vote in either chamber. The House bill called for a 7.8% increase for NEI, while the Senate bill would provide a 9.1% increase. These proposed percentage increases were also lower than that proposed for the NIH as a whole. Ms. Fivozinsky said that it was unlikely that NIH would have a signed appropriation bill before October 1, and that a Continuing Resolution (stop-gap funding measure) seemed likely. Many observers were predicting that a short-term Continuing Resolution would be passed and signed by the President, followed by attempts to pass an “omnibus” appropriations bill that would provide longer term funding for those agencies still without a separate, enacted appropriation.

VI. Extramural Research Program

Dr. McLaughlin’s presentation covered the latest budget estimates for the extramural research program for FY 1998 and the estimates associated with the FY 1999 House appropriations bill. He pointed out that the overall distribution of funds among the various extramural categories of support in FY 1998 would be similar to that of previous years. Dr. McLaughlin said that the success rate for FY 1998 competing research project grants would be approximately 40%, and that NEI would be able to fund more total research project grants in FY 1998 than it did in FY 1997.

With regard to the FY 1999 House bill, Dr. McLaughlin estimated that the total number of research project grants would increase from approximately 984 in FY 1998 to 1003 in FY 1999. Given this budget level, the success rate for competing grants should remain relatively high at about 38%. An important budget assumption of the FY 1999 PB and the House bill is that competing grants, on average, would not be cut from the study section recommended levels. The overall distribution of funds among the various extramural categories of support in the FY 1999 PB would be similar to that of FY 1998.

VII. Vision Plan Dissemination

Mr. Michael Davis, Associate Director for Science Policy and Legislation, NEI, reported that after the June meeting of the Council, his office began distribution of Vision Research–A National Plan: 1999-2003. Initially, copies of the full report and the executive summary were sent to the panel members and special reviewers who had assisted in the preparation of the plan. The week following the June Council meeting, approximately 1,375 copies of the executive summary were mailed to principal investigators of NEI grants and contracts. At the time of the September Council meeting, over 700 copies of the full report had also been mailed out.

The PDF versions of the full report and the executive summary were posted on the NEI website during the week of July 12. A report of website activity furnished by NEI’s worldwide web contractor indicated that nearly 500 visits were made to the report web page during the remainder of July and more than 1,500 were made by September 14. Mr. Davis reported that visits to the individual executive summary and full report sites were also tracked. Since posting, more than 650 visits were made to the executive summary site and more than 3,900 visits to the full report site.

The HTML versions were available during the first week in August. According to the activity report, these sites have not shown the level of activity seen on the PDF sites with 150 visits to the executive summary site and 190 to the full report site by September 14. Mr. Davis informed Council that a “text only” version will also be posted shortly.

In response to a question from Dr. Beebe concerning whether the NEI had received any comments about the plan, Mr. Davis responded that a few direct and a few indirect comments had been received, all of which were favorable. Dr. Nesburn reported that investigators at his institution have been using the plan in preparing their grant applications. He inquired whether the site activity report also indicated who was accessing the sites. Mr. Davis said the initial report was a simple summary, but a more detailed analysis of the site statistics was requested from the contractor and should provide much greater detail on the visitors to the website.

VIII. Mouse Genomics / Genetics Resources

Dr. Maria Y. Giovanni, Program Director, Division of Extramural Research, NEI, briefly described NEI’s participation in several trans-NIH initiatives. These included initiatives on zebrafish development, single nucleotide polymorphisms, quantitative methods for complex diseases, the Brain Molecular Anatomy Project, and an initiative on sequencing full-length cDNAs. She then described in more detail a trans-NIH initiative on mouse genomics and genetic resources for the mouse. Dr. Varmus, Director, NIH, had convened a group of scientists in March, 1998, to discuss needs and priorities for research on mouse genomics and genetic resources. The ultimate goal was to decide how best to facilitate research and investigators who use the mouse for understanding mammalian systems. Recommendations were developed in four areas: structural analysis of the mouse genome, functional analysis of mouse biology, resources, and training. The final report of the meeting is posted on the NIH web site at http://www.nih.gov/about/director/reports/mgenome.htm. Several Council members expressed their enthusiasm for these projects, and stressed the importance of obtaining more genetic information from specific eye tissues and from specialized regions of the eye and visual system.

In response to these recommendations, Dr. Varmus established a Steering Committee, which consists of representatives from the NIH institutes, co-chaired by Dr. Elke Jordon, Deputy Director of National Institutes of Human Genome Research and Dr. James Battey, Director of the National Institute of Deafness and Other Communication Disorders. The charge to the committee from Dr. Varmus was to generate a plan to implement the recommendations of the March 1998 meeting. Dr. Giovanni said that the Steering Committee had met a number of times over the summer to assess what is being funded by the various institutes that is responsive to the recommendations and to develop an inventory. She indicated that the Steering Committee would soon meet with the co-chairs of the original working group, and then begin to develop new research and training initiatives in this area.

IX. Age-Related Eye Diseases Study

Dr. Frederick Ferris, Director, Division of Biometry and Epidemiology, NEI, discussed plans to extend the followup of individuals participating in the Age-Related Eye Diseases Study (AREDS). AREDS is a prospective , natural history study of age-related macular degeneration and age-related cataract, two of the leading causes of blindness. Study data will be used to calculate rates of progression for both diseases and to identify subgroups of patients at particularly high risk for disease progression. In addition to the natural history study, AREDS includes a randomized clinical trial of high-dose vitamin and mineral supplements. AREDS has enrolled 4,757 participants, and by March, 2000, five-year followup would be available on nearly 4,000 participants. Dr. Ferris reviewed the specific objectives of a proposed five-year extension of follow-up of AREDS cohorts. The Council was very enthusiastic in recommending that the AREDS be extended as proposed.

X. Year 2000 (Y2K) Conversion

Mr. Terry L. Williams, Chief, Information and Technology Management Branch, NEI, presented an overview of the Year 2000 (Y2K) conversion problem. He described the significant steps that NIH and the NEI had taken in response to this problem. At the NEI, Mr. Williams indicated that a great deal of progress had been made in upgrading basic network operating systems, desktop personal computers, basic desktop software, and laboratory computer basic operating systems. He and Dr. McLaughlin said that a recent NEI reorganization consolidated management and oversight of all NEI information technology resources and brought about a significant improvement in the Institute’s capability for addressing this challenge. Mr. Williams indicated that NEI was on track in meeting its Y2K goals.

XI. Bioengineering Science and Technology Partnerships

Dr. Loré Anne McNicol, Acting Director, Vision Research Program, NEI, discussed a new trans-NIH initiative, Bioengineering Research Grants and Bioengineering Research Partnerships. The NEI is joining 19 other Institutes in a Bioengineering Consortium (BECON) to more fully integrate bioengineering into NIH research to advance science and human health. As part of this initiative, NEI would invite applications from scientists interested in capitalizing on the bioengineering approach to synthesize and integrate information from diverse fields into focused basic and application-oriented vision research. Areas of interest include, but are not limited to: Biomechanics, Bioprocessing, Imaging, Drug Delivery, Bioelectrics and Ion Channels, Organ Culture Systems, Informatics, Implants, Biomembranes, Sensors, Tissue Regeneration, Functional Genomics, and Rehabilitation. The initiative has two components, Bioengineering Research Grants, and Bioengineering Research Partnerships.

Information about the Bioengineering Research Grants component was published in the NIH Guide as PAR-99-009. The full text of the announcement is available on the worldwide web at: http://www.nih.gov/grants/guide/pa-files/PAR-99-009.html. This announcement calls for regular research grant (R01) applications for support of basic bioengineering research whose outcomes are likely to advance health or health-related research.

Information about the Bioengineering Research Partnerships program was published in the NIH Guide as PAS-99-010. The full text of the announcement is available on the web at: http://www.nih.gov/grants/guide/pa-files/PAS-99-010.html. This announcement calls for grant applications (R24) for up to $2 million annual total costs. The applications should propose multidisciplinary research teams applying an integrative, systems approach to developing knowledge and/or methods to prevent, detect, diagnose, and treat disease and understand health and behavior. They must include bioengineering expertise in combination with basic and/or clinical investigators. Applicants may propose design-directed or hypothesis-driven research.

XII. Intramural Research Program Binocular Alignment in Humans

Dr. Robert H. Wurtz, Chief, Laboratory of Sensorimotor Research, Division of Intramural Research, NEI, presented an overview of some recent work from the Laboratory regarding binocular alignment in humans. He described work in the rhesus monkey, which had particular relevance to the problem of strabismus in children. Dr. Wurtz said that very few scientists were working in this area, but that it was ripe for exploration. He introduced Dr. Richard Hertle, a pediatric neurophthalmologist, who had been recently recruited to the NEI intramural program. Dr. Hertle will pursue these sorts of problems in collaboration with other scientists in the Laboratory where integration of research on the monkey and the human visual system has been emphasized. Several Council members commented on the high quality of the science presented and expressed enthusiasm for this line of investigation.

XIII. Peer Review Issues

Dr. Ellie Ehrenfeld, Director, Center for Scientific Review (CSR), NIH, addressed the Council regarding a number of topics and issues affecting peer review. With regard to the integration of neuroscience-related study sections, Dr. Ehrenfeld said that the VISA and VISC study sections were now included with five other study sections in the Molecular, Cellular, and Developmental Neuroscience Initial Review Group (IRG). The VISB study section joins seven other study sections in the Integrative, Functional, and Cognitive Neuroscience. She indicated that there would be few immediate changes in the review of most vision-related applications, but that this could change. Dr. Ehrenfeld said that Ad Hoc Working Groups (of the CSR Advisory Committee) on IRGs, composed of outside scientists, are being formed as part of a plan to exploit the potential of the IRG as the functional review unit in CSR. The move from the individual study section toward the IRG as the fundamental unit presents opportunities for teamwork, flexible distribution of applications, and sharing of reviewer expertise. She indicated that a Working Group for the three neuroscience IRGs would be established in 1999. All of the Working Groups will examine study section boundaries and reviewer composition, and will try to identify best practices. The Groups may also play a role in identifying and recruiting reviewers.

The discussion turned to issues surrounding the review of applications submitted by members of study sections. Several Council members expressed a preference for the use of small ad hoc committees to review these types of applications, as had been the routine procedure in the past. Other members expressed an interest in the “leave of absence” approach where a study section member would simply not attend a meeting when his/her application was being reviewed.
Dr. Ehrenfeld said that these and other new approaches were the subject of ongoing discussions with her various advisory groups and that this important issue would be addressed carefully.

Several Council members commented negatively on the “micromanaging” tone of many summary statements, and the tremendous burden which resubmissions place on applicants, reviewers, and NIH staff. In response, Dr. Ehrenfeld discussed some of the steps that had been taken, including the recent changes in review criteria, to get study sections to focus more on the potential scientific impact of an application and less on methodological details. Council members also commented that the grant application kit and its instructions dictated the length and detail of submitted applications. Therefore, it was felt that these instructions should be examined in concert with the other activities described by Dr. Ehrenfeld.

In response to a question, Dr. Ehrenfeld discussed the current CSR procedures by which potential study section members are identified and recruited to serve. She emphasized the important role played by the CSR Scientific Review Administrators in this process. Dr. Ehrenfeld said that this was an important issue and one which was being addressed by various CSR advisory groups. She said that she welcomed input from the scientific societies.

Closed Portion of the Meeting

The next 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).

XIV. Review of Intramural Research Program

As required by the Public Health Service Act, each NIH Institute annually provides its Council a written description of the research reviewed by its Board of Scientific Counselors (BSC), and the results of that review. The Council may make recommendations to the Director, NEI, regarding this research. The Council considered the BSC review and recommendations for the Laboratory of Sensorimotor Research. Dr. Wurtz was present during the discussions to provide information and answer questions regarding implementation of the BSC recommendations.

XV. Review of Research and Training Applications

The Council considered 385 research and training applications requesting $380.9 million in total costs. The Council recommended 379 applications with a total cost of $361.1 million. Council 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 signed a statement to this effect.

XVI. Adjournment

Dr. Kupfer adjourned the meeting at 3:15 p.m. on September 17, 1998.

XVII. Certification

I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Jack A. McLaughlin, Ph.D.
Executive Secretary
National Advisory Eye Council
Deputy Director
National Eye Institute

Carl Kupfer, M.D.
National Advisory Eye Council
National Eye Institute

These minutes will be submitted for the approval of the Council at the February 4, 1999, meeting. Any corrections or notations will be incorporated in the minutes of that meeting. A complete, printed copy of the Council minutes, including attachments, may be obtained from:

Ms. Lois M. DeNinno
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-9110
FAX: (301) 402-0528
e-mail: lmd@nei.nih.gov

Attachment A

National Advisory Eye Council

National Eye Institute

(Terms end 11/30 of the designated year)

Adams, Anthony J., O.D., Ph.D. (00)
Dean and Professor of Vision Science & Optometry
School of Optometry
University of California, Berkeley
Berkeley, CA 94720

Beebe, David C., Ph.D. (98)
Professor of Ophthalmology & Visual Sciences
Washington University School of Medicine
St. Louis, MO 63110

Cepko, Constance, Ph.D. (01)
Department of Genetics
Howard Hughes Medical Institute
Harvard Medical School
Boston, MA 02115

Cloud, Jr., Sanford (01)
President & CEO
The National Conference
71 Fifth Avenue
New York, NY 10033

Fisher, Marian R., Ph.D. (98)
Senior Scientist
Department of Biostatistics
University of Wisconsin
Madison, WI 53706

Hellner, Richard T. (00)
President & CEO
Prevent Blindness America
Schaumburg, IL 60173

Higginbotham, Eve J., M.D. (98)
Professor and Chair
Department of Ophthalmology
School of Medicine
University of Maryland
Baltimore, MD 21201

Hubel, David H., M.D. (99)
John Franklin Enders
Professor of Neurobiology
Harvard Medical School
Boston, MA 02115

Knight, Millicent L., O.D. (99)
North Shore Eye Center
Evanston, IL 60201

Nesburn, Anthony B., M.D. (00)
Ophthalmology Research Laboratories
Cedars-Sinai Medical Center
Los Angeles, CA 90048

Zee, David S., M.D. (99)
Professor of Neurology, Ophthalmology,
Otolaryngology & Neuroscience
Johns Hopkins University
School of Medicine
Baltimore, MD 21287

Special Council Consultant

Dean Bok, Ph.D.
University of California, Los Angeles
Jules Stein Eye Institute
Los Angeles, CA 90095

Ex Officio Members

Shalala, Donna E., Ph.D.
Department of Health and Human Services
Washington, D.C. 20201

Varmus, Harold, M.D.
National Institutes of Health
Bethesda, MD 20892

Kupfer, Carl, M.D. (Chair)
National Eye Institute
National Institutes of Health
Bethesda, MD 20892

Department of Veterans Affairs Representative

Hatchell, Diane L., Ph.D.
VA Medical Center
Durham, NC 27705

Department of Defense Representative

Flynn, William J., Lt. Col., USAF, MC
Department of Ophthalmology
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Executive Secretary

McLaughlin, Jack A., Ph.D.
Deputy Director
National Eye Institute
National Institutes of Health
Bethesda, MD 20892