National Advisory Council for Human Genome Research - Summary of Meeting - April 2006

National Advisory Council for Human Genome Research
Summary of Meeting

Bethesda, Md.

May 4-5, 1998

The National Advisory Council for Human Genome Research (NACHGR) was convened for its twenty-third meeting at 8:30 a.m. on May 4, 1998, at the National Institutes of Health (NIH), Building 31, C Wing, 6th Floor, Conference Room 10. Dr. Francis Collins, director of the National Human Genome Research Institute, called the meeting to order.

The meeting was open to the public from 8:30 a.m. until noon on May 4. In accordance with the provisions of Public Law 92-463, the meeting was closed to the public from 1:00 p.m. on May 4 to adjournment May 5 for the review, discussion and evaluation of grant applications.

Council members present:

Aravinda Chakravarti
Ellen W. Clayton
David R. Cox
Troy Duster
Leroy Hood
H. Robert Horvitz
Jeanne Lawrence
Richard Mathies
Joseph Nadeau
Diane Smith
David Valle
Alan R. Williamson
Barbara Wold

Ex officio members:

Joel N. Buxbaum
William M. Nelson

Liaisons from Professional Societies:

Rosalie Goldberg, National Society of Genetic Counselors
Kurt Hirschhorn, American College of Medical Genetics
Steven Warren (substituting for Jeffrey Murray), American Society of Human Genetics

Staff from the National Human Genome Research Institute:

Jane Ades, OPC
Carol Almeida, OAM
Meg Bouvier, OPC
Joy Boyer, DER
Lisa Brooks, DER
Erin Burgess, OAM
Jean Cahill, OAM
Francis Collins, OD
Elise Feingold, DER
Leslie Fink, OPC
Mary Glynn, OAM
Bettie Graham, DER
Mark Guyer, DER
Linda Hall, OAM
Craig Higgins, OPC
Kathy Hudson, OPC
Linda Jacobson, OAM
Elke Jordan, OD
Charles E. Leasure, OD
Terri Messick, OAM
Tara Mowery, OAM
Kenji Nakamura, OSR
Sara Petersen, OPC
Jane Peterson, DER
Robin Prigal, OAM
Jerry Roberts, CIDR
Jeffery Schloss, DER
Sandra Taubenkibel, OAM
Elizabeth Thomson, DER
Elsa Weinstein, OAM
Monika Yakovich, OAM
Sally York, OAM

Others present for all or a portion of the meeting:

Deborah Applebaum-Bowden, NHLBI
Finley Austin, Merck Genome Research Institute
Kristina Borror, OD
Robert Boyd, Knight Rider
Cheryl Corsaro, CSR
Camilla Day, CSR
Machi Dilworth, NSF
Arthur Katz, DOE
Virginia Lapham, Georgetown University
Pam Moore, Capitol Publications
Kathryn Munoz, Merck and Co., Inc.
Ari Patrinos, DOE
Nancy Pearson, CSR
Lisa Putman, The Blue Sheet
Sara Radcliffe, SmithKline Beecham
Kevin Ryder, NCI
Meredith Wadman, Nature
Leon Washut, Consultant
Joan Weiss, Alliance of Genetic Support Groups

INTRODUCTION OF NEW MEMBERS, LIAISONS AND NEW STAFF

Dr. Jordan introduced the liaisons to the council from the professional societies: Dr. Kurt Hirschhorn, representing the American College of Medical Genetics; and Ms. Rosalie Goldberg, representing the National Society of Genetic Counselors. She indicated Dr. Steven Warren would be substituting for Dr. Jeffrey Murray, representing the American Society of Human Genetics. Dr. Jordan also introduced a new NHGRI staff member, Mr. Craig Higgins, who serves as the Institute's Legislative Liaison, and Dr. Leon Washut, who will be assisting the Institute in developing sequencing cost estimates.

APPROVAL OF MINUTES

The minutes from the February 12-13, 1998 NACHGR meeting were approved with the addition of four corrections requested by Dr. Ellen Clayton: 1) correct the spelling of Tucson on page 4; 2) under the "Report on ERPEG Activities" on page 19, change "disciplined intellectual inquiry" to "analytical inquiry;" 3) on page 20 in the second to last paragraph, correct a typographical error by changing "may" to "many"; 4) in the last paragraph on page 20 change "are far less effective in their review" to "are less consistent in their review."

FUTURE MEETING DATES

The following dates were proposed for future meetings: September 14-15, 1998; February 22-23, 1999; May 17-18, 1999; September 13-14, 1999; February 28-29, 2000; May 22-23, 2000; and September 11-12, 2000.

DIRECTOR'S REPORT

Recent Honors and Awards

Dr. Collins congratulated Dr. David Botstein and Dr. Ron Davis of Stanford University School of Medicine and Dr. Eric Lander of the Whitehead Institute/MIT Center for Genome Research for being named co-recipients of the 1998 Chiron Corporation Biotechnology Research Award. Dr. Botstein and Dr. Davis's major contribution was the theoretical work on restriction fragment length polymorphisms (RFLP) as genetic markers, while Dr. Lander was recognized for his research on the use of RFLPs in mapping disease genes and the use of statistical genetics methods for analyzing large data sets of genetic information. All three scientists have been actively involved in the Human Genome Project (HGP).

Dr. Jeffrey Murray of the American Society of Human Genetics was the recipient of the 1998 E. Mead Johnson Award for Pediatric Research given by the Society for Pediatric Research.

NHGRI grantees Drs. David Ward and William Dove were recently elected to the National Academy of Sciences.

Program Items of Interest

Total human sequence completed has risen from 3 percent to 4.5 percent.

The RFA on single nucleotide polymorphisms (SNPs) discussed at the last Council meeting has been issued. NHGRI has received 76 letters of intent. Applications are due May 7, with review in July and awards in September.

Dr. Alan Williamson reported on a meeting on SNPs held April 8, 1998 in New York City, to which a number of pharmaceutical companies sent representatives. The attendees agreed that it was advantageous for all concerned to create a large SNP database as quickly as possible. There was concern about finding the funding for this project, and it was agreed to form a consortium to support this activity. The group will meet again on May 26 in the New York City area. An article about the meeting appeared in Science, and the publicity may result in increased attendance at the next session.

Three kinds of career awards were approved by council at the February meeting: a revised K01 award and the new K12 and K07 awards. The announcements for these programs appeared in the NIH Guide on May 2.

An update was provided on the Center for Inherited Disease Research (CIDR). The brainchild of NHGRI scientist, Dr. Robert Nussbaum, CIDR is a centralized facility that provides genotyping and statistical genetics services for investigators seeking to map genes that contribute to human disease. CIDR was established in 1996 as a joint effort by eight institutes at the NIH and the Johns Hopkins University. Proposed projects are reviewed by the CIDR Access Committee (CAC), chaired by Anne Spence. At the last CAC meeting on April 30, 1998, 21 applications were reviewed and 10 were approved for access. CIDR has also set up an agreement with Affymetrix to beta-test their SNP genotyping chip. Dr. Collins praised Dr. Jerry Roberts for his leadership in coordinating the review of CIDR applications.

In order to encourage scientists to use the CIDR facilities, the Board of Governors has decided that genotyping for PIs funded by the participating eight institutes will be free. The cost for other researchers is $1/genotype. Scientists are encouraged to go the CIDR Web site [www.cidr.jhmi.edu] for further information.

Intramural Program Activities

NHGRI is collaborating with researchers at the new Human Genome Research Center at Howard University to study the genetic basis of diseases that affect African Americans and other minorities disproportionately. A study on the West African origins of diabetes mellitus in African Americans is currently being conducted on site in West Africa. Research on prostate cancer in African-American men has also begun. Support for this research is being provided by the Office for Research on Minority Health in the NIH Office of the Director.

Budget Issues

NHGRI continues to enjoy cordial relations with Congress. The FY 1999 NHGRI President's budget request is for $240.1 million, an increase of $22.4 million or 10.3 percent over the FY 1998 level. The House appropriations hearings were held on March 12, 1998 and the Senate appropriations hearings on April 1, 1998. Both Chairmen of the Appropriations Subcommittees, Congressmen Porter and Senator Specter, have publicly stated their support for significant increases in funding for the NIH. Senator Specter was particularly interested in hearing about what could be accomplished if additional funds were made available. The Senate budget resolution that was passed on April 2nd included an assumed increase for the NIH in FY 1999 of $1.5 billion, however there has been no mark-up of appropriation bills in the House or Senate so far.

The President's budget assumed enactment of a "tobacco settlement" to offset increased domestic spending. However, it is not clear whether a tobacco settlement will be enacted this year. In addition, many of the pending tobacco settlement bills would require that funds made available to the NIH be used only for "tobacco-related" research. So despite the reservoir of Executive and Congressional goodwill, the proposed increases for NIH are far from certain, and there is no consensus on the means to achieve the record increases proposed by the President and being discussed in the Congress.

On March 23, 1998, Senator Connie Mack (R-FL) toured the NIH and spoke with institutes and centers (IC) directors and NIH Director Dr. Harold Varmus regarding research advances and opportunities. Senator Mack has been a consistent advocate of medical research and the NIH. Dr. Collins updated the Senator on the HGP, of which he has been strongly supportive.

Legislative and Policy Update

In his State of the Union Address, President Clinton indicated that: "We must prevent the misuse of genetic tests to discriminate against any American." At the annual James Watson Lecture, Vice President Al Gore announced that the Clinton Administration was calling for legislation to bar employers from discriminating against workers in hiring or promotion because of their genetic makeup. Nevertheless, there is no imminent legislative solution at the federal level. Medical Records Privacy is also being debated in Congress and subsequent legislation could have significant impact on the conduct of research. Virtually all proposals contain rules to safeguard traditional medical records and would affect investigators' access to information for records-based research. It is unlikely that Congress will act on this legislation in this session, but the Health Insurance Portability and Accountability Act (HIPAA) passed last year requires privacy rules to be put in place for medical records by August 1999.

Recent and Upcoming Meetings

Third International Strategy Meeting on Human Genome Sequence The third meeting of the international large-scale sequencing group was held in Bermuda in February 1998. The attendees represent all of the major sequencing laboratories in the world and meet to discuss issues of communication and coordination of human genome sequencing, such as sequencing costs and quality standards. The attendees agreed to participate in an International Quality Assessment exercise. They also agreed that increased sequence contiguity is an important issue. Working groups were organized to address issues of cost accounting, finishing and clone fidelity. Participants urged all high throughput sequencing projects, regardless of organism, to adopt the policy of immediate release of data that applies to human genome sequence (i.e., data for all sequence assemblies of 2 kilobases or longer should submitted to a public database within 24 hours).

Dr. David Cox indicated that this resolution would create an awkward situation for researchers whose sequencing projects were funded from both public and private sources. This would preclude for-profit sequencing operations from applying for public funding. Dr. Lawrence pointed out that funding for a project could change over time.

Dr. Williamson posed the question that if a sequence were privately funded, could you then publicly fund it to get it into the public domain? These are issues in which council should become actively involved.

Dr. Duster felt that council should put together a consortium of people to make general recommendations. Dr. Hood stated that representatives from the private sector needed to participate in these discussions. Dr. Hirschhorn pointed out there was a difference between not revealing data and protecting intellectual property.

Full-length cDNA Cloning: A Workshop on Problems and Solutions was held at the Banbury Conference Center on March 22-25, 1998. The workshop reviewed the state of human cDNA cloning and sequencing. The group agreed that, while there was considerable progress being made in terms of the cloning of longer cDNAs, there was a need for further technology development as well as the establishment of community standards that could be used to more fully evaluate the quality and representativeness of libraries.

Jewish Leadership Meeting on Genetics. This meeting, held on April 22, 1998 in Washington, D.C., was initiated by Hadassah and the Jewish Council for Public Affairs, with assistance from NHGRI. This meeting was precipitated by concerns among the Jewish community resulting from the recent discovery that certain alleles of disease genes were more common in Ashkenazi Jews than in the general population. The meeting brought together NIH scientists, legal and legislative experts and Jewish community leaders to discuss the potential benefits and risks of genetic testing and research participation. Dr. Francis Collins and Dr. Richard Klausner both spoke at the meeting. Dr. Klausner proposed a series of guidelines to be followed and indicated that target populations should be involved in planning research studies involving them.

Dr. Troy Duster indicated that this experience with the Ashkenazi Jewish population should serve as a model when geneticists are studying a population with a limited set of founders. Either ERPEG or ELSI should be addressing the concerns that arise when researchers want to study a population deemed at risk, without making the members of the study group feel like they are being adversely singled out. Dr. Collins pointed out that at the upcoming Cold Spring Harbor meeting being held on May 13-17, there will be an ELSI session on genetics and race, with Dr. Harold Freeman as one of the speakers.

Dr. Lee Hood indicated there is another aspect of this issue. Recently he attended a meeting with members of the American Indian community. They were concerned that if there is no biological basis for race, that they could not claim certain privileges to which they are now entitled.

American Medical Association National Conference. The AMA hosted a meeting in New Orleans on March 13-15, 1998 in partnership with the NHGRI, the ASHG, the ACMG, and a number of professional medical groups. The meeting was titled "Genetic Medicine and the Practicing Physician" and targeted primary care providers. The purpose of the meeting was to raise the consciousness of doctors with regards to genetic issues in medicine, including genetics of specific diseases, genetic counseling, privacy/confidentiality, and informed consent. The AMA feels that not since antibiotics has there been such a mandate for educating the medical community. Dr. Collins indicated that the need to educate health care professionals of all sorts about genetics continues to be the focus of the National Coalition for Health Professional Education in Genetics (NCHPEG). One of the NCHPEG working groups is developing model curricula and looking into programs to facilitate the integration of genetics content into continuing education programs, certification and licensure exams.

Dr. Hirschhorn mentioned that New York state has funded and written practice guidelines on genetic counseling and congenital malformations. Dr. Buxbaum indicated that the Whitehead Institute recently sponsored a meeting in Boston with 800 registrants that addressed issues of consciousness raising on genetic issues. Dr. Collins indicated that at the recent FASEB Meeting in San Francisco, there were two symposia on genetics.

Hereditary Hemochromatosis Workshop. A workshop co-sponsored by CDC and NHGRI was held on March 3, 1997 to examine the ethical, legal and social implications of discovery of the gene for hereditary hemochromatosis and the possibility of widespread population-based testing for the disease.

NHGRI is currently working with National Heart, Lung and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Centers for Disease Control and Prevention (CDC) to develop an RFA to examine issues surrounding the use of genetic testing for hereditary hemochromatosis (HH). This RFA is enthusiastically supported by Dr. Varmus and should be released this summer. Research projects will be funded with FY 1999 funds. The RFA will focus on testing and screening, as well as psychosocial and ethical issues.

Dr. Jeanne Lawrence questioned how much of the NIH budget was devoted to ethical issues. Dr. Collins responded that while 5 percent of the NHGRI budget addresses ELSI issues, the amount is probably more modest for the rest of NIH. A trans-NIH group, recommended by the Spence/Rothstein ELSI evaluation committee, has been formed and is headed by Lana Skirboll in the NIH Office of the Director. This group, the trans-NIH Bioethics Committee, is working on a white paper on the medical records privacy issue, which is currently in draft form.

PRIORITY SETTING FOR MOUSE GENOMICS AND GENETICS RESOURCES

Dr. David Cox gave a presentation on the Mouse Genomics and Genetics Resources Meeting held March 19-21, 1998 in Bethesda, Md. The meeting was co-chaired by Dr. Cox and Dr. William Dove. Dr. Cox thanked Dr. Bettie Graham for her work in setting up and organizing the meeting, which had approximately 80 attendees.

The meeting was held at the initiative of Dr.Varmus. Attendees met to discuss what mouse genomic and genetic resources were needed in order to facilitate research in mammalian biology. Dr. Varmus also asked the group to address the issue of cost and priorities. The format of the meeting was a series of presentations in a plenary session about the state-of-the-science in mapping, sequencing and functional analysis. This was followed by discussions of specific questions in breakout groups. The breakout groups included: Physical Mapping, cDNAs/ESTs, Genetic Mapping, Genomic Sequencing, Targeted Mutagenesis, ENU Mutagenesis, Chromosomal Strategies, Insertions and Transgenes, and Mouse Resources. Each group included scientists representing generators and users of the resources. Dr. Cox was pleased that the attendees focused on the good of the community rather than championing individual needs.

Based on the recommendations of the breakout groups, $22.2 million/year in new money is needed for structural analysis research and $17.1 million/year in new money is needed for functional analysis over a three-year period. In addition, there were recommendations for resources and training for an overall total of $52.3 million for the first year.

A high priority for structural analysis was the production of full length mouse cDNAs. The discussion on sequencing the mouse genome indicated that it should focus on regions that could be compared to human sequence. Everyone felt that high quality finished sequence should be the goal. The main focus for the $17.1 million for functional analysis would be several large centers for mutagenesis that would be responsible for carrying out large scale phenotyping and developing new technology in various critical areas, such as mutagenesis and cryopreservation.

An official report on the mouse resource meeting will be presented to the NIH IC Directors on June 11, 1998. Dr. Hood felt that this was an historic meeting. He also brought up the issue of reducing the sequence accuracy in order to increase the number of base pairs produced. However, in view of the fact that the nature of the errors that would be produced with this strategy is unknown, it was decided that this might not be the best approach to pursue at this time.

Dr. Valle suggested a two-tiered approach with different regions sequenced to different levels of accuracy. But again, lacking data to support this as a reasonable approach, this too was not considered an optimal approach to pursue at this time. Dr. Nadeau brought up the importance of providing funds for informatics to organize, manage and disseminate the vast amount of information that would be derived from these studies.

Dr. Collins concluded the discussion by indicating there was a general consensus that the mouse sequence should be accomplished by 2008. We can either start sequencing the mouse now or wait until 2005 when the human genome should be complete and hope that the sequencing capacity will go up and costs of sequencing will come down significantly over this time period. Starting now, on at least a modest scale, seems highly desirable.

INFORMATICS WORKSHOP REPORT

Dr. Lisa Brooks presented a summary of the Genome Informatics Meeting jointly sponsored by DOE and NHGRI that was held April 2-3, 1998. Forty-six informatics and genomics experts met to identify informatics needs and goals to be addressed in the next genome five-year plan. The attendees were divided into four breakout groups to discuss the types of queries that will be important in genome informatics, and the types of data, tools, and databases that were needed.

The areas covered by the four breakout groups included: 1) sequencing, mapping for sequencing, gene maps; 2) gene finding, OMIM, variation; 3) annotation, function; and 4) comparative genomics.

The attendees came up with clear priorities on the kinds of databases needed:

• A reference human genome map and sequence database with links to other organisms, that is updated and curated by editors.
• Better integration and linkage between databases.
• A variation database that can link to phenotypic information.
• A functional/expression database.
• Comprehensive data capture in standard format using controlled vocabularies.

The workshop members also cited the need for more tools, including finishing tools, production tools, research tools, access tools, annotation tools, data capture tools, functional genomics tools, data mining tools, etc. A Web site that collects and annotates these tools would be very useful. Another suggestion was that the databases be subject to regular quality checks.

The group felt there should be open competition for supplying informatics needs and existing frameworks should be used where possible. There was concern that raw data should be captured to the maximum extent possible before it is irretrievably lost. Dr. Collins pointed out that the demise of GDB makes the development of alternative databases a critical issue.

UPDATE ON 5-YEAR PLAN ACTIVITIES

Dr. Aravinda Chakravarti summarized the activities of his Council subcommittee, which is helping to develop a new strategic plan for NHGRI. The committee has met three times to discuss issues relating to sequencing, sequence-based variation, sequence-based function, informatics, and ELSI concerns. The subcommittee will meet for a fourth time on May 5-6. In addition, Dr. Chakravarti has been instrumental in organizing workshops on human DNA sequence variation, functional analysis of genomic sequences, and resources for detecting genetic variations. A final workshop on genomic sequencing technology is scheduled for May 13. The recommendations resulting from these 5-year planning activities will be presented at the Airlie House meeting on May 27-29, 1998.

Dr. Chakravarti also mentioned that recommendations coming from other sources, such as the annual large scale sequencing meeting in Bermuda, the Banbury meeting on full-length cDNA libraries, and the responses to the letter that Dr. Collins sent to pharmaceutical and biotech companies, will be incorporated into the plan.

Council members urged that critical ELSI issues be well-integrated into the 5-year plan. Dr. Chakravarti indicated that six short introductory presentations will be given at the Airlie House meeting, including one on ELSI issues. The other major areas to be addressed are sequencing, technology development, sequence-based functional analysis, sequence variation, and bio-informatics/computational biology.

Dr. Jordan has already begun to put together a draft plan to be presented for discussion at the Airlie House meeting. The document that emerges from the meeting needs to be a "vision" that makes sense to the community as a whole and identifies the key issues that need to be addressed over the next five years. This document will be presented to September Council and published in October 1998. This will be the culmination of a planning process that began in March 1997.

Dr. Richard Mathies expressed concern over the need for innovative technology. The inability to get new technology out into the community is a significant barrier to progress. Council members wanted to be certain that representatives from industry were involved in discussions regarding the transition of technology into the research community. Dr. Hood felt that since an enormous amount of investment must be made for technology development, it was critical that all the key players participate in planning activities.

UPDATE ON ERPEG

At the last Council meeting, Dr. Ellen Clayton indicated that the ELSI Research Planning and Evaluation Group (ERPEG) was looking at 26 possible goals for the NHGRI ELSI research program. ERPEG has narrowed this down to five goals and related research questions and education activities to be addressed over the next five years:

1. Analyze and address the implications of completing the first human genome sequence and identifying variation. This topic raises issues of privacy, concepts of race and ethnicity, concerns about the commercialization of DNA sequence information and effective strategies for educating health professionals.
   
   
2. Facilitate the safe and effective integration of genetic technologies and information into health care. This topic will address potential risks and benefits of genetic testing for complex behaviors; new information technologies in the clinical setting; and how this affects patients, health care providers and health care costs.
   
   
3. Facilitate the appropriate integration of knowledge about genomics and gene-environment interactions in societal (non-clinical) settings. This would include studies looking at the use of genetic information in employment and educational settings and issues arising from the collection of stored tissues for use by the military, civil and criminal justice systems, public health agencies and commericial companies.
   
   
4. Explore how new genetic knowledge challenges or affirms long-standing philosophical and theological traditions. Projects in this area would look at the implications of new genetic information and technologies for traditional conceptions of humanity. Issues studied might include the impact of behavioral genetics on personal and legal notions of responsibility and the far-reaching implications of genetic enhancement technologies.
   
   
5. Explore and address sociocultural issues in genetic research, services and policy development. Research in this area would examine how various sociocultural groups perceive, participate in and make use of new genetic information and technologies, research and services.

ERPEG strongly recommends that a standing study section be established for ELSI issues. ERPEG would also like to see more funds being given to smaller R03 grants to do analytic work and pilot studies which may lead to larger empirical studies. Dr. Clayton indicated that ERPEG has developed into a very effective and productive working group and gave thanks for the assistance provided by NHGRI and DOE staff.

Dr. Buxbaum indicated that informatics structures also have ELSI implications. There is a need to consider the ELSI issues at the interface between clinical information and informatics databases.

REPORT FROM THE DEPARTMENT OF ENERGY

Dr. Ari Patrinos presented an update on activities at the Department of Energey (DOE), and assured council that despite any budgetary concerns affecting the DOE, the Human Genome Project (HGP) would be protected and continue to be funded.

Dr. Patrinos brought council up-to-date on the Joint Genome Institute (JGI). The JGI has been organized to consolidate and coordinate the genomic research efforts of the three National Laboratory-based DOE genome centers at Berkeley, Lawrence Livermore, and Los Alamos. The JGI will enable the DOE to support its fair share of the sequencing efforts of the HGP, and first-year production is expected to reach 20 megabases by the end of the fiscal year. The JGI will also develop collaboration with researchers at other sites who can contribute new sequencing technologies. The sequencing production effort is scheduled to move into the new Production Sequencing Facility (PSF) in Walnut Creek, Calif. next October. In the meantime, the Los Alamos National Laboratory is playing a significant role in yeast genomics, while the Oak Ridge National Laboratory is very involved in informatics issues. DOE is also concerned about technology development and has issued an RFA in this area.

Dr. Patrinos indicated that DOE continues to be very interested in the development of the new 5-year plan for the HGP and is carrying on planning activities in parallel with the NHGRI. Dr. Ray Gesteland of the University of Utah is the chair of the DOE planning committee. Dr. Patrinos said he is looking forward to the Airlie House meeting later this month.

STATEMENT OF UNDERSTANDING

Ms. Jean Cahill presented an amendment to the Statement of Understanding Between the Staff of the National Human Genome Research Institute and the National Advisory Council for Human Genome Research. The amendment would give NHGRI staff new administrative authority "to extend, with additional funds, the final budget period of a project period, or any other budget period where justified, for up to twelve months." This amendment would allow a project to continue to be funded while a competing continuation application is under review or permit the orderly phase-out of the project.

Ms. Cahill indicated that this change would streamline administrative matters in non-controversial cases. Dr. Jordan added that this authority would only be used in special circumstances and would not occur very often. Nevertheless, council members expressed reservations about the amendment. Once a supplemental award was made, council would not be able to rescind it if they did not feel the award was justified. Dr. Mathies indicated that he would prefer to be sent an e-mail ballot in between council sessions if there was need to extend the budget period of an award. In general, council felt they wanted to see these requests. Dr. Clayton felt that the request to extend this administrative authority needs further discussion.

ANNOUNCEMENTS AND ITEMS OF INTEREST

Dr. Jordan noted the items of interest, which are listed on the agenda.

COUNCIL-INITIATED DISCUSSION

Dr. Collins pointed out that the main topic of discussion at the next open session of the council would be the 5-year plan, and it was not necessary to solicit other issues for the agenda. He also referred to the budget table in the agenda and indicated there was little change from the last meeting.

Dr. Clayton indicated that NBAC would be making a statement on stored tissue samples in approximately two months.

REVIEW OF APPLICATIONS

The Council reviewed 65 applications, totaling $28,741,424. The applications included: 15 regular research grants, five pilot projects, two program projects, 12 ethics grants, 17 grants in response to request for application, four center grants, three continuing education training programs, five small business innovative research awards - phase II, one fellowship, and one "other." A total of 54 applications requesting $20,782,888 were recommended.

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