    [Senate Hearing 106-817]
    [From the U.S. Government Publishing Office]

                                               S. Hrg. 106-817, Pt. 1 deg.

      DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
              RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2001

    =======================================================================

                                    HEARINGS

                                    before a

                              SUBCOMMITTEE OF THE

                COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                           ONE HUNDRED SIXTH CONGRESS

                                 SECOND SESSION

                                       on

                           H.R. 4577 and 5656/S. 2553

     AN ACT MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF LABOR, HEALTH AND
      HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES, FOR THE FISCAL
             YEAR ENDING SEPTEMBER 30, 2001, AND FOR OTHER PURPOSES

                                   __________

                             Part 1 (Pages 1-572)

                     Corporation for Public Broadcasting
                            Department of Education
                    Department of Health and Human Services
                              Department of Labor
                           Nondepartmental witnesses
                  Federal Mediation and Conciliation Service
                     Physician Payment Review Commission
                  Prospective Payment Assessment Commission
                       United States Institute of Peace
                          Nondepartmental witnesses
                        Social Security Administration

                                   __________

             Printed for the use of the Committee on Appropriations

        deg.Available via the World Wide Web: http://www.access.gpo.gov/
                                congress/senate

                                   __________

                        U.S. GOVERNMENT PRINTING OFFICE
    62-799                     WASHINGTON : 2001

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                For sale by the U.S. Government Printing Office
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                                     20402

                          COMMITTEE ON APPROPRIATIONS

                         TED STEVENS, Alaska, Chairman
    THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
    ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
    PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
    CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
    SLADE GORTON, Washington             FRANK R. LAUTENBERG, New Jersey
    MITCH McCONNELL, Kentucky            TOM HARKIN, Iowa
    CONRAD BURNS, Montana                BARBARA A. MIKULSKI, Maryland
    RICHARD C. SHELBY, Alabama           HARRY REID, Nevada
    JUDD GREGG, New Hampshire            HERB KOHL, Wisconsin
    ROBERT F. BENNETT, Utah              PATTY MURRAY, Washington
    BEN NIGHTHORSE CAMPBELL, Colorado    BYRON L. DORGAN, North Dakota
    LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
    KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
    JON KYL, Arizona
                       Steven J. Cortese, Staff Director
                     Lisa Sutherland, Deputy Staff Director
                   James H. English, Minority Staff Director
                                     ------

     Subcommittee on Departments of Labor, Health and Human Services, and
                        Education, and Related Agencies

                     ARLEN SPECTER, Pennsylvania, Chairman
    THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
    SLADE GORTON, Washington             ERNEST F. HOLLINGS, South Carolina
    JUDD GREGG, New Hampshire            DANIEL K. INOUYE, Hawaii
    LARRY E. CRAIG, Idaho                HARRY REID, Nevada
    KAY BAILEY HUTCHISON, Texas          HERB KOHL, Wisconsin
    TED STEVENS, Alaska                  PATTY MURRAY, Washington
    JON KYL, Arizona                     DIANNE FEINSTEIN, California
                                         ROBERT C. BYRD, West Virginia
                                           (Ex officio)
    Strip offset folio 0 here deg....................................

                               Professional Staff

                                Bettilou Taylor
                                 Mary Dietrich
                                  Jim Sourwine
                                   Aura Dunn
                            Ellen Murray (Minority)

                             Administrative Support

                                 Kevin Johnson
                           Carole Geagley (Minority)

                                C O N T E N T S

                                  ----------

                           Tuesday, February 29, 2000

                                                                       Page
    Department of Labor: Office of the Secretary.....................     1
    Department of Health and Human Services: Office of the Secretary.    15
    Department of Education: Office of the Secretary.................    30

                            Thursday, March 30, 2000

    Department of Health and Human Services: Office of the Secretary.   127

                           NONDEPARTMENTAL WITNESSES

    Department of Health and Human Services..........................   325
        General Healthcare...........................................   325
        Centers for Disease Control and Prevention...................   385
        National Institutes of Health................................   400
    Department of Education..........................................   505
    Related agencies/general testimony...............................   533

      DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
              RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2001

                                  ----------

                           TUESDAY, FEBRUARY 29, 2000

                                           U.S. Senate,
               Subcommittee of the Committee on Appropriations,
                                                        Washington, DC.
        The subcommittee met at 9:34 a.m., in room SD-124, Dirksen
    Senate Office Building, Hon. Arlen Specter (chairman)
    presiding.
        Present: Senators Specter, Cochran, Craig, Stevens, Harkin,
    Reid, Murray, and Feinstein.

                              DEPARTMENT OF LABOR

                            Office of the Secretary

    STATEMENT OF ALEXIS M. HERMAN, SECRETARY

                   OPENING STATEMENT OF SENATOR ARLEN SPECTER

        Senator Specter. Good morning, ladies and gentlemen. The
    Appropriations Subcommittee on Labor, Health, Human Services,
    and Education will now proceed.
        We have an extraordinarily distinguished panel, the three
    secretaries of the departments, which are funded by this
    subcommittee. Protocol calls for identifying the secretaries in
    sequence of appointment.
        The Department of Labor goes back to 1913, and the
    Department of Health and Human Services to 1953, and the
    Department of Education to 1979.
        The President has submitted a budget which totals $106.2
    billion, which is a very substantial increase over the $95.1
    billion from last year. My own view is that in a Federal budget
    of $1.8 trillion, that this is a reasonable figure for the
    departments which have the responsibilities which these three
    departments have.
        Now I believe that when you talk about education or health
    or worker safety, you are talking about a capital investment in
    America. But my views are not widely shared on Capitol Hill.
    And there is already talk of a total allocation of a budget far
    below the $622 billion, which the President has requested.
        It is my hope that we will proceed with the budget process
    much faster this year than last year. And I believe that the
    leadership in both the House and the Senate agree with that.
        We really need to pass these bills and present them to the
    President in a timely way, so that they can be acted upon by
    the President long before the fiscal year ends and not have
    budgets submitted in October and November, bills submitted in
    October and November, when there is no opportunity to follow
    the constitutional process, which is the Congress submits the
    bills, and the President either signs them or vetoes.
        We have come to a practice where the Executive Branch sits
    in on the legislative process. And it is unconstitutional on
    its face, and I think it is highly undesirable. And there are
    some significant debates. My own sense is to try to beat the
    President's figure illustratively on education. Last year we
    came out of the Senate Appropriations Committee with $500
    million above the President.
        There may be some disagreements on priorities. And the
    Congress has a role, perhaps the lead role, on what those
    priorities ought to be. But that cannot be debated when you are
    into October or November and, if there is a gridlock, the
    consequence is closing down the government.
        This is a very, very ambitious program. The administration
    is moving into a great many areas which have traditionally been
    left to the States. Talk about classroom size and more
    teachers, talk about school constructions. I supported our
    former colleague, Carol Moseley-Braun, Senator Carol Moseley-
    Braun, on efforts to begin on the school construction program.
    But that is not a widely held view.
        And my own sense is that if we make provision for those
    kinds of programs, there ought to be some discretion at the
    local level, if the local boards decide they want to do
    something else, because all of the districts are not the same.
    But we cannot have that debate in October and November. But we
    could have that debate in July, August or September.
        If the President vetoes a bill, let us debate it. Let us
    see what we are going to do and how the public responds to a
    little difference in the point of view.
        This year's budget has a very ambitious program on youth
    violence. And I thank the three secretaries and also the
    Department of Justice, and specifically Deputy Attorney General
    Eric Holder, for working with the subcommittee on a series of
    meetings last year, which resulted in the reallocation of some
    $893 million on 16 programs to try to focus on juvenile
    violence in a quiet, unpublicized way. But the at-risk children
    in America are an enormous concern.
        I just saw these statistics today that the Senator prepared
    from 1992 to the present. There have been 257 school-related
    violent deaths, 62 of which involved multiple deaths. I sat
    down with Bruce Reed, the domestic counselor, and talked to him
    about the coordination program. And I think that really has
    great potential.
        We are going to take a new look at the drug prevention
    program this year, which is a first cousin of youth violence,
    and try to take a look to see if we might reallocate some funds
    with some specific evidence on the drug issue.
        The Foreign Operations Subcommittee last week heard
    testimony for $1.6 trillion for money for Colombia. And I am
    very much interested in stability in Colombia, but I have grave
    doubts about $1.6 trillion going after a supply, which, if it
    is not from Colombia, will be from Bolivia or Equador or
    somewhere else.
        And I believe we have an imbalance with two-thirds of the
    money going to the so-called supply side. You have to work on
    interdiction. You have to work on street crime. And I spent a
    lot of my professional life doing that. But the demand side, I
    think, is much more promising, rehabilitation and education, to
    deal with that issue.
        Well, those are just a brief overview of some of the items
    at the top of my mind as to where we are going to be heading.
    If we can hold the opening statements--your full statements
    will be admitted into the record--to double time, to 10
    minutes, that would be great. If you need a little more time, I
    have never seen a cabinet officer interrupted yet.
        So we will begin with our very distinguished Secretary of
    Labor Alexis Herman, if that is the proper name, Ms. Herman.
        Ms. Herman was recently married, and she may want to
    correct the record, or she may not.
        We have just been joined by the illustrious Senator from
    Iowa, Senator Tom Harkin. So I will interrupt my introduction
    of Secretary Herman to yield to my colleague.
        Senator Harkin. Thank you very much, Mr. Chairman. I
    apologize for being late. I will just ask that my statement be
    made a part of the record.
        Senator Specter. And then I will proceed with the
    introduction.

                    OPENING STATEMENT OF SENATOR TOM HARKIN

        Senator Harkin. I would welcome the three secretaries here,
    in this last budget year of the Clinton administration. I
    particularly want to thank all three of the secretaries who are
    here for their great leadership.
        Secretary Riley and Secretary Shalala for the entire
    duration over the last 7 years, your great leadership of your
    two departments. And what you have done to move this country
    forward both in education, Secretary Riley, and in covering the
    health needs of all of our citizens, Secretary Shalala, I
    compliment you and commend you for your great leadership over
    these several years.
        And to Secretary Herman, again for your great work for the
    administration in your previous iterations, but also in your
    role in this last 4 years with the Department of Labor.
        Again, I think the budget that we have, as submitted by the
    administration, is one that will continue the progress that we
    have made in all these areas to continue to move this country
    forward in a way that education gets to the kids that maybe are
    not in the highest income areas and have the best schools and
    the best education, and gets to middle income families for
    college, for sending their kids to college, and the health
    needs, the labor area.

                               PREPARED STATEMENT

        I guess I just want to thank you all for what you have done
    over the last several years. It has been great working with
    you. And I commend you for this last budget of the Clinton
    administration, because it does keep us moving in that
    direction that you have so stalwartly led over the last several
    years, all of you. I just thank you for it and welcome you here
    for this hearing.
        Senator Specter. Thank you very much, Senator Harkin.
        [The statement follows:]

                    Prepared Statement of Senator Tom Harkin

        Mr. Chairman, it's a pleasure to welcome Secretary Herman,
    Secretary Shalala and Secretary Riley today to testify about the
    Administration's fiscal year 2001 budget.
        In general, I was very pleased with the overall fiscal year 2001
    budget. I think the President has balanced the need to fund important
    domestic programs--many of which are funded in this bill--with the need
    to protect Social Security and Medicare.
        Secretary Herman, I was very pleased to see the large increase in
    funds to eliminate child labor and I look forward to working with you
    on that initiative this year. I also want to commend you for your
    request to set up an Office of Disability Policy at the Labor
    Department. As the chief sponsor of the Americans with Disabilities
    Act, I am committed to ensuring that every American with a disability
    has the opportunity to achieve economic self-sufficiency and
    independence. I am pleased that you share my commitment.
        Secretary Shalala, I was glad to see that the Administration has
    requested a substantial increase for child care. Last year, during
    consideration of this bill on the Senate floor, we were able to
    increase funding for the Child Care and Development Block Grant to $2
    billion. We lost that increase in the end but I am committed to seeing
    that we increase funding for child care to $2 billion in this year's
    bill. I am also glad to see the requested $1 billion increase for Head
    Start. The evidence is very clear that we need to reach children when
    they are very young.
        I was somewhat disappointed about the budget request for NIH--an
    increase of $1 billion. Last year, this subcommittee was able to
    provide a $2.3 billion increase for NIH--maintaining a course to double
    NIH funding in five years. This year's request does not keep us on that
    course. Senator Specter and I have introduced a Sense-of-the-Senate
    calling on the Budget Committee to reflect an $2.7 billion increase for
    NIH in this year's budget resolution. The opportunities are out there,
    the potential is great. But we have to commit the resources to get the
    job done
        I must add that I was disappointed in the requested cut in the
    Community Services Block Grant and I hope to work with Senator Specter
    to restore that cut during this year's appropriation process.
        Secretary Riley, I was very glad to see your fiscal year 2001
    budget which calls for a $4.5 billion increase for education programs.
    And it will come as no surprise to you that I am particularly pleased
    with you request of $1.3 billion for school renovations and repairs. As
    you well know, the GAO has found that the cost of bringing the Nation's
    schools into good repair is about $112 billion. Today, I will be
    introducing a bill to reauthorize the existing school infrastructure
    program and look forward to working with you on this important
    initiative this year.
        Thank you, Mr. Chairman--and I look forward to hearing from our
    witnesses.

                   SUMMARY STATEMENT OF HON. ALEXIS M. HERMAN

        Senator Specter. One additional note before turning to
    Secretary Herman. At a presidential request of $622 billion,
    that exceeds the $540 billion cap in the fiscal year 2001
    appropriations by some $82 billion. We have not addressed that
    yet.
        And the caps have not been followed. But that is going to
    have to be addressed. According to the President's figures,
    that will still leave a $9 billion on-budget surplus. That is
    somewhat speculative, but we at least ought to note that it is
    not in compliance with the act, and we are going to have to
    deal with that as we proceed.
        Back to the Secretary of Labor, confirmed in May of 1997,
    prior to which she served as assistant to President Clinton and
    director of the White House Public Liaison Office. She had
    served as deputy director of the Presidential Transition
    Office.
        During the administration of President Carter, she directed
    the Women's Bureau at the Department of Labor, a graduate of
    Xavier University.
        And again, we congratulate you, Ms. Herman, on your recent
    nuptials and look forward to your testimony.
        Secretary Herman. Thank you very, very much, Mr. Chairman.
    I appreciate your words, also of congratulations. And I am
    still known as Secretary Herman and now Mrs. Charles Franklin.
    And quite frankly, I see no reason why I have to choose.
        I shall be known as both. But thank you very, very much.
        Senator Specter. Ms. Herman, you have been chosen, so you
    do not have to choose.
        Secretary Herman. Mr. Chairman and Senator Harkin, thank
    you for the opportunity to present the Department of Labor's
    fiscal year 2001 budget. It is a special pleasure for me to
    join my colleagues, Secretary Riley and Secretary Shalala, in
    outlining the administration's goals and priorities.
        Mr. Chairman, I think that we are all aware of the strength
    of the American economy today. Yet despite widespread
    prosperity, we still face two major and related challenges.
    Business leaders tell me that they simply cannot find the
    skilled workers that they need. And at the same time, millions
    of Americans remain outside the mainstream of our prosperity
    for lack of job skills.
        Yet, if we take these two problems together, I believe they
    constitute an historic opportunity to provide the business
    community with the skilled workers it urgently needs, while at
    the same time bringing skills, jobs and hope to individuals and
    communities that for too long have been left behind.
        The President's budget for fiscal year 2001 requests $39.8
    billion for our department, $12.4 billion in discretionary
    funds. This is an increase of $1.2 billion over last year.
        The majority of this increase is for targeted initiatives
    to provide the skilled workers who can meet the needs of our
    economy. Our budget puts special emphasis on young Americans.
    The Department of Labor's new Youth Opportunity Movement is the
    most intensive effort to reach young people in our history.
        I recently announced youth opportunity grants to address
    skills training and job placement in 36 of the poorest urban
    and rural areas and Indian reservations in America, places
    where the unemployment rate is more than 6 times above the
    national average. Our new budget includes $375 million for this
    initiative, an increase of $125 million over the current year.
        Mr. Chairman, you and I have visited youth programs in
    Philadelphia, and we have seen how they change the lives of
    young people. I believe our Youth Opportunity Movement will
    create similar success stories for tens of thousands of at-risk
    youth from coast to coast.
        Last September we discussed with this subcommittee ways to
    reduce violence and drug abuse among our young people. One of
    the administration's responses has been the Safe Schools/
    Healthy Students Initiatives started last year by the
    Departments of Justice, Education and Health and Human
    Services. Our new budget includes $40 million to enable the
    Department of Labor to join them in supporting community-wide
    programs to prevent youth violence and drug abuse and to
    promote youth employment opportunity.
        Mr. Chairman, we share your concern that too many out-of-
    work young people get into trouble and wind up in jail. We need
    to provide positive alternatives and second chances. That is
    why our budget builds on the youth offender projects that began
    under your leadership and proposes to add $61 million for a
    total amount of $75 million.
        The youth offender program will bring young offenders into
    the workplace through job training and placement and new
    partnerships with the criminal justice system. We hope that we
    will now be able to work even more closely with the Department
    of Justice, which has a companion proposal to bring these young
    people back into community life.
        Too often, youth unemployment is a part of an environment
    that also includes high dropout rates, drug abuse, gang
    activity, violence and crime.
        Mr. Chairman, in answer to the questions you raised in your
    letter about drug abuse reduction and early intervention, we
    believe that our youth-related programs can reduce social
    problems. Studies show that well-designed school programs lead
    to better academic achievement and lower rates of drug abuse,
    violence and arrest.
        For all of our focus, however, on young people, this cannot
    be our only concern. We have to reach out to other untapped
    pools of workers. These include 5.7 million unemployed
    Americans, 4.4 million who are not in the labor force but say
    they want a job, and an additional 3.2 million who work part
    time because they cannot find a full-time job.
        Our budget includes $255 million for our Fathers Work/
    Families Win, a new two-part initiative that grows out of the
    successful Welfare-to-Work Program.
        Fathers Work will provide jobs for non-custodial parents,
    mostly fathers who owe child support. Families Win will help
    low-income parents who are struggling to make ends meet by
    providing better access to community services and upgrading job
    skills.
        We are reaching out to people with disabilities, whose
    unemployment rates are more than three times the national
    average. We took an important step last December, when
    President Clinton signed the Bipartisan Work Incentives
    Improvement Act, which makes it possible for millions of people
    with disabilities to take jobs without losing their health
    insurance.
        Our budget also includes funds to establish an Office of
    Disability Policy, Evaluation and Technical Assistance headed
    by an Assistant Secretary, which will provide leadership in
    helping disabled Americans enter the workforce.
        We are now in the second year of a 5-year effort to provide
    skills, counseling and other assistance to every dislocated
    worker who loses a job through no fault of their own. To meet
    our goal of Universal Re-employment, our budget includes an
    increase of $275 million for information, training and One-Stop
    Career Centers.
        Our concern is not only putting Americans in jobs, but
    ensuring that those jobs provide an adequate living for them
    and for their families. That is why the President has asked
    Congress to increase the minimum wage by $1 over 2 years. And I
    strongly endorse his request.
        Our budget also includes funds to oppose the worst forms of
    child labor around the world and to support international labor
    standards. These proposals reflect the President's challenge
    for us to put a human face on the global economy and to ensure
    that every American worker can compete on a level playing
    field, recognizing that today what happens around the globe in
    fact impacts workers around the corner.
        Mr. Chairman, there will never be a better time than today
    to put America to work and to build an even stronger, more
    inclusive national economy. We will work with you in every way
    that we can to meet these goals.

                               PREPARED STATEMENT

        I appreciate the opportunity to appear before this
    subcommittee, and I look forward to answering any questions
    that you may have. Thank you very much.
        Senator Specter. Thank you very much, Secretary Herman.
        [The statement follows:]

                     Prepared Statement of Alexis M. Herman

        Mr. Chairman, and distinguished Members of the Subcommittee, thank
    you for the opportunity to appear today to present the Department of
    Labor's fiscal year 2001 Budget. I am particularly pleased to join my
    colleagues, Secretary Riley and Secretary Shalala, to discuss key
    Administration priorities.
        Mr. Chairman, I am especially pleased to be here with you today
    because the proposals in DOL's fiscal year 2001 budget request are
    exciting and innovative and build on seven years of solid
    accomplishments.
        The President's request for fiscal year 2001 reflects the
    Department's goal that all workers have the opportunity to find and
    hold jobs, with safe and healthful working conditions, good wages,
    secure pensions and health benefits; and that they have opportunities
    to improve their skills over their lifetime.
        To meet this goal, the overall budget for the Department in fiscal
    year 2001 provides a total of $39.8 billion in budget authority. DOL's
    request for discretionary programs is $12.4 billion, $1.2 billion above
    the fiscal year 2000 level. Since 1993, President Clinton has committed
    to investing in today's workers in order to keep America strong in the
    years ahead. This budget is faithful to that commitment.
        President Clinton, in his State of the Union Message, spoke of the
    extraordinary state of our economy the more than 20 million jobs
    created over the past 7 years, the lowest unemployment rate in 30
    years, and low inflation. America's workers are more productive, and
    real wages have increased as well.
        The President also recognized that our prosperity is not
    universally shared among all Americans. The President called for a 21st
    Century revolution of opportunity, responsibility, and community. This
    vision includes steps to reward work, strengthen families, and expand
    opportunities to all our citizens. DOL has an important role to play in
    meeting those challenges.
        I believe that the Department's programs are part of those all-
    important investments in the workforce and workplace of the future. Our
    bottom line is about helping people obtain skills, jobs and
    opportunity. It is about ensuring that, as our Nation moves forward, no
    one is left behind. We acknowledge that the Government cannot
    accomplish this alone; we need to enter into appropriate partnerships
    with others who share our commitment for a better America.

         HELPING WORKING FAMILIES AT A TIME OF UNPRECEDENTED PROSPERITY

        The dynamic forces of technology and globalization, while providing
    prosperity for many, continue to change the workplace in ways that may
    not benefit some Americans. Those who work hard should be able to
    realize the American dream for their families. DOL's budget takes
    account of the dramatic changes that are sweeping through the Nation
    and the world economy, and proposes significant, realistic policies and
    programs to help America's working families manage change and succeed
    in this new century.
        Today we face two major workforce challenges: one new and one old.
    Many businesses report difficulty in filling vacancies. At the same
    time, millions of Americans, including many youth, dislocated workers
    and people with disabilities, are having a difficult time getting jobs,
    even during this period of unprecedented economic expansion. As I have
    often said, we do not have a worker shortage, but a skills shortage.
    Through the initiatives in the fiscal year 2001 Budget Request, we can
    help provide the business community with the skilled workforce it needs
    while bringing prosperity to individuals and communities that have been
    left behind.

                             THREE STRATEGIC GOALS

        DOL's fiscal year 2001 Budget Request provides the resources we
    need to continue to make substantial progress toward DOL's three
    strategic goals: a prepared workforce, a secure workforce, and quality
    workplaces. I will first briefly describe our three goals and then
    describe the initiatives and programs in the fiscal year 2001 Budget
    Request that will help us to achieve these goals.
        A Prepared Workforce.--DOL's budget request reflects one of the
    President's top priorities: investing in education and training to help
    ensure that every American has the education and the skills to succeed
    in the increasingly competitive global economy. Among other things, we
    must help young people make a successful transition to the world of
    work and family responsibility. Because a changing economy often
    requires our Nation's workers--of all ages--to acquire new skills, we
    must also serve dislocated workers in need of assistance as the labor
    market changes.
        A Secure Workforce.--We must ensure that all Americans are
    economically secure both while in the workforce and after they retire.
    Employment-based pension and health benefits are the foundation of
    family security. Yet only about one-half of all full-time workers in
    the private sector have pension coverage today. Three-quarters of the
    workers in small businesses are not covered by a pension plan at all.
    Increasing access to our private pension system and assuring that
    private pensions, health care, and other employee benefits are secure
    and properly administered are some of DOL's most critical priorities
    addressed in this budget.
        Quality Workplaces.--My third goal is to help guarantee every
    working American a safe and healthful workplace with equal opportunity
    for all. I believe tough enforcement is necessary when an employer's
    practices threaten workers' safety and health, discriminate on the
    basis of gender, race, religion, color, national origin, veterans'
    status, or disability, endanger children, or deprive workers of fair
    wages. DOL's ultimate goal, however, is compliance with employment
    laws. There must be an appropriate balance of fair and consistent
    enforcement, cooperative partnerships, and compliance assistance and
    training. Within the context of our global economy, I am also firmly
    committed to improving workplaces internationally, such as by improving
    implementation of core labor standards internationally and by
    eliminating abusive child labor practices abroad.

                              A PREPARED WORKFORCE

        We must ensure that every American has the skills, the education
    and the training to be ready for the challenges and opportunities of
    the 21st century. The funds in DOL's budget will support programs to
    provide skills to young Americans, to work toward the goal of Universal
    Reemployment, and to reach out to untapped pools of workers, such as
    homeless veterans and Americans with disabilities, and bring them into
    the mainstream of our economy.
        The fiscal year 2001 Budget Request puts a special focus on helping
    young people gain the skills they need to start up the career ladder.
    Even in today's booming economy, in some areas, unemployment among
    young people reaches 30 percent or more, and that is simply
    unacceptable. We cannot afford to lose even one of these young people.
    There has never been a better time to invest in workforce development
    initiatives. That is why we have launched our Youth Opportunity
    Movement to give young people skills, jobs and hope.

    Youth opportunity movement

        I am proposing several programs under the Youth Opportunity
    Movement umbrella to address the opportunity gaps and reach untapped
    labor markets in order to advance the goal to promote a prepared
    workforce.
        I am very pleased that President Clinton helped launch our Youth
    Opportunity Movement as part of his New Markets tour last July. This is
    the most intensive effort to reach young people in our Department's
    history, and it is no secret that it is a personal priority of mine.
    Our Labor Day 1999 report entitled ``Future Work: Trends and Challenges
    for Work in the 21st Century'' points out that there are almost 11
    million young people who are not in school and have a high school
    diploma or less. The four million high school dropouts are at a
    particular risk of being permanently disconnected and disenfranchised
    from our society. There are warning signs when this is about to
    happen--the absence of supportive and caring individuals in their
    lives; low academic success which often leads to diminished self-esteem
    and leaving school; use and abuse of drugs and alcohol; out-of-wedlock
    births; and contact with the criminal justice system.

    Youth opportunity grants

        The Department's fiscal year 2001 budget includes $375 million for
    Youth Opportunity Grants, an increase of $125 million above fiscal year
    2000. This program is intended to provide comprehensive, longer term
    intervention, primarily in the lives of out-of-school youth living in
    inner cities and high poverty areas, to help them graduate from high
    school, get jobs, and progress in the workforce. On February 19, the
    President announced the first round of grants to 36 communities across
    the country--from Philadelphia to the Pine Ridge Indian Reservation.
    The fiscal year 2001 request includes $250 million to provide for the
    third year of funding of these five-year grants. An additional $125
    million is requested in fiscal year 2001 to fund the first year of 12
    to 15 new competitive grants to high poverty areas. The program will
    serve an estimated 85,000 young people next year. These grants will
    focus on raising the high school graduation rates and long-term
    employment prospects of young people living in these poor areas.

    Responsible reintegration for young offenders

        As you know, we have shockingly high rates of incarceration in our
    Nation today--and many of those in jail are young people. Too many out-
    of-work young people get into trouble and wind up in jail, and that is
    a tragic waste. We need to provide positive alternatives and second
    chances.
        That is why our budget includes $75 million to bring young
    offenders into the workplace through job training, placement, and
    support services, and by creating new partnerships between the criminal
    justice system and our workforce development system. When we get young
    people out of trouble and into jobs, we are not just helping
    individuals, we are strengthening the future of our communities. Each
    year, approximately 500,000 people leave prison. We must do more than
    lock people in jail. We must lead them into hope for the future.
        This initiative will build on our experience with the Youth
    Offenders projects begun under your leadership, Mr. Chairman. This
    large scale Workforce Investment Act (WIA) Pilot and Demonstration
    initiative will link offenders under age 35 with essential services
    that can help make the difference in their choices in the future, such
    as education, training, job placement, drug counseling, and mentoring,
    which are the primary tools for reintegrating this population into the
    mainstream economy. Through local competitive grants, this program
    would establish partnerships between the criminal justice system and
    local workforce investment systems, and will complement a related
    program in the Department of Justice. An estimated 19,000 offenders
    will be served by this initiative.

    Safe schools/healthy students

        When we think about the problems young people have today, we also
    think of the tragic outbreaks of school violence that have shocked the
    Nation. We must ask what we can do to reduce violence and drug abuse,
    and help move young people in the right direction.
        One of the Administration's responses to this challenge is the Safe
    Schools/Healthy Students Initiative, begun in fiscal year 1999 by the
    Departments of Justice, Education, and Health and Human Services. DOL's
    budget for fiscal year 2001 includes $40 million to enable DOL to join
    this partnership in supporting community-wide programs to prevent youth
    violence and drug abuse. With DOL's participation, the activities for
    the next round of grants can be expanded to provide services to out-of-
    school youth, including connections among high schools, post-secondary
    schools, alternative schools, and work-based learning programs, in an
    effort to reduce violent behaviors.
        The White House Council on Youth Violence--of which I am a member--
    will play an important role in coordinating both the Safe Schools/
    Healthy Students and young offenders initiatives.

    Job Corps

        The Job Corps continues to be America's biggest and most successful
    residential job training program for at-risk youth. The Job Corps
    provides intensive skills training and academic and social education
    for these youth. I am requesting $1.4 billion for the Job Corps in
    fiscal year 2001 to allow us to serve more than 73,000 young people at
    122 centers in almost every State. This request includes a net increase
    of $35 million above fiscal year 2000 for the Job Corps to support
    efforts to attract and retain top-quality staff, and for the operating
    costs of new centers.

    Universal reemployment

        For all our focus on young people, they are not and cannot be our
    only concern. Many other Americans need help gaining the skills
    demanded by today's economy. Sometimes the challenge is not first-time
    employment but reemployment for those who have lost jobs and need new
    skills. Two years ago the President set an ambitious goal for our
    Nation called ``Universal Reemployment.'' We are on the path to meet
    the goal of providing assistance to all dislocated workers who lose a
    job through no fault of their own. The initiative will: provide all
    dislocated workers who want and need assistance the resources to train
    for or find new jobs; expand and improve the quality of employment
    services now available to all job seekers and enhance services for
    individuals receiving unemployment compensation; and ensure access to
    the One Stop System, either in person or electronically, to help
    workers find jobs and training.
        The Department's fiscal year 2001 request includes $1.975 billion,
    an increase of $275 million above fiscal year 2000, for Universal
    Reemployment. Of this amount, $1.8 billion, an increase of $181
    million, will support dislocated worker retraining and adjustment
    assistance activities under Workforce Investment Act. This initiative
    will provide State formula grants, as well as a national emergency
    grant account, to help 984,000 laid off workers return to work quickly.
    These resources are part of a phased in effort to assist all dislocated
    workers in need of these services.
        We are requesting $154 million for new and better ways of providing
    employment and related information through One Stop Career Centers and
    America's Labor Market Information System (ALMIS)--an increase of $44
    million above fiscal year 2000. ALMIS services include America's Job
    Bank which now lists about 1.5 million jobs, and America's Talent Bank,
    which lists more than 500,000 resumes. Also included in DOL's request
    for the Universal Reemployment initiative is an additional $50 million
    for the One Stop Employment Service for reemployment services grants
    that will provide targeted, staff-assisted services to unemployment
    insurance claimants identified as having a high probability of
    exhausting their benefits. This will speed their reentry into
    employment and reduce benefit duration. Finally, the request includes
    $10 million to implement AgNet nationally, a system that will match
    agricultural workers with employers.
        We are also concerned about the skill levels of currently employed
    workers. DOL's budget proposes $30 million for a new program of
    employment and training assistance to incumbent workers under WIA Pilot
    and Demonstration authority. This effort is intended primarily to
    address the major job losses in the manufacturing industry where one
    half million jobs have been lost since March, 1998. Complementing the
    activities under the Universal Reemployment proposal, this initiative
    will boost skills and wages of non-management U.S. workers through
    competitive grants to States to train and upgrade the skills of about
    20,000 incumbent workers and, through local partnerships, to help firms
    with training in order to prevent displacements.

    Fathers work/families win

        The Department's budget includes $255 million for Fathers Work/
    Families Win, a new two-part initiative that builds on the Welfare-to-
    Work program. Fathers Work/Families Win promotes responsible fatherhood
    and supports working families.
        We have all heard about deadbeat dads. Well, Fathers Work is about
    upbeat dads. It will provide jobs for noncustodial parents--mostly
    fathers--who owe child support. Most of these fathers are young and
    unemployed. Most want to meet their obligations, and Fathers Work will
    help make that possible. You cannot pay child support if you do not
    have a job.
        A complementary part of this initiative, Families Win, will help
    low-income parents who are struggling to make ends meet by helping them
    find work, obtain better access to community services and upgrade their
    skills so they can move up career ladders. Together, these two
    initiatives are an important, exciting new way to put America to work.
    The strong working relationship we have forged with the Department of
    Health and Human Services in administering the job training, Welfare-
    to-Work, and Temporary Assistance to Needy Families programs will serve
    our Fathers Work/Families Win initiative. For example, our grants will
    go only to entities that have established relationships with child
    support enforcement agencies, reinforcing linkages that have been
    developed under Welfare-to-Work.
        These competitive grants will be awarded to State and local
    Workforce Investment Boards, enabling States and local communities to
    complement welfare reform efforts by focusing on work connections,
    post-employment work support activities, and skills training. The
    initiative helps families with incomes up to 200 percent of the poverty
    level.

    Disability initiatives

        We are also reaching out to another untapped pool of talent. Last
    December, the President signed the bipartisan Work Incentives
    Improvement Act, which makes it possible for millions of people with
    disabilities to take jobs without losing their health care. At a time
    when our economy is booming, 26 percent of persons with a severe
    disability are working, as compared to over 80 percent of those persons
    without a disability. We cannot afford to waste the talents of millions
    of Americans.
        DOL's budget includes funds to establish an Office of Disability
    Policy, Evaluation, and Technical Assistance headed by an Assistant
    Secretary. This new office will provide leadership within the
    Department of Labor in helping people with disabilities enter, re-
    enter, and remain in the workforce. With the recent passage of the Work
    Incentives Improvement Act and the Workforce Investment Act, the stage
    is set to achieve real change in the unemployment rate of people with
    disabilities. In addition, DOL's budget continues the competitive
    grants enacted in fiscal year 2000, totaling $20 million to be awarded
    each year by the Department to partnerships of organizations to provide
    incentives for broader systems--building on efforts to coordinate
    service delivery through, and linkages across, the One Stop Career
    Center system established by the Workforce Investment Act.

                           HOMELESS VETERANS PROGRAMS

        Homeless veterans represent another group with untapped promise.
    The Department's request for fiscal year 2001 includes $15 million--a
    50 percent increase over the fiscal year 2000 level--to provide
    employment and training services to help about 15,000 homeless veterans
    obtain employment and progress toward self-sufficiency. We expect about
    8,700 homeless veterans to find jobs as a result of the services we
    provide.

    Economic indicators

        The Department is also requesting $20 million for the Bureau of
    Labor Statistics, $12 million of which is for new initiatives to
    improve major economic indicators, which are critical for monitoring
    the state of the economy and implementing Federal legislation. In its
    Producer Price Index program, BLS will extend coverage for the first
    time to the construction sector of the U.S. economy, and will continue
    its ongoing expansion of coverage in the service sector. This budget
    request includes $4.3 million to develop a new timeuse survey that will
    provide nationally representative estimates of how Americans spend
    their time in an average week, weekday, and weekend. This will provide
    important and meaningful data in many areas such as the amount of time
    invested in the care of the young and the elderly in our society,
    variations between single and two-parent families, and time invested in
    skills acquisition.

                               A SECURE WORKFORCE

        The second strategic goal is a secure workforce. It is not enough
    simply to have a job. The goal of a secure workforce helps attain
    important values, such as dignity, family and community. A job should
    pay a decent wage, should provide health care benefits and should lead
    to a quality retirement.
        You cannot have security, or strong families and strong
    communities, if people work hard and still cannot pay their bills. That
    is why the President has proposed to increase the minimum wage by one
    dollar an hour over the next two years. This increase would help more
    than ten million workers--almost 70 percent of them adults and 60
    percent of them women. For a minimum wage worker, a $2000 raise is
    enough for a family of four to pay its rent for five months or to buy
    groceries for seven months. Raising the minimum wage is simple economic
    justice.
        Too many workers are also insecure because they are afraid their
    jobs will be sent overseas. That is why the President again proposes
    legislation to consolidate, reform and extend the Trade Adjustment
    Assistance and NAFTA Transitional Adjustment Assistance programs for
    workers who lose their jobs due to trade. The proposals would expand
    eligibility for benefits to workers who lose jobs when production
    shifts abroad, increase training opportunities for trade-affected
    workers, link training and income support, and provide needed support
    services.
        Pension, health and other employee benefits are vital to the
    economic security of hard-working Americans and their families. As
    Secretary of Labor, I have the responsibility for protecting these job-
    based benefits for more than 150 million Americans.
        We work diligently to make sure workers feel secure in their
    promised benefits. We make certain that the assets held by pension and
    health plans are secure and available to pay promised benefits. The
    Department operates a nationwide program of educational outreach and
    technical assistance that serves to protect the rights of workers and
    their families entitled to benefits under their job-based benefit
    plans. We provide broad-based outreach to employers, especially small
    employers, to assist them with their questions about the plans they
    sponsor for their employees and to encourage those employers who do not
    sponsor a plan to consider setting one up. The Department also
    recognizes the importance of partnerships--we work with the employee
    benefits community to find innovative solutions that enhance our
    nation's system of employee benefits.
        That is why our budget request of $108 million for the Pension and
    Welfare Benefits Administration includes additional resources to expand
    our efforts to provide protection to the health care and pensions of
    workers and their families. These new protections will include
    implementing a new program (the Rapid ERISA Action Compliance Team) to
    better protect the rights and benefits of American workers and their
    families if their employer faces financial hardship and their pension
    and health benefits are in jeopardy. In addition, the budget request
    will expand the Department's Health Benefits Education Campaign and
    enhance our customer service efforts by developing new publications,
    multimedia educational products and the creation of a toll-free
    interactive system to provide individuals with maximum direct access to
    the customer service staff trained to answer their health care and
    pension related questions. These initiatives will build on our ongoing
    efforts and allow us to respond to the increasing demand from workers
    and their families for assistance--last year we responded to over
    153,000 inquiries from workers and their families and obtained benefit
    recoveries of over 62 million dollars.
        The Pension Benefit Guaranty Corporation (PBGC) also helps achieve
    the goal of a secure workforce by guaranteeing pension benefits for 42
    million workers and retirees in private-sector defined benefit plans.
    The budget request provides increases for enhanced computer security
    and to speed final benefit determinations.

                               QUALITY WORKPLACES

        Our third strategic goal is quality workplaces. By quality
    workplaces, we mean those that reflect such basic values as health,
    safety and fair play. Globalization means we must be concerned about
    the quality of workplaces overseas as well as at home. That is why the
    President has challenged us to put a human face on the global economy.

    International child labor
        According to the International Labor Organization, an estimated 250
    million children between the ages of 5 and 14 are working in developing
    countries, 120 million of them full time, and tens of millions under
    abusive or dangerous conditions. We are committed to improving the
    lives of children both at home and abroad by opposing abusive child
    labor wherever it exists and by providing the necessary resources for
    its elimination. Building on our past funding of the ILO's
    international child labor program, and the recent ILO convention on
    banning the worst forms of child labor that was unanimously approved by
    the U. S. Senate in November and signed by the President in December,
    the Administration proposes $100 million to support international
    efforts to eliminate abusive child labor. These funds would not only
    permit us to increase the global efforts to remove children from
    abusive and dangerous conditions, but would also allow us to increase
    our efforts to support the educational infrastructure in areas where
    oppressive child labor is a pervasive and systemic problem. Education,
    not hard labor provides children with real opportunities and hope for a
    better future. I would like to thank Senator Harkin for his impressive
    leadership on this issue over the past several years.

    International labor standards
        Additionally, our budget includes $40 million for international
    core labor standards initiatives. The Department proposes to expand the
    efforts begun last year to achieve internationally-recognized core
    labor standards, and to build social safety nets, so American workers
    can be more confident that we are building a global economy with the
    ``human face'' that President Clinton has called for. This should be a
    race to the top--not to the bottom. In all these ways, we are working
    to make globalization empower workers and improve their lives, not
    accept a lowering of standards at a time when so much progress is
    possible.
        When we consider quality in the international workplace, we must
    also consider the terrible harm being done by HIV/AIDS. When I was in
    Africa last year, I saw that AIDS is not only a vast human tragedy but
    a major economic disaster. When workers die, their skills and
    experience die with them. Production is down in many countries. This
    disease threatens not only development and progress in Africa but peace
    and stability.
        That is why our budget includes $10 million as part of a larger,
    government-wide Global HIV/AIDS Initiative that will work with African
    leaders to use the workplace as a forum for providing health education
    programs to prevent the spread of AIDS. The workplace has a great,
    potential for providing millions of workers with information that can
    literally save their lives.

    Domestic child labor
        To continue our commitment towards reducing the more than 200,000
    workplace injuries that occur among young workers in America each year,
    I am requesting $13 million for the Department's domestic child labor
    activities, including $8 million to continue to help eliminate
    violations of domestic child labor laws, particularly in the
    agricultural sector, and $5 million for demonstration programs to
    provide alternatives to field work for migrant youth. This request
    includes additional funds to implement targeted enforcement tools,
    including ``strike teams'' in the agricultural and garment industries,
    and to enhance education and outreach efforts undertaken as part of the
    ``Safe Work/Safe Kids'' initiative.

    Family leave
        Today, the Family and Medical Leave Act (FMLA) allows covered and
    eligible workers to take up to 12 weeks of job-protected, unpaid leave
    to care for a newborn or adopted child, attend to their own serious
    health needs, or care for a seriously ill parent, child, or spouse
    making it less likely that employees will have to choose between work
    and family. The President has again proposed to expand the FMLA to
    reach workers in firms with 25 or more employees, extending coverage to
    12 million more workers.
        For lack of money and other reasons many workers are unable to take
    advantage of unpaid leave. The Department is requesting $20 million to
    fund competitive planning grants for States and other interested
    entities to explore ways to make parental leave and other forms of
    family leave more affordable and accessible for American workers. This
    initiative will help identify in more detail the workers in need of
    financial assistance to take parental/family leave and to develop and
    evaluate options to aid these workers.

    Equal pay
        We cannot talk seriously about a quality workplace unless we also
    talk of equal pay for equal work. Today, the average woman who works
    full-time earns approximately 75 cents for each dollar that an average
    man earns. This gap, in part, is attributable to differing levels of
    experience, education and skills. However, even after accounting for
    these factors, a significant pay gap remains between men and women.
    When women are not fairly paid, their whole family suffers. We need to
    rid ourselves of this stubborn, lingering pay discrimination.
        That is why the President has proposed an Equal Pay Initiative to
    expand opportunities for women and help end wage discrimination. His
    proposal includes $17 million for the Department to support initiatives
    on behalf of equal pay. The Equal Pay Initiative dedicates $10 million
    from the current H-1B nonimmigrant fee for DOL to train women in
    nontraditional occupations such as those in high-tech industries and
    also provides $7 million to help employers assess and improve their pay
    policies, to provide nontraditional apprenticeships, and to support
    public education efforts. The President supports the Paycheck Fairness
    Act, which would strengthen wage discrimination laws and provide for
    additional research, training, and public education efforts on this
    important subject.

    Workplace safety
        Finally, safety and health are absolutely basic to a quality
    workplace. We are proud that for the sixth consecutive year, workplace
    injury rates have come down and are now at the lowest level since we
    began keeping records in the 1970s. But we can still do better. Even
    one workplace death is too many.
        Our budget includes $668 million to promote health and safety for
    more than one hundred million workers through programs of the
    Occupational Safety and Health Administration and the Mine Safety and
    Health Administration. Through a combination of targeted enforcement,
    compliance assistance and partnerships, these agencies work hard to
    protect workers from illness, injury and needless death.
        The Department's request includes a $44 million increase for OSHA
    which will enable OSHA to achieve better balance between its outreach
    activities, such as compliance assistance and training, and its
    enforcement activities, which in recent years have been targeted to
    high hazard worksites. The increase will improve our ability to provide
    expertise and services to both employers and employees.
        Among OSHA's efforts to provide safe and healthful workplaces is
    its ergonomics rulemaking. Workers suffer roughly 600,000
    musculoskeletal disorders each year. The proposed standard can protect
    27 million workers from the risk of incurring such injuries and
    illnesses. I remain committed to completing the standard this year.
        The Department is requesting an increase of $14.2 million for the
    Mine Safety and Health Administration's (MSHA's) programs to enhance
    protection of miners, by providing necessary training to miners and for
    better auditing of accident and injury reporting. Approximately $3.2
    million of this increase will augment MSHA's enforcement activities in
    the metal/nonmetal industries. DOL's budget also includes a request for
    additional funds for the State grant program to provide training
    assistance to miners and mine operators.

    Information technology initiative
        The Department's fiscal year 2001 budget establishes a permanent,
    centralized IT investment fund for DOL managed by the Chief Information
    Officer (CIO). In the past, DOL agencies have separately budgeted for
    and managed their own IT investments. While the investments met the
    immediate needs of the individual agency, a unified approach will
    provide more efficient and effective services.
        For fiscal year 2001, the Department's request includes $60 million
    to fund IT investments within three crosscutting areas: (1) Information
    Technology Architecture and Web Services; (2) Common Office Automation
    Implementation; and (3) Security-Critical Infrastructure Protection.
    These investments will enable the Department to implement a sound
    information technology investment strategy, and expand our Internet
    capacity for the elaws program which provides the public with
    additional access to information on labor laws.

                                   CONCLUSION

        These are some of the ways we will work in fiscal year 2001 to
    achieve our Department's strategic goals. These are important, exciting
    initiatives, because they are not just numbers or words on paper--they
    are about helping real people, with real talents to develop and real
    challenges to overcome.
        I will be happy to answer to any questions you may have about the
    fiscal year 2001 President's Budget for the Department of Labor.

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                            Office of the Secretary

    STATEMENT OF HON. DONNA SHALALA, SECRETARY

        Senator Specter. We now turn to the distinguished Secretary
    of Health and Human Services. As noted by Senator Harkin,
    Secretary Shalala has served during the full 7 years plus of
    the President's administration. And beyond that is the longest
    serving Secretary of Health and Human Services in U.S. history.
        During her career, she has been a scholar, a teacher, a
    public administrator, chancellor at the University of
    Wisconsin-Madison, where she was the first woman to head a big
    ten university, and named by Business Week as one of the five
    best managers in higher education. She earned a Ph.D. from the
    Maxwell School of Citizenship in public affairs.
        And we welcome you back, Madame Secretary.
        Secretary Shalala. Thank you very much, Senator Specter,
    Senator Harkin, members of the subcommittee.
        I would like to begin by thanking you, Mr. Chairman, for
    the leadership you have shown in working to prevent youth
    violence. And I would like to thank Senator Harkin for his kind
    words, too.
        When we presented our fiscal year 2001 budget, I noted the
    searing images that we saw last year at Columbine and other
    schools must never be repeated. If there was ever a bipartisan
    issue in this country, this is it. That is why the President
    worked with Congress to establish a new White House Council on
    Youth Violence to get all Federal agencies thinking and working
    together to prevent youth violence.
        And that is why my colleagues, Secretary Herman and
    Secretary Riley, and I join you in your determination to bring
    to bear the resources we need to fight this problem
    effectively. How pleased I am to be with both of them today.
        At HHS, the Surgeon General is developing a report on youth
    violence that we expect to be completed this year. However,
    this much we already know. Violence is preventable. So we
    intend to find out what works and what does not and then
    publish and disseminate a source book of the best practices.
    Our budget also increases the mental health block grant by $60
    million, a full 17 percent. And we are budgeting another $78
    million to stop youth violence.
        Now let me highlight other important features of our budget
    and why we believe this budget is critical to the health and
    future of the American people.
        Our fiscal year 2001 budget brings us to where we should be
    at the dawn of a new century, a great nation pledging
    allegiance to great goals. Those goals are expanded health care
    coverage, renewed support for children and families, greater
    scientific advancement, and the creation of a healthier
    America. Our fiscal year 2001 budget brings those goals within
    reach without loosening our commitment to fiscal discipline or
    to a balanced budget.
        This budget is about people. It makes a record investment
    in health care coverage, in access and in quality. Two years
    ago, with bipartisan support, we launched the State Children's
    Health Insurance Program. Two million children are now
    enrolled.
        Now we want to make sure that this new program, and
    Medicaid, carry millions more children and their parents into
    the safe harbor of quality health care. The President's Family
    Care Program will do just that.
        But even as we expand coverage to some parents through
    Family Care, we recognize that many low income adults work in
    jobs that do not offer health insurance. These workers
    frequently rely on local health institutions and local
    professionals who provide services at a reduced or no cost.
    Secretary Herman has married a man who does exactly that. Dr.
    Franklin is a family doctor.
        And while he gets reimbursement from many parts of the
    health care system, he told me the other night that he also
    often has to offer reduced cost services to make sure the
    families he has treated over the years, who might lose their
    health insurance, continue to get that treatment.
        This year we want to increase our support for community
    service networks to $125 million, five times our investment
    last year. We need to strengthen and modernize Medicare. First
    and foremost, that means dedicating more than $300 billion of
    the on-budget surplus over 10 years to extend the solvency of
    the trust fund until 2025.
        We also must add a voluntary prescription drug benefit to
    Medicare. And I emphasize voluntary. As the President said in
    his State of the Union message, we would never design Medicare
    today without a prescription drug benefit. We cannot change the
    past. However, we can change the future and catch up with
    modern medicine. But the longer we wait, the worse the problem
    will become. And the more expensive it will become.
        Government cannot step into the shoes of parents and
    communities. But government does have a role to play in helping
    families balance work and children. One recent study notes that
    in 1998 only 10 percent of the 14.7 million children eligible
    for Federal child care subsidies received them.
        So as part of the President's Child Care Initiative, this
    year's budget adds another $817 million to the Child Care
    Development Block Grant.
        Senator Specter, you will recognize that exact amount,
    because we talked about it during the appropriations process
    last year. This is part of our discretionary budget and brings
    the total block grant to $2 billion.
        Mr. Chairman, Head Start is one of the most successful
    bipartisan programs our two branches of government has ever
    created for children. And this year we are requesting $6.3
    billion for Head Start. That is $1 billion more than last year,
    the largest increase in the history of Head Start. We believe
    the program merits it.
        I cannot talk, of course, about children without talking
    about drugs, as you have yourself, Mr. Chairman. I know that
    you would like to pursue this further in our question and
    answer period.
        We know that marijuana use has leveled off among teens, but
    too many teens are still saying yes to drugs and alcohol. And
    that is why our budget includes over $3.3 billion for substance
    abuse treatment and prevention.
        I mentioned the success we have had in cutting the death
    rate from AIDS, but HIV/AIDS is still a disease without a cure.
    And it is still the greatest public health challenge both here
    and around the world. So fighting HIV/AIDS remains a top
    priority for the department. Our total AIDS budget this year is
    $9.2 billion, an increase of 8.4 percent over last year. Every
    agency's AIDS-fighting budget is going up, in prevention,
    treatment and research.
        On the prevention side, we have proposed to add an
    additional $75 million to help stop the spread of the disease.
    Specifically, the CDC will direct $40 million of the new funds
    to local communities, including prevention services to target
    minority communities. CDC will spend another $26 million to
    fight AIDS around the world.
        And at the same time, the Health Resources and Services
    Administration will spend $1.7 billion in Ryan White funding to
    help people living with HIV/AIDS. This is a $125 million
    increase over last year.
        Our budget requests for AIDS-related research at NIH is
    $2.1 billion, a 5.2 percent increase over last year. The total
    NIH budget this year is $18.8 billion, $1 billion more than
    last year. This subcommittee, of course, should take pride in
    the unprecedented investment it has made in basic and clinical
    research.
        Our shared commitment to the National Institutes of Health,
    and to producing quality science and quality scientists of the
    next generation on both the NIH campus and at the great
    research universities, is an extraordinary legacy.
        Years from now, I predict we will see results beyond our
    wildest dreams. And some of those results are certain to come
    from the $73 million we intend to invest over 2 years to build
    a National Neuroscience Research Center at the National
    Institutes of Health. This will put all NIH brain research
    under one roof. More important, the center will usher in what
    is certainly to be the century of the brain.
        In the interest of time, let me quickly mention three other
    areas where we intend to increase our discretionary budget. We
    take very seriously the need to stop infectious diseases and
    bioterrorism.
        Our budget increases by almost 50 percent CDC's funding for
    disease surveillance. As for bioterrorism, which may be the
    biggest threat of the 21st century, we are proposing to spend
    $265 million to prepare for and respond to biological attacks.
        We also want to make a major investment in bricks and
    mortar. In addition to the Neuroscience Research Center at NIH,
    CDC proposes to spend $127 million, $70 million more than last
    year, to modernize and expand three critical laboratory sites.
    The remaining funds will go towards completing the Edward R.
    Roybal infectious disease lab and construction of a new
    environmental health lab.
        Mr. Chairman, I want to conclude my testimony by noting
    that our greatest moral imperative is to close the gaps in
    health outcomes between minorities and the majority population.
    In 1998, the President set a goal of ending health disparities
    in six major areas. Now almost every operating division of my
    department is working to close these gaps.
        That includes an additional $35 million for CDC for
    community-based research and demonstration projects to reduce
    disparities, money aimed at those communities themselves.

                               PREPARED STATEMENT

        Thank you very much, Mr. Chairman and members of this
    committee. I would be happy to join my colleagues a little
    later to answer any questions you may have.
        Senator Specter. Thank you very much, Secretary Shalala.
        [The statement follows:]

                    Prepared Statement of Hon. Donna Shalala

        Good morning, Chairman Specter, Senator Harkin, and members of the
    Subcommittee. I am pleased to appear before you today to discuss the
    President's fiscal year 2001 budget for the Department of Health and
    Human Services. At the outset, let me thank you again, Mr. Chairman,
    for your leadership on the prevention of youth violence and substance
    abuse and on the treatment of mental health--issues which I will
    discuss in detail later in my testimony. I am honored to be here with
    Secretaries Herman and Riley to continue our dialogue and coordinated
    efforts in these areas.

                              A PROUD HISTORY. . .

        Mr. Chairman, before I discuss our plans for confronting the
    challenges that lie ahead, I think it is important first to take a look
    back at where we have been. Over the past seven years, we have worked
    together to develop innovative solutions that have improved the health
    and well being of all Americans. Let me note just a few of these
    accomplishments:
      --Working together, we have expanded enrollment in Head Start from
            approximately 714,000 children in 1993 to an estimated 950,000
            in this budget, while at the same time improving the quality of
            the program, thereby providing a strong foundation for success
            for hundreds of thousands of low-income children.
      --Two years ago, the President called for an increase of almost 50
            percent over five years in the NIH budget as part of his
            Research for America Fund. Since that time the NIH budget has
            increased by over $4.2 billion and, with the funding proposed
            by the President this year, we will be ahead of schedule in
            reaching our goal. In addition, we have increased the number of
            Research Project Grants funded by the National Institutes of
            Health by over 30 percent, from 23,952 in fiscal year 1993 to
            31,524 in this budget. This represents a dramatic expansion of
            our scientific knowledge base that will pave the way for
            biomedical advances in the years ahead.
      --We have nearly doubled the number of people receiving access to
            comprehensive combination drug therapy under the Ryan White
            Care Act AIDS Drug Assistance Program (ADAP), from almost
            49,000 in 1994 to approximately 75,000 with this budget.
      --We have improved the health of our seniors by increasing the number
            of healthy meals served to older Americans under the
            Administration on Aging's Nutrition programs from 240 million
            in fiscal year 1994 to 279 million in this budget year.
      --With the enactment of the Health Insurance Portability and
            Accountability Act of 1996, we have helped individuals keep
            their insurance when they change jobs, guaranteed renewability
            of coverage, and helped ensure access to health insurance for
            small business.
      --Together with the states, we have undertaken the largest health
            care coverage initiative since Medicare, namely the State
            Children's Health Insurance Program. In just the two years
            since its enactment, the number of children enrolled in SCHIP--
            now almost 2 million--has doubled. In addition, the number of
            states covering children up to 200 percent of poverty has
            increased by more than sevenfold.
      --Last year, the President signed into law the bipartisan Ticket to
            Work and Work Incentives Improvement Act that allows people
            with disabilities to maintain their Medicare and Medicaid
            coverage when they go to work. It also includes a new
            demonstration program that allows people with disabilities who
            are still working and are not sufficiently disabled to qualify
            for Medicaid to obtain coverage and reforms the training system
            for people with disabilities.
      --We created the Vaccines for Children Program, to finance
            immunizations for children without private health coverage.
            Childhood immunization coverage rates in 1998 were the highest
            ever recorded. Ninety percent of toddlers in 1996, 1997 and
            1998 received the most critical doses of each of the routinely
            recommended vaccines, surpassing the President's 1993 goal.
        We also have undertaken a number of new initiatives to target
    emerging threats and address long-standing problems. We have launched
    new initiatives to promote research on disease prevention and health
    care quality, to improve the quality of nursing home care, to provide
    support for our nation's children's hospitals, and to increase the
    number of children adopted from our child welfare systems. To educate
    Medicare beneficiaries about their health care options, we have
    implemented the largest peacetime outreach campaign ever undertaken by
    the federal government. We have stepped up efforts to increase the
    availability of substance abuse treatment, to eliminate racial and
    ethnic health disparities, and to address the AIDS crisis in minority
    communities. And we have invested significant resources to prepare the
    nation to respond to the medical and public health consequences of
    chemical and bioterrorist attacks. We have launched new initiatives to
    protect the rights of Americans in managed care and protect the privacy
    of electronic medical records, and most recently, to improve patient
    safety and reduce preventable medical errors in our health care
    systems.
        While we should be proud of past accomplishments, we must continue
    to address ongoing health and human services challenges. These include:
    expanding access to quality health care and extending protections to
    the uninsured and at-risk; supporting working families and bettering
    the lives of our nation's children; encouraging greater scientific
    advancement; and creating a healthier America.
        Thanks to our continuing economic prosperity, we have a great
    opportunity to meet these challenges. In the last two years, we have
    recorded back-to-back surpluses for the first time since the 1950's.
    The combination of a strong economy, fiscal discipline, and
    unprecedented advances in our scientific knowledge give us the
    opportunity to make the investments needed to build on all of our
    achievements over the last seven years.
        Mr. Chairman, the total HHS budget request for fiscal year 2001 is
    $421.4 billion (Outlays). The amount before this subcommittee totals
    $267 billion (BA), of which $44.8 billion is discretionary. This
    discretionary component represents an increase of $4.5 billion over
    last year. Let me now highlight the main components of our fiscal year
    2001 budget request.

                         EXPANDED HEALTH CARE COVERAGE

        We live in an age of remarkable advances in the biomedical
    sciences. Yet too many of our citizens are denied the benefits of these
    advances because they lack access to quality, affordable health care.
    Throughout his Administration, President Clinton has made expanding
    access to health care one of his most important goals. Working with the
    Congress, we have had some notable successes, including enactment of
    the State Children's Health Insurance Program, which today covers
    nearly 2 million children; the Health Insurance Portability and
    Accountability Act, which allows workers to keep health insurance
    coverage when they change jobs and limits the ability of insurers to
    deny coverage based on pre-existing conditions; and most recently, the
    Ticket to Work and Work Incentives Improvement Act, which allows
    disabled Americans to return to work without losing their Medicare and
    Medicaid coverage.
        But even with these successes, approximately one-seventh of the
    population still lacks health insurance. Our budget seeks to address
    these problems through a number of initiatives designed not only to
    expand access to care but to improve the quality of health care as
    well.

    Expanding coverage under Medicaid and SCHIP

        The State Children's Health Insurance Program (SCHIP), enacted in
    1997, now provides nearly two million low-income, uninsured children
    with access to health insurance, preventive medicine, and
    immunizations. While the success of the SCHIP program has greatly
    enhanced the health of these children, many of their parents remain
    uninsured. And there still are many children who are eligible for
    Medicaid and SCHIP who are not currently enrolled. With the country's
    resources growing, the economy booming, and the SCHIP program showing
    great progress, it makes sense to take advantage of this opportunity to
    implement new options for low-income working families without health
    insurance. The President's budget includes proposals to create a new
    ``FamilyCare'' program that expands coverage to the parents of children
    eligible for Medicaid and SCHIP, increase outreach efforts, and
    simplify the enrollment process.
        Under FamilyCare, parents would be enrolled in the same programs as
    their children, and states would receive the higher SCHIP matching
    payments for expanding coverage to parents. To ensure that the original
    intent of the SCHIP program is met, states would be required to expand
    eligibility for children up to 200 percent of poverty before accessing
    funds to cover parents. As is the case with children, priority in
    enrollment would be given to lower-income parents before covering
    higher-income parents.
        If, after five years, some states have not expanded coverage of
    parents to at least 100 percent of poverty, they would then be required
    to do so. By 2006, all poor parents would be eligible for coverage just
    as their children are today. We believe that enrolling parents in
    Medicaid or SCHIP will not only improve their health, but will also
    make it easier for entire families to access insurance through one
    source, thereby increasing the number of children participating in the
    program. This FamilyCare initiative is a practical, targeted approach
    to encouraging greater insurance coverage. Over eighty percent of
    parents of uninsured children under 200 percent of poverty are
    themselves uninsured, while nearly two-thirds of uninsured parents (6.5
    million) have children eligible for Medicaid or SCHIP. The budget
    proposes to extend and improve the transitional Medicaid program, which
    provides important health insurance coverage for families moving from
    welfare to work. Our proposals would use existing state administrative
    and delivery systems and no new bureaucracies would be needed.
        In addition to covering parents, states also will be given the
    option to extend Medicaid coverage to young people ages 19 and 20. If
    they do, they will also have the option to cover kids up to age 20
    under SCHIP. To further increase Medicaid and SCHIP enrollment, the
    President's budget supports new efforts to simplify eligibility and
    aggressively expand efforts to enroll eligible children identified
    through school lunch programs. To ensure that children are not
    overlooked in States that have different rules and procedures for
    Medicaid and SCHIP, we also propose to require that States conform
    certain eligibility rules between Medicaid and SCHIP. Our budget also
    proposes $10 million in mandatory funding for competitive grants to
    States that develop innovative plans for outreach to the homeless and
    the coordination of services across the Medicaid, SCHIP, TANF, Food
    Stamps, and Mental Health and Substance Abuse programs. If they do,
    they also will have the option to cover kids up to age 20 under SCHIP.
        Finally, our budget seeks to reverse some of the inequities that
    have resulted from the 1996 welfare reform legislation by giving states
    the option to provide Medicaid or SCHIP coverage to legal immigrant
    children and pregnant women. The budget also proposes to restore SSI
    and Medicaid eligibility to legal immigrants who entered the United
    States after the enactment of welfare reform, become disabled and live
    in the U.S. for five years. Parents of legal immigrant children would
    also be eligible for coverage under our FamilyCare proposal. In
    addition, the budget seeks to restore Food Stamps eligibility to legal
    immigrants who were in the country before the enactment of welfare
    reform and either subsequently reach age 65 or have children who are
    eligible for Food Stamps.
        In addition, the budget will take an important step to improve the
    health of low-income Americans by ensuring that they have access to
    drugs that help them quit smoking. The budget will ensure every state
    Medicaid program covers both prescription and non-prescription smoking
    cessation drugs, removing a special exclusion now in law, and requiring
    states to cover these drugs as they cover all other FDA-approved drugs.
    Modernizing and strengthening Medicare
        For the last thirty-five years, Medicare has been the cornerstone
    of our efforts to ensure that all seniors have access to the quality
    health care they need and deserve. However, since its enactment in
    1965, much in the health care system has changed, not only the types of
    care provided and the setting in which these services are performed,
    but also the makeup of the population that receives Medicare. These
    changes have dramatically increased the financial strains on the
    Medicare program, and current actuarial projections show that by
    approximately 2015, just as the large baby-boom generation is becoming
    eligible, Medicare may be faced with insolvency.
        The Clinton-Gore Administration budget also dedicates $432 billion
    over ten years to Medicare to extend the solvency of the Trust Fund
    until at least 2025 and to create a voluntary, affordable prescription
    drug benefit. It includes a new, multi-billion dollar reserve fund that
    can be used to add protections against catastrophic drug costs to the
    President's proposed drug benefit. This financing commitment is part of
    a comprehensive plant to modernize and strengthen Medicare to ensure
    that it can continue to deliver high quality, affordable care in the
    21st Century. These steps include making the program more competitive;
    introducing private sector purchasing and management tools; and
    continuing our historic fight against fraud, waste, and abuse.
        Over the last thirty-five years, the development of new
    prescription drugs to treat a variety of conditions has helped
    Americans to live longer and higher quality lives. The centerpiece of
    the President's plan to modernize Medicare is a voluntary prescription
    drug benefit that would be affordable and accessible to all
    beneficiaries. This benefit, which would rely on market competition to
    obtain lower prices, would have no deductible, and would pay half of
    all costs up to $2,000 in fiscal year 2003, increasing to $5,000 by
    fiscal year 2009. The plan would fully pay for costs for beneficiaries
    with incomes below 135 percent of the poverty level, and provide
    premium assistance for those with incomes between 135 and 150 percent
    of the poverty level, while providing financial incentives to employers
    to continue offering prescription drug benefits to current retirees.
        The President's budget also proposes much-needed incentives to
    increase the utilization of preventive services by Medicare
    beneficiaries. Our plan would eliminate existing coinsurance and
    deductibles for covered preventive benefits, including colorectal and
    prostate cancer screenings, pelvic exams, mammographies, bone mass
    measurement, and diabetes self-management. The President also is
    planning to develop a three-year demonstration for smoking cessation
    services. By lowering the cost and expanding the availability of these
    services, we will not only save lives, but will minimize the need for
    more extensive, and expensive, treatments in the future.
        While we work to strengthen Medicare to better serve current
    beneficiaries, our budget also includes proposals to expand access to
    Medicare to groups who face barriers to health insurance coverage.
    These proposals will allow Americans ages 62 to 65 to buy into Medicare
    by paying a premium, provide a similar buy-in option for displaced
    workers ages 55 to 62 who have lost employer-provided health coverage,
    and provide COBRA coverage to retirees between the ages of 55 and 65
    whose companies have reneged on their promise to provide health
    benefits. To make these buy-in options more affordable, the budget
    includes a proposal for a tax credit, available to displaced workers
    over age 55 as well as all eligible persons ages 62 to 64, that would
    be equal to 25 percent of the buy-in premiums.
        As important as our efforts to modernize the Medicare benefit
    package are, Medicare recipients will be able to realize the full
    benefits of these new services only when we give equal attention to
    strengthening and modernizing the management of our health programs.
    The President's budget continues efforts to improve the Health Care
    Financing Administration's (HCFA) management, building on the five-part
    reform plan advanced last year to increase flexibility while also
    increasing accountability. Our budget also maintains our commitment to
    fighting fraud and abuse, investing in a new Medicare contractor
    oversight initiative to address a number of concerns outlined in OIG
    and GAO reports last year. This initiative includes funding to improve
    evaluation of program operations, establish financial management
    controls at each contractor, develop an integrated general ledger
    accounting system that will ensure clean audit opinions into the
    future, and monitor and oversee these changes at all contractors.
        These actions will augment the successful efforts we have
    undertaken in partnership with you, Mr. Chairman, and Senator Harkin to
    combat fraud, waste, and abuse in the Medicare and Medicaid programs.
    As you know, the Department of Justice recently announced that, in
    conjunction with HHS, it had achieved a $486 million settlement with a
    national health provider that had been defrauding the Medicare program.
    This action is in addition to results reported in latest Health Care
    Fraud and Abuse Control account report that indicated that $490 million
    had been collected as a result of successful prosecutions in 1999. Of
    that amount, $369 million was returned to the Medicare trust funds. In
    addition, the Medicare Integrity Program reported an increase of 25
    percent in total overpayments prevented and identified in the first six
    months of fiscal year 1999 compared to the same period the year before.
    These successful efforts are why the latest Medicare Trustees' Report
    included this Administration's fraud and abuse efforts as a
    contributing factor in slowing the rate of growth of the Medicare
    program.

    Increasing access to health care for uninsured individuals

        Those who lack health insurance often are forced to rely on
    emergency rooms or ad-hoc networks of facilities and individual health
    professionals for whatever care they are able to receive, or to forgo
    any health care at all. Last year, the President's budget requested $25
    million to launch a new initiative to help community health clinics,
    public hospitals, academic health centers, and other institutions
    serving the poor to create new systems of comprehensive and coordinated
    care that uninsured workers and their families could depend on, and
    Congress responded by fully funding this request. To continue this
    effort, this year the President is proposing to increase funding for
    this initiative to $125 million. This increase will allow as many as 40
    to 60 additional communities to receive grants to improve the capacity
    of safety-net providers. The President's budget also continues to
    provide strong support for the nation's Community Health Centers, which
    provide care to nearly 10 million low-income and uninsured individuals
    in rural and inner city areas. Our budget requests $1.1 billion to
    support Community Health Centers, an increase of $50 million over last
    year.

    Long-term care

        With more Americans now living longer than ever before, one of the
    most pressing demands we face is the increasing need for long-term care
    services. Studies show that the great majority of individuals who need
    long-term care prefer to remain in their own homes and communities
    rather than receive care in institutional settings, but this places a
    heavy burden on the family members and friends who must provide
    supports for them. More than half of these caregivers are women, and
    one-third have full time jobs. Our budget seeks to address the pressing
    need for new long-term care solutions through a multi-faceted
    initiative designed to help both the millions of Americans who require
    long-term care and those who care for them.
        Our budget invests $125 million to support family caregiver
    activities in the Administration on Aging (AoA). This initiative will
    provide States and local communities with the flexibility to design and
    provide caregiver support activities to approximately 250,000 families
    nationwide who are caring for elderly relatives with chronic diseases
    and disabilities. Services provided will include quality respite care,
    information about local services, counseling, and training for complex
    care needs.
        The budget also proposes $140 million over five years to expand
    access to home and community-based care services under Medicaid through
    an option to equalize income eligibility standards for those who need
    institutional care but choose to live in the community. This long-term
    care initiative also includes a $3,000 tax credit to provide support
    for those with long term care needs and those who care for a disabled
    or elderly relative; an innovative housing initiative to integrate
    assisted living facilities and Medicaid home and community based care
    settings; and a program to provide Federal employees, annuitants and
    their families with the opportunity to purchase private long-term care
    insurance at group rates.

    Nursing home quality initiative

        As we begin to develop a support system for those who choose to
    receive long term-care in home and community-based settings, we must
    also continue to ensure that nursing home residents are receiving the
    highest quality care possible. The fiscal year 2001 budget includes $71
    million for continuing quality monitoring activities in last year's
    budget to improve federal and state oversight of nursing homes. Now in
    its third year, this initiative supports the efforts of states to
    strengthen enforcement and oversight of nursing home quality and to
    crack down on those who repeatedly violate program standards. Expanding
    on activities already underway, funding will support increased surveys
    of repeat offenders, improved training for surveyors, and enhanced
    legal services including resolution of the backlog of appeals.

                   RENEWED SUPPORT FOR CHILDREN AND FAMILIES

        Mr. Chairman, these investments in health care access and quality,
    in improving our public health system, and in broadening our scientific
    knowledge, all are fundamental to making sure that the new century is a
    time of good health and prosperity for all Americans. But just as we
    honor our commitments in the health arena, we also keep our commitments
    to improving the lives of the nation's children and families. The
    President's budget keeps our promise to work toward an America where
    every child, and every family, has the opportunity to succeed at work,
    at school, and at home.

                    HHS YOUTH VIOLENCE PREVENTION ACTIVITIES

        HHS is pursuing a range of activities to assist in the prevention
    of youth violence, and we have requested $78 million for these
    activities. The Safe Schools/Healthy Students Initiative is an
    unprecedented collaborative effort involving this Department, along
    with the Departments of Education and Justice. SAMHSA is our lead
    agency for this important effort. Through this initiative, we are
    assisting 54 school districts in designing and implementing
    comprehensive educational, mental health, social services, law
    enforcement and juvenile justice services for youth. The increase in
    this program provided by the Congress for fiscal year 2000 will enable
    us to increase that number to 70-75 Safe Schools/Healthy Students
    grants by the end of the fiscal year. In addition to its support for
    this partnership, SAMHSA has developed a comprehensive set of
    activities to provide direct grants for exemplary practices as well as
    a variety of activities for developing innovative technology, technical
    assistance, evaluation and social marketing in the youth violence
    prevention arena.
        The Surgeon General is developing a Report on Youth Violence that
    may be completed this year. Local communities, private organizations,
    academia, other federal departments, state and local governments, and
    other groups are providing information and assistance to ensure the
    report soundly addresses the prevention of youth violence. In addition,
    CDC is engaged in a variety of activities including research on school
    violence and suicide prevention. For example, CDC will evaluate
    programs for high risk youth and publish and disseminate The Best
    Practices to Prevent Violence by Children and Adolescents: A Sourcebook
    based on the input of experts from across the nation. CDC also will
    initiate National Centers of Excellence on Youth Violence and a
    National Youth Violence Prevention Resource Center. The Administration
    for Children and Families (ACF) is proposing to build on these efforts
    by focusing on the mental health needs of runaway and homeless youth.
        NIH research has demonstrated behavioral interventions in the home
    and classroom that address violence in children with behavioral
    disorders and is developing and improving programs aimed at prevention,
    early recognition, and intervention for youth violence in various
    community settings. Finally, the President has convened a White House
    Council on Youth Violence, which includes representatives from the
    Departments of Treasury, Labor, Justice, and Education. The Council's
    duties include developing a citizens' information hub; producing
    reports on youth violence; expanding the Safe Schools/Healthy Student
    model of collaboration; providing tools for parents to deal with the
    issue of youth violence; coordinating the federal research agenda; and
    developing further policy responses.

    Expanding substance abuse activities

        Even with all our efforts over the last few years to expand the
    availability of services to those addicted to drugs and alcohol, there
    continues to be a significant gap between the need for substance abuse
    treatment and the capacity available to provide treatment. Estimates by
    the Office of National Drug Control Policy show that less than half of
    the five million individuals who need substance abuse treatment
    actually receive these services. To further close this gap, the
    President's budget includes a total of $3.3 billion in HHS for
    substance abuse treatment and prevention, including $2 billion to
    support SAMHSA's substance abuse prevention and treatment activities.
    Included in this request is an additional $54 million for Targeted
    Capacity Expansion grants to support rapid and strategic responses to
    emerging areas of need. The request also includes an increase of $31
    million for the Substance Abuse Block Grant, which will provide funding
    through the states for over 10,500 community-based treatment and
    prevention organizations. In all, our budget request will enable more
    than 16,000 additional individuals to access treatment services.

    Improving mental health services

        The Surgeon General's Report on Mental Health, released in December
    1999, has focused new attention on the plight of those who suffer from
    mental illness. While about one in five Americans experiences a mental
    disorder in the course of a year, many of them will not receive the
    treatment they need. To address this problem, the President's budget
    proposes an increase of $100 million for mental health services
    provided by the Substance Abuse and Mental Health Services
    Administration (SAMHSA). This includes an increase of $60 million for
    the Mental Health Block Grant, to support state efforts to create
    comprehensive, community based systems of care for both adults and
    children. It also proposes to create a new $30 million Targeted
    Capacity Expansion Grant program to support prevention and early
    intervention services, as well as local service expansion.
    Improving access, affordability, and quality of child care
        For the millions of American families in which parents must work to
    support their children, the availability of child care is often the
    difference between self-sufficiency and dependency. But even though
    funding for child care has doubled under the Clinton Administration,
    recent studies showed that in fiscal year 1998 only ten percent of the
    children potentially eligible for federal child care subsidies received
    them. As we have said before, no parent should be forced to choose
    between the job they need and the child they love. We must take steps
    to close this gap and help all parents find child care that is safe,
    reliable, and affordable.
        As we close this gap, we also must continue to improve child care
    quality. Study after study has shown that safe, quality child care is
    essential to the healthy development of our children. But the lack of
    quality care has forced too many parents to place their children in
    less than desirable settings, and even low quality care can place a
    heavy financial burden on low-income families. The President's budget
    builds on our ongoing efforts to remedy these deficiencies with a
    comprehensive initiative designed to not only make child care more
    affordable but also to improve the quality of care.
        Our fiscal year 2001 budget requests an additional $817 million,
    for a total of $2 billion, for the discretionary Child Care and
    Development Block Grant. This increase will provide child care
    subsidies to almost 150,000 additional low-income children. Also
    included in the $2 billion total is $223 million to improve the quality
    of care, of which $50 million is for infant and toddler quality care
    efforts; $19 million is for school-aged care and resource and referral
    activities; and $10 million is for ongoing research, demonstration, and
    evaluation programs. Our budget also proposes an increase of $3 billion
    in mandatory funding over five years, including $600 million in fiscal
    year 2001, to establish an Early Learning Fund. This fund will provide
    money to states to offer community level challenge grants for programs
    that improve childhood development and school readiness and the quality
    and safety of care. The President's Child Care Initiative also includes
    critical increases for activities in the Departments of Treasury and
    Education.

    Enhancing head start

        Since its enactment thirty-five years ago, the Head Start program
    has been one of our greatest success stories, ensuring that millions of
    low-income children start school ready to learn. In 1993, the Clinton
    Administration set the goal of enrolling one million children in Head
    Start by fiscal year 2002. The President's $6.3 billion request for
    fiscal year 2001, an increase of $1 billion, will keep us on track to
    realize this goal, increasing the number of children enrolled to nearly
    950,000. A portion of these funds will be reserved for grants to
    unserved and under-served populations. Consistent with the focus of the
    1998 reauthorization of Head Start to improve the quality of services,
    $418 million of the proposed increase will be targeted for reducing
    class size, improving facilities, staff training, and school readiness;
    obtaining safer and better equipment; and attracting and retaining top-
    quality staff. Finally, our Head Start budget request includes $564
    million for the Early Head Start program, which will provide 54,000
    infants and toddlers and their families with continuous and
    comprehensive child development and family support services.

    Increasing parental responsibility through child support enforcement

        One of the key underpinnings of this Administration's support for
    working families is the idea of encouraging personal responsibility.
    Nowhere is this more evident than in our actions to step up child
    support enforcement, which is a critical support for children and
    families. Child support collections have almost doubled since 1992,
    reaching an estimated level of $15.5 billion in fiscal year 1999. Our
    package of child support enforcement proposals is self-financing and it
    increases collections to families by more than $1.8 billion over five
    years. These proposals build on our success in the program through
    changes designed to give states new options to get more money to
    families and to improve enforcement tools to increase collections.
    These actions are part of a comprehensive Administration initiative to
    promote and ensure that non-custodial parents who can afford to pay
    child support do so, and helping low-income non-custodial parents go to
    work so that they can support their children through ``Fathers Work''
    grants in the Department of Labor's budget. Under one proposal, we
    would match State efforts to allow families still working their way off
    welfare to keep a portion of the child support they are owed,
    increasing payments to these families by $388 million over five years.
    A second proposal provides States with the option to simplify their
    rules for distributing child support to ensure that families that have
    left welfare will keep all the child support paid by the non-custodial
    parent, resulting in increased payments to families of $815 million
    over five years. Both of these proposals build on our Family First
    distribution policies. Our package also includes proposals for better
    enforcement techniques and program improvements that will save the
    Federal government nearly $600 million over five years while increasing
    payments to families by over $650 million.

    Ensuring continued educational excellence in the nation's children's
            hospitals

        As we move to increase the number of children with health
    insurance, we also must continue our efforts to ensure that all
    children receive the highest quality care. Expertly trained
    pediatricians are a critical ingredient in providing high quality care
    to children, and children's hospitals play an essential role in their
    education, training over 25 percent of all pediatricians and the
    majority of pediatric specialists. Last year, the President proposed a
    new $40 million program to support the vital role children's hospitals
    play in training physicians. This year, our budget proposes to double
    this amount, providing $80 million to raise support for approximately
    60 free-standing children's hospitals to a level more consistent with
    other teaching hospitals.

    Advancing innovative treatments for asthma

        Approximately 5 million of our nation's children suffer with
    asthma, and children from low-income families are disproportionately
    affected. What makes this particularly disconcerting is that the number
    of children afflicted has doubled over the past 15 years, with the
    sharpest increases in rates among children under age 5. Asthma is a
    leading cause of school absenteeism, and children who suffer from
    asthma are often forced to limit their activities. To address this
    growing health problem, our budget proposes $100 million over two years
    in demonstration grants to states to test innovative asthma disease
    management techniques for children enrolled in Medicaid and SCHIP.
    Through appropriate clinical disease management, these programs will
    attempt to reduce asthma related incidents and keep children with
    asthma out of emergency rooms and in school.
    Providing heating and cooling assistance to low-income families
        The Nation has been severely affected by this winter's fuel oil and
    propane price increases which, in some cases, have doubled since last
    year. On February 16, the President took steps to respond to critical
    needs by releasing all remaining emergency Low Income Home Energy
    Assistance Program (LIHEAP) funds for this year, bringing the total
    heating assistance funds released this winter to $295 million. On
    February 25, the President submitted a supplemental request to Congress
    for an additional $600 million in contingent emergency LIHEAP funding
    to help as many people as possible meet the additional heating costs
    and to establish an emergency reserve in the event of a severe summer
    heat wave. It is essential that Congress act quickly on this request to
    help to relieve the burden of rising fuel bills. To further address
    this problem, I have encouraged States to take advantage of the
    flexibility of current law to reach families with high energy needs,
    including the option of raising State LIHEAP income eligibility limits.
    Federal law allows States to set income eligibility limits at the
    greater of 150 percent of the poverty level or 60 percent of State
    median income. I also have encouraged States to fully utilize their
    options under TANF to ensure low income families with children receive
    the assistance they need.

                         GREATER SCIENTIFIC ADVANCEMENT

        As we enter the new millennium, we stand on the cusp of an era of
    that promises unprecedented scientific advances. However, these
    breakthroughs only will be realized if we continue to make the
    necessary investments in biomedical research. Our budget continues
    along the path we set several years ago by investing in basic
    biomedical research as well as in research that will lead to
    improvements in the quality of care, thereby moving important
    scientific discoveries from the laboratory into our hospitals and
    clinics.

    Investing in biomedical research

        Biomedical research has been at the center of the unprecedented
    gains we have made in improving the health and quality of life for all
    Americans. Breakthroughs that did not seem possible only a few years
    ago are now within our reach, but it will require a sustained
    investment for these endeavors to bear fruit. The President's fiscal
    year 2001 budget includes almost $19 billion, an increase of $1 billion
    over last year's funding level, for biomedical research at NIH. This
    increase will support research in such areas as diabetes, brain
    disorder, cancer, disease prevention strategies, and development of an
    AIDS vaccine, and eventually lead to a revolution in our ability to
    detect, treat, and prevent disease. This request will enable NIH to
    fund 31,524 research project grants, the highest total in history, and
    enhance activities in critical areas such as research on racial and
    ethnic health disparities, biomedical information and technology,
    clinical research, and genomics.

    Using science to improve quality of care and reduce medical errors

        As we make new breakthroughs in biomedical research, we also must
    work to see that these scientific advances result in better quality
    health care. Even with all our scientific innovations, a recent study
    by the National Academy of Sciences' Institute of Medicine estimated
    that as many as 98,000 Americans die each year due to medical errors.
    The Quality Interagency Coordination Task Force, which HHS leads, just
    released its report, Doing What Counts for Patient Safety: Federal
    Actions to Reduce Medical Errors and Their Impact, which incorporates
    and expands on the report of the Institute of Medicine (IoM). Our
    report also builds on the extensive and thoughtful review of the
    medical errors issue that has been undertaken by this subcommittee. Our
    budget dedicates $20 million in the Agency for Healthcare Research and
    Quality (AHRQ) and $13 million in the Food and Drug Administration
    (FDA) for new activities to address medical errors and patient safety.
    In addition, HCFA will require that hospitals implement medical error
    reduction and patient safety programs in order to meet Medicare's
    conditions of participation.
        Overall, our budget invests $250 million in AHRQ to support
    research activities that will improve quality of care, and produce
    better health outcomes. These resources will be used to step up
    research efforts on the uses and tools of health information
    technology; sponsor clinical prevention research and research to
    enhance patient safety and reduce medical errors; and expand research
    on issues of workers' health. These activities will help us to learn
    how best to translate knowledge into daily practice and improve health
    care for all Americans.
        Our budget also invests and additional $20 million to implement a
    new Health Informatics Initiative designed to improve patient care and
    health outcomes through the efficient and effective use of data and
    information. This request will fund a set of cross-cutting and agency-
    specific investments in information systems and health data, thereby
    enabling HHS to assume a greater national leadership role in the
    establishment of health data standards while also strengthening the
    information base for decision-making, improving the uniformity and ease
    of transmission of health care data, and protecting the confidentiality
    of health information. In addition, our budget includes $45 million to
    enhance the Food and Drug Administration's post-market activities. This
    includes funds to expand their adverse-event reporting system and to
    allow FDA to investigate, identify and prosecute those selling
    prescription drugs over the Internet without proper certification.

    Food safety initiative

        Enhancing our capabilities to conduct surveillance also will help
    us in our ongoing fight against the threat of food borne diseases.
    Estimates show that food-related hazards are responsible for as many as
    76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each
    year. To combat these outbreaks, the budget seeks a $10 million
    increase for CDC's Food Safety Initiative programs. These funds will
    support enhanced public education efforts and the continued expansion
    of the PulseNet network of health labs. This award-winning network
    performs DNA ``fingerprinting'' of disease causing bacteria, enabling
    public health agencies to identify and respond more rapidly to disease
    outbreaks. In addition, the FDA is seeking an increase of $30 million
    for its Food Safety Initiative activities. These funds will be used to
    increase inspections so that all high risk food establishments are
    covered, expand the number of examinations of imported foods, increase
    laboratory capacity, broaden efforts to work with states and the
    industry to make standards more consistent, and in conjunction with the
    Department of Agriculture and the states, begin to implement the Egg
    Safety Action Plan prepared by the President's Council on Food Safety.

                          CREATING A HEALTHIER AMERICA

        Expanding access and improving the quality of health care are
    crucial steps toward ensuring that all Americans live long, healthy
    lives. But new threats to public health continue to emerge, and many
    long standing health problems still pose considerable risks. From AIDS
    prevention and treatment to food safety and the control of infectious
    disease, our fiscal year 2001 budget continues our work to vigorously
    safeguard the public health.

    HIV prevention initiative

        As a nation, we have made substantial progress in our fight to
    prevent the spread of HIV and AIDS. Thanks to the use of combination
    anti-retroviral therapy, the AIDS death rates in the United States
    continue to decline. But in some parts of the world, and in some
    communities in the United States, the virus continues to spread
    rapidly. Domestically, the impact of HIV among certain segments of the
    population, especially minority communities, continues to be severe. In
    1997, 45 percent of those newly diagnosed with AIDS were African
    American and 20 percent were Hispanic. Globally, the AIDS pandemic
    continues to be a major threat, particularly in developing countries.
    In sub-Sahara Africa, for example, it is estimated that four million
    people each year are newly infected with HIV. Internationally, the
    President's budget includes an increase of $26 million for the Centers
    for Disease Control and Prevention to continue the initiative
    undertaken last year to prevent the spread of HIV in developing
    countries.
        Domestically, our budget request supports our ongoing initiative to
    reduce the spread of HIV and AIDS in minority communities. It provides
    an increase of $50 million (including $10 million in reallocated
    funding) for CDC's domestic prevention programs to encourage
    individuals at risk to avoid behaviors that can result in the
    transmission of the disease. These funds will be directed to community
    based interventions designed to reduce the rates of HIV infections,
    with special emphasis on vulnerable populations including racial and
    ethnic minorities, women, injection drug users and their partners, and
    young gay men. Internationally, the President's budget includes $61
    million for Centers for Disease Control and Prevention (CDC), an
    increase of $26 million, to continue the initiative undertaken last
    year to prevent the spread of HIV in developing nations.

    Ryan White

        Up to one-third of the 750,000 Americans living with HIV are
    currently not in care. As we step up our efforts to prevent the spread
    of AIDS, we must also continue to help those who already suffer from
    this deadly disease. The President's budget keeps this commitment by
    providing $1.7 billion for the Ryan White Program, an increase of $125
    million. These additional funds will provide primary medical care,
    pharmaceuticals critical to treatment, and other critical support
    services for those living with HIV and AIDS. This includes an increase
    of $26 million for the AIDS Drug Assistance Program (ADAP), which will
    allow a total of approximately 75,000 individuals to receive
    comprehensive combination drug therapy.
    Reducing racial health disparities
        One of the long-standing priorities of this administration has been
    making sure that all people receive the highest quality health care,
    regardless of their race or ethnicity. Unfortunately, members of
    minority groups, including American Indians and Alaska Natives,
    continue to bear a disproportionate burden of the nation's disease and
    illness. The President's budget continues the effort to eliminate these
    health disparities. A targeted response to this problem is the request
    of $35 million to expand CDC's program of demonstration projects in six
    identified areas of health disparities: infant mortality, cancer, heart
    disease, diabetes, HIV/AIDS, and immunizations. Funds will support the
    continuation of ongoing projects and the development of projects in two
    new communities. The budget also proposes increasing funding for the
    Office for Civil Rights by nine percent, including new program
    resources to ensure that our racial health disparities initiative has a
    strong civil rights nondiscrimination component. We also request an
    increase of $230 million for the Indian Health Service, the largest
    funding increase in two decades, to implement a multi-pronged effort to
    improve the quality of care for Native Americans.

    Family planning

        Support for family planning services has been a key factor in
    preventing over one million unintended pregnancies each year. Family
    Planning Clinics provide a range of valuable services including
    sexually transmitted disease and cancer screening and prevention; HIV
    prevention and education; and contraception services and counseling. As
    part of our strategy to prevent teen pregnancies, these services have
    also contributed to reducing the teen pregnancy rate to its lowest
    level on record (since 1976). Our fiscal year 2001 budget request
    continues our strong commitment to family planning services, providing
    an increase of $35 million over fiscal year 2000. These funds will
    support grants to family planning clinics which will enable
    approximately 5.75 million low-income clients to receive reproductive
    health services and clinical care.

    Preventing emerging infectious diseases

        Thanks to the extraordinary advances in transportation and other
    technologies and the expansion of international commerce, we truly live
    in a global community. While these advances have resulted in numerous
    economic and cultural benefits, they also have placed increasing
    strains on our public health system. Since 1970, more than 35 new
    infectious diseases have been identified. More recently, we have begun
    to see the emergence of drug-resistant bacteria and viruses, and the
    spread of older diseases to areas where they were previously unseen,
    such as the recent outbreak of West Nile encephalitis in the New York
    City area. To combat these threats, our budget requests a total of $202
    million to support infectious disease prevention activities at the
    Centers for Disease Control and Prevention. This includes an increase
    of $26 million to fight emerging infectious diseases, of which $20
    million would be used to support the development of a national
    electronic disease surveillance system, which will enhance the ability
    of state and local health offices to respond to multi-state outbreaks
    of diseases and to share information, both among themselves and with
    CDC.

    Combating bioterrorism

        The recent arrests of suspected terrorists at the Canadian border
    has reminded us all of the serious threat that terrorism poses to the
    peace and prosperity of our nation. The threats posed by bioterrorism
    are particularly deadly because of their communicability and their
    ability to remain undetected for long periods of time. Continuing our
    efforts to prepare for and respond to the consequences of a
    bioterrorist event, the Department's budget includes $265 million for
    activities across agencies to mount a comprehensive public health
    effort to combat this deadly threat. This strategy includes four major
    components. First, our budget strengthens critical components of our
    public health infrastructure, including our surveillance systems,
    epidemiological and laboratory capacity, and communications technology.
    Second, it continues funds for the purchase of a stockpile of the
    pharmaceuticals needed to treat the most likely biological agents.
    Third, it provides funds for research, development, and regulatory
    review of new vaccines and new diagnostic screens for chemical agents.
    Finally, it would support the establishment of an additional 25 local
    area health care response systems, bringing the total number around the
    country to 97.

    Investing in HHS laboratory and health infrastructure

        To successfully overcome the public health challenges of the 21st
    century, we must invest now to modernize the infrastructure that
    provides the foundation for our public health and biomedical research
    systems. Many of the laboratories at CDC and FDA are overcrowded and
    outdated, while at the National Institutes of Health (NIH) the
    fragmentation of laboratory space delays the pace at which new
    discoveries are made. Our budget requests substantial increases to
    solidify this foundation and construct state-of-the-art facilities. For
    CDC, we are requesting a total of $127 million, an increase of $70
    million, for laboratory construction at three sites. First, our budget
    includes $85 million in fiscal year 2001 and additional funding in
    fiscal year 2002 and fiscal year 2003 to construct a laboratory to
    handle the most highly infectious and lethal pathogens studied at CDC,
    as well as housing important work on antibiotic resistant diseases,
    AIDS, sexually transmitted diseases, and tuberculosis. Second, we
    request $20 million to complete and equip the Edward R. Roybal
    infectious disease laboratory. Third, we request $4 million to design a
    facility to replace our antiquated environmental health laboratory. The
    remainder of the request will be used for security improvements and
    maintenance of existing facilities.
        For NIH, we are requesting $149 million for intramural buildings
    and facilities. Intramural projects include $73 million over two years
    to construct a new facility to house the new National Neuroscience
    Research Center, and $24 million to begin design and construction of a
    new centralized animal facility. Our budget also includes $20 million
    for new lab construction at FDA, as well as $65 million for health
    facilities construction in the Indian Health Service (IHS).

                   RIGOROUSLY EVALUATING PROGRAM PERFORMANCE

        Our budget request for fiscal year 2001 presents the annual
    performance information required by the Government Performance and
    Results Act (GPRA) of 1993. Notably, this includes the first GPRA
    performance report of HHS and its components, which compares fiscal
    year 1999 results to the goals in our fiscal year 1999 performance
    plan. Although GPRA reporting must mature before its full value will be
    realized, our performance report for this year shows improvements for
    critical HHS initiatives of the past few years. SAMHSA reports that
    retailers in more States have complied with rules prohibiting tobacco
    sales to youth than we had projected in our 1999 performance plan. HCFA
    achieved its 1999 goal for reductions in Medicare payment errors a year
    early, and pursues increasingly rigorous goals in fiscal year 2001 and
    fiscal year 2002. ACF and its program partners, including states,
    exceeded performance expectations when they moved 1.3 million welfare
    recipients into new employment. Information like this demonstrates that
    GPRA can be a valuable tool that will enhance our efforts to improve
    programs that serve the American people. As our performance measures
    continue to mature and performance trends emerge, the GPRA data will
    serve as important program indicators to support the identification of
    strategies and objectives to continuously improve programs across HHS.

                         A ROAD MAP TO A BETTER AMERICA

        Mr. Chairman, as I look back at the journey we have taken, I feel
    tremendous pride in what we have been able to accomplish. While there
    were occasional bumps in the road and we did not reach every
    destination we set out for, we have made great advances in improving
    the nation's health and well being. Today I have placed before you a
    road map for the destinations we have charted--improving health care
    access, coverage, and quality; making America a healthier and safer
    place; expanding our scientific knowledge, and giving all our children
    and families the opportunity for success--and these are destinations we
    all wish to reach. Thanks to the unprecedented economy, our fiscal
    discipline, and a new age of scientific breakthroughs, the conditions
    under which we set out on this road have never been more favorable.

                            FISCAL MANAGEMENT AT CDC

        Mr. Chairman, before concluding, I would like to speak about the
    recent news stories regarding the management of hantavirus funding at
    CDC. Dr. Koplan and I are deeply concerned about CDC's failure to
    report these reallocations to the Congress in a timely fashion. I
    strongly believe that the full accountability and integrity of our
    budgeting and reporting efforts are central to our responsibilities,
    and I have zero tolerance for inaccurate reporting or inaccurate
    statements. We have an obligation to expend our funds consistent with
    congressional expectations and to report in an accurate and timely
    fashion.
        In consultation with Dr. Koplan, I am taking what I consider to be
    aggressive and unprecedented actions to rectify this problem and
    restore the trust of this Congress. These actions, which will be
    coordinated by the Department and CDC, include:
      --The Chief Financial Officer (CFO) of the Department of Health and
            Human Services (HHS) will take such actions as necessary to
            certify all financial obligations made by the National Center
            for Infectious Diseases for the remainder of the fiscal year.
      --The Department's CFO also will work with Dr. Koplan to ensure that
            all senior decision-makers in the National Center for
            Infectious Diseases receive certified budget execution
            training.
      --CDC is commissioning an external review of the agency's fiscal
            management practices. The review is to be completed within six
            months. The results of this analysis will be communicated to
            the Congress as soon as the review is complete.
      --CDC program managers will conduct a top-to-bottom examination of
            CDC's 133 programs and projects to make sure there are no other
            areas of concern. During the 90 day period CDC managers will be
            able to fully and openly identify any area for which there may
            be a discrepancy between actual expenditures and the
            information provided to Congress. Dr. Koplan will share these
            findings with the Congress.
      --CDC has commissioned Pricewaterhouse Coopers, a firm of independent
            auditors, to thoroughly examine our hantavirus expenditures.
            The results will be communicated to the Chairman immediately
            upon completion. When this audit is complete, CDC will expand
            the effort to the entire National Center for Infectious
            Diseases.
        In addition, Dr. Koplan has for the past year put in place numerous
    corrective actions to respond to the Inspector General's report on
    Chronic Fatigue Syndrome. He has implemented new financial management
    systems; initiated improvements in the agency's budget displays and in
    the allocation of centralized agency costs. Again, let me state very
    clearly that neither any senior manager at HHS nor I have any tolerance
    for inaccurate reporting and that we are all devoted to restoring the
    credibility and integrity that is central to the important work done at
    CDC.
        Chairman Specter, Senator Harkin, and members of the Subcommittee:
    I would like to thank each of you for all of the hard work you have
    done to make everything we have accomplished a reality, and I look
    forward to working with all of you to meet the challenges before us in
    this budget. I would be happy to address any questions you may have.

                            DEPARTMENT OF EDUCATION

                            Office of the Secretary

    STATEMENT OF HON. RICHARD W. RILEY, SECRETARY

        Senator Specter. We now turn to the distinguished Secretary
    of Education, Secretary Richard Riley, who has also served
    during the entire tenure of President Clinton's Administration
    starting in January of 1993.
        Secretary Riley brought a wide breadth of experience to the
    position, having been governor of the State of South Carolina,
    a State Senator and a State representative, so that he has been
    in many fields, many capacities.
        He had a nationally recognized effort to improve education
    in South Carolina, which led to his appointment as secretary.
    He is a graduate of Furman University and a recipient of a law
    degree from the University of South Carolina.
        Thank you for joining us, Mr. Secretary, and we look
    forward to your testimony.
        Secretary Riley. Thank you so much, Mr. Chairman. I thank
    you and Senator Harkin and Senators Murray and Feinstein for
    the strong support of education that all four of you have shown
    us. It's clear that you really believe in the investment in
    young people's education and all people's education.

                          STATE OF AMERICAN EDUCATION

        It is a great pleasure to be here with my colleagues in the
    Cabinet. I just have completed my annual state of American
    education address, which I gave down in Durham, NC, at a turn-
    around school, a school that was predominantly African-American
    and was really a school that was classified as a low-performing
    school. But they had a new principal, and it was a very
    exciting thing. It is now an exemplary school there in Durham.
        I talked about higher expectations. I talked about the
    achievement gap between the students whose families are
    educated and have money and students who are minorities, and,
    oftentimes, limited English proficient. I talked about the
    digital gap and really those things that we can do about those.
    And we are trying to close that gap. I see good things
    happening. We have a lot of work to do.
        The E-rate, for example, is other work that we have done in
    technology. We just recently had a determination that 95
    percent of our schools are connected to the Internet. And we
    have gotten up to 63 percent of all classrooms connected. That
    is enormous growth, and I am very proud of it.
        Increased attention to early childhood programs that my
    colleagues spoke about is making a real difference. Parents
    have an absolute focus on keeping their children out of harm's
    way and school safety is a paramount issue.
        Overall, the American people have made education clearly
    one of their top priorities. The budget reflects these
    priorities. Turning around failing schools, school safety,
    improving teacher quality, modernizing our nation's schools,
    technology, safe schools, helping working and middle class
    families pay for college.
        The American people, I think, are getting into a new
    position when it comes to how we improve education. I think
    they have moved beyond the debate on Federal versus local
    control. I strongly believe that State and local control, in
    terms of control, must be there.
        But it is so interesting to see that we have come to a new
    place. The American people want practical answers. They want to
    know specifics. If we are going to have national priorities,
    what are they? What are our expectations? And they want
    accountability for those.
        They want local, State, and Federal interests working
    together to create new partnerships, partnerships that are not
    just government, obviously, but include business, community
    groups, jump old boundaries, and make things happen. The
    Federal Government is the junior partner in all of that, but a
    very important partner.

                         THE GOOD NEWS ABOUT EDUCATION

        So where are we when it comes to education? Higher
    standards are now in place in all 50 States. The big job now is
    to get standards down in the school classroom, where they
    impact every child and have real accountability measures. We
    are also starting to see the early benefits of our sustained
    focus on raising standards. I think it is making a difference
    in every State.
        And I would like to submit for the record a new release
    from the Center on Education Policy and the American Youth
    Policy Forum, entitled ``Do You Know the Good News About
    American Education?'' And it is, I think, a very good
    indication that across the board very interesting things are
    happening.

                     DEPARTMENT OF EDUCATION BUDGET REQUEST

        But I will be the first to tell you that we still have a
    very long way to go. There are schools out there that should
    not even be called schools, and they need fixing immediately.
    The proposed investment in this budget, I think, moves in that
    direction. We are requesting $40.1 billion, an increase of $4.5
    billion or 12.6 percent over the fiscal year 2000 spending.
        The budget continues a strong emphasis on improving
    accountability in Title I, reducing class size, improving
    teacher quality, technology, modernizing our schools,
    increasing after-school opportunities to help keep children out
    of harm's way. And I remain very excited about the President's
    college opportunity tax cut proposal. It can make a real
    difference in giving young people the chance to go to college,
    and middle income families as well.

                       TEACHER RECRUITMENT AND RETENTION

        This budget includes $1 billion to support better teaching
    with a strong emphasis on recruiting and retaining high-quality
    teachers. There is no single way to get that job done, and we
    come at it from many angles, that have been carefully thought
    about.

                    21ST CENTURY COMMUNITY LEARNING CENTERS

        One of the best ways to keep our children out of harm's way
    is through positive after school experiences. That is why we
    are proposing a $547 million increase for 21st Century
    Community Learning Centers, doubling the funding to the total
    of $1 billion, making the after-school effort very important.

                          SCHOOL SAFETY AND DISCIPLINE

        School safety and discipline are very immediate. We do not
    need another Columbine. I worry about that every single day,
    and I know each of you do. And the other incidents that have
    happened, even though they are very rare, are still so terribly
    important. Any one of them makes it a crisis.

               SMALL, SAFE AND SUCCESSFUL HIGH SCHOOLS INITIATIVE

        Young people need to have a strong sense of connection. I
    think that is very important, when you look at school violence.
    We propose to scale up our Small, Safe and Successful High
    Schools initiative by providing $120 million to help 700 high
    schools create schools within schools. These are these large,
    often consolidated schools.

                    SAFE SCHOOLS/HEALTHY STUDENTS INITIATIVE

        We are now in our second year of funding for our joint
    safety initiative with HHS and the Justice Department. There is
    an enormous demand for this initiative. I think there is great
    potential in that. It is something, Mr. Chairman, you have been
    interested in. Over 440 cities applied for those grants. We
    were able to grant 54 of them in the first year, to show you
    how significantly it is seen by cities. We expect another 20 to
    23 to be funded this year.

                      CHILDREN'S HEALTH INSURANCE PROGRAM

        I would mention CHIP, Mr. Chairman and members of the
    committee. I think all of us ought to be talking about that,
    how we get young people out there to get health care. That is,
    just like these other issues, an overlapping issue. But under
    eligibility of Medicaid and CHIP, really every poor young
    person in the country ought to be receiving health care. And
    that is, too, related to these issues.

                   SAFE AND DRUG-FREE SCHOOLS AND COMMUNITIES

        But it is important to remember that our nation's schools
    still are basically safe. We have 53 million young people in
    school every day. That is an awful lot of young people. Yet
    less than 1 percent of the homicides among youth aged 12 to 19
    occur in schools, at school functions or on the way to school,
    way less than 1 percent.
        Drug use is falling slightly, but remains much too high. It
    is one of the reasons why we continue to work hard to improve
    the effectiveness of the Safe and Drug-Free Schools program.
    The budget reflects those changes. We believe that our middle
    school coordinators effort can play a positive role in helping
    parents and school officials who are on the front line, and I
    think our effort to support character education and civic
    education also help as well.

                              SCHOOL MODERNIZATION

        I also urge the Congress to pass our school modernization
    legislation. Many rural and urban school districts need the
    help. Our modernization proposal now comes in two parts. And I
    want to try to urge you all to take a look at that. Both are
    worthy, I think, of consideration.
        We are putting strong emphasis on our new $1.3 billion
    appropriation for school renovation, a request to help school
    districts renovate and repair thousands of old schools that are
    in urgent need of repair, often in areas that cannot float a
    bond issue. They really do need some special help.
        Our school buildings are wearing out in many of these older
    cities. They are old, overcrowded in other areas. We think that
    that bears an awful lot of attention.

                            PELL GRANT MAXIMUM AWARD

        Let me conclude by a comment on higher education. We are
    proposing increasing the maximum Pell Grant to $3,500, up from
    $3,300, a $200 increase, up more than 50 percent since 1994.

                         COLLEGE OPPORTUNITIES TAX CUT

        The President's new 10-year, $30 billion College
    Opportunities Tax Cut--which I would be happy to discuss in
    detail, if you would like, will be of significant help to
    working class families who make under $43,000 a year. It
    provides special help for them, as well as middle class parents
    with several children going to college with special cost
    problems.
        I thank you very much for giving me the chance to be here
    with my colleagues. And I, like they, welcome questions. Thank
    you.

                               PREPARED STATEMENT

        Senator Specter. Thank you very much, Secretary Riley.
        [The statement follows:]

                  Prepared Statement of Hon. Richard W. Riley

        Mr. Chairman and Members of the Committee: Thank you for this
    opportunity to discuss the President's fiscal year 2001 budget request
    for education. I want to begin by thanking you, Mr. Chairman, as well
    as other Members of this Subcommittee, for your strong and consistent
    support for education over the past several years. Working together, I
    believe we have made real progress in helping to expand educational
    opportunity for all Americans.
        The American people have made education one of their top national
    priorities. We recognize that the Federal government is the junior
    partner in our education system, and that real progress in improving
    education depends primarily on State and local efforts. But we can play
    a critical role in encouraging and supporting State and local
    initiatives, particularly in the areas of raising standards, improving
    accountability for results, and helping to meet the needs of
    disadvantaged and limited English proficient students and students with
    disabilities.
        The American people also see this time of peace and prosperity as a
    unique opportunity for the Nation to be investing in the long-term
    future of our great country by improving education at all levels. Some
    might argue that the growing Federal budget surplus should be used for
    broad-based tax cuts, but that's not what I hear when I talk with
    students, parents, and teachers across the country. What I hear instead
    is a strong consensus on paying down the national debt and building for
    the future by investing in the education of our children.
        That is why the President is requesting $40.1 billion in
    discretionary spending for the Department of Education, an increase of
    $4.5 billion or 12.6 percent. This budget reflects the transition to
    the second phase of the standards-based reform efforts we launched
    seven years ago. First, we worked with the Congress to support State
    and local efforts to raise standards and put accountability measures in
    place. Standards are now in place in all 50 States and we are working
    hard to improve accountability. Now we need to ensure that States and
    communities have the resources needed to ensure that all students can
    achieve to higher expectations and that teachers are prepared to teach
    to the new standards.
        The Department's request provides significant new resources to help
    States and communities implement higher standards in their schools
    while coping with booming enrollments and the need to modernize
    academic facilities. The request also provides substantial new support
    to help prepare disadvantaged students for postsecondary education and
    make college more affordable for all Americans.

                            INCREASED ACCOUNTABILITY

        The 2001 budget for education once again emphasizes accountability
    for results, particularly for chronically failing schools. Our purpose
    is not to punish the students in those schools, but to provide the
    right combination of incentives and support that will accelerate the
    changes needed to improve the quality of their education.
        The President's request for Title I includes $250 million for a
    second year of accountability grants, an increase of $116 million over
    the 2000 level. These funds would enable States and school districts to
    provide the additional assistance needed to help failing schools--
    primarily those identified for corrective action under Title I--turn
    around and improve student achievement.
        The President's proposal also recognizes that in too many schools,
    students and parents have waited far too long for meaningful change and
    improvement. For this reason, school districts participating in Title I
    would be required to offer students enrolled in a school identified for
    corrective action the choice of attending another public school not
    identified for corrective action. The goal here is to help ensure that
    no student is trapped in a truly bad school, and to reinforce the idea
    of serious consequences for schools that consistently fail to improve.
    At the same time, we are emphasizing efforts to turn around poor-
    performing schools, because even with a public school choice option the
    majority of students will continue to attend their neighborhood school.

                        IMPROVING LOW-PERFORMING SCHOOLS

        We want to balance accountability for meeting high standards with
    new resources to help students meet those standards and to help school
    districts turn around failing schools. This is why, for example, the
    request includes a $547 million increase for 21st Century Community
    Learning Centers, for a total of $1 billion for after-school and other
    extended-learning programs. These funds would support high-quality
    extended learning opportunities for nearly 2.5 million children,
    including students in low-performing schools.
        We also would add $450 million to reduce class size in the early
    grades, for a total of $1.75 billion to help children get more personal
    attention, improve discipline, and learn more. There's no better way to
    rapidly improve student achievement than to put highly trained teachers
    into small classrooms where they can provide the individual attention
    students need to reach high standards. The request would bring the
    total number of teachers hired under this program to about 49,000, or
    almost halfway to the President's goal of hiring 100,000 teachers over
    seven years.
        One of the best ways to bring about real change and turn around
    failing schools is to help communities and schools to put in place
    reforms based on solid research. This is why our budget includes $190
    million for the Comprehensive School Reform Demonstration program to
    help an additional 1,900 schools develop and implement proven,
    comprehensive reform models. We would also increase funding for
    educational research by $30 million to help meet the growing need for
    research-based information on what works in education.
        The request also expands the Small, Safe and Successful High
    Schools initiative to help create smaller, safer, and more disciplined
    and supportive learning environments in approximately 700 of the
    Nation's largest high schools. The President's budget would provide
    $120 million for such effective innovations as schools-within-schools
    or career academies that assign students to groups of a few hundred--
    helping to replace the isolation many students feel in large schools
    with smaller, more nurturing communities.
        Another way to accelerate change is by giving parents more choices
    of public schools. Our budget would increase the choices available to
    parents and students through a $175 million request for Charter
    Schools. These funds would support the start-up of some 1,700 new or
    redesigned charter schools, which have the flexibility to offer
    innovative educational programs in exchange for greater accountability
    for student achievement. The 2001 request would bring to 2,400 the
    number of charter schools helped by this program, supporting the
    President's goal of creating 3,000 charter schools by 2002.
        We also are seeking $20 million for the Opportunities to Improve
    our Nation's Schools initiative, or OPTIONS. This flexible new
    authority would support 40 grants to States and school districts to
    implement and test new approaches to public school choice, including
    inter-district programs and public schools at work sites and on college
    campuses.
        Our budget also acknowledges the importance of recognizing success.
    A new, $50 million Recognition and Reward program would reward States
    for improving student achievement and for reducing the achievement gap
    between high- and low-performing students, as measured by State results
    on the National Assessment of Educational Progress.

                            MODERNIZING OUR SCHOOLS

        A key priority for 2001 is to help ensure that all students have
    the opportunity to attend safe, modern school facilities that are
    equipped with up-to-date educational technology. With public school
    buildings averaging some 42 years of age and a backlog of more than
    $100 billion in repairs, it is clear that we have a lot of work to do.
    This is why the 2001 request includes two proposals to upgrade school
    facilities.
        The School Renovation program, a major new $1.3 billion
    discretionary initiative, would help school districts repair or
    renovate their schools. The $1.3 billion total includes $50 million in
    grants to approximately 119 districts with at least 50 percent of their
    children residing on Indian lands, $125 million in grants to high-need
    school districts, and $1.125 billion that would leverage an estimated
    $6.5 billion in 7-year, no-interest loans.
        The School Renovation initiative would complement the President's
    School Modernization Bonds proposal, which would provide nearly $25
    billion in tax credit bonds over two years to modernize up to 6,000
    schools. Tax credit bonds, which the President is proposing for the
    third year in a row, would provide interest-free financing to help
    State and local governments pay for modernizing schools and addressing
    overcrowding.
        An additional factor driving the demand for the upgrade of school
    facilities is the explosion in the development and use of educational
    technology based on multimedia computers and access to the resources of
    the Internet. Computers are the ``black board and chalk'' of the
    future. A key resource for this revolution in educational technology is
    the E-rate, created by the Telecommunications Act of 1996, which
    provides nearly $2 billion annually in subsidies to help schools and
    libraries connect to the Internet.
        The Department budget would provide $450 million for the Technology
    Literacy Challenge Fund, an increase of $25 million, to help schools
    integrate technology into the curriculum and ensure that teachers in
    high-poverty communities are prepared to use educational technology
    effectively. We also would double funding to $150 million for the
    Preparing Tomorrow's Teachers to Use Technology program, which helps
    prepare new teachers to use technology effectively to improve
    instructional practices and enhance student learning in the classroom.
        And to help close the digital divide in our communities between
    those who enjoy the full benefits of computers and the Internet and
    those economically disadvantaged individuals and families who lack
    access to such technology, the budget would more than triple funding
    for Community Technology Centers. The $100 million request would
    support up to 1,000 new centers offering area residents access to
    extended learning opportunities before and after school, adult
    education, and online job databases.

                              MASTERING THE BASICS

        The President's budget also expands support for programs that help
    students master the basics and close achievement gaps between
    disadvantaged and minority students and their more advantaged peers.
    The request includes $8.4 billion for Title I Grants to Local
    Educational Agencies and $286 million for the third year of the Reading
    Excellence program, which helps all children to read well and
    independently by the end of the third grade. We would increase funding
    for Special Education Grants to States by $290 million for a total of
    $5.3 billion, while boosting support for Special Education Parent
    Information Centers by 40 percent.
        Indian Education programs would receive $116 million, an increase
    of 50 percent, to provide larger formula grants to school districts for
    Indian Education programs, and to launch a new $5 million American
    Indian Administrator Corps that would train American Indian teachers
    and professionals to become school administrators.
        It is difficult if not impossible to master the basics in
    communities and schools threatened by youth violence. I know that
    preventing youth violence is a priority shared by both President
    Clinton and the Chairman of this Subcommittee. To help expand the Youth
    Violence Initiative that you helped launch last year, Mr. Chairman, we
    are requesting a $50 million or 25 percent increase in funding for Safe
    and Drug-Free Schools National Programs. These funds would be used
    primarily to make new awards under the Safe Schools/Healthy Students
    initiative. This interagency initiative--funded by the Departments of
    Education, Health and Human Services, Justice, and Labor--would receive
    a total of $247 million in 2001, an increase of more than $100 million
    over the 2000 level.

                           IMPROVING TEACHER QUALITY

        We need to elevate the teaching profession and expand opportunities
    for teachers to continually update their skills. Improving teacher
    quality is a major emphasis in the Educational Excellence for All
    Children Act, the Administration's proposal for reauthorizing the
    Elementary and Secondary Education Act of 1965. We need to make sure
    our teachers are prepared to teach to the new State standards, and we
    need to help States and communities deal with the projected nationwide
    shortage of 2 million teachers over the next 10 years. Our budget
    provides $1 billion for a comprehensive approach to reaching these
    goals, with an overall focus on preparing both new and experienced
    teachers to bring high standards into the classroom.
        This includes $690 million for Teaching to High Standards State
    Grants, our TitleII reauthorization proposal to promote professional
    development linked to State standards and assessments. A new $75
    million Hometown Teachers proposal would support comprehensive
    approaches to teacher recruitment and retention in high-need districts,
    while a $50 million Higher Standards, Higher Pay initiative would help
    high-poverty school districts attract and retain high-quality teachers
    through better pay linked to a rigorous peer-review process.
        To help meet the growing demand for high-quality leadership in our
    school districts and schools, particularly in the area of implementing
    standards-based reforms, the budget includes $40 million for a School
    Leadership Initiative. This new program would fund consortia-based
    efforts to provide current and prospective superintendents and
    principals--particularly those serving high-poverty, low-performing
    districts and schools--with the professional development opportunities
    needed to help them serve as effective leaders.
        The request also would provide $50 million to reward school
    districts that show the largest increases in the number of teachers who
    are fully certified and teaching in the field in which they are
    trained, $25 million to encourage career-changing professionals to
    enter the teaching ranks, and $30 million to train some 15,000 early
    childhood educators and caregivers in techniques to improve early
    literacy skills and prevent later reading difficulties.
        In addition, the 2001 budget includes $100 million for Bilingual
    Education Professional Development to help address the critical
    national shortage of well-prepared bilingual and English-as-a-second-
    language (ESL) teachers.

                            NEW PATHWAYS TO COLLEGE

        A college education remains the best guarantee of success in a
    rapidly changing, technology-based economy that demands critical-
    thinking skills and the ability to adapt to new ways of doing business.
    Postsecondary institutions are enjoying their own enrollment boom--
    climbing last fall to a record 14.9 million students--but too few
    disadvantaged and minority students are entering and completing
    college.
        To help give these students and their families new pathways to
    college, the 2001 budget includes a $125 million increase for GEAR UP
    to provide 1.4 million low-income elementary and secondary school
    students the skills and encouragement they need to enter and succeed in
    college. We also are asking for $725 million for TRIO outreach and
    support services to more than 760,000 disadvantaged postsecondary
    students. The TRIO request includes $35 million for a new College
    Completion Challenge Grant program that would help reduce the college
    dropout rate, particularly among poor and minority students. Another
    pathway to college is Tech-Prep Education, which supports efforts by
    partnerships of high schools, postsecondary institutions, and employers
    to create comprehensive technical education programs that prepare
    students for both college and high-tech careers. The 2001 budget nearly
    triples Tech-Prep funding to $306 million.

                         MAKING COLLEGE MORE AFFORDABLE

        Just as important as preparing for college is helping students and
    families pay the rising costs of a postsecondary education. Over the
    past six years larger Pell grants, expanded work-study opportunities,
    lower borrowing costs on student loans, and Hope and Lifetime Learning
    tax benefits have made college financially possible for all who
    qualify.
        Paying for college is still a difficult burden, however, especially
    for low- and middle-income families. Our 2001 budget would help reduce
    that burden. For example, we are proposing a maximum Pell Grant award
    of $3,500, a $200 increase over the 2000 level. A $60 million increase
    for Supplemental Educational Opportunity Grants would provide a total
    of $875 million in grant assistance to an estimated 1.2 million
    undergraduate students, or 64,000 more than in 2000. And a $77 million
    increase for Work-Study would continue the President's commitment to
    give 1 million students the opportunity to work their way through
    college.
        Outside the discretionary budget for postsecondary education,
    President Clinton would dramatically expand tax benefits for
    postsecondary education through a new College Opportunities Tax Cut.
    This proposal would build on the Lifetime Learning Tax Credit to give
    over 5 million families the option of taking a tax deduction or
    claiming a 28 percent tax credit on up to $5,000 in annual
    postsecondary education tuition and fees. The limit would rise to
    $10,000 in 2003, and the Treasury Department estimates families would
    save an additional $30 billion over 10 years, compared to the current
    Lifetime Learning tax credit.
        To increase academic opportunities for minority students and
    increase their numbers in high-skill fields such as science and
    engineering, the President's budget proposes $40 million for Dual-
    Degree Programs for Minority-Serving Institutions. This program would
    provide competitive grants to partnerships between Minority-Serving
    Institutions (MSIs) and nationally recognized research universities.
    Participating students would earn two degrees in five years, one from
    the MSI and one from the partner institution in a field in which
    minorities are underrepresented.
        Finally, the President's budget targets additional funds to Latinos
    as part of the Administration's Hispanic Education Action Plan. The
    2001 request includes more than $800 million in increases intended to
    help expand educational opportunities and improve outcomes for Latinos.
    In addition to increases for programs like Title I and TRIO that serve
    large numbers of Latino students, the request provides an $86 million
    increase for Adult Education, most of which would be used to triple
    funding for Common Ground Partnership Grants. These grants support
    demonstration programs that provide immigrants and other participants
    with English literacy skills, coupled with civic education and basic
    skills that are necessary to effectively navigate key institutions of
    American life. The budget also includes nearly a 50 percent increase
    for Hispanic-Serving Institutions to support postsecondary education
    institutions that serve large percentages of Latino students.
        I believe this budget is a fitting start to a new century--the
    Education Century--and would provide the resources needed to increase
    both quality and opportunity in our education system. The 2001 request
    will, as the President noted in his State of the Union address, move
    the Nation ``a long way toward making sure every child starts school
    ready to learn and graduates ready to succeed.''
        I will be happy to answer any questions you may have about the
    President's 2001 budget for education.

        Senator Specter. Before proceeding to our customary 5-
    minute rounds of questioning from the members, we have been
    joined by the chairman of the full committee, Senator Stevens.
        We would be delighted to hear from you, Mr. Chairman.

                    Opening Statement of Senator Ted Stevens

        Senator Stevens. Well, thank you very much. I apologize for
    being late. I do have a conference. I just have a very short
    statement I would like to make and submit some questions for
    the record, if that can be done.
        I do welcome all three of you secretaries. I think it is a
    very great thing that you all would come at the same time, so
    we can have everyone here with responses that are of mutual
    importance to all of us, I am sure.
        I would like to put the full statement in the record, if I
    can.
        Senator Specter. Without objection, it will be.
        Senator Stevens. Secretary Shalala, I want to thank you
    particularly for providing Alaska some great help, particularly
    in the area of combating a very high rate of fetal alcohol
    syndrome and fetal alcohol effect problems in our State. Fetal
    alcohol syndrome, as we all know, is estimated to cost over
    $1.4 million for each person that is born with it.
        And unfortunately, we have the highest level per capita in
    the country. We believe it is an entirely preventable condition
    and appreciate what you are doing to help us work on the
    prevention side.
        I also am grateful to you for your assistance in making PET
    scans available to our seniors under the Medicare program. We
    talked about this last week. And I understand your staff and
    the Health Care Financing Administration have agreed to a
    reasonable level of Medicare payment for PET scans under the
    new Outpatient Hospital Payment System that is going to go into
    effect in the summer. I congratulate you very much for that.
        I appreciate your agency's willingness to continue working
    cooperatively with the PET community on getting full, broad,
    coverage for PET scans.
        It is my understanding the PET community will be submitting
    revised information to HCFA in the next 45 days. We will all be
    following the progress on that. And hopefully we will be able
    to get full approval of PET coverage by this summer.
        Incidentally, in flying back from California on Sunday, I
    read a whole series of new brochures that are out from across
    the country on the use of PET, how we are expanding its use
    into all forms of cancer, as well as the brain. I think it just
    an invaluable new system of imaging and diagnosis.
        I am very interested in it because of my great friend, Dr.
    Michael Phelps of UCLA, who is the inventor of that. And I am
    very proud of him as a friend. It has been about 20 years ago
    now that I stopped off to see him at UCLA. And he gave me a
    rundown of the PET scan.
        I told him I was supposed to make a speech to the National
    Convention of the American Legion that day. When he got through
    giving me his presentation, I asked him what time it was, and
    he said it was 8:00 p.m. I started at 3:00 with him, and
    unfortunately missed that convention altogether, I was so
    mesmerized by what he was doing. He has undoubtedly made a
    significant contribution to our medical diagnostic capability.
        And I do believe that it is going to be expanding in its
    use, primarily because of the help you and your staff are
    providing.

                     Importance of Technology in Education

        Secretary Riley, I am also here to tell you I am
    particularly pleased with your recognition of the importance of
    technology in our classrooms and training teachers to
    effectively use that technology.

                            Long-distance education

        I am sure you know we are going into our State with a whole
    new concept of education by distance, long-distance education.
    Tele-medicine and tele-education are two very important
    opportunities for our State, which is, after all, one-fifth the
    size of the whole United States.
        In the past, many opportunities were denied to our teachers
    and students in Alaska because of the isolation of rural
    communities and villages. But distance education will change
    that.
        Alaska and Hawaii in particular, and some of the rural
    south 48 States will benefit tremendously from the new
    technologies in distance education. I am very grateful to all
    you for what you and your people have done working with us.

                     Balance budget request with resources

        A word of caution, however. I am disappointed in the
    President's budget request because it promises more than we can
    deliver. It includes paying out monies that theoretically come
    in as taxes, which have no chance of being approved.
        And because of that, we are going to have a real difficulty
    in maintaining our commitment to a balanced budget and our
    position that we will not use the Social Security surplus in
    financing the working operations of the Federal Government.
        I look forward to working with the chairman, the members of
    this committee, and all of you to try to come up with a
    realistic spending plan for the next fiscal year that will meet
    our needs and not return to the days of a heavy deficit.

                               PREPARED STATEMENT

        Thank you very much. And I will submit the questions.
        Senator Specter. Thank you, Senator Stevens.
        [The statement follows:]

                   Prepared Statement of Senator Ted Stevens

        Senator Specter, Senator Harkin, and members of the subcommittee.
        I'd like to begin by thanking you, Mr. Chairman for the leadership
    you have shown in working to prevent youth violence.
        When we presented our fiscal year 2001 budget, I noted that the
    searing images we saw last year at Columbine and other schools must
    never be repeated.
        If there was ever a bi-partisan issue--this is it.
        That's why the President worked with Congress to establish a new
    White House Council on Youth Violence to get all Federal agencies
    thinking and working together to prevent youth violence.
        And that's why my colleagues, Secretary Herman and Secretary Riley,
    and I join you in your determination to bring to bear the resources we
    need to fight this problem effectively.
        At HHS, the Surgeon General is developing a Report on Youth
    Violence that we hope will be completed this year.
        However, this much we already know: Violence is preventable. So we
    intend to find out what works. What doesn't. And then publish and
    disseminate a sourcebook of best practices.
        Our budget also increases the Mental Health Block Grant by $60
    million--a full 17 percent.
        And we're budgeting another $78 million to stop youth violence.
        Now let me highlight other important features of our budget and why
    we believe this budget is critical to the health and future of the
    American people.
        Our fiscal year 2001 budget brings us to where we should be at the
    dawn of a new century: A great nation pledging allegiance to great
    goals.
        Those goals are: Expanded health care coverage; renewed support for
    children and families; greater scientific advancement; and the creation
    of a healthier America.
        Our fiscal year 2001 budget brings those goals within reach--
    without loosening our commitment to fiscal discipline and a balanced
    budget.
        This budget is about people.
        It makes a record investment in health care coverage. In access.
    And in quality.
        Two years ago, with bipartisan support, we launched the State
    Children's Health Insurance Program.
        Two million children are now enrolled.
        Now we want to make sure that this new program--and Medicaid--carry
    millions more children, and their parents, into the safe harbor of
    quality health care.
        The President's FamilyCare program will do that.
        Even as we expand coverage to some parents through FamilyCare, we
    recognize that many low income adults work in jobs that do not offer
    health insurance.
        These workers frequently rely on local health institutions and
    professionals who provide services at a reduced or no cost.
        This year we want to increase our support for these community
    service networks to $125 million--five times our investment last year.
        We need to strengthen and modernize Medicare.
        First and foremost that means dedicating about $300 billion of the
    on-budget surplus over 10 years to extend the solvency of the Trust
    Fund until 2025.
        We must also add a voluntary prescription drug benefit to Medicare.
        As the President said in his State of the Union, we would never
    design Medicare today without a prescription drug benefit.
        We can't change the past. However, we can change the future.
        But, the longer we wait, the worse the problem will become--and the
    more expensive it will become.
        Government cannot step into the shoes of parents and communities,
    but government does have a role to play in helping families balance
    work and children.
        One recent study notes that in 1998 only 10 percent of the 14.7
    million children eligible for Federal child care subsidies received
    them.
        So as part of the President's Child Care Initiative, this year's
    budget adds another $817 million to the Child Care Development Block
    Grant.
        This is part of our discretionary budget and brings the total Block
    Grant to $2 billion.
        Mr. Chairman, Head Start is one of the most successful bipartisan
    programs our two branches of government has ever created for children.
        This year we're requesting $6.3 billion for Head Start.
        That's $1 billion more than last year--and the largest increase in
    the history of Head Start.
        I can't talk about children without talking about drugs. I know,
    Mr. Chairman, that you would like to pursue this further in our
    question and answer period.
        We know marijuana use has leveled off among teens. But too many
    teens are still saying ``yes'' to drugs and alcohol.
        That's why our budget includes over $3.3 billion for substance
    abuse treatment and prevention.
        I mentioned the success we've had cutting the death rate from AIDS.
        But HIV/AIDS is still a disease without a cure--and is still the
    greatest public health challenge both here and around the world.
        So fighting HIV/AIDS remains a top priority for the Department.
        Our total AIDS budget this year is $9.2 billion--an increase of 8.4
    percent over last year.
        Every agency's AIDS-fighting budget is going up in prevention,
    treatment and research.
        On the prevention side, we propose to spend an additional $75
    million to help stop the spread of this disease.
        Specifically, the CDC will direct $40 million of the new funds to
    local communities--including prevention services targeted to minority
    populations.
        CDC will spend another $26 million to fight AIDS around the world.
        At the same time, the Health Resources and Services Administration
    will expend $1.7 billion in Ryan White funding to help people living
    with HIV/AIDS.
        This is a $125 million increase over last year.
        Our budget request for AIDS-related research at NIH is $2.1
    billion, a 5.2 percent increase over last year.
        The total NIH budget this year is $18.8 billion--$1 billion more
    than a year ago.
        This subcommittee should take pride in the unprecedented investment
    we have made in basic and clinical research.
        Our shared commitment to NIH, . . .
        . . . and to producing quality science and scientists--on both the
    NIH campus and at great research universities--is an extraordinary
    legacy.
        Years from now, we will see results beyond our wildest dreams.
        Some of those results are certain to come from the $73 million we
    intend to invest--over 2 years--to build a National Neuroscience
    Research Center at NIH.
        This will put all NIH brain research under one roof.
        More important the Center will usher in what is certain to be The
    Century of the Brain.
        In the interest of time--let me quickly mention three other areas
    where we intend to increase our discretionary budget.
        We take very seriously the need to stop infectious diseases and
    bioterrorism.
        Our budget increases by almost 50 percent CDC's funding for disease
    surveillance.
        As for bioterrorism--which may be the biggest threat of the 21st
    century--we're proposing to spend $265 million to prepare for, and
    respond to, a biological attack.
        We also want to make a major investment in bricks and mortar.
        In addition to the Neuroscience Research Center at NIH, CDC
    proposes to spend $127 million--$70 million more than last year--to
    modernize and expand three laboratory sites.
        The remaining funds will go toward completing the Edward R. Roybal
    infectious disease lab, and construction of a new environmental health
    lab.
        Mr. Chairman, I want to conclude my testimony by noting that our
    greatest moral imperative is to close the gaps in health outcomes
    between minorities and the majority population.
        In 1998, the President set a goal of ending health disparities in
    six major areas.
        Now, almost every operating division is working to close these
    gaps.
        That includes an additional $35 million at CDC for community-based
    research and demonstration projects to reduce disparities.
        Thank you.

                   TRANSPORTATION FUNDING FOR WELFARE WORKERS

        Senator Specter. Secretary Herman, when you talk about
    areas of needs, of trying to move workers from, say, the inner
    city, where there are no jobs, to the suburbs, where there are
    jobs, I think that is an area which requires special attention.
        And I thank you for taking the initial steps to free $1.3
    million for Philadelphia. We talked about that week before
    last, and you acted on it last week. But when I visited the
    transit system yesterday, I was told the check was in the mail.
    Do you know how far along the delivery route that check is?
        Secretary Herman. I believe it will arrive on Thursday.
        Senator Specter. OK. So I will report back to them that it
    is still in the mail.
        That program needs a lot of additions. They transport 1,500
    people in buses, and they have some 9 vans. But I am making a
    survey to see how many poor people need that transportation,
    what it would do for the lives of people giving them dignity
    and a job, and what it would do for the taxpayers on reducing
    welfare payments. So we are going to come back to you there,
    but I do appreciate your help.

                                  BIOTERRORISM

        Secretary Shalala, you commented specifically about the
    $265 million on bioterrorism. A commission just finished its
    work a few months ago on dealing with weapons of mass
    destruction. I served as vice chairman. And the commission did
    not move into the domestic area. And I believe that is
    something that we ought to be doing more on, this subcommittee,
    and will.
        But could you give us in a general way the use of the $265
    million on anti-bioterrorism?
        Secretary Shalala. Yes. Thank you, Mr. Chairman. As you
    well know, unlike other kinds of terrorism, bioterrorism, the
    response for it needs to be done on the ground in local
    communities.
        And, much of this money is focused on building up the
    public health infrastructure and educating the medical
    community, both in terms of identifying what may turn out to be
    a release of some kind of disease and reporting it as quickly
    as possible.
        So what we do on the ground level is strengthen the
    existing public health infrastructure and the State and
    community public health officials that are responsible. And,
    simultaneously strengthen our surveillance systems, which were
    set up originally for infectious diseases, but now are full
    reporting systems for any kind of outbreaks, which are reported
    from the community, State, and then to the CDC, and our
    response time in our laboratory capacities across the country
    in being able to make a diagnosis quickly.
        Senator Specter. Could you give me your evaluation as to
    the adequacy of our domestic program against potential
    bioterrorism?
        Secretary Shalala. The current program is inadequate. And
    that is the reason for these substantial investments at both
    the local level, the State level, as well as the national
    level.
        Senator Specter. I would like to work with you on the staff
    level. I do not want to cut you short, but I want to come to a
    couple more questions.
        Secretary Shalala. We would be happy to do that. The person
    who is coordinating it in the Department, I want to point out,
    is the Assistant Secretary for Planning and Evaluation, Peggy
    Hamburg, who is a physician and the former New York City health
    commissioner.
        Senator Specter. That is a good start.
        Secretary Shalala. We particularly picked someone who
    actually knows what you do on the ground and how you can
    strengthen the system from the bottom up.

                   MEETING DIVERSE NEEDS OF SCHOOL DISTRICTS

        Senator Specter. Secretary Riley, last year we had a real
    battle over the potential for local flexibility on the issue of
    providing additional teachers. And the question which I would
    like you to provide for the record, because I want to ask
    another question before my red light goes on, I intend to
    observe it, is what is the disadvantage of allowing a school
    board to go for books or computers or some other facet, instead
    of hiring teachers to reduce class size?

                          PREVENTION OF UOUTH VIOLENCE

        But the question I want to get a response from all three of
    you secretaries on is, our program against youth violence has
    looked at existing resources on the National Institute of
    Mental Health and Center for Disease Control, the parenting
    initiatives, et cetera.

                  MASS MEDIA ENTERTAINMENT AND YOUTH VIOLENCE

        But what about the role of movies and television and the
    computer and video games? And we do not want to point fingers,
    as many have, there specifically. But to what extent should we
    look at that? Considering the first amendment rights and
    freedom of speech, how big a problem is it? And what are your
    suggestions as to what we ought to be doing there? May we just
    work through the panel?
        Secretary Riley, why do you not start?
        Secretary Riley. Well, when you have the distribution
    system this country has, the capacity to deliver and the amount
    and availability of information that we have now--and we have
    really only scratched the surface, you then are going to have
    considerable issues to deal with. And that is the availability
    of undesirable information and so forth to youngsters.
        And I emphasize the important role that parents and
    teachers play in that. I think no matter how many filters you
    have, how much you try to deal with that--I was in the mine
    force in the Navy, and we were always talking about measures
    and countermeasures. And you get a countermeasure for filtering
    out something, and then they develop a measure to produce it in
    a different way.
        So I think you can have all of that, and it is a help. But
    really, it falls back on, I think, parents working with young
    people, making sure that the availability and the use of these
    powerful tools is supervised and managed.
        And the same applies with teachers in schools. Schools can
    do a better job than families, because they have the constant
    supervision of computers and other information. So I think it
    is a combination of things. All of these technical things are
    important. But really, it falls back on quality teachers and
    quality parents.
        Senator Specter. I am going to come back to this question
    in the second round, because we have quite a large attendance.
    And I do not want to exceed the 5-minute rule here.
        Senator Harkin.

                     PENSIONS PAID VIA LUMP SUM VS. ANNUITY

        Senator Harkin. Thank you very much, Mr. Chairman.
        Secretary Herman, I sent you a letter on January 28
    discussing what appears to be an increasingly common, but
    unfortunate, practice concerning pensions. What is happening is
    that many major companies offer employees retiring early the
    option of taking their pension benefits as a lump sum. ERISA
    requires that all defined benefit plans must pay benefits as an
    annuity, must pay it as an annuity, unless the employee and his
    or her spouse knowingly agrees to waive the annuity form.
        Although the statutes and regulations require the plan
    fiduciary to disclose the ``relative value'' of the optional
    forms of a benefit, a growing number of these employers not
    only fail to disclose, some, I think, even try to hide the fact
    that the lump sum has a value far less than the annuity. I
    think this represents a clear violation of the specific ERISA
    statutes and regulations, as well as an employer's general
    fiduciary responsibility.
        Have you looked into this? And are you proposing any plans
    to stop this kind of an abusive practice?
        Secretary Herman. Senator, we are looking very carefully
    into it. And I certainly appreciate the concern and the
    interest that you have taken in particular in this issue,
    because what it really boils down to is the ability of
    beneficiaries, of participants, to make informed judgements and
    their right to know. It is not necessarily the quantity of the
    information, but it is about the quality of the information
    that is needed to make critical retirement decisions.
        And we want to continue to work with you and others in
    efforts to advance the whole education effort to ensure, first
    of all, that plan participants are getting the information that
    they need to make informed decisions about their own
    retirement.
        But additionally, as your letter points out, we are also
    working with Treasury, and the IRS, to look at what formal
    steps we may need to take in this area regarding the specific
    obligations of ERISA. And I will be sure to have a written
    response to your letter in the very near future.

                         CDC'S BUILDINGS AND FACILITIES

        Senator Harkin. I appreciate that, and I appreciate your
    attention to this. And one of the examples I used in my letter,
    the annuity option had an actuarial value 80 percent larger
    than the lump sum. And yet, the information that was given to
    the employee did not point that out at all.
        And, of course, you hold out a lump sum and tell them they
    can invest in the stock market and they can make all this fast
    money and stuff. It looks very nice. But really what is
    happening is, basically the employer is buying back the annuity
    at a very reduced rate.
        So I encourage you to pursue this vigorously, and I am sure
    that you will.
        Secretary Shalala, recently I visited the Center for
    Disease Control in Atlanta. And I have to tell you, I was
    shocked at the condition of the facility at the world's premier
    disease control center, the one that people around the world
    look to for the prevention of outbreaks, the rapid response to
    the various diseases and viruses that are coming out. I
    understand just in the last 20 years 35 newly emerging diseases
    have been identified and are becoming virulent.
        I remember when Senator Hatfield left the Senate. He spoke
    on the Senate floor about the fact that with the Cold War over,
    it is no longer the Russians are coming, but the viruses are
    coming. And he spoke about the need to invest more basically in
    NIH.
        I think we have focused a lot on NIH. You have, to your
    great credit, we have on this committee, to the chairman's
    credit, focused on doubling NIH research. He has been a great
    leader in that. I wonder if maybe we have not somehow kind of
    shortchanged the Center for Disease Control. I remember the
    movie Outbreak with Dustin Hoffman in it. I always assumed it
    was filmed there.
        Senator Harkin. That is sort of what I assumed. I get down
    there and find out that the movie producers came down there and
    looked at CDC and, as I understand it, refused to film it there
    because no one would believe how bad it was. So they went to
    Hollywood and built their own set. So what you see in the movie
    was not the actual Center for Disease Control.
        Now I know they have a proposal in for new buildings. And I
    must say that the time frame is too long. I think somehow we
    have to collapse that time frame. I am just shocked. I do not
    know why I had not really paid more attention to this myself in
    the past. I think perhaps a lot of focused on NIH and the basic
    research.
        But when you are talking about these newly emerging viruses
    and diseases and outbreaks of food-borne illnesses, I mean,
    this is where we look worldwide for rapid intervention.
        So I just--and I have to believe that it makes it more
    difficult to recruit scientists, too, when they go down and
    take a look at that place. Who wants to work there? I mean, it
    really is bad. I know you know that. I mean, you have been
    there.
        But I am just wondering for your response, just a general
    response, on the conditions and whether you think we should be
    pushing a little bit harder and faster on the buildings and
    renovation of CDC than what we are doing.
        Secretary Shalala. Senator Harkin, I welcome the
    opportunity to talk to you about that. I do not disagree with
    your comments. In fact, this year's budget has 122-percent
    increase in our request for construction money. It is part of a
    master plan.
        What I would like to do is to work with the committee and
    identify and show you what we have done in a master plan. If
    you would like to shorten the amount of time, we would
    certainly be prepared to talk to you. But we have now laid out
    a master plan.
        This may be a case of a little out of sight, out of mind.
    And, we need to pay attention. The focus on CDC, in this
    budget, is my personal highest priority. As I am ending my tour
    of duty in government and since I spent much of my career
    working with State governments, we could figure out how to
    finance capital projects.
        We have to do it out of every year's budget, as opposed to
    stretching it out over time. And the budget rules are just
    irresponsible, in my judgment, about the financing of capital
    projects. We have to put everything in the budget in 1 year----
        Senator Harkin. Crazy.
        Secretary Shalala [continuing]. As opposed to spreading it
    over time. And we need to work through these issues when we are
    investing in institutions as important as the CDC or the NIH or
    any of the other institutions where we have to build
    facilities.
        FDA also has a proposal here. It has been just as difficult
    to struggle to make sure that FDA has first-class facilities,
    because of the way the budgeting rules work, and not our lack
    of interest or attention to the structures that we think are so
    responsible and important to the quality of work.
        Senator Harkin. Thank you.
        Senator Specter. Thank you, Senator Harkin.
        Senator Feinstein.

                           CLINICAL TRIALS DATA BASE

        Senator Feinstein. Thanks very much, Mr. Chairman.
        I want to compliment the three of you on your
    presentations. I thought they were excellent. With your
    permission, Mr. Chairman, I will submit a statement for the
    record.
        [The statement follows:]

                 Prepared Statement of Senator Dianne Feinstein

        Thank you to all of you for coming before our subcommittee today.
    You are responsible for addressing some of the nation's most pressing
    problems. Let me name a few that face my state, the largest state in
    the nation, 34 million people.

                                   EDUCATION

    California's needs

        Our nation's schools face huge challenges--low test scores, crowded
    classrooms, teacher shortages, booming enrollments, decrepit buildings.
      --California has 5.8 million students, more students than 36 states
            have in total population and one of the highest projected
            enrollments in the US.
      --California will need 300,000 new teachers by 2010. Eleven percent
            or 30,000 of our 285,000 teachers are on emergency credentials.
      --California has 40 percent of nation's immigrants; we have 50
            languages in some schools.
      --For school construction, modernization and deferred maintenance,
            California needs $21 billion by 2003 or 7 new classrooms per
            day. Two million California children go to school today in
            86,000 portable classrooms.
      --California's Head Start programs serve only 13 percent of eligible
            children.
      --For higher education, the University of California has the most
            diverse student body in the US. Federal programs provide nearly
            55 percent of all student financial aid funding that UC
            students received. Our colleges and universities are facing
            ``Tidal Wave II,'' the demographic bulge created by children of
            the baby boomers who will inundate California's colleges and
            universities between 2000 and 2010 because the number of high
            school graduates will jump 30 percent.
        So our needs are huge.

    Fiscal year 2001 education budget

        While these needs cry out for resources, the federal share of
    elementary secondary education funding has declined from 14 percent in
    1980 to 6 percent in 1999. Funding is so short in my state that
    California teachers are spending around $1,000 a year out of their own
    pockets to pay for books, magic markers, scissors and other school
    supplies, according to the San Diego Tribune, August 16, 1999.
        I commend the Administration for proposing to increase education
    funding in fiscal year 2001 to $40.1 billion or 12.6 percent. I welcome
    this increase. I hope we can do better because the status quo in
    American public education is not enough.
        I would like to share with you, Secretary Riley, some of my
    concerns:
        Title I: For the Title I program, I have two concerns: First is the
    ``hold harmless'' provision. Thank you, Secretary Riley, for opposing
    the Title I ``hold harmless'' provision that has been included in our
    appropriations bills. I hope you will more actively work to prevent its
    enactment again.
        In 1994, Congress included in the Title I law a requirement that
    you annually update the number of poor children so that the allocation
    of funds would truly reflect the most up-to-date number of poor
    children. This is a very important provision to growing states like
    mine. However, despite my opposition, the hold harmless provision has
    been included in annual appropriations bills, effectively overriding
    the census update requirement and locking in historic funding amounts
    for states despite the change in the number of poor children.
        Secretary Riley, I whole-heartedly agree with your statement last
    year--which I hope you will reaffirm today--that ``a basic principle in
    targeting should be to drive funds to where the poor children are, not
    to where they were a decade ago.''
        With 18 percent of the country's Title I students, California only
    receives 11.4 percent of Title I funds. Please join me in vigorously
    fighting the hold harmless provision. At least, 775,000 eligible Title
    I students are not getting services in my state.
        Second, on Title I, I hope we can work together to better focus the
    funding on academic achievement. Title I reaches virtually every school
    district and can be an important force for change. I hope you will give
    me your thoughts on how to put more ``academic teeth'' into Title I.

    Head Start

        Head Start is one of the most important federal programs because it
    has the potential to reach children early in their formative years when
    their cognitive skills are developing. Many studies have confirmed the
    significance of bringing positive influences to early brain
    development. But we know that poor children disproportionately start
    school behind their peers--they are less likely to count to 10 or to
    recite the alphabet. Every child deserves not just a good start, but a
    head start.
        And yet, ``Head Start has only vague performance standards and no
    curriculum to stimulate the growth of literacy and numeracy,'' say
    Henry Aaron and Robert Reschaeur in Setting National Priorities, The
    2000 Election and Beyond. Research tells us that for every dollar
    invested, we save $7.00 in decreased expenditures for compensatory
    education, crime and welfare. I hope that both you Secretary Riley and
    Secretary Shalala will discuss the plight and challenges of Head Start
    with me. I will have some very specific questions to pose to you.
        The proposed addition of $1 billion for HeadStart to enroll 1
    million more children by 2002, a 19 percent increase, is good first
    step. California has 764,462 poor children age 5 and under in poverty,
    but we only serving only 13 percent of eligible children. We must do
    better. I want to explore with you the challenge of major reform of the
    Head Start program to better prepare children for school at a time when
    high quality preschool programs can have long lasting benefits.

    Impact aid

        I am disappointed in your impact aid request. You are proposing to
    cut Impact Aid from $906.5 million in fiscal year 2000 to $770 million
    in 2001.
        California has 119 school districts receiving Impact Aid, helping 1
    million students. In fiscal year 2000, California is receiving $57
    million in Impact Aid. In California, Impact Aid funds only 23 percent
    of the cost of educating a federally-connected student. This is an
    important program in a state that has many tax-exempt federal
    properties.

    Immigrant education

        I am disappointed that your budget request proposes flat funding--
    no increase--for immigrant education. Appropriations were $150 million
    in 1998, $150 million in 1999, and $150 million in 2000 and you have
    requested $150 million.
        California receives $180.00 for each eligible immigrant child which
    hardly begins to address the needs these children bring to the
    classroom. These are the most at-risk of all children. They speak
    another language; their schooling has been interrupted and they have
    huge adjustment challenges. Can't we do better?
    Other education challenges
        I commend the President's initiatives on school construction, both
    the tax credits for bondholders and the new school renovation grants.
    These are long overdue.
        The continued drive to hire teachers and reduce class sizes is
    right on target. California started reducing class sizes in grades K-3
    in the 1996-1997 school year. We had then and we still have some of the
    largest class sizes in the country. And every parent knows that the
    smaller the class the more individualized attention students receive
    and the more effective the teacher can be.

                                   CHILD CARE

        Secretary Shalala, I am so pleased to see that the Administration
    has recommended $818 million for the Child Care Development Block
    Grant. As you know, Senators Dodd and Jeffords offered an amendment
    last year to increase funding to assist working families with the costs
    of child care. The Dodd-Jeffords amendment doubled the discretionary
    funding for the CCDBG by $818 million to a total of $2 billion. The
    amendment passed 41-54, but was dropped in conference with the House
    and was not included in the final version of the bill. I understand
    that Senator Specter has committed to including the increased funding
    in his chairman's mark for fiscal year 2001 appropriations. I am hoping
    these funds will not be forward funded this year, as in previous years.

                                  HEALTH CARE

        Now I will turn to health care, another important concern of
    Californians.
    California's needs
        We have an uninsured rate of 24 percent (7.3 million people), far
    above the national rate of 17 percent. Despite a thriving economy, the
    number of Californians without health insurance grows by 23,000 per
    month, far exceeding the national rate.
        California has the second highest incidence of HIV/AIDS in the
    US.While the AIDS death rate has declined, it is till too high; 40,000
    new infections develop each year. In California, 100,000 people are
    living with HIV/AIDS. Nationally, half of all HIV-infected people do
    not receive regular medical care (Rand study, December 1998).
        California ranks 37th overall among states having children
    immunized by the age of 18 to 24 months.
        In my state, 37 hospitals have closed since 1996 and 15 percent
    more may close by 2005. Over half my state's hospitals are losing
    money. Seismic safety requirements add more cost strains.
    Health budget

                NATIONAL INSTITUTES OF HEALTH

        While I welcome the $1 billion or 5.6 percent increase, I am told
    that to keep us on the path toward doubling NIH over five years, the
    increase should be $2.7 billion. Even though Congress has given NIH
    generous increases in the last two years, NIH is 1999 could still only
    fund 32 percent of grant proposals.
        Our investment in biomedical research has given us longer lives,
    healthier lives, and cures and new treatments.
        This is an area of governmental activity that Americans
    overwhelmingly support. Fifty-five percent of Californians said they
    would pay more in taxes for more medical research
    Cancer
        The President proposed only a 5.9 percent increase for cancer
    research.
        Cancer is a concern of virtually every American. Fifty percent of
    Americans have had someone close them die from cancer.
        The American Cancer Society and other major cancer groups are
    calling for a 15 percent increase for the National Cancer Institute,
    raising NCI from $3.25 billion to $4.1 billion.
        The Cancer March, that came to Washington in September 1999, called
    for increasing the National Cancer Institute budget by 20 percent each
    year for 4 years, to get to $10 billion by 2005. They cited the
    impending ``cancer explosion,'' coming with the aging of the American
    population. Because of the aging of the population, the incidence of
    cancer will reach staggering proportions by 2010, with a 29 percent
    increase in incidence and a 25 percent increase in deaths, at a cost of
    over $200 billion per year. The cancer burden will balloon especially
    in the next 10 to 25 years as the country's demographics change.
        Why invest more in cancer research? The Cancer March Research Task
    Force said we could reduce cancer deaths from 25 to 40 percent over the
    next 20 year period, saving 150,000 to 225,000 lives each year. Other
    areas that could be enhanced are bringing new cancer drugs from the
    laboratory to clinical trials; continuing to identify genes involved in
    cancer; improving our understanding of the interaction between genes
    and environmental exposures; finding new ways to detect cancers earlier
    when they are small, not invasive and more easily treated.
        We must also improve participation in cancer clinical trials.
    Medicare beneficiaries account for more than 50 percent of all cancer
    diagnoses and 60 percent of all cancer deaths, but only two percent
    participate in clinical trials.
        Along this line, I hope Secretary Shalala can tell us today that
    the clinical trials database that we enacted in 1997 is all ready to
    go. This is an important 1-800 number for patients and doctors to find
    out what research trials for serious and life-threatening diseases are
    underway.
        Cancer prevention is another area that needs increased resources.
    The American Cancer Society says that 60 to 70 percent of all cancers
    are preventable. We need to do more in this area so that Americans
    never get cancer.
    Other health programs
        I welcome the President's initiatives to fill in some of the gaps
    in health care--new initiatives like expanding the CHIP program to
    children's parents; strengthening enrollment in CHIP through schools
    and child care centers; increasing funding for community health
    centers; restoring Medicaid to immigrant children who entered the U. S.
    after August 1996 and to legal immigrant pregnant women; increases for
    immunizations; for HIV/AIDs services. All of these are very important
    to my state.
        I do have to question why the HHS budget cuts funding to train
    health professionals by $84 million. Almost one in five Californians
    lives in a health professions shortage area. We are facing a nursing
    shortage and will need 43,000 more nurses by 2010, which is a
    conservative estimate based on a projected 23 percent increase in the
    state's population.
        Even though we have a booming economy, we are faced with many
    challenges to which your budgets respond. I look forward to working
    with you to craft a final bill that responds to these concerns that I
    have outlined.
        I am also concerned about the delay in establishing the clinical
    trials database. We passed the FDA bill requiring NIH to set up a toll-
    free 1-800 number in 1997. We created it at the suggestion of patients
    and their doctors who said they need one simple place to go to find out
    what research trials were being conducted. I am quite concerned that,
    two and a half years later, this still not be set up and announced. I
    hope you will have good news today, Secretary Shalala.
        Thank you again for coming before our subcommittee.

        Senator Feinstein. Secretary Shalala, it is my
    understanding that last night your department announced that
    you are implementing the clinical trials database Senator Snowe
    and I authored. Will it now be possible for an individual to
    call a 1-800 number and get information about clinical trials
    relating to acute diseases?
        Secretary Shalala. More important than just the 1-800
    number, they will be able to go on the website, get information
    about individual clinical trials, and find out who to contact
    about that particular clinical trial. So it is a very
    transparent system on clinical trials. I think the first 4,000
    are up and on the website.
        So from our point of view, your initiative and our ability
    to get this up on the website so that people find out what the
    clinical trial is doing, how to enroll, and specifically who to
    call, this is a major step forward in health in this country.
        Senator Feinstein. Well, thank you very much.
        Secretary Shalala. And thank you for your leadership.

                                   HEAD START

        Senator Feinstein. Well, Senator Snowe and I appreciate
    that very much. Thank you.
        Let me just share with you some of my thinking about Head
    Start. I appreciate very much that there is an additional $1
    billion to expand the program by about 17 percent. I am coming
    to question whether we should expand the program prior to the
    time we make Head Start truly a Head Start program. I am
    finding that many Head Start classrooms do not teach any
    cognitive skills whatsoever.
        I am also finding that the standards are vague and that
    Head Start is a missed opportunity. One of the major cities in
    California has just told me they can only pay $22,000 a year
    for a Head Start teacher. You are not going to get a Head Start
    teacher that is going to bring about any quality education for
    that.
        And then I took a look at the French system, looked a
    little bit about what the Core Knowledge Foundation is doing in
    setting up some model Head Start programs. I really think we
    are missing the boat by expanding Head Start without improving
    the quality of the program first.
        And since this is a 100-percent federally funded program,
    it seems to me that not only do we miss the boat, but we have
    an obligation to see that standards and quality are present. I
    think there is enough information. Cognitive learning is quite
    possible in children of a Head Start age.
        My questions are these, and I will just ask them, and then
    perhaps you can respond: What is HHS doing to move Head Start
    from custodial child care to a program that stresses cognitive
    development and learning?
        Second, would HHS be opposed to changing the focus of the
    Head Start program so that more attention is placed on the
    development of cognitive skills?
        Third, what kind of coordination or communication does the
    Department of Education have with HHS on this program?
        And finally, should we not really move Head Start to the
    Department of Education and convert it into a strong preschool
    program and focus on cognitive development?

                  COGNITIVE SKILLS AND STANDARDS IN HEAD START

        Secretary Shalala. Let me answer those questions quickly.
    The answer is that Head Start is the strongest preschool
    program that we have in this country. Over the last 7 years
    this administration has invested substantially in improving not
    only the cognitive learning part of the program, but in raising
    the standards. In fact, 25 percent of all the new money going
    into Head Start has been invested specifically in raising the
    quality of the program.
        So tough have we been on this program that we have closed
    over 150 Head Start programs that did not meet our standards.
    No other government program has been as effective in both
    raising standards and closing down programs that did not meet
    our standards.
        Before we came into this administration, not one Head Start
    program had ever been closed for not meeting its standards in
    the history of its program.
        The difference between Head Start and other kinds of
    custodial programs is in fact its investment in training and in
    specific standards. In fact, the specific rules of Head Start,
    are much more detailed than other programs.
        I would be happy to talk to you at some length about the
    cognitive part of Head Start. But the genius of Head Start is
    that it is comprehensive. It integrates both health, social
    services, education and learning.

                      CUSTOMER SATISFACTION IN HEAD START

        The evaluations of the program have concluded that it is a
    stronger program than any other preschool programs in this
    country. And parents' satisfaction of this program is the
    highest of any government agency or government program that we
    have. It is even higher than the ratings for Mercedes and BMW
    in customer satisfaction of the program.

                SHOULD HEAD START BE TRANSFERRED FROM HHS TO ED?

        Do I think it should be transferred to Education? I do not.
    But let me tell you specifically why. First, the history of
    Head Start is a history of a program that was started because
    of what was perceived as the weakness in the education programs
    in this country, a lack of parental involvement. However, we
    have built a series of partnerships with the Department of
    Education.
        And increasingly there are incentives in Head Start for
    public schools to integrate Head Start programs with their
    other preschool programs, their kindergarten programs. So there
    is a seamless program.
        But evaluations have shown something very interesting. And
    that is, where Head Start programs are standalone, there is
    more parental involvement than in these new cooperative
    endeavors with public schools. That is, you get less parental
    integration into the program when there is a cooperative
    agreement with a public school than you do with standalone
    programs.
        That means we see ourselves as reformers of the role of
    public schools and of public education. And no one has been a
    stronger supporter in HHS than I have been of public education
    in this country.
        But it is a different kind of program of the highest
    quality that has played an important role, I believe, in our
    understanding of preschool education and its quality by any
    measure.
        If you trotted out here the world's greatest experts on
    early childhood education, including the experts from the Yale
    Study Center, they would say to you, this program has gone
    through a transformation over the last 7 years, that it is
    strong both cognitively in terms of what it teaches and in the
    way it is managed and the way programs are integrated.
        So we started out with an overall assessment by experts in
    the field. They told us what to do. We have incorporated those.
    We have invested this money heavily in improving the quality,
    teacher training, and all the other parts of the program.
        But simultaneously, we have kept the heart of the program.
    And that is integrating parents into the learning process for
    these young people.
        Senator Specter. Secretary Shalala, you are on a very big
    subject. Could you supplement your answer for the record?
        Secretary Shalala. I will, yes.
        Senator Specter. Because we are pretty much over time.
        Secretary Shalala. With both the data and the research. And
    I would be happy to look at any California programs that my
    good friend, the Senator from California, thinks are weak in
    particular. And I would be happy to have our teams look at them
    very carefully.
        Senator Feinstein. Mr. Chairman, would it be possible to
    ask Secretary Riley to respond to that as well?
        Senator Specter. Well----
        Secretary Riley. How about in writing?
        Senator Feinstein. In writing?
        Senator Specter [continuing]. If you can briefly.
        Senator Feinstein. In writing would be fine.
        Senator Specter. If you can briefly respond orally, and
    supplement it, Mr. Secretary, in writing, because we do have
    other Senators who are waiting.

                  FOCUS ON COGNITIVE SKILLS IN EARLY CHILDHOOD

        Secretary Riley. Very briefly, I want to thank Secretary
    Shalala for really honing in during the reauthorization of Head
    Start a couple years ago and all the work that has been done
    since in centering on standards and quality.
        I think the question, Senator, is the cognitive skills for
    early childhood, which, as you point out and as Secretary
    Shalala has pointed out, have gotten more attention with all
    the brain research and so forth. The question is, are they
    provided, and not how and where.
        I am not into the empire building of the Department of
    Education. I am interested in cognitive skills being there in
    Head Start. And as I read it, they are very strong. That is a
    very strong focus from HHS now, and they really are trying to
    move in that direction as rapidly as possible and are doing a
    grand job moving in that direction.

                  HHS AND EDUCATION COORDINATION ON HEAD START

        We are working closely with them, with the overlap of Title
    I. The flexibility of Title I enables school districts to use
    Title I for early childhood. And so we are seeing more and more
    of that, and we are working very well in a cooperative way.
        [The information follows:]

                                   HEAD START

        Head Start is America's premiere early childhood education program,
    and continues to lead the way in state-of-the-art approaches to
    enhancing young children's development. Head Start's performance
    standards are, in fact, quite comprehensive and clearly delineate what
    programs must do in serving children and families. These standards
    cover the areas of Education and Early Childhood Development, Child
    Health, Child Mental Health, Child Nutrition, Family Partnerships,
    Community Partnerships and Program Governance, among others. A copy of
    these standards is attached. Furthermore, it should be noted that the
    Performance Standard on Education and Early Childhood Development
    clearly requires that all programs must, in collaboration with Head
    Start parents, implement a curriculum and goes on to discuss what this
    curriculum must include.
        This Administration has invested heavily in improving not only the
    cognitive learning aspects of this program, but in raising its
    standards. We have paired investment in critical elements of quality
    such as teacher compensation and training with a tough approach to
    enforcement of high standards in every Head Start program. Annual
    salaries for Head Start teachers have increased from $14,600 in 1992 to
    $20,700 this year. Since 1995, more than 140 local grantees have been
    replaced because they have been unable to rectify deficiencies in
    program quality. We will continue these investments in fiscal year 2001
    and will devote more than half of all new Head Start money to continued
    improvements in the quality of the program.
        In addition, Head Start has made a commitment to measuring child
    outcomes, including cognitive outcomes as well as other key aspects of
    children's development and parental involvement. Our research shows
    that typical children leave Head Start with a wide range of specific
    knowledge and skills that prepare them for kindergarten. These
    practical, common sense achievements form the foundation for continued
    progress in learning by Head Start children in kindergarten where they
    show statistically significant growth in vocabulary, letter
    recognition, writing and other pre-reading skills.
        Head Start provides top-quality early childhood education along
    with comprehensive services, such as health, nutrition, and family
    support services, to almost 900,000 low-income, preschool children and
    their families across the nation, including more than 81,000 children
    and their families in California.
        Head Start currently places a strong emphasis on cognitive skills.
    Preliminary results from the Family and Child Experiences Survey
    (FACES) indicate that average program quality is in the ``good'' to
    ``excellent'' range and no classroom scored below the ``minimal
    quality'' range. Head Start children are ready for school, performing
    above the levels expected for children from low-income families who
    have not attended center-based programs. The survey also found that 66
    percent of Head Start parents read to their child three or more times a
    week and that 70-90 percent of parents teach their children letters,
    numbers or songs.
        We are building upon this progress with new initiatives, including
    expanded training in family literacy services, new partnerships with
    pre-kindergarten and child care programs, and the development of local
    grantee systems to track and analyze child outcome data.
        The Head Start Bureau has extensive collaborative relationships and
    initiatives with the Department of Education, including the following:
      --Recent joint sponsorship with Title I, Even Start, and HHS's Child
            Care Bureau of a national leadership forum of State leaders and
            managers of pre-kindergarten, Head Start, and child care
            programs to explore new opportunities to use State and Federal
            early childhood funding to reach more children with higher
            quality services and to identify ways to eliminate barriers to
            cross-program collaboration.
      --Long-standing involvement with ED in joint efforts to serve
            infants, toddlers, and young children with disabilities,
            including participation in the Federal Interagency Coordinating
            Council, and public-private partnerships such as the Conrad
            Hilton Foundation/Head Start $15 million initiative to training
            community teams of Early Head Start, ED early intervention
            program providers, parents and other community agency leaders
            to improve serving to infants and toddlers with disabilities.
      --Collaborative efforts in research and accountability efforts,
            including joint sponsorship and funding of major longitudinal
            studies of early childhood development (including the National
            Center for Education Statistic's Early Childhood Longitudinal
            Survey, Kindergarten & Birth Cohorts) and emerging efforts in
            Title I and Even Start to utilize the Head Start Performance
            Measures outcome measures in Federal evaluations and State-
            level accountability efforts.
      --Additional leadership efforts between Head Start and public
            education programs and systems occur at the State and local
            level through the nationwide network of Head Start-State
            Collaboration Offices which give priority attention to forging
            linkages among local Head Start agencies, family literacy
            initiatives, State pre-kindergarten programs, and local
            education agencies.
      --Finally, and most importantly, every local Head Start grantee is
            held accountable for maintaining strong and effective
            partnerships with local elementary schools and districts
            through specific mandates covering the provision of family
            literacy and adult education services, services to children
            with disabilities, and preparing every child and family for a
            successful transition to kindergarten.

        Senator Specter. Mr. Secretary, thank you for that
    amplification.

                         HEAD START STAFF SALARY LEVELS

        Senator Harkin. If I might just say one thing to my friend
    from California. You are not going to get good cognitive skills
    teaching to the point that we want in Head Start if you are
    going to keep paying Head Start teachers as babysitters.
        Secretary Riley. That is true.
        Senator Harkin. If you are going to pay them at the rate of
    babysitters, that is what you are going to get. Now if you want
    to start getting cognitive skills--the big scam on Head Start
    is what we are not paying the Head Start teachers.
        Senator Specter. Secretary Shalala and Secretary Riley,
    Senator Feinstein raises a very important question. And we have
    been in conference on these figures, debating precisely the
    issues which both Senator Feinstein and Senator Harkin have
    raised.
        If you would--I think this is something we ought to pursue
    at the staff level. This may even be a subject for a full blown
    hearing. But let us pursue it at the staff level. And if you
    could supplement your verbal answers in writing, we would
    appreciate it.
        Senator Murray.

                   OPENING STATEMENT OF SENATOR PATTY MURRAY

        Senator Murray. Thank you very much, Mr. Chairman. And
    thank you to all three of the cabinet members who are here
    today, and I just personally thank you for all the work you
    have done on behalf of so many children and families in this
    country in your service. And I really do appreciate it.

                          CLASS SIZE REDUCTION FUNDING

        Secretary Riley, let me begin with you. The chairman asked
    you a question and a response in writing, but I really would
    like to hear your opinion on the debate that we continue to
    have on whether or not to focus targeted money on reducing our
    class sizes by hiring additional teachers or whether or not
    just sending that money out to schools to allow them to
    purchase books or pencils or paper or computers or whatever
    their needs are.
        I do not think there is any doubt in anybody's mind that
    there are tremendous needs in our public schools for those
    kinds of things. But what are the advantages of targeting it
    directly to hiring additional teachers?

                       ROLE OF FEDERAL EDUCATION PROGRAMS

        Secretary Riley. Well, of course I look at the Federal role
    as being one of support of the States and local schools, but
    with a national identification of a priority and a targeted
    effort. That is how Federal programs are most effective, and
    that is the role as I see it.

                   CLASS SIZE REDUCTION--USE OF PROGRAM FUNDS

        We have as a goal for this Nation to get the class size of
    early grades down to 15 to 18 pupils per teacher--and the
    research shows that that works. It works in those grades. It
    works in the eighth grade, in the twelfth grade, and on into
    college. It makes a difference in a child's education.
        So by setting the national goal to do that--to reduce class
    size, and that is a proposal that you have strongly supported,
    then we have to move in that direction. If you then lump that
    in with a block grant kind of approach, what you do is you take
    your eye off the prize.
        You take your eye off the focus, your eye off the national
    goal in this country of saying that all children will have a
    relatively small classroom in those early grades with a teacher
    well qualified to teach reading.
        So I am very much in opposition to lumping national goals,
    national focus, in with a number of other things. You have no
    way for accountability. There is no way you can look at how
    well it is working, if people have all kinds of options.
        Now I think within a program, there should be enormous
    flexibility. In the Federal Government, of course, under the
    proposal that you and I have supported, they do not pick the
    teachers, they do not decide what classes to do what in. It
    simply is a Federal priority targeted for that direction. And
    that is what makes a difference. And you can look at it in the
    future, see if it's working, or if it is not, determine why.

                         CLASS SIZE AND SCHOOL VIOLENCE

        Senator Murray. Thank you very much, Mr. Secretary. And the
    chairman asked about this issue of school violence. In talking
    to the teachers who are now in classes of 15 or 16, they tell
    me specifically that they now can focus attention on young kids
    and have them have that adult-child relationship that they
    believe will make a difference on the issue of violence later
    on.
        So if we do have that targeted approach, we will be able to
    follow that more closely. And I appreciate your response.

                  EDUCATIONAL TRAINING AND WELFARE RECIPIENTS

        Secretary Shalala, I have a question for you. I am hearing
    a lot of anecdotal evidence in my State and elsewhere that many
    of the community college programs that typically were filled
    with returning welfare-to-work mothers, nursing programs,
    things like that, are empty this year. Enrollments are way
    down. And a concern that because education is no longer
    considered a--that you need education as part of your welfare,
    that we have lost a lot of those moms, young moms, either back
    home in perhaps an abusive situation that they cannot get out
    of or in jobs that are going to go nowhere.
        Are you hearing this at your level as well? And I really
    would like to hear from Secretary Herman and even Secretary
    Riley on this, because both of you mentioned the disparity in
    people who are able to go to college and in the disparity in
    the workforce between those who are able to get into higher
    paying jobs and not.
        And I am worried about this component of those welfare-to-
    work moms, if they are not getting into programs in our
    colleges that will help them get into those higher paid jobs.
        Secretary Shalala. Senator Murray, when the welfare bill
    was written, it left to the States the decision about whether
    full-time college attendance could be integrated, and you would
    not lose the 2-year time frame. So those decisions were left to
    the State, as opposed to something that was automatic.
        The vast majority of college students in this country are
    now going part time. That is, they are working and going to
    school. And while that is a particularly heavy burden for young
    moms and for people coming from welfare to work, the fact is
    that in their own neighborhoods, in the houses next to them,
    are people who are combining work and going to school.
        And I just think the States have struggled with this issue.
    Is it fair to allow a small group of people, because they came
    through the welfare system, to go to school full time and be
    subsidized by the welfare system as an investment in their
    long-term earning potential versus people who live next door to
    them that have chosen to go directly into dead end jobs, but at
    the same time go to school part time to help increase their
    earning power over a period of time?
        There are numerous programs which Secretary Herman can
    outline that are available for people to combine the two or
    that they can get into. But the States addressing the issue of
    fundamental fairness, some States have struggled with it and
    said, yes, you can go to a 2-year community college. Other
    States have said, well, maybe for certain people a 4-year
    program in nursing, for example.
        I fought the State of New York, when I ran Hunter College,
    trying to get them to allow welfare, former welfare, recipients
    to stay in 4-year nursing programs because my belief was that
    their earning power at the end would be substantially better.
    But I do understand the fairness problem, because at that
    institution were people from the same neighborhoods, with the
    same socioeconomic backgrounds that were combining the two and
    killing themselves in the process for doing that.
        Senator Murray. Well, if nobody----
        Secretary Shalala. So I think the States have----
        Senator Murray [continuing]. Is in our nursing programs,
    then we do have a problem.
        Secretary Shalala. Right. And nursing programs are a
    particular problem, because it is hard to do them part time.
    There are a set of programs, physical therapy, nursing, where
    it is a particular problem because it is hard to do those
    programs part time. You can do a 2-year program part time
    often, a certification program, but it is hard to do a 4-year
    program part time.
        So the States can make the decision to allow someone to do
    it, and many of them have struggled with the decision. We do
    not have a national standard that we can impose. Congress
    specifically----
        Senator Specter. Senator Murray, would you like that answer
    amplified for the record? Because we are going to have to move
    on.
        Senator Murray. I would. I know Secretary Herman, if she
    could just comment in a 10-second time frame, I would like to
    hear what she has to say.
        Senator Specter. Take 10 seconds, Secretary Herman.
        Secretary Herman. I think Welfare-to-Work had unintended
    consequences in regard to educational opportunities. We did
    amend that last year to allow vocational education and job
    training for up to 6 months. And we are making further
    progress.
        Senator Specter. Thank you very much.
        Thank you very much, Senator Murray.
        Senator Reid.
        Senator Reid. Thank you very much, Mr. Chairman.
        I am wondering if--in the audience is Dr. Koplan. I wonder
    if he could respond to some questions. He is head of the
    Centers for Disease Control.
        Senator Specter. Well, we had planned to call him at the
    conclusion of this panel. But if you want to do that in your 5-
    minute round----
        Senator Reid. That would be great.
        Senator Specter [continuing]. We would do that.
        Wait just a minute, though.
        We have asked Dr. Jeffrey Koplan to be present at this
    panel today. And I had, as I stated, planned to call him at the
    conclusion of this round. But to accommodate Senator Reid on
    his schedule, we will move to Dr. Koplan at the present time.
        We have written Dr. Koplan, and he has responded. And those
    letters will be made a part of the record concerning
    expenditures made at the Center for Disease Control, which are
    at variance with what the congressional authorizations were,
    congressional appropriations.
        With that, Senator Reid, you can begin your round of
    questioning.

                        DR. WILLIAM BELLINI'S STATEMENT

        Senator Reid. Thank you very much, Mr. Chairman. You, as
    usual, are right on line. I was greatly disturbed to read a
    quote earlier this month in newspapers all around the country,
    in The Washington Post particularly, when one of Dr. Koplan's
    staff members, a Dr. William Bellini, who is in charge of the
    measles program, told the inspector general, and I quote,
    ``It's a bigger crime to follow Congress's direction than to
    spend money where science dictates,'' end of quote.
        This is the basis for a very troubling thing. In the mid-
    1980s, Mr. Chairman, in Lake Tahoe, a series of people came
    down with a disease that was then known as Epstein Barr
    syndrome that is now is chronic fatigue syndrome. Under the
    good auspices of this committee, we were able to get some money
    to specifically study that disease.
        We were very disappointed to learn that that money was
    spent for something else, because they thought it could be
    better spent on something else. If it were only Epstein Barr
    that money has not been spent properly for, maybe we could say
    that was a mistake. But now we learn that the Hanta virus,
    money that was set aside for that, which is also a western
    United States disease where people are dying as a result of
    this disease, who are being exposed to something, we believe,
    dealing with rats. We are not too sure.
        And then I have been getting mail the last few days, Lyme
    disease, the same thing. You know, we have report language, and
    it is ignored on many occasions. But when we appropriate money
    for a specific program, that is the program it should be spent
    on. And words cannot describe how disappointed I am.
        I have people all over the country that are writing to me
    that have been extremely sick. And this is not just Congress
    coming up with this. We have had the Inspector General look at
    this, and he acknowledges that they are spending money on
    programs other than what it was dictated for.
        So, Dr. Koplan, as I say, I just think this is outlandish.
    And I think the excuses that we have from your department are
    not very good. I appreciate the apology. You in writing
    apologized. But the answers that we have are just very, very
    bad.
        I recently received an employee, who, if their name were
    disclosed, would of course get fired. But they have sent me a
    batch of stuff, which I have sent on to the inspector general,
    where this is going on in the Centers for Disease Control.
        I do not know how to say this, but a stop has to be put to
    this. It is very, very difficult. It took me more than 10 years
    to get specific money for this Epstein Barr program. And then
    to have your office, your department, spend it on something
    else, and then we learn later it is Hanta virus, it is Lyme
    disease, we do not know what else.
        How do you respond to this? And I would also like to know
    how in the world can you have somebody working for you that in
    effect spits in Congress's face, William Bellini, who says,
    ``It's a bigger crime to follow Congress's direction than to
    spend money where science dictates.''
        [The information follows:]

                         QUOTE FROM THE WASHINGTON POST

        The comments at the hearing, drawn from a Washington Post article,
    were inaccurately attributed to Dr. William Bellini, a Centers for
    Disease Control and Prevention employee.

        Secretary Shalala. Senator, if I might----
        Senator Reid. I asked the questions, Ms. Secretary, to Dr.
    Koplan.
        Dr. Koplan. Senator Reid, thanks for giving me the
    opportunity to respond to this. First of all, let me answer
    your last question first, which is that we have 8,000
    employees, and the sentiments that you just expressed, that one
    of them was quoted as saying, are antithetical to my own
    beliefs and opinion.
        As Director of CDC, I can tell you that the vast majority
    of our staff, and all of our senior managers and decision
    makers believe strongly in following the directions of
    Congress, the budgetary directions of Congress and
    congressional intent. And that has been made clear to our staff
    top to bottom. And I strongly believe that, and I cannot
    emphasize it enough to you.
        Individual quotes, certain individuals in the institution
    do not speak for the institutional as a whole.
        Senator Reid. Do we just let that go? Is there anything in
    his record? Do we let it--is he just down there drawing his
    merit pay with this?
        Dr. Koplan. I do not know the individuals involved in
    detail.
        Senator Reid. But do you not think that should be flagged
    and take a look at this? I mean, this does not speak well of
    the Centers for Disease Control.
        Dr. Koplan. All of our staff have been told by me----
        Senator Reid. I want to know what----
        Dr. Koplan. Might I finish, Senator?
        Senator Specter. Senator Reid. Senator Reid, let him finish
    his answer.
        Dr. Koplan. All of our staff have been told in very clear
    terms what the relationship with Congress is, how I view the
    importance of that, and what our responsibilities and
    obligations are, both the Congress and the American public. And
    the type of attitude you just described is not tolerated in
    what we do.
        We have put in place----
        Senator Reid. OK. Not tolerated. What has happened to
    Bellini? Nothing?
        Dr. Koplan. I cannot describe personnel actions toward
    individuals, but I believe individuals are still allowed to
    express themselves on a wide variety of topics that I cannot
    necessarily tell them what to think.
        That is not an attitude or an expression of opinion that is
    likely to encourage someone to take any more management
    responsibility or have any policy options within our
    organization.
        By the same token, I have not had a chance to speak to this
    individual. I do not know what he was saying in general. And I
    do not know where the quote comes from.
        Senator Reid. I told you.
        Senator Specter. Senator Reid. Senator Reid, let us come
    back to this. Senator Craig has been waiting.
        We are going to take it up, and we will have another round
    in a moment or two.
        Senator Craig.
        Senator Craig. Mr. Chairman, I came here to listen. I am
    intrigued by what Senator Reid is saying. If you can trust the
    Center for Disease Control, nearly every agency--not every
    agency. A good many agencies I work with more dominantly than I
    do these----
        Senator Reid. If the Senator would yield, I heard the
    Senator dealing the Forest Service a week ago, the same
    situation.
        Senator Craig. Last year it was $400 million there, and
    they do not come back to their authorizing committees to get
    reauthorization. They just reprogram. And that is very
    frustrating to a Congress that oftentimes directs very
    specifically where the money should be spent.
        Now there are ways to reprogram money. You come back to the
    authorizing committees, and you get the consent of Congress to
    do so. Somehow in this administration we have had a real
    problem at times. But I am not singling out any one of these
    secretaries. When I say that, I am saying that in a generic
    form.
        And, you know, as a member of the Appropriations Committee,
    we only know how to get tougher by firewalling and
    straightjacketing. And that does not offer the flexibility that
    sometimes is necessary. But I do not blame the Senator for
    being frustrated. There is clear evidence of those kinds of
    remarks and attitudes.
        Senator Harkin. Would the Senator just yield for a second?
    I think the Senator may have just misspoke. Reprogramming comes
    to the appropriating.
        Senator Craig. You are correct. Reprogramming comes to the
    appropriating committees. But oftentimes, reprogramming, if it
    is significant enough, the appropriating chairman also consults
    with the authorizing chairman, which is wise and responsible to
    do when it comes to significant changes in direction that have
    happened. That is what I am suggesting.
        Mr. Chairman, thank you very much.
        Senator Specter. Thank you, Senator Craig.
        Let us proceed with Dr. Koplan, since Senator Reid has
    brought it up. And we will conclude this. We do have some other
    questions for secretaries.
        Dr. Koplan, the difficulty arises in part from the fact
    that there had also been misstatements by the Center for
    Disease Control as to the chronic fatigue syndrome research
    program, where funds were allocated in a different way, so that
    it appears to be a repetitive problem.
        Senator Reid has pressed you about Mr. Bellini's statement.
    Had you heard that before Senator Reid raised it with you this
    morning?
        Dr. Koplan. I have not heard Mr. Bellini's statement
    before. No.
        Senator Specter. You had not heard about it before today?
        Dr. Koplan. We had an inspector general's report that was
    delivered to me in May. There were background paperwork to that
    report that an inspector general's office did not provide me
    with. And I believe some of the quotes that are being provided
    are from background documents that I had not seen.
        Senator Specter. But your statement to the subcommittee is
    you had not heard about what Mr. Bellini had said prior to the
    time Senator Reid brought it up this morning.
        Dr. Koplan. I had not heard Mr. Bellini's quote.
        Senator Specter. All right. Well, that is--first of all, we
    ought to make the determination as to whether it is true that
    he in fact did say it. And if we make that determination, then
    I think there ought to be an investigation by you in the first
    instance, Dr. Koplan, as head of the Centers for Disease
    Control, to see what an explanation would be, if we determine
    the statement was made.
        When you deal with this sort of a statement, you have a
    potential violation of the Penal Code Section 1001, a false
    official statement. And we do not want to start to deal with
    that. But there is a high level of concern, really anger, in
    the Congress about what has happened here.
        Dr. Koplan. Chairman Specter, I share it. I share that
    concern. And the institution, CDC, and myself as responsible,
    erred in both reallocating funds and in not reporting it and
    not having appropriate discussions with the folks who we are
    dependent on for our well-being and for your trust. We have
    made a mistake. That mistake seems to be larger than just one
    unit.
        And because of that, we have put in place recently I think
    strong measures to address it and to address it across the
    whole institution. We have done several of them in partnership
    with Secretary Shalala.

                                   OIG REPORT

        Senator Specter. Have you inquired of the inspector
    general, who made the report, what the details were, so you
    would be in a position to answer?
        Dr. Koplan. The inspector general presented me with a
    report last May.
        Senator Specter. You have already said that. My question
    is: Have you inquired of them to find out more?
        Dr. Koplan. We met with them. They gave us a set of
    recommendations to put in place. We put those in place and went
    several steps further in putting into place recommendations.
        Senator Specter. Let me come back to my question, which you
    still have not addressed. Did you inquire of them as to what
    other information they had? You said they submitted a report.
    You said you met with them, and you put more steps into play.
    But have you found the details of their investigation? Have you
    said to the inspector general, tell us all you found here, so
    we can deal with it?
        Dr. Koplan. We asked for all they had found, and they gave
    us that set with recommendations. They did not provide us with
    background material, which they normally do not supply to
    agencies; in other words, interviews they do with everyone who
    they met with.
        Senator Specter. Did you ask for that?
        Dr. Koplan. No, we did not ask for it.
        Senator Specter. Well, I suggest that you do that. I would
    suggest you make the inquiries.
        What assurances are you in a position to give that this
    problem is going to be corrected in a forceful way?
        Dr. Koplan. Thank you. One, we are working with the
    department. The Department is placing a financial officer to
    provide oversight for our Center for Infectious Disease
    expenditures. That is the larger unit in which Hantavirus and
    chronic fatigue syndrome sits.
        Senator Specter. Are there any items besides those two
    where you have knowledge that there has been misstatements by
    the Centers for Disease Control?
        Dr. Koplan. There are no items besides those two in which I
    believe there are misstatements. But we are putting in place a
    system that is going to look broadly throughout the agency,
    including a management review of all of CDC's budgetary
    practices, to look everywhere and try to uncover it.
        Senator Specter. Have you taken any disciplinary action
    against anybody who made a false report?
        Dr. Koplan. I have reassigned a senior official in our
    Division of Virology and put new leadership in the Division of
    Virology.
        Senator Specter. Anything beyond the reassignment?
        Dr. Koplan. Reassignment is a pretty strong action in our
    institution.
        Senator Specter. Well, sir, my question was: Anything
    beyond a reassignment?
        Dr. Koplan. No.
        Senator Specter. Just one individual, one reassignment.
        Dr. Koplan. That is correct.
        Senator Specter. Is that individual the only one who has
    been determined to have made a false statement?
        Dr. Koplan. I am not sure that individual has made a false
    statement. That individual was reassigned to assume other
    duties to----
        Senator Specter. OK. Why did you make a reassignment of
    that individual?
        Dr. Koplan. I think there are other duties to which he is
    better suited. And we can make more improvements in the
    division for which he was responsible and----
        Senator Specter. So that reassignment is not related to the
    false statements.
        Dr. Koplan. I am not sure of the false statements you are
    referring to, sir.
        Secretary Shalala. Senator Specter.
        Senator Specter. I want to finish this. I want to finish
    this.
        Have you made a determination as to any employees at CDC
    who made false reports relating to these two items, chronic
    fatigue syndrome and Hantavirus?
        Dr. Koplan. There have been disciplinary actions taken at
    CDC to personnel.
        Senator Specter. How many for false statements made with
    respect to Hantavirus and chronic fatigue syndrome?
        Secretary Shalala. Senator Specter, we have a privacy issue
    here, if we might take a break and talk to you privately about
    what we can say on the record.
        Senator Specter. Well, is there a privacy issue, Madame
    Secretary, if names are not named?
        Secretary Shalala. Yes.
        Senator Specter. Why?
        Secretary Shalala. Because anything that could lead to the
    individuals--you are the lawyer. But I certainly would like to
    discuss this, not on the record, before the director of the CDC
    responds to that.
        Senator Specter. Well, I do not see a privacy issue in the
    absence of any specified person being identified or a category
    which could lead to the identification. But at your request, we
    will take a brief recess.
        Let us step into the back room, Madame Secretary, Dr.
    Koplan, Senator Reid.
        Senator Harkin. I think I am next. I just might say that I
    have looked at this issue, too. And I am equally upset about it
    as just about anybody else could be. And I think I have looked
    into it in-depth. I would just like to state for the record
    that I have met with Dr. Koplan both here and in Atlanta about
    this issue.
        It goes without saying that people should follow the intent
    of Congress. I can somehow see how this thing transpired. I do
    not know that anyone made intentionally false statements.
        I think the budget office responded to a question asked by
    Congressman Porter, I think, using what knowledge they had at
    the time of what was done. I do not think that the budget
    office--this is my own opinion--really had the information
    about what had happened to the funds.
        I am not--I do not want to sit here and go on with this
    thing that somebody made false statements. I do not know that
    that is so. And from my look at it, I do not believe that is
    so. I believe statements were made based upon the best
    information that people had at the time when they made that
    statement. That is not intentionally making a false statement.
    I want to make that clear.
        Second, I think what maybe Secretary Shalala said earlier
    about being out of sight, out of mind, I really do believe that
    whereas we have in the past continually worked with NIH as to
    how they are spending the money that we give them, and we do
    not earmark, but a lot of times we make our intentions known
    about where Congress wants to move, whether it is in AIDS, Ryan
    White type of initiatives, or whether it is in breast cancer
    research, a myriad of things that we give congressional intent.
        We are constantly--you do it, Mr. Chairman. I did it
    before, when I was chairman. We constantly have them up here to
    tell us what they are doing and how they are proceeding. And I
    would say even myself, when I was ranking on this, I did not
    bring CDC up here to talk to them. They were down there doing
    their thing.
        And I just think that perhaps we need a new relationship
    with the Centers for Disease Control and Prevention, to keep a
    closer working relationship on exactly how this money is going
    out and what they are doing and how they are operating.
        I talked with Dr. Koplan about what had happened down there
    and the reassignment of certain individuals. I had not heard
    the statement before either. This is the first time I had heard
    that statement. And I obviously need to know more about whether
    it is so and how it was said and that kind of thing before we
    can take action on it.
        But from what I have heard from Dr. Koplan, I am reasonably
    assured that steps have been taken on their end to correct this
    and make sure it does not happen again. I think what we do,
    what we have to do here as appropriators, I believe, is to
    establish a closer type of a working relationship with CDC and
    to have them up here more often to talk about where we are
    investing this money and what the intent of Congress is.
        But I think this is a two-way street. You had that
    relationship with NIH. I just do not think we have had it with
    the CDC.
        Senator Specter. Well, thank you, Senator Harkin. I do not
    know if there has been a false statement made either here. But
    when Dr. Koplan testifies that one person has been reassigned
    and that that is not related to a false statement, but for
    efficiency, that is really not--that is really beside the point
    of the question.
        And then he said there has been disciplinary action taken.
    With the record of the Center for Disease Control and the very
    substantial sums involved here, my sense is that this
    subcommittee has a duty to inquire and to find out what has
    happened.
        We are going to respect privacy. The questions asked of Dr.
    Koplan did not go to any individual or any category of
    individual, but just to find out if there had been a report of
    falsification and, if so, whether it was determined to be true
    or false and, if so, what action was taken.
        But when Secretary Shalala wants a session off the record,
    we will do that. Let us do that promptly, because we are going
    to have to conclude this hearing in the course of the next 10
    minutes.
        Do you want to step back, Secretary Shalala, Dr. Koplan.
        Senator Specter. The subcommittee will resume.
        We had allocated 2 hours for this hearing. And I am
    scheduled to meet with the House leadership at 11:30 to see
    what the funding is going to be for this subcommittee.
        We are working far in advance of the October sessions on
    that with my purpose being to try to see if we cannot get
    adequate funding for these three departments.
        Secretary Shalala has raised a question about the Privacy
    Act, and I have grave reservations as to its applicability in
    this situation. But we will pursue it to see if there is a
    basis for it. And we will proceed to work with Secretary
    Shalala and Dr. Koplan on private meetings and then make a
    determination as to what further hearings are needed.
        My sense is that on a matter of this sort, there is public
    interest and a right to know, and that this incident could have
    very substantial therapy for other branches of government. I do
    not know what the facts are, whether there has been any
    violation or whether there is any implication of 18 U.S. Code
    101. We have to make that determination.
        But in view of the time and in view of the request, we will
    do that privately. And we will report publicly what our
    findings are. And to repeat, if there is a necessity for a
    public hearing, we will reconvene.
        Let me turn now to Senator Cochran.

                            DELTA REGIONAL AUTHORITY

        Senator Cochran. Mr. Chairman, thank you very much. I came
    over to urge the secretaries to look at the Delta Regional
    Authority proposal the President has made. Yesterday they had a
    meeting at the White House with governors from the States that
    are involved.
        And in each of these instances, I think there are
    significant roles that can be played by these three departments
    in this undertaking, without really using any of the proposed
    spending to establish a new Federal agency.
        This authority, in my judgment, may or may not be needed in
    the context that is being proposed, if we use the resources
    that we have and some of the existing programs, like Job Corps,
    where we can train people who need jobs. We have a growing
    economy all over the country, but it is growing much slower.
    And in some places, it is negative, for example in the
    Mississippi Delta and in the lower Mississippi River Valley
    region.
        But in education, we have teacher training programs. Delta
    State University has a $1.5 million appropriation that this
    committee approved last year. There are more parts to this
    training and upgrading of skills, of teachers, recruiting
    people, a superintendents training program that has been
    proposed as a part of this program that has not been funded.
        We think that if you could go back and take a look at some
    of the proposals that places like Delta State University,
    Mississippi Valley State University, Alcorn State University--
    those are all in my State--but the community colleges, too, can
    play a major role, if we give them a little extra money. They
    have the know-how. They know what the problems are.
        And I think we are missing the bet, if we divert attention
    from some of the existing resources that we have, like Job
    Corps, teacher training programs and the rest, and in the rural
    health centers, to be sure that we have an infrastructure
    there.

                    RURAL HEALTH CENTERS IN THE DELTA REGION

        We have introduced legislation this week to double the
    appropriation over the next 5 years for rural health centers.
    They have done a very effective, cost-effective, job. We hope
    the administration can support this increase in funding that
    Senator Bond and I and others are sponsoring here in the
    Senate.
        So I do not have any real questions. I have some, but I am
    not going to ask them, because we are out of time. But I just
    wanted to let you know what my highest priority was this
    morning for discussion with you.
        So we appreciate you being here and look forward to working
    with you on these and other issues as we go through this next
    fiscal year. Thank you very much.
        Secretary Riley. Mr. Chairman, if I might respond to the
    comment. And I thank you for it. As you know, I was in
    Mississippi last week and got over into the Delta Region and
    went to Delta State University and I also was in the Cleveland
    area. And I strongly support the tenor of your remarks. I was
    there. I talked to a lot of school people and parents, higher
    education people.
        I did the same thing in Iowa a couple of weeks ago and saw
    in those rural areas--one little school district in Mississippi
    even told me they had 17,000 people in the district, and they
    had lost something like 1,000 jobs over the last couple of
    years.
        And then we have a program that they very much want to use,
    like Gear Up to connect up colleges with these struggling
    middle schools, and yet it calls for a match, which is a very
    legitimate thing for it to do. But they say they have no way of
    participating. They do not have any money for the program match
    requirement.
        In this school construction thing, where we do have
    resources for some grants in those very needy areas, they
    cannot support a school bond issue. And so I think it is good
    for all of us to get out and see the kind of thing you are
    talking about. Those people are working so hard in the Delta
    Region, and I was very proud to be there with them.
        Senator Cochran. Thank you very much, Mr. Secretary.
        Senator Specter. Thank you very much, Senator Cochran.

                YOUTH SAFETY AND HEALTH QUESTIONS FOR THE RECORD

        There will be more questions submitted for the record.
    Senator Campbell and Senator Domenici made specific requests.
    And I would like the observations of all three of you in
    writing on what we ought to be looking toward on movies,
    television and video games, an enormously sensitive subject.
    And in structuring our program against youth violence, we have
    deliberately not moved in the direction that everybody pummels,
    but have treated this as a national health problem, very much
    as Dr. Koop suggested years ago, putting it under the Surgeon
    General, so he has the responsibility.
        And I have asked each of you to let me know who your point
    persons will be, because this subcommittee intends to conduct
    extensive oversight, really working with you, as we started to
    do last year, but give our views on the subject and interact,
    so we can make more money available to you or make more
    reallocations or get the legislative branch in with our power
    of the purse to help out on that.

                        STEM CELL RESEARCH AND DIABETES

        We are going to ask you some questions on stem cells. There
    is a report today about some phenomenal new advances on mice
    and diabetes. We had a postponement hearing on that subject
    that Senator Lott has agreed to bring that subject up as a
    free-standing bill, very important medical research. And we are
    going to do our best to come to grips with these budget issues.
        Senator Stevens came and told you that the money was not
    there for what you have asked for. And that is a prevailing
    view. When you have a total budget of $622 billion, it pushes
    up, aside from the Balanced Budget Act and the caps, which we
    are going to have to act on one way or another, you do have the
    issue. Nobody wants to invade the Social Security surplus. So
    that is a limit that nobody is going to transgress.
        But we are going to work with you and try to see to it that
    you are adequately funded. I think you were last year, and we
    are going to try to the good job for America this year, with
    your cooperation. Thank you all very much.
        I will insert a statement from Senator Gorton for the
    record.
        [The statement follows:]

                   Prepared Statement of Senator Slade Gorton

        For decades now, Washington, D.C. has taken almost complete
    responsibility from local communities for how our schools should be
    run. Over the past few years, I've visited perhaps over 100 schools and
    listened to countless numbers of parents, teachers and principals, and
    they almost universally agree that it's time for Congress and the
    President to restore the authority local communities once had to make
    decisions for their local schools.
        Last year I proposed, along with Mr. Goodling in the House, the
    Academic Achievement for All Act, also known as Straight A's. This bill
    is based on the simple premise that in exchange for a significant
    increase in flexibility states and school districts would be held to a
    higher standard of accountability. Under my proposal, states would have
    the option of submitting a charter proposal that would set specific and
    measurable performance goals to reach by the end of five years. If
    approved, states would be allowed to use any of their regular Federal
    K-12 formula program funds for state education priorities and programs,
    in exchange for being held accountable for meeting their goals. States
    would be free to combine their federal funds from multiple programs to
    more effectively address the needs of students in their state.
    Alternatively, states would be free to administer Federal education
    programs the old way--Straight A's does not eliminate any program. It's
    the state's choice of which approach to use.
        What this means for states and school districts is that they can
    use federal funds for any initiative that improves performance of
    students in your state. States that choose to participate can focus
    more funds on disadvantaged students, increase efforts to improve
    teacher quality, reduce class size or even hook up all their classes to
    the Internet. The one string is that these efforts must increase the
    achievement of all students--including the lowest performing students--
    over the course of five years.
        If states do not substantially meet those goals, they would lose
    their Straight A's status, and revert to the categorical, regulated
    approach under current law. If states do well and significantly reduce
    achievement gaps between high and low performing students, they will be
    rewarded with additional funds.
        Finally, school districts would not lose any Title I funding. If
    Title I, Part A ($8 billion program for educationally disadvantaged
    children) is included by a state, each school district in the state
    would be assured of receiving at least as much money as they received
    in the preceding fiscal year.
        I've received a good deal of feedback from my constituents on my
    proposal, and a great deal of it has been positive. They do not shy
    away from being held strictly accountable for the academic success of
    all children if they are freed from the myriad of rules and regulations
    imposed on them by the federal government. Mr. Secretary, tomorrow the
    Senate education committee will take a closer look at reauthorizing
    ESEA and included in the package is Straight A's.
        The very fact that Straight A's is being adopted into any ESEA
    reform bill sends a dramatically different message to state and local
    school districts across the country. For the past 35 years, we have
    consistently told our local educators that ``D.C. is in charge of
    running schools across the country.'' Now, as the education debate gets
    underway, we are going against the grain by trusting our state and
    local education officials to do what they think is best for our
    children. I ask you to back me in that endeavor and put your trust
    behind our teachers, rather than D.C. bureaucrats.
        All children can learn, and they will do so only because of the
    dedication and hard work of those who know their names, not because
    those of us in Washington, D.C., create a number of new programs with
    good intentions. Mr. Secretary, I urge you to seriously consider the
    merits of the Straight A's proposal and support funding priorities that
    provide those who know our children best--their parents, teachers,
    principals, superintendents, and school board members--with the
    flexibility they need to educate our children.

                         ADDITIONAL COMMITTEE QUESTIONS

        Senator Specter. Thank you very much. There will be some
    additional questions which will be submitted for your response
    in the record.
        [The following questions were not asked at the hearing, but
    were submitted to the Department for response subsequent to the
    hearing:]

                              DEPARTMENT OF LABOR

              Question Submitted by Senator Kaye Bailey Hutchison

                              BONUS INCENTIVE ACT

        Question. Madam Secretary, as you know, the Senate recently passed
    legislation I introduced, the Bonus Incentive Act, which will allow
    employers to pay their hourly wage employees performance-based bonuses,
    without the unnecessary and burdensome need to go back and recalculate
    the employee's overtime pay. Typically, this results in very small
    changes to overtime pay, while it clearly discourages thousands of
    American businesses from paying their employees bonuses. One estimate
    is that if my bill passed, it could mean an average increase to an
    hourly worker of $1,000 per year in bonus pay. Do you support this
    legislation, and if not, why not?
        Answer. The Bonus Incentive Act was attached to a provision to
    increase the minimum wage in an amendment to the Bankruptcy Reform Act
    of 1999 and passed by the Senate in February. This measure would amend
    the Fair Labor Standards Act (FLSA) to exclude from the definition of
    ``regular rate''--the basis for calculating overtime premium pay (time-
    and-a-half-pay)--any payments made to reward employees for meeting or
    exceeding productivity, quality, efficiency, or sales goals, i.e., the
    additional compensation provided through gainsharing plans, incentive
    bonuses, commissions, or other performance contingent bonus plans.
        The Department strongly opposes this amendment. If enacted, it
    would substantially reverse the FLSA's long-standing overtime policy
    and drastically weaken existing protections for workers to receive true
    time-and-a-half overtime premium pay. These requirements, which have
    been in place for over 60 years, provide vital worker protections that
    discourage employers from working their employees excessively long
    hours and ensure fair compensation to those who bear the burden of
    working extended hours.
        This bill would not guarantee workers the right to receive
    incentive compensation for any additional hours they work and
    therefore, does not ensure that workers--who may have to work
    excessively long hours for their employers--will ever share in any of
    their employer's gains. The amendment would, however, allow an employer
    to pay artificially low hourly wages and structure its compensation
    system on newly ``excludable'' bonus pay. Such a compensation structure
    would enable the employer to effectively transfer much of its business
    risk directly to its employees. The workers' only rights would be
    overtime pay at time-and-a-half a reduced hourly wage--not their true
    wage.
        Moreover, the amendment would encourage employers to require
    employees to work longer hours at lower earnings, directly contrary to
    the statute's original intent-to limit the detrimental impact that long
    work hours can have on the health, efficiency and general well-being of
    workers and their families. The Administration's Statement of Policy on
    November 8, 1999 regarding the Bankruptcy Reform Act of 1999 reiterates
    the President's position in stating that if Congress sends him a bill
    ``delaying the [minimum wage] increase, repealing overtime protections
    for certain workers, adding costly and unnecessary tax cuts . . ., he
    will veto it.'' In considering identical legislation in the House (H.R.
    1381, the Rewarding Performance in Compensation Act) I advised Chairmen
    Ballenger and Goodling that I would recommend that the President veto
    the legislation because it is contrary to the best interest of this
    Nation's working men and women.
                                     ______

                 Questions Submitted by Senator Robert C. Byrd

                    NATIONAL MINE SAFETY AND HEALTH ACADEMY

        Question. What amount of revenues did the Academy receive for the
    use of its facilities by mining officials from foreign nations for
    fiscal year 1998, fiscal year 1999, fiscal year 2000, and the projected
    amount for fiscal year 2001?
        Answer. The training facilities of the National Mine Health and
    Safety Academy are used to promote international mine safety and health
    through training and exchange of information and techniques. Because of
    the mutual benefit of exchanging health and safety information with
    other nations, we have waived food and lodging fees for international
    groups that have been invited to participate in MSHA training programs.
    No change is anticipated for fiscal year 2001. The sponsoring country
    pays travel costs to and from the Academy.
        Question. What were the staffing levels at the Academy for those
    same years?
        Answer. Staffing levels at the Academy have remained relatively
    constant in recent years. For the years in question, they are:
        Fiscal year 1998--63 FTE
        Fiscal year 1999--65 FTE
        Fiscal year 2000--66 FTE
        Fiscal year 2001--66 FTE (est.)
        Question. Has the training provided by the Academy to mining
    officials from foreign nations led to a reduced number of mine-related
    deaths in those countries? What countries benefitted most from this
    training?
        Answer. Since 1998, the Academy has trained mine inspectors and
    mining officials from South Africa, Hungary, Poland, Peru, Malaysia,
    Australia, Mexico, the Ukraine, Croatia, Russia, and Thailand. In
    addition, the Academy has hosted a number of international mine rescue
    teams, including those from Russia, Poland, and the Ukraine.
        The following information reflects the actual and estimated number
    of mining officials from foreign nations trained or provided training
    guidance at the Academy during fiscal years 1998 through 2001:
        Fiscal year 1998--59
        Fiscal year 1999--83
        Fiscal year 2000--124 (est., with 32 to date)
        Fiscal year 2001--250 (est.)
        Both MSHA and the visiting officials recognize the value of sharing
    technical expertise to reduce hazards in the mine industry. Training
    and materials provided to these delegations give the international
    delegations a basis to make improvements in health and safety
    conditions in their respective countries. Generally, improvements in
    the reduction of mining-related accidents are realized over extended
    periods.
        At this time, there are no statistics available to indicate the
    degree to which this training has affected miners' health and safety in
    the individual countries. There is, however, anecdotal evidence that
    suggests that it has led to some improvements in participating
    countries. For example, following the March 2000 methane explosion in
    the Ukraine, we received a letter from the Ministry of Labor and Social
    Policy requesting assistance from MSHA in developing health and safety
    programs. Additionally, the letter stated that they attributed their
    improvements in mining safety during 1999 to the assistance and support
    provided by MSHA (letter attached).

                Ministry of Labor and Social Policy of Ukraine,
                                                        March 20, 2000.
    Hon. Steven K. Pifer,
    Ambassador of the United States of America,
    Vul. Yuriya Kotsyubinskoho 10, Kiev, Ukraine.
        Dear Ambassador Pifer: As you are aware, the coal industry of
    Ukraine has recently experienced another unfortunate accident--this
    time at the Barakova Mine that resulted in the death of eight-one coal
    miners, and seven more being injured. During the past few days we have
    received many conveyances of sympathy and concern from various U.S.
    governmental organizations, individuals, and friends. All of this has
    been greatly appreciated.
        This was the worst accident that the coal industry has experienced
    for over twenty years, and it came after we had achieved a positive
    trend during 1999 in the number of deaths and accidents in this
    industry. We attribute many of these positive results to the assistance
    and support that we have received from your Department of Labor-Mine
    Health and Safety Administration (MSHA) during the past two years under
    our Cooperative Agreement. This program has been instrumental in
    raising the awareness of safety at our coal mines; it has greatly
    enhanced the effectiveness of the Labor Safety Committee and the morale
    of its workers.
        The purpose of my letter is humbling but very necessary under the
    current situation in Ukraine. The Labor Safety Committee requests your
    consideration and support in a program to help create a safer
    environment for the coal miners of Ukraine. Specifically, we would be
    interested in joining with MSHA in developing a program to address the
    following issues:
      --raising awareness of coal miner safety by developing and presenting
            a training program designed for Ukrainian mining conditions and
            practices,
      --develop a program to use the Barakova Mine as a test case to
            demonstrate the effectiveness in the utilization of rockdust to
            control excess underground dust. The success of this program
            will result in the writing of new regulations that will be
            implemented at all Ukrainian coal mines, and
      --a method to improve communication during mine accident
            investigations.
        We are aware that the resources of the U.S. Government are not
    unlimited, but believe that a jointly developed program between MSHA,
    the Labor Safety Committee, and the Ministry of Fuel and Energy can be
    a cost effective method ti improve the health and safety of our miners.
    Thank you for your consideration of this vital issue.
                Sincerely,
                                                 P. Ovcharenko,
                                                 First Deputy Minister.

                                 CONVENTION 176

        Question. The General Conference of the International Labor
    Organization adopted Convention 176 on June 21, 1995, establishing
    minimum mine safety and health standards for the international
    community. Convention 176 was based on the Federal Mine Safety and
    Health Act of 1977, and if ratified, the U.S. would be in full
    compliance without the need for any further legislation. Would you
    please explain the Administration's position on Convention 176, and any
    externalities that could result from its ratification.
        Answer. The Administration strongly supports ratification of
    Convention 176. The Convention recognizes the importance of preventing
    injuries and deaths in the mining industry throughout the world.
    Widespread ratification of the Convention is in our interest since it
    would help raise international standards to the same high level
    reflected in our own law. U.S. ratification would reinforce the
    important role of the ILO in developing effective labor standards for
    the global economy. The National Mining Association and the United Mine
    Workers of America worked with the Department of Labor in developing
    Convention 176, and both organizations support its ratification.
        Convention 176, as you indicated, is patterned after our own
    Federal Mine Safety and Health Act of 1977 (Mine Act). Ratification
    therefore does not require any change to U.S. mine safety and health
    law or regulation. This conclusion was reached by the Tripartite
    Advisory Panel on International Labor Standards (TAPILS), which
    carefully examined Convention 176, including its negotiating and
    legislative history. TAPILS' membership includes representatives of the
    Departments of Labor, Commerce, and State, the U.S. Council for
    International Business, and the AFL-CIO.
        The Mine Act is the foundation of the safety and health successes
    that we have achieved in this country. The Mine Act, as well as its
    predecessor statute, the Federal Coal Mine Health and Safety Act of
    1969, are universally regarded as critical in having reduced the number
    and severity of mine explosions, mine fires, and other catastrophic
    events in the mining industry in this country. In developing Convention
    176, the U.S. Government, industry and labor agreed that the adoption
    and enforcement of a common set of safety and health laws by the
    international community will help ensure safe and healthful working
    conditions for miners throughout the world, as well as help ensure that
    U.S. businesses can compete fairly in the world economic market.
        In recent years, the Department of Labors' Mine Safety and Health
    Administration has provided mine safety and health assistance and
    advice to several countries. These exchanges have made us even more
    firm in our conviction that establishing uniform safety and health
    standards is essential for raising labor standards globally. Mining
    remains one of the most hazardous industries, both here and abroad. In
    part due to inadequate health and safety standards, the human toll
    associated with mining is particularly high in certain foreign
    countries. As recently as last month (March), a methane explosion in
    the Ukraine resulted in the death of 80 coal miners. According to
    reports, at least 274 miners were killed in the Ukraine in 1999, and
    about 360 in 1998. Reports indicate that South African mines recorded
    312 work-related deaths in 1999, and that mining accidents in China
    killed more than 3,000 people in the first 9 months of that year.
        Convention 176 has been ratified by 12 nations. The South African
    Parliament agreed to ratification in December 1999, and is currently
    processing the procedural papers needed for the International Labor
    Organization to officially recognize South Africa as a ratifying
    country. We were extremely pleased that the U.S. Senate gave its advice
    and consent to ratification of Convention 182, the Worst Forms of Child
    Labor Convention in November 1999. Like ratification of Convention 182,
    U.S. adoption of Convention 176 would reflect our commitment to work
    together with labor and business interests to raise labor standards
    around the world.
                                     ______

                    Questions Submitted by Senator Herb Kohl

               WORKER ADJUSTMENT AND RETRAINING NOTIFICATION ACT

        Question. Recently there have been plant closings in Wisconsin that
    have violated the WARN Act. This act has several loopholes in it,
    however, and it does not allow the Department of Labor to investigate
    or enforce the act. If the Department of Labor had the authority to
    investigate and enforce the act, how many workers could be helped and
    what would the possible impact be? How much funding would this effort
    require of the DOL?
        Answer. As part of the development of our dislocated worker
    consolidation bill in 1993, DOL conducted consultations on the
    possibility of amending WARN in the areas of coverage and enforcement.
    No action was taken for a number of reasons, including:
      --The concern that amendments might reopen issues and upset the
            fragile consensus that produced the original statute, and
      --The belief that coverage changes would have to be accompanied by
            agency enforcement in order to be effective and the cost of
            that enforcement, in both dollars and Federal positions, would
            be great.
        These factors have not changed. In fact, support for the
    Department's role in enforcing labor laws and the positions and funds
    comprising that enforcement has become an issue in cases where Federal
    law already assigns the Department these responsibilities.
        Advance notice of layoff is a critical component for workers to
    begin the adjustment process, and for the workforce system to provide
    the specialized assistance needed by affected workers. The importance
    of early notification is recognized by the Department.
        The positive impact of DOL having enforcement authority would be in
    the number of additional workers who receive advance notice of layoff.
    (This assumes that DOL enforcement authority leads to greater employer
    compliance with WARN.) The Department does not have data on the number
    of workers who should have received notice under WARN, but did not.
        To promote greater employer awareness of their obligations under
    WARN, the Department is exploring a public information campaign and
    targeted outreach to employees, employers, and organized labor to (1)
    stress the employers' obligations under WARN, (2) encourage advance
    notice on a voluntary basis even when WARN may not apply, and (3)
    encourage even earlier notification of impending layoffs and closures
    than WARN requires.
        Finally, WARN enforcement would require about 30 staff, including
    those in regional offices, in a management unit in the national office,
    and in the Office of the Solicitor, which would involve an estimated
    staffing cost of $3.3 million.

                        WORKFORCE INVESTMENT ACT IMPACT

        Question. There is some concern that the Workforce Investment Act,
    which will be fully implemented in Wisconsin in July, will already face
    a sunset in 2003, too early to fairly judge if the new act is
    successful. What is the Department of Labor doing to measure the
    Workforce Investment Act's successes or shortcomings and will the data
    be enough to get a clear picture?
        Answer. The Department has contracted with Social Policy Research
    Associates to conduct a process evaluation of WIA implementation. While
    there will be a lag time for the receipt and analysis of the initial
    WIA performance data (including customer satisfaction), the information
    will be instrumental in determining State and local success in
    achieving the WIA reforms and the core measures. Our technical
    assistance, discretionary grant investments, and performance incentive
    awards authorized by WIA are targeted at expanding partnerships in the
    One-Stop delivery system. In sum, our focus and resources are directed
    at assuring positive outcomes for the customer--increased employment,
    retention, and earnings, increased occupational skill attainment, while
    meeting the needs of American employers in staying globally
    competitive.

                         TRAVELING SALES CREW INDUSTRY

        Question. As you know, I recently introduced legislation, S. 1989,
    to make it illegal for young people under the age of 18 to participate
    in the traveling sales crew industry. These sellers travel around the
    country and go sell products door-to-door. In my state there was a
    tragic accident taking the lives of several sellers, many under 18.
    Recently there was another accident in California that took the life of
    two adults. All in all almost 40 people have been killed in this
    industry due to negligence and criminal behavior. I believe that this
    is no environment for a child to be in and that it is too dangerous for
    minors. Does the Department of Labor agree that the traveling sales
    crew industry presents a workplace safety problem?
        Answer. Yes. Vehicle related incidents of all types are the number
    one killer of young workers--accounting for 43 percent of fatalities
    for workers under the age of 18. When you also consider the dangers of
    peddling door-to-door in unfamiliar neighborhoods, working long hours
    in strange surroundings, this industry is clearly characterized by a
    number of serious occupational risks. The Senate Permanent Subcommittee
    on Investigations, in 1987, also documented problems of worker
    exploitation in the traveling door-to-door sales industry.
        Question. Does the industry present an unacceptable risk for
    minors?
        Answer. As you know, child labor is one of the Department's top
    priorities. When children work, they must do so safely and legally. The
    youth peddling industry, in general, presents special hazards for young
    workers. Children as young as eight-years-old are recruited from poorer
    neighborhoods and transported by crew leaders to unfamiliar locations
    to peddle candy and other consumer goods door-to-door, at subway stops,
    and at shopping malls. We have been looking at the issue of commercial
    youth peddling and the special hazards that this industry poses for
    young workers. This past spring, the Department joined with the
    Interstate Labor Standards Association and the National Child Labor
    Coalition to launch a public awareness campaign to educate parents and
    young people about the dangers of the youth peddling industry. We are
    also working with our State colleagues to coordinate enforcement
    activities to protect children who are being exploited. And, we have
    sought and obtained additional resources to undertake a thorough
    evaluation of the hazardous occupations orders, which began last year
    through the National Institute for Occupational Safety and Health.
        As you know, we have been and will continue to assist you and
    Senator Harkin in your efforts to address problems in this industry. As
    I have often stated, the Department is committed to doing everything
    possible to ensure that the early work experiences of our young workers
    are positive and safe, and do not interfere with their primary
    occupations-as students.
                                     ______

                  Questions Submitted by Senator Patty Murray

               JOB TRAINING HIGHLIGHTS OF THE 2001 BUDGET REQUEST

        Question. The President has requested a total of $2 billion to
    provide effective job training assistance to those workers who are
    struggling to keep their skills current in our changing global economy.
    Can you briefly highlight some of the President's initiatives in his
    fiscal year 2001 budget as well as the success of a new innovative
    approach to job training in the 21st Century?
        Answer. The 2001 budget includes $2 billion for the second year's
    request for the President's Universal Reemployment initiative which
    will ensure that by 2004: (1) all dislocated workers will have access
    to the training and employment services the want and need; (2) that all
    unemployment insurance claimants who have been profiled as unlikely to
    return to work quickly will get the reemployment services they need to
    return to work; and (3) all Americans will have access to the
    information and services of One-Stop Career Centers. This initiative
    will provide resources to train for or find new jobs, expand and
    increase quality of employment services, enhance services for
    individuals receiving unemployment compensation, and ensure
    availability of the One Stop System, either personally or
    electronically.
        The programs to be funded are increased by $275.5 million, as
    follows:
        Dislocated Workers Employment and Training:
      --Second year's funding of the President's Universal Reemployment
            Initiative.
      --The request is $1.77 billion--an increase of $181.5 million over
            2000.
      --984,000 dislocated workers will be assisted under this initiative.
      --Included in the request is $105,100,000 for Skill Shortages grants
            that will be financed only if the Administration's proposal for
            an employer user fee on the permanent labor certification
            process is enacted. Upon enactment of the fee, a budget
            amendment will be proposed reducing budget authority.
        America's Labor Market Information System (ALMIS):
      --Component of the One-Stop Career Centers budget.
      --ETA request is $154 millions for ALMIS, $44 million over 2000.
      --The major components are: Core Employment Statistics; Universal
            Access for Customers/Digital Divide Initiatives; Lifelong
            Learning and Earning; and Measuring and Displaying Performance
            Information
      --ALMIS Services and Products: Mobile One-Stop Vans; Nationwide Toll-
            Free Number; America's Job Bank, America's Talent Bank;
            Occupation Network (O*Net); America's Learning Exchange; Access
            America; Agricultural Network (AgNet).
        Reemployment Services Grants to States.--ETA requests $50 million
    to provide reemployment services to unemployment insurance claimants to
    help them return to work.
        I view this historic time of economic prosperity as an opportunity
    to address the challenge of bringing skills, jobs and hope to
    individuals and communities that for too long have been left behind.
    That is why our Budget not only proposes increases in funding for some
    formula-funded Workforce Investment Act programs, but also proposes
    several targeted initiatives for groups that we have not paid adequate
    attention to in the past.
        We have asked for an increase of $125 million for Youth Opportunity
    Grants to address skills training and job placement in the poorest
    urban and rural areas and Indian reservations in America. I recently
    announced 36 of these grants. With this first grant competition we were
    able to fund only about 25 percent of the eligible communities that
    submitted applications. Over 160 communities put together the broad
    partnerships and developed comprehensive plans for meeting the needs of
    this target population. We had far more high quality applications than
    we could fund. These additional dollars will allow us to reach about 20
    additional communities . We know that the needs were great in all the
    communities that applied and these additional funds will take us a few
    steps closer to reaching these communities.
        Responsible Reintegration for Young Offenders is a $75 million
    pilot and demonstration initiative that will test new approaches to
    bring young offenders into the workplace through job training and
    placement, and by creating partnerships between the criminal justice
    system and our workforce development system. We hope that by developing
    models showing how we can work effectively with the criminal justice
    system, we can expand services to this population through our State and
    local grant programs.
        Safe Schools/Healthy Students is an ongoing collaboration among the
    Departments of Education, Health and Human Services, and Justice to
    promote healthy childhood development and to prevent school violence
    and the abuse of alcohol and other drugs. We believe the Department of
    Labor has something to contribute to this interagency initiative and
    have proposed $40 million so that we can join in this initiative to
    enrich the connections among secondary and post-secondary schools,
    alternative schools, out-of-school youth programs, and work-based
    learning. Some of these funds will be used to assist in building the
    infrastructure of youth councils under WIA.
        Fathers Work/Families Win is a $255 million, two-part initiative
    that grows out of the successful Welfare-to-Work program. Fathers Work
    will provide jobs for non-custodial parents--mostly fathers--who owe
    child support. Families Win will help low-income parents who are
    struggling to make ends meet by providing better access to community
    services and upgrading job skills. These families often include members
    who have been on welfare or may be at risk of going on welfare, but
    because they are employed, most have not received services under JTPA.
        I view these initiatives as addressing some needs and target groups
    that our workforce development system has not sufficiently dealt with
    in the past, and that would not be addressed through our formula
    grants. For example, the youth formula programs provide a relatively
    small amount of funds to every area in the country, while Youth
    Opportunity Grants concentrate a large amount of funds in targeted
    high-poverty urban, rural and Native American communities, exactly
    where the need is the greatest.
        With respect to job training in the 21st Century, I believe the
    Workforce Investment Act (WIA), which we are now implementing and which
    becomes fully effective on July 1, 2000, offers us a new innovative
    approach. Under WIA, information and access to training and other
    services will be provided through customer-focused One-Stop Career
    Centers in each local area. Training will generally be provided through
    the use of Individual Training Accounts, and clients of the Workforce
    Investment System will be provided information on the past performance
    of training providers to help them make career choices. The new WIA
    system will be accountability-driven and all training providers must be
    certified. The Workforce Investment Act also provides the authority for
    a state of the art, quality information system that helps American
    workers and companies navigate the labor market and exercise informed
    choice in their workforce decisions. Together, these new tools will
    help us respond to the demands of the changing global economy.

                                   PAY EQUITY

        Question. In his State of the Union Address, President Clinton
    highlighted the issue of pay equity or pay inequity for women. We all
    realize this is an important issue of fairness, however, pay inequity
    for many women plagues them well beyond their working life. More women
    live in poverty after the age of 65 and single women over 65 are at a
    much higher risk of living in poverty. How does addressing pay equity
    for women during their working life impact their economic status after
    the age of 65? In addition, isn't pay equity really a family issue, not
    just a women's issue? What impact does bridging the salary gap between
    men and women in the workplace have on the family?
        Answer. We recognize that pay inequity is not just about pay--it is
    also about benefits. And although the pay and pension gap between men
    and women has been narrowing, we know we must work hard to reduce it
    further--and to someday see equal employment opportunity and pension
    equity for all.
        On average, women who work full-time earn only about 75 cents for
    every dollar that a man earns. Less than 40 percent of all working
    women in the private sector are covered by a pension (compared to 46
    percent of men). Only 32 percent of current female retirees receive a
    pension (compared to 55 percent of men). Recent (1994) men retirees'
    median annual benefits were $9,600, compared with only $4,800 for
    women, half the benefit amount for men.
        Women's economic status after age 65 often depends on what wages
    they received when they were working--and whether or not they have a
    pension from their own work. If a woman has a pension but received
    lower pay while working, she will face a lifetime of inequity because
    most pensions are based, in large part, on wages. If a woman receives
    lower wages while working and does not have a pension, she will face an
    even more difficult time making ends meet when she retires. And with or
    without a pension, lower wages make it harder for women to save their
    own money for retirement.
        The pay gap is a family issue. Women's earnings are a significant
    source of family income. Women's earnings help support nearly three out
    of four working American families. Yet women tend to be concentrated in
    lower paying jobs. Fifty-four percent of full-time female workers earn
    less than $25,000 a year compared to 36 percent of full-time male
    workers. When women aren't paid equally or don't have equal access to
    high-paying jobs, the whole family pays the price.
                                     ______

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                  Questions Submitted by Senator Arlen Specter

               LOW INCOME HOME ENERGY ASSISTANCE PROGRAM (LIHEAP)

        Question. Over the past several months, the price of crude oil has
    increased from $10 to $30 a barrel, causing the subsequent increase of
    diesel fuel, heating oil and unleaded gas. As a result of increases in
    home heating fuel prices this winter, the President released all of the
    emergency LIHEAP funds ($300 million) on 3 dates: January 25, February
    8, and February 16. The President is requesting $600 million in
    additional emergency funding in the supplemental. The President's
    fiscal year 2001 request for LIHEAP is the same as last year: $1.1
    billion in regular funding and $300 million in emergency funding. How
    many additional families have applied for assistance? In light of the
    dire situation this year, does the President's request adequately
    reflect the funding needs?
        Answer. LIHEAP is one of the 1981 block grants. As a result, ACF
    does not have specific current information on the number of additional
    families that have applied for assistance. ACF is, however, in daily
    contact with their State partners to keep abreast of needs and
    developments in the State LIHEAP programs. A number of States have
    modified their program eligibility requirements as a result of the
    large fuel oil price increases. LIHEAP funds are distributed to the
    States as block grants. States have used this flexibility to leverage
    emergency funds in a variety of ways to support the energy needs of low
    income households, including increasing benefit levels for emergency
    heating assistance for current recipients and raising eligibility
    limits to serve greater numbers of households. As example, Pennsylvania
    raised its maximum crisis payment from $250 to $300, provided a
    supplemental payment of $250 to households already eligible under the
    program (up to 110 percent of the federal poverty level), and provided
    a payment of $250 to households up to150 percent of poverty. The State
    also delayed the closing date for the State's crisis program from March
    15 to April 30.
        Fiscal year 2000 emergency funds served their function well,
    addressing the needs of low income households facing significant
    increases in heating costs. This year was an extraordinary situation,
    which we do not expect to be repeated. However, the Administration is
    seeking a $600 million supplemental appropriation for LIHEAP, to assist
    families with this winter's heating bills and provide a reserve in the
    event emergency summer cooling assistance is needed.

                                 WORKER HEALTH

        Question. Within the funds provided for the Agency for Healthcare
    Research and Quality, the President proposes to spend $10 million for
    ``improving worker health.'' How does this research differ from the
    research being conducted by the National Institute of Occupational
    Safety and Health (NIOSH)?
        Answer. The research focus at NIOSH is on the causes and prevention
    of work-related illness and injury. Two components of AHRQ's proposed
    worker health initiative focus on the outcomes and effectiveness of
    clinical treatment and the quality of the systems in which care is
    provided after a worker has been injured or otherwise becomes ill.
    These two components have a focus on quality of patient care and
    return-to-work that responds to research requests we have received from
    the business community, labor, and major purchaser groups. The third
    component of this initiative focuses on the health care workplace and
    the impact of the ways we organize and manage the delivery of health
    care services on the quality of patient care. This part of the
    initiative builds upon past AHRQ research on the relationship between
    professional staffing patterns and the quality of patient care as well
    as research requests we have received from major health clinics and
    hospitals in our stakeholder outreach meetings. This area of
    investigation is complementary to NIOSH's work on health care worker
    health and safety. AHRQ and NIOSH have collaborated effectively on this
    issue and will continue to do so in the new initiative. This initiative
    will help employers ensure that injured workers receive quality health
    care.

                      HEALTH CARE ACCESS FOR THE UNINSURED

        Question. The President is requesting $125 million for an
    initiative he calls ``Health Care Access for the Uninsured.'' It
    appears that your request requires authorizing legislation before
    Congress can appropriate funds. Please explain how this program would
    work and the goals that the administration hopes to achieve.
        Answer. In fiscal year 2000 Congress appropriated $25 million for
    the Health Care Access for the Uninsured program which we are operating
    under Section 330 demonstration authority of the Public Health Service
    Act. In order to strengthen the program the Administration provided
    Congress with the draft bill, ``Community Access to Health Care Act of
    2000'' on March 22, 2000. The Community Access Program (CAP), included
    in our budget request as the Health Care Access for the Uninsured
    program, is an innovative effort to help communities build and
    strengthen integrated health care delivery systems for uninsured and
    underinsured persons. The health care services available to the
    uninsured can be fragmented, often with little to no coordination among
    providers who serve this population. Not only can patient care be
    compromised, but much-needed resources can be wasted as providers
    duplicate efforts. CAP addresses this growing problem by fostering
    community-based efforts to improve service integration for the
    uninsured. Building off the critical foundation established by
    providers who have traditionally provided services without regard to
    ability to pay, CAP will provide new resources to help communities
    coordinate core services more effectively. CAP grants will support the
    development of infrastructure, such as information systems, referral
    relationships, and clinical protocols, that will help providers improve
    access to existing services and promote the efficiency of the care that
    is delivered. By supplementing existing categorical programs to fund
    safety net services and targeting infrastructure development not
    currently supported through those programs, CAP will allow communities
    to better harness their current capabilities and resources.
        CAP is designed to encourage community-wide collaboration and
    stimulate creative approaches to the development of coordinated,
    comprehensive care systems. CAP recognizes that the ``safety net'' of
    providers willing to deliver care to the uninsured can vary from
    community to community, resulting in a wide array of integration
    challenges. To accommodate this variability and to promote innovation,
    CAP is intended to be flexible to community needs. No single model for
    integration is being promoted; rather it is our goal that a diversity
    of models be explored. While the methods used to achieve integration
    may differ, all CAP grantees will represent community-wide coalitions
    focused on developing sustainable infrastructure for improved services
    integration.

                            FAMILY CAREGIVER PROGRAM

        Question. Last year, the President requested $125 million for a
    ``Family Caregiver Program.'' Congress did not appropriate funds
    because this program was not authorized. You are requesting the same
    level of funding this year. Do you believe that you can undertake this
    program without authorizing legislation?
        Answer. Yes, Title III-D of the Older Americans Act provides
    existing authority to support caregivers. As we look at the needs of
    our older population we become more and more cognizant of the needs of
    their caregivers. Establishment of the National Family Caregiver
    Support Program, through reauthorization of the Act, has the advantage
    of providing the kind of visibility we would like for this program, and
    would probably afford a better opportunity to systematize the services
    we are suggesting need to be put into a package. However, Existing
    authority will permit us to do the work that is essential to intervene
    immediately. We will continue our efforts to seek reauthorization of
    the Older Americans Act and the formal establishment of the National
    Family Caregiver Support Program.

                                 MEDICAL ERRORS

        Question. Last week, the President issued his recommendations for
    reducing medical errors, following the Institute of Medicine's report
    ``To Err is Human: Building a Safer Health System.'' The President has
    requested $20 million to reduce medical errors. Is this investment
    significant enough, given the fact that medical errors cause up to
    100,000 deaths annually? How long do you think it would take to
    accomplish your goals to truly see a reduction in the rate of medical
    errors?
        Answer. The recommendations you refer to are much broader than
    HHS--they also address work needed in other agencies involved in health
    care and health coverage, such as the Department of Defense, The
    Department of Veterans Affairs, the Office of Personnel Management, and
    the Department of Labor. Our budget includes increases of $33 million
    to start this work. An increase of $20 million is requested in the
    Agency for Healthcare Research and Quality (AHRQ). AHRQ will create a
    Center for Quality Improvement and Patient Safety which will carry out
    a wide range of research activities to reduce medical errors. An
    increase of $13 million is requested in the Food and Drug
    Administration to reduce medical errors related to adverse events from
    FDA-regulated products, as well carry out a wide range of activities
    recommended by both the Institute of Medicine and the Quality
    Interagency Coordinating Task Force (QuIC), which I co-chair. In
    addition to activities for which dedicated funding is requested, HCFA
    will require that hospitals implement medical error reduction and
    patient safety programs to meet Medicare's conditions of participation.
    These activities, combined with other work recommended by the QuIC,
    will give us a good start on the work of reducing medical errors.

                                 YOUTH VIOLENCE

        Question. On February 25, Bruce Reed sent a letter describing the
    Administration's progress on instituting the youth violence prevention
    initiative. What specific ways will you encourage HHS agencies to
    coordinate with the Department of Labor and the Department of Education
    to ensure the coordination of efforts to reduce youth violence?
        Answer. In developing the Youth Violence Prevention Initiative, our
    efforts extend across Department lines. A Federal Coordinating
    Committee on the Prevention of Youth Violence has been convened, which
    includes representatives from the Department of Labor, Justice and
    Education. This committee is assessing the cross-cutting issues in
    violence among youths and is exploring ways on how to synchronize and
    maximize our collective efforts into a meaningful blueprint of an
    effective initiative.
        The Department of Health and Human Services is already working
    closely with the Departments of Education and Justice to continue
    coordination of the Safe Schools/Healthy Students initiative begun in
    fiscal year 1999. The Safe Schools/Healthy Students is an unprecedented
    collaborative effort to assist communities in designing and
    implementing comprehensive educational, mental health, social service,
    law enforcement and juvenile justice services for youth. Our efforts in
    this collaboration, through the Substance Abuse and Mental Health
    Services Administration's Center for Mental Health Services, have
    resulted in the funding of 54 grants to school districts around the
    country. While no increase in funding is requested for SAMHSA, the
    overall President's fiscal year 2001 Safe Schools/Healthy Students
    budget request includes funding for an additional 40 grants, and would
    include the Department of Labor as a new partner in this effort.
        CDC, and the U.S. Department of Education, Department of Justice,
    and the National School Safety Center continue to examine homicides and
    suicides associated with schools and identified common features of
    school-related violent deaths. The study examines events occurring to
    and from school, as well as on both public or private school property,
    or while someone was on the way or going to an official school-
    sponsored event. The first study looked at deaths occurring during
    1992-1994. CDC and its partners are updating and expanding the original
    study, examining school-associated violent deaths since July 1994.
        In addition, the Office of the Surgeon General is developing a
    ``Surgeon General's Report on Youth Violence'' that will be completed
    this year. Information and assistance is being obtained from HHS
    operating divisions, other Federal Departments such as Education,
    Justice and Labor, communities, private organizations, academia, State
    and local governments, and other groups to ensure the report soundly
    addresses the prevention of youth violence as a collaborative
    intervention requiring a well-coordinated approach.

              MEDICARE COVERAGE OF INJECTABLE DRUGS AND BIOLOGICS

        Question. When will HCFA issue a program memorandum to carriers as
    required by the report language accompanying Section 219?
        Answer. The program memorandum (AB-00-21) was issued on Friday,
    March 17, 2000.
        Question. What is the status of the policy conveyed in the
    transmittal of August 13, 1997 of the Deputy Director of the Division
    of Acute Care to regional offices regarding injectable drugs?
        Answer. We have directed our contractors to disregard the
    memorandum and all other documents based on that memorandum until
    further notice. Contractors are to base any determinations they make
    with respect to self-administered injectable drugs on policies that
    pre-existed that memorandum.
        Question. I am concerned that some carriers may consider the August
    13, 1997 transmittal to be the current Medicare policy on injectable
    drugs. Can you assure me that, today, it is Medicare's policy among all
    carriers to cover injectable drugs for program beneficiaries if the
    physician determines that it is inappropriate or impossible for a
    particular patient to self-administer the drug?
        Answer. In accordance with the DHHS Appropriations Act, 2000
    requirements, we have suspended the August 13, 1997 memorandum and have
    instructed our contractors to make determinations with respect to self-
    administered injectable drugs based on policy guidance that pre-existed
    that date. This law also effectively precludes us from clarifying our
    policy, since any clarification could easily be read as restrictive;
    therefore, our contractors are making determinations based on policies
    in place prior to August 13, 1997. While our contractors will be acting
    independently, I can say that historically they have not been inclined
    to provide coverage for injectable drugs that can be self-administered.
                                     ______

               Questions Submitted by Senator Ernest F. Hollings

                           LIVER ALLOCATION POLICIES

        Madam Secretary, I'm a bit confused by the Department's December 21
    Federal Register notice, and was wondering if you could clarify your
    understanding of the moratorium imposed on the OPTN Final Rule by
    Section 413 of the Ticket to Work and Work Incentives Improvement Act
    of 1999.
        The Amended Final Rule would have required the OPTN to submit
    revised liver allocation policies by February 15, 2000--88 days after
    the Rule was to become effective on November 19, 1999. But Section 413
    imposed a moratorium on the effective date and all provisions contained
    in the Amended OPTN Final Rule Until March 16, 2000.
        The Department's December 21 notice states on page 91626: ``Because
    we do not seek to have the deadline occur during the period when the
    regulation is stayed, we have decided to extend the deadline to March
    16, 2000''--just 30 days after the original deadline, and the first day
    the Rule can become effective under the moratorium.
        Question. Could you please explain to me why requiring the OPTN to
    work on the most controversial new allocations policies required by the
    Rule during a period when its implementation has been stayed by
    Congress does not violate both the spirit and the letter of the
    moratorium?
        Answer. The OPTN has been working on the refinement of the liver
    allocation policy continuously since the NPRM was published in 1994. We
    did not believe it was wise to interfere with their deliberations. Nor
    did we believe it was wise to suggest that the patients could wait for
    the benefits of an improved liver allocation system. The OPTN delivered
    a liver allocation policy proposing wider sharing for patients with the
    most urgent need and plan for further refining the medical distinctions
    among chronically ill patients on March 15, 2000. The Department is
    reviewing that submission. I believe it is a reflection of the OPTN's
    efforts to address the problem and a testament to the Department's
    persistence that a policy that puts patients first was delivered on
    time.
        Question. Section 413 also requires the Department to solicit and
    review comments on the Rule, and to revise it appropriately in
    accordance with this review. How, then, can you justify your December
    21 Federal Register notice, which announced a March 16, 2000 effective
    date for the rule, when you had not even begun to receive, much less
    review, comments on your October amendments? What kind of message do
    you think this sends to those who will be so deeply affected by the
    provisions of this Rule?
        Answer. We were confident that our staff could review the comments
    and identify any new issues that would require modifications to the
    rule quickly. In fact, no new issues were raised by the public comments
    and no change was needed. A Federal Register Notice so stating was
    published March 21, 2000.
        Question. Do you plan to revise the Rule based on public comments?
    If so, what is your time frame? Why wouldn't you postpone the effective
    date until you make the additional modifications? If you do not plan to
    modify the regulation, why not?
        Answer. We were confident that our staff could review the comments
    and identify any new issues that would require modifications to the
    rule quickly. In fact, no new issues were raised by the public comments
    and no change was needed. A Federal Register Notice so stating was
    published March 21, 2000.
                                     ______

                 Question Submitted by Senator Daniel K. Inouye

                             HEALTH CENTERS WAIVERS

        Secretary Shalala, On April 20, 1998, HCFA sent a letter to State
    Medicaid Directors requiring States with Section 11 15 waivers to
    comply with the terms and conditions of their waiver as they relate to
    federally qualified health centers. In this letter, HCFA committed to
    review those States' compliance with the waiver and to take corrective
    action if necessary.
        Madame Secretary, it has been nearly two years since that policy
    was released and it is my understanding that States with Section 11 15
    waivers are still not complying with the terms and conditions
    specified. This has created a very serious problem in my state costing
    Hawaii health centers $1.2 million a year as a result of this non-
    compliance.
        Question. What is the Department's plan to take corrective action
    regarding this problem and when do you plan to implement this course of
    action?
        Answer. On July 15, 1998 HCFA sent a letter to all State Medicaid
    Directors with the section 1115 waiver of cost-based reimbursement for
    federally qualified health centers (FQHCs). This letter requested that
    each State submit information pertaining to the methodology used to
    reimburse FQHCs under their section 1115 demonstrations. The submitted
    information was to include an analysis of how the methodology was
    developed to calculate a cost-related or risk-based adjustment, as well
    as a description of how the methodology was implemented.
        We received the State responses and on September 30, 1998 we wrote
    to the Primary Care Association (PCA) in each State in order to share
    the State response and to request that the PCA review the response. We
    asked each PCA to provide us with their assessment of the State
    response as well as any comments they wished to provide on the adequacy
    of the State's methodology for meeting the FQHC term and conditions.
        On January 4, 1999 we sent a follow up letter to seven States,
    including Hawaii, requesting further information and clarification of
    their methodology. We received all of the State responses by May 1999.
    Since that time we have worked in partnership with the Health Resources
    and Services Administration to assess the State and PCA responses. We
    expect to be in contact with the Hawaii regarding this assessment
    shortly.
                                     ______

                  Questions Submitted by Senator Patty Murray

                          BATTERED WOMEN AND CHILDREN

        Question. I would like to focus my questions on my concerns
    regarding the impact of welfare restructuring on battered women and
    children, who are some of the most vulnerable citizens. Secretary
    Shalala, as you are aware, I fought to implement a ``family violence
    option'' within Federal welfare guidelines. My objective was clear--to
    make clear that punitive welfare restrictions did not result in more
    women and children becoming trapped in violent homes or relationships.
    I feel confident that the final regulations issued by HHS for the
    States to implement a family violent option will meet my objective.
    However, I have become increasingly concerned that States are not
    screening properly and are not directing services and benefits to
    battered women. Can you briefly outline what steps you are taking to
    ensure that battered women do not end up being victimized by our
    welfare structure and do we have any real outcome data on the number of
    battered women impacted? How many of those who have fallen off welfare
    are now trapped in violent homes or relationships?
        Answer. The Department's Administration for Children and Families,
    Office of Family Assistance has a number of initiatives that address
    domestic/family violence.
        In fiscal year 1997, a grant was awarded to the Anne Arundel County
    Department of Social Services, Maryland to develop and pilot test a
    domestic violence training curriculum for administrative and front line
    service staff. The training model developed in collaboration with the
    YWCA of Annapolis (Maryland) is intended to better equip staff to
    identify and serve clients of TANF and other public assistance programs
    who may be victims of domestic violence. New staff receives training on
    how to identify and screen for potential domestic violence situations.
        Anne Arundel County was awarded a subsequent grant in fiscal year
    1998 to increase its capacity to provide technical assistance to human
    service agencies on integration of services and organizational change.
    The organizational change model included strategies to assess and
    provide services to families at risk of domestic violence, and other
    barriers to self-sufficiency.
        Anne Arundel County Department of Social Services like many local
    welfare offices places information in public restrooms about domestic
    prevention services and hotline telephone numbers.
        ACF has funded our Regional Offices to provide targeted workshops
    around domestic violence issues such as identification, screening,
    confidentiality, and safety planning. A major conference is planned for
    our Northeast Hub (Regions I-III) in August of this year.
        ACF's Office of Community Services funds the National Family
    Violence Hotline, which provides assistance to families in immediate
    danger of violence, and provides grants to community organizations for

    Family Violence Prevention Services.
        The Department has an ongoing Family Violence workgroup composed of
    senior staff from its operating divisions who coordinate DHHS program
    policies and activities to provide education on domestic violence
    prevention and services.
        With reference to outcomes, as of February 2000, we are beginning
    to receive detailed quarterly data from states on individuals receiving
    TANF assistance. We will not have outcome data on battered women, but
    we will know the number of women who are exempt from the work
    requirements based on receipt of a domestic violence waiver.
        In addition to these cooperative efforts, DHHS and DOL convened a
    series of conferences to share with other welfare reform stakeholders,
    an informational ``road map'' on how to succeed in moving welfare
    families to self-sufficiency. The information presented included models
    of promising practices for helping families move from welfare to work.
    The conference objectives were to help participants:
      --gain insight on how agency practitioners and the private sector
            have responded to challenges of moving welfare recipients to
            work;
      --learn from practitioners how to prepare for the difficult task of
            moving welfare clients with multiple barriers to work;
      --interact with peer practitioners from a broad cross-section of
            Federal, State and local agencies, community-based
            organizations, employers, and other disciplines; and
      --gather practical information, helpful practices, and names of
            professional contacts to help structure programs to move
            families to self-sufficiency.

                                   CHILD CARE

        Question. One of the greatest challenges to meeting welfare-to-work
    goals is child care. I have listened to this Administration and many
    Governors talking about the success of welfare restructuring. However,
    there has been little action at the state level to increase the
    availability of affordable, quality child care, especially infant care.
    We know that early childhood development is essential, yet I am not
    convinced that we are targeting limited resources to implementing new,
    innovative child care programs. I know the President is calling for
    additional resources. I=d like to know B what are we doing to ensure
    that parents, especially those caught between work and welfare, can
    locate quality, affordable child care?
        Answer. A recent report, Access to Child Care for Low-Income
    Working Families, found that in an average month in fiscal year 1998,
    only 10 percent of the 14.7 million children eligible for child care
    subsidies under Federal regulations received them. The fiscal year 2001
    budget request includes several proposals to help low-income families
    find and afford quality child care. For fiscal year 2001, we are
    requesting $2 billion, an increase of $817 million, for the
    discretionary Child Care and Development Block Grant (CCDBG). These
    funds are critically needed to help address the gap between available
    funds and the child care subsidy needs that low-income working families
    re experiencing. This increase will provide child care subsidies to
    nearly 150,000 additional children. $223 million of the total funds
    requested will support State activities that improve the quality of
    child care, including $50 million for infant and toddler quality
    activities and $19 million for school-aged care and resource and
    referral activities.
        In addition, the budget includes $600 million in entitlement funds
    for an Early Learning Fund to focus on the quality of child care. The
    Early Learning Fund will be used to provide grants to communities to
    improve school readiness by fostering the cognitive, physical, social
    and emotional development of children under five years-old through
    improvements in the quality of child care settings, among other things.
    The President=s budget also proposes an increase in the Child Care and
    Dependent Care Tax Credit (DCTC) of $7.5 billion over 5 years and an
    expansion of the Earned Income Tax Credit (EITC) of $23.6 billion over
    10 years, both of which would help low-income working families obtain
    quality, affordable child care.
                                     ______

                   Questions Submitted by Senator Larry Craig

        Question. Is the Federal Center for Substance Abuse Prevention part
    of the Substance Abuse and Mental Health Services Administration or
    SAMHSA?
        Answer. Yes, the Center for Substance Abuse Prevention (CSAP) is
    part of the Substance Abuse and Mental Health Services Administration
    (SAMHSA).
        Question. A survey was sent out to Missourian students in grades 6,
    8, 10, and 12 by the State of Missouri, and funded by the Federal
    Center for Substance Abuse Prevention, for the purpose of participating
    in a study designed to ``develop important information that will help
    combat such problems as alcohol and other drug use in our schools and
    communities.'' If the states purpose of the SAMHSA sponsored survey is
    to help combat alcohol and drug use problems, then why do 10 percent of
    the questions deal with handguns?
        Answer. This survey was conducted as part of a Missouri needs
    assessment contract. Needs assessment provides a means for States to
    obtain data critical for prevention planning, resource allocation, and
    to establish baselines for performance measurement. States are
    collecting uniform data through school and community resource studies
    and assessing risk and protective factors in four domains--Peer/
    Individual, Family, School, and Community--using readily available
    surveys, including the CSAP Student Survey Risk and Protective Factors
    Instrument, the Youth Risk Behavior Assessment Survey (CDC) and/or
    other community-based instruments
        To assist States with needs assessment, CSAP contracted with
    Hawkins, Catalano, and Miller to help develop a survey instrument.
    Hawkins et al. worked with a six state consortium (WA, OR, CO, ME, KS,
    and UT) to develop the Student Survey and pilot it. CSAP and ONDCP
    assessed the viability of the Student Survey among the first 3 cohorts
    (11 out of 23 states, or 48 percent) and determined that the Survey was
    an accurate needs assessment instrument. Discussions with the ONDCP
    regarding the State needs assessments determined that these assessments
    would be of more value if we could compare the data gathered for one
    State to the data of other States. Since the Student Survey is a
    reliable needs assessment instrument, the Survey was designated as a
    mandatory instrument for subsequent needs assessments. Based on this,
    Missouri is required to use this instrument. States that have, or are
    scheduled to use the Student Survey include: Washington, Florida,
    Kansas, New Jersey, South Carolina, Maine, Utah, Oregon, Arkansas,
    Delaware, Montana, Arizona, Hawaii, Missouri, Virginia, Alabama,
    Michigan, and Tennessee. Three states also using the survey, but not as
    part of the CSAP needs assessment are: Louisiana, Kentucky, and
    Pennsylvania. NIDA also is using the Student Survey in communities as
    part of a seven state consortium diffusion study.
        Research has consistently shown a strong association between
    substance use and violence. This is reflected in studies depicting
    violence as a precursor to substance abuse (by victims of violence) as
    well as depicting substance use as a precursor to violence (by
    assailants). The Student Survey, in use since 1993, includes questions
    related to individual, peer, family, and community antisocial behavior
    because of this consistent relationship. Student survey results from
    both a CSAP six state consortium and the National Institute on Drug
    Abuse (NIDA) seven state consortium further support this relationship.
        The handgun questions, which comprise 5.2 percent of the survey,
    are part of scales that measure:
      --association with antisocial peers
      --early initiation of problem behavior
      --attitude toward antisocial behavior
      --antisocial behavior
      --convention involvement
      --perceived availability
      --community laws and norms
      --family history of antisocial behavior
        NIDA study data show that every one of these constructs is strongly
    correlated with 30-day substance use as well as with antisocial
    behavior. Hence, the survey scales are important for identifying risk
    factors that potentially should be targeted within a State program.
                                     ______

                 Questions Submitted by Senator Robert C. Byrd

                               STATUS OF REPORTS

        Question. On December 9, 1999, I wrote to your office to inquire as
    to the status of certain initiatives identified in Senate Report 106-
    166 accompanying the fiscal year 2000 Departments of Labor, Health and
    Human Services, and Education, and Related Agencies Appropriations bill
    and/or Conference Report 106-479 accompanying the Consolidated
    Appropriations bill. I respectfully ask you to provide me with a status
    report of the following projects:

    $38,500,000 and 303 full-time equivalent employees for the new National
            Institute for Occupational Safety and Health laboratory in
            Morgantown, West Virginia; (CDC)

        Answer. The investment in the new National Institute for
    Occupational Safety and Health (NIOSH) laboratory in Morgantown, West
    Virginia, continues to yield significant scientific advances in
    understanding and preventing work-related disease, injury, and death.
    Activities at the new laboratory include: applied and preventive,
    multi-faceted laboratory-based research into the causes, mechanisms,
    prevention, and control of occupational disease and injuries; the
    development of high-tech engineering solutions for the control of
    occupational hazards; and basic and applied health communications
    research to improve the effectiveness of NIOSH communication efforts.
        Highlights of the laboratory's fiscal year 1999 accomplishments
    include:
      --Hexavalent Chromium Research.--NIOSH researchers developed a field-
            portable method for on-site determination of hexavalent
            chromium (a carcinogen found in structural components of
            buildings, as well as ink, paint, textile dyes, graphic art
            supplies, and wood preservatives), which is critical for
            assessing worker exposure and the effectiveness of control
            measures. Additional NIOSH basic research is examining the
            mechanism of hexavalent chromium-induced carcinogenesis.
      --Modeling Silica Exposure.--NIOSH investigators performed a silica
            inhalation study using animal models to examine pulmonary
            damage, pulmonary inflammation, fibrosis, and dust retention.
            The study found explosive increases in lung damage and
            inflammation when dust burdens stabilize, and observed that
            inflammation progressed even in the absence of continued
            exposure. The data will be used to model dust deposition,
            clearance, and retention in rats and to compare results to
            models for humans.
      --Carcinogenesis Mechanisms for Cadmium.--NIOSH studied the molecular
            mechanisms responsible for tumorigenic potential of cadmium.
            Findings suggest that genetic instability and changes in the
            cancer-related and novel genes may be responsible for the cell
            transformation and tumorigenesis induced by these metals.
            Identification of mechanisms for workplace-related
            carcinogenesis will help identify appropriate strategies for
            therapeutic intervention and prevention, as well as improve
            risk assessment for carcinogens.
      --Laboratory-based Models for Work-related Stress.--To determine the
            role of acute and chronic stress as occupational risk factors
            or contributors to disease, NIOSH is working with external
            partners to use laboratory-based models to determine the
            biochemical, cellular, and molecular changes engendered by
            specific stressors alone and in conjunction with various
            disease models. Results from this work indicate that
            glucocorticoid release associated with stress enhances skin
            response to chemicals and can exacerbate damage in the brain
            areas important for cognition.
      --Silicosis Outreach for Hispanic and Latino Workers.--NIOSH is
            developing an outreach project to increase the awareness of the
            seriousness of silica exposure among construction workers in
            Texas (who experience an alarming number of deaths attributed
            to silicosis) and to increase the use of engineering controls
            and respiratory protection in these workers. NIOSH assessed the
            workers' knowledge, beliefs, and behaviors about silicosis
            prevention, as well as their information seeking habits and
            barriers to and facilitators of prevention. NIOSH is using
            these data to develop a silicosis prevention program in fiscal
            year 2000.
      --Preventing Deaths from Tractor Overturns.--Tractor overturns are
            the largest single source of agricultural fatalities,
            accounting for approximately 132 deaths per year. Current
            rollover protective structures (ROPS) do not provide adequate
            protection because farmers manually lower them when working in
            low clearance areas and may forget to raise them. NIOSH has
            developed a ROPS prototype that is stored normally in a compact
            form but automatically deploys to full dimension, without
            operator input, to protect the operator in the event of an
            overturn. The new system includes: (1) a roll bar and
            deployment mechanism, which were successfully tested for
            appropriate protective strength according to industry
            standards, and (2) a sensor to identify an impending overturn
            and trigger the roll bar deployment. A patent application is
            being developed for this device.
        Research at the new laboratory will continue to focus on critical
    areas in occupational safety and health in fiscal year 2000. For
    example, researchers at the new laboratory are: coordinating an
    Institute-wide intramural initiative to study allergic and irritant
    dermatitis, including latex allergy, using state-of-the-art research
    methods; studying the genetic mapping of lung and prostate cancer to
    aid in the identification of at-risk worker populations; and using
    virtual reality technology to study the prevention of falls, which are
    one of three leading causes of injuries occurring in the workplace.
    $3,000,000 for the construction of West Virginia University's Eye
            Center; and $1,1135,000 for the construction and equipment of
            the Harts Health Center in Harts, West Virginia
        Answer. Congress provided $120 million for eighty-six specific
    projects in fiscal year 2000 and this amount has been reduced to $112.4
    million under the fiscal year 2000 government-wide discretionary
    spending rescission authority. The projects at the West Virginia
    University's Eye Center and the Harts Health Center in Harts, West
    Virginia will be notified in April 2000 of the amount available for
    their specific project and they will be provided with an application
    kit and application guidelines. They will be given 60 days to submit
    their application and supporting documentation. Following a 75-day
    review period, given the large number of projects, grant awards are
    scheduled for the end of September 2000.

    Approximately $1,000,000 for West Virginia University's Prevention
            Center funded through the Centers for Disease Control and
            Prevention; (CDC)

        Answer. In fiscal year 1994, West Virginia University received a
    four-year Prevention Research Center (PRC) grant from CDC. Under this
    cooperative agreement, they received approximately $1,000,000 per year
    in core funding.
        In fiscal year 1998, at the end of West Virginia's 4-year project
    period, they competed for renewal of their core PRC cooperative
    agreement along with the other 13 PRCs which existed at the time. In
    fiscal year 1998, CDC approved a 12-month extension of the project to
    allow the PRC time to expend their remaining funds to complete program
    goals and objectives.
        CDC's fiscal year 1999 appropriations committee report language
    mandated that all ``incumbent'' PRCs were to be funded. Based on this
    language, CDC awarded West Virginia a new 5-year PRC cooperative
    agreement, which began on February 1, 1999. The fiscal year 1999 award
    amount for the first year of this new 5-year project period included
    $600,000 in new core funds, which was commensurate with the level of
    funding received by the other 13 incumbent PRCs. The award also
    included $133,611 in new supplemental funds, and $285,000 in funds West
    Virginia withheld in previous years, for a total approved amount of
    $1,018,611.
        In fiscal year 2000, the West Virginia PRC received $650,000 in new
    core funds to support the second year of the current project period,
    which began on February 1, 2000. This increase in core funding was
    equal to the funding level of the other incumbent centers. They will
    also again have the opportunity to request funding for continuation
    projects and compete for new special interest project funding this
    year.
        Current center activities include evaluating the efficacy of a new
    teen smoking cessation program, Not on Tobacco, in two Appalachian
    states. Other research projects focus on diabetes, cardiovascular
    disease, nutrition, tobacco, and mental health. The Center continues to
    be the Coordinating Center for the Women's Cardiovascular Health
    Network and participates in the Tobacco Control Network. The Center
    also provides participatory research training to West Virginia Bureau
    for Public Health funded projects and has strong relationships with the
    West Virginia Department of Education, the American Lung Association,
    other voluntary health organizations, and other community-based groups.
    $687,000 for Marshall University's Autism Training Center; (CDC)
        Answer. CDC will encourage Marshall University to broaden its
    intervention program to include secondary conditions in children with
    autism as well as to examine etiologic factors and conduct surveillance
    for the condition.

    $850,000 for the Farm Resource Center through the Center for Mental
            Health Services of the Substance Abuse and Mental Health
            Services Administration

        Answer. SAMHSA will announce the availability of a demonstration
    grant program in April 2000. The Rural Outreach Program demonstration
    would continue outreach activities that ameliorate stress associated
    with unemployment in rural communities and increase access to, and
    utilization of, mental health and substance abuse services for coal
    miners, farmers, and their families in Illinois and West Virginia and
    western Pennsylvania. This program, designed to result in more
    effective mental health and substance abuse services delivery, is
    intended to address the needs of adults and their families in rural
    areas who have or may be at risk for developing a mental illness or
    substance abuse problem. Needs of their children who have or may be at
    risk for developing emotional or other behavioral problems are
    addressed also.

    Report language and $500,000 for the Office of the Surgeon General, in
            conjunction with the Public Health Policy Board and other
            agencies, to establish a process for selecting health
            priorities based on clear scientific data on emerging health
            threats to children

        Answer. The final fiscal year 2000 appropriation did not include
    funding to establish a process for selecting health priorities.
    However, in January 2000 the Surgeon General launched Healthy People
    2010, the third iteration of the Healthy People initiative first
    launched in 1979 with the publication of Healthy People: The Surgeon
    General's Report on Health Promotion and Disease Prevention. Healthy
    People 2010 sets the nation's health agenda for the next decade and
    states a set of common goals developed through a national consultative
    process; it also provides a mechanism to monitor progress toward
    achieving those goals. The scope of the Healthy People initiative has
    grown over the last three decades to more than 460 objectives--about a
    third of which relate to children. This approach identifies important
    public health issues for children and families, and assesses the
    relevant science available on these topics, in order to stimulate
    public discussion and effective interventions. The multidisciplinary
    and broad public health expertise of the Public Health Policy Advisory
    Board has taken a similar approach. Dr. Louis W. Sullivan, the current
    Chairman & CEO of the Public Health Policy Advisory Board, was among
    the distinguished leaders who participated in the release of the
    Healthy People 2010 Report. Healthy People 2010, which now includes a
    set of ten leading health indicators, has provided a monitoring
    apparatus to measure and achieve progress towards our child health
    goals.

    Report language urging the Surgeon General to host a summit on obesity
            policy to develop a national strategic plan to prevent obesity
            and to complete the Surgeon General's Report on Nutrition and
            Health which was to focus on dietary fat

        Answer. The Surgeon General is very concerned about the increasing
    health burden of obesity and overweight, and has considered how best to
    contribute to its alleviation. Towards this end, HHS and the U.S.
    Department of Agriculture (USDA) are jointly planning a National
    Nutrition Summit for May 30-31, 2000, that will have a major focus on
    overweight and obesity. This summit will highlight: accomplishments in
    food, nutrition, and health that have occurred since the 1969 White
    House Conference on this topic; the continuing challenges and emerging
    opportunities in this area; and nutrition and lifestyle issues across
    the human lifespan, especially those that we confront in solving the
    nation's epidemic of overweight and obesity. The summit will include
    policy makers, leading researchers in obesity, nutrition, physical
    activity and community-based prevention, and representatives of
    consumer, trade, business, and health professional organizations. An
    HHS/USDA interdepartmental steering committee is coordinating the
    summit, and held a public meeting in December 1999 to solicit input on
    the agenda. The committee will continue to solicit input and to involve
    other relevant government agencies in its planning efforts.
        As a follow-up to the 1988 Surgeon General's Report on Nutrition
    and Health, and to fulfill the requirements of Public Law 103-183, a
    Surgeon General's Report on Dietary Fats and Health was being developed
    under the aegis of the Department's Nutrition Policy Board. However, it
    became clear to the report drafters that, while the role of dietary
    fats (especially saturated fats) in coronary heart disease is well
    established, the science related to dietary fat intake and other
    chronic diseases is still evolving--and has become increasingly complex
    and, in some cases, contentious. There is also emerging evidence that
    energy balance is a key dietary factor affecting health and disease
    risks, independent of the effects of fats. Because dietary fats are a
    component of energy intake, it is difficult to parse the effects of fat
    or types of fat on disease risk and energy intake per se.
        Therefore, in order to obtain the balanced review needed to address
    this issue, the Office of Public Health and Science turned to the
    Institute of Medicine (IOM). In the fall of 1999, IOM began a 24-month
    comprehensive review of macronutrients with dietary fats and health,
    and including energy balance as a major component. This review is part
    of the IOM's multi-year project to evaluate nutrient requirements and
    establish recommended dietary intakes. Several other significant
    reviews with relevance for dietary fat and health issues parallel the
    IOM study; these include: a National Cancer Institute-funded systematic
    review and synthesis of the research literature concerning diet-related
    behavior change interventions; a Rand Corporation study funded by the
    Centers for Disease Control and Prevention on healthy aging, which will
    include diet, nutrition, and fat; and the National Cholesterol
    Education Program's expert panel review of current detection,
    evaluation and treatment methods for high blood cholesterol. As these
    reports are finalized, the science related to dietary fats will be
    better understood, and the Department will be better able to take
    appropriate action to promote and protect public health.

    Report language under the National Institute on Alcohol Abuse and
            Alcoholism regarding Fetal Alcohol Syndrome (FAS), genetics,
            neuroscience, medications development, alcohol and Hepatitis C,
            alcoholic liver disease, and ``Research to Practice'' Forums

        Answer. Fetal Alcohol Syndrome (FAS)--FAS research at NIAAA is
    supported in both the intramural and extramural programs and accounted
    for approximately 6.7 percent of the Institute's budget in fiscal year
    1999. Prevention of FAS is a high priority for the Institute. All
    meritorious candidates submitted in response to a recent request for
    applications have been funded. Research continues in a large community-
    based trial of comprehensive interventions to prevent FAS and other
    alcohol-related birth defects among four Plains Indian tribes, with two
    other Native American communities serving as comparison sites. A
    project to develop a screening tool and determine the prevalence of
    drinking in women in prenatal clinics in the District of Columbia also
    was cosponsored by the National Institute of Child Health and Human
    Development (NICHD). Data collection now has been completed, and data
    analysis is under way.
        To aid the health care community in addressing the problem of FAS,
    the NIAAA has developed two manuals for use in clinical practice. These
    manuals soon will be ready for distribution. One is designed to train
    health practitioners who treat women of childbearing age on the
    assessment of risk drinking and on referral and intervention methods.
    The other provides a guide for pediatricians on screening children for
    FAS. The NIAAA plans to pilot test the effectiveness of both manuals
    with primary care health professionals. In addition, the NIAAA is
    preparing a Request for Proposals to establish a FAS clearinghouse.
        The NIAAA will continue its leadership of the Interagency
    Coordinating Committee on Fetal Alcohol Syndrome (ICCFAS). Member
    organizations include seven organizations within the U.S. Department of
    Health and Human Services (DHHS), the Office of Special Education in
    the U.S. Department of Education (DoED), and the Office of Juvenile
    Justice and Delinquency Prevention in the U.S. Department of Justice
    (DOJ). To promote information exchange and to assure high quality
    research, the NIAAA sponsored an investigator workshop at the October
    1999 ICCFAS meeting.
      --Genetics--Approximately 50-60 percent of total population
            vulnerability to alcoholism is mediated by genetic factors. The
            NIAAA-funded Collaborative Study on the Genetics of Alcoholism
            (COGA) has found significant evidence for genetic linkages on
            several chromosomes. These chromosomal regions are likely to
            contain genes that influence alcohol-related behavior. This
            powerful new data set generated by COGA is now ready for
            release to the general scientific community. The COGA databases
            contain extensive clinical, diagnostic, psychological,
            neurophysiological, pedigree, and genetic data on thousands of
            individuals, who comprise hundreds of families of alcoholics
            under study. The neurophysiological data will be distributed by
            SUNY Downstate Health Sciences Center (New York, NY); all other
            data will be distributed by Washington University (St. Louis,
            MO). The companion collection of cell lines and DNA samples
            from individuals studied will be distributed by Rutgers
            University (Piscataway, NJ). The Institute plans to encourage
            intensive analysis of the substantial COGA data set by the
            broadest possible spectrum of investigators.
      --Neuroscience--Approximately 25 percent of the NIAAA's resources are
            committed to neuroscience research. Recent neuroscience
            findings on the biologic mechanisms that underlie alcohol's
            effect represent new possibilities for development of
            medications for alcohol disorders. Most pharmaceuticals target
            specific protein sites. Scientists have identified at least one
            protein site on a neuroreceptor implicated in alcohol's
            neurodepressant actions, opening the potential for design of
            compounds to block such protein sites and, thus, alcohol's
            effects. In response to these and other findings, the Institute
            has solicited research grants for the study of in vivo
            screening models that will test new compounds for alcoholism
            pharmacotherapy. Another initiative solicits research that will
            examine how alcohol affects neurochemical changes that take
            place during adolescence.
      --NIAAA-supported scientists are using and expanding powerful new
            techniques for studying specific protein areas of
            neuroreceptors. Site-directed mutagenesis and chimeric
            techniques permit researchers to examine, individually,
            components of neuroreceptor proteins to determine if they are
            involved in the brain's response to alcohol. Gene knock-out
            techniques eliminate the activity of specific genes and the
            proteins they encode. These genetic techniques thus allow
            scientists to test whether specific proteins, including
            components of neuro-
            receptors, mediate alcohol's effects on nervous system
            function. The NIAAA will issue a Request for Applications (RFA)
            to apply these techniquest to alcohol studies in fiscal year
            2000. In addition, NIAAA-funded investigators are among the
            pioneers of a microdialysis technique that enables researchers
            to directly measure--simultaneously--neurotransmitter and
            neurophysiologic response in freely-behaving rats exposed to
            cognition-altering substances.
          Based on these neuroscience finding, NIAAA-supported scientists
            are developing new pharmacologic compounds. Grants awarded
            under the pharma-
            cotherapy-screening initiative will enhance the laboratory
            testing process for evaluating the therapeutic potential and
            likelihood of risk associated with these substances. Once this
            screening task has been accomplished, promising compounds will
            follow the usual route in the medication-development pipeline;
            namely, testing for efficacy and safety in animal studies, then
            small-scale human trials, when appropriate. Compounds shown to
            be safe and effective in small-scale human trials will then
            become candidates for large-scale human clinical trials.
      --Medications Development--NIAAA-supported scientists are making
            rapid progress in understanding the neurobiologic mechanisms
            that underlie alcohol's effects. With this understanding comes
            the potential to design compounds that therapeutically alter
            these mechanisms. To channel this rapid accumulation of data
            toward medication development, the NIAAA is encouraging
            research grant applications that will result in new methods of
            screening promising compounds with therapeutic potential. This
            screening initiative also includes a component intended to
            stimulate research on pharmacotherapy for the sequelae of
            alcoholism, such as liver disease.
      --Project COMBINE, a large, multi-site, clinical trial of promising
            alcohol-treatment medications--naltrexone and acamprosate--is
            ongoing. Investigators are testing the effectiveness of these
            medications alone and in combination. The medications are being
            evaluated with two behavioral interventions which are
            applicable to two types of treatment settings. One is
            applicable to primary care medical practices, and the other is
            suitable for addiction medicine speciality practices.
            Preliminary studies evaluating safety of the combination of the
            medications and the feasibility of the study protocol are in
            progress, and the main trial will begin early in year 2000.
      --Alcohol and Hepatitis C--The NIAAA is an active and integral
            component of the research initiatives and collaborations among
            the NIH Institutes regarding hepatitis C virus (HCV). Heavy
            drinking increases the severity of hepatitis C and complicates
            its treatment. Recognizing the substantial increased risk for
            infected individuals to advance to end-stage liver disease and
            liver failure, the NIAAA has released a Request for
            Applications (RFA) in fiscal year 2000. This solicitation
            specifically focuses on the role of alcohol in promoting end-
            stage liver disease and subsequent death in HCV patients.
            Principal goals of this research include elucidating alcohol's
            impact on the course of hepatitis C, as well as exploring
            potential mechanisms and their exploitation in the development
            of successful treatment options.
          In fiscal year 1999, the NIAAA also cosponsored other HCV
            initiatives. For examples, the NIAAA participated in the
            requests for Hepatitis C Research Centers, sponsored by the
            National Institutes of Allergy and Infectious Diseases (NIAID),
            that will provide a national research network blending basic
            research and clinical investigations to promote translational
            research in HCV research--that is, bring the basic research
            findings into the clinic. In addition, the NIAAA co-sponsored a
            request for Small Business Innovation Research (SBIR)
            applications to establish new animal models to advance the
            field of alcohol and hepatitis C research. An underlying
            premise is that multi-disciplinary basic laboratory, animal
            model and clinical research is needed to advance our
            understanding of HCV and the liver disease and cancer it can
            cause. The Institute also has established a new collaboration
            with the American Liver foundation's (ALF's) ``Hepatitis C
            Initiative'' and is working closely with the ALF in advancing
            patient-related information and activities.
      --Alcoholic Liver Disease--Scientists have made significant progress
            in understanding the biological mechanisms that lead to organ
            damage in alcoholic liver disease (ALD), the fourth leading
            cause of death among urban U.S. males and a source of costly
            morbidity. Among the findings are that reactive oxygen species
            (namely, producers of free radicals, which cause harmful
            changes in many molecules) and Tumor Necrosis Factor (TNF), a
            protein that causes an inflammatory response, play major roles
            in ALD, NIAAA-funded investigators are researching numerous
            methods to either inhibit TNF expression in liver cells
            directly through genetic manipulation or by specific insertion
            of TNF-inhibitors into liver cells. In fiscal year 1999, the
            Institute expanded this research area through a Program
            Announcement (PA), entitled ``Mechanisms of Alcohol-Induced
            Hepatic Fibrosis,'' which solicits grant applications
            elucidating new therapeutic approaches for the fibrosis seen in
            alcoholic liver diseases. Since TNF is implicated in many major
            diseases (for example, cancer, arthritis, and multiple
            sclerosis), advances in discovering how to selectively express
            cytokines associated with organ damage will benefit a variety
            of disciplines.
      --Research and Practice Forums--In 1997, the Director of New York's
            Office of Substance Abuse Services met with NIAAA Director Dr.
            Enoch Gordis to discuss a number of issues affecting prevention
            and treatment services in the State. Two ideas emerged: (1)
            directing research dissemination efforts specifically to
            clinical directors of treatment programs, and (2) developing a
            rigorous research demonstration project to test recommended
            science-based clinical practices and measure outcomes in four
            or six volunteer treatment programs. To fund these efforts, the
            Institute entered a partnership with the Center for Substance
            Abuse Treatment (CSAT). The first phase of the collaboration
            was a ``research-practice forum'' held in Saratoga Springs, NY,
            in October 1998. The research symposium was designed
            specifically for clinical supervisors and directors in New York
            who received the most cutting-edge research findings on issues
            affecting their work for incorporation into their programs. In
            turn, researchers also benefitted from input and information
            from the supervisors about real world barriers and difficulties
            encountered in their clinics.
          The NIAAA and CSAT continue work with New York State, the
            provider's association, and clinical directors of six programs
            on phase II of this project. Six programs have been selected to
            participate in the Best Practices/Researcher in Residence
            Program. The program's goal is to encourage the adoption in
            clinical practice of recent treatment research advances by
            placing nationally recognized scientists in brief periods of
            residence at participating clinical treatment sites.
            Information exchange between participating researchers and
            clinical supervisors and staff will occur through training
            sessions, research seminars, presentations of recently-
            developed techniques, case reviews, and clinical problem
            solving.
          This program has been expanded to the State of North Carolina
            where a forum was held in November 1999. Phase II of the North
            Carolina project is under discussion and will be implemented in
            year 2000. If efforts in these two states shod sufficient
            promise, they will be repeated elsewhere throughout the
            country.

                    INTERNATIONAL CONFERENCE ON RURAL AGING

        With more than fifteen percent of the West Virginia's population
    being at least sixty-five years of age, a percentage that is expected
    to increase over the next several years, such statistics underscore the
    need to take a closer look at how the needs of an aging population may
    affect West Virginia, the United States, and nations around the world.
    To help address the challenges associated with aging, delegates from
    around the globe are slated to converge in Charleston, West Virginia,
    this coming June for the international ``Rural Aging: A Global
    Challenge'' conference. The rural aging conference is planned to direct
    special attention toward meeting the needs of the elderly residing in
    the some of the least developed areas of the world. Organizers hope
    that the event will result in a stronger commitment to senior citizens
    by both the public and private sectors.
        Question. Currently, West Virginia University has submitted its
    application to the Administration on Aging for release of the remaining
    $500,000 that I secured for implementation of the conference. What
    steps will you take to ensure the funds are released before the June 9,
    2000 deadline?
        Answer. The Administration on Aging has been in frequent contact
    with the staff from West Virginia University to assure processing of
    funds as quickly as possible. Extensive technical assistance has been
    provided to assist in the planning of the conference. The Project
    Officer at the Administration on Aging has helped University staff
    connect with representatives of the U.S. Federal Committee, State
    International Year of Older Persons coordinators and internationally
    recognized speakers. She has also developed publicity, recommend
    substantive program content and identified partners who are providing
    help in handling the details of this event. Based on all the assistance
    provided HHS has every confidence the funds will be released before
    June 9.
         With more than fifteen percent of the West Virginia's population
    being at least sixty-five years of age, a percentage that is expected
    to increase over the next several years, such statistics underscore the
    need to take a closer look at how the needs of an aging population may
    affect West Virginia, the United States, and nations around the world.
    To help address the challenges associated with aging, delegates from
    around the globe are slated to converge in Charleston, West Virginia,
    this coming June for the international ``Rural Aging: A Global
    Challenge'' conference. The rural aging conference is planned to direct
    special attention toward meeting the needs of the elderly residing in
    the some of the least developed areas of the world. Organizers hope
    that the event will result in a stronger commitment to senior citizens
    by both the public and private sectors.

                            OBESITY IN WEST VIRGINIA

        Question. The West Virginia Department of Health and Human
    Resources reported in May 1999 that 4.2-percent of West Virginia's
    population falls into the category of being clinically obese. This
    alarming statistic places West Virginia first in the nation in obesity,
    with the percentage reportedly growing higher each year. Sadly, it is
    the children who are falling prey to this epidemic, making them the
    fastest growing portion of the obese population. What steps are you
    taking to create heightened obesity awareness and prevention,
    particularly with regard to West Virginia?
        Answer. The Department sees obesity as a very serious public health
    problem. In fiscal year 2000, CDC received approximately $4.5 million
    in new funds for nutrition/obesity activities. With these funds, CDC
    will provide support to up to eight states to initiate nutrition and
    physical activity programs to prevent and control obesity and related
    chronic diseases. In carrying out these programs, states will (a)
    select one or more priority population in which to plan and initiate
    activities; (b) develop appropriate internal and external partnerships
    to carry out the plan; and develop, conduct, and evaluate nutrition and
    physical activity intervention programs. West Virginia is encouraged to
    apply for CDC funding.
        Currently, CDC provides funding for State-based school health
    programs in West Virginia to: (1) develop a state system of support for
    coordinated school health programs ($225,000) and (2) expand
    comprehensive school health education, with a focus on physical
    activity, nutrition and tobacco use prevention ($212,000). West
    Virginia has used these funds to:
      --Assist in the development and implementation of child nutrition
            polices. The West Virginia's Department of Education requires
            food served in school cafeterias to meet the dietary guidelines
            and prohibits the sale of high sugar and high fat foods during
            the school day;
      --Evaluate and develop revised physical education requirements. The
            State Board of Education requires Physical Education
            requirements in grades K-8, and a full unit of Physical
            Education instruction as a high school graduation requirement;
      --Develop physical fitness requirements. President's Physical Fitness
            Test is required by law for all students in grades K-9 which
            includes a new accreditation standard that requires schools to
            have a 40 percent passage rate on the test or show improvement
            in each of the previous 3 years;
      --Develop standards in health education and physical education for
            the State Board of Education;
        West Virginia plans to hold a Nutrition Symposium in 2001 for
    school health teams that will focus on obesity and being overweight;
    and continued physical education summits to help physical education
    teachers change their focus from sports to lifetime fitness activities.

                  MEDICARE REIMBURSEMENT OF AMBULANCE SERVICES

        Question. Earlier this year, the Health Care Financing
    Administration (HCFA) advised all carriers to suspend any Inherent
    Reasonable (IR) pricing until the Government Accounting Office (GAO)
    has finished their study of current IR authority as revised by the
    Balanced Budget Act of 1997 (BBA). Although HCFA is scheduled to
    implement a fee schedule reimbursement for ambulance services beginning
    January 1, 200 1, counties such as Doddridge and Marion are in dire
    need of a reassessment. What can you do to provide relief to West
    Virginia's ambulance services?
        Answer. Since our instructions to the carriers to suspend any
    inherent reasonableness activities, the Congress enacted the Balance
    Budget Refinement Act of 1999 (BBRA). Section 223 of BBRA prohibits use
    of the inherent reasonableness authority by the Secretary or her
    contractors until (1) the General Accounting Office (GAO) reports on
    its inherent reasonableness study, and (2) HCFA publishes a final rule
    that responds to the GAO report as well as to the comments received on
    the January 1, 1998 Interim Final Inherent Reasonableness regulation.
        Therefore, we currently have no mechanism to provide relief to
    ambulance suppliers in your state at this time.
                                     ______

                Questions Submitted by Senator Dianne Feinstein

                                   HEAD START

        Question. The President's goal is to enroll $1 million children in
    Head Start by 2002. Providing children with access to programs that
    improve cognitive and social development in their early years is
    important. And yet, ``Head Start has only vague performance standards
    and no curriculum to stimulate the growth of literacy and numeracy,''
    say Henry Aaron and Robert Reschaeur in Setting National Priorities,
    The 2000 Election and Beyond. What is HHS doing to move Head Start from
    custodial child care to a program that stresses cognitive development
    and learning?
        Answer. Head Start is America's premiere early childhood education
    program, and continues to lead the way in state-of-the-art approaches
    to enhancing young children's development. Head Start's performance
    standards are, in fact, quite comprehensive and clearly delineate what
    programs must do in serving children and families. These standards
    cover the areas of Education and Early Childhood Development, Child
    Health, Child Mental Health, Child Nutrition, Family Partnerships,
    Community Partnerships and Program Governance, among others. A copy of
    these standards is attached. Furthermore, it should be noted that the
    Performance Standard on Education and Early Childhood Development
    clearly requires that all programs must, in collaboration with Head
    Start parents, implement a curriculum and goes on to discuss what this
    curriculum must include.
        This Administration has invested heavily in improving not only the
    cognitive learning aspects of this program, but in raising its
    standards. We have paired investment in critical elements of quality
    such as teacher compensation and training with a tough approach to
    enforcement of high standards in every Head Start program. Annual
    salaries for Head Start teachers have increased from $14,600 in 1992 to
    $20,700 this year. Since 1995, more than 140 local grantees have been
    replaced because they have been unable to rectify deficiencies in
    program quality. We will continue these investments in fiscal year 2001
    and will devote more than half of all new Head Start money to continued
    improvements in the quality of the program.
        In addition, Head Start has made a commitment to measuring child
    outcomes, including cognitive outcomes as well as other key aspects of
    children's development and parental involvement. Our research shows
    that typical children leave Head Start with a wide range of specific
    knowledge and skills that prepare them for kindergarten. These
    practical, common sense achievements form the foundation for continued
    progress in learning by Head Start children in kindergarten where they
    show statistically significant growth in vocabulary, letter
    recognition, writing and other pre-reading skills.
        Question. Would HHS be opposed to changing the focus of the Head
    Start program so that more attention is placed on the development of
    cognitive skills?
        Answer. Head Start provides top-quality early childhood education
    along with comprehensive services, such as health, nutrition, and
    family support services, to almost 900,000 low-income, preschool
    children and their families across the nation, including more than
    81,000 children and their families in California.
        Head Start currently places a strong emphasis on cognitive skills.
    Preliminary results from the Family and Child Experiences Survey
    (FACES) indicate that average program quality is in the ``good'' to
    ``excellent'' range and no classroom scored below the ``minimal
    quality'' range. Head Start children are ready for school, performing
    above the levels expected for children from low-income families who
    have not attended center-based programs. The survey also found that 66
    percent of Head Start parents read to their child three or more times a
    week and that 70-90 percent of parents teach their children letters,
    numbers or songs.
        We are building upon this progress with new initiatives, including
    expanded training in family literacy services, new partnerships with
    prekindergarten and child care programs, and the development of local
    grantee systems to track and analyze child outcome data.
        Question. What kind of coordination or communication does the
    Department of Education have with HHS on this program?
        Answer. The Head Start Bureau has extensive collaborative
    relationships and initiatives with the Department of Education,
    including the following:
      --Recent joint sponsorship with Title I, Even Start, and HHS's Child
            Care Bureau of a national leadership forum of State leaders and
            managers of prekindergarten, Head Start, and child care
            programs to explore new opportunities to use State and Federal
            early childhood funding to reach more children with higher
            quality services and to identify ways to eliminate barriers to
            cross-program collaboration.
      --Long-standing involvement with ED in joint efforts to serve
            infants, toddlers, and young children with disabilities,
            including participation in the Federal Interagency Coordinating
            Council, and public-private partnerships such as the Conrad
            Hilton Foundation/Head Start $15 million initiative to training
            community teams of Early Head Start, ED early intervention
            program providers, parents and other community agency leaders
            to improve serving to infants and toddlers with disabilities.
      --Collaborative efforts in research and accountability efforts,
            including joint sponsorship and funding of major longitudinal
            studies of early childhood development (including the National
            Center for Education Statistic's Early Childhood Longitudinal
            Survey, Kindergarten & Birth Cohorts) and emerging efforts in
            Title I and Even Start to utilize the Head Start Performance
            Measures outcome measures in Federal evaluations and State-
            level accountability efforts.
      --Additional leadership efforts between Head Start and public
            education programs and systems occur at the State and local
            level through the nationwide network of Head Start-State
            Collaboration Offices which give priority attention to forging
            linkages among local Head Start agencies, family literacy
            initiatives, State prekindergarten programs, and local
            education agencies.
      --Finally, and most importantly, every local Head Start grantee is
            held accountable for maintaining strong and effective
            partnerships with local elementary schools and districts
            through specific mandates covering the provision of family
            literacy and adult education services, services to children
            with disabilities, and preparing every child and family for a
            successful transition to kindergarten.
        Question. Shouldn't we move Head Start to the Department of
    Education and convert it into a strong preschool program and focuses on
    cognitive development?
        Answer. I do not believe that Head Start should be transferred to
    the Department of Education. While the cognitive elements of Head Start
    are extremely important, the genius of the program is that it is
    comprehensive. It integrates health, nutrition and family support
    services with education and learning. The American Customer
    Satisfaction survey found that Head Start=s composite satisfaction
    score of 87 is unsurpassed among all public and private entities in the
    survey. Head Start parents said that they would recommend Head Start to
    other parents and that they are confident that Head Start will continue
    to do a good job of providing preschool education in the future. In
    addition to these high levels of parent satisfaction, Head Start
    programs demonstrate exemplary levels of parent involvement, a key
    ingredient in children=s success.
        We are continuing to introduce new initiatives to challenge and
    support Head Start's drive for excellence, including expanded training
    in family literacy services (in collaboration with the Department of
    Education's Even Start program), new partnerships with pre-kindergarten
    and child care programs and funding sources, and the development of
    local grantee systems to track and analyze child outcome data.

                                 IMMUNIZATIONS

        Question. You have told me that opening up the Federal Vaccines for
    Children Program to SCHIP beneficiaries would require a legislative
    change. Would you support legislation to make SCHIP beneficiaries
    eligible for the Vaccines for Children Program? If no, why not?
        Answer. The Department would not oppose such legislation.

                                    HIV/AIDS

        Question. What are your plans to reinvigorate the government's
    focus on preventing the further spread of HIV/AIDS, particularly in
    communities of color?
        Answer. The Centers for Disease Control and Prevention has the lead
    for the Department in preventing the further spread of HIV/AIDS. CDC
    has initiated a number of national, regional, and community-based
    programs designed specifically to reach racial and ethnic minorities at
    greatest risk of HIV infection. CDC is focusing specifically designed
    programs on the HIV/AIDS prevention needs of African- Americans and
    other disproportionately affected racial/ethnic minority communities in
    three broad categories: technical assistance and infrastructure
    support, increasing access to prevention and care services, and
    building stronger linkages to address the needs of specific
    populations.
        In October 1999, CDC awarded funds to more than 100 organizations
    throughout the nation to expand HIV prevention efforts in African-
    American and other communities of color at high risk of infection,
    including Latinos, Native Americans and Asian Pacific Islanders
    communities. The 1999 awards represented a 50 percent increase in
    funding earmarked for HIV prevention efforts in African-American
    communities. Awards include 47 African American community-based
    organizations (CBOs) and 7 State and city health departments to develop
    HIV prevention programs in correctional facilities to reach high-risk
    minority populations, as well as, new national efforts to encourage HIV
    testing among African- Americans and others at high risk of HIV
    infection.
        In addition, CDC continues to provide funds to State and local
    health departments for HIV prevention. Funding priorities for the
    health departments are determined through a community planning process.
    Community planning provides an approach to ensure community voices and
    programs to keep pace with the local epidemic, and States are strongly
    encouraged to direct resources towards their HIV epidemic. Funds are
    used to (1) address prevention needs in communities of color; (2) build
    capacity of grassroots organizations to deliver effective, targeted,
    culturally competent interventions; and (3) supplement funds for
    demonstration projects focusing on HIV seropositive persons,
    correctional activities, and perinatal prevention work. In fiscal year
    2001, an increase of $40 million will fund grants allocated through the
    community planning process to focus on high risk populations, including
    minorities. An additional $10 million will also be directed towards
    the"Know Your Status'' campaign in fiscal year 2001 to focus
    predominantly on minority populations.
        Question. What has HHS learned during the past year about the
    effectiveness of the current role and structure of the CARE Act in
    improving access to HIV treatments among underserved communities?
        Answer. Over 67 percent of Ryan White CARE Act programs provide
    services to minorities, based on 1997 Annual Administrative Reports
    from CARE Act grantees. An initial draft of a study conducted by the
    University of California, San Francisco, and supported by HRSA, did not
    find minorities disproportionately under represented in acquiring
    access to HIV treatments when other public funding and entitlement
    benefits programs (e.g., state programs and Medicaid) are taken into
    consideration. The study's final report is expected by the end of
    fiscal year 2000.
        Question. Do you think the current formula used to distribute
    funding is effective and working? Why or why not? If not, what changes
    would you propose to the formula?
        Answer. We do believe the current formula for distributing funds
    under Title I and II, which was revised when the CARE Act was
    reauthorized in 1996, is effective and works. In order to more fully
    understand and address the complex set of issues associated with the
    allocation formulas, the Administration supports the authorization of
    an Institute of Medicine study to examine the financing and delivery of
    HIV services to low-income, under and uninsured persons with HIV.
        Question. Do you think the current formula effectively sends funds
    to areas where the AIDS epidemic is? Why or why not? If not, what
    changes would you propose to make?
        Answer. We believe the current formula effectively sends funds to
    areas where the AIDS epidemic is. In order to more fully understand and
    address the complex set of issues associated with the allocation
    formulas, the Administration supports the authorization of an Institute
    of Medicine study to examine the financing and delivery of HIV services
    to low-income, under and uninsured persons with HIV.
        Question. What can HHS do to make certain that the funding is going
    to communities most impacted by the epidemic? What should Congress do?
        Answer. As you already know, Congress appropriated additional funds
    to address the needs of minority communities through the Congressional
    Black Caucus initiative in both the fiscal year 1999 appropriation and
    the fiscal year 2000 appropriation. The Agency allocated funds to
    communities based on the allocation process specified in the report
    language accompanying the fiscal year 1999 appropriation and is
    assessing the impact of these funds. In allocating these funds,
    grantees were provided direction in the use of these funds. The fiscal
    year 2000 appropriation significantly increased the amount of CARE Act
    funding designated for minority communities.
        We understand that the Senate is beginning to discuss Ryan White
    reauthorization. We believe that this reauthorization can strengthen
    the Ryan White program's ability to ensure that funding is going to
    communities most impacted by the epidemic. This can be accomplished by
    considering changes to the Act that will focus on methods for
    identifying and reaching HIV-positive individuals who are not currently
    receiving care, increasing the service capacity of providers in
    underserved communities, and establishing increasingly accountable
    service networks.

                                     BIDIS

        Question. Given the widespread availability of bidis and their
    harmful health effects, it is especially important that bibis be
    included in all anti-tobacco programs. What is HHS, FDA, and CDC doing
    to address the increasing use of bidis?
        Answer. Research has shown that bidis are a significant health
    hazard to users, leading to an increased risk of coronary heart disease
    and cancers of the mouth, pharynx and larynx, lung, esophagus, stomach,
    and liver. One study found that a bidi produces more than three times
    the amount of carbon monoxide and nicotine and more than five times the
    amount of tar than a cigarette, when tested on a standard smoking
    machine.
        In 1996, the Food and Drug Administration (FDA) published a final
    rule prohibiting the sale of cigarettes and smokeless tobacco products
    to minors. The Agency has been enforcing the provision since 1997 in an
    enforcement partnership with state and local governments.
        Bidis are not ordinarily sold in conventional tobacco retail
    establishments. FDA is carrying-out research to determine the types of
    retail outlets that are likely to sell bidis; results are expected
    shortly. Once this information is available FDA can then determine
    whether additional unannounced inspections should be conducted in those
    establishments.
        This is of course, contingent upon the Supreme Court's review of
    FDA's legal authority to regulate tobacco and tobacco related products.
        Recent trends related to bidi use among youth underscore the need
    for a greater focus on preventing young people from ever starting to
    use bidis or any other tobacco product and to help young people to quit
    tobacco use. The Centers for Disease Control and Prevention (CDC)
    continues to help States address the use of bidis and other tobacco
    products through the implementation of comprehensive tobacco prevention
    and control programs. In particular, CDC is working with States to
    develop messages to inform the public about the health risks attributed
    to bidis use to refute the notion that they are safer to smoke than
    cigarettes, explore ways to involve young people and their families in
    efforts to prevent tobacco use to include bidis, and survey teens in
    order to determine trends in bidis use.
        There is still much to be done, but we have established dialogue
    and provide ongoing technical assistance to the states and national
    organizations in their efforts to effectively address all tobacco
    issues, including bidi use.
        Question. Shouldn't all bidis packages carry health warning labels?
    If so, what are you doing to make certain this happens?
        Answer. The Federal Trade Commission (FTC) is working with bidis
    manufacturers and the U.S. Customs Department to ensure that health
    warning labels are properly placed and appear on bidi packages imported
    into the U.S. Anecdotal evidence indicates that some bidi packages
    imported and sold in the U.S. do not contain health warning labels. The
    public is encouraged to notify the FTC if they observe bidi packages
    not containing health warning labels. The FTC should answer further
    questions regarding the placement of the Surgeon General's rotating
    health warning labels on packs of bidis.
        Question. Shouldn't they be sold with the same age restrictions as
    other tobacco products? If so, what are you doing to make certain this
    happens?
        Answer. Bidis are subject to the same age restrictions as other
    tobacco products. Bidis are not safe and should never be considered a
    safe alternative to any form of tobacco product including cigarettes,
    spit tobacco, cigars or pipes. Therefore, concerns regarding the
    accessibility of bidis among youth are similar to minors' access issues
    for other tobacco products. Currently, bidis are available through the
    Internet, tobacco shops, some ethnic food and convenient stores, and in
    selected health stores. Anecdotally, youth (under the age of 18) have
    little difficulty purchasing them.
        The Synar Amendment, enacted in 1992 and implemented by the
    Substance Abuse and Mental Health Services Administration (SAMHSA),
    requires States to enact and enforce laws prohibiting any manufacturer,
    retailer, or distributor from selling or distributing tobacco
    products--including bidis--to individuals under the age of 18. The goal
    of the amendment was to reduce the number of successful illegal
    purchases by minors to no more than 20 percent of attempted buys by
    minors in each State within a negotiated time period.
        SAMHSA is working closely with the States to broaden their
    enforcement to include spit tobacco, cigars, bidis, etc. in addition to
    cigarettes. In addition SAMHSA is conducting a series of State and
    regional studies to measure the availability of these tobacco products
    to youth, and whether there are differences in retailers' willingness
    to sell to youth based on the type of tobacco product.
        Question. How can we expand health services in underserved areas by
    reducing training opportunities of qualified health professionals? Why
    did you propose to cut funding?
        Answer. The fiscal year 2001 budget will work to ensure a diverse
    workforce that is adequately distributed. The request is $218 million,
    an $84 million reduction. Within this overall funding level HRSA will
    focus resources on programs which will help disadvantaged students and
    reflects the Administration's goal to move away from broad-based
    categorical programs. Within this level there is a $10 million increase
    for the Centers of Excellence and the Health Careers Opportunity
    programs, both of which have success in increasing diversity by
    recruiting and retaining promising racial and ethnic minority students
    in health professions training. Also included in the total request is
    $80 million for the Children's Hospitals Graduate Medical Education
    (GME), doubling the funding available in fiscal year 2000. These funds
    will raise the level of GME support for approximately 60 freestanding
    Children's Hospitals to be more consistent with other teaching
    hospitals.

                                 NIH SALARY CAP

        Question. Wouldn't an increase in the NIH salary cap benefit
    biomedical research?
        Answer. An increase in the NIH salary cap is unlikely to benefit
    biomedical research directly. In those instances in which an
    institution chooses to provide a base salary that exceeds the current
    statutory salary cap, an increase in the salary cap could affect the
    amount of their own funds that research institutions have available for
    the support of the government-university research enterprise. However,
    covering the additional costs for those grants resulting from an
    increase in the NIH salary cap could reduce the number of awards the
    NIH is able to make.
        Question. Do you support an increase in the salary cap to Executive
    Level I?
        Answer. In the fiscal year 2001 President's Budget, the
    Administration proposes to maintain the salary cap at Executive Level
    II.

          STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP) ENROLLMENT

        Question. Why is enrollment in SCHIP so low?
        Answer. In December 1999, HHS announced that enrollment in SCHIP
    was nearly 2 million for fiscal year 1999. This represents a doubling
    in enrollment since December 1998. We are pleased with States' success
    in finding and enrolling these eligible children.
        Remember, SCHIP is still a relatively new program and now that all
    States have programs approved, we expect to see further increases in
    enrollment once the programs are fully implemented.
        States continue to engage in and improve upon outreach activities
    that will increase the number of children enrolled in SCHIP.
    Furthermore, States continue to submit plan amendments to expand the
    eligibility levels for their programs.
        Question. What are the Department's current efforts to improve
    enrollment and decrease obstacles to enrollment in SCHIP?
        Answer. The Administration's FamilyCare coverage proposal builds on
    States' operating SCHIP programs by expanding SCHIP to parents. This
    will increase enrollment of children in the program because States
    would be required to cover children up to 200 percent of the Federal
    Poverty Level before covering parents in fiscal year 2001-2005.
    Furthermore, we believe enrollment of children in SCHIP and Medicaid
    will increase because children are more likely to be enrolled in health
    insurance if their parents are also enrolled.
        FamilyCare also permits States to pool allotments with employer
    contributions toward the purchase of private coverage. Thus, families
    that would be eligible for FamilyCare will be able to access their
    employers' health plan as long as the employer contributes half the
    family premium costs and the health plan met FamilyCare standards.
        In addition to covering the parents of SCHIP and Medicaid eligible
    children, we expect to cover an additional 400,000 uninsured children
    over the next 10 years through several new tools, including:
      --allowing school lunch programs to share eligibility information
            with Medicaid,
      --expanding sites authorized to determine presumptive eligibility for
            SCHIP and Medicaid,
      --requiring States to make their Medicaid and SCHIP enrollment
            processes equally simple.
        Over the next 10 years, we expect to cover 4 million additional
    people, that is, 3.5 million new adults (parents of Medicaid-eligible
    children) and 500,000 new children in Medicaid and SCHIP.
        Question. What are the current efforts to ensure retention in the
    programs?
        Answer. Since the welfare reform law was enacted in 1996, the
    Department has issued guidance and other information to the States
    about how Medicaid eligibility rules and procedures have been affected
    by welfare reform. Perhaps the most significant was a detailed guide,
    released in March 1999, that sets forth the Federal requirements and
    proposes a range of options that can promote enrollment among eligible
    families, including those leaving welfare. This guidance made it clear
    that transitional Medicaid is available to all families that would
    otherwise lose their Medicaid coverage due to earnings. HCFA is working
    with States to ensure that eligible families continue to receive
    Medicaid after they leave welfare without any gap in coverage.
        Through its Regional Offices, HCFA recently conducted on-site
    reviews in every State and territory to examine current policies and
    practices with regard to Medicaid applications, eligibility and
    enrollment in the post-welfare reform environment. One goal of this
    effort is to take the appropriate steps to ensure that eligible
    families receive and retain Medicaid, including ``transitional''
    Medicaid.
        In addition, we will be synthesizing the findings from the site
    visits and developing a plan for the next steps, including technical
    assistance, corrective action if appropriate, and best practices
    identified through our site visits.
        On January 6, 2000 we released guidance advising States of the
    continued availability of Federal funds set aside in the 1996 welfare
    law to help States cover the costs of adapting their Medicaid policies
    and systems to welfare reform changes. At the end of last year, the
    Administration worked successfully with Congress to extend the life of
    this fund. Most States have a considerable amount of funds to use for
    these purposes.
        Finally, on April 7, 2000 we released guidance to ensure that
    eligible low-income families are able to enroll and stay enrolled in
    Medicaid. The letter to State Medicaid Directors covers State
    responsibilities in three related areas: identifying and reinstating
    people terminated improperly; processes for redeterminations for
    eligibility; computerized eligibility systems.

            REPORTS REQUESTED IN LAST YEAR'S APPROPRIATIONS LANGUAGE

        Question. What is the status of these reports?
        Answer. Reports will be submitted at a later date.
        Question. When will we receive these reports?
        Answer. Reports will be submitted at a later date.

                         INDIAN HEALTH SERVICE FUNDING

        The budget calls for an increase of $192 million for the Indian
    Health Service. While the increase in funding is appreciated, I fear it
    will not be enough to bring Indian Health up to even minimal standards.
        In 1998, the House Appropriations Subcommittee on Interior directed
    the Indian Health Service to work with Tribes to address the question
    of funding equity for Indians. That group used outside consultants with
    proven experience in actuarial research and analysis. Using the Federal
    Employee Benefit Package (FEBP) as a model, the group analyzed funding
    for Indian Health in four defined Indian populations.
        What the group found was that an additional $1.2 billion dollars
    would have been needed in fiscal year 1999 to fully provide services
    comparable to those in the FEBP. The average cost of providing the
    FEBP-like services is $2980 per American Indian per year (of which
    approximately $750 is available from non-IHS sources such as Medicaid,
    CHIP and Medicare.) The IHS currently has on average only $1,200 of the
    needed residual amount of $2,230 per person per year.
        Question. Congress asked for this funding study, the results are
    in. Why, then, did the Administration not ask for more funding for the
    IHS?
        Answer. The Administration has proposed an increase of $230 million
    for the Indian Health Service as a step towards eliminating the
    disparities in health outcomes which currently exist between Indian
    people and other Americans. This 10 percent increase is the largest
    requested for the Indian Health Service in over two decades.
        Much of the disparity in health outcomes is closely linked to
    poverty, unemployment, and lower levels of educational attainment in
    much of Indian country. To address these problems, the Department's
    budget includes a $96 million increase in other programs targeted
    towards American Indians and Alaska Natives including increases in Head
    Start, Child Care, tribal TANF, the Administration for Native Americans
    and the Administration on Aging. The requested increase for the
    Administration for Native Americans is also the largest in over two
    decades. Looking at the Administration's entire budget for Native
    Americans, a total of $9.4 billion is requested, an increase of $1.2
    billion over fiscal year 2000.
        Question. What can the Administration do to help me bridge this gap
    between supply and demand?
        Answer. The Administration has requested an increase of $1.2
    billion in funds for Native Americans for a total of $9.4 billion.
    HHS's part of this request includes an increase of $326 million in
    funding targeted to American Indians and Alaska Natives for an HHS
    total of $3.5 billion. Funding requests for both HHS Agencies which
    exclusively serve Native Americans-the Indian Health Service and the
    Administration for Native Americans-are the largest in over two
    decades.
        In addition to requesting increased funding, better inter-agency
    cooperation is an important means of bridging this gap. The Health Care
    Financing Administration has worked to increase Medicare and Medicaid
    collections at Indian Health Services facilities by 103 percent since
    1995. The Indian Health Service has recently entered into
    collaborations with the Centers for Disease Control and Prevention, the
    Head Start Bureau, the Substance Abuse and Mental Health Services
    Administration, the National Institutes of Health, the Bureau of Indian
    Affairs, the Agriculture Department, the Justice Department and the
    Veterans Administration.
        Tribal consultation is also important to ensure that we understand
    the problems of Indian communities and to assist these communities in
    accessing assistance from all parts of the Department. In May of 1999,
    HHS held its first Department-wide tribal budget consultation meeting,
    Leaders from 35 tribes and tribal organizations presented
    recommendations covering the entire Department. Our second Department-
    wide tribal budget consultation meeting is scheduled for this coming
    April. The Deputy Secretary has also held a series of five regional
    meetings with tribal leaders over the past year.
        A fourth way to bridge this gap is through supporting tribal self-
    determination efforts allowing tribes to provide their own health
    services under contract with the Indian Health Service. A recent
    National Indian Health Board survey of tribal leaders found that
    contracting tribes were significantly more likely to than non-
    contracting tribes to believe that their health services had improved
    over the past three years. The share of IHS's budget going for tribally
    operated programs increased from 28 percent in fiscal year 1993 to 44
    percent in fiscal year 1999. To support continued growth in tribal
    self-determination efforts, the Indian Health Service's budget includes
    an increase of $40 million for contract support costs.

                            CLINICAL TRIALS DATABASE

        In 1997, Congress passed the FDA bill and included the Snowe-
    Feinstein bill requiring HHS to establish a database and a 1-800 number
    for clinical trials so that patients and doctors can find out what
    research trials are being conducted for serious and life-threatening
    diseases. It has been almost 3 years. I received a press release last
    night saying you announced the launch at 12:01 a.m. Thank you very
    much.
        Question. Is it operational? Can people now call an 800 number? Can
    they access it via the Internet? Are all research trials on it?
    Federal, private, others?
        Answer. The ClinicalTrials.gov database is operational and
    available on the Web. The strategy adopted by the NIH was first to
    develop, test, and implement an Internet-accessible database of
    clinical trials; NIH is now investigating how best to implement an 800
    number. There are presently about 4,200 clinical trials in this first
    phase of the database. These are primarily clinical trials sponsored by
    the NIH. There are also several hundred privately sponsored trials in
    the database, primarily related to AIDS and cancer. In the second phase
    of ClinicalTrials.gov, we will enter many more clinical trials
    sponsored by other Federal agencies and private and commercial trials.
        Question. When will it be completed? How often will it be updated?
    What took it so long?
        Answer. The ClinicalTrials.gov database will continue to evolve
    indefinitely as new trials are added. The database is updated nightly
    as new data are received by the NLM from the sponsors of clinical
    trials. The clinical trials database was mandated by the November 1997
    FDA Modernization Act. After considering various options for
    implementation, NIH tasked the National Library of Medicine in
    September 1998 to create the database. During fiscal year 1999, the NLM
    worked expeditiously to organize the 20-plus NIH institutes to
    establish standard data elements for each clinical trial and to input
    the data for the first 4,200 NIH-supported clinical trials into the
    system. The database was released to the public on February 29, 2000.

                               CANCER REGISTRIES

        Last September, the Sacramento Bee reported under a headline,
    ``Retreat on Cancer,'' that California's landmark cancer registry is
    ``slowing falling apart.'' We were the leader in efforts to track
    cancer at one time, dating back to the 1940s. But it's budget has been
    flat for a decade.
        Question. Admittedly the State should put more resources into our
    cancer registry, but your proposal for funding cancer registries is
    flat for fiscal year 2001, at $24 million. The American Cancer Society
    recommends an appropriation of $55 million. Why aren't you increasing
    funding for cancer registries?
        Answer. As you know, developing a budget involved hard choices
    between deserving programs. The Department is working hard to improve
    cancer registries nationwide. The National Institutes of Health and the
    Centers for Disease Control and Prevention are working more closely
    than ever to provide good epidemiological information on cancer. They
    will pool their cancer data resources and create a national
    infrastructure for cancer control and surveillance activities. CDC's
    National Program of Cancer Registries (NPCR) and NIH's SEER together
    cover virtually the entire U.S. cancer patient population. CDC supports
    registries in 45 States, the District of Columbia, and three
    territories. The SEER program covers 5 States, 5 major metropolitan
    areas, rural areas in one State, and selected populations of American
    Indians.
        The California Cancer Registry has participated as an enhancement
    state with the CDC's NPCR since 1994. On the basis of 1996 data, the
    California registry has been certified by the North American
    Association of Central Cancer Registries for its data completeness,
    timeliness, and quality. An example of California's accomplishments
    with its limited resources is that the state routinely reports cancer
    rates for Asian and Pacific Islanders and for Hispanics. These rates
    can then be compared with the more readily available rates for whites
    and blacks. A recent registry report suggested that the state's tobacco
    control program may have helped decrease incidence rates for lung
    cancer among women in racial and ethnic minority populations.
        The California registry is one of eight registries participating in
    a special NPCR-supported childhood cancer project to design, implement,
    and evaluate a method to use data from a state population-based central
    registry to compute expected numbers of incident cancer cases in
    children. The registry will evaluate completeness of its data and of
    other existing pediatric cancer databases, such as the Pediatric
    Oncology Group/Children's Cancer Group, by performing data linkage.

                     CANCER AND ENVIRONMENTAL RISK FACTORS

        Question. NCI, NIEHS and CDC sponsor cancer research. Should we be
    doing more on environmental risk factors for cancer?
        Answer. The emergence of new research tools for clarifying how
    environmental factors and susceptibility to cancer interrelate, has
    opened many new possibilities for research on environmental risk
    factors. The NCI has identified ``Genes and the Environment'' as a
    major scientific opportunity for cancer research for fiscal year 2001.
    Among the research areas for emphasis at both NCI and NIEHS are:
    identify more fully the environmental causes of cancer using new
    epidemiologic and genetic approaches; identify genes that modify
    (increase or decrease) cancer risk, including the risk resulting from
    environmental exposures; integrate information on genetic
    susceptibility and environmental exposure to estimate cancer risks for
    individuals, families, and populations; and develop new strategies for
    cancer prevention, early detection, and treatment, building upon new
    knowledge about the genetic and environmental determinants of risk.
        The study of geographical variation in cancer rates has provided
    important clues to the role of lifestyle and other environmental
    factors that affect cancer risk. A new edition of the Atlas of Cancer
    Mortality in the United States from 1950-1994 was recently published by
    the National Cancer Institute. The geographic patterns of cancer
    displayed in the atlas should help target further epidemiologic
    investigations into the causes of cancer and to set priorities for
    public health activities aimed at cancer prevention and control.
    Epidemiology and Exposure Assessment
        NCI and NIEHS have a long history of working together to explicate
    the role of environmental factors in geographic variations in cancer
    mortality patterns, especially for breast cancer. This working
    relationship was established with the Congressionally mandated Long
    Island Breast Cancer Study Project (LIBCSP) and the Northeast/Mid-
    Atlantic Breast Cancer Program, both of which the Institutes have co-
    funded. The latter program, comprised of highly productive research,
    focusing on exposure to pesticides and related chemicals and
    electromagnetic frequency radiation in relation to breast cancer risk,
    has been completed and a report has been submitted to me.
        Investigators on the Long Island Breast Cancer Study Project have
    explored new ways to study the relationships between the environment
    and breast cancer. However, much remains to be learned about the role
    of environmental exposures and other risk factors and their interaction
    with genes in promoting the development of breast cancer. Beginning in
    mid-2000, a series of papers are expected to be published that will
    address results of biomarker analyses, analysis of environmental
    samples, and interview data on exposures both environmental and non-
    environmental (e.g., diet, medications, medical irradiation,
    electromagnetic field radiation).
        In 1999, NCI, in collaboration with NIEHS, convened an ad hoc
    advisory group of experts from many disciplines to discuss the present
    status of environmental exposure assessments and cancer epidemiology.
    Considerations for advancing the field during the next five years were
    summarized, focusing on research needs and new research directions. NCI
    and NIEHS program staff are currently preparing a request for
    applications (RFA) on exposure assessment incorporating the discussions
    at that meeting. It is expected that the RFA will be issued and funded
    in fiscal year 2000.
        An RFA issued by NCI and NIEHS, entitled ``Regional Variation in
    Breast Cancer Rates in the United States,'' launched new projects in
    which investigative teams are using statistical and epidemiologic
    methods to investigate factors that may influence, contribute to, or
    account for the reported differences in breast cancer incidence and
    mortality rates across different geographic regions. Data on women
    residing in California, Connecticut, Georgia, Hawaii, Iowa,
    Massachusetts, Michigan, New Mexico, Washington, Wisconsin, and Utah
    will be analyzed. A supplement to an ongoing study in New York is
    evaluating the effect of electromagnetic field radiation (EMF) on
    breast cancer risk. The results of these studies will be critically
    assessed to help direct the future research agenda on the environment
    and cancer.
        The NCI and CDC have worked collaboratively in several areas,
    including cancer surveillance. A recent Memorandum of Understanding
    lays out areas for future growth and development of this collaboration.
    NCI will support CDC's efforts to enhance state-specific use of cancer
    surveillance systems for cancer control and to develop appropriate risk
    communications tools for use with public inquiries about cancer rates
    and trends.
        The NCI's Epidemiology and Genetics Research Program (EGRP) was a
    co-sponsor of four initiatives led by the National Institute of
    Occupational Safety and Health (NIOSH) within CDC. The NCI component
    supported the environmental and/or occupational exposure assessments
    for epidemiologic studies of cancer.
        In response to two of these initiatives, entitled ``Implementation
    of the National Occupational Research Agenda'' and ``Mechanistic-Based
    Cancer Risk Assessment Methods,'' four new grants were awarded to
    develop and/or improve methods for assessing past environmental and
    occupational exposures that could be associated with geographically
    related cancers, including breast cancer. Research of this type (called
    exposure assessment) is important in understanding breast cancer for
    two reasons. First, we must be able to link breast cancer development
    to a carcinogen exposure that occurred years before the diagnosis; and
    second, we must be able to obtain environmental data for assessing the
    role of gene-environment interactions in the etiology of breast cancer.
    Intramural Geographic Information System Projects
        A new area that offers some promising technologic methods for
    assessing the impact of environment on cancer is the Geographic
    Information Systems (GIS). NCI has completed several intramural
    projects designed to develop methods to use GIS in estimating exposure
    to crops sprayed with pesticides, drinking water contaminants, and
    measures of proximity to industries that release toxic substances.
    Methods to identify populations potentially exposed to agricultural
    pesticides using remote sensing and a GIS were evaluated. Several
    future efforts are planned to further examine the usefulness of GIS in
    cancer-related studies. Researchers will evaluate the accuracy of
    several ``address-matching algorithms'' that determine the geographic
    location of respondents in health-related studies, and a comparison
    will be made of household levels of pesticides in dust with proximity
    measures to pesticide-treated crops, as estimated by GIS methods. A
    ``pesticide drift model'' will be incorporated into GIS estimates of
    pesticide exposures among persons living adjacent to crop fields
    sprayed with pesticides.
        In studies of cancer etiology, GIS methods will be used to help
    evaluate geographic patterns in prostate cancer mortality in relation
    to nitrate levels in drinking water and pesticide use. A GIS will be
    used to map populations in the Platte River Valley usingpublic and
    private water supplies and to estimate nitrate exposure in drinking
    water to evaluate associations with rates of several cancers. In a
    study of bladder cancer, Global Positioning System measurements will be
    collected and locational information will be used to link residences to
    information on water quality in existing databases and to evaluate
    proximity to industries and industrial releases of toxic substances.
    Environmental Genome Project and Gene Expression Technology
        The many rapid advances in technologies for molecular genetics
    research are providing new opportunities to understand the genetic
    basis for individual differences in susceptibility to environmental
    exposure and how exposure and susceptibility interrelate to the
    development of diseases like cancer. The NIEHS has established a
    research program on genetic susceptibility to environmentally-
    associated diseases through its Environmental Genome Project, which is
    aimed at the identification of allelic variants (polymorphisms) of
    environmental disease susceptibility genes in the U.S. population, the
    development of a central database of polymorphisms for these genes, and
    population-based studies of gene-environment interaction in disease
    etiology. By identifying those genes and allelic variants that affect
    individual response to environmental agents, scientists can better
    predict health risks and assist regulatory agencies in the development
    of policies on environmental protection policies. As previously
    mentioned, NCI has identified ``Genes and the Environment'' as a major
    scientific opportunity in cancer research for fiscal year 2001. We are
    only beginning to amass these data, and much more work is needed.
        cDNA microarrays are tools that can be used to analyze changes in
    patterns of gene expression that contribute to cancer development. This
    technology may revolutionize the way problems in environmental health
    are investigated. Given that exposures to different classes of
    toxicants result in distinct patterns of altered gene expression,
    microarray technology can be utilized to categorize and classify these
    effects through the direct comparison of gene expression patterns in
    control samples versus those treated with toxicants. In defined model
    systems, treatment with known toxic and carcinogenic agents, such as
    polycyclic aromatic hydrocarbons, dioxin-like compounds, peroxisome
    proliferators, oxidant stress, or estrogenic chemicals, may provide a
    gene expression ``signature'' on a microarray which represents the
    cellular response to these agents. These same systems can then be
    treated with unknown, agents under suspicion, to determine if one or
    more of these standard signatures is elicited. This approach will also
    help elucidate an agent's mechanism of action and may also be used to
    detect changes in exposed human populations, information essential for
    the risk assessment process. cDNA microarrays also hold promise for the
    determination of interactions between combinations of agents (e.g.,
    dioxin and estrogen). It is also likely that new molecular targets of
    toxic or carcinogenic action will be identified, and that these new
    targets may be good candidates for analysis in the Environmental Genome
    Project. NIEHS and NCI each have established the capacity to do cDNA
    microarray technology. In a collaborative research project with the
    National Human Genome Research Institute; NIEHS is developing custom
    cDNA arrays or ``chips'' that comprise human cDNA clones oriented
    toward the detection of the expression of genes involved in responses
    to toxic insult. The initial ``ToxChip'' we have designed includes
    genes for xenobiotic metabolizing enzymes, cell cycle components,
    oncogenes, tumor suppressor genes, DNA repair genes, estrogen-
    responsive genes, oxidative stress genes, and genes known to be
    involved in apoptotic cell death. Plans call for this technology to be
    available eventually to both intramural and extramural scientists on a
    collaborative basis. NCI has been actively promoting and funding the
    use of DNA microarray technology into the extramural community through
    a variety of approaches. The NIEHS is also working to enhance capacity
    for cDNA microarray technology in research institutions.
        By exploiting recent advances in human genetics and recombinant DNA
    technology, we can develop animal models and in vitro assay systems to
    identify carcinogens and toxicants in a matter of weeks rather than
    years, with considerable savings in terms of money and use of animals.
    Using cDNA microarray technology, for example, toxicologists may be
    able to expose cells or tissues to chemicals whose toxicity is unknown
    and match the results against the ``signature,'' or common set of
    changes in gene expression, produced by a known class of toxicants.
    This would reduce the need for lengthy and expensive rodent bioassays
    and could lend itself to testing the effects of low-dose as well as
    long-term exposure. The use of cDNA microarray technology to assess
    changes in gene expression in response to specific environmental
    exposures is a rapidly growing research area that will have a large
    impact on the environmental health sciences, including molecular
    epidemiology, and drug discovery. It is appropriate that the
    development and validation of this new application to environmental
    health science is being led by the NIEHS since this technology could
    revolutionize the field. Similarly the leadership of the NCI in
    applying this new technology, in cancer research, will speed new
    discoveries of environmental factors that contribute to cancer.
        Also, it is now possible to modify genes in animals thus
    orchestrating the carcinogenic process. For example, incorporation of a
    chemically inducible oncogene into the germline produces animals with
    multiple copies of the modified gene in all the cells of the organism.
    Conversely, one can delete one copy of a gene that acts as a tumor
    suppressor. Such so-called transgenic animals are much more responsive
    to carcinogenic exposures. In preliminary studies, a carcinogen can be
    identified in these animals in six months (rather than two years).
    NIEHS has taken the lead to establish a major collaborative effort
    involving the Environmental Protection Agency (EPA), the Food and Drug
    Administration (FDA), the pharmaceutical and chemical manufacturing
    industry, and two foreign governments (Japan and the Netherlands) to
    validate the four transgenic mouse models currently available for their
    capacity to predict carcinogenicity.
        The NCI is planning to augment its Mouse Models of Human Cancer
    Consortium to develop new experimental models that parallel human
    cancer related genes, pathways and processes. The use of model systems,
    particularly the mouse with its powerful genetics, will elucidate the
    genetic basis of the etiology of cancer. The NIEHS is establishing
    Comparative Mouse Genomic Centers which will focus on developing mouse
    models for studying the biological function of variants of DNA repair
    and control genes, found in the human population. Having identified
    relevant genes in the mouse, we can then assess whether the comparable
    human genes contribute to the cause of human cancer. Manipulating the
    genetics of the mouse experimentally will enable us to decipher not
    just the major genetic risk factors, but also those whose effects on
    risk are more subtle. To find these same less penetrant genetic
    effectors in human populations will require much more time and the
    accumulation of very large populations. Transgenic mice also afford the
    opportunity to test the contributions of nutrients and endogenous and
    exogenous environmental factors in cancer etiology.
        Question. Isn't it well established that cancer can develop from
    the interaction of genes and the environment (broadly defined)?
        Answer. The importance of lifestyle and other environmental
    exposures as causes of cancer is unquestionable. The pivotal role of
    environment is reflected in the substantial variation in cancer
    incidence around the world and in the changes in risk observed among
    groups that migrate and become acculturated in a new host country.
    Furthermore, epidemiologic research has succeeded in identifying a wide
    range of factors that affect cancer risk, including tobacco use,
    dietary components, sunlight, ionizing radiation, environmental
    chemicals, infectious agents, obesity, exercise, and hormones.
    Nevertheless, the causes of many cancers remain elusive. While improved
    approaches to measuring exposures will provide new insights, it is
    clear that the environment represents only part of the equation in
    determining who is susceptible to cancer. It is also important to
    understand cancer susceptibility. For example, why does one person with
    a cancer-causing exposure (such as smoking or infection with human
    papillomavirus) develop cancer while another does not?
        Viewing such questions through the lens of genetics promises to
    provide insights into these apparent paradoxes. The scientific
    investment in cancer genetics, initially focused on the intensive study
    of rare cancer-prone families, already has paid huge dividends. These
    studies have opened a unique window into the basic mechanisms of
    cancer, with benefits extending well beyond the rare families from
    which they were derived. This is because the genes identified by these
    studies are altered forms of normal genes involved in key biochemical
    pathways controlling fundamental cell processes. It has become clear
    that these same pathways contribute to the development and progression
    of the more common, non-hereditary forms of cancer. Despite evidence
    that one's genetic makeup may influence susceptibility or even
    resistance to cancer-causing exposures, only recently have the tools
    become available to systematically determine how variations in these
    genes combine with environmental and other factors to induce cancer in
    the general population.
        Question. What is the right balance?
        Answer. It is difficult to answer since NIH is striving to
    understand the causes of cancer through a comprehensive evaluation of
    genetic and environmental determinants as well as their interactions.
    In particular, by incorporating recent major advances in molecular
    genetics into epidemiologic studies, it will be possible to gain not
    only insight into genetic susceptibility but also a more complete
    understanding of the specific lifestyle and other environmental
    exposures that are mediated through genetic pathways and affect the
    risk of developing cancer.
                                     ______

             Questions Submitted by Senator Ben Nighthorse Campbell

                       HEALTH STATUS OF AMERICAN INDIANS

       Question. It is my understanding that you have made statements
    regarding your support of efforts to improve the health status of
    American Indians and Alaskan Natives and that one of your most recent
    public statements was made last July to a number of tribal leaders here
    in Washington. Could you clarify what role you see the Department of
    Health and Human Services, outside of the Indian Health Service, taking
    in these efforts?
        Answer. A major goal of both the Department and the Administration
    is the elimination of racial disparities in health outcomes.
    Accomplishing this goal will require substantial improvements in health
    outcomes for Native Americans who suffer a greater disease burden than
    other Americans. The Indian Health Service has primary responsibility
    for improving Native American health outcomes but many other parts of
    HHS also have a role to play. For example, the Health Care Financing
    Administration has worked to increase Medicare and Medicaid collections
    at Indian Health Services facilities by 103 percent since 1995. The
    Centers for Disease Control and Prevention, the Substance Abuse and
    Mental Health Services Administration, and the National Institutes of
    Health all collaborate with the Indian Health Services, assist Indian
    communities directly, and or conduct research into diseases and health
    conditions affecting Native Americans. While it is not a health Agency,
    the Administration on Children and Families supports empowerment and
    economic development of Indian communities through programs such as
    Head Start, Child Care, Social and Economic Development Strategy
    grants, and support for Tribes running their own TANF and Child Support
    Enforcement programs.
        To ensure that all parts of the Department play their part, we
    hosted our first annual Department-wide tribal budget consultation
    meeting last May. This annual meeting is called for in our policy on
    Consultation with American Indian/Alaska Native Tribes and Indian
    Organizations. Our second annual meeting is scheduled for next April.
        Question. I have heard that it was a Department view that Indian
    health issues were the responsibility of the Indian Health Service. Can
    you tell me how you expect a direct health service organization to
    research the causes of disease among Indian people or to test new
    prevention efforts for Indian people when, by all accounts, it cannot
    even fund the services necessary to treat existing health problems that
    occur in American Indian and Alaskan Native people?
        Answer. The Indian Health Service has primary responsibility for
    improving the health status of American Indians and Alaska Natives but
    many other parts of HHS also have a role to play. The Indian Health
    Service has demonstrated its ability to make significant improvements
    in Indian health, for example reducing maternal and infant mortality by
    more than two thirds since the early 1970s. In order to continue these
    improvements, we have requested a ten percent increase for the Indian
    Health Service, the largest requested increase for this Agency in over
    two decades. The total amount request for all Health and Human Service
    programs targeted to American Indians and Alaska Natives is $3.05
    billion, an increase of eleven percent over fiscal year 2000. The
    request for the Administration for Native Americans is also the largest
    increase requested for that Agency in over two decades.
        The Grants for Special Diabetes Program for Indians offers a good
    example of the work done by other HHS Agencies to assist the Indian
    Health Service. The Centers for Disease Control and Prevention works
    with this program to ascertain the epidemiology of diabetes, provide
    technical assistance to tribal Diabetes Program grantees and helps to
    establish partnerships between grantees and State Diabetes Control
    Programs. Much of our information about type two diabetes and its
    impact of on Indian communities comes from ongoing cooperative studies
    between the Pima tribe and the National Institutes of Health. The
    National Institutes of Health and the Indian Health Services are
    cosponsors of a national multi-center study to determine if type two
    diabetes can be prevented in those at high risk for the disease.
    Volunteers from four Indian communities are participating in this
    study.
        Question. Aren't there agencies located within the Department of
    Health and Human Services which specifically research the causes of
    disease and test prevention efforts that would be better able to handle
    those activities?
        Answer. The Indian Health Service was created to carry-out the
    Federal Government's commitment to deliver health services to Federally
    recognized American Indians and Alaska Natives. It has demonstrated its
    ability to make significant improvements in Indian health, for example
    reducing maternal and infant mortality by more than two thirds since
    the early 1970s. Other HHS Agencies address the health care needs of
    all Americans but they do so by focusing on differing areas: research
    at the National Institutes of Health, mental health and substance abuse
    at the Substance Abuse and Mental Health Services Administration,
    disease control and prevention at the Centers for Disease Control and
    Prevention. Each of these agencies addresses the health care needs of
    Indian people as part of its overall mission and each assists the
    Indian Health Service in its delivery of health services to Federally
    recognized American Indians and Alaska Natives. For example research at
    the National Institutes of Health has provided much of our information
    about type two diabetes and its impact of on Indian communities. The
    National Institutes of Health and the Indian Health Services are
    cosponsors of a national multi-center study to determine if type two
    diabetes can be prevented in those at high risk for the disease.
    Volunteers from four Indian communities are participating in this
    study. In addition to its work on diabetes, the National Institutes of
    Health supports the study of other disease in Indian populations such
    as asthma and lung cancer. The Centers for Disease Control and
    Prevention has established the National Diabetes Prevention Center to
    address the epidemic of diabetes in Indian country, works with tribes
    and tribal organizations to reduce breast and cervical cancer mortality
    and is conducting studies to better control several Indian health
    problems including Hantavirus, Hepatitis A and Pneumococcal infections.
    The Substance Abuse and Mental Health Services Administration provides
    funds to tribes and tribal organizations to plan and evaluate systems
    of mental health care, prevent substance abuse, work with high risk
    youth, and provide substance abuse treatment services.

                                   HANTAVIRUS

        Question. I recently picked up the Washington Post and read a story
    alleging that the Centers for Disease Control and Prevention had
    diverted millions of dollars of funds slated for hantavirus research to
    other work. I know that several of my colleagues are concerned about
    the way CDC officials handled the original hantavirus outbreak, and now
    we hear that the same agency has been diverting millions of dollars of
    money it has claimed was used on hantavirus research, contrary to
    Congressional reports. Have you been able to determine exactly how much
    was diverted form the hantavirus research program?
        Answer. CDC made a mistake by not informing Congress of the need to
    use some of the hantavirus funding for other deadly infectious
    diseases, including ebola, lassa fever and Nipah virus. We have
    commissioned an external firm, PriceWaterhouseCoopers, to conduct an
    audit to determine specifically how the hantavirus funds were spent in
    fiscal year 1999. In the fiscal year 2001 Congressional Justification,
    CDC has proposed changes related to the hantavirus line to more
    accurately reflect that these resources will be used for hantavirus and
    other special pathogens.
        In order to prevent such a situation from reoccurring, we have
    established the following corrective action plan:
      --The Department's Chief Financial Officer (CFO) will review and
            certify, along with CDC's Financial Management Office (FMO),
            the correctness of all of the National Center for Infectious
            Diseases' (NCID) financial obligations through the remainder of
            fiscal year 2000.
      --The Department's CFO will ensure that all senior decision-makers in
            the NCID will receive certified budget execution and financial
            management training.
      --CDC has initiated an external review of their fiscal management
            practices, similar to the review done at NIH, to be completed
            in six months. The results of this analysis will be
            communicated to Congress as soon as the review is complete.
      --CDC program managers will conduct a top to bottom review of CDC's
            133 programs and projects to make sure there are no other areas
            of concern. During a 90-day period, CDC managers will be able
            to fully and openly identify any area for which there may be a
            discrepancy between actual expenditures and the information
            provided to Congress. This information will be reported to
            Congress.
      --CDC has commissioned Price Waterhouse Coopers, a firm of
            independent auditors, to thoroughly examine its hantavirus
            expenditures. The results will be communicated to Congress
            immediately upon completion.
      --CDC has appointed a new Acting Director for the Division of Viral
            and Rickettsial Diseases while CDC seeks new leadership for
            its' viral disease programs.

                             INDIAN HEALTH RESEARCH

        Question. The President's request unveiled an initiative to improve
    the lot of the ``First Americans''. Yet at least one proposed program
    in the Centers for Disease Control and Prevention which would
    specifically fund research benefitting American Indians/Alaskan
    Natives, originally proposed as $40 million program, was first slashed
    by 75 percent, then zeroed out as the budget process played out. Can
    you explain why this program was such a low priority considering this
    ambitious ``initiative?''
        Answer. Our fiscal year 2001 request includes significant budget
    increases, six percent for the Centers for Disease Control and
    Prevention and ten percent for the Indian Health Service. While a
    separate grant program for Tribes was not included in CDC, funding is
    requested for similar activities in both the Centers for Disease
    Control and Prevention and the Indian Health Service.
        Our request for the Centers for Disease Control and Prevention
    includes $35 million for Racial and Ethnic Approaches to Community
    Health to support community demonstrations to eliminate health
    disparities. Of the 32 grantees who received funding to plan these
    demonstration, one was an Indian Tribe and two others focused on health
    disparities of American Indians and Alaska Natives. Our $35 million
    request also includes an increase of $1.5 million to fund eight to ten
    Core Capacity Grants for American Indian and Alaska Native
    organizations. The Centers for Disease Control and Prevention is also
    working with tribes and tribal organizations to address diseases such
    as diabetes and breast and cervical cancer.
        Our request for the Indian Health Service, the largest requested
    increase in over two decades, includes $230 million in total additional
    funding to increase access to health care and reduce the gap in health
    disparities. Included in this total increase is $11.5 million for
    Preventive Health activities, including Public Health Nursing, Health
    Education, and tribal Community Health Representatives; $41 million to
    increase purchase of health care from the private sector, $40 million
    to provided contract support costs for tribes operating their own
    health programs, and $3 million for grants to improve the basic public
    health infrastructure of tribes enabling them to conduct effective
    community based injury prevention programs. Grants would be provided to
    approximately 25 tribes.

                          INDIAN HEALTH SERVICE BUDGET

        Question. Did you consult with Tribes or Tribal representatives in
    the development of the Department of Health and Human Services budget,
    outside of the Indian Health Service? Did you consult with Tribes or
    Tribal representatives regarding the budget of the NIH or the CDC? Who
    did you consult with and what was the extent of your consultation?
        Answer. In August of 1997, HHS issued its first Department-wide
    policy on consultation with American Indian and Alaska Native tribes
    and Indian organizations. Under this policy, each Operating Division-
    including the Indian Health Service-develops its own tribal
    consultation plan. Budget matters are generally considered to be
    critical for consultation.
        In May of 1999, HHS held its first Department-wide tribal budget
    consultation meeting prior to developing its fiscal year 2001 budget
    submission. Leaders from 35 tribes and tribal organizations met with
    members of the HHS Budget Review Board making recommendations covering
    the entire Department. This coming April, we will hold our second
    Department-wide tribal budget consultation meeting to consider the
    fiscal year 2002 budget submission. As part of our consultation
    process, the Deputy Secretary has held a series of five regional
    meetings with tribal leaders over the past year.

                             INDIAN HEALTH RESEARCH

        Question. I see in your budget justification that there are a
    number of specific research initiatives for racial and ethnic groups,
    but I did not see any that were directed only toward a single American
    Indian or Alaskan Natives health issue. For example, there is a cancer
    research effort at the University of Hawaii which focuses on the high
    cancer incidence among Native Hawaiians, and a study of the excessive
    prevalence of high blood pressure among African Americans. Yet I did
    not come across a single initiative that targets a disease that
    uniquely affects American Indians. Can you explain?
        Answer. In general, the Department does not request funds for
    initiatives targeting diseases which affect particular racial and
    ethnic groups. One exception, of course is the $230 million increase we
    have requested for the Indian Health Service to improve the health of
    Federally recognized American Indians and Alaska Natives. While funding
    in our other health agencies is not specifically requested for diseases
    uniquely affecting American Indians, these agencies do carry-out
    specific activities which improve the health of Native Americans. For
    example research at the National Institutes of Health has provided much
    of our information about type two diabetes and its impact on Indian
    communities. In addition to its work on diabetes, the National
    Institutes of Health supports the study of other disease in Indian
    populations such as asthma and lung cancer. In fiscal year 2000, NIH
    estimates it will spend a total of $98 million on research into
    diseases and health conditions affecting American Indians and Alaska
    Natives. The Centers for Disease Control and Prevention is also
    addressing a number of diseases as they affect Indian people including
    diabetes, breast and cervical cancer, Hantavirus, Hepatitis A and
    Pneumococcal infections. In fiscal year 1999, CDC spent about $21
    million for American Indians and Alaska Natives. The Substance Abuse
    and Mental Health Services Administration provides funds to tribes and
    tribal organizations to plan and evaluate systems of mental health
    care, prevent substance abuse, work with high risk youth, and provide
    substance abuse treatment services. In fiscal year 2000, the Substance
    Abuse and Mental Health Services Administrations estimates it will
    provide a total of $64 million for American Indians and Alaska Natives.
                                     ______

                Questions Submitted by Senator Pete V. Domenici

         NATIONAL INSTITUTES OF HEALTH/DEPARTMENT OF ENERGY PARTNERSHIP

        Secretary Shalala, as you are aware the fiscal year 2000 Labor-HHS
    Appropriations Bill contained a provision urging the Director of NIH to
    establish a pilot program to ensure the National Institutes of Health
    may benefit from technologies developed within the Department of Energy
    weapons programs in terms of their potential to enhance health sciences
    and improve medical care. The Pilot seeks to ensure that technologies
    developed within the nuclear weapons program, as well as other
    programs, of the Department of Energy are carefully evaluated for their
    impact on the health sciences, with the goal of achieving clinical
    applications and improved national health care.
        Question. What is the status of the NIH/DOE Medical Technology
    Partnerships?
        Answer. NIH is evaluating the adequacy of current interagency
    collaborations and the applicability of DOE laboratory technical
    resources and capabilities to improving human health and quality of
    life. In the area of biomedical engineering, the NIH research
    institutes and centers have been made aware of DOE laboratory
    capabilities and biomedical research programs to through the
    Bioengineering Consortium (BECON) of which DOE has been a member since
    1997. A meeting was held on January 18, 2000, between the staff of the
    NIH Office of Extramural Research and representatives of the DOE's
    Office of Science to discuss specific areas of interagency cooperation
    in bioengineering research and training. Possible joint research
    funding initiatives were identified and are being pursued. Potential
    interagency training and personnel sharing opportunities were
    discussed, as were ways for DOE staff to become more familiar with and
    involved in NIH research programs. With regard to the weapons
    laboratories, a meeting of NIH Office of Extramural Research staff, NIH
    research institute staff, key DOE weapons laboratory technical
    representatives, and DOE Headquarters personnel was held on February
    24, 2000, to identify areas of potential collaboration and ways to
    facilitate more effective interaction.
        At the upcoming April 19, 2000, BECON meeting, DOE's Office of
    Science will make a presentation to NIH staff to provide further
    information on DOE's laboratory biomedical technology capabilities
    within its bioengineering program. NIH staff will also be attending and
    participating in the DOE Bioengineering Contractor's Meeting scheduled
    for May 16-18, 2000, in Albuquerque, New Mexico. Based on the results
    of these meetings and current NIH/DOE collaborative efforts, an
    evaluation will be made of the need for a formal interagency
    partnership and appropriate follow-up actions initiated.
        Question. What other steps are being taken by NIH to ensure that
    technologies being developed by other Federal agencies are identified
    for possible medical/research applications?
        Answer. Since 1997, the NIH's Bioengineering Consortium (BECON) has
    provided a link with other Federal agencies in areas associated with
    applications of engineering/physical science technologies and
    principles to biomedicine. To ensure that technologies developed by
    other Federal agencies are identified for possible medical
    applications, BECON actively facilitates interagency communication,
    sponsors bioengineering symposia, and coordinates NIH participation in
    interagency bioengineering initiatives. To directly communicate
    biomedical research progress and directions to NIH staff, other Federal
    agencies (e.g., DARPA, NSF, and DOE) are invited to provide
    presentations during the regular monthly BECON meetings which are open
    to the public. BECON also coordinates NIH participation in interagency
    biomedical initiatives such as the Interagency Working Group on
    Nanotechnology (IWGN), the Multi-Agency Tissue Engineering Science
    (MATES) Working Group, and the Bioengineering Materials and
    Applications (BEMA) Roundtable. Information on these types of
    activities is shared with BECON members during regular monthly
    meetings. To afford engineering and physical science researchers at all
    Federal agencies opportunities to make the biomedical community aware
    of technologies that could have possible biomedical applications, BECON
    sponsors major annual bioengineering symposia that are open to all
    interested participants. Finally, the BECON has developed and maintains
    a Web site aimed at providing information on all aspects of biomedical
    engineering (including technology development) to the general public,
    scientific community, and Consortium members.

                                    DIABETES

        Question. Diabetes contributes to approximately 200,000 deaths each
    year and is the leading cause of blindness, kidney failure and lower-
    limb amputations. The disease costs the nation $105 billion annually in
    direct and indirect costs. Today CDC operates only 16 comprehensive
    diabetes programs. Does CDC have any plan to expand this program in a
    phased fashion to all 50 States? What will in take in your professional
    judgment to reach all 50 States?
        Answer. The overall financial constraints in the fiscal year 2001
    budget forced many hard choices in public health and other programs.
    One of those hard choices was whether to increase the number of
    comprehensive diabetes programs, or fund other pressing needs. CDC
    currently provides funding for diabetes programs in 50 States; 16
    comprehensive programs with average funding of $800,000 each, and 34
    capacity-building programs. CDC also carries out a wide range of
    surveillance, applied research, and public education activities that
    are essential in making its partnership with the States effective. The
    $51 million requested in the budget will enable CDC to continue making
    significant progress in reducing the burden of diabetes. CDC has
    estimated that, absent competing needs in CDC and other agencies, its
    diabetes program could make good use of up to about twice that amount.

                                   NIH BUDGET

        Question. In recent years, NIH has recommended to Congress
    allocations that generally spread the funding increase evenly among
    institutes. This method of funding causes smaller institutes that also
    have viable research opportunities to lack the necessary monies to fund
    important research. Do you think that across-the-board percentage
    allocations every year adequately fund all new scientific
    opportunities? How about funding new scientific opportunities in those
    institutes who receive lessor funding? How do automatic across-the-
    board percentage allocations really reflect new discoveries?
        Answer. This is a time of great productivity in the biological
    sciences. Many fields of medical research deserve increased financial
    support and could move faster with more funds. However, historical
    factors and the level of research funds already committed to grant
    recipients leave a relatively small fraction of each year's
    appropriation that can effect changes in funding policies. Since
    resources are not infinite, providing considerable funds to a
    particular area of emphasis limits what is available to others.
        Allocations to the Institutes and Centers do vary to reflect many
    factors and consultations. Decisions that affect resource allocation or
    priorities at the NIH, including distribution of funds among the ICs;
    how much to devote to a certain discipline, disease, or grant
    mechanism; or which applicants to fund are influenced by several
    factors:
      --An obligation to respond to public health needs, as judged by the
            incidence, severity, and cost of specific disorders. However,
            calculations of public health needs are difficult, and the
            results cannot be correlated with research spending in a simple
            manner.
      --A commitment to support work of the highest scientific caliber. A
            basic tenet of our stewardship is the pledge to maximize the
            return on the public's investment in research; to do this, we
            demand that all requests for support pass stringent peer review
            in regard to scientific quality.
      --A responsibility to seize the scientific opportunities that offer
            the best prospects to develop new knowledge and lead to better
            health. As administrators of science, we have learned that the
            most significant and rapid advances are likely to occur when
            new findings, often serendipitous, lead to expansion of other
            research opportunities.
      --A need to maintain a diverse portfolio that supports work in many
            scientific disciplines and on a wide range of diseases. Because
            we cannot know when major discoveries will occur and what
            opportunities they will create, it is important to support
            ongoing research across a broad frontier.
      --An obligation to insure a strong scientific infrastructure, with a
            high quality workforce and excellent research facilities.
            Productive science cannot be done without well-trained
            investigators and modern equipment and laboratories.

                                   NIH BUDGET

        Question. Dr. Varmus was very fond of saying ``research in one area
    would lead to discoveries in other areas.'' How, then, are these
    promising areas being applied to those diseases that receive less
    funding?
        Answer. Research probes and seeks to understand the unknown. The
    scientific insights that provide a basis for solutions usually
    accumulate over many years, and often are derived from the efforts of
    investigators from diverse disciplines with expertise in specific areas
    of science working on and communicating about differing facets of a
    problem. Medical discovery is marked by stops and starts, and a vital
    interplay among theories or questions (hypotheses), experimental
    evidence, and clinical observations. It is very hard--if not
    impossible--to predict the next discovery or to anticipate what
    advancement in prevention, treatment or diagnosis of one disease will
    be applicable to new knowledge about another, seemingly unrelated,
    disease.
        NIH's medical research program is a diverse and continually
    evolving portfolio that reflects the agency's obligation to respond to
    public health needs, commitment to supporting research of the highest
    scientific caliber, and judgment as to the scientific opportunities
    that offer the best prospects for gaining new knowledge and better
    health. Sometimes scientists, when exploring the fundamental mysteries
    of the cell, know at the outset of their research that its findings
    will be applicable to understanding many diseases. For example,
    scientists hard at work determining the structure and electrochemical
    properties of a specialized pore, called the potassium channel, that
    helps regulate heart rhythm know that this information will be used in
    physiologic investigations of potassium channels, which are critical
    for many bodily functions, besides regulating the heartbeat, such as
    nerve signaling, digestion, and insulin release. A better understanding
    of potassium channels may help scientists develop drugs to treat
    diseases ranging form heart ailments to diabetes to epilepsy.
        However, despite our best efforts to ascribe or assign research to
    a particular disease or condition, the serendipitous nature of science
    makes it hard to predict, with any real certainty, just which diseases
    will benefit from a particular line of investigation. Although
    different disease processes vary in their nature and complexity, they
    often have some commonalities. The progress made in understanding one
    disease often yields new ways of thinking about the etiology of
    another, seemingly unrelated, disease. Thus, new knowledge gained from
    one line of research may help re-frame or re-focus the entire approach
    being used to solve the most perplexing problems associated with
    understanding a totally different disease. For example, cancer is a
    disease which has its origin in the function, or malfunction, of the
    most fundamental process, cell division, and the enzymes that affect
    the process. New knowledge about the function of enzymes in cancer
    cells can have and indeed, has had a profound effect on scientists'
    understanding of other diseases that may also have their origins in
    similar enzyme malfunctions, such as inherited metabolic diseases.
    Similarly, new information about how some osteoporosis drugs for
    osteoporosis preserve the integrity of bones, have suggested that these
    same drugs might be useful in reducing the spread or metastasis of
    prostate and colon cancers to bone.
        A surprising example of this kind of cross-fertilization started in
    the area of cardiovascular disease. Years of research focused on the
    formation of new blood vessels as a means of improving circulation in
    patients with atherosclerosis (hardening of the arteries). Researchers
    now have taken this knowledge and applied it to a totally different
    goal--if we knew how to promote the formation of new blood vessels,
    could we block their formation? And would this not impede the growth of
    tumor cells, which, like all living cells need a blood supply to
    survive and grow. This effect, then set cardiovascular researchers to
    look at the role of blood vessel formation. They found that such
    formation promoted the development of plaques that blocked the flow of
    blood. This intersection of scientific discoveries has now set
    researchers on a course to identify ways to block this effect and to
    develop new therapies for improving circulatory diseases. These stories
    are not unique in the annals of innovation and scientific discovery.
        In addition to basic research yielding discoveries that can be
    applied in many different areas, discoveries from research in one
    specific disease area often prove to be related to other diseases. For
    example, AIDS research is unraveling the mysteries surrounding many
    other infectious, malignant, neurologic, autoimmune, and metabolic
    diseases. AIDS research has provided an entirely new way to design
    drugs and to treat viral infections. The development of the new ``flu''
    drug, RelenzaTm (zanamivir), which directly benefitted from AIDS
    research. Another drug developed to treat AIDS is now the most
    effective therapy for chronic hepatitis B infection. Drugs developed to
    prevent and treat AIDS-associated opportunistic infections also provide
    benefit to patients undergoing cancer chemotherapy or receiving therapy
    to prevent rejection of transplants. AIDS research also is providing
    new understanding of the relationship between viruses and cancer.
        One line of investigation often yields several potential and
    unpredicted new uses, which can be applied to the treatment or
    prevention of more than one disease. Thus, because scientific findings
    cross disease lines, so does the distinction or attribution of research
    investment and discovery cross Institute and Center lines.
        Question. Don't automatic across-the-board increases for every
    institute each year actually pit one disease against another? By
    allowing large institutes to grow at the same rate as small institutes,
    aren't you actually ignoring many potential scientific opportunities in
    the smaller ones? Doesn't this prevent NIH from following their own
    stated research funding criteria meant to identify areas of greatest
    need and greatest potential?
        Answer. Decisions that affect resource allocation or priorities at
    the NIH, including the distribution of funds among the ICs; how much to
    devote to a certain discipline, disease, or grant mechanism; or which
    applicants to fund are influenced by the numerous factors outlined
    above. Advice is solicited from and provided by a large number of
    individuals and groups, including the members of the scientific
    community, Advisory Councils, patient advocacy groups, Congress, the
    Administration, and NIH staff. Each Institute and Center (IC) convenes
    meetings of its national advisory council or board, composed of members
    from the public, medical, and scientific communities, to review a broad
    range of policies. Scientific opportunities arise with the advent of
    new technology and new discoveries in various diseases. As these
    discoveries are made, areas of greatest need and greatest potential are
    prioritized based on scientific opportunity and the financial resources
    that can be allotted to the study of these diseases so as to ensure
    that outstanding science is being funded and that such studies are
    aimed at obtaining results.
        Question. Given that CDC has called diabetes ``the epidemic of our
    time,'' do you think NIH devotes adequate funds to research this
    serious disease? If so, why? If not what can be done to increase the
    diabetes research portfolio at NIH?
        Answer. The President's fiscal year 2001 Budget Request for
    diabetes research across the NIH is $561 million. The NIH are
    implementing many of the new and expanded initiatives in response to
    the scientific recommendations of the DRWG. However, there are
    scientific opportunities in diabetes-and indeed in most areas of
    research--that the NIH will not be able to pursue as rapidly or as
    fully as it might wish, given the NIH budgetary framework and our
    responsibility to support an overall national biomedical research
    agenda that addresses the many diseases afflicting Americans.
                                     ______

               Question Submitted by Senator Kay Bailey Hutchison

        Question. Madam Secretary, recently, there was an editorial in the
    Houston Chronicle by Nobel Prize winner Dr. Norman Borlaug, known as
    ``the Father of the Green Revolution'' on the benefits of agricultural
    biotechnology. A growing number of scientists and agriculture producers
    in Texas and throughout the world are realizing the tremendous
    potential of biotechnology in agriculture to feed a growing population
    with better environmental outcomes. In Texas, for example, over 60
    percent of cotton grown in the Texas Panhandle is already enhanced by
    modern biotechnology. What measures are you and your Department taking
    to support, foster, and encourage this promising new technology?
        Answer. As you know, FDA has authority over the safety of nearly
    all domestic and imported foods and food products in interstate
    commerce, including bioengineered foods. One of the most important
    roles of this Agency in supporting this technology is to ensure that
    the bioengineered foods that enter the marketplace are as safe as the
    traditionally developed products in our grocery stores, and that such
    foods undergo appropriate safety testing prior to marketing. We are
    confident that the bioengineered foods that have reached the U.S.
    market to date meet the standards of safety that apply to other food
    products.
        In the fall of 1999, FDA announced an initiative to engage the
    public about foods made using bioengineering, and held a series of
    public meetings in November and December. One of the purposes of those
    meetings was to inform participants about FDA's policy and processes
    for ensuring the safety of bioengineered foods. FDA personnel shared
    the Agency's experience over the past five years in reviewing safety
    and nutritional assessments conducted on foods from more than 40
    bioengineered plant varieties. FDA also solicited information from
    participants and the public regarding whether FDA's policy or
    procedures should be modified and also solicited comments on
    appropriate means of providing information to the public about
    bioengineered products in the food supply.
        During those public meetings, we did not hear any evidence of food
    safety concerns about the products that have been marketed thus far,
    although some participants expressed concerns about potential safety
    issues with products that may be included in the next generation of
    bioengineered foods. Other participants suggested ways in which FDA
    could better inform the public about its processes and procedures. FDA
    is currently reviewing comments received in response to the public
    meetings and the agency's call for information. When we have completed
    that review, the agency will be in a position to develop and implement
    strategies for its biotechnology program and to articulate its plans
    for next steps.
                                     ______

                    Questions Submitted by Senator Herb Kohl

        Question. Why does the Administration fail to require background
    checks for all long-term care workers?
        Answer. The Administration has proposed a system of abuse registry
    and criminal background checks for nursing home workers. Our provider
    agreements make these facilities clearly identifiable, our statutory
    and regulatory authority and annual surveys provide the means for
    monitoring and enforcing the proposed new requirements, and existing
    State nurse aide registries can provide information for the proposed
    national abuse registry. Our proposed system would include developing
    the national abuse registry, adding FBI background checks, and creating
    a new capacity in each State to screen and report FBI data to nursing
    homes. Even with start up funding and user fees, it would take some
    time for these systems to develop the ability to promptly respond to
    background checks from the nation's 17,000 nursing homes. For these
    reasons, it seems prudent to begin efforts on criminal background
    checks for long term care workers with nursing home staff.
        HCFA also has regulatory and survey authority for home health
    agencies, hospices, and ICFs/MR. Once we have developed the systems and
    experience to handle background checks for nursing home employees, we
    would be in a better position to assess whether and how to expand such
    checks to these other three long term care settings that we do not
    regulate or survey. It would be problematic and to effectively enforce
    employee background check requirements in these other settings.
        Question. As it appears in the HHS budget, it seems that the
    Administration's background check proposal will be funded by user fees
    within both HHS and DoJ. Unfortunately, there are few details about how
    these two agencies would coordinate their systems so that facilities
    can have one-stop shopping. Could you please elaborate on how you
    envision this system working? Do you have estimates on how much this
    would cost nursing homes annually?
        Answer. For purposes of developing the President's budget, HCFA
    assumed that the background checks would be a two step process. First,
    a nursing home would request a query of the national abuse registry. If
    a report comes back that the prospective employee has a history of
    abuse, neglect, or misappropriation of resident property, the process
    would end there with the individual disqualified from employment with
    the nursing home. We estimate that nursing homes would pay HHS about $4
    per query for a total of about $4.3 million for this portion of the
    background check in the first year of implementation.
        If the abuse registry check produces no disqualifying information,
    the nursing home would proceed to the second step, a criminal
    background check request. The nursing home would obtain finger prints
    and other information from the prospective employee and forward them to
    a designated agency in their State. From that point, the designated
    State agency would serve as the ``one-stop shop,'' collecting an
    additional fee from the nursing home for the remainder of background
    checks. The designated State agency would forward the finger prints and
    other information to appropriate law enforcement authorities in the
    State and in the FBI to conduct State and national criminal background
    checks. The designated State agency also would receive the State and
    FBI data it receives to identify any disqualifying information, report
    the results back to the nursing home, and handle disputes by
    prospective employees of the accuracy and relevance of disqualifying
    information. We estimate that the second, criminal background check
    phase of the process would cost nursing homes about $70 per check or
    about $41.1 million in the first year, with the designated State agency
    forwarding the appropriate portions of the fee to the FBI and State law
    enforcement agency.
        The first step in the development of this system will be to
    determine the most effective and cost efficient methods for
    implementing a national abuse registry. HCFA plans to conduct such a
    study to include an assessment of current processes used by States and
    providers. We will be examining ways to create a ``one-step shop''
    where all information could be accessed. The information from the study
    will feed into the ultimate implementation of the proposal.
        Question. As you know, I have worked hard for the past several
    years to boost funding for nursing home inspections under the Survey
    and Certification program. I realized that the Administration continues
    to work hard on the Nursing Home Initiative to improve the quality and
    safety of nursing home residents. This year, you've asked for $234
    million for Survey and Certification, but you've again assumed $63
    million that would come from user fees, which Congress has declined to
    enact in the past. Assuming that trend continues, will the
    Administration still support the full $234 million and find money in
    the budget to pay for it?
        Answer. The Administration strongly supports the need for the full
    $234.1 million amount for the State Survey and Certification program.
    User fees have been proposed the past three years as a means of
    reducing pressure due to Government-wide discretionary funding
    limitations. If enacted as proposed, the user fee would reduce HCFA's
    $234.1 million appropriation request by $63 million, to a total of
    $171.1 million in fiscal year 2001. Should Congress decide to not enact
    the user fee proposal, the Administration request the entire $234.1
    million in appropriated funds to support State Survey & Certification
    activities.
        Question. Would the Clinton Administration support, and more
    importantly, actively advocate for legislation to restore the SSBG's
    funding and transfer levels?
        Answer. Under section 8401 of the Social Security Act, the
    authorization for the Social Services Block Grant was reduced to
    $1,700,000,000 for fiscal year 2001 and each year thereafter. In
    addition, under that same section, the limitation on the amount
    transferable to Title XX was reduced to 4.25 percent in the case of
    fiscal year 2001 and each succeeding fiscal year.
        The President's Budget for fiscal year 2001 for the Social Services
    Block Grant includes a proposal to increase the amount provided to the
    Block from $1,700,000,000 to $1,775,000,000. It also is expected that
    states will use state funds to help offset any impact that this change
    might cause.
                                     ______

                            DEPARTMENT OF EDUCATION

                  Questions Submitted by Senator Arlen Specter

                              CLASS SIZE REDUCTION

        Question. Mr. Secretary, it is my understanding that the class size
    reduction funds are to be distributed to the neediest schools with the
    highest numbers of poor children. If the very purpose of the program is
    to help schools that are struggling to resolve overcrowding in poor
    districts, how do you expect these schools to meet the matching funds
    requirement?
        Answer. The Department does not believe that requiring local
    districts to provide a 35 percent match on any new Class Size Reduction
    funds they receive would be burdensome for most districts, and those
    districts that would have the greatest difficulty in providing such a
    match would be exempt from the requirement. In addition, a district
    would match only the amount above what it received in fiscal year 1999.
    At the 2001 request level, for an average district, the amount of the
    match would be only about $15,700.
        We need to help poor schools and districts overcome the challenges
    they face in preparing their students to meet high standards. Research
    has demonstrated the benefits of reducing class size in the early
    elementary grades, particularly for lower-achieving, minority, low-
    income, and inner-city students. Class Size Reduction funds enable
    districts to reduce class size, particularly in the early elementary
    grades, so that teachers can provide students with more individualized
    attention, spend more time on instruction, cover more material
    effectively, and provide students and parents with more detailed
    feedback on each child's progress. The Department believes districts
    welcome Federal support to help them reduce class size in the early
    grades.
        Question. Further, how is the exemption for low-income school
    districts realistic when 80 percent of the formula grant relies on
    poverty data?
        Answer. All schools districts, not just districts that serve large
    numbers or percentages of low-income students, are eligible to receive
    Class Size Reduction funds. We are proposing to exempt only those
    districts in which at least 50 percent of the students they serve are
    from low-income households. We estimate that, after exempting the
    highest-poverty districts, the average national match provided by local
    districts would equal 30 percent of the Federal appropriation.

                  FLEXIBILITY IN CLASS SIZE REDUCTION PROGRAM

        Question. Given the diversity of needs that different school
    districts have throughout the country--whether it is costs related to
    special education, books, or computer technology investments--what is
    the disadvantage of using class size funds to address the most pressing
    demands identified by local school districts?
        Answer. I believe that the strong, demonstrated benefits of reduced
    class size in the early elementary grades justify making such an effort
    a national priority. Students who receive instruction in small classes
    make more rapid educational progress than their counterparts in larger
    classes. This is particularly true for lower-achieving, minority, poor,
    and inner-city children.
        Under the appropriations language and our proposal for authorizing
    the Class Size Reduction program as Title VI of the Elementary and
    Secondary Education Act of 1965, districts that have met the target
    level in grades 1 through 3 may use their funds to further reduce class
    size in those grades, to reduce class size in additional grades, or to
    improve teacher quality. Also, States that can demonstrate conditions
    in certain districts that would make achieving the goal of 18 students
    per classroom in the targeted grades a hardship, such as a lack of
    facilities or a shortage of qualified teachers, can apply to the
    Department for a waiver from some of the program provisions.

                              SCHOOL CONSTRUCTION

        Question. According to the 1999 School Planning and Management
    Construction Report, public school districts completed more than $15
    billion worth of construction in fiscal year 1998, an increase of
    almost $3 billion over the fiscal year 1997 level. The latest figures
    indicate that almost $18 billion worth of construction was completed in
    fiscal year 1999 and districts are starting $23 billion in fiscal year
    2000, resulting in roughly $70 billion of construction completed/
    planned in the last 4 years. To support its $26.1 billion proposal, the
    Administration cites a GAO study that estimated $112 billion was needed
    to bring schools into good condition.
        Mr. Secretary, given the tremendous progress being made and the
    fact that you have stated that the Federal Government is a junior
    partner in the area of education, please justify the Administration's
    proposal to assume a significant Federal role within a State and local
    responsibility?
        Answer. School construction is, and will remain, primarily a State
    and local responsibility under the Administration's school construction
    proposal. The vast majority of school facility needs will continue to
    be met with non-Federal resources, and decisions about school
    construction plans will continue to rest with State and local
    governments. However, some States and communities are not, on their
    own, able to meet the burden of providing adequate school facilities
    for all students, and the poorest communities have had the greatest
    difficulty meeting this need. The Administration's proposal would
    provide financial assistance to school districts with substantial
    construction needs and a limited ability to meet those needs.
        We owe it to our children to improve the condition of schools in
    order to improve their academic achievement and promote their physical
    health. Students have difficulty learning when they attend schools that
    are overcrowded, poorly lighted, either too hot or too cold, or unable
    to accommodate modern technology. In addition, students can be exposed
    to health hazards when they attend schools that are poorly ventilated
    or contain hazardous substances, such as lead paint and asbestos.
        While expenditures for school construction have increased over
    recent years as the economy has improved, we believe that the need
    persists for approximately $112 billion to bring schools into adequate
    condition. Substantial school construction expenditures are necessary
    just to keep from slipping further behind as school facilities continue
    to depreciate and student enrollments swell. In addition, the increase
    in school construction funding has not likely been targeted to those
    communities with the greatest need for school construction funds.

                    FEDERAL SHARE OF SPECIAL EDUCATION COSTS

        Question. Over the last 4 fiscal years, the annual increase
    requested by the Administration for the State grants program, under the
    Individuals with Disabilities Education Act (IDEA), has averaged about
    5 percent per year. For fiscal year 2001, the request is once again for
    about a 5 percent increase. Over the same period, Congress has
    increased funding by over 20 percent per year. Federal funds are used
    to help pay for the excess cost of providing special education and
    related services for children with disabilities ages 3 through 21. The
    Administration claims that the Federal contribution toward meeting the
    excess cost of special education is currently 13 percent of the
    national average per pupil expenditure.
        Given the financial burdens that the requirements of the
    Individuals with Disabilities Education Act (IDEA) place on States and
    school districts, why are you so reluctant to substantially increase
    spending for this program?
        Answer. No State is required to participate in IDEA. However, the
    rights and protections embedded in IDEA are fundamental civil rights
    that guarantee children with disabilities access to equal educational
    opportunity.
        IDEA authorizes a maximum Federal contribution toward meeting the
    excess cost of special education of 40 percent of the national average
    per pupil expenditure. We believe that the legislative history
    surrounding the enactment of Public Law 94-142 in 1975, which served as
    the basis for the current IDEA, indicates that members of Congress
    regarded the 40 percent as a goal, not a promise or commitment, and
    members acknowledged that the authorized amounts were not likely to be
    appropriated.
        I support that goal. However, I also believe that the requested
    level of funding for Special Education Grants to States provides an
    appropriate level of support given the fact that States have the
    primary responsibility for educating all children, including children
    with disabilities. Our budget for the Department is designed to address
    a broad range of needs and a number of national priorities. We believe
    that our budget request for the Department reflects the best
    combination of programs and funding to address the needs of all
    children within our limited resources.
        Question. How do you respond to school officials and parents who
    say that the Federal Government is not meeting its financial obligation
    with respect to special education?
        Answer. There is a tendency to view the IDEA Grants to States
    program as the Federal program for providing assistance to States in
    serving children with disabilities. In fact, there are many Federal
    programs that assist States in serving these children, but they are not
    focused solely on children with disabilities. These programs include
    programs such as 21st Century Community Learning Centers, which provide
    a safe environment and expanded learning opportunities for children
    before and after school; and the Class Size Reduction program, which
    helps school districts improve education in the early elementary grades
    by providing funds to hire highly qualified teachers and reduce class
    size. Federal subsidies for school construction bonds that will be used
    to repair, renovate, and construct schools will help ensure that our
    school buildings enhance the teaching and learning of all children,
    including children with disabilities.
        The $290 million increase requested for Special Education Grants to
    States would maintain the Federal contribution toward meeting the
    excess cost of special education at 13 percent of the national average
    per pupil expenditure by providing more than sufficient funds to offset
    the impact of inflation and the additional cost expected to result from
    serving more children.

           TEACHER RECRUITMENT AND PROFESSIONAL DEVELOPMENT PROGRAMS

        Question. Mr. Secretary, the President's 2001 budget request
    includes $1.4 billion for teacher recruitment and professional
    development programs, double the amount provided in fiscal year 2000,
    excluding the amount provided for the Class Size Reduction Initiative.
    Most of these programs are scattered throughout the Department and are
    unauthorized. Furthermore, a 1999 GAO report found that over $1.5
    billion in Federal funds is invested in professional development
    programs, which span 13 agencies through 87 different programs. The
    report also stated that over 86 percent of the Department of
    Education's funding was used for professional development purposes.
        Mr. Secretary, shouldn't the bulk of education dollars be delivered
    to the student, especially those in the greatest need?
        Answer. The Administration believes that investing in high-quality
    professional development and teacher recruitment is one of the best
    ways to ensure that all students, including those most at risk of
    school failure, get the help they need to raise their academic
    performance. That is why the Administration's 2001 budget request would
    increase funds for teacher recruitment and professional development
    programs, including $1 billion for the Title II programs that are
    included in the Administration's proposal to reauthorize the Elementary
    and Secondary Education Act (ESEA). We believe that these programs, in
    total, will help States and school districts ensure that all students
    are taught by fully qualified teachers who have the training they need
    to teach to challenging State and local content standards.
        Research indicates that high-quality professional development,
    especially when it is focused on academic content, can contribute to
    improvements in teachers' skills and practice and thereby raise student
    achievement. The most recent evaluation report of the Eisenhower
    Professional Development State Grants program (1999) indicates that
    teachers believe professional development contributes the most to
    improving their knowledge and skills if it: (1) is sustained over an
    extended period of time; (2) is connected to State and district
    standards and assessments; (3) emphasizes academic content and the way
    students learn that content; (4) encourages teachers from the same
    grade levels, departments, and schools to work in teams; and (5) offers
    opportunities to observe and practice the teaching techniques being
    introduced. The Teaching to High Standards State Grants program, the
    Administration's proposal to reauthorize Title II of the ESEA, would
    encourage school districts to implement professional development with
    these characteristics, so that all students can be better prepared to
    meet the challenges of the 21st century. In addition, provisions in our
    Teaching to High Standards proposal ensure that funds are targeted to
    those students who are most in need.
        The 1999 General Accounting Office (GAO) report, Teacher Training:
    Over $1.5 Billion Federal Funds Invested in Many Programs, found that,
    in various Federal agencies in fiscal year 1999, over $579 million was
    provided by programs that focus exclusively on teacher training and
    that about $933 million was provided by programs that are designed to
    achieve purposes other than just teacher training but support a
    significant amount of teacher training.
     department of education teacher training programs as a percentage of
                          all federal teacher training
        Finally, I want to clarify findings in the GAO report. The report
    did not find that over 86 percent of the Department of Education's
    funding was used for professional development purposes. Rather, the
    report states that teacher training programs administered by the
    Department of Education accounted for over 86 percent of the $1.5
    billion provided for teacher training programs across the Federal
    Government in fiscal year 1999.

     PROFESSIONAL DEVELOPMENT PROGRAMS AND EARLY INTERVENTION ADDRESS THE
                                ACHIEVEMENT GAP

        Question. How do these programs address one of the most important
    components of narrowing the achievement gap, which is early
    intervention?
        Answer. Early Childhood Educator Professional Development Grants, a
    new program proposed as part of the Administration's ESEA
    reauthorization bill, would create high-quality professional
    development opportunities to improve the knowledge and skills of early
    childhood educators and caregivers who work in communities with high
    concentrations of young children living in poverty. The program would
    promote school readiness and better learning outcomes for those
    children by focusing on professional development designed to further
    their language and literacy skills before they enter school.
        The National Research Council report, Preventing Reading
    Difficulties in Young Children (1998), concluded that the majority of
    reading problems faced by today's adolescents and adults could have
    been avoided or resolved in the early years of childhood. Reading
    problems more often occur in children from poor families with little
    education, and, as more of those children enter group care settings,
    ongoing high-quality professional development for their preschool
    teachers and caregivers is a key strategy in helping cultivate
    children's literacy and language skills as a foundation for reading.
        The Cost, Quality and Child Outcomes report (June 1999), partially
    funded by the Department, concludes that children's cognitive and
    social competence in the second grade can be predicted by the
    experiences they had 4 years previously in child care, even after
    taking into account kindergarten and first-grade classroom experiences.
    The report also found that children who have traditionally been at risk
    for not doing well in school are more affected by the quality of
    childcare experiences than are other children. Many early childhood
    providers have little formal education beyond high school, and
    preschool and other group care settings for young children, in
    particular those available to families with limited economic resources,
    often provide relatively impoverished language and literacy
    environments.
        The Department would concentrate on funding projects that provide
    professional development opportunities for early childhood educators
    and caregivers working in high-poverty communities, including staff
    working in Title I preschools, Head Start, Even Start, and public day
    care programs.

      IMPLEMENTATION OF TEACHER RECRUITMENT AND PROFESSIONAL DEVELOPMENT
                                    PROGRAMS

        Question. Please explain how the Department of Education plans to,
    first, inform States and local educational agencies of all of these
    programs; and second, ensure that both the Federal and State
    governments implement them efficiently and effectively.
        Answer. The Administration would provide information about these
    programs to States, school districts, and other eligible recipients
    through the channels that the Department has found to be most
    successful in disseminating information about our programs. For
    example, the Department would publish Federal Register notices about
    the availability of funds, provide information about the programs at
    conferences, such as the Department's annual Improving America's
    Schools Conference, place information about the programs on the
    Department's web site and in print materials, sponsor outreach meetings
    to alert eligible applicants about opportunities to apply for funds,
    and carry out other networking strategies the Department typically uses
    to alert the public about new programs.
        Strong accountability provisions in the Administration's
    reauthorization proposal for the Elementary and Secondary Education Act
    (SEA) will help ensure that these programs are implemented efficiently
    and effectively, while allowing States and school districts the
    flexibility that they need to address local needs. For example,
    accountability provisions include requirements that grantees develop
    and report on their success against performance indicators as part of
    annual performance reports, and States would provide annual data about
    the number of teachers who are fully certified or licensed and who are
    teaching in their main teaching field.

                        EDUCATION FOR INCARCERATED YOUTH

        Question. Mr. Secretary, there are over 2 million incarcerated
    adults in the United States, the highest incarceration rate in the
    world; and, according to the Department of Justice's most recent study,
    there were 106,000 juvenile offenders residing in correctional
    facilities in 1997. The National Adult Literacy Study indicates that
    the majority of prison inmates either are illiterate or have marginal
    reading, writing, and math skills. Most of these adults will return to
    free society in 4 years, having received little to no education, which
    has proven to be the key to preventing recidivism.
        In light of these facts, can you justify the President's request
    for a $2 million reduction in the State grants to incarcerated youth
    offenders program, and the elimination of the Literacy Programs for
    Prisoners?
        Answer. The President's request for 2001 would continue support for
    the Youth Offenders program at the fiscal year 1999 appropriation level
    of $12 million, which is also the amount the Administration requested
    in fiscal year 2000. The request, which is $2 million less than the
    amount provided in the fiscal year 2000 appropriations act, will
    provide States with a level that is consistent with the Department's
    general policy of targeting funding increases to other priority
    initiatives. At the requested level, States would have enough funds to
    serve approximately 6,700 youth offenders. Through the program, States
    expect to improve academic and vocational achievement, increase
    participation in job placement programs, lower recidivism rates, and
    increase job retention among youth offenders.
        The Department requested no funds for Literacy Programs for
    Prisoners in 2001 because this program's authorization ended with the
    enactment of the Adult Education and Family Literacy Act of 1998
    (AEFLA). States may use up to 10 percent of their AEFLA local grant
    funds for programs for corrections education and services to
    institutionalized individuals.

                       12-MONTH WORKING YEAR FOR TEACHERS

        Question. Mr. Secretary, in your recent address to the Nation on
    the state of American education, you proposed that teachers work a full
    year to improve teacher quality and raise their pay. Can you tell me
    specifically what steps the Department will take to establish this
    policy?
        Answer. The annual State of American Education address gives me the
    opportunity to take a broad view of our education system and talk about
    both what is working and where we might make some improvements. With
    the success of the standards movement, one area we are really focused
    on now is improving teacher quality. Our proposal to reauthorize the
    Elementary and Secondary Education Act and our fiscal year 2001 budget
    request contain a variety of measures to strengthen teaching in our
    schools.
        My call for elevating teaching to a year-round profession was not a
    proposal for a new Federal policy, but a suggestion that we need to
    look at the teaching profession in a new way. We need to attract highly
    qualified individuals to the profession, in part through better pay,
    and provide a working environment that lets them use all their talent
    and skill to teach to the new high standards. I believe one way to do
    this is through longer contracts that would give teachers more time to
    plan the curriculum and improve their teaching skills.
        States and school districts, of course, are responsible for setting
    standards for teacher quality and determining the length of teacher
    contracts. I am not proposing any Federal intrusion into this area.
    What I said in my address is that I believe now is the time to begin a
    national discussion about making teaching a better-paid, year-round
    profession, and that governors and school boards should give serious
    consideration to this idea.
        Question. Given the Federal role in education, how will these steps
    affect decisions that are made on the State and local levels?
        Answer. We are not taking any specific actions to promote making
    teaching a year-round profession, merely putting an idea out for
    discussion at the State and local levels.
        Question. Is this approach part of the Administration's
    reauthorization proposal for the Elementary and Secondary Education
    Act, which the Senate intends to consider in the next couple of weeks?
        Answer. No. As mentioned above, we are not proposing any specific
    actions to promote the idea, but simply putting it out for discussion.

                           YOUTH VIOLENCE PREVENTION

        Question. Mr. Secretary, please provide your observations of the
    relationship between movies, video games, and other related forms of
    youth entertainment and youth violence?
        Answer. Each day, children are exposed to numerous examples of
    violence in the media--either through television, video games, music,
    or the Internet. A 1999 study conducted by the Kaiser Family Foundation
    found that on a typical day, children spend five hours and 29 minutes
    using the media. Children ages 8 to 18 spent almost seven hours; 2- to
    7-year-olds spent nearly three hours and 34 minutes. The media have
    been successful in perpetuating, and even glamorizing, various images
    of violence aimed toward children. Norms supporting and justifying
    violence are seen daily in music videos, movies, and television. Yet,
    despite the far-reaching influence of the media and popular culture on
    children, there is little consensus regarding the impact that the media
    have on youth violence. Several studies have related violence in the
    media to actual violence by children, while other studies have
    discounted the role and influence of the media on children, since the
    media are only one of several sources of violent messages in our
    society.
        However, what we do know is that more and more children are being
    exposed to violence in the media on a daily basis and that much of this
    exposure is unsupervised by parents. And while we cannot point to a
    direct relationship between violence in the media and violence in
    children, we can assume that the images portrayed in music and on the
    screen may contribute to, or reinforce, violent behavior and a lack of
    empathy for victims.
        While it may not be possible to eliminate violence in the media, as
    parents and educators we can teach children how to be wise consumers of
    the media and the messages portrayed. Media literacy training can be
    useful, especially for students in the younger grades. In addition it
    is important for parents to monitor their children's exposure to the
    media. Parents need to know what types of movies, videos, television,
    and websites they are viewing, and what types of music lyrics they are
    hearing.
        I have asked, and continue to ask, the leaders in the entertainment
    industry and our expanding Internet industry to step back and think
    about their responsibilities. Do we really need these violent video
    games to excite our children in order to gain a profit? Is that extra
    violent scene in a movie really needed to make a point? Does every
    action hero need to wear a long black coat and carry a sawed-off
    shotgun? The prime audience for movies in America today is the
    impressionable teenager, and the key word is impressionable. I urge
    Hollywood to help us raise our children right by ending their fixation
    with violence. We need their vision and creativity to help in the fight
    for our children's future. So my message to the entertainment industry
    is clear and simple--stop glamorizing the assassin and the killer and
    the use of guns. Stop listening to scriptwriters and start listening to
    parents. Stop listening to advertisers and start listening to teachers.
                                     ______

              Questions Submitted by Senator Kay Bailey Hutchison

               VOLUNTARY SINGLE-SEX SCHOOL AND CLASSROOM PROGRAMS

        Question. Mr. Secretary, as you may know, I have proposed
    specifically authorizing the use of Federal education funds for public,
    single-sex school and classroom programs, as long as the existing
    Department requirement is met that students of both sexes receive
    comparable educational opportunities. My amendment has passed
    overwhelmingly in the Senate, by a vote of 69 to 29. Do you believe
    that public schools should be able to use Federal funds for voluntary
    single-sex education programs, and if so, will you support my effort to
    include this amendment in reauthorization of the Elementary and
    Secondary Education Act?
        Answer. The Department of Education is examining whether there is a
    legal basis for interpreting Title IX of the Education Amendments of
    1972 (20 U.S.C. 1681 et. seq.) to permit single sex classrooms and
    schools where they are justified on educational grounds and do not
    involve stereotyping or stigmatizing students based on gender, and
    where equivalent educational opportunities are afforded to students of
    both sexes. These issues are sensitive and complex, including
    consideration of the constitutional implications of any change, but we
    have made substantial progress in our review and hope to issue proposed
    regulations this spring.
        With regard to your specific question, we are very committed to
    exploring the permissibility of single sex schools and classes in
    public schools, but believe that this issue should be addressed under
    Title IX, and the answers should apply whether Federal, State, or local
    funds are used for that purpose. Developing a separate civil rights
    standard for single sex schools or classrooms under ESEA would create
    confusion and would be inconsistent with the Civil Rights Restoration
    Act. I hope that when we release our proposed regulation we will
    receive your comments. In the meantime, however, I cannot support your
    amendment because it defines the permissibility of single sex education
    only within the context of ESEA.

                 CIVILIAN-BASED ``TROOPS-TO-TEACHERS'' PROGRAM

        Question. Mr. Secretary, while I understand your desire to hire
    additional teachers and reduce class size, I have an alternative or
    perhaps complementary proposal that I would like your reaction to and
    consideration of. I have introduced legislation to expand the very
    successful Troops to Teachers program and apply it to the civilian
    world, under the direction of your agency. Would you agree to consider
    this proposal, and wouldn't you agree that this may be a tremendous
    opportunity to place highly qualified, successful individuals in our
    classrooms?
        Answer. I support expansion of the highly successful Troops to
    Teachers program as one strategy for helping to ensure that our
    Nation's classrooms have highly qualified teachers who can help all
    students achieve to challenging academic standards. In addition to the
    Administration's request of $1.75 billion for the Class Size Reduction
    program, the Administration has also requested $1 billion for a variety
    of programs to improve teacher quality, including teacher recruitment
    and retention.

    Transition to Teaching program
        One of these programs is the Transition to Teaching program, which
    would continue the highly successful Troops to Teachers program and
    provide additional funds to recruit, prepare, and support a wide range
    of talented career-changing professionals--such as engineers and
    scientists, corporate professionals, and returning Peace Corps
    volunteers--as teachers, particularly in high-poverty school districts
    and high-need subject areas. Former members of the military services
    would continue to be a key focus of the new program's recruitment
    efforts.
        The Transition to Teaching program is included in the
    Administration's proposal to revise and reauthorize the Elementary and
    Secondary Education Act of 1965. Under the Administration's legislative
    proposal, the Secretary, before awarding any grants or contracts, would
    consult with the Secretaries of Defense and Transportation to determine
    how much funding is needed to continue the Troops to Teachers program.
    Once the Secretaries agree on an amount, the Secretary would transfer
    these funds to the Department of Defense.
    Recruiting teachers for high-poverty areas
        With the remaining funds, the Secretary would award grants or
    contracts to institutions of higher education, public agencies, and
    nonprofit organizations to recruit, prepare, place, and support mid-
    career professionals for teaching positions in high-poverty school
    districts. Allowable activities would include post-placement induction
    programs to support new teachers once they begin teaching, through
    mentoring and other activities that build upon their teacher
    preparation training.
        Grantees could use program funds to provide each program
    participant with up to $5,000 in training stipends and other financial
    incentives, including moving expenses. Participants who complete
    training would teach in a high-poverty school district for at least 3
    years; those participants who received a training stipend or other
    financial incentives but fail to meet their service obligation would be
    required to repay all or a portion of the stipend.

       IMPACT AID FUNDING AND THE ADMINISTRATION'S CONSTRUCTION PROPOSAL

        Question. Your budget again contains what can only be described as
    a paltry request for Impact Aid funding, particularly with regard to
    the critical construction needs at many of our coterminous and other
    Impact Aid school districts, the buildings of which are in many cases
    owned by your Department. How can you support an unprecedented and
    costly new role of the Federal Government in funding school
    construction when your Department and your Administration have
    completely neglected the construction needs of the school buildings you
    own, which are used to educate tens of thousands of children, including
    the children of members of the armed services and Native American
    children?
        Answer. We believe that money can and should be spent concurrently
    on both schools that are federally owned and those that are not. All of
    the schools that are currently owned by the Department are located on
    military bases and are used by local school districts for educating
    children whose parents are typically members of the uniformed services.
    The Administration requested $5 million, the same amount as Congress
    appropriated for fiscal year 2000, for Facilities Maintenance in order
    to upgrade and transfer school facilities to school districts, which
    can manage school buildings more effectively than can the Federal
    Government. In addition, these funds would be used to perform emergency
    repairs to those school buildings that have not yet been transferred.
        The Administration is also concerned about the poor condition of
    school facilities that are not owned by the Department but are used to
    educate our Nation's children, particularly American Indian children.
    The General Accounting Office estimates that it would cost $112 billion
    to bring our Nation's public schools into good overall condition. The
    Administration's School Renovation proposal would help meet this need
    by financing school renovation in communities that lack the resources
    to repair their schools. The proposal would reserve $50 million out of
    the $1.3 billion for approximately 118 Impact Aid local educational
    agencies (LEAs) that have 50 percent or more of their students residing
    on Indian lands. These LEAs lack the resources to undertake urgently
    needed renovations, such as roof or plumbing repairs and upgraded
    climate-control systems. The balance of the funds requested under the
    proposal would go to school districts that similarly lack the resources
    to meet their urgent school construction needs.
                                     ______

                    Questions Submitted by Senator Herb Kohl

               FLEXIBILITY OF BLOCK GRANTS OVER TARGETED PROGRAMS

        Question. Mr. Secretary, I want to commend you for your commitment
    and hard work on behalf of our Nation's public school children. Since
    1994, we have made some important gains in raising the achievement of
    students. Unfortunately, I think we share the same concerns that
    academic achievement has not been raised enough, and that the gap
    between economically disadvantaged and more affluent students remains
    alarmingly and inexcusably large.
        As you know, we have a full menu of Federal education programs
    today. Most are focused on very specific issues. I am concerned,
    however, that we have gotten away from what I believe is the Federal
    Government's central role as a partner in education: helping States and
    school districts lift academic achievement for all students, and
    eliminating the achievement gap between poor and affluent students. I
    am concerned that the current structure of Federal education programs--
    that is, to create a new program to address each and every education
    issue--actually results in spreading Federal dollars too thin to be
    useful for local educators.
        For example, one school district might need more money to buy
    computers, but they might not have any pressing safety issues to
    address. Another school district might have a sufficient number of
    after-school programs, but they might really need more funding for
    school counselors. Under the current structure of ESEA, these school
    districts have little flexibility to move Federal money around. That
    means one of two things: either they get too little money to address
    their biggest problems, or they miss out on money from some Federal
    programs because those programs have no relevance for their schools.
        Don't you agree that States and local school districts are in the
    best position to know what their education needs are and to devise ways
    to address them?
        Answer. I absolutely agree that States and communities are in the
    best position to address their education needs, and that the Federal
    role is that of a junior partner. I also believe that Federal programs
    provide more flexibility than is commonly recognized. For example, the
    Goals 2000 State Grant program provides funds that can be used for a
    very wide variety of activities that support standards-based reform,
    from teacher training to curriculum to buying computers. Title I funds
    also support many different approaches to improving student
    achievement, including early childhood education, adoption of research-
    based reform models, after-school programs, and school safety efforts.
        Question. Isn't it possible that consolidating many Federal
    education programs would actually give States and school districts even
    more resources to pour into their most pressing needs?
        Answer. Our experience with block grants has shown that this
    approach is what really leads to funds being spread too thinly to have
    much impact. In fact, in a recent report from the General Accounting
    Office on the Goals 2000 program, State officials expressed concern
    that if Goals 2000 funds were not restricted to support of State and
    local standards-based reform efforts, they would be diverted to non-
    reform activities.
        Question. Isn't it possible that allowing maximum flexibility to
    move Federal money around might result in some of these needs being
    better met?
        Answer. It is possible, but in my view--and I say this as a former
    governor--not likely. I think it is important to remember that we are
    trying at the Federal level to exercise leadership and stimulate
    change. One reason this is so hard is that people everywhere--and not
    just in our schools--tend to keep doing things the same way, the way
    they are comfortable with. In my view, the ``maximum flexibility'' you
    are talking about would only encourage this kind of educational
    inertia.
        The American people have made clear their support for more
    investment in critical national priorities--like smaller class sizes,
    expansion of after school programs, improving reading in the early
    grades, and helping students and their families get ready for college.
    It is precisely because our role--and our resources--are limited that
    we must target the Federal education investment to those areas where it
    can make a real difference. At the same time, we continue to work to
    provide the flexibility districts and schools need to raise student
    achievement, while ensuring accountability for the effective use of
    taxpayer funds.

                         TURNING AROUND FAILING SCHOOLS

        Question. As you know, we have over 7,000 failing schools in our
    country. For years, regardless of the fact that they consistently fail
    to educate children, they continue to receive a steady stream of
    Federal money. In effect, we are subsidizing their failure. I believe
    that failing schools should be given the tools they need to turn
    themselves around--and successful schools should be rewarded for their
    hard work. However, at some point, I believe we actually do more harm
    than good for children when we continue to subsidize schools that fail
    to educate them.
        What do you believe should be done with chronically failing
    schools?
        Answer. Greater accountability is at the core of our proposal to
    reauthorize the Elementary and Secondary Education Act (ESEA). The
    Administration's reauthorization bill would strengthen statewide
    accountability systems, provide new resources for States and school
    districts to turn around failing schools, and require tough measures
    for chronically failing schools. For example, schools in corrective
    action under Title I could be reconstituted with a new staff and
    curriculum or actually closed down and reopened as a new school or as a
    charter school.
        Question. Does the Administration believe that at some point there
    must be real consequences for schools that can't or won't improve?
        Answer. Yes, we do. In addition to our reauthorization proposals,
    we are implementing the new Title I Accountability Grants program,
    which couples additional resources for school improvement efforts with
    the requirement that gives students in schools identified for
    improvement under Title I the option to attend a better school. Our
    2001 budget proposal would require all school districts participating
    in Title I to give students attending schools identified for corrective
    action the option of transferring to a school not identified for
    corrective action.
        Question. Doesn't the Federal Government have a responsibility to
    taxpayers not to subsidize failure?
        Answer. I believe we do, and so does President Clinton. This is why
    he took the lead more than a year ago to launch a broad-based
    accountability initiative that includes the measures described above.
    Other proposals to increase accountability, such as report cards for
    parents and tougher qualifications for teachers and paraprofessionals,
    have been incorporated into the President's ESEA reauthorization bill.
                                     ______

                  Questions Submitted by Senator Patty Murray

                  CLASS SIZE REDUCTION PROGRAM--TEACHERS HIRED

        Question. Mr. Secretary, the President has requested an additional
    $1.75 billion to maintain our goal of hiring 100,000 new teachers to
    address the severe problem of overcrowded classrooms. Opponents of this
    funding have argued that these funds may not be accessible for all
    school districts and may never make it to the classroom. Can you
    provide for us a brief status report on how many teachers have been
    hired to date and how many we could hire with the additional $1.75
    billion?
        Answer. Based on data from 55 percent of districts, we estimate
    that local districts have used their 1999 Class Size Reduction funds to
    hire more than 29,000 teachers.
        We estimate that the $1.75 billion budget request for the program
    in 2001, along with the 35 percent local matching requirement, would
    support the hiring of as many as 49,000 teachers. Without the local
    matching requirement, the requested amount would support the hiring of
    as many as 43,000 teachers.

     TECHNOLOGY LITERACY CHALLENGE FUND PROGRAMS AND PREPARING TOMORROW'S
                           TEACHERS TO USE TECHNOLOGY

        Question. Mr. Secretary, as you are aware, I have focused not just
    on class size but also working to make sure we give teachers the skills
    to use technology in the classroom. It does little good to wire every
    classroom to Internet or to provide Internet access to every school if
    teachers are not prepared to use these tools in the classroom. Can you
    provide a brief summary of the President's Technology Literacy
    Challenge Fund activities as requested in his fiscal year 2001 budget?
        Answer. In 2001, we are requesting a total of $450 million for the
    Department's Technology Literacy Challenge Fund (TLCF) program, an
    increase of $25 million. The TLCF helps local districts put into place
    strategies to enable all schools to integrate technology fully into
    school curricula to improve teaching and learning. The Department's
    proposal for reauthorization of the TLCF would limit eligibility for
    awards to districts with high concentrations of poor children and a
    demonstrated need for technology, or to partnerships that include such
    districts. Districts would use their funds to increase the capacity of
    teachers in high-poverty, low-performing schools to use technology
    effectively in their classrooms. The amount requested would support
    approximately 3,400 local grants.
        In addition to the TLCF, the Department's other educational
    technology programs help States, districts, and schools achieve the
    four goals of the Administration's Technology Literacy Challenge, which
    are to: (1) provide access to modern, multimedia computers for all
    teachers and students; (2) connect every school and classroom to the
    Internet; (3) provide all teachers with the training and support they
    need to use technology effectively in their classrooms; and (4) develop
    effective and engaging software and on-line resources as an integral
    part of schools curriculum. The technology programs and the 2001
    requested amounts are:
      --Next-Generation Technology Innovation, for which we are requesting
            $170 million in 2001, would replace the current Technology
            Innovation Challenge Grants and Star Schools programs. The new
            program would focus on developing ``cutting edge'' applications
            of educational technology. In 2001, new awards would focus on
            developing advanced technology applications, supporting the
            development of high-quality on-line coursework, and a special
            initiative to help prepare middle school teachers in the
            Mississippi Delta region to use technology effectively and to
            develop challenging coursework on-line.
      --Preparing Tomorrow's Teachers To Use Technology assists public and
            private entities to develop and implement teacher training
            programs that prepare prospective teachers to use technology to
            improve instructional practices and enhance student learning.
            The $150 million requested in 2001, a $75 million increase over
            2000, would support approximately 466 awards.
      --Community Technology Centers supports efforts to establish or
            expand technology centers to provide residents of impoverished
            rural and urban communities with access to computers and
            technology, particularly educational technology. The $100
            million requested in 2001, a $67.5 million increase, would
            allow approximately 400 communities to establish or expand
            1,000 technology centers.
      --Regional Technology In Education Consortia, for which we are
            requesting $10 million, the same as the 2000 appropriation,
            supports regional centers that carry out professional
            development, resource and information dissemination, and
            technical assistance to help States, districts, and schools
            integrate technology effectively into classrooms.
      --Ready To Learn Digital Television, for which we are requesting $16
            million in 2001, supports the development of educational
            television programming and related activities aimed at
            cultivating a love of language, reading, and learning in young
            children.
      --Telecommunications Program For Professional Development, for which
            we are requesting $5 million in 2001, would replace the current
            Telecommunications Demonstration Project for Mathematics
            program. This new program would support telecommunications-
            based projects designed to provide professional development to
            elementary and secondary school teachers in the core academic
            subjects.

    STUDENT DEBT--GROWING IMBALANCE OF STUDENT EDUCATION LOANS TO GRANTS IN
                               PAYING FOR COLLEGE

        Question. Over the past 10 years, I have witnessed a disturbing
    trend in higher education. We have a growing number of students who
    must depend entirely on borrowing in order to pay for their higher
    education. The percentage of loans versus direct grants to students has
    dramatically increased. Students are graduating with huge debts and
    many discontinue or do not pursue a postsecondary education simply out
    of fear of carrying such a large debt. In addition, many students are
    looking at careers based on starting salary because they know they will
    have large loan payments. I realize this problem cannot be solved in
    one budget cycle, but I would welcome your thoughts on steps we can
    begin to take to reverse this trend.
        Answer. One of the major steps we need to take is to continue
    increasing support for the Pell Grant program, where the maximum award
    has risen from $2,300 in fiscal year 1994 to $3,300 in fiscal year
    2000. The maximum Pell Grant in fiscal year 2000 covers about 95
    percent of the average tuition and fees at a 4-year public college, but
    still only about 38 percent of the total cost of attendance. This
    program is vital to the overall student aid picture, as is funding for
    campus-based programs such as Federal Work-Study where an estimated 1
    million students will help earn their way through college with Federal
    assistance in fiscal year 2000.
        We need to do a better job of counseling students up front on what
    amount of borrowing is appropriate to their specific situation. We also
    can encourage States and institutions to increase their level of
    assistance so that students may take advantage of available non-Federal
    aid as well.
        Many students who are dependent on borrowing may be ineligible for
    grant aid due to family income levels. We, too, are concerned about the
    rising loan debt that numbers of these and other postsecondary students
    are carrying. One of our performance measures focuses on keeping median
    Federal debt burden below 10 percent of income in the first year of
    repayment. While this is not entirely within the Department's control,
    since many outside factors play a role, there are options that we have
    instituted to help borrowers manage their debt.
        For instance, the Administration established flexible repayment
    plans such as Income Contingent Repayment, which allows Direct Loan
    borrowers to repay based on size of debt and income. Other options
    include graduated, extended, and income sensitive repayment plans that
    can help make monthly payments more affordable and keep borrowers out
    of default.

                           EDUCATIONAL TAX INCENTIVES

        In addition, we need to encourage eligible students and their
    families to use the variety of educational tax incentives available.
    For instance, taxpayers may be able to deduct up to $2,000 in student
    loan interest in 2000. Hope and Lifetime Learning tax credits are
    another possibility to lower overall postsecondary tuition and fee
    expenses. The Hope tax credit allows up to $1,500 annually toward
    tuition and fees paid in the first 2 years of postsecondary education
    and the Lifetime learning tax credit currently permits up to $1,000.
    The Administration is seeking to expand the Lifetime learning tax
    credit up to $2,800 annually and raise the income phase-out ranges so
    greater numbers of families can take advantage of it.
        In combination, all of the ways mentioned above, represent positive
    steps that can help in alleviating the burden of student loan debt.
                                     ______

                 Questions Submitted by Senator Robert C. Byrd

                            BYRD SCHOLARSHIP PROGRAM

        Question. Over the life of the program, how many students have
    received Byrd Scholarships and how many new and continuing awards have
    been made?
        Answer. Since the program was first funded in fiscal year 1987,
    76,376 students have received Byrd Scholarships and a total of 173,897
    new and continuing awards have been made. In fiscal year 2000, 26,572
    new and continuing scholarships will be made and in fiscal year 2001,
    our budget would provide an additional 7,310 new scholarships and
    20,024 continuing scholarships.

    DEPARTMENT OF EDUCATION EXPENDITURES FOR NEEDS-BASED STUDENT FINANCIAL
                                   ASSISTANCE

        Question. In 1999, how much did the Department of Education spend
    on needs-based student financial assistance?
        Answer. In 1999, the Department obligated nearly $7.7 billion in
    the Student Financial Assistance account in support of need-based
    student aid. Those funds, together with required matching funds under
    the Campus-Based and Leveraging Educational Assistance Partnership
    (LEAP) programs, less allowable administrative costs, provided an
    estimated $10.2 billion in available aid to students. With an
    additional $15.7 billion in need-based mandatory student loans
    (guaranteed and direct subsidized Stafford loans), the Department made
    approximately $25.9 billion in need-based aid available to students in
    1999.

    Obligations in the SFA Account in Fiscal Year 1999

    Pell Grants.............................................  $6,043,864,720
    Campus-based programs:
        SEOG................................................     619,307,364
        Work-study..........................................     875,536,832
    Perkins loans:
        Federal capital contributions.......................     101,662,353
        Teacher cancellations...............................      29,980,923
    LEAP....................................................      25,000,000
                        --------------------------------------------------------
                        ____________________________________________________
            Total obligations...............................   7,695,352,192

    DEPARTMENT OF EDUCATION EXPENDITURES FOR MERIT-BASED STUDENT FINANCIAL
                                   ASSISTANCE

        Question. How much did the Department spend in the same year for
    merit-based student financial assistance?
        Answer. In addition to $39.3 million in the Byrd Honors
    Scholarships program for merit-based financial assistance to
    undergraduate students, in fiscal year 1999, the Department spent a
    total of $31 million in the Graduate Assistance in Areas of National
    Need (GAANN) and Javits Fellowships programs for merit-based assistance
    to graduate students studying in areas of national need and doctoral
    students studying in the arts, humanities, and social sciences.

              REWARDING EXCELLENCE IN STUDENT FINANCIAL ASSISTANCE

        Question. The purpose of the Byrd Scholarship program is to award
    students who work hard at their schoolwork regardless of economic
    factors. How does the Department of Education intend to build upon
    these efforts to reward excellence?
        Answer. The Administration's fiscal year 2001 budget request
    recognizes the success of the Byrd Honors Scholarships program in
    helping high achieving students pay for a college education and would
    build on this success by moving the program closer to the maximum
    funding level authorized by law. In addition, the budget request would
    continue support for the GAANN and Javits Fellowships programs because
    of their critical role in rewarding excellence and encouraging
    continued learning.

                              SCHOOL CONSTRUCTION

        Question. With the Elementary and Secondary Education Act due to be
    marked up by the Senate Health, Education, Labor, and Pensions
    Committee this week, I would like now to turn to those issues of
    importance to students, parents, and teachers in creating a stronger,
    more educated national population. I strongly believe that educating
    oneself is a lifelong journey, and the skills by which one learns to
    read and study are fostered at a young age, making these years of
    schooling extremely important in shaping one's future pursuit of
    education. Mr. Secretary, would you please respond to the following
    questions.
        I have noted the Department's new efforts to increase budget
    spending for school construction. Specifically, how will these
    projections assist our small, rural schools in high poverty areas such
    as we find in my State of West Virginia?
        Answer. The Administration's School Renovation proposal would
    provide $1.3 billion in grants and loan subsidies to provide support
    for urgent renovations in areas of high need. These funds would assist
    schools in high poverty areas, such as those in small, rural areas of
    West Virginia, because they would be targeted to school districts based
    on poverty rates, school repair needs, and fiscal capacity.
        Question. When available construction funding requires matching
    funds, how does the Federal Government assist the small rural
    communities with high poverty levels and low tax bases to be
    competitive?
        Answer. The Administration's School Renovation proposal would
    provide both grants that require no matching funds and subsidies equal
    to the size of interest payments on 7-year loans. The Administration
    intends to target both the grants and the loans to needy areas, while
    reserving the grants for areas with the greatest need.

        TEACHER CERTIFICATION--NATIONAL BOARD FOR PROFESSIONAL TEACHING
                                   STANDARDS

        Question. Are there any national efforts to encourage teachers to
    participate in the National Board for Professional Teaching Standards
    certification process?
        Answer. The National Board for Professional Teaching Standards
    (NBPTS) itself encourages participation in the certification process in
    several ways. One way is through Teacher Subsidies (funded at $2.5
    million of the Department's grant to the Board). The Board provides
    funds to each State to pay up to one half of the candidate fee. As a
    result of the program, staff in the departments of education in each
    State engage in a variety of strategies to increase the number of
    teachers in their States who are seeking certification. The Board also
    sponsors a series of national facilitator institutes for individuals
    interested in helping recruit candidates and providing support for
    candidates going through the certification process.
        The Board has also partnered with national organizations such as
    the Council of Great City Schools, the National Council of Social
    Studies, the International Reading Association, and the National
    Alliance of Black School Educators to increase participation. The Board
    has exhibits at the national conferences of many major education and
    content associations. In addition, the Board works with the private
    sector to increase participation; e.g., State Farm is supporting
    candidates through its offices in each State.
        Question. How can we assist States with very low numbers of
    participating teachers?
        Answer. In those States with large numbers of National Board
    Certified Teachers (NBCT), there is significant State support through
    financial incentives, including fee support and salary increases,
    coupled with an increased awareness of the NBCT process. The reverse is
    true in those States with low numbers of National Board Certified
    Teachers.
        Through its grant to the NBPTS, the Department is helping to
    increase the number of candidates for National Board Certification in
    States with low participation by providing support to the Board:
      --to increase State and local incentives through meetings with State
            stakeholders and legislators; and
      --to increase awareness of the NBCT process through partnerships with
            the private sector, encouragement of candidate support groups,
            participation in national meetings involving teachers, and
            working with ED's Regional Educational Laboratories and
            institutions of higher education.
                   teacher shortages and the budget proposal
        Question. With the incredible predictions for teacher shortage
    rates growing almost daily, what efforts might we expect to see
    emerging to reverse this threatening crisis?
        Answer. The Administration shares your concern about reports that
    many school districts are having difficulty hiring and retaining fully
    qualified teachers. According to the National Commission on Teaching
    and America's Future's report, What Matters Most: Teaching for
    America's Future (1996), ``Much of the problem of teacher supply is a
    problem of distribution that could be solved with more thoughtful and
    coherent policies. While there are shortages of qualified candidates in
    particular fields (e.g., mathematics and science) and particular
    locations (primarily inner city and rural), the nation each year
    produces more teachers than it needs. . . . Thousands of teachers fail
    to make the transition from the places they were prepared to the places
    where the jobs are due to lack of information about where to apply,
    lack of reciprocity in licensing between States, and ridiculously
    cumbersome application procedures.'' (pp. 37-8)
        In addition, the report concludes that inadequate efforts to retain
    teachers contribute to the teacher shortage. For example, the report
    states that ``Of all of education's self-inflicted wounds, the
    continued tolerance for extraordinary turnover among new teachers is
    among the most remarkable. Chronic, high rates of teacher replacement--
    particularly for teachers in the first 2 or 3 years of their careers
    and particularly in urban school districts--increase the pressure on
    teacher recruitment and initial placement systems incessantly. . . .
    Turnover in the first few years is particularly high because new
    teachers are typically given the most challenging teaching assignments
    and left to sink or swim with little or no support. They are often
    placed in the most disadvantaged schools and assigned the most
    difficult-to-teach students, with the greatest number of class
    preparations (many of them outside their field of expertise) and a slew
    of extracurricular duties. With no mentoring or support for these
    teachers, it is little wonder that so many give up before they have
    really learned to teach.'' (p. 39)
        The Administration is requesting funds for several programs to help
    school districts address their immediate teacher shortage concerns,
    including a proposed new initiative, Hometown Teachers, and the
    Transition to Teaching program. We believe that these and other teacher
    training programs, for which we are requesting a total of $1 billion,
    would encourage school districts to develop and implement longer-term
    solutions for recruiting and retaining high-quality teachers. For
    example, States and school districts would be able to use funds to
    develop strategies that could include mentoring programs for new
    teachers, higher teacher salaries, more desirable working conditions,
    better professional development opportunities for teachers and school
    leaders, and other efforts to improve the quality of the teaching
    profession.

                   DEPARTMENTAL RESPONSE TO TEACHER SHORTAGES

        Question. What is the Department doing to specifically address
    these issues?
        Answer. The Administration is requesting $1 billion in support of a
    comprehensive set of ESEA reauthorization proposals focusing on
    professional development and teacher recruitment. Programs that would
    be implemented as part of the package include Teaching to High
    Standards State Grants (which would replace the Eisenhower Professional
    Development State Grants and Goals 2000 programs), a School Leadership
    Initiative, National Activities for the Improvement of Teaching and
    School Leadership, the Eisenhower Regional Mathematics and Science
    Education Consortia, Teacher Quality Initiatives, Transition to
    Teaching: Troops to Teachers, and Early Childhood Educator Professional
    Development.
        The Administration believes that these programs, in total, would
    help States and school districts address their teacher shortages both
    directly and indirectly by helping them to develop and implement short-
    and long-term solutions to teacher recruitment issues and to reduce
    their teacher attrition rates. In addition to the programs that
    specifically address teacher recruitment, such as the Hometown Teachers
    and Transition to Teaching programs, other programs in the $1 billion
    request would provide high-quality professional development to both
    teachers and school leaders to help ensure that all students are being
    taught by teachers who are fully qualified and who are receiving the
    support they need to teach to challenging State and local standards.
        For example, the Administration is requesting $690 million for the
    Teaching to High Standards State Grants program, which would help
    educators improve learning in American classrooms by supporting State
    and local efforts to align curricula and assessments with challenging
    State and local content standards and to provide teachers with
    sustained and intensive high-quality professional development in the
    core academic subjects. A $60 million set aside in this program would
    provide grants to colleges and universities that agree to partner with
    at least one school district to provide professional development in the
    core academic subjects. States would be required to give priority to
    those colleges and universities that plan to focus on induction
    programs for new teachers that provide mentoring and coaching by
    trained mentor teachers. The Administration believes that induction
    programs such as these can provide the support that new teachers need
    to help them to become more effective teachers and to improve the
    likelihood that they will stay in the teaching profession.

     RECOGNIZING HIGHER EDUCATION INSTITUTIONS WITH EFFECTIVE ALCOHOL AND
                            DRUG PREVENTION PROGRAMS

        Question. As you recall, I authored a component of the Higher
    Education Act Amendments of 1998 to establish a National Recognition
    Awards program to identify institutions of higher education with
    effective alcohol and drug prevention programs. With the first year of
    the program complete, would you please provide me with a report on the
    second year's implementation status of the program, as well as any
    intentions the Department may have to broaden the program given the
    increase in funding?
        Answer. Because the second year of the program is being funded
    under a different authority than last year (that is, under Safe and
    Drug-Free Schools National Programs rather than under the Fund for the
    Improvement of Postsecondary Education), the Department has needed to
    undergo rulemaking to implement the program for 2000. On February 14,
    2000, the Department published in the Federal Register a notice of
    proposed priority, eligible applicants, and selection criteria for
    evaluating applications for new grants under for this program. We
    received very few comments from the public and expect to publish a
    final notice in the Federal Register in early April, at which time we
    will begin soliciting grant applications from institutions of higher
    education. The application deadline date will be May 12, 2000. The
    program will be operated in essentially the same manner as it was
    implemented in 1999.
        The Department is planning to use the additional $100,000 in 2000
    funds to make additional awards and to support enhanced dissemination
    activities by each grantee. A total of $600,000 will be available for
    awards (compared to $500,000 in fiscal year 1999). Once again $250,000
    of the appropriation will be used to administer the peer review
    process, conduct a recognition ceremony, and develop and disseminate a
    publication describing the model programs. We plan to make grant awards
    in June, and anticipate making between eight and ten awards, ranging
    from $50,000 to $90,000 each.
                                     ______

                Questions Submitted by Senator Dianne Feinstein

                             TITLE I HOLD HARMLESS

        Question. You have given important opposition to the Title I ``hold
    harmless'' provision that effectively negates the law's requirement
    that the Department use the most up to date child poverty data in
    allocating Title I funds. Hold harmless provisions freeze in amounts to
    States whether the number of poor children goes up or down. In fast-
    growing States like mine, the hold harmless hurts and we don't get our
    fair share. California lost $40 million in fiscal year 2000 because of
    the hold harmless. California received $944.9 million instead of the
    $984.5 million we should have received.
        Will you vigorously oppose the hold harmless publicly?
        Answer. I could not agree with you more on the harmful impact of
    the 100 percent hold-harmless on Title I allocations. This provision
    does indeed prevent Title I funds from flowing, as intended by the
    authorizing statute, to States and school districts experiencing rapid
    growth in poor students. Research shows clearly that high
    concentrations of school poverty are directly correlated with low
    student achievement, and that even non-poor students tend to perform
    poorly in schools with high poverty levels. This is why the various
    Title I formulas are designed to target additional resources to high-
    poverty districts and schools. Unfortunately, in many cases the 100
    percent hold-harmless provision undermines this targeting and dilutes
    the impact of the $8 billion annual investment in Title I. Our budget
    would eliminate this provision, and we certainly will support efforts
    by you and others to resist the continuation of this 100 percent hold-
    harmless requirement in the fiscal year 2001 appropriation.

     STRENGTHENING TITLE I ACCOUNTABILITY PROVISIONS TO INCREASE ACADEMIC
                                  ACHIEVEMENT

        Question. Current law has some accountability requirements for the
    Title I program, yet I question whether there have been real
    achievement gains under the current program. I know you agree that the
    early years--learning the basics--are critical to a student's lifetime
    success.
        How can we strengthen Title I's accountability requirements to make
    sure the funds are spent on improving learning in the core academic
    curriculum?
        Answer. As I indicated earlier, greater accountability is at the
    core of our proposal to reauthorize the Elementary and Secondary
    Education Act. We would strengthen statewide accountability systems to
    ensure that Title I schools are held to the same high standards as
    other schools, provide new resources for States and school districts to
    turn around failing schools, and require tough measures for chronically
    failing schools. We also would require tough corrective actions for
    chronically failing schools, including reconstituting them with a new
    staff and curriculum or actually closing them down and reopening them
    as a charter school.

          REAUTHORIZATION PROPOSAL TO INCREASE TITLE I ACCOUNTABILITY

        Question. What are your proposals?
        Answer. The Administration's reauthorization proposal for Part A of
    Title I would encourage each State to develop a single, rigorous
    accountability system that holds all local educational agencies (LEAs)
    and schools, including Title I schools, accountable for making
    continuous and substantial gains in student performance and in the
    performance of the lowest-performing students. This statewide
    accountability system would be based on the State's content and student
    performance standards, and would include procedures for identifying and
    intervening in LEAs and schools that are not making gains in student
    performance, as well as recognition and rewards for successful LEAs and
    schools. States that do not operate such a system for all their schools
    would be required to develop one for their Title I schools.
        The Administration's reauthorization proposal includes strong
    corrective actions to turn around consistently low-performing schools.
    Once a Title I school is designated for corrective action, the LEA
    would be required to carry out one of the following measures: (1)
    implement a new curriculum that research has shown offers substantial
    promise of improving student achievement; (2) redesign or reconstitute
    the school, which may include reopening it as a charter school; or (3)
    close the school and allow its students to transfer. Districts also
    could allow students in schools subject to corrective action the option
    of transferring to a new school.
        The Administration's reauthorization bill also includes a proposal
    to provide additional resources to States and school districts to
    support school improvement efforts. The fiscal year 2000 Department of
    Education Appropriations Act jumpstarted this new initiative by
    providing $134 million for school improvement activities at the LEA
    level. These funds must be used for technical assistance and other
    interventions designed to improve low-performing schools and to help
    such schools enable all students to meet challenging State standards.
    In addition, Congress directed, through appropriations language, that
    all LEAs receiving these funds must provide students enrolled in
    schools identified for improvement with the option to transfer to
    another public school within the LEA that has not been identified for
    improvement.
        The President's 2001 budget would expand funding for these new
    accountability grants to $250 million, with 30 percent of grant funds
    reserved for State-level accountability and school improvement
    activities and 70 percent allocated to LEAs. And to help ensure that no
    student is trapped in a chronically failing school, the
    Administration's 2001 budget proposal would require LEAs to give
    students attending corrective action schools the option of attending
    another public school within the LEA that has not been identified for
    corrective action. This requirement would apply to all LEAs
    participating in Title I, whether or not they receive accountability
    grant funds.

                           IMMIGRANT EDUCATION FUNDS

        Question. Under the immigrant education programs, the Department of
    Education awards grants to school districts based on the number of
    immigrant children enrolled, if the district has an immigrant
    population of at least 500 or 3 percent of their enrollment. Students
    counted are those that have been in this country for less than 3
    academic years.
        New immigrant students are probably the most at-risk students. In
    addition to language barriers, their schooling has been interrupted and
    they are in unfamiliar communities.
        Funding for this program has been flat--at $150 million in 1998,
    1999, and 2000. And you have requested $150 million for fiscal year
    2001. California has 25 percent of the U.S. legal immigrants and 40
    percent of the Nation's illegal immigrants. Last year California
    received $36.5 million to educate immigrant children.
        In light of the serious needs these children bring to the
    classroom, shouldn't we be increasing immigrant education funds?
        Answer. We strongly agree that school districts need Federal
    assistance in serving recent immigrant students. The Administration
    proposed, and Congress enacted, increased funding for this program in
    each of fiscal years 1996, 1997, and 1998. However, since 1995, the
    number of eligible immigrant students in the Nation has declined by 2
    percent, and in California by 29 percent. With this decline, we believe
    that the proposed appropriation level is adequate. As you know, for
    2001, the Administration has proposed large increases for both the
    Title I and Bilingual Education programs that serve large numbers of
    immigrant students.

                  FLEXIBILITY OF CLASS-SIZE REDUCTION PROGRAM

        Question. The Clinton Administration's push to reduce class sizes
    in the lower grades is a good use of Federal education funds.
    California has been reducing class sizes in grades K-3 since the 1996-
    1997 school year. Because these efforts have largely succeeded in
    reducing class sizes in grades 1-3, in fiscal year 2000 California
    received a waiver that allowed my State to use class-size reduction
    funds to reduce class sizes in higher grades.
        Will you accommodate States that have taken the initiative in
    reducing class size by making funds flexible enough to suit the
    specific class size reduction needs of the State?
        Answer. Districts have considerable flexibility in the use of their
    Class Size Reduction funds. A district that has met the target level of
    18 children or fewer in the early grades, or has reduced class size to
    a State or local class size reduction goal that was in effect prior to
    November 29, 1999, can use its funds to further reduce class size in
    those grades, to reduce class size in additional grades, or to improve
    teacher quality. We will work with States to provide them with
    flexibility in the use of the funds they receive under the Class Size
    Reduction program so that each State is able to address its specific
    class-size reduction needs.

                            REDUCTION IN IMPACT AID

        Question. Impact Aid is an important program without which many
    schools in California and other States would be in severe financial
    straits. Currently in California, $57 million in Impact Aid is spent
    educating 1 million students in 119 school districts. Impact Aid is a
    basic obligation that the Federal Government has to school districts to
    compensate them for the lost revenues because of tax-exempt Federal
    property. More than half of the Administration's proposed $128 million
    cut in Impact Aid comes from the elimination of the ``Payments for
    Heavily Impacted Districts.''
        Why did the Administration propose a drastic $128 million, or 15
    percent, cut in Impact Aid?
        Answer. In the Administration's budget, the types of Impact Aid
    funds that are targeted to the school districts with the clearest needs
    would increase. For example, Basic Support Payments on behalf of an
    Impact Aid ``a'' child would increase 7 percent on average from the
    2000 level. (Impact Aid ``a'' children are generally those children who
    reside with their parents who both live and work on Federal land.
    Impact Aid ``b'' children are generally those students who reside with
    their parents who work or live on Federal land.) Under the
    Administration's proposed funding level and formula, the Department
    estimates that school districts in California would receive an increase
    of nearly 10 percent in Basic Support Payments, from $51.8 million in
    2000 to $56.6 million in 2001.
        The Administration's budget does not support payments on behalf of
    ``b'' children because we believe (as did previous Administrations)
    that ``b'' children do not present a real, uncompensated burden for
    school districts. Families that reside on private property either pay
    property taxes or rent property on which their landlords pay property
    taxes. Since local governments typically finance education using
    property taxes, the local cost of educating off-base children can be
    financed using property and other local taxes.
        The Administration proposes no funding for Payments for Heavily
    Impacted Districts because the program no longer meets its purpose
    under the authorizing statute--to assist school districts with large
    proportions of federally connected students and a strong tax effort in
    reaching the per-pupil expenditures of similar school districts in
    their State. The appropriations for fiscal years 1999 and 2000
    essentially rewrote both the eligibility criteria and the payment
    formula for this supplemental funding authority.
        The program now functions more as a set of funding earmarks than a
    legitimate program meeting a genuine need. No school districts in
    California receive Payments for Heavily Impacted Districts.
        By eliminating funding for authorities that fail to meet their
    intended purpose, the Administration is able to focus on funding
    increases for high priorities, such as a substantial increase for
    payments on behalf Impact Aid ``a'' children under the Basic Support
    Payments formula.

                    PAYMENTS FOR HEAVILY IMPACTED DISTRICTS

        Question. Why, if the Department of Education believes that the
    funds for heavily impacted schools are not targeted effectively, does
    the Department not try to change the legislation rather than simply
    cutting the funding in its entirety?
        Answer. The Administration is proposing changes to the legislation
    for Payments for Heavily Impacted Districts in its proposal for
    reauthorizing the Elementary and Secondary Education Act. However,
    neither the Senate nor the House committee bills to reauthorize Impact
    Aid include these changes.
        The Administration's proposed changes would simplify the payment
    formula and bring this program back to its original purpose of
    assisting school districts with large proportions of federally
    connected students and a strong tax effort to increase their per-pupil
    expenditures so that they would be in line with similar school
    districts. These changes would discontinue the practice of distributing
    these funds to school districts that no longer have large proportions
    of federally connected children.

                               HEAD START PROGRAM

        Question. Should the Head Start program be moved to the Department
    of Education and converted to a strong preschool program?
        Answer. I see no reason to move the Head Start program to the
    Department of Education. Head Start, as it now exists, is a strong
    program that helps prepare our highest need children to succeed in
    school. The Department of Health and Human Services (HHS) has worked to
    ensure that Head Start is a comprehensive program that integrates
    health and social services with education and learning and is geared
    toward promoting both social competence and school readiness for our
    Nation's low-income children. With the greater focus on improving the
    standards and quality of all aspects of Head Start in the last
    reauthorization, HHS has worked hard to focus on improving quality,
    including the improvement of key school readiness indicators.
        In 1998, the National Academy of Sciences released information
    about critical research on the importance of preventing reading
    difficulties in young children by focusing efforts on improving
    opportunities for young children to develop language and literacy
    skills in preschool in order to enter school ready to learn to read.
    The Department of Education has worked closely with HHS to focus
    Federal early childhood programs on this goal and to disseminate this
    research widely. These efforts have focused on improving the language
    and literacy skills of young children through the Head Start, Title I,
    Even Start, and Reading Excellence programs. I am confident that we
    will make great strides in helping all young children, especially those
    from poor families, improve their reading readiness.
         Question. Would the program be a stronger program if moved to the
    Department of Education?
        Answer. Again, I see no reason to move the program. Both of our
    agencies are working together to ensure that young children are able to
    start school ready to learn--by offering a wide range of approaches and
    services to reach the young children who are most at risk of school
    failure, by encouraging parents to become involved in their young
    children's development, and by stressing the importance of cognitive
    development in young children. We have learned some important lessons
    in recent years about how to meet the range of needs of target families
    and how to manage our programs more effectively.

                     HHS AND ED COORDINATION ON HEAD START

        Question. What is the coordination between HHS and ED vis-a-vis
    Head Start?
        Answer. The Department of Education (ED) and the Department of
    Health and Human Services share the mission of providing services to
    young children in order to ensure that they are healthy, safe, and able
    to start school ready to learn. During the past 7 years, our agencies
    have worked to improve collaboration and communication in order to
    serve our Nation's children more effectively. While significant strides
    have already resulted from this increased interagency collaboration, we
    will continue our efforts to improve program efficiency and
    accountability. Some examples of ways in which ED is working with HHS,
    specifically in the areas of early childhood services, research, and
    performance measures are:
        In the area of School Age Care and After School Programming, ED and
    HHS have collaborated on several successful programs, including the
    Federal Support to Communities Initiative (FSC), Safe School/Healthy
    Students, 21st Century Community Learning Centers, and Child Care and
    Development Block Grants (CCDBG). These programs address the growing
    need to provide stimulating out-of-school-time programs for our
    Nation's children.
        In the area of accountability at the Federal level, Title I, Even
    Start, Head Start, CCDBG, and the Individuals with Disabilities Act
    (IDEA) programs are developing outcomes systems for use in improving
    program effectiveness and complying with the Government Performance and
    Results Act of 1993 (GPRA). As a next step toward coordinated
    indicators and measures, ED and HHS will conduct an assessment of the
    scope, quality, and frequency of measurement of the current set of ED
    and HHS program performance indicators for their early childhood
    programs. Included in this analysis will be a comparison of the GPRA
    indicators for the programs, as well as the studies, reporting systems
    and evaluations, and measures used to report on the indicators and
    evaluate the programs.
        Even Start, Title I, and Head Start staff are coordinating programs
    on a number of fronts by focusing on ways to sustain coordination
    efforts at the Federal, State, and local levels. For example, Federal
    Even Start and Head Start staff are planning a joint conference for the
    summer of 2000 on coordinating accountability systems. This conference
    will include staff from Head Start State Collaboration Offices and Even
    Start Statewide Family Literacy Initiative grants, in addition to other
    key State offices involved in early care, education, and family
    literacy. In addition, ED and HHS will soon issue guidance on models
    for collaborating and blending Head Start, Special Education, Even
    Start, and Title I, Part A funds (i.e., models for combining funds to
    provide whole-day and year-round preschool services, or models with
    Title I paying for educational services and Head Start paying for
    health, nutrition, and parent involvement). Also, HHS and ED are
    exploring ways to provide joint family literacy technical assistance
    through the Head Start Family Literacy Technical Assistance Initiative.
        HHS is also partnering with ED in the development of ED's Survey of
    Early Care and Education Programs, a nationally representative sample
    of child care providers and early childhood programs serving children
    under the age of six. This project is the first national survey in
    recent years to examine the supply of center-based programs and
    licensed home-based care.

              TEACHING OF COGNITIVE SKILLS IN HEAD START PROGRAMS

        Question. Are real cognitive skills being taught in the Head Start
    program?
        Answer. Yes. Head Start has adopted the ``whole child'' view of
    school readiness that was recommended by the Goal One Technical
    Planning Group of the National Education Goals Panel. This view sees
    school readiness as comprising five developmental domains that are
    important to the child's readiness for school: physical well-being and
    motor development, social and emotional development, approaches to
    learning, language usage and emerging literacy, and cognition and
    general knowledge. Each of these domains is represented in the Head
    Start performance standards and measures and in the battery of
    assessments in the FACES study, a nationally representative
    longitudinal study of Head Start children that is being used to
    determine the effectiveness of Head Start. The FACES study, initiated
    in 1997, is entering its final phase in the spring of 2000. In the next
    year, the study should yield important information about how Head Start
    is succeeding in helping children achieve in the five designated
    development domains addressed in the study, including the cognitive
    domain.

                       HEAD START PROGRAM STAFF SALARIES

        Question. What is the impact on the program of the low ``teacher''
    salaries being paid to Head Start workers?
        Answer. Head Start salaries have increased in recent years as the
    Administration has continued to emphasize program quality. However, I
    cannot speak specifically to the issue of the impact of the salaries of
    Head Start workers, since I do not administer the program. I do know
    that low salaries tend to discourage some highly qualified individuals
    from entering the teaching profession at the elementary and secondary
    education levels, and I assume that that is also true for the Head
    Start program.

                              SUBCOMMITTEE RECESS

        Senator Specter. Thank you all very much. The subcommittee
    will stand in recess to reconvene at 9:30 a.m., Thursday, March
    30, in room SD-124. At that time we will hear testimony from
    the Honorable Dr. Ruthe L. Kirschstein, Acting Director,
    National Institute of Health.
        [Whereupon, at 11:25 a.m., Tuesday, February 29, the
    subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
    March 30, 2000.]

      DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
              RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2001

                                  ----------

                            THURSDAY, MARCH 30, 2000

                                           U.S. Senate,
               Subcommittee of the Committee on Appropriations,
                                                        Washington, DC.
        The subcommittee met at 9:31 a.m., in room SD-124, Dirksen
    Senate Office Building, Hon. Arlen Specter (chairman)
    presiding.
        Present: Senators Specter, Cochran, Stevens, Harkin, Kohl,
    and Feinstein.

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                         National Institutes of Health

    STATEMENT OF DR. RUTH L. KIRSCHSTEIN, ACTING DIRECTOR
    ACCOMPANIED BY:
            DR. YVONNE T. MADDOX, ACTING DEPUTY DIRECTOR, NATIONAL
                INSTITUTES OF HEALTH
            DR. RICHARD D. KLAUSNER, DIRECTOR, NATIONAL CANCER INSTITUTE
            DR. CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD
                INSTITUTE
            DR. HAROLD SLAVKIN, DIRECTOR, NATIONAL INSTITUTE OF DENTAL AND
                CRANIOFACIAL RESEARCH
            DR. ALLEN M. SPIEGEL, DIRECTOR, NATIONAL INSTITUTE OF DIABETES
                AND DIGESTIVE AND KIDNEY DISEASES
            DR. GERALD D. FISCHBACH, DIRECTOR, NATIONAL INSTITUTE OF
                NEUROLOGICAL DISORDERS AND STROKE
            DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
                AND INFECTIOUS DISEASES
            DR. MARVIN CASSMAN, DIRECTOR, NATIONAL INSTITUTE OF GENERAL
                MEDICAL SERVICES
            DR. DUANE ALEXANDER, DIRECTOR, NATIONAL INSTITUTE OF CHILD
                HEALTH AND HUMAN DEVELOPMENT
            DR. CARL KUPFER, DIRECTOR, NATIONAL EYE INSTITUTE
            DR. KENNETH OLDEN, DIRECTOR, NATIONAL INSTITUTE OF
                ENVIRONMENTAL HEALTH SCIENCES
            DR. RICHARD J. HODES, DIRECTOR, NATIONAL INSTITUTE ON AGING
            DR. STEPHEN I. KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS
                AND MUSCULOSKELETAL AND SKIN DISEASES
            DR. JAMES F. BATTEY, Jr., DIRECTOR, NATIONAL INSTITUTE ON
                DEAFNESS AND OTHER COMMUNICATION DISORDERS
            DR. STEVEN E. HYMAN, DIRECTOR, NATIONAL INSTITUTE OF MENTAL
                HEALTH
            RICHARD MILLSTEIN, DEPUTY DIRECTOR, NATIONAL INSTITUTE ON DRUG
                ABUSE
            DR. ENOCH GORDIS, DIRECTOR, NATIONAL INSTITUTE ON ALCOHOL ABUSE
                AND ALCOHOLISM
            DR. PATRICIA A. GRADY, DIRECTOR, NATIONAL INSTITUTE OF NURSING
                RESEARCH
            DR. FRANCIS S. COLLINS, DIRECTOR, NATIONAL HUMAN GENOME
                RESEARCH INSTITUTE
            DR. JUDITH L. VAITUKAITIS, DIRECTOR, NATIONAL CENTER FOR
                RESEARCH RESOURCES
            DR. STEPHEN E. STRAUS, DIRECTOR, NATIONAL CENTER FOR
                COMPLEMENTARY AND ALTERNATIVE MEDICINE
            DR. SHARON HRYNKOW, Ph.D., ACTING ASSOCIATE DIRECTOR FOR
                PROGRAM COORDINATION, FOGARTY INTERNATIONAL CENTER
            DR. DONALD A.B. LINDBERG, DIRECTOR, NATIONAL LIBRARY OF
                MEDICINE
            DR. NEAL NATHANSON, DIRECTOR, OFFICE OF AIDS RESEARCH
            DENNIS P. WILLIAMS, DEPUTY ASSISTANT SECRETARY, BUDGET

                   OPENING STATEMENT OF SENATOR ARLEN SPECTER

        Senator Specter. Good morning, ladies and gentlemen.
        The hour of 9:30 having arrived, we will proceed with the
    hearing for the Appropriations Subcommittee on Labor, Health,
    Human Services and Education.
        Today our hearing will focus on the National Institutes of
    Health, an extraordinary organization from very humble
    beginnings in 1887 with a budget of $300. The NIH today is
    comprised of 24 separate institutes and centers with 75
    buildings of medical care on more than 300 acres in Bethesda,
    MD. The budget is somewhat more than $300 today.
        And Senator Harkin and I have taken the lead on major
    increases, as you all know very well, with the cooperation of
    Congressman Porter and Congressman Obey on the House side.
        The achievements of NIH have been spectacular in my
    opinion. And we have added funding at very substantial amounts
    in recent years, frankly, over the--perhaps not quite over the
    objections, but without the enthusiasm of as many members of
    Congress as we would like to see.
        Three years ago, we put up a resolution to add $1 billion
    to NIH funding. And on a Senate vote, it was defeated 63 to 37.
    But we found the money, Senator Harkin, Senator Taylor and I,
    and the subcommittee, but candidly at the expense of other
    programs, because it was not budgeted. And we ended up with
    $907,000 million 3 years ago.
        Having lost the resolution for $1 billion, we decided the
    next year to try for $2 billion. And we got a few more votes,
    but still substantially under 50. And we found $2 billion 2
    years ago, as you all know.
        Last year, we went again for $2 billion and got a few more
    votes, but still less than 50. And Congressman Porter wanted to
    trump the Senate's $2 billion with $300 million more. And when
    we had the final roundup last year on the budget negotiations,
    the leadership in both the House and the Senate did not like
    it; we were taking too much money.
        But with your good work and our persistence, we put it in
    at $2.3 billion. And then there was the across-the-board cuts.
    So it came down to $2.2 billion.
        And this year we have put in a resolution for $2.7 billion.
    And a question which I consistently get is: Is there too much
    money being thrown at NIH? Is NIH able to utilize the money
    which it has? And then there is always the issue of how well it
    is being spent and what is being produced and what could be
    produced with more. And as the funding has gone up, of course,
    you have more applications for grants.
        So we talk about those 100 doors out there, and we are only
    opening 29 or 30 or 31 of them. But when the grants go up, or
    the appropriations go up, rather, then your grants come in with
    higher numbers.
        But this subcommittee is dedicated to funding NIH
    generously, because we think you are worth it. When you have a
    Federal budget of $1.850 trillion, $18 billion for NIH is not
    really, in my judgment, too much.
        Well, having said that, I think we do not need a hearing.
    We will just bring out the bank.

                  SUMMARY STATEMENT OF DR. RUTH L. KIRSHSTEIN

        NIH has been blessed with very able directors. We miss Dr.
    Harold Varmus and we miss Dr. Bernadine Healey. And we have an
    outstanding acting director at the moment.
        Dr. Ruth Kirschstein served as deputy director of NIH from
    July of 1993 until the present time. From 1974 to 1993, she
    served as the director of the National Institute of General
    Medical Sciences, the first woman to hold such a position. She
    came to NIH in 1956 as a medical officer in clinical pathology.
        Dr. Kirschstein, that is the same year I started practicing
    law. So you and I are experienced.
        She received her bachelor's magna cum laude from Long
    Island University and an M.D. from Tulane University School of
    Medicine.
        Welcome, Director Kirschstein. And the floor is yours.
        Dr. Kirschstein. Mr. Chairman, I and my colleagues
    appreciate all the wonderful things you have said about NIH
    this morning. And we want to pledge to you that we will
    continue to do excellent work.
        I am honored to appear before the subcommittee to present
    the President's budget for NIH for fiscal year 2001. As you
    have already said, I have been at NIH for many years. And
    although this is the first time I am testifying about the
    overall NIH budget, it has been my privilege to appear before
    this subcommittee annually for 19 years as the Director of the
    National Institute of General Medical Sciences.
        As you have also said, the increases for the NIH for fiscal
    year 1999 and 2000, both nearly 15 percent, were dramatic and
    unprecedented and have allowed us to undertake many new and
    important programs.
        And it has been the support of this subcommittee and the
    subcommittee in the House that has made a substantial
    difference in improving the public's health and well-being. And
    so the funds requested for fiscal year 2001 will permit us to
    continue our fiscal year 1999 and 2000 initiatives and allow us
    to begin some new ones.
        I would like to mention just two of the many, many advances
    that occurred during the last year: First, the completion of
    the first full sequence of a human chromosome, number 22. Its
    genes have importance for immune system function and in the
    development of congenital heart disease, schizophrenia, mental
    retardation and several cancers.
        And second, the identification of the gene that causes
    salmonella bacteria to be deadly when ingested in food. And
    this should open up the possibilities for the development of
    new antibiotics, as well as vaccines.
        In fiscal year 2001, we propose to emphasize first clinical
    research on diabetes, osteoporosis, heart disease, neurological
    diseases, cancer and a host of other serious diseases and
    disasters, particularly those that have a disparate effect on
    minority and underserved populations.
        Second, the neurosciences will be emphasized; third,
    genetic medicine; and fourth, bioengineering, bioimaging and
    biomedical computing.

                              PREPARED STATEMENTS

        Finally, Mr. Chairman, we will strive to ensure that the
    NIH supports new initiatives that offer the most promise of
    expanding knowledge and improving health and to ensure the
    support of an appropriate number of new and young investigators
    of the highest caliber.
        I and my colleagues will be happy to respond to your
    questions.
        [The statements follows:]

                 Prepared Statement of Dr. Ruth L. Kirschstein

        Mr. Chairman and Members of the Committee: I am Ruth Kirschstein,
    the Acting Director of the National Institutes of Health (NIH). I am
    honored to appear before the Subcommittee to present the President's
    budget for NIH for fiscal year 2001. Although this is the first time I
    have appeared before this Subcommittee to testify about the overall NIH
    budget, it has been my privilege to appear annually for 19 years as
    Director of the National Institute of General Medical Sciences. Mr.
    Chairman, your support and the support of the members of the
    Subcommittee, has made a substantial difference inimproving the
    public's health and well-being.
        Mr. Chairman, all of us, we at NIH, Members of Congress and the
    citizens we serve, have similar expectations for medical research. We
    want better ways of diagnosing and treating, and, in the long run,
    preventing and curing disease. And we want the federal dollars invested
    in medical research to result in the fulfillment of these expectations.
        In the last century, the scientific community, both public and
    private, worked in collaboration to cure or prevent once deadly
    infectious diseases that are now given no more thought than the common
    cold. I was fortunate enough to be at the forefront of the final
    development of the polio vaccine, one of the truly monumental
    achievements of the last century. There is not enough time today to
    list the astounding medical breakthroughs that followed our increased
    understanding of medical science. I will mention just a few: the
    development of antibiotics and organ transplantation, life-extending
    and life-saving cancer therapies, the identification of the AIDS virus
    and the drugs to treat AIDS, and discoveries involving the chemicals in
    the brain that are important in drug addiction and mental illness.
        As we begin a new century, medical science stands on the threshold
    of research advances that were once inconceivable. We have identified
    the genes responsible for a large number of our normal functions and
    the genetic abnormalities that cause many diseases, such as
    Huntington's disease, cystic fibrosis, and certain forms of deafness.
    You will hear much more from my colleagues.
        In his budget plan for fiscal year 2001, the President is
    requesting $18.8 billion for the NIH, an increase of $1 billion or 5.6
    percent more than the fiscal year 2000 appropriation. By any measure,
    the amounts we received in fiscal year 1999 and 2000, both nearly 15
    percent increases, were dramatic and unprecedented. These generous
    budgets have allowed us to undertake many new and important programs
    and to improve conditions throughout the medical research enterprise.
    The funds requested in fiscal year 2001 will permit us to continue our
    fiscal year 1999 and 2000 initiatives and to begin new undertakings and
    expand others under our Areas of Research Emphasis. I will say more
    about these areas later.
        We are pleased that the public, the Congress, and the
    Administration place a high value on good health and understand the
    role that medical research plays in improving the health of the
    American public. These improvements result from new diagnostic
    advances, more effective treatment options, better ways to prevent some
    diseases, and ways to delay the onset or progression of other diseases
    and disabilities.
        We feel confident of public support for our research enterprise,
    but are aware of our need to deliver to the public the two things it
    most wants from the NIH:
      --research advances, year after year, that improve the health of all
            members of society;
      --assurance that we spend the public's money wisely.

    What the Public Wants from the NIH: Research Advances that Contribute
            to the Health of Everyone

        In the past year alone, we have seen dramatic advances that are
    likely to have a direct, near-term effect on public health. The NIH
    will continue to emphasize clinical research in fiscal year 2001
    because it is critical in improving public health:
      --Scientists completed the first sequence of a human chromosome, 22,
            which has been implicated in immune system function, congenital
            heart disease, schizophrenia, mental retardation, birth
            defects, and several cancers, including leukemia. The 33.4
            million nucleotides that make up chromosome 22 comprise the
            longest continuous stretch of DNA ever deciphered. The
            magnitude of this work is amplified by the insights it will
            give us into many diseases.
      --A clinical trial (carried out in cooaboration with scientists and
            clinicians in Uganda) has demonstrated an affordable and
            practical strategy for preventing transmission of the HIV virus
            from mother to infant. A single oral dose of the antiretroviral
            drug nevirapine given to an HIV-infected woman during labor and
            another to her baby within three days of birth reduced the
            transmission of virus by half compared with a similar short
            course of AZT. This treatment might prevent some 300,000 to
            400,000 newborns per year from becoming infected and eventually
            developing AIDS at a cost which is affordable in developing
            countries.
      --Preeclampsia is a precursor to eclampsia, a potentially fatal
            complication of pregnancy. It is characterized by high blood
            pressure, excessive weight gain, and severe headaches.
            Eclampsia leads to convulsions and causes a variety of birth
            complications. Months before symptoms appeared, women with
            preeclampsia were compounds, prostacyclin and thromboxane,
            which control blood pressure. The discovery suggests new and
            early treatments for this condition for which there is
            currently no cure or treatment.
      --An important gene that makes Salmonella a deadly bacterium was
            identified. Without the gene, which encodes for the enzyme
            called Dam, Salmonella bacteria not only did not kill the mice
            into which they were injected, but also serve as a vaccine
            against future infection by deadly Salmonella. Because Dam is
            found in many other dangerous bacteria, this discovery opens
            possibilities for a whole new generation of antibiotics and
            vaccines.

    What the Public Wants from the NIH: Assurance that its Funding is Well
            Spent

        It is clear that the public wants a fuller understanding of the
    NIH's funding allocations and how it sets priorities--that is, an
    assurance that the taxpayers' dollars are well spent. We believe, in
    fact, that the more the public knows about our processes the more it
    will support both what we do and how we do it. I want to touch on six
    principles relevant to establishing priorities:
      --An obligation to respond to public health needs, judged variously
            by the incidence, severity, and cost of specific disorders.
            However, calculations cannot be correlated with research
            spending in a simple manner.
      --A responsibility to capitalize on previous discoveries and to eize
            the scientific opportunities that offer the best prospects for
            obtaining new knowledge and better health. Not all problems are
            equally approachable, regardless of their importance to public
            health. Some only yield to a new technology or insight. We
            must, however, create environments that stimulate new ideas
            about difficult problems.
      --A need to maintain a diverse portfolio on a wide range of diseases.
            We cannot always know in advance which discovery will be
            applicable to which disease.
      --An obligation to insure first-rate scientific workforces and
            research facilities.
      --A need to seek advice from many sources, including the public.
      --And last, but truly foremost in our minds, a commitment to support
            scientific work of the highest caliber.
        Peer review is the cornerstone of our efforts to fund the best
    science. To identify research worthy of funding, about 40,000 grant
    applications are peer reviewed at the NIH each year. Of these,
    approximately 75 percent are evaluated within the NIH Center for
    Scientific Review (CSR). The NIH is ensuring that CSR has sufficient
    resources so that its review will recognize, and capitalize on, the
    opportunities created by the diverse successes of the medical research
    enterprise, will anticipate emerging fields of research, and
    accommodate to the rapid pace of scientific change.
        In 1998, the Congress asked the Institute of Medicine (IOM) to
    review the NIH's process for setting priorities. While supporting our
    principles, the IOM made some useful suggestions about ensuring that
    our programs are responsive to the public. Over the past year, NIH has
    responded by appointing a Council of Public Representatives (COPR). The
    COPR improves our accountability by bringing public views to the NIH,
    by looking at how the NIH carries out different aspects of its mission,
    and by conferring on trans-NIH issues. The COPR will be involved in
    many aspects of NIH programs and policies.
        Following another suggestion in the IOM report, this past year the
    NIH Director required each Institute and Center to produce a strategic
    plan of research needs and opportunities over two to five years. The
    plans were developed with input from a wide range of NIH constituents,
    including patient and other health advocates, scientists, health-care
    providers, the Congress, the Administration, NIH staff, and other
    representatives of the public. These strategic plans will be available
    in the near future and should improve public understanding of the
    challenges all components of the NIH are facing.
        This past year, for the first time, the NIH held a Budget Retreat
    in June to help develop its presentation of priorities and Areas of
    Research Emphasis for the President's 2001 budget. The meeting involved
    ten external advisors, five from COPR and five from the Advisory
    Committee to the Director (ACD), and created enthusiasm for new areas
    for collaboration across institutes.
        In another major effort to bring public views to bear upon the
    NIH's programs, priorities, and activities, 26 individuals from outside
    the agency--scientists, physicians, other health-care providers,
    patients, and representatives of the ACD and the COPR--met in October
    to evaluate the scientific quality and relevance of the outcomes of NIH
    research, a requirement of the Government Performance and Results Act.
    A report of their assessment has been sent to the Congress as part of
    the President's budget.

    Realizing the Potential of the fiscal year 2001 Budget Request

        Generous increases in the last two budget cycles have allowed the
    NIH to begin many new programs. The funds requested for fiscal year
    2001 will advance these programs and, with sound management, allow us
    to begin new ones. To ensure that NIH can support new initiatives that
    offer the most promise of expanding knowledge and improving health, and
    to ensure our ability to support a healthy number of new and young
    investigators, we will limit growth in commitments and in the size of
    awards to a two percent average increase for new and continuing grant
    awards. In addition to initiatives on mental health, cancer, and
    diabetes, new activities include:
        Clinical Research.--To take full advantage of rapid research
    advances in the last five years, which have provided abundant new
    therapies to study, the NIH will begin a series of programs to expand
    clinical research. Career development programs will continue to improve
    the number and quality of investigators. We will start new pilot and
    early-phase clinical trials thereby speeding the testing of new
    therapies. We will develop new, and expand older, networks for multi-
    center studies of pediatric cardiovascular disease, diabetes, digestive
    diseases, and treatment for drug abuse. We will establish new multi-
    center clinical trials to evaluate complementary and alternative
    medical practices for insomnia, pain relief, and liver diseases.
    Moreover, the public will have greater access to new information on an
    expanded national clinical trials database (ClinicalTrials.gov) to be
    launched soon . It will carry information on the many clinical trials
    funded by the NIH, by other federal agencies, and by industry.
        Health Disparities.--The NIH has a central role to play in
    eliminating persistent, even increasing, health disparities through
    medical research, research training, and dissemination of
    scientifically sound medical information. In fiscal year 2001, the NIH
    will continue to invest in this area, allocating $20 million to
    establish a new Coordinating Center for Research on Health Disparities
    within the Office of the NIH Director. A new trans-NIH Working Group
    will develop a strategic plan to eliminate or reduce health disparities
    among different segments of the American population. The plan, will
    include goals, timetables, and mechanisms for tracking budgets and
    accomplishments.
        Genetic Medicine.--Last November, the Human Genome project finished
    sequencing one billion of the estimated three billion base pairs of
    human DNA and deposited them in GenBank, NIH's public database, thus
    putting us on schedule to have a working draft of the full human genome
    by this spring. Scientists can use this information to find the genes
    involved, e.g., in heart diseases, cancer, epilepsy, Alzheimer's, and
    psychiatric disorders. Companion activities, like developing genomic
    resources for organisms such as mice, rats, and fruit flies, will help
    speed the arrival of more precise medical interventions. We are rapidly
    moving to a time when diagnosis, treatment and even prevention will
    depend on a precise understanding of the genetic makeup of an
    individual.
        Neurosciences.--This is a particularly exciting time for expansion
    of research in fields of neuroscience, such as neurogenetics and
    imaging. To foster collaboration and sharing of ideas among the many
    Institutes which support intramural research in this area, we are
    requesting funds for construction of a facility for the new National
    Neuroscience Research Center to house outstanding trans-NIH
    neuroscience research programs. A total of $73 million is requested
    over two years, with $47 advance for fiscal year 2002.
        Other Sciences, Including Biomedical Computing.--Many medical
    advances build on the knowledge and technology of other scientific
    disciplines. To exploit our new understanding of biological processes,
    we need new teams of diverse and skilled researchers to overcome
    complex technological and research problems. In fiscal year 2001, NIH
    will establish an Office of Bioengineering and Bioimaging to help the
    Institutes and Centers set priorities in these areas of science and to
    enhance collaboration with other agencies.
        Based on a report by outside experts, NIH has developed the
    Biomedical Information Science and Technology Initiative to work toward
    an intellectual fusion of biomedicine and information technology. In
    fiscal year 2001, the NIH plans to provide the infrastructure to train
    the next generation of interdisciplinary scientists, to develop new
    means for storing, managing, and accessing vast data collections, and
    to enhance basic research in biomedical computing.
        Mr. Chairman, that concludes my opening statement. I will be glad
    to respond to any questions.
                                     ______

                   Prepared Statement of Dr. Yvonne T. Maddox

        Mr. Chairman, Members of the Committee: I am pleased to be here
    today to discuss the fiscal year 2001 budget request for the Office of
    the Director (OD). The OD provides leadership and coordination for the
    research activities of NIH, both extramural and intramural. The OD also
    is responsible for a number of special programs and for management of
    centralized support services essential to the operation of the entire
    NIH.
        The President has proposed that the OD receive $262.5 million in
    fiscal year 2001, an increase of $25.2 million over the comparable
    fiscal year 2000 appropriation. Including the estimated allocation for
    AIDS in both years, total support proposed for the OD is $309.0
    million, an increase of $27.0 million over the fiscal year 2000
    appropriation. Funds for OD efforts in AIDS research are included
    within the Office of AIDS Research budget request.
        The OD guides and supports research by setting priorities;
    allocating funding among these priorities; developing policies based on
    scientific opportunities and ethical and legal considerations;
    maintaining peer review processes; providing oversight of grant and
    contract award functions and of intramural research; communicating
    health information to the public; facilitating the transfer of
    technology to the private sector; and providing fundamental management
    and administrative services such as budget and financial accounting,
    and personnel, property, and procurement management, administration of
    equal employment practices, and plant management services, including
    environmental and public safety regulations of facilities. The
    principal OD offices providing these activities include the Office of
    Extramural Research (OER), the Office of Intramural Research (OIR), and
    the Offices of: Science Policy; Communications and Public Liaison;
    Legislative Policy and Analysis; Equal Opportunity; Budget; and
    Management. This request contains funds to support the functions of
    these offices.
        The OD also maintains several trans-NIH offices and programs to
    foster and encourage research on specific, important health needs. I
    will now discuss the budget requests for each of these trans-NIH
    offices in greater detail.

    HEALTH DISPARITIES, THE OFFICE OF RESEARCH ON MINORITY HEALTH, AND THE
                           MINORITY HEALTH INITIATIVE

        The Secretary, through the Department's Healthy People 2010
    initiative, has made a major commitment to reduce health disparities
    affecting minorities and other medically underserved socioeconomic
    groups of Americans. To address these inequities, NIH has established
    health disparities research as a budget priority and an area of
    emphasis. This year, we have established the Office of Research on
    Minority Health (ORMH) as the Coordinating Center for developing a
    trans-NIH Strategic Plan for Health Disparities that will integrate the
    various research activities of the ICs toward the goal of significantly
    reducing health disparities. Additionally, in fiscal year 2001, NIH is
    requesting $20 million in new funding and related legislative authority
    for the Coordinating Center to award grants for minority health
    research under exceptional circumstances, when the Institutes and
    Centers do not fund such research that has been identified as a
    priority.
        The Minority Health Initiative (MHI) is a comprehensive, trans-NIH
    program with a focus on developing and testing ways to reduce the
    disproportionate burden of disease among minority populations and on
    developing strategies to promote positive health behaviors across the
    life span. The MHI specifically targets the elimination of health
    disparities experienced by racial and ethnic minority populations in
    four key areas: infant mortality; breast, cervical, and prostate cancer
    screening and management; cardiovascular disease; and complications
    arising from diabetes. The MHI will also support the Minority
    Institution Cancer Center Partnerships designed to create collaborative
    relationships between institutions that primarily serve minorities and
    the NCI-designated cancer centers to conduct research, training,
    education, and outreach activities that focus on the disproportionate
    incidence of cancer in ethnic minority populations.

                        THE OFFICE OF DISEASE PREVENTION

        The Office of Disease Prevention (ODP) has several specific
    programs/offices that strive to place new emphasis on the prevention
    and treatment of disease.
        In fiscal year 2001, the Office of Dietary Supplements (ODS) will
    continue to develop the Dietary Supplements Research Centers
    Initiative. Currently, three such Centers are being funded in
    conjunction with the National Center for Complementary and Alternative
    Medicine (NCCAM), the National Institute of General Medical Sciences
    (NIGMS), the National Institute of Environmental Health Sciences
    (NIEHS), and the Office of Research on Women's Health (ORWH). The long-
    term goal of the Initiative is to fund eight Centers, four on
    botanicals and four on other categories of dietary supplements. The ODS
    will continue to support investigator-initiated research through the
    Research Enhancement Awards Program (REAP), and through collaborations
    with other Institutes and Centers at NIH.
        In continuing efforts to inform the public about the benefits and
    risks of dietary supplements, the ODS plans to release a new computer
    information database on dietary supplements, and will offer, with the
    NIH Clinical Center, the first collection of public-oriented
    information pages (fact sheets) on specific dietary supplements, in
    print and through Internet access. ODS will follow with a series of
    fact sheets for botanical and herbal supplements to be released in
    collaboration with NCCAM.
        Another component of ODP, the Office of Rare Diseases (ORD),
    supports research activities on rare diseases and conditions, develops
    and disseminates information to health care providers and patient
    support groups, and forges links among investigators with ongoing
    research activities in this area. The ORD continues to support
    workshops and symposia to stimulate research and to identify research
    opportunities related to rare diseases. The effectiveness of these
    workshops as a valid mechanism to stimulate research on rare diseases
    and conditions is now being evaluated.

             THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH

        As NIH continues its efforts to improve health outcomes, there is
    increasing awareness that many of our most serious health concerns are
    related to individual behaviors and social context. In fact, four
    health-damaging behaviors-tobacco use, physical inactivity, dietary
    patterns, and alcohol abuse--are responsible for nearly 40 percent of
    the annual deaths in our Nation. The Office of Behavioral and Social
    Sciences Research (OBSSR) works to integrate a psychological and social
    perspective across all research programs at NIH and to increase the
    support for behavioral and social science research and training.
        One strategy that OBSSR uses to increase support for behavioral and
    social sciences research is the development of broad trans-NIH
    initiatives that address issues relevant to many Institutes and
    Centers. In order to gain a better understanding of the obstacles and
    facilitators to engaging in healthy behaviors, OBSSR and 16 other NIH
    Offices, Institutes and Centers recently specifically solicited grant
    proposals for research on disease prevention through behavior change
    which focused on tobacco use, insufficient exercise, poor diet and
    alcohol abuse. The OBSSR, with several ICs, also supports centers to
    investigate aspects of the interactions between mind and body in health
    and disease. In addition, OBSSR has joined with 12 Institutes to
    solicit grant applications addressing the problem of inadequate
    adherence to prescribed medications and therapies.
        OBSSR has long been concerned about the issue of violence in our
    society as a public health problem, and has worked to establish a
    trans-NIH Expert Panel on Youth Violence. This panel found that more
    research on youth violence interventions was needed. Subsequently,
    OBSSR developed a trans-NIH grant solicitation for interventions to
    prevent and reduce youth violence.

                    THE OFFICE OF RESEARCH ON WOMEN'S HEALTH

        The Office of Research on Women's Health (ORWH) is the focal point
    for women's health research at NIH and strives to ensure that research
    supported by NIH addresses the health concerns of women, that women are
    appropriately included as subjects in research protocols and clinical
    trials, and that women are encouraged to pursue careers in medical
    research. The science-based activities of ORWH are determined by the
    Agenda for Research on Women's Health for the 21st Century, an agenda
    developed following public hearings and scientific workshops involving
    some 1,500 representatives dedicated to improving the health of women.
    In fiscal year 2001, the ORWH will pursue a number of recommendations
    within this agenda including research on the effects on women of
    therapeutic agents, studies to develop gender-based treatments for
    kidney disease, studies that address prevention and elimination of lung
    cancer in women. In addition, the ORWH will support career development
    programs that encourage the pursuit of interdisciplinary research
    careers relevant to women's health and encourage patient-oriented or
    population-based clinical research careers. Finally, ORWH will continue
    to monitor compliance with established policies for the inclusion of
    women and minorities in clinical research.

                              OTHER OD ACTIVITIES

        The OD also supports a number of additional NIH programs that
    promote research and enhance research career development.
        The Office of Extramural Research (OER) coordinates the Academic
    Research Enhancement Award (AREA) program to provide grants to
    institutions that award degrees in health sciences but are not major
    recipients of NIH grant funds. These awards enable college students to
    participate in research projects and encourage them to pursue careers
    in medical research. OER also sponsors the Extramural Associates
    Research Development Award (EARDA) program to provide competitively
    awarded grants to institutions that have a significant enrollment of
    underrepresented minority students who, with their faculty, participate
    in medical research programs. The grants are designed to provide
    faculty at these institutions with skills needed to become more
    competitive in obtaining Federally sponsored research funds.
        In May of fiscal year 2000, the Office of Bioengineering/Bioimaging
    (OBB) will be established within the OER to advance the fields of
    bioengineering and bioimaging. OBB will foster new collaborations among
    the biomedical and engineering/physical sciences with the goals of
    developing innovative technologies and novel products for improving
    human health.
        The OBB will develop and coordinate programs for transdisciplinary
    training and career development, sponsor major symposia and smaller
    meetings aimed at enhancing communication among the biomedical and
    engineering/physical science communities, and focus attention on
    research in bioengineering and bioimaging. The OBB will also coordinate
    the Bioengineering Consortium (BECON), which consists of senior
    bioengineering representatives from all NIH research institutes and
    centers and other federal agencies.
        The OER request will also provide funds for the new Extramural
    Clinical Research Loan Repayment Program. This program is designed to
    counter economic barriers to the pursuit of clinical research careers
    and to provide an incentive to engage in this area of research. The
    program will award contracts to repay the educational costs of health
    professionals conducting clinical research in extramural institutions
    who agree to enter into two-year service contracts to pursue clinical
    research.
        The NIH, through the Office of Intramural Research (OIR), maintains
    intramural loan repayment and scholarship programs as important
    instruments for recruiting high quality candidates in basic and
    clinical research positions. The request contains funds for the NIH
    Clinical Research Loan Repayment Program and the Undergraduate
    Scholarship Program, both for individuals from disadvantaged
    backgrounds, and for the General Research Loan Repayment Program. Each
    program provides for the payment of educational costs in return for
    specific commitments of service in NIH's intramural research
    facilities.
        The Office of Science Policy (OSP) has a role in addressing science
    policy issues on behalf of NIH and in coordinating several science
    education activities. Specifically, the OSP has developed, with the
    Institutes and Centers, curriculum supplements to complement existing
    science curricula in grades K-12 that benefit both students and
    teachers and encourage students to consider careers in research.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        I will be pleased to answer questions.
                                     ______

                 Prepared Statement of Dr. Richard D. Klausner

        Mr. Chairman and Members of the Committee: I am pleased to appear
    before you for the fifth time to describe our progress in and hopes for
    the programs of the National Cancer Institute (NCI). I would also like
    to recognize with personal sadness that this will be the last hearing
    where I will have the pleasure of appearing before our remarkable
    Chairman, Mr. Porter.

                              THE BURDEN OF CANCER

        Each year, I have begun this testimony by reporting one critical
    measure of the cancer burden, the annual statistics of cancer
    incidence, survival rates and mortality. We have recently begun to
    review the latest numbers and the decrease in overall cancer mortality
    rates first observed in the early 1990s are accelerating between 1995
    and 1997, the latest year for which we have data. Drops continue to be
    seen for the four major cancer sites of lung, colorectal, breast and
    prostate. Cancer sites where mortality rates are still increasing
    include liver and non-Hodgkin's lymphoma. Overall, mortality rate drops
    are seen in both the black and white population. Remarkably, the
    magnitude of these drops are such that, for the first time, between
    1996 and 1997, the total number of cancer deaths did not rise, despite
    a growing and aging population.
        As this Subcommittee has discussed before, the burden of cancer is
    not equally experienced across our population. Monitoring rates and
    trends over time, by geography, by gender, age and racial and ethnic
    groups has been a priority for the NCI. We are particularly concerned
    about the disproportionate burden of cancer among the poor, the
    medically underserved and among certain ethnic minorities. In response
    to our planning processes, we are in the midst of a number of
    expansions in our programs aimed at the ability to assess, explain and
    affect the unequal burden of cancer. These expanded and new initiatives
    address the important message of last year's Institute of Medicine
    (IOM) report on the unequal burden of cancer.
        We are in the process of expanding the Surveillance Epidemiology
    and End Results (SEER) program (our cancer surveillance program) to
    enhance coverage of rural whites and blacks, non-Mexican Hispanics and
    Native Americans. We are completing a new Memorandum of Understanding
    (MOU) with the Centers for Disease Control and Prevention (CDC) to
    formalize collaboration and integration of the NCI's surveillance and
    surveillance research programs with the CDC's National Program of
    Cancer Registries. This will allow a strategic integration of the NCI's
    more intensive surveillance and research system with the CDC-funded
    state registry systems, to help develop data standards and tools for
    pooling data.
        In fiscal year 2000, we will begin to fund a new research program
    to create Special Population Networks (SPNs) for cancer control and
    research. These new consortia will be based within various communities
    serving different segments of our diverse society in order to establish
    cancer control and research infrastructures to work within and to serve
    these communities. To support the activities of these SPNs, we are
    establishing a cancer control academy at the NCI for training and will
    link these community-based research networks to the full range of
    information and communication resources of the NCI. These SPNs, we
    hope, will provide the basis for a new national platform for cancer
    research to address the distinct cancer burdens of special populations.
    We are setting aside $50-60 million over five years to fund about 14
    SPNs, the largest program of its kind we have ever funded.
        This year, in collaboration with the NIH Office of Research on
    Minority Health, we began funding five research partnerships between
    NCI-designated cancer centers and minority institutions to create
    active and successful research programs linked to our most successful
    cancer research institutions. We plan to release a new Request for
    Applications (RFA) to sustain and enhance these new enterprises. A more
    complete description of our activities in this crucial area can be
    found at the NCI Office of Special Populations Research Web site
    (www.ospr.nci.nih.gov).
        Monitoring cancer incidence and mortality trends can help us
    formulate questions about the distribution of cancer control and care,
    as well as about possible causes of cancer. This year, the NCI
    released, for the second time in its history, 25-year cancer mortality
    maps. These cover all 3,100 United States counties and state economic
    areas, for 40 cancer sites, by gender and race. These maps are
    available on the NCI Web site in a user-friendly and dynamic format.
    They do not tell us causes of cancer or indeed whether a geographic
    pattern reveals either a localized environmental factor, a behavioral
    pattern or a socio-economic pattern. But, by providing the starting
    point for addressing these issues, these maps are crucial resources.
    The NCI will release a Request for Application (RFA) to support two
    types of studies linked to these maps: epidemiologic research to search
    for explanations for geographic and temporal cancer patterns, and
    methodologic research to develop Geographic Information Systems (GIS)
    for evaluating environmental associations with cancer. These maps are
    one part of NCI's extensive ($472 million in fiscal year 1999) program
    in establishing environmental (exogenous) causes of cancer.

                           PROGRESS IN BASIC RESEARCH

        Progress in our understanding of the biology of cancer continues at
    an astonishing pace. Let me highlight two examples. For decades,
    scientists have tried to define the minimum number of molecular changes
    and the number and nature of molecular pathways that must be perturbed
    to turn a normal cell into a cancer cell. This year, NCI-funded
    investigators identified that alterations of only three genes and four
    molecular pathways are sufficient to transform a normal human cell to
    one capable of producing a tumor. These identified pathways are already
    providing long-sought targets for new therapeutics. Identifying the
    specific molecular pathways that define each type of human cancer has
    allowed us to begin to replicate these changes in the genes of mice. As
    predicted, these mice develop cancer and for the first time, we can
    accurately mimic human cancer in the mouse. This is allowing us to
    finally test whether molecular changes associated with human cancer and
    its development are actually the causes of the progression and behavior
    of cancer. To accelerate the output of these breakthroughs and to use
    them to discover and test ways of preventing and curing cancer, we have
    established the Mouse Models of Human Cancers Consortium, an
    international collaboration of over 70 institutions. This consortium
    will support the development and validation of mouse models for human
    cancer. It is a new research structure that will enable the sharing of
    reagents and expertise, the development and dissemination of new
    technologies, the establishment of standards and prioritization of
    research questions. We hope to expand the activities of the MMHCC to
    support the development and utilization of these important new cancer
    research tools.

                   NEW APPROACHES TO DETECTION AND DIAGNOSIS

        The knowledge that cancer cells develop by changing their molecular
    profile has set the stage for a new and systematic approach to both
    early detection and accurate diagnosis. Three years ago, the NCI set
    out to establish a full index of all the genes that are altered in each
    type of cancer. This project, called the Cancer Genome Anatomy Project
    or CGAP, has been extremely successful, identifying tags for the vast
    majority of human genes, annotating what types of cells and cancers
    express those genes, developing catalogues of chromosomal changes in
    cancer and discovering common genetic variations that will help to
    explain why individuals are different in their risk of getting cancer,
    their sensitivity to diet and the environment and their response to
    therapy. CGAP has become one of the most widely used sources of
    information and reagents in the research world (www.ncbi.nlm.nih.gov/
    ncicgap/).
        As we approach a complete list of all of the molecular tags
    associated with each cancer and its development, we can systematically
    search for ``markers'' for the early detection of cancer. To utilize
    the wealth of discovery coming from CGAP in the development of cancer
    markers, we have created a new national research infrastructure, called
    the Early Detection Research Network (EDRN). The EDRN is a novel and
    complex research structure established to discover, develop and
    validate markers for the early detection of cancer. Researchers from
    multiple institutions will work together to assure that potential
    markers are prioritized, developed into reliable and standardized
    assays and validated on readily available and well characterized
    clinical materials. Four components of the EDRN are now funded: (1)
    Marker discovery laboratories (18 institutions); (2) Marker development
    laboratories (2 institutions); (3) Clinical and Epidemiology Centers (8
    institutions); and (4) a data and statistical center. In its first
    year, the EDRN will focus on markers for breast, prostate, ovarian,
    lung and GI cancers.
        Systematic gene discovery through CGAP and other projects is about
    to profoundly change our approach to the classification and therefore
    the accurate diagnosis of cancer. To do this has required the
    development and dissemination of new technologies to read the complete
    molecular profiles of cancer. To enable this, the NCI funded the
    establishment of 24 ``microarray'' centers across the country. Next,
    the Institute announced a new funding initiative called the Director's
    Challenge whose goal is to identify new molecular classification
    schemes for cancer to replace the purely histologic schemes of the last
    century. The initial funding established 10 consortia involving 24
    institutions addressing breast, prostate, ovarian, and colorectal
    cancers as well as lymphomas and leukemias. Already, results from these
    groups are revealing new types and subtypes of cancer that appear to
    predict which patients will respond to particular therapies. This year,
    we hope to expand this program to more types of cancer and to define
    the clinical implications of these new classes of cancers to help
    predict prognosis and guide the choice of therapy.

                                 IMAGING CANCER

        Four years ago, the NCI identified imaging as one of its
    extraordinary opportunities for investment. We have developed new
    funding mechanisms for exploratory, innovative grants (almost 150
    grants received), the establishment of six small animal imaging
    centers, and the establishment of a national clinical trials network to
    rapidly evaluate the clinical utility of new imaging approaches. This
    network, called the American College of Radiology Imaging Network
    (ACRIN) has a number of clinical trials in preparation including a
    comparison of Magnetic Resonance (MR) and Computed Tomography (CT) in
    gynecologic malignancies, the use of Positron Emission Tomography (PET)
    to follow response to chemotherapy, the value of spiral CT for lung
    cancer screening, comparative studies of virtual colonoscopy and of
    digital mammography. We are also funding the development of centers to
    foster the new field of functional imaging, whereby we can detect not
    only the presence of a tumor but query its molecular characteristics
    and its behavior. This year, we will be able to fund 2-3 full multi-
    disciplinary In Vivo Cell and Molecular Imaging Centers (ICMICs). In
    addition, 27 institutions have applied to receive planning grants to
    develop such centers. This year, we created the Unconventional
    Innovations Program (UIP) aimed at developing truly novel detection and
    imaging systems by bringing revolutionary technologies of molecular
    sensing, nanoscale devices and microexplorers to enable the remote
    sensing of cancer. We have funded six consortia of investigators to be
    part of this program and hope to add more members in response to a
    second release of this Broad Agency Announcement. Over the past year,
    our investment in imaging research and technology has increased 30
    percent.
        Finally this year, the NCI organized a unique forum to bring
    together academics, industry (through the National Electrical
    Manufacturer's Association), the Food and Drug Administration (FDA) and
    Health Care Financing Administration (HCFA) to coordinate practices
    relevant to the development, testing and adoption of new imaging
    modalities and applications. This collaborative enterprise will be a
    standing forum to facilitate communication and progress in this
    critical area.

          MOLECULAR TARGETS--NEW APPROACHES TO PREVENTION & TREATMENT

        For the past three years, the NCI has been redirecting its drug
    discovery program to one based on the success of basic research in
    identifying the precise molecular targets implicated in the development
    (prevention targets) and behavior/survival (therapeutic targets) of
    cancer. The recent encouraging results of Herceptin for the treatment
    of advanced breast cancer, Rituximab for the treatment of non-Hodgkin's
    lymphoma, STI 571 for the treatment of leukemia, tamoxifen for reducing
    the risk of breast cancer and a growing list of others, all point to
    the future face of molecularly targeted therapeutics and preventives.
    We have funded four new centers to develop new libraries of chemical
    diversity and to screen for promising molecular targets, and this year,
    we will fund new Centers of Excellence for drug development, each of
    which will focus on specific cancer pathways to speed the discovery of
    useful targets.
        Last year, we initiated a novel program called RAID (Rapid Access
    to Intervention Development) that evaluates promising drug candidates
    in the laboratories of academic investigators and, via peer review,
    manages the movement of these candidate drugs from the lab to the point
    of clinical trial. To date, 32 novel agents have entered the RAID
    pipeline and in one year 4 have reached or are ready for clinical
    trials. We will expand this successful program in the coming year.

            CLINICAL TRIALS--A CORNERSTONE OF PROGRESS FOR PATIENTS

        Last year, the NCI supported over 1500 clinical trials in
    prevention and treatment, covering virtually all human cancers and
    asking a wide variety of clinical questions. We initiated the formal
    restructuring of our national clinical trials system, as described to
    the Subcommittee last year. This restructuring is aimed at improving
    the quality of scientific questions asked, increasing the speed and
    efficiency and decreasing the administrative burdens of participating
    in clinical trials. Furthermore, it aims to assure that all patients
    and all participating physicians have access to the full menu of
    available clinical trials. This year, we continued the development and
    deployment of a standard informatics system, funded a central Clinical
    Trials Support Unit to serve the entire national clinical trials system
    and began disease-specific state-of-the-science meetings to develop
    prioritized clinical trials questions and opportunities. This past
    year, 20,000 new patients were enrolled in NCI-sponsored treatment
    trials. Over the past three fiscal years, our investment in our
    national clinical trials program has increased almost 43 percent.
        Clinical trials are complicated enterprises, and streamlining and
    improving their function while maintaining the highest standards of
    rigor, care and protection of human subjects requires attention to many
    different facets of the initiation, review, approval, funding,
    oversight and management of trials. This year, we have continued to
    expand the use of simplified and uniform informed consent documents and
    in the spring, in collaboration with the Office for Protection from
    Research Risks (OPRR), we will begin an important pilot project to test
    the feasibility and performance of a central Institutional Review Board
    (IRB) for multi-institutional trials.
        This year, we unveiled a new, user-friendly clinical trials
    information system to enable patients and physicians to readily access
    information about all NCI-sponsored trials (www.cancernet.nci.nih.gov).
    We continue to work with the FDA and industry to expand this database
    to include industry and other sponsored trials.
        Each year, clinical trials results help shape the course of
    clinical practice and set the stage for new questions that need to be
    addressed. This year, we saw the first, long-awaited results on the
    value of high dose chemotherapy with peripheral stem cell or bone
    marrow rescue for women with advanced breast cancer. These results did
    not support the significant and hoped-for benefits that this approach
    demonstrated in earlier, non-randomized clinical trials. These results
    underscored the crucial role that such clinical trials play in the type
    of evidence-based medicine to which we all aspire. In the past two
    years, the results of clinical trials have set new standards for
    increasing the effectiveness and reducing the toxicity of regimens for
    childhood cancers, leukemia, myeloma, breast cancer, ductal carcinoma
    in situ (DCIS), cervical cancer, head and neck cancer, lymphoma,
    colorectal cancer, prostate cancer and others.

                     QUALITY CANCER CARE--A RESEARCH AGENDA

        One of the themes of NCI activities is to address gaps--gaps
    between what we need to know and our current state of knowledge, gaps
    between the burden of cancer across different segments of our
    population, and gaps between scientific discovery and medical
    breakthroughs. One of the most important gaps is between evidence-based
    best practice and actual practice. It is this last gap that we intend
    to address via a new major initiative called the Quality Cancer Care
    Committee (QCCC). This initiative was formulated in response to a
    recent report of the National Cancer Policy Board (NCPB) called
    ``Ensuring Quality Cancer Care.'' The NCPB was established at my
    request as part of the Institute of Medicine (IOM) of the National
    Academy of Sciences. Its purpose is to provide a forum of independent
    and broad-based expertise to advise the Nation on cancer-related policy
    issues. The QCCC will be a trans-agency initiative led by the NCI to
    develop a comprehensive research infrastructure to address the issues
    of quality cancer care across the cancer continuum from prevention to
    treatment to survivorship and end-of-life care; and to provide a
    mechanism whereby the health delivery and reimbursement activities of
    DHHS, especially HCFA, are informed by a discussion of evidence and
    through direct interaction with the cancer research agenda of the
    various research agencies of the Department. The research agenda of the
    QCCC will focus in four areas: 1) developing measures of cancer
    outcomes; 2) strengthening the methodologic and empiric base for
    quality assessment; 3) strengthening the national clinical trials
    infrastructure; and 4) improving the quality of cancer communications.
        I am pleased to present the President's non-AIDS budget request for
    NCI for fiscal year 2001, a sum of $3.25 billion which reflects an
    increase of $183 million over the comparable fiscal year 2000
    appropriation. Including the estimated allocation for AIDS, total
    support requested for NCI is $3.505 billion an increase of $193 million
    over the fiscal year 2000 appropriation. Funds for the NCI efforts in
    AIDS research are included within the Office of AIDS Research budget
    request. With this, we can sustain the many new and productive
    programs, some of which I have tried to illustrate in this testimony.
        NIH budget request includes the performance information required by
    the Government Performance and Results Act (GPRA) of 1993. Prominent in
    the performance data is NIH's first performance report which compares
    our fiscal year 1999 results to the goals in our fiscal year 1999
    performance plan. As our performance measures mature and performance
    trends emerge, the GPRA data will serve as indicators to support the
    identification of strategies and objectives to continuously improve
    programs across the NIH and the Department.
                                     ______

                    Prepared Statement of Dr. Claude Lenfant

        Mr. Chairman and Members of the Committee: I am pleased to address
    this Committee, once again, on behalf of the National Heart, Lung, and
    Blood Institute (NHLBI). During the latter half of the Twentieth
    Century, tremendous progress was made in improving the health of the
    American public. Research supported by the NHLBI was instrumental in
    enabling us to diminish, halt, and eventually reverse the epidemic of
    deaths from two major chronic diseases--coronary heart disease and
    stroke. Vital statistics indicate that, since its peak in 1963, the
    death rate for coronary disease has fallen 60 percent and the rate for
    stroke fell 66 percent during that time period. This has been a
    tremendous achievement.
        Nonetheless, these two diseases have retained their ranking as the
    first and third most common causes of death in the United States and,
    during the past decade, mortality has not fallen as rapidly as it once
    did. We have, in a sense, weeded out many of the ``easy'' cases; those
    that remain are more complex and demand far more sophisticated
    solutions. Our challenge is twofold: first, to make maximal use of the
    new technologies that are rapidly becoming available and, second, to
    ensure that ``real world'' health practices reflect a rapid and
    thorough utilization of the knowledge that we have acquired. Both are
    essentially matters of closing the gap between what can be done and
    what is being done.

                         PROGRAMS FOR GENOMIC ANALYSIS

        The generous increases in funding that the NIH has received in the
    past several years have provided extraordinary opportunities to invest
    in cutting-edge research programs to capitalize on the new
    technologies. As you know, the Human Genome Project is on the verge of
    producing its draft ``blueprint'' for the entire genetic make-up of
    humankind, which will be invaluable to the research community. In
    anticipation of this tremendous resource of data and technologies, the
    NHLBI is establishing Programs for Genomic Analysis in cardiovascular,
    lung, and blood diseases and sleep disorders. This ambitious new
    undertaking will call upon the expertise and collaboration of
    scientists from a wide variety of disciplines--and often from diverse
    geographical areas--to identity relevant genes, understand their
    function, and test hypotheses about the causes and treatments of
    disease. An essential requirement of the Programs is that the
    information and reagents generated will be made immediately and freely
    available to the research community, a practice that will enable a
    broad range of investigators to exploit the promising opportunities
    provided by this fast-moving field. This initiative has generated
    tremendous enthusiasm within the research community, and it promises to
    advance our knowledge of health and diseases in ways that could not
    have been dreamed of a decade ago.

                     PROGRAMS OF EXCELLENCE IN GENE THERAPY

        Despite the recent troubling publicity about gene therapy, the
    NHLBI remains committed to pursuing this approach because of its
    potential usefulness for many intractable diseases. We just have to do
    it right. Accordingly, we are establishing comprehensive Programs of
    Excellence in Gene Therapy that will focus on rapid translation of
    findings from basic research into pilot studies in human volunteers,
    with appropriate attention to safeguarding the welfare of the patients.
    A major goal of this initiative will be to provide shared access to
    specialized services such as preclinical toxicology testing and the
    development of ``vectors'' to ferry therapeutic genes to their target
    tissues. The promise of gene therapy to cure hemophilia, cystic
    fibrosis, sickle cell disease, and other devastating diseases has long
    been recognized, but the path to its fulfillment has been fraught with
    many difficulties. We believe that this coordinated approach will make
    it a reality.

                       USING MRI TO DIAGNOSE HEART ATTACK

        A pilot program at Suburban Hospital in Bethesda is testing a new
    approach to diagnosing heart attack patients who may be candidates for
    thrombolytic therapy. The value of this clot-dissolving treatment in
    limiting damage from a heart attack has been well established for some
    time. However, its effectiveness is highly dependent on the promptness
    with which it is administered, and many patients have not had the
    opportunity to benefit from this approach. We have been working through
    our National Heart Attack Alert Program to reduce delays in treatment,
    and data from the National Registry of Myocardial Infarction indicate
    that the time between arrival at the emergency room and administration
    of thrombolytic therapy has been reduced from 60 minutes to about 35
    minutes in patients for whom an EKG is diagnostic of a heart attack.
    However, for many patients, diagnosis currently requires measurement of
    enzymes that appear in the bloodstream only hours after the heart
    attack has occurred--too late for effective thrombolysis. The
    experimental program at Suburban Hospital is using MRI (magnetic
    resonance imaging) technology, which can provide a diagnosis in about
    35 minutes. In light of recent evidence that thrombolytic therapy may
    also benefit patients who experience a thrombotic stroke, we have also
    teamed up with the National Institute of Neurological Disorders and
    Stroke to use MRI in evaluating patients who come to the emergency room
    with stroke symptoms. We have every confidence that this program will
    form the basis for an entirely new approach to delivering prompt
    treatment to patients who are likely to benefit from it.

                           CLINICAL RESEARCH NETWORKS

        During the past few years, the NHLBI has been an innovator in
    establishing clinical research networks to close the gap between what
    is known about the causes and mechanisms of disease and the tools that
    are available to treat them. These networks maintain a core structure
    of clinical centers and a data coordinating center that collaborate in
    conducting high-quality, systematic, rigorous clinical research. The
    advantage is that promising findings from basic research can rapidly be
    translated into information to assist the practicing physician in
    making the best possible decisions about how to treat patients. We
    began in 1994 with clinical research networks for adult asthma and
    acute respiratory distress syndrome (ARDS), and then moved on to
    develop such a network for pediatric asthma. This year, we are
    establishing a Thalassemia Clinical Research Network, which is expected
    to provide an invaluable resource for evaluating new therapies for
    patients with Cooley's anemia, who are few in number and widely
    scattered across the country. We have also announced plans for a
    similar effort in pediatric cardiovascular medicine, which will enable
    rigorous testing of both medical and surgical approaches to treating a
    variety of cardiovascular malformations in children.
        Our experience with the ARDS Clinical Network illustrates the value
    of this approach. ARDS is a form of respiratory failure that affects
    about 150,000 Americans annually--many of whom were previously
    healthy--and kills about half of them. We have struggled with it for 30
    years, but made very little headway, in part because of the daunting
    logistics of attempting to conduct timely and meaningful clinical
    trials in large numbers of critically ill patients. The ARDS Network,
    established in 1996, has already moved the field forward immeasurably
    by establishing the effectiveness of an innovative approach to
    mechanical ventilation. The new approach was shown to reduce mortality
    by 25 percent--a remarkable achievement for a disease in which
    mortality had remained stubbornly high despite many years of research.
    The results of this study are currently being implemented in intensive
    care units throughout the world. It is evident that clinical research
    networks save time, save money, and produce results of tangible value
    to the patient.

                        FOCUS ON THE INDIVIDUAL PATIENT

        One of the most promising new developments that we foresee is the
    increasing ability to understand individual susceptibility to a
    disease, or individual response to an intervention, so that we can
    target our treatments accordingly. We currently employ many broad--
    brush approaches in the expectation that at least a portion of the
    population will benefit. For example, we recommend that everybody limit
    sodium intake to prevent high blood pressure--prudent advice, in that
    the subset of people who are sensitive to salt will profit and no harm
    will come to others. All the same, it makes for a fairly ``weak''
    public health message that has not been universally adopted. On the
    horizon, however, are several promising tests to identify salt
    sensitivity; they may enable us to more narrowly focus our dietary
    recommendations and, thereby, gain the attention of individuals who
    most need to heed them.
        A second example is in the area of sudden cardiac death, a fatal
    arrhythmia that claims the lives of about 150,000 Americans annually.
    There is much recent interest in placing automatic defibrillators in
    public places to ``rescue'' victims of this malady, and we have just
    initiated a community-based research program on the topic. However,
    this is an after-the-fact approach, and it is clear that much more
    could be achieved in the long run if we were able to identify
    susceptibility to fatal arrhythmias and initiate preventive measures.
    In this regard, we are greatly encouraged by research that points to
    two possible approaches. One, called T-wave alternans, is a measure of
    irregular electrical activity of the heart that appears to correlate
    with the potential for life-threatening arrhythmia. An even simpler
    approach--which might someday, for instance, be used by coaches to
    screen young athletes--is suggested by the recent finding that a delay
    in the return of the heart rate to a normal pace after exercise is
    strongly predictive of mortality.
        Of course, the hope of understanding individual response to
    treatment or individual variations in the course of a disease is what
    drives our efforts to unravel the genetic basis of disease, and we are
    looking at many diseases in this light. With regard to congestive heart
    failure, for instance, scientists have recently reported that a fairly
    common gene variation is associated with disease severity, and we see
    much potential for ultimately developing approaches targeted to
    patients whose disease is likely to follow a rapid downhill course.
    Particularly aggressive efforts are being made with respect to sickle
    cell disease, which has long been a puzzle because all patients have
    the same genetic ``mis-code'' yet the severity of the disease ranges
    from mild to life-threatening. We recently initiated a new research
    program to identify other aspects of a person's genetic make-up that
    modulate disease severity. This work has taken on particular urgency
    because we now have a cure for sickle cell disease in the form of stem
    cell transplantation, but we have been reluctant to use it in this
    country because it is literally a cure that can kill. If we were able
    to distinguish, early in life, the patients who will suffer severely
    from the disease, it would open the door to applying this treatment
    selectively in cases where the potential benefits substantially
    outweigh the risks.

                         ADDRESSING HEALTH DISPARITIES

        Despite impressive strides toward our goal of disease prevention,
    we are acutely aware that not all segments of society have benefitted
    equally from this trend. Death rates from cardiovascular diseases, for
    example, are disproportionately high among U.S. blacks--and among
    blacks in Mississippi, they are the highest in the nation. The NHLBI's
    Jackson Heart Study is exploring the reasons for this phenomenon in a
    long-term study of 6,500 men and women. In addition to collecting data
    on conventional risk factors, the study will focus on newer areas,
    including early indicators of disease, genetics, socio-cultural
    influences such as socioeconomic status and discrimination, and
    physiological relations between common disorders that are related to
    cardiovascular disease, such as high blood pressure, obesity, and
    diabetes. We have emphasized the involvement of local people in the
    development and support of this study, and are optimistic that it will
    provide new directions for disease prevention in the black community.

                               NEUROFIBROMATOSIS

        As a final note, we have been asked by the Committee to comment on
    our activities with regard to neurofibromatosis, a condition that
    appears to be linked to certain forms of congenital heart disease. The
    NHLBI recently provided funding for some research in neurofibromatosis,
    in the expectation that it may help unravel molecular pathways that
    affect abnormal heart development not only in neurofibromatosis, but
    also in other conditions. The NHLBI will be working with the National
    Institute of Neurological Disorders and Stroke and other NIH components
    to develop a workshop, planned for 2000, that will summarize the
    current status of NIH-supported neurofibromatosis research, identify
    needs and opportunities, and stimulate and focus future NIH research in
    this area.

                              PRESIDENT'S REQUEST

        I am pleased to present the President's non-AIDS budget request for
    the NHLBI for fiscal year 2001, a sum of $2,069,582,000 which reflects
    an increase of $108,679,000 over the comparable fiscal year 2000
    appropriation. Including the estimated allocation for AIDS, total
    support requested for the NHLBI is $2,136,757,000, an increase of
    $110,327,000 over the fiscal year 2000 appropriation. Funds for the
    NHLBI efforts in AIDS research are included within the Office of AIDS
    Research budget request.

                     GOVERNMENT PERFORMANCE AND RESULTS ACT

        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report,
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        I would be pleased to respond to any questions that the Committee
    may have.
                                     ______

                  Prepared Statement of Dr. Harold C. Slavkin

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the National Institute of
    Dental and Craniofacial Research (NIDCR) for fiscal year 2001, a sum of
    $263.1 million, which reflects an increase of $14.1 million over the
    comparable fiscal year 2000 appropriation. Including the estimated
    allocation for AIDS, total support requested for NIDCR is $284.2
    million, an increase of $15.0 million over the fiscal year 2000
    appropriation. Funds for the NIDCR efforts in AIDS research are
    included within the Office of AIDS Research budget request.

                   DISCOVERING SOLUTIONS TO COMPLEX PROBLEMS

        In his classic analysis, The Structure of Scientific Revolutions,
    Thomas S. Kuhn puts forward the concept of science as a pursuit to
    solve complex problems. Solving problems can range from a chess match
    between grandfather and granddaughter, to the challenges of discovering
    fundamental principles of biological systems, finding solutions to
    health promotion in a diverse society, preventing disease, and
    designing ``smarter'' diagnostics and therapeutics for diseases and
    disorders that compromise health. By discovering solutions to the
    complex problems posed by craniofacial, oral and dental diseases and
    disorders, NIDCR-funded scientists are fulfilling the mission of the
    Institute to improve and promote health through research.

            BURDEN OF DENTAL AND CRANIOFACIAL DISEASES AND DISORDERS

        The mission of our Institute is to reduce the burden of diseases
    and disorders that are among the most common health problems both
    nationally and globally. The NIDCR supports research ranging from the
    prenatal developmental processes that form the human face and
    dentition, to the many local and systemic diseases and disorders that
    involve craniofacial tissues and structures throughout the lifespan.
    These include spontaneous preterm births possibly linked to maternal
    oral infections, birth defects like cleft lip and palate, trauma to the
    head, face and teeth, severe malocclusions, oral infectious diseases,
    head and neck cancers and chronic and disabling facial pain. Oral
    microbial infections producing dental caries, periodontal diseases,
    candidiasis and herpes lesions are common. Chronic and disabling facial
    pain is a major component of temporomandibular joint diseases (TMD),
    Bell's palsy, trigeminal neuralgia and fibromyalgia. Oral
    manifestations of systemic diseases such as AIDS, diabetes and
    osteoporosis are also common. Finally, oral complications from both
    cancer therapies and numerous therapeutic drugs often include yeast
    infections termed candidiasis, xerostomia (dry mouth), aggressive
    dental caries, and severe bone loss.
        Health disparities are associated with the burden of these diseases
    and disorders, falling disproportionately upon children and adults from
    particular ethnic and racial groups, historically underrepresented
    minorities, and lower socioeconomic classes. To accelerate discovery of
    solutions to these complex problems, we plan to link research, training
    and access to oral health care using innovative and collaborative
    Centers to Reduce Oral Health Disparities located in critical areas
    around the country. The emphasis is placed on the oral health needs of
    children and their caregivers. We envision these Centers as
    partnerships between academic health science institutions, state and
    local health and health financing agencies, community and migrant
    centers, Indian Health Service clinics, Centers for Disease Control and
    Prevention (CDC)-sponsored Prevention Research Centers, minority and
    minority-serving institutions, and other interested groups. Our
    strategy is to partner with the Health Resources and Services
    Administration (HRSA), CDC, the National Institute of Child Health and
    Human Development (NICHD), the National Institute of Nursing Research
    (NINR), and the NIH Offices of Behavioral and Social Sciences Research,
    Research on Women's Health, and Research on Minority Health, with
    funding to begin in fiscal year 2001.

                  GENE DISCOVERIES: THE RAPID RATE OF PROGRESS

        NIDCR actively supports the rapid discovery of genes related to
    inherited dental and craniofacial diseases and disorders, head and neck
    cancer genes, and genes related to the pathogenicity of viral,
    bacterial and yeast infections in the human mouth. The rapid rate of
    progress in these three areas is highlighted in.
        The discovery of craniofacial, oral and dental genes that are
    altered or mutated in more than a thousand inherited diseases, leads to
    smarter diagnosis and possibilities for improved treatments and new
    biomaterials. Of the 5,878 gene loci relevant to inherited human
    diseases, 1,250 of these are associated with craniofacial-oral-dental
    diseases and disorders. Over the last 5 years, more than several
    hundred mutated craniofacial regulatory and structural genes have been
    found to cause abnormal formation of the skull, cranial sutures,
    maxilla and mandible, teeth, tongue, salivary glands, bone, cartilage,
    cementum, dentin, enamel and periodontal ligament. Curiously, many of
    these genes involved in craniofacial development also have far-reaching
    effects, directing formation of such diverse body parts as the brain,
    limbs, thyroid glands, heart and kidney, and even has a role later in
    life with neoplastic diseases such as the role of patched mutations in
    Gorlin's syndrome. Furthermore, evidence is beginning to assist in
    solving the complexities of multiple gene networks and their collective
    interactions with environmental factors. For example, variant gene
    forms for enzymes required for folic acid metabolism are implicated in
    spina bifida and craniofacial malformations. We now assume that
    multiple gene-environment interactions produce birth defects in more
    than one hundred thousand babies each year. NIDCR is actively
    collaborating with other NIH Institutes and federal agencies to reduce
    the burden of craniofacial birth defects.
        Discovery of the multiple and sequential gene mutations involved in
    the progression of oral and pharyngeal cancer will result in early
    diagnosis and improved treatments and therapeutics. The Head and Neck
    Cancer Genome Anatomy Project, a collaboration between NIDCR and the
    NCI Cancer Genome Anatomy Project (CGAP), was recently established.
    Genes expressed in squamous cell carcinoma and normal head and neck
    epithelial tissues are being compared. This strategy is expected to
    identify a specific combination of multiple gene mutations involved in
    the premalignant to malignant neoplastic process, and will also provide
    clinically useful biomarkers that can be used for diagnosis and for
    monitoring the progression of head and neck cancers.
        A remaining complex problem is to determine how microbes living in
    homeostatic ecosystems or biofilms in the mouth become infectious
    pathogens. Discovery of microbial genes will lead to remarkable
    advances in early diagnosis and targeted drug development for improved
    treatments of oral infectious diseases. Since Antoni van Leeuwenhoek
    invented the microscope and discovered microbes growing in biofilm
    scrapings from his own teeth in the 17th Century, we have come to
    understand that more than 6 billion microbes live in the oral cavity,
    and these billions of microbes belong to a list of more than 500
    different strains that continues to expand. Just 2 months ago,
    scientists identified 37 previously unknown strains of bacteria that
    reside in the biofilms on the surfaces of teeth. To address this
    problem, NIDCR and other NIH Institutes have accelerated efforts to
    decipher the genetic lexicon of 60 microbial genomes. Presently, NIDCR-
    funded genome projects include the following microorganisms: Candida
    albicans, Porphyromonas gingivalis, Streptococcus mutans,
    Actinobacillus actinomycetemcomitans, Treponema denticola, and
    Streptococcus sanguis. Genomic studies of seven additional microbial
    organisms with significant roles in oral infections are planned for the
    near future.

                   ORAL INFECTION LINKED TO SYSTEMIC DISEASE

        There has been extraordinary progress in the understanding of
    periodontal disease in the last 25 to 30 years. A most significant
    discovery is our new appreciation for linkages between oral infection
    and systemic diseases, and this paradigm shift has already provided
    important new diagnostic, preventive, early intervention and treatment
    strategies for patients with periodontal diseases and beyond. The
    presence of oral infections has been associated with systemic diseases
    including spontaneous preterm births, cardiovascular and pulmonary
    diseases and diabetes. One example is particularly useful in conveying
    how investments in scientific research may result in significant human
    and cost savings benefits. Accumulating evidence suggests that maternal
    infections are a major risk factor for spontaneous preterm babies.
    Preliminary findings supported by NIDCR and NICHD suggest a dose-
    response relationship between the level of maternal oral infection and
    the risk of preterm low birth weight babies. The risk posed by the oral
    infection may prove to be amenable to treatment interventions. If
    successful, future intervention studies would demonstrate a cost
    effective approach to reduce some of the burden of spontaneous
    premature births.

                      GENES OF INFLAMMATION AND TOOTH LOSS

        Molecular genetic studies have discovered genes that regulate
    chronic inflammation processes and tooth loss. Papillon-Lefevre
    syndrome (PLS) is a genetic disorder that typically affects both skin
    and teeth. Two new studies have discovered gene mutations in the
    cathepsin C gene (CTSC) as the primary cause of PLS. Severe early onset
    periodontitis in PLS patients is unresponsive to traditional oral
    therapies and results in premature loss of both primary and permanent
    teeth; in some cases, all primary teeth are lost by age 4 years and all
    permanent teeth are lost by age 14 years. The periodontitis infection
    results in severe destruction of bone tissue in the jaws needed to
    support the teeth. This new discovery demonstrates the emerging
    significance of gene discovery and the availability of smarter
    diagnosis and future therapies for the oral manifestations of systemic
    inflammatory diseases and disorders.

                           GENETICS OF TOOTH AGENESIS

        We are discovering that multiple gene networks are required to
    produce teeth. Mutations in several of these genes have been found to
    cause congenitally missing teeth. These molecular foundations will
    eventually provide the basis for the biomimetic design and fabrication
    of replacement teeth later in the 21st century. Nearly 20 percent of
    the U.S. population has congenitally missing teeth. The missing teeth
    are often third molars, but may be any of the other teeth found in the
    human dentition. The forms of missing teeth ranging from least to most
    severe, are called hypodontia, oligodontia, and anodontia,
    respectively. Recent studies identified multiple gene networks that
    control the formation of teeth. Mutations in two of these genes, in
    particular, MSX1 and PAX9, have been discovered to cause missing teeth.
        The MSX1 gene is essential to tooth development and is found in
    chromosomes of multiple species including the fruit fly, the mouse, and
    humans. In a mouse model, deletion of the MSX1 gene resulted in animals
    with cleft palates and no teeth. Recently, selected families with
    congenitally missing teeth, known as familial tooth agenesis, were
    found to have a mutation in the human MSX1 gene. A second study,
    published last month, found that a mutation in the PAX9 gene resulted
    in congenitally missing molar teeth in three generations of a
    particular family. PAX9 is a member of a transcription factor family of
    genes involved in eye, primary and secondary palate, tooth, and thyroid
    gland formations. These discoveries are rapidly becoming gene-based
    diagnostics for dental anomalies, and also provide a biological basis
    for the future design and fabrication of tooth replacements.
        The NIH budget request includes performance information required by
    the Government Performance and Results Act (GPRA) of 1993. Prominent in
    the performance material is the first NIH performance report, comparing
    fiscal year 1999 results to the goals in the fiscal year 1999
    performance plan. As our performance measures mature and trends emerge,
    the GPRA data will serve as indicators to support the identification of
    strategies and objectives to continuously improve programs across the
    NIH and the Department.
        Finally, I want you to know how privileged I feel to have been
    selected by Harold Varmus to be part of the leadership team at the NIH.
    It has been a unique honor to lead the world's largest sponsor of
    dental, oral and craniofacial research. My tenure at the NIH has been
    memorable, including: Government shutdowns, the blizzard of 1996, a
    50th anniversary and a name change for our Institute, growth of the
    NIDCR portfolio into significant new scientific areas, remarkable
    growth in NIH funding, development of novel funding mechanisms, and
    most recently, another blizzard. I especially want to thank you Mr.
    Porter and the Committee Members for your confidence and support over
    the last 5 years as I have served as the sixth director of this
    Institute. This coming July, my wife and I will return to our home in
    California and I will return to the private sector. Thank you. My
    colleagues and I will be happy to respond to any questions you may
    have.
                                     ______

                   Prepared Statement of Dr. Allen M. Spiegel

        Mr. Chairman and Members of the Committee: I am pleased to testify
    on behalf of the National Institute of Diabetes and Digestive and
    Kidney Diseases (NIDDK). This year is the NIDDK's 50th anniversary. I
    have been with the Institute for nearly 27 of those 50 years--for the
    past 3 months as Institute Director. Throughout this time I havehad the
    privilege of conducting and directing basic and clinical research,
    often in collaboration with superb investigators at many academic
    centers and at NIH. The unique juxtaposition of laboratories and
    patient facilities in the NIH Clinical Center has afforded me a
    valuable perspective on the connections between basic and clinical
    research. As NIDDK Director, one of my main goals will be to strengthen
    those connections in order to accelerate progress toward relieving the
    burden of the many chronic and costly diseases within our mission. The
    challenges posed by these diseases are enormous. Significant gaps in
    our knowledge concerning their causes leave us as yet unable to prevent
    or treat them as effectively as we would wish. Yet, we are poised as
    never before to make dramatic progress in closing these gaps. New,
    powerful tools are becoming available to propel our progress. The
    support provided to NIH and NIDDK has been greater than ever before.
    Thus, it is with great scientific excitement and optimism that I have
    accepted the challenge, as Director of NIDDK, of leading the effort to
    alleviate the burden of diabetes, endocrine and metabolic diseases;
    digestive and nutritional disorders; and kidney, urologic and blood
    diseases.

                            POWERFUL RESEARCH TOOLS

        Shortly, we will have in hand the sequence of the entire human
    genome. Merely knowing the sequence, however, does not allow one to
    utilize this powerful tool. This sequence or ``book of life'' is not
    written in English and lacks obvious punctuation marks. An NIDDK
    intramural scientist has recently discovered gene ``insulators,'' a
    type of punctuation mark that allows a gene to be expressed without
    interference from surrounding regions. This discovery is already
    finding wide application in the biotechnology industry. Within the
    ``book of life'' are genes that either cause or contribute to many of
    the diseases within our mission. Our task in making full use of the
    human genome sequence is to identify all the genes within it, discover
    their function and how changes in these genes cause disease. New tools
    such as microarray technology allow simultaneous measurement of changes
    in expression of thousands of genes. Bioinformatics methods allow us to
    analyze vast amounts of sequence information. These tools will help us
    to apply new genetic knowledge to revolutionize diagnosis, prevention
    and treatment of many diseases.
        Bioinformatics methods have revealed that many human genes have
    counterparts in the genomes of yeast, roundworm and fruitfly. The
    function of these genes can thus be studied at the cellular level in
    these experimentally simpler model organisms. Vertebrate models such as
    zebrafish and mouse, while more difficult to study than worms or flies,
    are closer in organ structure and genetic sequence to humans. Zebrafish
    mutants with disorders of red blood cell formation or of appetite
    regulation have been discovered. Mouse mutants expressing too much or
    too little of almost any gene in any organ can now be created. Such
    models not only help clarify the function of genes and their role in
    causing disease, but also provide systems for testing possible
    treatments and preventions in ways not feasible in humans. Powerful
    imaging methods are being developed that will allow detection of subtle
    changes at the cell and organ level, thereby helping to elucidate the
    causes of disease, monitor disease progression, and assess preventive
    or therapeutic measures not only in animal models but in humans.
    Bioengineering approaches to cell and organ replacement hold great
    promise as well.

               RESEARCH ADVANCES: PKD, HEPATITIS C, AND DIABETES

        Polycystic kidney disease (PKD) is one of the most common inherited
    disorders and the fourth leading cause of end-stage kidney failure,
    according to the U.S. Renal Data System. A long hunt led to
    identification of the gene responsible for the most common form of PKD,
    and shortly thereafter, researchers found a second gene responsible for
    a rarer form. The molecular function of these two gene products is
    still incompletely understood, but the recent surprising discovery in
    the roundworm--that mutations in one of the corresponding genes leads
    to defects in the functions of sensory neurons--opens up new avenues to
    understand the basic defect in PKD. Studies of PKD genes in humans have
    established that cyst formation is an abnormal growth process,
    analogous to benign tumor formation. Indeed, just last month, NIDDK-
    supported investigators reported that treatment with an inhibitor of a
    cellular receptor for a growth factor in a mouse model of PKD prevents
    cyst formation and dramatically enhances survival. Of course, further
    studies are needed before human trials, but NIDDK is already supporting
    research to develop noninvasive imaging methods to monitor cyst growth.
    Such methods will be critical in evaluating the effectiveness of new
    treatments.
        The CDC estimates that 4 million Americans are infected with the
    hepatitis C virus. Hepatitis C is the most common cause of chronic
    hepatitis and the most common reason for liver transplantation in the
    United States. Epidemiologic studies show that 70 to 80 percent of
    infected individuals fail to clear the virus and as many as 20 percent
    of these develop chronic liver disease. Intramural NIDDK studies first
    showed that interferon, an antiviral agent, is effective in treating
    hepatitis C, but it completely clears the virus in only a small
    minority of patients. Recently, NIDDK investigators reported a major
    advance in treatment; by combining interferon with another antiviral,
    ribavirin, they were able to clear the virus in up to 40 percent of
    patients. Developing even more effective treatments and a vaccine to
    prevent infection remain as major challenges.
        According to data compiled by the congressionally established
    Diabetes Research Working Group, diabetes affects an estimated sixteen
    million Americans. It is a chronic and costly disease both in human and
    financial terms. The complications of uncontrolled elevation in blood
    sugar make diabetes the leading cause of end-stage kidney failure,
    adult blindness, and non-traumatic amputations, and a major risk factor
    for heart disease. Type 1 diabetes affects primarily children and young
    adults, with more than 13,000 new cases per year in the United States.
    This form of the disease is characterized by autoimmune destruction of
    the insulin-secreting beta cells of the pancreatic islets. Type 2
    diabetes affects primarily adults, and is increasing in the United
    States at an alarming rate, nearly 800,000 newly diagnosed cases per
    year. It is caused by both reduced insulin secretion and resistance to
    insulin action. Genetic abnormalities contribute to both forms of
    diabetes, but unlike single gene disorders such as PKD, most cases of
    diabetes are thought to be due to subtle abnormalities in multiple
    genes. Even before completion of the human genome sequence and full
    deployment of new genetic tools, significant progress has been made in
    identifying genes that cause diabetes. Why is such information
    important?
        In type 1 diabetes, knowledge of which genes predispose to the
    disease should allow identification of those at risk and to whom
    preventive measures should be targeted. Advances in understanding the
    immune basis for type 1 diabetes have identified candidate
    interventions to ``re-educate'' the immune system to prevent beta cell
    destruction. One such intervention is being tested currently in an
    NIDDK-supported multi-center trial. For those with type 1 diabetes in
    whom beta cell destruction has progressed to the point where little or
    no function remains, preventive measures are too late. The focus must
    be on maintaining excellent control of blood sugar, as the landmark
    Diabetes Control and Complications Trial showed clearly that intensive
    treatment with insulin can prevent or delay the onset of kidney, eye
    and other complications. Trying to maintain tight control of blood
    sugar with insulin treatment, however, can be difficult and
    frustrating, particularly in children. For this reason, NIDDK is
    committed to supporting research both to improve existing insulin
    treatment and to find innovative, new treatments that will represent a
    true cure for this disease. Recent improvements in glucose-sensing
    devices that can eliminate the need for multiple finger sticks
    represent a small step toward the goal of an artificial pancreas.
    Recent animal studies using novel methods to block the immune system
    have demonstrated the feasibility of pancreatic islet transplantation.
    These promising results are being carefully extended to studies of
    kidney and islet transplants in humans in a newly opened NIDDK branch
    in the NIH Clinical Center.
        In type 2 diabetes, genetic studies have shown that rare forms of
    the disease with onset at younger than usual age can be caused by
    single gene mutations. At least five such genes, each involved in some
    aspect of regulation of insulin secretion, have already been
    identified. A striking example is the gene termed insulin promoter
    factor-1, in which different degrees of mutation result in different
    conditions. Mutation of both copies of this gene leads to failure of
    the entire pancreas to develop. A severe mutation in one copy of the
    gene is one cause of the rare forms of early onset type 2 diabetes.
    Recent studies have shown that more subtle mutations of the same gene
    contribute to the more common form of type 2 diabetes by impairing
    insulin secretion. Identification of disease genes is important in
    providing novel targets for drug development and in enabling
    individualized therapy that is optimally effective for each patient.
        Another recent advance illustrates how information about a drug
    target can be used to identify a new diabetes gene. A new class of
    diabetes drugs that increase insulin sensitivity was shown to act on a
    cell receptor protein termed PPAR-gamma. This led investigators to
    search for mutations in the gene for PPAR-gamma in type 2 diabetes
    patients. Such mutations were found in rare patients with an early
    onset form of diabetes characterized by insulin resistance, high blood
    pressure, and abnormal blood lipids. Because all of these features are
    frequently seen in patients with type 2 diabetes, more subtle defects
    in the PPAR-gamma gene may be responsible for more common forms of type
    2 diabetes. Thus, understanding the genetic basis of even rare forms of
    type 2 diabetes is important, not only for care of patients with those
    forms of the disease, but also for what it can tell us about the causes
    of more common forms.

                             FUTURE RESEARCH PLANS

        While these advances are indicative of the important progress we
    have made, clearly extraordinary challenges remain for virtually all
    the diseases within the NIDDK mission. Indeed, the congressionally-
    established Diabetes Research Working Group identified five
    extraordinary diabetes research opportunities: genetics, autoimmunity
    and the beta cell, cell signaling and regulation, obesity, and clinical
    research and trials. The NIDDK intends to seize each of these
    opportunities. To take full advantage of the soon available human
    genome sequence, we will bolster a consortium formed to identify type 2
    diabetes genes and try to form a similar group to identify type 1
    diabetes genes. We will form a diabetes trial network to do pilot
    studies of innovative methods to prevent type 1 diabetes, as clues
    emerge from studies of the mechanism of beta cell destruction. We will
    stimulate research using the most advanced methods to image islet beta
    cells, so that effectiveness of diabetes preventions can be sensitively
    monitored, and more rapidly tested. We will expand our support for
    studies of islet transplantation in humans by establishing a consortium
    and an islet transplant registry so that progress may be maximized. We
    will form a ``Virtual Center'' of interdisciplinary investigators whose
    goal will be a complete understanding of the biology of the beta cell.
    This will include identification of every gene expressed at every
    developmental stage and their regulatory interactions, so that we would
    ultimately know how a stem cell differentiates to become a beta cell.
    It would include elucidation of all the signaling pathways regulating
    insulin secretion, so that we would know every step at which this
    process can malfunction and identify new targets for correction. We
    will form a consortium of investigators who will create new mouse
    models to understand the causes and test possible treatments for the
    complications of diabetes. We will launch a major new trial to study
    whether sustained weight loss can be achieved in obese individuals with
    type 2 diabetes, and if it can, to determine whether this is in fact
    beneficial to health. We also plan an obesity prevention initiative
    building on recently successful pilot programs.
        Health disparities pose a particular challenge for NIDDK, because
    minorities are disproportionately affected by many of the diseases for
    which we have research responsibility including type 2 diabetes,
    hepatitis C, and end-stage kidney failure. Our major type 2 diabetes
    prevention trial has enrolled nearly fifty percent of its patients from
    minority groups, and we will be supporting a new initiative directed at
    the alarming incidence of type 2 diabetes in children, especially from
    minority groups. We are supporting efforts to understand why certain
    groups such as African-Americans and Native Americans show increased
    susceptibility to the kidney complications of diabetes, so that we can
    learn how to prevent them. We are planning a clinical trial of
    interferon treatment in African-Americans to determine why they are
    less responsive to treatment. This should lead to improved therapies.
    In addition to these areas, NIDDK will be emphasizing basic and
    clinical studies of prostate disorders, such as BPH and prostatitis;
    bladder disorders such as interstitial cystitis; inflammatory bowel
    disease and irritable bowel syndrome; progressive kidney failure; food-
    related illnesses; and other health problems within our research
    mission.
        In developing our future research agenda, we have the benefit of
    input from our National Advisory Council, from our many constituency
    organizations both lay and scientific, and from investigators attending
    the scientific workshops convened by our staff. As the new NIDDK
    Director, I have already met with many of these groups and will
    continue actively to reach out to them, so that we may effectively
    collaborate in framing future research directions. Working together, we
    can take full advantage of this unique time of scientific momentum to
    mobilize the national biomedical research enterprise for the benefit of
    all the people of this country.
        I am pleased to present the President's non-AIDS budget request for
    the NIDDK for fiscal year 2001, a sum of $1.186 billion which reflects
    an increase of $66.8 million over the comparable fiscal year 2000
    appropriation. Including the estimated allocation for AIDS, total
    support requested for the NIDDK is $1.209 billion, an increase of $67.8
    million over the fiscal year 2000 appropriation. Funds for the NIDDK's
    efforts in AIDS research are included within the Office of AIDS
    Research budget request.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report,
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
                                     ______

                 Prepared Statement of Dr. Gerald D. Fischbach

        Mr. Chairman and Committee Members: I am pleased to present the
    President's non-AIDS budget request for the NINDS for fiscal year 2001,
    a sum of $1,050,412,000, which reflects an increase of $54,327,000 over
    the comparable fiscal year 2000 appropriation. Including the estimated
    allocation for AIDS, total support requested for NINDS is
    $1,084,828,000, an increase of $55,085,000 over the fiscal year 2000
    appropriation. Funds for the NINDS efforts in AIDS research are
    included within the Office of AIDS Research budget request.
        I became Director of NINDS eighteen months ago with great
    enthusiasm about neuroscience research and the likelihood of
    significant advances in treating neurological disorders that were
    considered intractable only a few years ago. My enthusiasm has grown
    with time because new discoveries, generous public support and a
    widening sphere of collaborations within the NIH and with outside
    organizations have brought our mission of reducing the burden of
    neurological diseases into clearer focus.
        We are now in the second year of a strategic planning process that
    has galvanized our research and patient communities as well as our own
    staff. Last year's planning document, ``Neuroscience at the New
    Millennium,'' identified major targets of opportunity and laid out a
    strategy for approaching disease problems and for strengthening the
    capacity of the research community to continue the stunning advances of
    recent years. The momentum generated by this process, that engaged
    efforts of more than 100 distinguished extramural and intramural
    scientists, professional societies, and many patient advocates,
    resulted in many new initiatives. The Strategic Plan is based on the
    cross-cutting topics of neurodegeneration, neural repair,
    neurodevelopment, neurogenetics, synapses and circuits, cognition and
    behavior, and the neural environment. Our Plan is now in its second
    phase. Because the planning panels were so successful, we reorganized
    the extramural program staff into working clusters that track the major
    planning topics. This flexible, non-hierarchical structure has led to
    productive interactions among our program directors, senior staff, and
    external advisors in advancing our research agenda and in responding to
    the initiatives of investigators and to concerns of the lay members of
    the planning community.

                       USES OF FISCAL YEAR 2000 INCREASE

        The fiscal year 2000 appropriation will allow NINDS to maintain and
    build on critical initiatives begun in fiscal year 1999 and to take
    advantage of new, extraordinary opportunities, including support of 200
    more project grants and 50 more scientists in training and career
    development. I am pleased to report that in fiscal year 1999 we were
    able to fund eight new Morris K. Udall Centers of Excellence in
    Parkinson's Disease, instead of the five we had planned. Together with
    the three Centers funded in late 1998, we now have a national network
    of eleven Centers that includes a wide spectrum of basic and clinical
    research. Annual meetings of the Centers, along with ongoing informal
    interactions, will increase opportunities for collaboration and
    maximize this significant investment. Each Center has a training
    component, so new investigators will be introduced to Parkinson's
    disease and related disorders each year.
        Another new initiative this year seeks to explore the promising new
    technology of deep brain stimulation in Parkinson's disease and other
    neurological disorders. Studies of electrode design, patterns of
    stimulation, and clinical trials will determine if DBS can halt the
    progress of neurodegeneration as well as reverse disabling symptoms.
        Another solicitation is concerned with the safety of the blood
    supply. We seek a rapid and sensitive test for the infectious agent
    (prion) responsible for the new variant Creutzfeldt-Jakob Disease. The
    public must be confident in the safety of the blood supply.
        During the current year we will expand our efforts to apply
    sophisticated technology to map the location and timing of gene
    expression in the brain. This is an essential step in determining the
    function of normal and mutant, disease-causing genes. We will expand
    our successful neural prosthesis program, and we will develop
    innovative, high throughput screens for potential therapeutic agents.
    We intend to promote new approaches to spinal cord injury, and we plan
    a broad approach to analyze the efficacy of neural stem cells in
    repairing focal and generalized lesions. Building on one of our most
    successful innovations in fiscal year 1999, we plan to expand our
    support for a full range of infrastructure needed for modern
    neuroscience research. Finally, we plan to increase our investment in
    training physician-scientists who are most likely to engage in
    translational research and patient oriented research. Looking to the
    future, I would like to tell you about just a few of our major
    initiatives and priorities for fiscal year 2001.

                            A HEALTHY BRAIN FOR LIFE

        We are concerned with neurological disorders over the entire
    lifespan. It is important to focus on developmental and degenerative
    disorders of children that can produce a lifetime of disability. Our
    efforts range from a new, exploratory grants program looking for new
    insights into common disorders such as autism and epilepsy, rare
    disorders such as Rett's Disease, Batten's Disease, and lipid storage
    diseases. We have emphasized gene discovery in epilepsy because it
    seems that even the most common forms such as febrile convulsions have
    a heritable component. At the same time we seek to promote better
    treatments, and even a cure, for the large number of people with
    ``intractable'' epilepsy. Many of these individuals are children, whose
    lives are disrupted by inadequately controlled seizures. Later this
    spring we will sponsor a White House-initiated conference, ``Curing
    Epilepsy: Focus on the Future.''

                    HALTING THE PROCESS OF NEURODEGENERATION

        As requested by the Appropriations Committees, NINDS is working on
    the first phase of an effort to develop a comprehensive research agenda
    for Parkinson's disease. We were joined in this effort by NIH
    Institutes and Centers with significant programs in Parkinson's
    disease, by patient advocacy groups, and by distinguished intramural
    and extramural scientists. We are confident that the proposed research
    agenda will advance the fight against Parkinson's disease and point the
    way for similar progress in other neurodegenerative disorders.
        Neurodegeneration is more widespread than previously thought. In
    addition to classical adult neurodegenerative disorders such as
    Alzheimer's, Parkinson's, Huntington's and Lou Gehrig's diseases,
    neurodegenerative processes are at work in a number of serious
    disorders of childhood. Neurodegeneration also complicates conditions
    as disparate as stroke, spinal cord injury, epilepsy, multiple
    sclerosis, and depression. A cell death program, named apoptosis,
    appears to be a ``final common pathway'' in the process of
    neurodegeneration. Encouraging evidence indicates that inhibition of
    this pathway may be a useful therapeutic strategy, regardless of the
    initial causes of the degeneration.
        We must not lose sight of our goal of cognitive and emotional
    health throughout life. The study of disease is teaching us that
    decline in cognitive and emotional health is not an inevitable
    consequence of aging. For many, perhaps most of us, a healthy brain is
    as realistic a goal as is a healthy heart. But we cannot achieve our
    goal without a much better understanding of disease, particularly the
    risk factors and early changes that point to possible preventive or
    corrective measures. A new patient registry for Parkinson's disease, to
    be followed by a larger population-based study, will point the way to
    further study of neurodegenerative diseases at every stage of life.
    Through collaboration with other Institutes, we will expand these
    studies to include cognitive and emotional disorders and to define and
    promote cognitive and emotional health across the life span.

                      REPAIRING THE INJURED NERVOUS SYSTEM

        Modern neuroscience is rewriting the textbooks that tell us that
    nerve cells cannot recover from deadly injury. Research on a number of
    fronts has produced tantalizing evidence that manipulating the cells'
    environment--by adding factors that promote growth or interrupting
    processes that disrupt it--will eventually redefine the future for
    those who have lost function due to injury. A recent initiative is
    seeking additional research on interneuronal circuits to restore lost
    function. As in so many other areas of neuroscience, the ability to
    manipulate and implant stem cells from a variety of sources is
    particularly promising for both acute and chronic injury. Complementing
    these efforts are advances in our ability to design neural prostheses-
    devices that connect with the patient's own nerves and muscles to
    restore or augment function.

                          REDUCING HEALTH DISPARITIES

        As we rejoice in the progress of modern medicine, we must not
    neglect those who, by virtue of biology or circumstance, bear a
    disproportionate share of the burden of disease. NINDS enthusiastically
    shares the commitment of NIH to reducing health disparities, and we
    will continue our leadership in this area. Stroke is a major health
    problem for the entire population but one that disproportionately
    affects minority citizens, particularly African-Americans. We support a
    broad program directed at the impact of stroke on minority populations,
    ranging from epidemiological and descriptive studies of disease
    patterns to specific therapies and educational approaches. The
    neurological complications of diabetes, another common disorder that
    particularly affects minority groups, is a major focus of interest.
        Progress against health disparities also depends on building a
    diverse scientific workforce--a strategy that makes sense in general
    but is particularly important in working with minority populations.
    NINDS has a long history of leadership on this front. More recently,
    with support from the Office of Research on Minority Health, we
    initiated the first prototype of a Specialized Neuroscience Research
    Program (SNRP) at the Morehouse School of Medicine in Atlanta. A unique
    feature of the program is the establishment of collaborations and
    professional networks between investigators at minority institutions
    and those from more research intensive institutions and community-based
    organizations. Based on excellent results from the pilot program at
    Morehouse, and recognizing the work still to be done, the NINDS, in
    collaboration with NCRR, is now supporting additional SNRPs. This year
    we will expand the program to include a focus on HIV/AIDS, a particular
    problem in the nervous system, where the virus can cause dementia and
    neuropathy even when other manifestations of disease are well
    controlled.

                    WORKING TOGETHER TO FIGHT BRAIN DISEASE

        Neuroscience is recognized as one of a few great unifying themes in
    modern science. Nowhere is this more evident than at NIH, where almost
    every Institute and Center is involved to some extent in brain
    research. Here we have a unique opportunity to break down what is
    increasingly recognized as an artificial barrier between mind and
    brain, between neurology and psychiatry. Our goal is to develop a model
    for collaborative neuroscience with an emphasis on translational
    research. The National Neuroscience Research Center, for which start-up
    funds are requested in the Buildings and Facilities budget, will
    provide an environment that will promote modern neuroscience in the
    form of collaboration, communication, and shared resources. It will
    build on the impressive progress already made by intramural science
    leaders and on the example being set by the National Vaccine Research
    Program.
        The emphasis on collaboration will, in my view, stand out as the
    distinguishing feature of NIH in our time. NINDS is actively working
    with one or more Institutes and Centers on diseases including autism,
    Duchenne and facioscapulohumeral dystrophy, and neurofibromatosis. Our
    efforts against neurodegenerative disease include collaborations with
    the National Institute of Aging on clinical trials for Alzheimer's
    disease and with the National Institute of Environmental Health
    Sciences on Parkinson's disease, as well as plans for an innovative
    public-private partnership to foster future research. Our collaboration
    with the National Cancer Institute to map the genes involved in a
    deadly form of brain tumor has blossomed into the formation of a joint
    Progress Review Group for brain tumor research, building on a planning
    technique that has been highly successful for research on other forms
    of cancer. In stroke, we have joined forces with the National Heart,
    Lung, and Blood Institute and with Suburban Hospital in Bethesda to
    improve rapid diagnosis and treatment of both stroke and heart disease.
    We continue to work with the Brain Attack Coalition to raise public and
    professional awareness of stroke as a preventable and treatable
    disease.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department. For NINDS, this
    effort will be augmented by our strategic planning process, which
    provides an ongoing forum for assessing progress and setting
    priorities, and by our strong commitment to efficient and effective
    management of our resources.
        Mr. Chairman, this concludes my prepared statement. I would be
    happy to answer questions you or the other Members may have.
                                     ______

                   Prepared Statement of Dr. Anthony S. Fauci

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Institute of Allergy
    and Infectious Diseases (NIAID) for fiscal year 2001. The non-AIDS
    portion of the budget request is $935,166,000, which reflects an
    increase of $54,019,000 over the comparable fiscal year 2000
    appropriation. Including the estimated allocation for AIDS, total
    support requested for NIAID is $1,906,213,000, an increase of
    $109,582,000 over the fiscal year 2000 appropriation. Funds for NIAID
    efforts in AIDS research are included within the Office of AIDS
    Research budget request. I would note that the National Institutes of
    Health (NIH) budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report,
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan.

                                 GLOBAL HEALTH

        The NIAID research program is predicated on the view that we live
    in an interconnected, global community. Because of the enormous volume
    of international travel and trade, we cannot separate the health
    problems of the United States from those of the rest of the world.
    Clearly, it is folly to think that we are somehow isolated from
    diseases that are public health challenges elsewhere. In 1999 alone, we
    witnessed the first known appearance of West Nile fever in the western
    hemisphere (in New York City and surrounding areas), as well as
    alarming reports of dengue fever outbreaks in Texas and Florida. The
    yearly U.S. epidemic of influenza, which originates in Asia, is the
    prototypic example of the maxim ``microbes do not recognize borders.''
    Indeed, the memory of three recent influenza pandemics (1918, 1957 and
    1968), as well as the ever-present threat of another flu pandemic is
    perhaps the best reminder of humanity's shared vulnerability to
    disease.
        As a nation, our interest in global health stems both from
    humanitarian concerns and what has been called ``enlightened self-
    interest.'' In addition to our obligation to ameliorate human suffering
    wherever possible, history tells us that healthy, stable countries make
    strong allies and trading partners. Conversely, poor health status can
    have a profound negative impact on social and economic development, and
    frequently contributes to political instability. Significantly, this
    year the United Nations Security Council for the first time devoted an
    entire session to a health issue--AIDS in Africa--recognizing the
    enormous threat that the disease poses to the security not only of that
    continent but the world.

               INFECTIOUS DISEASES: CHALLENGES AND OPPORTUNITIES

        The World Health Organization (WHO) estimates that 1,500 people die
    each hour from an infectious disease. Half of these deaths occur in
    children under five years of age, and most of the rest are working
    adults who frequently are breadwinners and parents. Virtually every
    year one or more newly recognized diseases add to the burden of known
    infectious conditions; in 1999, for example, the deadly Nipah virus
    emerged in Malaysia and Singapore. Because of the emergence of
    microbial drug resistance, many infectious diseases are increasingly
    difficult to treat. In addition, it is now clear that many chronic
    diseases have an infectious etiology: approximately 20 percent of all
    cancers are related to infections, and mounting evidence indicates that
    pathogenic organisms may be the underlying causes of chronic diseases
    such as coronary artery disease, diabetes, multiple sclerosis, and
    chronic lung diseases.
        NIAID's Strategic Plan, available on the World Wide Web at http://
    www.niaid.nih.gov/strategicplan outlines the progress made in
    infectious disease research, including advances in HIV treatment,
    prevention and vaccine development, and delineates the scientific
    opportunities to strengthen our preparedness for infectious threats,
    known and unknown.

                        THE PROMISE OF PATHOGEN GENOMICS

        Many of the challenges posed by infectious diseases lend themselves
    to research in a relatively new field: pathogen genomics, or sequencing
    of the genes of microbes, a central focus of the Institute. Pathogen
    genomics, coupled with data from the Human Genome Project, as well as
    the use of new tools such as microarray and DNA ``chip'' technologies
    to delineate the functional expression of these microbial genes, will
    likely underpin infectious diseases research for the coming decades and
    will be critical to the development of new vaccines, therapies and
    diagnostics.
        In an important technical achievement, researchers have determined
    the complete genetic sequence of chromosomes 2 and 3 of P. falciparum,
    the most deadly malaria parasite. This new information will help to
    identify virulence factors and proteins involved in the parasite's
    lifecycle that may serve as targets for the development of drugs and
    vaccines. Researchers also have determined the complete genomic
    sequence of two strains of M. tuberculosis, the TB bacterium. These
    sequencing efforts are central to NIAID's detailed plans for the
    development of malaria and TB vaccines.
        NIAID-supported researchers have also published complete or partial
    genomic sequences of the agents of the sexually transmitted diseases
    chlamydia and syphilis, as well as the leishmaniasis parasite
    Leishmania major. The Institute also supports the genetic sequencing of
    many other important pathogens that exact an enormous toll and are
    increasingly drug-resistant. Examples include important species of
    enterococci, streptococci, and staphylococci, including Stapyhlococcus
    aureus, which in some cases has become virtually untreatable because of
    drug resistance.

                              VACCINE DEVELOPMENT

        Vaccination has been recognized as the greatest public health
    achievement of the 20th century, and vaccine research has long been a
    cornerstone of the NIAID research portfolio. NIAID-supported research
    has been instrumental in the development of many new and improved
    vaccines, such as those against hepatitis A and B, Haemophilus
    influenzae type b, pertussis, typhoid, varicella, and pneumococcal
    disease. A new vaccine against Streptococcus pneumoniae, the leading
    cause of morbidity and mortality in children worldwide, shows
    particular promise. Widespread use of this vaccine could greatly reduce
    the 1.2 million child deaths worldwide attributed to S. pneumoniae each
    year, according to WHO. The domestic potential of this new vaccine is
    also significant: pneumococcal disease causes 40,000 deaths, 500,000
    cases of pneumonia, and 7 million middle ear infections in this country
    every year, according to CDC.
        The rapidly evolving science base in pathogen genomics, immunology
    and microbiology will facilitate further progress in developing new and
    improved vaccines. In particular, vaccines that target mucosal surfaces
    such as those in the intestine or respiratory tract are of great
    importance, because many pathogens gain entry to the host via mucosal
    sites. Vaccines administered orally, nasally or transdermally are easy
    to administer and therefore have potentially great utility in
    developing countries and for mass immunization programs. The
    development of new adjuvants, which boost the immune response to
    vaccines, is another important area of research that has progressed
    rapidly in recent years. In addition to the development of vaccines
    against classic infectious diseases, vaccines are being pursued to
    fight potential agents of bioterrorism; chronic diseases with
    infectious origins; and autoimmune diseases and other immune-mediated
    conditions.

                   ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS)

        AIDS, caused by the human immunodeficiency virus (HIV), is one of
    the greatest threats to global health and one of the most destructive
    scourges in human history. Since the beginning of the HIV pandemic,
    more than 50 million people worldwide have been infected with HIV, of
    whom more than 16.3 million have died, according to UNAIDS. In the
    United States, approximately 650,000-900,000 people are living with
    HIV/AIDS; an additional 420,200 people with AIDS had died as of June
    30, 1999, according to the Centers for Disease Control and Prevention
    (CDC). UNAIDS estimates that the global HIV-infected population
    continues to expand: in 1999 alone, there were 5.6 million new
    infections worldwide, half of which occurred among people younger than
    25 years of age. In the United States, the rate of new HIV infections
    has reached an unacceptable plateau of 40,000 per year, with minority
    communities disproportionately affected.
        Although potent combinations of anti-HIV drugs have reduced the
    number of AIDS deaths and new AIDS cases in many western countries, the
    utility of these medications is limited by their substantial cost,
    toxicities, complicated and disruptive dosing regimens, and the
    development of drug resistance. Many patients do not respond adequately
    to current regimens; even in patients who are successfully treated, the
    virus persists in sanctuaries where the drugs cannot penetrate and in a
    latent form on which the drugs have no effect. Therefore, the
    development of a new generation of therapies remains a major priority.
    In addition, approaches to purging the virus from its sanctuaries in
    certain cells and tissues are being vigorously pursued, as are methods
    to boost the body's immune defenses so they can better fight the virus.
        In developing countries in which per capita health care spending
    may be only a few dollars a year, and where health care infrastructures
    are weak, anti-HIV therapies are invariably beyond the reach of all but
    the privileged few. This situation, coupled with the upward trajectory
    of the global HIV/AIDS epidemic, underscores the urgent need for
    effective and affordable tools of HIV prevention. Notable progress has
    been made. For example, an NIAID-supported study in Uganda found that
    two doses of the drug nevirapine, one given to the mother at the onset
    of labor and one given to the infant within 72 hours after birth, can
    markedly reduce perinatal HIV transmission. The entire regimen costs
    $4.00, making it feasible in resource-poor settings. Other methods of
    preventing HIV transmission, such as education and behavior
    modification and the social marketing and provision of condoms have
    also proven effective, both in the United States and in developing
    countries such as Uganda, Senegal and Thailand.
        Approximately 46 percent of people living with HIV/AIDS are women.
    An important NIAID focus is developing interventions that will empower
    women to protect themselves in situations where they are unable to
    avoid sex with HIV-infected partners or cannot persuade their partners
    to use a condom. A critical effort is the development and testing of
    products for vaginal use--called topical microbicides--that may protect
    women (and their partners) from HIV and other sexually transmitted
    diseases. Promising microbicide candidates are now in various stages of
    testing in animal models and in humans.
        The development of a safe and effective vaccine for HIV infection
    is a central goal of AIDS research, and a necessary tool to bring the
    HIV epidemic under control. In addition to the Institute's substantial
    commitment to pre-clinical HIV vaccine research, NIAID has conducted
    more than 50 clinical studies of HIV vaccines. Among these is the first
    HIV vaccine trial in Africa, a study initiated in Uganda last year in a
    growing effort to collaborate with scientists from developing countries
    to identify safe and effective vaccines suitable for worldwide use.
    Last year also marked the dedication of the Dale and Betty Bumpers
    Vaccine Research Center, a program within the NIH intramural research
    program to stimulate multidisciplinary vaccine research.

                            IMMUNE-MEDIATED DISEASES

        The burden of immune-mediated diseases is staggering; these
    conditions, like infectious diseases, are important global health
    concerns. For example, 100 to 150 million people worldwide suffer from
    asthma; in this country alone, 15 million people are asthmatics.
    Asthma-related deaths worldwide number approximately 180,000 annually
    and are increasing both in the United States and abroad.
        The past two decades of intense and highly productive research on
    the immune system have resulted in a wealth of new information and
    extraordinary growth in conceptual understanding. These accomplishments
    now provide realistic opportunities for major advances in the
    diagnosis, treatment, and prevention of a broad range of immunologic
    conditions.
        Among the most exciting developments is our growing understanding
    of tolerance induction. By blocking only those components of the immune
    system that attack healthy tissues, it may be possible to prevent graft
    rejection in transplant patients without immunosuppressive drugs that
    dampen protective immune responses as well as deleterious ones. The
    ability to selectively block the immune response also holds great
    promise for treatment of many immune-mediated conditions, including
    autoimmune diseases such as juvenile (type 1) diabetes, rheumatoid
    arthritis and multiple sclerosis, as well as asthma and allergic
    diseases. In addition, understanding the mechanisms of immune tolerance
    will likely prove important for efforts to prevent unresponsiveness to
    vaccines, and for enhancing natural host responses and defenses to
    infection.
        In October 1999, NIAID launched a major initiative to develop new
    ways of inducing immune tolerance, in partnership with the Juvenile
    Diabetes Foundation International and the National Institute of
    Diabetes and Digestive and Kidney Diseases. The Collaborative Network
    for Clinical Research on Immune Tolerance involves more than 40
    research institutions. Network researchers will conduct clinical trials
    to improve the success of kidney transplants using tolerogenic
    approaches and clinical trials are planned for patients receiving
    transplanted human islets to treat type 1 diabetes. Network
    investigators will test similar therapeutic approaches for other
    autoimmune diseases, such as systematic lupus erythematosus, rheumatoid
    arthritis and multiple sclerosis, and will pursue better ways to
    measure immune tolerance in humans. In addition, the network plans to
    conduct clinical trials in immune modulation to treat asthma and
    allergic diseases.

                         ADDRESSING HEALTH DISPARITIES

        Virtually all of NIAID's research efforts address the health
    disparities that exist in our country, as well as the growing gap in
    health status between developed and developing countries. Perhaps the
    best example of this is the development of vaccines to prevent
    infectious diseases, which disproportionately affect the poor, both at
    home and abroad. Other efforts, such as HIV treatment and prevention
    research, hepatitis C research, asthma research, tissue typing and
    other transplantation research, and autoimmunity research, address
    conditions that exact a significant toll in minority communities. In
    addition, NIAID has a long-standing commitment to increasing the cadre
    of minority investigators involved in biomedical research.

                                   CONCLUSION

        The United Nations, in the International Declaration of Health
    Rights, asserted that ``The enjoyment of the highest attainable
    standard of health is one of the fundamental rights of every human
    being. It is not a privilege reserved for those with power, money or
    social standing.'' As the NIAID faces the new millennium, we anticipate
    that our research efforts will result in new and improved vaccines,
    diagnostics, and treatments that will make ``the highest attainable
    standard of health'' a global reality.
                                     ______

                    Prepared Statement of Dr. Marvin Cassman

        Mr. Chairman and Members of the Committee, good morning. I am
    pleased to present the President's non-AIDS budget request for the
    National Institute of General Medical Sciences (NIGMS) for fiscal year
    2001, a sum of $1.389 billion, which reflects an increase of $73
    million over the comparable fiscal year 2000 appropriation. Including
    the estimated allocation for AIDS, the total support requested for
    NIGMS is $1.428 billion, an increase of $74 million over the fiscal
    year 2000 appropriation. Funds for the NIGMS efforts in AIDS research
    are included within the Office of AIDS Research budget request.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report,
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        The mission of the National Institute of General Medical Sciences
    is to support basic biomedical research that is not targeted to
    specific diseases. NIGMS funds studies on genes, proteins, and cells,
    as well as on fundamental processes like communication within and
    between cells, how our bodies use energy, and how we respond to
    medicines. The results of this research increase our understanding of
    life and lay the foundation for advances in disease diagnosis,
    treatment, and prevention. NIGMS attempts to ensure the vitality and
    continued productivity of basic biomedical research, while producing
    the next generation of scientific breakthroughs and training the next
    generation of scientists. I am particularly pleased to announce that
    once again the current Nobel laureate in physiology or medicine, Dr.
    Gunter Blobel of Rockefeller University, was supported by NIGMS during
    the period when the work for which he was recognized was performed.

                     SNAPSHOT OF THE CELL'S PROTEIN FACTORY

        I would like to begin by describing a major advance of the past
    year, the determination of the detailed structure of the ribosome. This
    stunning accomplishment is the result of a broad body of research,
    largely supported by NIGMS, over a period of several decades. The
    ribosome is the particle in the cell where proteins are synthesized. It
    is a factory, made up of many molecules, which is small by our daily
    measures but is a giant compared to most other elements in the cell. It
    carries out a central activity for life--the accurate synthesis of the
    proteins that form the body's structures, such as muscle and collagen,
    and that catalyze the chemical reactions in living systems.
    Consequently, ribosomes are found everywhere in nature, and they don't
    appear to differ much between species. It's as if nature got it right
    the first time and didn't want to make many changes.
        A major goal of modern biology has been to lay bare the mechanism
    by which the protein synthesis factory functions. To do so, it was
    ultimately necessary to identify, in great detail, the three-
    dimensional structure of the particle, using x-ray crystallography as a
    primary tool. The difficulties of this undertaking can be appreciated
    when it is understood that the ribosome is made up of two subunits of
    unequal size, comprised of a total of 54 individual proteins as well as
    three RNA strands. The determination of a single protein structure can
    still be a difficult process, so attempting to understand such a
    complex entity was an intimidating prospect.
        The astonishing breakthroughs of the past year are the result of
    dogged effort, with contributions over many years from many sectors of
    science. The next figure shows the different avenues of research
    leading to the current achievements. It represents selected highlights,
    with the NIGMS-supported efforts shown in yellow. What is clear is that
    contributions were required from chemistry and physics, as well as
    genetics, biochemistry, and structural biology, to arrive at our
    current understanding. We are particularly pleased to have supported
    Dr. Ada Yonath, from the Weizmann Institute of Science in Israel, at a
    time when there was still great doubt that it would be possible to
    achieve the structure. This investment, and our subsequent support over
    15 years, demonstrates the value of funding high-risk, high-payoff
    approaches.
        Although the detail currently visible is not yet at a level
    sufficient to identify individual atoms, we are confident that the
    research teams we are supporting will arrive at this goal. This should
    provide unique insights into antibiotic action and resistance, since
    many antibiotics--including erythromycin and tetracycline--work by
    blocking bacterial ribosome function. Even this will only mark a new
    beginning, since, as with any factory, the various machines operate to
    absorb raw material, process it, and then release it in a form that can
    be used. To follow this process, it will be necessary to capture and
    visualize the machine at different points in the manufacturing cycle.
    But this is yet to come, and where we are today is exciting enough, for
    the new knowledge will greatly improve our understanding of a
    fundamental component of living systems.

                               MAJOR INITIATIVES

        I would like to spend the rest of my time describing some of the
    opportunities that are being addressed with the increased funds that
    Congress appropriated to NIGMS. In particular, I would like to focus on
    three new initiatives--pharmacogenetics, structural genomics, and
    large-scale collaborative research--and then close with a description
    of the expansion in our support for minorities in research.
        Pharmacogenetics is the effect of inheritance on drug action. In
    1998, it was reported that adverse drug effects account for 100,000
    deaths per year, as well as 5-10 percent of hospital admissions. The
    old joke of ``take two pills and call me in the morning'' may be
    appropriate for many people, but what works for the majority of the
    population may not be effective, and could even be dangerous, for some.
    The program we have initiated plans to systematically collect and
    interpret information about the inherited variations in humans that
    result in poor responses to drugs. The scientists we will support will
    coordinate their activities in a research network so that the results
    obtained can be maximally useful, and all will deposit their results in
    a shared repository. This effort will be conducted in collaboration
    with the National Heart, Lung, and Blood Institute; the National Human
    Genome Research Institute; the National Institute of Environmental
    Health Sciences; the National Institute of Mental Health; and the
    National Institute on Alcohol Abuse and Alcoholism.
        As part of the pharmacogenetics initiative, we assembled an
    advisory group in May of 1999 to consider possible areas of
    misunderstanding and the ramifications of future research in
    pharmacogenetics. Since many identifiable differences in the response
    to drugs have emerged from studies of populations, it is necessary to
    consider issues of stereotyping and stigmatization of communities, and
    the possible resulting harm to individuals, such as discrimination in
    access to various social benefits, that might arise from membership in
    an identified group. The members of the advisory group, as well as
    participants in several follow-up focus groups, felt that the possible
    benefits of the pharmacogenetic research efforts outweighed the risks.
    However, they recommended that we provide a clear statement to the
    public of the goals of the research and the issues involved, and that
    we ensure that we have appropriate mechanisms in place to maintain
    privacy and confidentiality.
        A second major effort is the Protein Structure Initiative, which
    attempts to use the information developed by the Human Genome Project
    and other genomic programs to identify the structures of all the
    proteins in nature. The benefits of understanding three-dimensional
    protein structure have been demonstrated many times. Applications
    include drug design and understanding of the molecular basis of
    disease. It is certain that a complete catalog of structures and their
    relation to function would provide insights into the operation and
    integration of biological systems that we cannot now fully comprehend.
    However, such an experimental effort directed at solving the structure
    of every protein in nature is not feasible. It would take decades and
    be extremely expensive. Fortunately, there is a shorter route to this
    goal. Proteins appear to fall into ``families'' of related structures.
    If the detailed structure of one or a few members of each family is
    known, it is possible to infer the structures of the other family
    members.
        We have mounted a program, beginning in fiscal year 2000, to test
    approaches to identifying appropriate protein family targets, as well
    as to develop high-speed procedures to determine structures. Grant
    recipients will be asked to operate as an interactive team, sharing
    information about progress on a regular basis and depositing data in a
    shared repository to ensure there is no duplication of effort. This
    will be integrated with other such programs around the world. To this
    end, an international meeting to ensure coordination and collaboration
    is planned for the spring of 2000.
        The last initiative I would like to describe attempts to address
    major problems in biomedical research by facilitating the collaboration
    of large groups of investigators. Although awards to individual
    investigators are the mainstay of our support for research, it has
    become clear that to put all the information together to understand how
    biological systems operate, something more may be required. We are
    attempting to provide that additional support through an approach which
    we term ``glue grants.'' This is because we will supply the ``glue''
    that will catalyze the interactions between already funded
    investigators to aim at problems that they could not pursue
    individually. In general, the glue grants will support large-scale,
    interdisciplinary approaches to significant biological problems by
    providing the resources for such items as core facilities, database
    development, and electronic media for effective collaboration. This
    approach is itself an experiment in the organization of scientific
    effort. It should provide one opportunity to see how the flood of
    information coming from individual laboratories can be integrated and
    amplified to address important problems of biology.
        Finally, a major goal of the NIGMS is to establish programs that
    will result in a cadre of highly qualified researchers. This requires
    developing flexible training mechanisms that reflect the rapidly
    changing needs of science, as well as providing cross-disciplinary
    training. The NIGMS predoctoral training programs remain a benchmark
    for graduate training, and have evolved to incorporate new areas as
    science developed. Most recently, we have initiated a training program
    in bioinformatics--the field at the interface of biology and computer
    science--to address this emerging area. Bioinformatics is increasingly
    needed to manage and mine the vast quantities of data that biomedical
    scientists are generating.
        Similarly, we have expanded our programs targeting underrepresented
    minorities to ensure that future demands for scientific personnel will
    be met. We have developed new programs to enhance the research
    environment at minority-serving institutions; to support computer
    infrastructure via supplements to existing grants; to provide technical
    assistance in grant writing; and to combine a traditional postdoctoral
    experience with an opportunity to develop teaching skills through
    mentored assignments at minority-serving institutions. At the same
    time, the average size of individual research budgets in our Minority
    Biomedical Research Support (MBRS) programs has doubled over the last 3
    years, while the number of students supported in these programs has
    increased by 60 percent. We anticipate our increased investments to
    show real benefits in an increasing number of minority students going
    into biomedical research, and we are developing evaluation procedures
    to track the outcomes of our efforts.
        We are particularly pleased with the results of the Bridges to the
    Future Program, which is cofunded by NIGMS and the NIH Office of
    Research on Minority Health. The results indicate that students in the
    program make the transition from 2-year to 4-year institutions and
    receive bachelor's degrees at a rate of about twice the national
    average. Although the part of the program that supports the transition
    from a master's degree to a Ph.D. has as yet only small numbers, the
    data available also suggest that the transfer rate of these students to
    Ph.D.-granting programs is also about twice the national average.
        In conclusion, NIGMS remains dedicated to developing approaches to
    ensure that biomedical research continues to progress. The resources
    that we have received will permit us to take advantage of the rapidly
    expanding opportunities in science.
        Thank you, Mr. Chairman. I would be pleased to answer any questions
    that you may have.
                                     ______

                   Prepared Statement of Dr. Duane Alexander

        Mr. Chairman and Members of the Committee: I am pleased to present
    the fiscal year 2001 President's budget request for the National
    Institute of Child Health and Human Development (NICHD). The request of
    $810.5 million reflects an increase of $40.8 million over the
    comparable fiscal year 2000 appropriation. Including the estimated
    allocation for AIDS research, total support requested for NICHD is
    $904.7 million, an increase of $45.4 million over the fiscal year 2000
    appropriation. Funds for the NICHD efforts in AIDS research are
    included within the Office of AIDS Research budget request.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        The NICHD seeks to assure that every individual is born healthy and
    wanted, that women suffer no adverse consequence from the reproductive
    process, and that all children have the opportunity to fulfill their
    potential for a healthy and productive life unhampered by disease or
    disability. In pursuit of this mission, the NICHD conducts and supports
    laboratory, clinical, and epidemiological research on the reproductive,
    neurobiologic, developmental, and behavioral processes that determine
    and maintain the health of children, adults, families, and populations.

                               MENTAL RETARDATION

        Since this Institute was established 37 years ago, a major portion
    of our research has been devoted to better understanding the causes,
    treatments, and prevention of mental retardation. One by one, in large
    part as a result of the support for research from this Committee,
    causes of mental retardation are being eliminated:
      --phenylketonuria or PKU--eliminated;
      --congenital hypothyroidism--eliminated;
      --hemophilus influenzae type b meningitis or Hib--eliminated;
      --measles encephalitis--nearly eliminated;
      --congenital rubella syndrome--nearly eliminated;
      --bilirubin encephalopathy--nearly eliminated.
        Our progress toward understanding and eliminating the causes of
    mental retardation has continued during the last year. In a highly
    significant advance, Dr. Huda Zoghbi, an NICHD grantee in our Mental
    Retardation Research Center at Baylor, identified the gene responsible
    for Rett Syndrome, a mysterious condition that causes seemingly normal
    infant girls to lose their ability to walk and to develop symptoms of
    severe mental retardation. After years of exploration, researchers
    discovered the genetic difference between girls with Rett Syndrome and
    unaffected children. Girls with Rett Syndrome have a defective gene on
    one of their two X chromosomes. These girls have some normally
    functioning copies of the gene, so their symptoms are not immediately
    apparent at birth. However, between 6 and 18 months of age, these girls
    begin to exhibit the symptoms of Rett Syndrome when the function of the
    normal single gene is insufficient to meet the growing child's needs.
    [This discovery also sheds light on why only females are affected by
    the syndrome. Males with the Rett Syndrome gene possess only the mutant
    version of the gene because they have only one X chromosome.
    Presumably, male fetuses with the gene for Rett Syndrome die before
    birth or soon thereafter because they do not have a back-up copy of the
    normal gene.] The gene that is abnormal in Rett syndrome, called MECP
    2, controls the function of several other genes, so when it is
    defective, multiple other genes, including some that are essential for
    brain development and function, operate improperly. Based on this
    exciting discovery, the NICHD is encouraging investigators to try to
    find pharmacologic agents that can substitute for the control
    mechanism, and thereby reverse or prevent the progression of Rett
    Syndrome.
        Another significant finding we reported this year may provide a way
    to reduce the risk of mental retardation for children born to women who
    have hypothyroidism during their pregnancy. We have known for many
    years that congenital hypothyroidism in children is associated with a
    lower IQ and we have eliminated that problem by screening all newborn
    infants. Now NICHD research has demonstrated that children born to
    mothers who have untreated hypothyroidism during pregnancy scored lower
    on IQ tests than children of healthy mothers, with 19 percent in the
    borderline or retarded range. However, when mothers with hypothyroidism
    were being treated for the condition, their children's IQ scores were
    virtually identical to those of children born to healthy mothers. This
    study suggests that screening women for hypothyroidism before or early
    in pregnancy may provide a way to prevent mental retardation. A
    protocol is in preparation to test this possibility in the 14 ob-gyn
    departments that are part of the NICHD Maternal-Fetal Medicine Network.
    This network is also studying ways to reduce the incidence of low birth
    weight, another significant cause of mental retardation.
        NICHD has also provided important testing for a proposed new
    treatment of autism. In recent months a number of reports suggested a
    potential benefit to using secretin in the treatment of autistic
    children. We were intensely interested in these reports, but they
    contained no scientific data to assess the degree or duration of
    potential benefits. For this reason, NICHD launched a series of
    placebo-controlled studies to investigate potential benefits and risks
    of using secretin to treat autism. In results from the first of these
    studies, NICHD researchers found that treatment with the synthetic
    version of secretin offered no more benefit for children with autism
    than did treatment with placebo. Additional studies will seek to
    determine if secretin may be effective when given at various doses or
    on more than one occasion. We are also investigating whether secretin
    benefits autistic children with a particular group of symptoms and
    whether biological secretin is more effective than the synthetic
    version.

                               HEALTH DISPARITIES

        Another area in which the NICHD has both a deep concern and a deep
    commitment is the elimination of health disparities among minority
    populations. The Institute is developing a comprehensive and
    coordinated research plan for eliminating health disparities among
    racial and ethnic minorities. Our plan will address infant mortality,
    reproductive health, medical rehabilitation, and child and adolescent
    health. I would like to highlight some of the initiatives which
    illustrate our strong commitment to eliminating health disparities.
        Over the last two years, the NICHD awarded funds to 20 departments
    of obstetrics and gynecology to develop young investigators in the
    field and prepare the next generation of principal investigators. We
    also support 15 Reproductive Science Research Centers. In fiscal year
    2001, the NICHD will enhance these programs by funding a program of
    Specialized Centers for Research in Reproductive Medicine in Minority
    Institutions that pairs minority institutions with established research
    centers. The goal of this program is to increase the capacity of
    minority institutions and investigators to conduct cutting-edge
    research in the field of obstetrics and gynecology, focusing on
    problems particularly prevalent among minorities.
        The Institute's national Back to Sleep campaign, which urges
    caretakers to place infants on their backs to sleep, has met with
    significant success. In the five years since the campaign was launched,
    deaths due to Sudden Infant Death Syndrome (SIDS) have dropped 38
    percent. Despite this overall success, both the SIDS rate and the rate
    of stomach sleeping among African-Americans remain more than double
    that of white infants. To address this marked disparity, the NICHD
    invited the leaders from a number of national African-American
    organizations, as well as officials from Federal, state, and municipal
    governments, to join us in developing and implementing strategies for
    reducing SIDS in African-Americans. The group identified the need for
    culturally sensitive materials and programs designed by and for
    African-American communities. The NICHD is committed to carrying out
    this strategy. As a first step, NICHD is conducting research with
    African-American caretakers such as parents, grandparents, relatives,
    and child care workers to identify more effective ways to communicate
    the Back to Sleep message. One component is a transit ad, which will be
    used first in the DC Metro system, and eventually in other cities
    around the country. The Institute's goal is to eliminate the racial
    disparity in infant back sleeping position within three years and
    hopefully thereby eliminate the racial disparity in SIDS rates.
        We are also exploring ways to improve reading skills in populations
    of culturally and linguistically diverse students. Three years ago, the
    NICHD began a reading instruction research program with nine DC public
    schools. The purpose of the program was to determine whether applying
    what we have learned in other reading programs could be applied
    successfully with regular teachers in regular classrooms. Data from the
    Early Intervention Project are still being collected and analyzed, but
    preliminary data show a pattern of remarkable improvements in reading
    ability. For instance, reading scores in schools that have historically
    been at the 10th to 15th percentile have improved to better than the
    50th percentile. Moreover, the entire class in intervention schools is
    now performing at the national average. In a related area, the NICHD
    and the Department of Education this year are jointly soliciting
    research proposals for systematically studying the most effective ways
    to teach reading English to children whose primary language is Spanish.

                                  HIV RESEARCH

        In previous years, I reported on the research that led to the
    remarkable reduction in the rate of HIV transmission from mother to
    infant during pregnancy and birth. NICHD and NIAID research have made
    another important contribution to reducing maternal HIV transmission
    this past year. Grantees discovered that the amount of HIV in a
    pregnant woman's blood, known as maternal HIV viral load, is the prime
    risk factor for transmitting the virus to the baby. By focusing
    treatment on reducing the viral load during pregnancy, the risk of HIV
    transmission from mother to infant can be further decreased.
        In the developing world, where logistics and the cost of multiple
    drug therapy for HIV are often prohibitive, research reported last year
    showed that administering the antiviral drug nevirapine to the mother
    just before delivery and to the infant just after birth can reduce HIV
    transmission significantly. NICHD and NIAID are now conducting studies
    to evaluate whether nevirapine, administered during the time a mother
    is breast-feeding can reduce the rate of HIV transmission through
    breast milk.

                        PEDIATRIC TRAUMA REHABILITATION

        We also plan to expand research for children and teens in the area
    of trauma. Injury is the leading cause of death for children five to 18
    years old; violence is the third leading cause of death for this age
    group. However, many clinical treatments for trauma are tailored
    exclusively to adults and fail to consider the long-term effects of
    these interventions on a developing child. The NICHD is planning a
    multi-disciplinary, collaborative program to address this issue, led by
    the Institute's National Center for Medical Rehabilitation Research.
    This program will allow us to develop and assess therapies specifically
    targeted to the physical, emotional, and social needs of children. As
    part of this program, we will start a collaborative pediatric injury
    and trauma clinical trials network. Concurrently, we will be examining
    ways to actually prevent the risky behaviors that often result in
    injury and trauma.
        In 1998, the NICHD held a consensus conference on traumatic brain
    injury or TBI. The panel identified specific concerns that require
    further study regarding the impact of TBI on children. Brain injuries
    can have a profound impact on new learning and future physical and
    mental development of children. Based on the panel's recommendations,
    the NICHD will establish specialized research programs on treatment
    tailored directly to the needs of young children with traumatic brain
    injury.

                              BEHAVIORAL RESEARCH

        In the area of behavioral research, the Institute is identifying
    some of the major influences on the health and health behavior choices
    of young people. Since 1994, the Institute has supported The National
    Longitudinal Study of Adolescent Health, also know as the Add Health
    Study. The study has provided new insights into the ways that peers,
    families, schools and neighborhoods can influence positive health
    outcomes, as well as negative outcomes, such as violent behavior,
    smoking, drinking, illegal drug use, and sexual behavior. Data from
    this survey informed and will continue to inform public policy. With
    the increased funding provided by this Committee in fiscal year 2000,
    the Add Health study will collect additional data from the full
    original cohort. This study will help identify the major determinants
    of health and health behaviors during the transition from adolescence
    to early adulthood.
        Mr. Chairman, the support from this Committee for the research of
    the National Institute of Child Health and Human Development has
    contributed to the elimination and near elimination of some of the
    major causes of childhood diseases and lifelong disabilities. We are
    proud of this progress but we know we still face many daunting yet
    exciting research challenges. In the years ahead, with your continued
    support, I am confident that we will return to this room and report
    back to you that we have eliminated some of the causes of learning
    disabilities, that we have eliminated some of the causes of infant
    mortality, that we have eliminated some of the life-long adverse
    consequences of child-bearing, and that we have contributed in a
    significant way to eliminating the health disparities that separate
    racial and ethnic communities. I will be pleased to answer any
    questions you have at this time.
                                     ______

                     Prepared Statement of Dr. Carl Kupfer

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the National Eye Institute
    (NEI), for fiscal year 2001, a sum of $462.8M, which reflects an
    increase of $23.6M over the comparable fiscal year 2000 appropriation.
    Including the estimated allocation for AIDS, total support requested
    for the NEI is $474M, an increase of $23.9M over the fiscal year 2000
    appropriation. Funds for the NEI efforts in AIDS research are included
    within the Office of AIDS Research budget request.

                         THIRTY YEARS OF ACCOMPLISHMENT

        The NEI was formally established by Congress in 1968 and began full
    operations in 1970. Significant progress has been made in the last 30
    years in understanding and treating many diseases of the eye and visual
    system, including:
      --Developing highly effective treatments for severe diabetic
            retinopathy, a potentially blinding disease that affects half
            of the 16 million Americans with diabetes, according to the
            NIH's Diabetes in America. Thirty years ago, half of those who
            developed severe retinopathy were blind within five years of
            diagnosis, according to the British Journal of Ophthalmology.
            Today, because of NEI-sponsored clinical research, people with
            advanced retinopathy have less than a five percent chance of
            becoming blind when they get timely and appropriate treatment,
            according to the Journal of the American Medical Association.
      --Finding that Black and White individuals with advanced glaucoma may
            respond differently to two surgical treatments for the disease,
            with Blacks likely to respond more favorably to one treatment,
            and Whites likely to respond more favorably to the other.
      --Identifying a freezing treatment called cryotherapy that
            significantly reduces vision loss from advanced cases of
            retinopathy of prematurity, a potentially blinding visual
            disorder affecting premature infants.
      --Showing that rejuvenation of the immune system of people with AIDS
            will prevent progression of a potentially blinding AIDS-related
            eye complication called CMV retinitis.
      --Developing two new medical therapies--latanoprost and dorzolamide--
            for glaucoma. Both are given as eye drops.
      --Finding that an antiviral drug--acyclovir--decreases the recurrence
            of herpes infection of the eye, a very painful and potentially
            blinding eye disorder.
      --Identifying a gene that causes juvenile macular degeneration. This
            finding may bring researchers closer to finding the cause of
            age-related macular degeneration, a blinding eye disease
            affecting about 1.7 million older Americans, according to the
            NEI's Beaver Dam Study.
      --Identifying several defective genes suspected of causing retinitis
            pigmentosa, a group of inherited, blinding diseases that slowly
            damage the retina and affect 100,000 Americans, according to
            the American Journal of Ophthalmology. Identifying these genes
            may lead to treatments that prevent nerve cell degeneration and
            visual loss.
      --Discovering a more effective treatment for optic neuritis, which
            primarily affects women ages 15-45 and is often associated with
            multiple sclerosis. This treatment--a combination of
            intravenous and oral corticosteroids--restores vision more
            rapidly and decreases relapses.
      --Finding a simpler, more successful treatment of an infection of the
            inside of the eye which, if left untreated or inadequately
            treated, can cause loss of vision.
      --Demonstrating that a surgical procedure thought to be beneficial in
            treating an inflammation of the optic nerve is instead
            potentially harmful.
      --Developing a questionnaire to assess the impact of vision loss on a
            person's quality of life. Called the Visual Function
            Questionnaire, it is being used to evaluate the effectiveness
            of new treatments being tested in clinical trials.

                                   LOW VISION

        NEI-supported researchers continue to focus on finding better ways
    to prevent, treat, and hopefully cure diseases of the eye and visual
    system. Despite these efforts, there are, according to The Lighthouse,
    about 14 million Americans--one in 20--who have low vision due to eye
    diseases and disorders of the visual system. We define low vision as a
    visual impairment, not correctable by eyeglasses, contact lenses,
    medicine, or surgery, that interferes with the ability to perform
    everyday activities. As our population ages, it is expected that the
    number of people with low vision will increase dramatically.
        The impact of low vision on quality of life can be devastating. It
    can lead to a loss of independence. It can affect people's ability to
    move about safely, to make decisions, and to communicate with others.
    It can lead to frustration and uncertainty with profound lifestyle and
    economic consequences.
        To bring the message that information and help are available to
    people with low vision and their families, the NEI launched a Low
    Vision Education Program last October. The goal of the Program is to
    help improve the quality of life for people with low vision and outline
    steps people can take to use their remaining vision more effectively. A
    public awareness program that conveys positive, encouraging, and
    uplifting messages will alert the public and health professionals to
    this issue. People with low vision need to know that help exists, such
    as visual rehabilitation services and devices. The eye care
    professional should never tell his or her patient that nothing can be
    done about low vision. The fact is something can be done about it.
        As part of the program, we have introduced a Low Vision Traveling
    Exhibit that increases public awareness about low vision and provides
    important information for people who do not see well. This exhibit,
    which will be displayed in shopping malls nationwide during the next
    few years, is now debuting in Birmingham, Alabama. The exhibit features
    an interactive CD-ROM touch screen program and provides first-person
    stories of how Americans are living successfully with the condition.
    The exhibit will help us reach those who need this information the
    most--people with low vision and their families and caregivers.
        The Low Vision Education Program is part of the National Eye Health
    Education Program (NEHEP), the first Federally-funded eye health
    education program. It is coordinated by the NEI in partnership with
    close to 60 public and private organizations united behind a nationwide
    effort to educate people about the importance of good eye health.
    Through this network of ``grass roots'' organizations, the NEHEP
    multiplies its efforts in educating the public.
        As we launch the Low Vision Education Program, the National Eye
    Institute is furthering progress in the area of low vision research,
    and is currently supporting 26 grants at a cost of about $6 million.
    Some of these projects involve laboratory research. Some involve
    research to develop low vision devices and explore emerging
    technologies. The auto focus binocular low-vision telescope has been
    improved. Research has yielded several new methods of presenting
    magnified text on computer screens. Another key advance is the
    development of new technology, such as route planning database systems
    and personal guidance systems, to improve way finding for people who
    are visually impaired. The NEI is a full partner in the NIH's
    bioengineering initiatives that bring together the necessary basic
    science, engineering, and/or clinical expertise to focus on a
    significant area of bioengineering research.

                             TRANSLATIONAL RESEARCH

        Although the NEI is a clinically-oriented Institute, work performed
    in the laboratory is a fundamental pillar of research on visual
    impairment and blindness. It must be conducted before new therapies for
    preventing or treating disease can be developed and tested in a
    clinical trial setting. One of the greatest strengths of the NIH
    intramural program is that laboratory research can be conducted, and
    the findings quickly applied, to a small group of patients before
    large-scale testing.
        An excellent example of our ``lab-to-bedside'' research is the
    discovery of a possible new treatment for uveitis, a severe eye
    inflammation that affects children and young adults. The current
    treatment for uveitis involves powerful drugs that can cause serious
    side effects, such as decreased kidney function, cataracts, glaucoma,
    and brittle bones. A collaboration between scientists at the NEI and
    the National Cancer Institute will result in an alternative therapy,
    called humanized anti-Tac monoclonal antibody, which can be given
    intravenously once a month. This biological substance seems to control
    uveitis as effectively as the standard treatment in this study, but
    with a marked decrease in complications and side effects. This study
    serves as a model for future studies.

                           VISUAL HEALTH DISPARITIES

        The NEI is supporting a number of studies to improve understanding
    of eye disease and visual impairment in traditionally underserved
    populations. For example, among African Americans, glaucoma is the
    leading cause of blindness. Results from NEI-funded studies confirm the
    rates for blindness due to glaucoma in African-Americans are six times
    higher than the rates for Whites. On the other hand, age-related
    macular degeneration is rare for Blacks as compared to Whites.
        Clinical Studies will help identify people at highest risk for
    glaucoma and those most likely to benefit from early medical treatment.
    To closely follow people who are at moderate risk of developing
    glaucoma, the NEI is conducting a clinical trial called the Ocular
    Hypertension Treatment Study. This multi-center clinical trial has
    enrolled 1500 patients, of which 25 percent are African-American. The
    high percentage of African Americans participating will enable analyses
    of the effectiveness of topical medications in preventing the
    development of glaucoma in Blacks.
        Previous research has provided estimates of the prevalence of eye
    disease among Whites and Blacks in the US, but no published comparable
    data exists on the US Hispanic population. This paucity of data hampers
    the design of appropriate eye health services. The NEI is now
    supporting two large studies--The Los Angeles Latino Eye Study and the
    Visual Impairment Among Hispanics in Arizona Study--that will help
    direct manpower and resources toward the major eye health needs of the
    Hispanic population.
        The NEI is also conducting an investigation of eye development and
    nearsightedness in schoolchildren. This study will compare and contrast
    normal eye growth and development in Hispanic, African-American, and
    Asian schoolchildren ages 6-14 years with what happens in Caucasian
    children. With this information, we hope to be able to predict
    nearsightedness in small children before it is clinically evident.

                      FUTURE DIRECTION OF VISION RESEARCH

        There are eye diseases that have resisted our best efforts at
    improving treatment. But the NEI is exploiting new advances in
    molecular biology, genetics, immunology, cell biology, and other
    disciplines to accelerate efforts to find cures for blinding diseases.
        The NEI has outlined new therapeutic strategies--such as gene
    replacement, tissue and cell transplantation, and growth factor
    therapy--that show great potential. We can produce--and directly view--
    abnormal blood vessels in the eyes of animal models. This allows us to
    determine if various treatments for diabetic retinopathy and macular
    degeneration are effective in eliminating these blood vessels, which
    lead to blurred vision.
        The vision researcher has the advantage of utilizing noninvasive
    technology. Adaptive optics technology has recently been applied to the
    visual system, giving the clearest views yet of the living retina
    inside the eye. This may allow scientists to track the progression of a
    number of retinal diseases such as retinitis pigmentosa and diabetic
    retinopathy, and evaluate the efficacy of rescue of cell types in the
    retina.
        To help develop genomic resources that facilitate understanding of
    the normal visual system and related disorders and diseases, NEI
    sponsored a two-day multi-disciplinary functional genomic workshop last
    September. The purpose of genetics studies related to the eye is not
    only to identify eye genes, which will be aided greatly by NIH's Human
    Genome Project, but also to determine what the genes do normally and
    what happens when the genes are mutated. Some ideas generated at the
    workshop included creating a visual system web site to enhance access
    to existing, or newly created, databases for genes expressed in the
    visual system; producing and characterizing expressed genes of the
    visual system; and encouraging programs for genomics, functional
    genomics, and disease. We have begun to implement many of these
    suggestions.
        Research will continue to examine all these possibilities, guided
    by our goal of the past 30 years to improve the prevention, diagnosis,
    and treatment of all diseases of the eye and visual disorders. Much
    remains to be done. We understand that progress does not always occur
    as quickly as we would hope. But we put ahead of us this goal and
    vision for the new century. With the continued support of the American
    people and the research priorities outlined in our strategic plan, we
    will endeavor to protect this most precious sense of sight for all
    Americans and all of humanity.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report,
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        Mr. Chairman, I will be happy to answer your questions.
                                     ______

                    Prepared Statement of Dr. Kenneth Olden

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for NIEHS for fiscal year 2001,
    a sum of $460,971,000 which reflects an increase of $25,824,000 over
    the comparable fiscal year 2000 appropriation. Including the estimated
    allocation for AIDS, total support requested for NIEHS is $468,649,000
    an increase of $25,961,000 over the fiscal year 2000 appropriation.
    Funds for the NIEHS efforts in AIDS research are included within the
    Office of AIDS Research budget request.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, this data will help identify new strategies
    and objectives to improve programs across NIH and the Department.
        There is a paucity of information to make important environmental
    health regulatory decisions. When it's time for many of us to buy a car
    or a house, we take great pains to study the market, examining factors
    like reliability, safety and resale value, before committing ourselves
    to make such a major investment. As a nation, however, we frequently
    make decisions about how (or whether) to regulate chemical and physical
    agents to improve environmental health--moves that cost the public and
    private sectors hundreds of billions of dollars--without adequate
    information. This lack of information is becoming more evident as we
    move into an era when the biggest threats we face are from exposures to
    low doses, not the high doses we have traditionally faced and tried to
    control.
        The most commonly used words in reference to environmental health
    risks are ``not enough information.'' For example, a committee by the
    National Research Council recently concluded that ``there is
    insufficient research, and therefore insufficient evidence, to say
    whether particular environmental contaminants known as endocrine
    disruptors may be dangerous to humans.'' This information gap is not
    unique to endocrine disruptors. Most experts agree that inadequate
    information exists regarding the toxicity of chemicals, the variation
    in susceptibility to toxic substances, the type, pattern, and magnitude
    of human exposure to chemicals through the diet, the workplace, and the
    environment.
        In part, the current dilemma has resulted from the success of
    environmental remediation and pollution control and reduction efforts
    over the past 30 years. These efforts have dramatically reduced the
    human health threats posed by the thousands of new chemicals and
    technologies introduced into our environment. In fact, there are those
    who argue the environment no longer represents a serious threat to
    human health because the low-dose exposures currently experienced by
    most Americans pose no significant health threat. But the assumption
    that low-dose exposures do not present a potential health risk is
    seriously flawed. We now know that chronic low-level exposures have the
    capacity to accumulate and attain toxic concentrations in brain and
    other tissues. For example, it is well documented that ingested
    methylmercury can be completely absorbed from the digestive tract and
    easily accumulate in the brain and poison the neurons involved in
    learning and memory processes.
        Managing today's risks will also require consideration of
    biological concepts that were not part of the environmental health
    science vernacular as recently as ten years ago. Concepts such as
    susceptibility, environmental genomics, high-throughput screening and
    transgenic technology were not among the priorities of the
    environmental health research enterprise. We need to develop new
    science, new technologies and new ways of conceptualizing and
    investigating threats to human health. Environmental decisions of the
    future will require better information and pollution prevention
    strategies than currently exist today. New approaches are needed to
    promote greater participation of local communities and public health
    officials in environmental health research and policy development in
    terms of priority setting and development of prevention strategies to
    protect public health. Particular emphasis should be made to include
    disadvantaged and minority populations in research and policy
    determinations. These groups often bear the greater burden of
    environmental hazards and, as has been clearly documented, suffer from
    poorer health than do more affluent groups.
        Realizing the public health and economic potential of environmental
    health research requires a number of critical investments. I will focus
    on three of them--high throughput technologies, susceptibility to
    environmental toxicants, and exposure assessment.

                          HIGH THROUGHPUT TECHNOLOGIES

        In my testimony before this Committee in 1997, I updated you on our
    efforts to develop and validate high throughput technologies for
    carcinogenicity and toxicity testing, including transgenic animal
    models. Today, I am pleased to report that because of our leadership in
    this area of research, transgenic animal models, as a tool to study
    chemical carcinogenesis, is the subject of intense research. In fact, a
    recent paper used one of these models to successfully assess chemical
    carcinogenesis in vascular tissue. The hope is that such animal models
    can be used in a carcinogenicity testing strategy, potentially reducing
    our dependence on the conventional two-year rodent bioassay. The
    transgenic bioassays use fewer animals, cost less, and take less time
    because of their increased sensitivity to carcinogens and low incidence
    of spontaneous tumors. While I am optimistic that transgenic animals
    will be validated for assessment of carcinogenic or toxic potential of
    chemicals, we have already initiated efforts to develop the second
    generation of alternative test systems based on differential gene
    expression. Given that gene expression is continuously modulated by
    environmental cues, exposure to toxic agents can be expected to elicit
    unique patterns of gene expression. Thus, DNA microarray technology,
    which can monitor gene expression, could be a sensitive tool to assess
    toxicity. The assumption is that toxic exposures are likely to evoke
    quantitative and qualitative changes in gene expression. Therefore,
    this technology should allow toxicologists to expose cells or tissues
    to chemicals whose toxicity is unknown and match the results against
    the ``signature,'' or common set of changes in gene expression,
    produced by a known class of toxicants. This would reduce the need for
    lengthy and expensive rodent bioassays (conventional and transgenic)
    and would lend itself to testing at low doses and to automation. Today,
    I want to announce our intent to establish a DNA Microarray Resource
    Center to develop and distribute so-called ``Tox-Chips'' containing
    candidate genes--genes known to be involved in cell growth and
    proliferation and in the biotransformation of environmental carcinogens
    or toxin--derived from human, mouse and other animal sources. This
    approach to developing and applying this new technology to the field of
    toxicology will ensure that all investigators will have access to this
    expensive resource and that the products are the highest quality.
                   susceptibility to environmental toxicants
        It is well known that most smokers do not develop lung cancer and
    most women exposed in utero to diethylstilbestrol never develop vaginal
    and cervical cancer. A common question asked of physicians is, ``Why
    me, Doc?'' One answer to this question is that genetically-determined
    differences in susceptibility are at least partly responsible.
        Significant advances in our understanding of human genetics have
    shown that specific genes play key roles in disease susceptibility. For
    example, mutations in BRCA1, P53, XPB, and ATM are predisposing for
    breast cancer, Li-Fraumeni syndrome, xeroderma pigmentosum, and ataxia
    telangiectasia, respectively. Thus, it is reasonable to expect that
    several of the genetic alterations in other genes will also have a
    significant influence on disease susceptibility. With rapid advances in
    cloning and sequencing of the human genome, it is now possible to
    identify the genetic alterations responsible for differences in
    susceptibility. The ``sequence'' of the entire human genome will be
    elucidated within the next 12 months. However, the order of the bases
    in the human genome is not one sequence but rather many variations of a
    common theme. In fact, sequence variation is ubiquitous in human
    populations; what differs is the frequencies of these variations.
        Susceptibility also is influenced by the timing of exposure, the
    gender and behavior of the individual, the nutritional state and
    socioeconomic status. For example, exposure during rapid or critical
    stages of development of the various organ systems such as embryonic
    development, adolescence, puberty and old age, is likely to be an
    important factor in disease development. We currently have little
    information to guide decision-making with respect to these issues since
    most toxicologic assessments have been done in adults, both animals and
    humans, under otherwise optimal conditions.
        To investigate the genetic basis for differences in predisposition
    to disease, NIEHS extended the domain of genomic mapping and sequencing
    to address the challenge of genetic diversity. The Environmental Genome
    Project, initiated two years ago, seeks to identify genetic changes
    that increase risk for disease development, and the results from these
    studies will have profound implications for the practice of medicine
    and environmental health risk assessment. The challenge will be to
    create a repository of all common variants--a diversity map--and
    correlate them with specific environmental exposures and disease
    phenotypes through functional and epidemiologic studies.
        Today, I am announcing our intent to support the development of
    Comparative Mouse Genomics Centers that will make use of all available
    DNA sequence variation data to produce novel transgenic and knockout
    mouse models which will mirror specific variants of human
    environmentally responsive genes found in the general population. The
    Mouse Genomics Centers will bring together a team of investigators to
    develop mouse models of environmentally relevant human diseases,
    provide a comprehensive analysis of their phenotype and genotype, and
    validate them for their use by the research community. The new models
    produced by the Centers will then be used by the scientific community
    to study diseases resulting from specific insults, including exposure
    to environmental agents, viruses, nutritional factors, pharmacological
    drugs, and other physical and chemical stresses.
        It is important to emphasize that susceptibilities modify risk
    rather than cause disease. This ``gene-hunt'' and ``mouse-model''
    development exercise could have profound implications for risk
    assessment in terms of setting standards for environmental exposures.
    Data on the prevalence of susceptibility genes could take the guesswork
    out of environmental decision-making with respect to susceptible
    populations. These studies challenge a fundamental tenet of toxicology;
    that is, that the dose makes the poison. We now know that it is the
    host, plus the dose and the time of exposure, that makes the poison.
                              exposure assessment
        Exposure monitoring is a ``right-to-know'' issue for citizens who
    are involuntarily exposed to environmental pollutants. However, little
    is known about actual human exposure and body burdens of environmental
    pollutants. This knowledge gap hampers regulatory decision-making and
    introduces uncertainties in setting exposure limits. It also limits our
    capacity to develop effective prevention strategies. Exposure is
    typically estimated using indirect surrogates of environmental quality
    such as toxic release and production inventories and environmental
    monitoring. Individual exposure, though, is highly variable and is a
    function of individual uptake, metabolism, excretion and behavior. So
    the assumption that everyone living in the same geographic area have
    similar exposure is seriously flawed. What we need are direct measures
    of exposure based on tissue analysis or deposition. Simple monitoring
    of levels of chemicals in the environment does not necessarily reflect
    amounts taken up and deposited in tissues.
        Exposure assessment is emerging as a scientific field due to the
    revolutionary advances in genetics, molecular imaging, molecular
    biology, and microenvironmental and personal measurement technology. As
    these technologies become more robust, sensitive and inexpensive, they
    will provide the scientific foundation for the quantitative assessment
    of human health risk. Exposure analysis provides the long-awaited
    connection between toxicology and epidemiology, and will provide the
    basis for hypothesis-driven research and examination of exposure-
    disease relationships.
        Several public health areas will benefit from improvements in
    exposure assessment. The absence of adequate exposure data restricts
    our ability to (1) evaluate low-dose effects of exposure to chemicals
    encountered in the home, workplace and general environment, (2)
    identify at-risk populations based on age (e.g., children), genetic
    susceptibility and socioeconomic status, (3) design studies to
    efficiently evaluate exposure/response relationships, (4) make full use
    of the human genome effort for studying gene/environment interactions,
    and (5) to link exposure to human diseases.
        In September 1999, the NIEHS and the American Industrial Health
    Council co-sponsored an interagency workshop on ``The Role of Human
    Exposure Assessment in the Prevention of Human Disease.'' With more
    than 400 participants, the three-day workshop represented experts from
    the various federal agencies, public interest groups, academia, and
    industry. Participants considered the workshop a landmark event in the
    field of exposure assessment in that it provided the vision and
    enthusiasm for moving the field of exposure assessment away from solely
    an applied discipline to one in which hypothesis-driven research can
    effectively connect technological advances to public health problems
    and controversies. Since the workshop, NIEHS has developed a
    collaborative relationship with the National Center for Health
    Statistics and the U.S. Geological Survey to develop a population-based
    geographical information system and disease prevalence maps.
        In conclusion, the power of the science base for environmental
    health decision-making can now be transformed at a pace that could not
    have been foreseen a decade ago by even the most astute visionaries.
    The scientific opportunities presented here develop an entirely new
    framework to understand how environmental exposures affect human
    health.
                                     ______

                   Prepared Statement of Dr. Richard J. Hodes
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the National Institute on
    Aging (NIA) for fiscal year 2001, a sum of $721,651,000, which reflects
    an increase of $37,933,000 over the comparable fiscal year 2000
    appropriation. Including the estimated allocation for AIDS, total
    support requested for the National Institute on Aging is $725,949,000,
    an increase of $38,088,000 over the fiscal year 2000 appropriation.
    Funds for NIA efforts in AIDS research are included within the Office
    of AIDS Research budget request.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        Since the NIA's inception in 1974, tremendous strides have been
    made in uncovering the mysteries of the aging process, reducing disease
    and disability, and improving the quality of life for older Americans.
    The pace of scientific discovery has been impressive, and the Institute
    anticipates building upon these advances in the future. I am pleased to
    report the NIA's recent progress, in reducing disability and extending
    healthy active years of life for all Americans.
                          alzheimer's disease research
        Alzheimer's disease (AD), the most common cause of dementia, is the
    result of abnormal changes in the brain that lead to a devastating
    decline in intellectual abilities and changes in behavior and
    personality. Tragically, as many as four million Americans \1\ now
    suffer from Alzheimer's disease--a number that threatens to increase
    dramatically as the population of people most at risk for dementia,
    those aged 85 and older, reaches almost 20 million by the middle of the
    21st century.\2\ NIA, as the lead Federal agency responsible for
    Alzheimer's disease research, recognizes the urgency of this looming
    public health threat and is supporting basic, clinical, and behavioral
    research to improve AD diagnosis, treatment, and patient care, and to
    delay, and eventually prevent, the onset of this devastating disease.
    Advances in our understanding of AD over the last 20 years have been
    substantial, enabling the NIA to launch the Alzheimer's Disease
    Prevention Initiative. In collaboration with other Federal agencies and
    the private sector, the AD Prevention Initiative is invigorating
    discovery of new treatments, risk and preventative factors, methods of
    early detection and diagnosis; and strategies for improving patient
    care and alleviating caregiver burdens. The initiative is also
    accelerating movement of promising new treatments and prevention
    strategies into clinical trials, and is improving understanding of
    normal brain function.
    ---------------------------------------------------------------------------
        \1\ Small, GW, Rabine, Barry, PV, Barry, PP, et. al. Diagnosis and
    Treatment of Alzheimer's Disease and Related Disorders. JAMA 16: 1363-
    1371, 1997.
        \2\ Bureau of the Census, Middle Series Projections, 1996.
    ---------------------------------------------------------------------------
        In 1999, the NIA launched the first large-scale AD prevention
    clinical trial supported by the NIH, the Memory Impairment Study (MIS),
    being conducted at more than 65 medical research institutions in North
    America. In this trial, vitamin E, and donepezil (Aricept) will be
    evaluated over a three-year period for their effectiveness in slowing
    or stopping the conversion from mild cognitive impairment (MCI), a
    condition characterized by a memory deficit without dementia, to AD.
    Other ongoing or upcoming AD prevention trials will examine the
    effectiveness of ibuprofen (an anti-inflammatory drug) in reducing the
    development of AD; the effect of estrogen replacement therapy in
    preventing AD in women with a family history of the disease; and
    whether treatment with a variety of agents, such as aspirin, vitamin E,
    antioxidants, or combined folate/B6/B12 supplementation can prevent AD.
    The effects of these agents on normal age-related decline will also be
    evaluated. Information about ongoing clinical trials is available to
    the public through the NIA-supported Alzheimer's Disease Education and
    Referral Center web site (www.alzheimers.org) and toll-free number (1-
    800-438-4380).
        The ability to assess the effectiveness of early treatments or
    interventions, such as those being tested in the AD Prevention
    Initiative, will be enhanced by our ability to visualize brain function
    using new imaging techniques. In a recent study, investigators used
    magnetic resonance imaging (MRI) to determine volume measurements of
    the hippocampus, the region of the brain responsible for memory
    function, in individuals diagnosed with mild cognitive impairment
    (Chart #1). Based on three years of observations, researchers found
    that in older people with MCI, the smaller the hippocampus at the
    beginning of the study, the greater the risk of developing AD later.
    This imaging study illustrates how abnormal cerebral function or
    anatomy can be detected before clinical diagnosis and how diagnostic
    advances can help ensure the effective application of emerging early
    interventions. Advances in imaging techniques also have important
    diagnostic implications for other neurodegenerative diseases, such as
    Parkinson's disease.
        Developing effective treatments for AD based on advances in basic
    research is a major focus of NIA-supported studies. The ability of
    researchers to conceptualize effective treatments was enhanced by the
    discovery of two enzymes, beta and gamma secretase, that are involved
    in the clipping of a normal cell surface protein to produce the amyloid
    peptide that forms the senile plaques found in the brains of AD
    patients (Chart #2). Identifying and understanding how these two
    enzymes work will accelerate the development of interventions to block
    their action and stop the development of AD plaques. NIA will also
    support research to evaluate the potential of an immunization approach
    recently developed by researchers in the private sector, which, in
    mice, prevented the formation of amyloid plaques associated with AD.
        A transgenic mouse strain that expresses a human tau gene and
    develops AD-like tau tangles has been developed. This model will help
    scientists understand how tau produces AD in the brain, and together
    with other AD models, will move researchers closer to developing
    effective preventive or treatment interventions. In another study,
    researchers demonstrated that shrinkage and dysfunction of certain
    brain cells that occur with age might be reversible. Researchers
    inserted into skin cells a gene that makes human nerve growth factor
    (NGF) and then injected the modified cells into the brains of
    experimental animals. After three months, the older animals injected
    with NGF-expressing cells had brains that resembled those of younger
    animals. Such gene transfer approaches to recovering cellular function
    could eventually have important implications for the treatment of AD
    and other chronic age-related neurodegenerative disorders in humans.
                                biology of aging
        Research on the biology of aging has led to a revolution in
    understanding the cellular and molecular changes that occur with aging
    and the abnormal changes that are risk factors for or accompany age-
    related diseases. Further, research is revealing genetic and other
    biologic factors associated with extended longevity in animal models,
    contributing to the development of interventions to reduce or delay
    age-related degenerative processes in humans. Presently, caloric
    restriction is the only intervention known to slow the intrinsic rate
    of aging in mammals. Rodents and other laboratory animals that are
    given a diet that includes necessary nutrients, but 30 to 40 percent
    fewer calories than in usual diets, live far beyond their normal life
    spans and have reduced rates and later onset of diseases. A recent
    study analyzed the gene expression profiles of cells from young and
    from old mice on usual or calorically restricted diets. Of the 6,347
    genes surveyed by new micro-array techniques, fewer than one percent
    displayed a greater than twofold decrease in expression. Thus, the
    aging process may be associated with changes in expression of a limited
    subset of genes, rather than involving widespread changes in most
    genes. It was further observed that caloric restriction completely or
    partially suppressed age-associated alterations in expression of a
    large proportion of genes. This type of molecular assessment of
    mammalian aging will provide new tools to evaluate experimental
    interventions for age-related conditions.
        Over the last ten years, numerous genes have been implicated in
    normal aging processes, in age-related pathologies and diseases, and in
    determination of longevity in several species including humans (Chart
    #3). Understanding the molecular genetics of aging and longevity is a
    rapidly advancing field; recent research advances have greatly expanded
    our knowledge of genes and biological pathways which play significant
    roles in determining longevity and health span. Recent discoveries in
    non-mammalian species including S. cerevisiae (yeast), C. elegans,
    (roundworms), and D. melanogaster, (fruit flies), have identified
    striking effects of mutations, either singly or in specific
    combinations, on lifespan, increasing life spans 2 to 3 times longer
    than those of (wild type) normally aged animals. These findings suggest
    signaling and metabolic pathways that may be critical in determining
    longevity. In addition, cross-species comparisons have identified
    homologous (similar) genes in animals and in humans that have similar
    or related functions. For example, mutations that double the life span
    of C. elegans occur in genes that are homologous to genes associated
    with insulin and glucose (sugar) metabolism in humans, and may
    therefore be relevant to weight control and diabetes.
                        reducing disease and disability
        Studies have shown that disability rates for people age 65 and
    older have been falling at an accelerating pace since 1982 and that the
    benefits of this trend extend to both men and women, and to minority
    groups. Initial field reports from the 1999 wave of the National Long-
    Term Care Survey indicate that disability rates have continued to fall.
    These data parallel heartening news from investigators who found that
    many centenarians remain functionally independent for the vast majority
    of their lives. More research is needed to understand the genetic and
    environmental factors responsible for centenarians' prolonged good
    health and extreme longevity. Similarly, more research is necessary to
    understand the causes and economic consequences of the decline in
    disability rates and to further accelerate these improvements.
        Increasingly, researchers are understanding the benefits of
    exercise, especially for older people, as a key to preventing or
    delaying the onset of disease and disability. Specifically, studies
    have revealed that moderate physical activity can: reduce the risk of
    falls; benefit people suffering from a variety of ailments, including
    osteoarthritis and depression; and may enhance learning, memory and the
    generation of brain cells. There is also scientific evidence that
    exercise may be a factor related to increased life expectancy and the
    number of years people live free of disability. In a recent study, it
    was shown that becoming fit, even in later years (as measured by
    performance on an exercise treadmill test), is associated with lower
    mortality rates (Chart #4). The study, which included 9,000 men aged 20
    to 82, compared death rates in physically unfit men who remained unfit
    over five years with physically unfit men who became fit during the
    same period. The study found that unfit men aged 60 and over who became
    fit had death rates 50 percent lower than those who remained unfit. In
    another clinical trial involving chronically ill older adults, aged 70
    and older, researchers reported that one year of increased physical
    activity, combined with chronic-illness self-management resulted in
    fewer reported hospitalizations and total hospital days. These studies
    show that exercise can benefit older people and that it is never too
    late to start. The challenge remains to motivate more people to engage
    in regular physical activity--particularly older women and minorities
    who, according to national surveys, are consistently less active. Last
    year, the National Institute on Aging published a free manual,
    Exercise: A Guide from the National Institute on Aging, the cornerstone
    of the Institute's ongoing campaign to encourage older people to
    exercise. The Guide is based on scientific evidence and is intended to
    help people design their own exercise program. To date, the Institute
    has distributed over 230,000 copies.
                          reducing health disparities
        Health disparities are associated with a broad, complex, and
    interrelated array of factors, including race, ethnicity, gender,
    socioeconomic status, age, education, occupation, and as yet unknown
    lifetime and lifestyle differences. Prevalence rates of specific
    diseases are also associated with race, ethnicity and socioeconomic
    status. One recent multi-ethnic epidemiologic study indicated that
    prevalence rates for Alzheimer's disease may be higher for African-
    Americans and Hispanics. In an examination of genetic risk factors for
    AD, although APOE4 is associated with higher risk of AD among
    Caucasians, African Americans and Hispanic elders with the APOE4 allele
    were not at higher risk than those with other APOE alleles.
    Understanding the genetic and environmental risk factors contributing
    to this difference will be crucial to developing effective
    interventions to reducing the disparity.
        NIA has made reducing health disparities a major priority of its
    five-year strategic plan. Last year, with support from the NIH Office
    of Research on Minority Health, the NIA intramural program designed a
    mobile medical research vehicle to extend the opportunity to
    participate in the Baltimore Longitudinal Study of Aging and in other
    clinical research projects to minority and socioeconomically diverse
    subjects. The NIA, working with the National Advisory Council on Aging,
    also undertook a comprehensive review of its minority aging research
    activities and training initiatives. The NIA is developing an
    implementation plan to integrate the resulting recommendations into its
    programs, such as the Resource Centers for Minority Aging Research,
    which provide mentoring and training opportunities to individuals
    interested in studying the health of minority elders, and the
    Alzheimer's Disease Centers satellite clinics, which recruit minorities
    for research protocols conducted by the NIA's 28 AD centers.
        Investigators supported by the NIA continue to report exciting
    scientific advances that may help eliminate health disparities among
    groups of elders. Investigators recently published a study, which
    suggests that there is a difference between African-American and
    Caucasian women in their experience of peri-menopausal symptoms.
    African-American women were significantly more likely than white women
    (58 percent vs. 29 percent) to experience hot flashes, but fewer than 7
    percent had discussed menopausal management with their physicians.
    Given our developing understanding of hormone replacement therapy in
    controlling menopausal symptoms as well as in reducing risk of problems
    in later life, such as osteoporosis, improved, culturally-appropriate
    patient education programs should be encouraged.
        A decade ago, few interventions were available to address the major
    health concerns of older people. Entering the 21st century, the outlook
    has improved considerably. More interventions exist and research into
    treating, as well as preventing, the onset of age-related diseases is
    escalating. With the knowledge this research will derive, aging will be
    a healthier, more vigorous stage of life. I am happy to answer your
    questions.
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                   Prepared Statement of Dr. Stephen I. Katz
        Mr. Chairman and Members of the Subcommittee: I am pleased to
    present the President's non-AIDS budget request for the NIAMS for
    fiscal year 2001, a sum of $363,479,000, which reflects an increase of
    $19,021,000 over the comparable fiscal year 2000 appropriation.
    Including the estimated allocation for AIDS, total support requested
    for the NIAMS is $368,712,000, an increase of $19,232,000 over the
    fiscal year 2000 appropriation. Funds for the NIAMS efforts in AIDS are
    included within the Office of AIDS Research budget request.
        I am honored to appear before this Subcommittee. I want to begin by
    providing a context for the research mission of our Institute. As the
    Director of the NIAMS, I am acutely aware that the every day life of
    the American people is enormously improved by the research that our
    Institute supports. Children on the playground, women and ethnic
    minorities who are disproportionately afflicted by the many diseases
    that affect their daily activities, adults in the work place, and
    elderly Americans striving to live independently--all have their lives
    enhanced or compromised by the health and functioning of their bones,
    joints, muscle, and skin. Ensuring improved quality of life and
    increased longevity of life for all Americans is our primary mission.
        I want to express my appreciation for the fiscal year 2000
    appropriation--the second year of an extraordinary budget that enabled
    us to invest in medical research with much more breadth and depth than
    ever before. I will share specific examples of ways in which we
    invested our budget over the last year and some of the research
    directions we are pursuing.
                               clinical research
        The focus of most of my remarks today will be on clinical research.
    While the backbone of medical science has been and will continue to be
    fundamental research on how the body functions, the ultimate goal of
    research supported by the NIH is improving public health. In order to
    achieve this, we must also serve as translators--translating the basic
    research findings from the laboratory to improving patient care at the
    bedside as well as utilizing the information learned at the patient
    bedside to inform more focused and sophisticated basic studies. This
    translation is the cornerstone of the research supported by the NIAMS.
        Highlights of particularly exciting and promising translational
    research on bones, joints, muscles and skin include the findings that
    lower doses of estrogen than we normally prescribe can be effective in
    preventing osteoporosis, that some of the new treatments for rheumatoid
    arthritis can be targeted directly at the disease-causing factors, that
    normal hair growth is controlled by genes that encode for proteins that
    may be excellent targets for new therapies, and that proteins that are
    essential for normal muscle formation can, in mouse models, be produced
    by injecting particular genes into the muscles that contain the
    defective proteins. These examples provide only a broad sample of some
    of the most recent findings from research studies that we have
    supported.
        The reality is that clinical research is vitally important, but is
    also very costly. The significant increase in our appropriation last
    year enabled us to launch a number of clinical initiatives in
    particularly challenging areas of health, including: (1) Pilot studies
    in rheumatic diseases and skin diseases--These studies include expanded
    research on some of the most difficult public health challenges such as
    leg ulcers, rheumatoid arthritis, scleroderma, lupus, spondylitis and
    others where new treatment approaches are needed. (2) Osteoporosis in
    men--A major clinical trial will determine the extent to which the risk
    of fracture in men is related to bone mass and structure, biochemistry,
    lifestyle, tendency to fall, and other factors. The study will also
    seek to determine if bone mass can be correlated with an increased risk
    of prostate cancer. (3) Combination therapies for osteoporosis--It is
    important to determine whether combinations of drugs, often produced by
    different pharmaceutical companies, will be more effective and have
    fewer side effects than any of the drugs used alone for osteoporosis.
    (4) Treatment of back pain--Back pain is very common and has a serious
    impact on people's personal and professional lives, and results in
    significant costs to businesses and the American economy. We have
    launched a major clinical trial studying surgical versus nonsurgical
    treatment of three different back disorders. We anticipate that this
    study will have a significant effect on clinical practice and the cost
    of medical services for people with any of these three back disorders.
    (5) The Spondylitis Consortium--The NIAMS has partnered with the
    American Spondylitis Association in establishing the North American
    Spondylitis Consortium to search for genes that determine
    susceptibility to ankylosing spondylitis, a painful inflammatory
    disease of the spine, also known as arthritis of the spine. and (6)
    Clinical research training and career development--Because we need to
    develop and maintain a pipeline of researchers who are training to
    plan, conduct, analyze, and disseminate the findings of clinical
    research, the NIAMS has enthusiastically embraced and participated in
    the NIH initiatives to develop and maintain careers in clinical
    research.
                                  autoimmunity
        The NIAMS supports a broad and diverse portfolio of research on
    autoimmunity, including studies of rheumatoid arthritis, systemic lupus
    erythematosus, Sjogren's syndrome, scleroderma, alopecia areata, and
    many blistering skin diseases--all potentially devastating chronic
    diseases which exact a huge toll in human suffering and economic costs.
    The additional funds provided by Congress for the Autoimmunity
    Initiative last year provided the opportunity for the NIAMS to expand
    its research in the following key areas: (1) pilot trials on innovative
    therapies for rheumatoid arthritis and scleroderma; (2) target organ
    damage in autoimmune diseases, also focusing on scleroderma and
    rheumatoid arthritis; (3) autoimmune rat repository and transgenic
    resource--a national resource and development center for rat models of
    autoimmune disorders; (4) NIAMS patient data registries--in which
    information will be collected on neonatal lupus and on juvenile
    rheumatoid arthritis, with an expansion to include genetic studies; and
    (5) new imaging technologies for autoimmune diseases, through a project
    involving in vivo imaging of tiny blood vessels in animal models of
    rheumatoid arthritis.
                                  fibromyalgia
        The NIAMS has a firm commitment to identifying the causes of
    fibromyalgia and improving the daily life of people affected by this
    debilitating disease, and we have a broad portfolio of research in this
    area. Last year the NIAMS as well as the NIDCR, NINDS, and the ORWH
    funded fifteen new clinical and basic research studies on fibromyalgia,
    and we are confident that these new studies will provide much-needed
    information on the causes of fibromyalgia as well as new strategies for
    treatments.
                                muscle diseases
        People affected by muscle diseases face profound changes and
    challenges in their every day lives. We now know that many of these
    diseases are caused by genetic mutations, and we are supporting
    research to further define these mutations and to overcome the current
    barriers to effective gene therapy of muscle diseases. We are
    optimistic that genetic manipulation of skeletal muscle will improve
    therapy for muscle diseases such as Duchenne muscular dystrophy and
    Facioscapulohumeral dystrophy. The Institute, in collaboration with the
    National Institute of Neurological Disorders and Stroke, is sponsoring
    workshops in both of these areas in May 2000 and we are looking forward
    to hearing recommendations from experts in these fields on research
    directions we could pursue in fiscal year 2001.
                                 osteoarthritis
        As many Americans are well aware, osteoarthritis is the most common
    disease of joints. The NIAMS continues to support a substantial amount
    of research across the full spectrum of scientific approaches and
    strategies to understand this disease and improve life for affected
    people. In July 1999 we sponsored a major conference on osteoarthritis
    with the participation of leading experts in this field and many
    related fields. We used this opportunity to have a tandem educational
    meeting for patients whose daily lives are affected by osteoarthritis.
    We learned a great deal about the disease from both kinds of experts--
    those doing research on osteoarthritis and those living with it. We are
    carefully considering the recommendations made from both sets of
    experts to strengthen our portfolio in osteoarthritis using the fiscal
    year 2001 appropriation, particularly in the area of prevention. The
    NIAMS is also partnering with our colleagues in the National Institute
    on Aging, the Food and Drug Administration, many pharmaceutical
    companies, and several professional and voluntary lay organizations to
    try to create a public-private partnership to identify biomarkers for
    osteoarthritis. Our goal is to support clinical and laboratory
    evaluations of biomarkers and imaging techniques as potential surrogate
    endpoints for clinical trials that would assess the efficacy of
    osteoarthritis disease-modifying interventions.
                                  osteoporosis
        We have known for some time that osteoporosis has genetic
    components, but the genes that are actually associated with fractures
    themselves had not previously been identified. Scientists have found
    that older women who have the gene for apolipoprotein E, also known as
    APOE*4, are at increased risk for hip and wrist fractures. We know
    about this gene from other studies of its association with common,
    late-onset forms of Alzheimer's disease and with osteoporosis in
    patients on dialysis. This represents a promising area for further
    study in patients with osteoporosis as well as those with Alzheimer's
    disease, who are known to have a higher risk of hip fracture.
        In March 2000 the NIAMS and other NIH components will hold a
    Consensus Development Conference on osteoporosis to address many key
    questions and to bring a focus to scientific opportunities that could
    be pursued in this major public health problem that compromises daily
    activities for millions of Americans of all ages. The information that
    comes from this Conference will be broadly disseminated to physicians
    and other caregivers, as well as to the public.
                          systemic lupus erythematosus
        In genetic studies of lupus, researchers have found an association
    between the disease and a region on chromosome 1. Fine mapping of this
    region has identified another candidate gene involved in immune
    function. Studies of the genetics of lupus may identify potential
    therapeutic targets and may facilitate the development of markers of
    disease activity. While medical research has certainly made a
    significant difference in the daily lives of people (primarily women)
    with lupus, this remains a major public health problem that compromises
    the quality and longevity of life for many Americans. In addition to
    the many systems of the body that are affected, patients with lupus
    also have a higher risk of neuropsychiatric manifestations and
    accelerated atherosclerosis. In 1999 the NIAMS sponsored workshops in
    both of these areas, and we intend to follow-up on the many excellent
    recommendations from experts who participated in these two meetings.
                                 skin diseases
        Gene therapy has potential for treating many skin diseases,
    diseases that significantly compromise daily life for millions of
    Americans both physically and psychologically. In addition, skin can
    also serve as a factory for the production of molecules including
    hormones such as insulin and human growth hormone that are used in the
    treatment of many systemic diseases. Skin provides a number of
    advantages for gene therapy approaches, including the ability to remove
    genetically altered skin by simple excision if problems develop. The
    NIAMS is supporting a scientific conference in March 2000 to increase
    the level of interest in gene therapy using skin and to identify
    scientific opportunities and needs in this area.
                               health disparities
        While we know that disease can strike people at every age, of
    either gender, and in every ethic group, we also know that many
    diseases affect women and members of minority groups
    disproportionately--both in increased numbers and increased severity of
    the diseases. Even if variables such as socioeconomic status, access to
    health care, and insurance coverage are eliminated, the fact remains
    that diseases like lupus, scleroderma, osteoarthritis, and vitiligo all
    account for disparities in the health of women and minorities. We are
    actively seeking to understand the causes of these gender and ethnic
    differences, and we are expanding our commitment to better
    understanding of health disparities. We are also increasing our efforts
    to disseminate health information to minority populations and have
    established a toll-free line in both Spanish and English as well as
    produced a number of our publications in Spanish. Plans are underway
    for a workshop to address promising opportunities for research in this
    area. In addition, members of our Intramural Research Program are
    designing an outreach program targeted toward the minority community.
    While it is still in preliminary stages, it will ultimately include
    both local and national outreach efforts.
                                   conclusion
        Bones, joints, muscles, and skin are central components of the
    human body. When the functions of any of these areas are affected, the
    daily lives of people are compromised. We are committed to continuing
    to support basic research as well as the many clinical studies
    underway, including those exploring the roles of genetics, the
    environment, diet, and behavior in disease. I cite our scientific
    achievements with pride, and I pledge to continue my commitment to
    support high quality science that will continue to improve the health
    of the American people.
        The NIH budget request includes the performance information
    required by the Government Performance Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        I will be happy to answer any questions you may have.
                                     ______

                 Prepared Statement of Dr. James F. Battey, Jr.
        Mr. Chairman and Members of the Committee, I am pleased to present
    the President's non-AIDS budget for the National Institute on Deafness
    and Other Communication Disorders (NIDCD) for fiscal year 2001, a sum
    of $276.4 million, which reflects an increase of $14.3 million over the
    comparable fiscal year 2000 appropriation. Including the estimated
    allocation for AIDS, total support requested for NIDCD is $278 million,
    an increase of $14.3 million over the fiscal year 2000 appropriation.
    Funds for the NIDCD efforts in AIDS research are included within the
    Office of AIDS Research budget request. Within the last year, we have
    witnessed outstanding research progress in human communication and
    communication disorders by NIDCD-supported scientists and clinicians,
    progress further accelerated by the efforts of other NIH institutes.
                                  development
        How Inner Ear Hair Cells Grow.--In humans, auditory sensory cells
    (hair cells) and other internal parts of the ears develop within the
    third month of development. These fragile, highly specialized cells,
    which are essential for the hearing process, are often damaged or lost
    as a consequence of noise, genetic mutation, drugs or other
    environmental insults. The resulting hearing impairment is permanent,
    since these cells do not regenerate in humans. NIDCD-supported
    scientists are examining the cellular and molecular processes that
    direct progenitor cells to differentiate into hair cells, leading to
    new approaches to stimulate hair cell regeneration after damage. These
    investigators have shown that in the mouse, the Math1 gene is essential
    for regulating the development of hair cells and progenitor cells.
    These findings provide novel insight into the molecular mechanisms
    regulating hair cell differentiation and specification.
                             infancy and childhood
        Better Procedures to Screen Infants for Hearing Impairment.--The
    American Speech-Language-Hearing Association estimates that as many as
    12,000 infants each year in the U.S. are born with significant hearing
    loss, making it a common congenital disorder. Research supported by
    NIDCD has shown that detection of hearing impairment and intervention
    within the first six months after birth is very important for
    optimizing language development in young children. In a five-year,
    multi-center study, NIDCD-supported scientists determined the optimal
    test procedures for neonatal hearing screening. This study was the
    first controlled comparison of normal hearing and hearing-impaired
    infants evaluating physiological responses to sound. The development of
    precise and timely diagnostic screening techniques for hearing
    impairment is the first step in providing early intervention strategies
    that will optimize the development of either spoken or signed language
    skills. The NIDCD is supporting research to develop and validate
    intervention strategies that are tailored to the individual with
    hearing impairment.
        Hereditary Hearing Impairment--Gene Discovery and Implications.--
    Not only is hearing screening becoming available to all newborns,
    breakthroughs in medical genetics will enable scientists to identify
    the precise genetic change leading to hereditary hearing impairment.
    NIDCD-supported scientists have learned that about one-third of all
    recessive hereditary hearing impairment within the U.S. is caused by
    mutations in the GJB2 gene. But further studies have shown that there
    is significant variation in the degree and time-of-onset of hearing
    impairment among individuals with exactly the same mutation in both
    GJB2 genes. Given this variation, it would be difficult to predict
    onset and degree of impairment in these infants using only data from a
    GJB2 genetic test. The NIDCD is interested in pursuing areas of
    research to develop and validate diagnostic genetic tests, to assess
    the potential impact of genetic testing and the utilization of genetic
    information on attitudes and behaviors of various cultural groups and
    individuals.
        Otitis Media--Vaccine Development and Genetic Susceptibility.--In
    an NIDCD-supported study, scientists have discovered that there is a
    strong heritable component to prolonged time with and recurrent
    episodes of otitis media (middle ear infection) in children. The
    results of this study may have future implications for primary care
    physicians to identify children and siblings at high risk for otitis
    media for careful monitoring and early intervention. In addition, with
    the recent emergence of antibiotic resistant bacterial isolates, it is
    clear that the best long-term strategy for otitis media is prevention.
    NIDCD scientists have developed a detoxified lipooligosaccharide-
    protein conjugate to be used as a possible vaccine against nontypable
    Haemophilus influenzae, a leading cause of otitis media in children for
    which there is no vaccine currently available. A Phase I clinical study
    is nearing completion in adult volunteers to evaluate the safety and
    potential efficacy of the investigational vaccine. Preliminary data
    from this study show that the vaccine is able to elicit the production
    of specific antibodies against the bacteria in a number of volunteer
    subjects. The results of this trial suggest that this investigational
    vaccine may be useful for preventing otitis media in children.
        Cochlear Implants May Improve Language Achievement in Children.--
    The cochlear implant is an array of electrodes that converts sound into
    electrical impulses that stimulate the acoustic nerve, restoring the
    perception of sound. It is the only neural prosthesis in widespread
    clinical use with over 20,000 recipients, about one-half of whom are
    children. Scientists supported by the NIDCD conducted a study to
    measure language achievement in children with cochlear implants. The
    study, comparing a group of children who had received cochlear implants
    and a second group who were using hearing aids, showed significant
    differences in language achievement levels favoring the children using
    cochlear implants.
        Improved Methods for Diagnosing Early Childhood Stuttering.--
    Stuttering is a disorder that typically begins between the ages of 2
    and 5. When it persists, the disorder causes serious impairment in
    verbal communication that is often associated with significant
    difficulties in emotional and social adjustments. NIDCD is supporting a
    large-scale longitudinal investigation of children who stutter to
    examine various aspects of stuttering as it persists or subsides during
    childhood. In addition, the study is identifying risk factors that can
    help differentiate between children who develop persistent stuttering
    and those who tend to recover. The data reveal a strong genetic
    component to stuttering and differences in genetic liability between
    different subsets of children who stutter. Based on these findings,
    NIDCD-supported investigators have initiated a genetic association
    study to map and identify the genes that predispose individuals to
    stutter.
        Defining and Identifying Specific Language Impairment in
    Children.--Specific Language Impairment (SLI) is a language disability
    observed in the absence of any other cognitive disorders, affecting as
    many as 8 percent of all kindergarten-age children. Research to
    understand and treat SLI has been hampered by the lack of uniformity in
    the definitions and measures that are used to identify preschool-aged
    and older children, adolescents or adults with SLI. NIDCD-supported
    researchers have developed definitional guidelines and research
    directions that will lead to enhanced abilities to diagnose and assess
    SLI, determining that a brief non-word repetition task is a powerful
    predictor of SLI. This test differentiates between children who will
    benefit from language intervention and children who will not require
    intervention to achieve normal language skills.
        Eliminating Health Disparities in Hearing and Language Disorders.--
    As research moves forward to reduce the burden of disease in America,
    the NIDCD is committed to the idea that all segments of American people
    should benefit from this progress. In comparison to the general U.S.
    population, Native American children have one of the highest rates of
    otitis media. The NIDCD is continuing its support of a study on the
    epidemiology of this disorder and hearing loss among Native American
    infants, from birth to age two, at the White Earth Reservation in
    Minnesota. Recent assessment shows that intervention programs should
    focus on parental smoking as a significant risk factor for otitis media
    in Native American infants. The study also includes the development and
    implementation of prevention strategies to reduce the burden of otitis
    media such as promoting breastfeeding.
        Treatment for Deafness Caused by Neurofibromatosis Type 2.--The
    NIDCD is conducting research on neurofibromatosis type 2 (NF2), a
    genetic disorder that often results in bilateral tumors of the acoustic
    nerves causing deafness in children and adults. Scientists supported by
    the NIDCD have determined that specific mutations in the NF2 gene
    result in different levels of severity of the disease. This finding
    will facilitate early DNA-based diagnoses that will improve disease
    management and increase the preservation of hearing in NF2 patients.
    For many individuals with NF2, surgical intervention required to remove
    tumors also involves resection of both acoustic nerves, so that sound
    perception cannot be restored with cochlear implantation. To help these
    individuals, NIDCD is supporting research to develop a specialized
    auditory prosthesis for NF2 patients. Multiple, ultraminiature
    microelectrodes have been implanted directly into the ventral cochlear
    nucleus of animals, the portion of the central auditory system where
    the acoustic nerve fibers once made connections. These animal studies
    have demonstrated the safety of this technique and deaf NF2 patients
    are now scheduled to be fitted with these devices within the next few
    years with the hope of restoring auditory perception.
                                   adulthood
        The Hazards of Noise-Induced Hearing Loss.--When an individual is
    exposed to sounds that are too loud, the hair cells needed to detect
    sound in the inner ear can be damaged, resulting in noise-induced
    hearing loss (NIHL). NIHL is a major health concern, but it is
    preventable. In a public outreach effort, the NIDCD has launched the
    ``WISE EARS!'' campaign, where a national coalition of over 60
    government agencies, public organizations, businesses, industries and
    unions is working to inform the public about the risk of NIHL.
        Molecular Mechanisms Governing Our Sense of Taste.--In humans, the
    loss of taste sensation can contribute to the loss of appetite and poor
    nutrition, a particularly common problem for older Americans. In a
    collaborative effort joining molecular biologists supported by the
    National Institute of Dental and Craniofacial Research, NIDCD, and
    investigators at the University of California, San Diego, candidate
    sweet and bitter taste receptors have been cloned and characterized.
    These receptors are selectively expressed in a non-overlapping subset
    of taste receptor cells on the tongue. This research is an important
    step in determining the molecular pathway activated by sweet and bitter
    substances, and will guide future research studies in identifying
    additional molecules in this poorly understood pathway.
        Genetic Association and Age-Related Causes for Hearing Loss.--A
    recent NIDCD-supported study has demonstrated that a genetic component
    exists for age-related hearing loss. It is likely that different
    mutations in the same genes that cause profound hereditary hearing
    impairment in children also cause age-related hearing loss
    (presbycusis), a common problem for older Americans. With the ability
    to predict who is at increased risk, better strategies to minimize or
    delay hearing loss within the aging population can be developed.
        NIDCD/Department of Veterans Affairs Hearing Aid Clinical Trial
    Yields Important Results.--The prevalence for hearing impairment
    significantly increases with age and hearing aids are the most common
    means of assistance for persons with hearing loss. The Department of
    Veterans Affairs and the NIDCD conducted a multi-center trial, which
    included elderly volunteers, to compare the efficacy of three commonly
    used hearing aid circuits. Data from the trial showed that performance
    differences among the three hearing aid circuits were minimal. Of
    greater importance, the trial demonstrated that each circuit improved
    speech recognition with improvement observed under both quiet and noisy
    listening conditions. NIDCD remains committed to support research
    leading to smaller and better hearing aids, capitalizing on
    bioengineering advances in microelectronics.
         The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan.
        My colleagues and I will be happy to respond to any questions you
    may have.
                                     ______

                   Prepared Statement of Dr. Steven E. Hyman
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Institute of Mental
    Health (NIMH) for fiscal year 2001, a sum of $896,059,000, an increase
    of $50,083,000 (or 5.9 percent) above the comparable fiscal year 2000
    appropriation. Including the estimated allocation for AIDS, total
    support requested for NIMH is $1,031,353,000, an increase of
    $56,680,000 over the fiscal year 2000 appropriation. Funds for the NIMH
    efforts in AIDS research are included in the Office of AIDS Research
    budget request.
                            areas of new investment
        This has been a remarkable year for the NIMH, both in our
    development of scientific programs and in our ability to contribute to
    public understanding of mental illness. Thanks to a healthy increase in
    our budget, we expanded our new Translational Centers program, which
    aims to bring basic science as rapidly as possible into the clinical
    arena. We built on our investment in studies of genetic risk factors
    for schizophrenia, manic depressive illness, and early onset major
    depression, with particular emphasis on expanding our gene repository
    for research on autism. We initiated two major clinical trials, one on
    best use of new antipsychotic drugs and one on the treatment of
    individuals with depression who do not benefit from standard, initial
    treatments. We reported the findings of a multi-site collaborative
    study on treatment of attention deficit hyperactivity disorder, a
    public health problem of immense concern to parents, teachers, and
    health care providers, and we have initiated epidemiologic studies that
    will enable us to address disparities in mental health treatment
    outcomes with ever greater effectiveness.
                 heightened public awareness of mental illness
        Growing recognition that mental illnesses are real diseases of an
    organ, the brain; that they are diagnosable and treatable; that they
    represent an enormous public health burden--for example, depression is
    the leading cause of disability in the United States; and that current
    treatments can have an enormous impact on diminishing that burden
    spurred several important public education efforts in 1999. These
    included the White House Conference on Mental Health and Mental
    Illness, and the Surgeon General's Report on Mental Health, the first-
    ever on this topic. Responding to a report from the National Center for
    Health Statistics that 31,000 Americans committed suicide in 1996, more
    than half again the approximately 20,000 U.S. homicides that year, the
    Surgeon General issued a Call to Action to Prevent Suicide, which now
    is the ninth leading cause of death in the U.S. and, as the Centers for
    Disease Control reports, the third-leading cause of death among 15 to
    24 year old Americans. NIMH has been privileged to play a critical role
    in providing scientific data and educational materials for all three of
    these activities.
        We have come far in the science of mental illness and mental
    health, but we still have much to learn. We are thankful that the
    generous support of the American people, through the Congress, has made
    it possible to attack difficult problems at many levels. Perhaps most
    critical to our long-term goals of curing--and ultimately preventing--
    serious and disabling diseases like autism, schizophrenia, manic
    depressive illness, depression, anxiety disorders, and eating
    disorders, is our enhanced ability to expand long-term investments
    aimed at understanding the fundamental organization of brain and
    behavior. This is a time of remarkable progress in molecular and
    cellular biology, systems-level neurobiology, and cognitive
    neuroscience, and a time of unparalleled opportunity afforded by
    technologies ranging from gene chips to noninvasive neuroimaging. As
    our basic science matures, we have initiated programs aimed at speeding
    and enhancing the translation of that basic science into clinical
    applications.
                       centers for translational science
        What do I mean by ``translational science?'' Let me describe
    briefly how several projects at one Center link basic and clinical
    research. Collaborating scientists at the University of Pittsburgh and
    Carnegie Mellon University are testing a hypothesis that certain
    abnormalities in thinking (or cognition) that are characteristic of
    schizophrenia reflect an impairment of functions in a particular brain
    region, the dorsal lateral prefrontal cortex. This disorder typically
    strikes in the late teen years or early twenties--just when families
    and, indeed, society are completing their investment in the education
    of a young person. Thus, this project is examining in animal models and
    in clinical research how the brain's circuitry changes over the course
    of development and, particularly during adolescence. Since both genes
    and environment influence brain development, one component of this
    study uses new gene chip technologies to examine how genes influence
    the circuitry of the prefrontal cortex; using the new chip technology,
    the investigator can determine which genes have been active and which
    have been suppressed in the post-mortem brains of patients with
    schizophrenia compared with normal controls; a similar gene analysis is
    being done with adolescent monkeys. Other facets of the project involve
    studies of a neurotransmitter, dopamine, that plays a critical role in
    memory functions served by the prefrontal cortex, and functional brain
    imaging studies of patients with schizophrenia and controls, with the
    aim of determining the extent to which cognitive abnormalities can be
    ascribed to the effects of dopamine on frontal cortex. What's exciting
    is that each of these discrete projects is addressing fundamental
    biological questions, allowing investigators to relate findings
    obtained from basic animal studies to clinical research with an
    unprecedented degree of coordination. Given the awesome complexity of
    the brain, we believe that team efforts like this have the best chance
    of understanding what goes wrong in the brain in schizophrenia.
        In another Translational Center, investigators are exploring the
    relationship between fear and stress in animal models; a key aim is to
    determine whether the effects of stress on fear circuits mimic changes
    that occur in fear-related disorders in humans, such as post-traumatic
    stress disorder, anxiety and panic disorders, and paranoid
    schizophrenia. Investigators at NYU, Columbia University, and
    Rockefeller University, are using an identical behavioral paradigm--
    fear conditioning--to examine fear circuits from multiple perspectives,
    in animal and human studies. One effort that will benefit immensely
    from its interaction with other Center studies will follow up on
    findings that acute and chronic stress inhibits neurogenesis--that is,
    the generation of new neurons in the adult brain. This question has
    extraordinary ramifications for understanding mental disorders and
    refining treatments.
              identifying vulnerability genes for mental disorders
        We have greatly augmented our investment in the genetics of
    schizophrenia, manic depressive illness, major depression, autism, and
    other mental disorders. It is now certain that these disorders have a
    genetic component, but solving the genetics and identifying disease
    vulnerability genes is extremely difficult because vulnerability to
    these disorders results from the effects of many genes, each
    contributing relatively small and interactive effects, as opposed to an
    illness, such as Huntington's disease, in which a single gene
    contributes a large effect. However, as we have learned from other
    central nervous system disorders, such as Alzheimer's disease, the
    discovery of vulnerability genes can lead to the identification and
    validation of exciting new targets for development of therapies. During
    the coming year, all of our genetics efforts will be aided by the
    sequencing of the human, mouse, and other animal model genomes and by
    ongoing projects to investigate human genetic diversity, especially as
    it might apply to disease risk.
                          treatment research on autism
        Pending findings from the genetics studies that I mentioned, NIMH
    remains deeply committed to improving treatments currently available
    for autism, a brain disorder that affects between 1 to 2 of every 1,000
    Americans, with often devastating, lifetime effects on thinking,
    feeling, and social functioning--all uniquely human attributes. A
    network of five NIMH-supported psychopharmacology research units are
    evaluating drug treatments for autism, such as risperidone and
    valproate. Among studies of psychosocial treatments in autism, we fund
    two projects evaluating parent training interventions that are tailored
    to the particular characteristics of child and family. Of course, we
    participate in the NIH Autism Coordinating Committee.
                       new clinical effectiveness trials
        During the last fiscal year, NIMH has initiated large-scale
    clinical trials on the best use of new antipsychotic medications and
    the treatment of individuals who failed to respond to initial
    antidepressant treatments. Along with our ongoing trials in adolescent
    depression and in bipolar disorder, which we initiated over the past
    two years, this thrust represents a substantial recommitment to
    clinical treatment studies for people with mental illness. These
    particular studies represent a new frontier in clinical treatment
    research because they will study truly representative samples of
    individuals with mental disorders. That is, eligibility for
    participating in these treatment studies no longer is limited to
    rarified populations within academic health centers, but is open to
    general populations in diverse health care settings. This new approach
    requires NIMH take great care to observe appropriate stewardship of the
    trials while our field develops the infrastructure and expertise to
    conduct such trials. In future years, we hope to expand this program to
    address such issues as depression in young children, and mood disorders
    that co-occur with psychotic disorders. We are also interested in
    cross-NIH collaborations to focus on co-occurring substance use
    problems with mental disorders.
                           research on youth violence
        As recognition grows that violence by young people represents a
    public health problem, we are encouraging a new generation of studies
    that will attend, particularly, to the relationships between mental
    disorders and violence, including suicide. We know that anxiety
    disorders, depression, or suicidal ideation often co-occur with
    behavior problems, and that the combination of depression with conduct
    problems may be a combustible mix. Also, youth with conduct problems
    often exhibit inattention and impulsiveness, often coexisting with
    hyperactivity. We are coordinating our research involving dissemination
    of prevention and early intervention strategies with the Centers for
    Disease Control and other federal agencies, including the departments
    of Education and Justice. Finally, I am pleased to report that NIMH
    will assume a lead role in developing a Surgeon General's report on the
    topic of youth violence. Dr. Satcher and, indeed, all of us have been
    gratified by the overwhelmingly positive response of the American
    public to the Surgeon General's Report on Mental Health, and we believe
    this follow-up report will be an effective and highly credible means of
    educating the public about the interaction of mental disorders and
    youth violence.
                    multi-modal treatment assessment of adhd
        In December, NIMH and collaborating investigators reported findings
    from the landmark Multi-Modal Treatment Assessment Study--the MTA
    study--of attention deficit/hyperactivity disorder, a major public
    health problem that affects 3-5 percent of school children. The
    experiences of 600 children enrolled in the study revealed that
    carefully monitored medication management, with monthly followup and
    input from teachers, is more effective than intensive behavioral
    treatment. For measures such as improved academic performance and
    family relations, combining behavioral therapy and medication proved
    effective and satisfying to parents and teachers and permitted somewhat
    lower doses of medication. Among the important insights of the MTA
    study was documentation of the extent of undertreatment or
    inappropriate medication treatment in normal, community-based care.
                         research on health disparities
        A primary goal of NIMH and NIH research is to ensure that advances
    in treatment benefit all Americans, including racial and ethnic
    minorities who experience significant disparities of outcomes with
    respect to many illnesses. Within the past year, NIMH conducted the
    first two of a projected series of State-wide conferences on mental
    health needs and opportunities that permit us to hear, first-hand,
    citizens' perspectives on health disparities. We initiated a large-
    scale study of the epidemiology of mental disorders among African
    Americans and plan on parallel studies to understand the epidemiology
    of mental disorder in other minority groups. These studies will
    complement a new, state-of-the-science epidemiologic study of mental
    disorders in the broader population that will be funded under a 5-year,
    $7.3 million dollar grant to investigators at Harvard University who
    will survey a representative sample of 10,000 Americans ages 15 and
    over. For several decades, NIMH has set the standard for modern mental
    health epidemiologic research, and this new study will ensure that we
    have data necessary to allocate resources and design policies in this
    era of massive change in the U.S. health care system.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report,
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will support the
    identification of strategies and objectives to improve programs across
    the NIH and the Department.
        NIMH is committed to a research portfolio that stretches from
    molecules and genes to brain and behavior to clinical investigation to
    health services research and economics. This research portfolio is
    thriving thanks to the development of new scientific approaches ranging
    from genomics to neuroimaging to new clinical trial designs. In
    parallel, we have been able to renew our Institute structure and also
    the vitality of our Intramural Research Program by a combination of
    rigorous review and recruitment of outstanding scientists. I look
    forward to this new millennium with humility about the scope of the
    problems that we must address but great optimism about the ability of
    our research community to meet the challenge.
        I will be pleased to answer any questions.
                                     ______

    Prepared Statement of Dr. Alan I. Leshner, Director, National Institute
                                 on Drug Abuse
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the National Institute on
    Drug Abuse (NIDA) for fiscal year 2001, a sum of $496.3 million, which
    reflects an increase of $27.1 million over the comparable fiscal year
    2000 appropriation. Including the estimated allocation for AIDS, total
    support requested for NIDA is $725.5, million an increase of $38.1
    million over the fiscal year 2000 appropriation. Funds for the NIDA
    efforts in AIDS research are included within the Office of AIDS
    Research budget request.
                       building on recent accomplishments
        Thanks to the commitment of both the Administration and the
    Congress, including particularly this Committee, NIDA has been able to
    launch some truly significant activities in the past year. Perhaps the
    most noteworthy undertaking has been establishing the foundation for a
    vehicle that will increase dramatically the quality of drug addiction
    treatment throughout this country. Last year, we promised to build a
    National Drug Abuse Treatment Clinical Trials Network (CTN) to test and
    disseminate new science-based addiction treatments in real life
    settings. I am pleased to be able to tell you that we not only have
    established the first five nodes of this Network, but are about to
    begin implementing the first three protocols. Moreover, adding five
    more nodes to this infrastructure this year will take the CTN one step
    closer to becoming the truly national research and research
    dissemination network that we know it can and should be. Under NIDA's
    overall guidance, the CTN will foster partnerships between treatment
    researchers and community-based treatment providers to move well-tested
    science-based addiction treatments into use in diverse patient
    settings.
        We are also building other areas of our research portfolio to
    better inform how this country approaches drug addiction, including
    looking more closely at the role genetic factors may play in
    determining the likelihood someone will become addicted to drugs. In
    the same way we are making great progress in understanding how genetics
    can predispose one to cancer, heart disease, or diabetes, drug abuse
    researchers are making similar advances in the addiction arena as well.
    By better understanding the factors determining an individual's
    vulnerability to addiction, our treatment and prevention success rates
    will dramatically improve.
        The research community is committed to this endeavor. The response
    to NIDA's ``Genetics of Drug Addiction Vulnerability'' Initiative has
    been overwhelming. We were able to fund five new grants last year to
    examine the role of genetics in nicotine, cocaine, and heroin
    addiction, and we hope to support in the coming years some of the other
    outstanding proposals we received in response to this initiative.
              long-term neurobehavioral effects of drugs of abuse
        Advances within NIDA's neuroscience research portfolio also
    continue coming at an accelerated pace. Let me give you one example of
    how far our science has come since last year's appropriations hearing.
    You may recall that I showed you images of how drugs, such as
    methamphetamine and MDMA (Ecstasy), produce long-lasting changes in
    brain function, changes that persist even years after the individuals
    stopped using the drugs. Researchers have now taken those research
    findings one step further and have begun to unravel exactly how these
    brain changes dramatically affect an individual's behavior.
        For example, researchers studying the residual effects of
    methamphetamine in users who were drug free for ten months before this
    study began, found that they had significantly impaired motor and
    memory function. When they were asked to complete a battery of tests
    that examined working memory and reaction times, as well as verbal
    memory skills, these former methamphetamine users did far worse than
    non-drug-using individuals. Importantly, the researchers also found
    that the impaired memory in the former users was clearly associated
    with significant reductions in the functioning of the brain's dopamine
    neurotransmitter systems, in this case the number of dopamine reuptake
    transporters. And the study showed that the greater the degree of
    transporter loss, the greater the memory deficits.
        Researchers at NIDA's intramural program have found similar
    cognitive deficits with chronic cocaine abusers. Thus, these studies
    are clarifying how it is that illicit drugs compromise cognitive and
    behavioral abilities.
        NIDA-supported researchers are not just using new imaging and
    molecular genetic technologies, they are also making significant
    contributions to the field by advancing the technology themselves. This
    is best exemplified by our efforts in the fast paced world of
    nanotechnology. For example, NIDA-supported researchers recently
    developed a biosensor system to analyze what is happening inside a
    single cell. These techniques are allowing us to see how important
    neurotransmitters like dopamine are stored and can move in and out of
    cells. This opens up many new avenues of research; allowing us to see
    with much greater resolution the impact that drugs of abuse have on the
    brain.
               determinants of drug use preferences and patterns
        Understanding why some individuals abuse drugs while others do not
    and why some develop more problematic drug use than others are some of
    the most challenging dilemmas being probed by researchers today. As we
    bring new and improved technologies and new groups of researchers into
    the search for answers to these questions, we are beginning to unveil
    some important and astonishing results. For example, using the advanced
    brain imaging technique of positron emission tomography (PET),
    researchers have found the first clues as to why some individuals are
    prone to use stimulant drugs and why some are not. As an example, as
    shown in POSTER 1, these studies have shown a dramatic association
    between an individual's pre-drug exposure brain dopamine receptor
    levels and how much the individual reports ``liking'' or ``disliking''
    a psychostimulant. Here you see two individuals with different levels
    of dopamine D2 receptors shown before any drug exposure. (Brighter
    colors represent higher numbers of receptors). The individual whose
    brain is shown on top and who had high levels of D2 receptors reported
    an unpleasant response to the mild stimulant methylphenidate. On the
    other hand, the individual on the bottom, with low D2 receptor levels,
    found the stimulant quite pleasant. This suggests that differences in
    brain chemistry predisposes people to respond in different ways to
    drugs of abuse.
             understanding the transition from drug user to addict
        In past years, we also have shown you data clearly indicating that
    we know quite a bit about both the behavioral and the biological
    differences between addicted and non-addicted individuals. What we do
    not know much about, however, is the literal transition that occurs
    between these states. What is actually happening both behaviorally and
    biologically when one moves from being an occasional to a compulsive,
    addicted drug user? What changes an individual from a voluntary to a
    compulsive drug user? Understanding this transition is central, of
    course, to developing more effective addiction prevention and treatment
    strategies, and its importance has led NIDA to develop a focused
    ``Transition to Addiction'' initiative.
        NIDA-supported researchers will approach these issues from many
    disciplinary perspectives. As just one example, they will use new
    molecular biology techniques, such as microarrays, to build on recent
    discoveries from animal studies suggesting that gradual increases in
    the levels of a specific brain protein, delta Fos B, are a critical
    part of this transition process. We know that this protein triggers the
    expression of other genes and the use of this technology will help
    identify which genes are expressed, when, and where in the brain.
              research bringing about shifts in national strategy
        Scientific advances have not only improved our fundamental
    understanding of addiction, but continue to reduce many of the public
    health and safety consequences of this destructive disease as well.
    Nowhere is this better exemplified than in the philosophical shift in
    strategic thinking about drug abuse and its consequences that is
    occurring throughout many levels of society. A case in point is how
    advances in addiction research are leading to a blending of criminal
    justice and health approaches to dealing with drug abuse and
    criminality. NIDA-supported research has demonstrated that treating
    drug users while under criminal justice control dramatically reduces
    recidivism to both later drug use and later criminality by 50 to 70
    percent. This finding is one of the reasons why NIDA and other facets
    of the Department of Health and Human Services have teamed with the
    Justice Department to work toward making drug abuse treatment more
    commonplace in the criminal justice environment.
                         addressing health disparities
        Members of minority populations are disproportionately affected by
    the consequences of drug abuse. Accordingly, NIDA is taking extra
    effort to understand the causes of and contributing factors to these
    inequalities and working to ensure that minority issues are addressed
    and minority populations are adequately represented not only in NIDA's
    comprehensive research portfolio, but in our research communities as
    well. NIDA supports a wide array of programs to recruit minority
    populations into drug addiction research fields. In fact, NIDA has
    increased the number of supported minority researchers by 97 percent in
    the past six years. In the last few years, NIDA has also put together
    three new working groups representing African-American, Asian-Pacific
    Islander, and Hispanic researchers and scholars to help recruit and
    train new minority investigators and improve the quantity and quality
    of minority-related research.
        These working groups are helping NIDA expand opportunities for
    working with scholars who are most knowledgeable about these
    populations. Minority researchers will be particularly helpful as NIDA
    increases its efforts to study the impact and health consequences of
    drug abuse in minority populations. By simultaneously increasing
    research and research training efforts, NIDA expects to make
    significant improvements in racial and ethnic disparities.
             rapid and authoritative research dissemination efforts
        As the world's ability to exchange information expands
    exponentially, NIDA continues to take full advantage of these
    opportunities to disseminate science-based information more effectively
    and rapidly to a wide variety of audiences. For example, when one of
    our early drug warning systems, NIDA's Community Epidemiology Work
    Group, noted increases in the use of ``club drugs'' such as
    methamphetamine and ecstasy among adolescents and young adults, NIDA
    initiated a multi-element research and education campaign to stave off
    further growth of this problem. NIDA will increase funding for relevant
    research by 40 percent. In addition, the Institute has joined with an
    array of partners in the drug abuse professional and constituency
    communities to launch a multi-media education campaign as well. We
    developed and disseminated a community drug alert bulletin that has
    been sent to over 150,000 people, developed a new website
    (www.clubdrugs.org), and teamed with the American Academy of Child and
    Adolescent Psychiatry, the Community Anti-Drug Coalitions of America,
    Join Together, and National Families in Action to hold a national
    meeting to increase awareness and attention to this problem, share
    research findings, and identify research gaps.
        We also have taken an idea from what has become a NIDA bestseller,
    our Prevention booklet, ``Preventing Drug Use Among Children and
    Adolescents: A Research-Based Guide,'' and created a corresponding
    ``Principles of Drug Addiction Treatment: A Research-based Guide.''
    Since the guide debuted in October, more than 100,000 copies have been
    disseminated. This lay language booklet provides health care providers,
    patients, families, and policy makers with the latest science-based
    information on drug treatment. It describes the nature of addiction and
    the addiction treatment enterprise, and then outlines 13 overarching
    principles that characterize effective drug addiction treatment.
        We are also taking full advantage of other dissemination
    opportunities. In fact, we are doing exactly what members of this
    Committee encouraged us to do last year. We are taking state-of-the-art
    brain scans showing the effects of drug abuse and addiction and using
    them as the core of a multi-media public education campaign. What you
    see here is a portion of a story board (POSTER 2) for one of our public
    service announcements emphasizing how drug use can damage your brain in
    important ways. In addition to using powerful images, we are using
    findings from the prevention research arena on what works and what does
    not work to develop persuasive, and scientifically accurate messages.
    We plan to send these messages to television outlets nationwide this
    spring.
                     government performance and results act
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
                                   conclusion
        In conclusion, NIDA is taking advantage of emerging technologies to
    confront the disease of addiction head on. Our comprehensive research
    portfolio, our track record in sharing our research findings, and a
    continued commitment from the Administration and the Congress to
    furthering the science will serve as this Nation' s best defense
    against this devastating public health and safety plague. I will be
    pleased to answer any questions you might have.
                                     ______

                     Prepared Statement of Dr. Enoch Gordis
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the NIAAA for fiscal year
    2001, a sum of $288,578,000, which reflects an increase of $14,587,000
    over the comparable fiscal year 2000 appropriation. Including the
    estimated allocation for AIDS, total support requested for the NIAAA is
    $308,661,000, an increase of $15,427,000 over the fiscal year 2000
    appropriation. Funds for the NIAAA's efforts in AIDS research are
    included within the Office of AIDS Research budget request.
        Nearly 14 million American adults meet diagnostic criteria for
    alcohol addiction or abuse, and 100,000 Americans die of alcohol-
    related causes each year, according to NIAAA epidemiology data. While
    death is the ultimate consequence of alcohol-use disorders, their
    impact on the living, in sheer numbers, is even greater. The NIAAA's
    epidemiology research reveals that 442,000 people occupy hospital beds
    each year as a result of these disorders. The financial burden that
    alcohol misuse imposed on the Nation in 1998 was approximately $185
    billion, in direct and indirect costs, according to the Lewin Group.
    The sequelae of alcohol-use disorders include damage to the liver,
    brain, and other organs; cancer; fetal alcohol syndrome and the
    lifetime disabilities it produces; accidental injury to self and
    others; property damage; crime; broken families; and loss of
    productivity that deprives the Nation of valuable resources.
        Biological, behavioral, and social factors converge to produce
    alcohol-use disorders, making them particularly complex diseases. In
    terms of biology, alcohol is unique among addictive substances, in that
    it targets not just one but many neurotransmitter systems--chemical
    messengers between nerve cells--resulting in unusually pervasive
    effects on the entire nervous system and in unique challenges for
    scientists. Researchers have made striking advances in identifying the
    molecular structures where alcohol binds to these neurotransmitter
    systems and in learning how variations in genes determine alcohol's
    actions on them.
                                  neuroscience
        Because alcohol's effects on the nervous system are so pervasive,
    neuroscience is a particularly active field of research at the NIAAA.
    One promising area involves neuropeptide Y (NPY), a substance in the
    brain that increases food consumption and relieves anxiety. Studies are
    underway to determine the role of NPY in controlling alcohol
    consumption. Preliminary studies suggest that NPY may, indeed, play a
    role in propensity for alcohol. Surprisingly, these studies revealed
    that mice in which the NPY gene was inactivated (knocked out) drank
    more alcohol than did their normal siblings and were less sedated by
    alcohol. If NPY is found to play a key role in human alcohol-use
    disorders, NPY and its receptors--its ``docking sites'' on cells--
    become potential targets for medications to control alcohol intake.
        Physical problems from long-term alcohol use do not necessarily
    resolve once people stop drinking. Using new MRI techniques,
    researchers have found persistent damage in the cerebellum, the locus
    of gait and balance in the brain, even in long-abstinent alcoholics.
    Previous anatomic measurements of cerebellar damage were difficult,
    because of the cerebellum's convoluted structure, resulting in less
    accurate data. Scientists can use these new imaging techniques to
    clarify the potential for reversing cerebellar damage in recovered
    alcoholics and to explore a new topic: the role of cerebellar damage in
    cognitive impairment.
        These and other findings from the NIAAA's comprehensive
    neuroscience portfolio reflect the ubiquitous nature of alcohol's
    effects on the nervous system. For example, research designed to
    identify the protein structures where alcohol binds to nerve cells may,
    one day, provide groundwork for development of better medications to
    treat alcoholism. In another protein-related finding, NIAAA-supported
    scientists have found that genes in the brains of deceased human
    alcoholics produced less of a crucial nervous-system protein, myelin,
    than did those in nonalcoholics. With this information, scientists can
    better define changes in gene activity that result in damage to
    specific areas of alcoholics' brains. Other investigators are
    identifying alcohol-related neurobiological risks that fluctuate during
    adolescence and that might be related to the higher risk of adult
    alcoholism predicted by earlier onset of drinking in the young.
                                    genetics
        That genetics underlies much of the biology of alcohol-use
    disorders is unquestionable. Variations in genes result in variations
    in many components of the nervous system, and, thus, in how people's
    bodies handle alcohol. The way in which people's bodies' handle alcohol
    affects, in turn, their behaviors toward alcohol and risk for
    alcoholism. Evidence suggesting that alcoholism is a polygenetic
    disease--that many genes contribute to it--greatly complicates the
    search for the genes involved.
        The Collaborative Studies on the Genetics of Alcoholism (COGA), a
    major project supported by the NIAAA, has identified several
    chromosomal regions likely to contain genes that influence the risk for
    alcoholism. The NIAAA is pleased to announce that it is making
    available to the general scientific community the substantial data and
    DNA samples generated by COGA. Scientists who take advantage of these
    resources can analyze them further in their own research projects,
    expediting the search for genes that contribute to alcoholism. The data
    also can be used to evaluate new methods of statistically analyzing
    genetic data, not only for alcoholism, but also for other diseases.
        Among the goals of the COGA project is to elucidate the genetics of
    alcoholism in African Americans. While COGA recruits both Caucasian and
    African-American subjects, the latter have not been present in numbers
    large enough to permit a reliable examination of whether the genetic
    basis of alcoholism is different in Black Americans than in White
    Americans. Through a NIAAA grant, Howard University Medical School will
    study this question and contribute its findings to the growing COGA
    database.
        Neuropeptide Y, discussed earlier, is one of more than 20
    substances that NIAAA scientists study as gene knockouts, to determine
    their influence on alcoholism. Some of these substances are found to
    increase alcohol consumption; others are found to reduce it. A recent
    study examined the effects of knocking out, in mice, the gene that
    produces protein kinase C epsilon (PKC ), an enzyme involved in
    intracellular signaling. Absence of PKC resulted in significantly less
    alcohol consumption and abnormally high sensitivity to alcohol's
    sedating properties. Insensitivity to alcohol's sedating effects is
    among the factors that portend alcoholism at some point in life. Since
    much of the mouse genome resembles the human genome, these types of
    findings may lead to clues about human genetic defects related to
    alcoholism.
                                   toxicology
        Alcohol is unique among abused drugs in the extent of the organ
    damage it causes. Animal studies by NIAAA intramural researchers have
    demonstrated that chronic alcohol use leads to a decrease in essential
    fatty acids (EFAs), nutrients that play a crucial role in brain health.
    The same investigators recently demonstrated that EFA-deficient rats
    lose nerve cells in an area of the brain involved in memory and
    learning, another common result of chronic alcohol use. The NIAAA
    continues to perform research to evaluate the potential of EFA
    supplementation to reduce organ damage among alcoholics.
        Between 40 percent and 90 percent of U.S. deaths from cirrhosis are
    due to alcohol, according to NIAAA epidemiology data. These statistics
    underscore the importance of understanding the potential for reversing
    this currently irreversible disease. Scientists suspect that an immune-
    system protein, tumor necrosis factor (TNF), plays a
    role in alcohol-induced liver damage. NIAAA-funded researchers recently
    found that alcohol-fed mice in which TNF's molecular receptor
    had been genetically knocked out, eliminating TNF's actions,
    suffered liver pathology seven times less severe than that of alcohol-
    fed mice with normal TNF levels. This finding strongly
    supports the assertion that TNF is involved in alcohol-induced
    liver damage and is lent even more significance by the recent
    development of pharmaceuticals that inhibit TNF in the
    treatment of inflammatory diseases, such as arthritis.
                      advances in prevention and treatment
        Recent studies illustrate what the NIAAA's prevention research can
    contribute to decisions about alcohol legislation. Many states have
    taken the important step of lowering their legal definition of
    drunkenness from a blood-alcohol concentration (BAC) of 0.10 percent to
    0.08 percent. However, studies of simulated merchant-ship piloting by
    maritime cadets revealed that even half of that concentration, a BAC of
    0.04, resulted in significantly impaired performance. The cadets failed
    to sense their decreased judgment, underscoring the hazards of alcohol
    use in the context of heavy-machinery operation and the workplace. Many
    states still allow people to drive cars with a BAC more than twice that
    of the alcohol-impaired cadets.
        The public also benefits from prevention findings that the NIAAA
    provides to alcohol-treatment practitioners. Thirty percent of
    Americans are subjected to domestic violence at some point in their
    lives, according to studies published in the New England Journal of
    Medicine and funded by the National Institute of Mental Health, the
    Emergency Medical Foundation, and the UCLA Southern California Injury
    Prevention Research Center. NIAAA-funded investigators recently
    concluded, in the Journal of Studies on Alcohol, that a combination of
    behavioral marital therapy and standard treatment for alcoholism
    resulted in a six-fold reduction in domestic violence. Of significance
    here is not only the magnitude of reduction in violence, but also that
    the reduction is sustained, as investigators determined in a 2-year
    follow-up study.
        In the treatment arena, NIAAA-supported studies reveal that the new
    medication nalmefene is at least as successful in preventing relapse
    among recovering alcoholics as is naltrexone, the recently FDA-approved
    drug of choice. Nalmefene may have advantages over naltrexone,
    including less risk of liver toxicity, providing another option for
    recovering alcoholics whose livers have been damaged by alcohol. A
    Finnish company plans to seek FDA approval for this new medication.
                             adolescent alcohol use
        During last year's hearings, the NIAAA reported that initiation of
    drinking earlier rather than later in youth is associated with a
    dramatically higher risk of alcoholism at some point in life. For this
    and many other reasons, the NIAAA continues to make drinking among
    adolescents a research priority. The ``hard-wiring'' of the brain is
    vulnerable to change during adolescence, including change caused by
    toxic substances. Investigators supported by the NIAAA have found that
    adolescent animals are less sensitive than adult animals to the motor-
    incapacitating and sedating effects of alcohol. This suggests that
    adolescents have higher drinking capacities, perhaps putting them at
    higher risk for alcohol-related problems. Other researchers have found
    that human youths who engaged in heavy, protracted drinking during
    early and middle adolescence, when compared with nonabusing adolescents
    of similar demographics, score significantly more poorly on
    neuropsychological tests, and that these deficient scores may persist.
    For example, young people who have withdrawn from alcohol recently have
    poor visuospatial functioning, and those who have withdrawn in the past
    show poor retrieval of verbal and nonverbal information.
        The Washington Post and CNN recently reported another NIAAA
    finding: An estimated one in four U.S. children is exposed to
    alcoholism in the family. The stressful and unpredictable environment
    in such families can lead to a variety of problems in these children.
                                    outreach
        In addition to conducting research on adolescent alcohol abuse, the
    NIAAA has taken a leadership role in the Surgeon General's campaign to
    prevent alcohol use among youth and engages in numerous outreach
    activities. Recently, the NIAAA issued a pamphlet that educates parents
    about alcohol use among youth, and this pamphlet now is being written
    in Spanish. The NIAAA also is collaborating with the Robert Wood
    Johnson Foundation to recruit governors' spouses in a National
    Leadership Initiative to Keep Children Alcohol-Free. In January, the
    NIAAA and Mothers Against Drunk Driving held two press briefings, one
    for editors of teen magazines and the other for editors of women's
    magazines. The NIAAA and the Substance Abuse and Mental Health Services
    Administration (SAMHSA) are preparing to award a grant for public-
    service announcements aimed at preventing underage drinking. In
    addition, prominent scientists and 10 college presidents have formed a
    subcommittee of the NIAAA Advisory Council, to identify ways of
    reducing binge-drinking among college students.
        Other NIAAA outreach activities include Alcohol Screening Day, the
    first of which was held last year. Almost 500 college campuses were
    among the 1,700 sites that participated. Approximately 52,000 people
    attended, and 29,000 of them asked to be screened. This successful
    event will be held again on April 6, 2000.
        To ensure that its research findings reach the people to whom they
    matter most--people who suffer from alcohol disorders--the NIAAA, in
    collaboration with State agencies and SAMHSA, cosponsors a Research-to-
    Practice initiative. Senior clinical investigators spend several days
    at alcohol-treatment facilities, giving staff hands-on help in
    incorporating innovations from basic and clinical research into their
    treatment regimens.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report,
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        My colleagues and I will be happy to answer any questions you may
    have.
                                     ______

                  Prepared Statement of Dr. Patricia A. Grady
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the National Institute of
    Nursing Research (NINR) for fiscal year 2001, a sum of $84,714,000,
    which reflects an increase of $2,672,000 over the comparable fiscal
    year 2000 appropriation. Including the estimated allocation for AIDS,
    total support requested for NINR is $92,524,000, an increase of
    $2,985,000 over the fiscal year 2000 appropriation. Funds for the NINR
    efforts in AIDS research are included within the Office of AIDS
    Research budget request.
        I would like to thank the Committee for your interest and support
    for NINR and for nursing research. In this period of rapid
    technological and demographic change, it is imperative that nursing
    research grow to help meet present and future needs and expectations of
    our nation's people for improved health care. More people will live
    longer and face chronic illness and disabilities in older age. More
    will be caregivers who will need to know how to live their own lives
    while caring for ill relatives and friends. Many will be minorities at
    risk for experiencing disparities in the incidence, prevalence and
    seriousness of disease and access to care. How people live and how they
    experience illness will be influenced by new technologies in the
    healthcare system. Increasingly, they will demand a role in managing
    their own health. Individuals will appreciate the value of prevention,
    but will still need help in achieving healthier lifestyles. And
    virtually everyone wants to die with dignity and a sense of control.
    Today I will discuss our targets for fiscal year 2001 that relate to
    these concerns.
           chronic disease--a long-range view about long-term illness
        Chronic illness continues to be an important NINR research
    emphasis. We are investigating how to both avoid complications of
    disease and disability and control symptoms such as pain, nausea and
    poor sleep. Other studies will be directed at patients who are
    discharged early from the hospital and still need substantial care at
    home. A special focus will be on family caregivers, who have varying
    expertise and financial and complex care demands for multiple lengthy
    illnesses.
        In addressing early hospital discharge, recent nursing research has
    verified the value of a transitional care model that has been tested in
    several patient populations. The model uses a multidisciplinary team
    and involves comprehensive discharge planning, including determination
    of patient care needs outside the hospital, and follow-up in the home
    by advanced practice nurses specializing in geriatrics. As the chart
    shows, six months following discharge, the intervention group of older
    adults with common medical and surgical problems had 48 percent fewer
    rehospitalizations, 54 percent fewer multiple hospital readmissions,
    and 65 percent fewer days in the hospital at a 48 percent savings to
    the healthcare system when compared to controls. Widespread use of this
    model could save significant healthcare dollars and improve quality of
    care.
        Early hospital discharge has placed a research spotlight on family
    caregivers, who often undertake the responsibility for care of their
    ill relatives. Caregivers of Alzheimer's patients bear special burdens.
    They must cope with the physical downward spiral of illness, and they
    also must deal with the stress of patients' behavioral problems that
    include agitation, depression, and wandering. Nurse researchers have
    developed a successful intervention that offers behavioral management
    skill training to caregivers. Five months after the intervention,
    researchers found that caregiver stress continued to be reduced when
    coping with disruptive behaviors of older adults in their care. The
    study also showed a moderate decrease in caregivers' perceptions of
    their burdens in providing care. Furthermore, those who were initially
    depressed were less depressed. These positive results may be applicable
    to caregivers of patients with other chronic illnesses, such as stroke
    or congestive heart failure.
        A life-long chronic illness that often starts in childhood, Type I
    diabetes, represents 5 to 10 percent of the total number of people with
    diabetes, and can seriously impact physical health and quality of life.
    Our research on adolescents with this condition compared two types of
    recommended intensive therapies--either multiple daily injections of
    insulin--three or more a day--or subcutaneous infusion of insulin
    delivered by insulin pump--a therapy which is currently used by fewer
    than 5 percent of young people. Adjusting to the insulin pump has been
    difficult for young adults, but when they are provided with an
    intervention consisting of instruction and support, the outcomes have
    been positive. Advanced practice nurses visited the adolescents every
    four to six weeks and provided them with diabetes education,
    adjustments in managing their diabetes and clinical assessments,
    including measurements of hypoglycemia and adherence to dietary
    restrictions. Investigators found that compared to teens on multiple
    daily injections of insulin, those who used the insulin pump had fewer
    severe hypoglycemic episodes and were able to maintain their blood
    glucose levels within the proper range. The ``pump'' group scores also
    showed better self esteem, coping skills, and quality of life. This
    finding identifies the education and support that enables adolescents
    to use the newer pump technology effectively.
        NINR is committed to expand chronic illness research in fiscal year
    200l to help patients manage their conditions over time. This involves
    a major investment of resources. We will focus on strategies to be
    applied broadly across chronic illnesses, including prevention of
    disease and its complications, self-monitoring by patients of the
    course of their disease, and promotion of patient success in problem
    solving and in maintaining a healthy lifestyle.
                  the end of life--an emerging research focus
        Just as biomedical advances are changing the way we live with
    illness, they are also changing the way we eventually die. The duration
    of both chronic illness and the dying process has been prolonged. In
    fiscal year 2001, we will expand our focus on end of life to better
    understand at what point palliative care becomes the primary goal. We
    also need to know how best to facilitate communication and decision
    making among all involved in the end-of-life period--the patient,
    nurse, physician, family, and friends.
        NINR is pleased that the response to last year's Request for
    Applications for research on end-of-life care resulted in more than 100
    applications--an impressive result for a relatively new area of
    research. Those that were funded will form a basis upon which to build
    an important, growing effort.
                      health disparities--closing the gap
        Another area of importance to nursing research and to the nation is
    reduction of persistent health disparities among certain populations in
    our country. We must provide interventions that are more responsive to
    the needs of our multiethnic and multicultural society. Nursing
    research has long incorporated ethnic and cultural factors in designing
    projects and testing interventions--with the goal of tailoring care to
    the individual patient's needs. Yet more research is needed to identify
    why disparities exist and what to do about them.
        Let me provide an example of nursing research that addresses an
    area of disparity in a growing population. For many years, there were
    few resources available for Hispanics with arthritis to help them
    manage their condition. Limited fluency in English had the effect of
    excluding them from most health research projects. In response to this
    need, nurse researchers developed and tested a successful Spanish
    language arthritis education program. This endeavor was not limited to
    translation from English to Spanish. Cultural differences within Latino
    communities and accurate Spanish language measurement tools were also
    addressed. During the program, patients learned how to exercise,
    communicate with health care professionals, and manage pain, fatigue
    and depression. Throughout a one-year period, patients experienced
    significant improvements in all areas. The components of this course
    have provided a useful model that is being tested for Hispanic
    populations with coronary artery disease, chronic obstructive pulmonary
    disease, and Type II diabetes.
        NINR plans to continue its ongoing programs next year to help
    eradicate healthcare disparities. We will focus specifically on
    diabetes and its gaps in morbidity across ethnic groups. We will
    emphasize strategies for effective self-management of illness, and
    investigate the influence on health of genetics, education, poverty,
    diet, behavior and social support. Another goal is to increase the
    number of well-trained investigators to conduct minority health
    research. To do this, we plan to expand core research centers and
    career development opportunities.
                               clinical research
        Most nursing research studies are clinical in nature, although they
    can also involve basic research. An example of a recent finding
    concerns the use of feeding tubes to provide required nutrition. Every
    year an estimated one million hospital patients or residents of nursing
    homes are fed through use of feeding tubes. Incorrect insertion or
    dislocation of the tube may deliver food to the respiratory system,
    which can be fatal to the patient. Studies have shown that current
    clinical methods that rely on a stethoscope rather than X-rays for tube
    placement are correct only 6 to 34 percent of the time. Nurse
    investigators have discovered that an accurate, less costly alternative
    to both techniques is measuring pH and bilirubin levels in aspirated
    contents from the feeding tube. This method has identified the
    misplacement of tubes in lungs with 100 percent accuracy and is less
    expensive and safer than repeated X-rays.
        Another important innovation for clinical research and practice is
    telehealth--a long distance technology to reach underserved areas, such
    as rural communities. NINR has been active in supporting telehealth
    studies for treatment and monitoring of patients and for providing
    health information. In the next fiscal year, NINR plans to expand
    research to determine the effects of telehealth on various patient
    populations and cost savings associated with telehealth strategies. We
    also plan to target patients most likely to benefit from telehealth
    interventions, identify barriers, and find ways to integrate telehealth
    into other treatment and care regimens.
                       building nursing research capacity
        Next year provides an opportunity to initiate new programs to
    increase the nursing research capacity. In the current fiscal year, we
    are launching the Summer Genetics Institute for extramural researchers.
    This new eight-week training course emphasizes genetics in clinical
    practice, in the research laboratory, and in nursing curricula. Other
    training initiatives include an intramural career transition award that
    combines postdoctoral training with subsequent support for beginning
    research at an extramural institution.
        NINR continues its collaboration with the Office of Research on
    Minority Health in a career development program for minority nurse
    researchers. Studies being carried out by these minority investigators
    include reduction of serious developmental problems of migrant infants,
    suicide prevention in a population of rural Indian youth, and improving
    screening for prostate cancer in African-American men. NINR is also
    collaborating with the National Coalition of Ethnic Nursing
    Associations on a workshop to identify important research questions and
    training needs for minority nurse scientists.
                 government performance and results act (gpra)
        Prominent in the GPRA performance data is NIH's first performance
    report which compares our fiscal year 1999 results to the goals in our
    fiscal year 1999 performance plan. As our performance measures mature
    and performance trends emerge, the GPRA data will serve as indicators
    to support the identification of strategies and objectives to
    continuously improve programs across the NIH and the Department.
                                   conclusion
        In conclusion, health research, health care, and health choices are
    increasingly interdependent, and nurses and nurse researchers play a
    vital role in all three areas. Continued growth of nursing research is
    critical to meet public demands and urgent national health needs. Our
    contributions to the scientific foundation that nourishes the work of
    healthcare practitioners are already making a difference in health care
    or have significant potential to do so. This base of knowledge merits
    expansion in creative new directions. NINR looks forward to the
    challenge.
        Mr. Chairman, I am pleased to answer any questions the Committee
    may have.
                                     ______

                  Prepared Statement of Dr. Francis S. Collins
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the National Human Genome
    Research Institute (NHGRI) for fiscal year 2001, a sum of $353.4
    million, which reflects an increase of $21.8 million over the
    comparable fiscal year 2000 appropriation. Including the estimated
    allocation for AIDS, total support requested for the NHGRI is $357.7
    million, an increase of $21.9 million over the fiscal year 2000
    appropriation. Funds for the NHGRI efforts in AIDS research are
    included within the Office of AIDS Research budget request. The NIH
    budget request includes the performance information required by the
    Government Performance and Results Act (GPRA) of 1993. Prominent in the
    performance data is NIH's first performance report that compares our
    fiscal year 1999 results to the goals in our fiscal year 1999
    performance plan. As our performance measures mature and performance
    trends emerge, the GPRA data will serve as indicators to support the
    identification of strategies and objectives to continuously improve
    programs across the NIH and the Department.
        This is my seventh appearance before this Subcommittee. I am again
    pleased to report that the Human Genome Project continues to be ahead
    of schedule and under budget. When I appeared before you last February,
    Human Genome Project scientists had just completed sequencing the DNA
    of the worm known as C.elegans; laying out the entire genetic code of
    an animal for the first time. At that time, 405 million base pairs of
    human DNA sequence had been deposited in GenBank by the large scale
    human DNA sequencing pilot projects that were initiated in 1996. These
    projects tested new ways to apply sequencing strategies to the large
    and complex human genome.
                              human dna sequencing
        A lot has happened in a year. Following the success of the pilot
    projects, the NHGRI, the Department of Energy, and our international
    partners (the U.K., France, Germany, Japan, and China) initiated last
    March full-scale production sequencing of the 3 billion bases that
    comprise the human genetic instruction book. The newly tested
    sequencing strategies, coupled with advances in sequencing technology,
    provided the necessary foundation to begin full-scale production.
        Later this year, this international consortium will produce a
    ``working draft'' of the human genome sequence, an essential resource
    for the whole research community. The working draft will provide 90
    percent coverage of the human genome with an accuracy of 99.9 percent.
    Then we will move on to complete the final, highly accurate, finished
    human genome sequence in 2003 or sooner, two years ahead of the
    original schedule
        All sequence data produced by the international consortium is
    deposited every 24 hours in GenBank, where it is freely available to
    any researcher with an internet connection, without restrictions on
    use. The rapid public availability of the sequence is invaluable to
    academic scientists studying the molecular basis of human health and
    disease, as well as corporate researchers engaged in drug development.
    By November 17, 1999, the consortium had deposited the sequence of one
    billion bases in the human genome. Today, over half of the sequence,
    approximately 1.7 billion base pairs of non-redundant sequence, resides
    in GenBank. This marks the production of over a billion base pairs of
    human DNA since last year's hearing.
        To reach this milestone, Human Genome Project participants actually
    had to sequence over 12 billion base pairs of human DNA in overlapping
    pieces. As project manager, I know this could not have been done
    without the tireless work of the hundreds of dedicated scientists and
    technicians at the major sequencing centers. The largest five of these
    are referred to as the G-5 (the Whitehead Institute at MIT, the
    Washington University School of Medicine in St. Louis, the Baylor
    College of Medicine in Houston, the DOE's Joint Genome Institute in
    California, and the Sanger Centre in the U.K.) and will do about 85
    percent of the work.
                                 chromosome 22
        The Human Genome Project achieved another historic milestone this
    year when an international scientific team announced the unraveling of
    the genetic code of an entire human chromosome for the first time. The
    33.5 million base pairs of Chromosome 22 were published in the December
    2, 1999 issue of the journal Nature. Research now will focus on
    determining what it all means. Sequencing and mapping efforts have
    already revealed that genes on chromosome 22 are implicated in the
    workings of the immune system, congenital heart disease, schizophrenia,
    mental retardation, birth defects, and several cancers including
    leukemia, but many more secrets will be discovered in this decoded
    text. The results of this work give scientists insights into the way
    genes are arranged along the DNA molecule and pave the way for major
    advances in the diagnosis and treatment of disease.
        Until last year, scientists were uncertain about whether an entire
    human chromosome could be sequenced in this manner. For example, they
    did not know whether insurmountable problems would prevent completing
    the assembly of large stretches of contiguous sequence. The work done
    on chromosome 22 not only answered any doubts about the ability to
    sequence a chromosome, it validated the strategy being pursued by the
    publicly supported Human Genome Project in sequencing the entire human
    genome.
                           beyond the human sequence
        While laying out the precise sequence of the 3 billion letters of
    the human genome is an awesome and audacious undertaking, it is but one
    of the many important objectives of the Human Genome Project. The 5-
    year research plan published in the October 23, 1998 issue of Science
    outlines seven other ambitious goals critical to the success of the
    Project. One such tool is a catalog of common genetic variants.
                            human genetic variation
        Any two human beings, regardless of ethnic or racial self-identity,
    are 99.9 percent the same at the genetic level. But certain changes in
    the sequence, some as subtle as a single letter change, contribute to
    disease or disease risk. Today, to find the misspelling, or
    misspellings, that contribute to common diseases, such as cancer,
    Parkinson's disease, asthma, depression, or heart disease, researchers
    must study pedigrees and search through large chromosome
    ``neighborhoods'' using the genetic map. But having the reference
    sequence, and new technologies for finding those places in the genome
    that vary among us, means that assembling a catalog of common genetic
    variants is now possible, and will greatly speed the process of disease
    gene discovery.
        Most variants will be single letter differences, known as SNPs or
    single nucleotide polymorphisms. Any SNPs found to be associated with a
    disease will provide targets for further study to understand the
    biological processes underlying health and disease and facilitate
    development of diagnostic tests. This understanding will in turn fuel
    development of improved prevention and treatment strategies. Because
    genetic variants can also contribute to individual differences in
    response to drugs, the identification and understanding of these
    variants will allow doctors to choose the most effective drug based on
    a patient's particular genetic makeup.
        In fiscal year 1999, with contributions from 16 NIH institutes, the
    NHGRI began an initiative to discover and catalog common variants in
    human DNA. In the next two years, NIH-supported researchers expect to
    find about 100,000 SNPs. Over the past year, this initiative has been
    complemented by an innovative collaboration in the private sector. Last
    April 15, a collaborative effort of 10 large pharmaceutical companies
    IBM Motorola and the Wellcome Trust, announced the formation of The
    SNPs Consortium (TSC). The Consortium's goal is to identify an
    additional 310,000 SNPs. All SNPs identified by either the NIH or TSC
    are regularly deposited into the publicly available SNP database. This
    collaboration between the public and private sectors has already
    produced and deposited 25,000 SNP's into the public database.
                        sequencing the laboratory mouse
        Last fall, NHGRI began sequencing of the genome of the laboratory
    mouse, one of The most frequently used mammals in biomedical research.
    Ten laboratories, now referred to as the Mouse Genome Sequencing
    Network (MGSN), collectively received funding. All mouse sequence
    produced will fall under the same data release principles adhered to
    for the sequencing of the human genome, i.e., assemblies greater than
    2,000 base pairs will be released to public databases within 24 hours.
        Mouse and humans are approximately 70 percent identical at the
    genetic level. Both genomes contain approximately 3 billion base pairs
    and encode an estimated 100,000 genes. The invaluable contribution of
    mouse models toward a better understanding of human disease has long
    been recognized in biomedical research. For example, mouse models
    provide scientists with unprecedented insights into the molecular basis
    of disease and the response to potential therapeutic agents. Intramural
    scientists at NHGRI are developing and utilizing mouse models to study
    a diverse array of human diseases. These include brain disorders such
    as Huntington's disease, Parkinson's disease, neural crest disorders,
    and blood disorders such as acute myeloid leukemia.
        Sequencing the mouse is a priority for a wide spectrum of
    biomedical scientists. Every institute at NIH, with support of the NIH
    Office of the Director, made a contribution to the first year of
    funding. NHGRI has assumed responsibility for funding the mouse
    sequencing network in the second year and beyond. A significant
    fraction of NHGRI's fiscal year 2000 increase is dedicated to support
    of mouse sequencing.
                            finishing the fly genome
        Looking ahead, achievement of another significant milestone is just
    around the comer. Publication of the complete sequence of the fruit
    fly, Drosophila melanogaster, is expected within a matter of weeks. The
    fruit fly is another useful model organism for studying genetics, with
    a genome of 160 million base pairs of DNA. Providing this research tool
    is important because understanding the role of a gene in the human body
    is often clarified by comparing its DNA code to that of other
    organisms.
        NHGRI supported scientists at the University of California at
    Berkeley and the Baylor College of Medicine carried out the initial
    scaffold sequencing of the fruit fly genome. In 1998, encouraged by
    NHGRI, Celera Genomics began a collaboration with these groups. In
    order to facilitate the work in both sectors, a Memorandum of
    Understanding (MOU) was prepared between the publicly funded scientists
    and Celera Genomics to outline the respective roles of each of the
    partners. The MOU maintained the public sequencing effort's commitment
    to seeing that complete, accurate sequence for this important model
    organism is made freely accessible to all scientists by requiring that
    the annotated sequence be released to GenBank upon publication.
                    tools for understanding the human genome
        Once we have the sequence of the human and key model organisms in
    hand, we will need the tools to allow us to explore and understand its
    significance in health and disease. While this exploration will take
    many years, it will be aided by tools now in development by the Human
    Genome Project; tools that enable researchers to study the entire
    genome and all its genes in a single experiment.
        NHGRI has launched a number of initiatives to develop tools to
    understand gene function that will grow in coming years. One such
    initiative is the Mammalian Gene Collection, led jointly by NHGRI and
    NCL This initiative will create a complete collection of cloned and
    sequenced genes for humans and other mammals. In the future, scientists
    will be able to go to the freezer to pull out any gene they want to
    study. In parallel, new technologies such as microarrays are being
    developed, that can measure and compare the extent to which a gene is
    active under various conditions and in various tissues. The NHGRI
    intramural program is one of the world leaders in this technology. Many
    other clever approaches to studying gene function are being explored
    and the field is expanding rapidly.
        Both genomic sequencing and these new functional studies generate
    vast amounts of data that must be organized, stored and analyzed in
    order to allow scientists to pursue new leads in medical research. One
    significant outcome of the Human Genome Project has been the
    transformation of biology into a field that is rich in data, which has
    spawned a new discipline, called computational biology. New tools for
    handling data to make it readily accessible to scientists, as well as
    new approaches for understanding the significance of the data, are
    urgently needed. In view of this need, NHGRI plans to place a major
    emphasis on funding computational genomics studies in the future. In
    fiscal year 2001, NHGRI will launch a new Genome Centers of Excellence
    program to support the development of novel technology and
    computational approaches for studying the function of genomes. in
    addition to funding innovative science, these Centers will also provide
    an environment in which a new generation of genomic scientists can be
    trained. The concept for the centers is similar to that recommended by
    an Advisory Committee to the NIH Director for ``Programs of Excellence
    in Biomedical Computing.'' The NHGRI anticipates that these Genome
    Centers of Excellence will meet many of the objectives outlined in the
    Committee's report, known as the ``BISTI'' (Biomedical Information
    Science and Technology Initiative) report.
                safeguarding the fair use of genetic information
        From the outset of the Human Genome Project, the NHGRI has
    supported research into the ethical, legal, and social implications
    (ELSI) of genomic research and fostered the development of relevant
    policy recommendations. We have a fundamental obligation to assess and
    deal with concerns such as protecting the privacy and fair use of
    genetic information, and the integration of new genetic technologies
    into health care. If we do not and the public is fearful of obtaining
    or disclosing genetic information, or has limited access to genetic
    technologies, the promise of genetic medicine will not be realized and
    we will have achieved little.
        Progress on safeguarding the fair use of genetic information was
    made just in the last few weeks. On February 8, 2000, President Clinton
    signed an Executive Order to protect federal workers from
    discrimination based upon their genetic information. This is built on
    the bedrock principle that an individual's predictive genetic
    information should be used for their benefit and not for harm. A
    variety of important organizations, such as the American Medical
    Association, Hadassah, the Genetic Alliance, the American College of
    Medical Genetics, the Biotechnology Industry Organization (BIO) and the
    National Society of Genetic Counselors, immediately expressed their
    support for the President's action.
        The Executive Order, which built upon the recommendations published
    by the NIH-DOE ELSI Working Group and the National Action Plan on
    Breast Cancer, is an important step toward assuring federal workers
    that their genetic information will be kept private and be used against
    them by their employer. It also provides federal and state legislators
    with a useful template for extending protections to all workers. We
    hope to see this step built upon in 2000 by the passage of effective
    federal legislation barring the discriminatory use of predictive
    genetic information in health insurance and employment.
                                   conclusion
        The dramatic progress of the Human Genome Project has exceeded the
    expectations of even the most optimistic just a few years ago. In a
    matter of months, the majority of the fundamental ``Book of Life'', the
    human sequence, will be in hand. Having this virtual guidebook to the
    human genome will permit many exciting opportunities. Combining this
    with the catalog of human variation, and with new tools and
    technologies developed by the Human Genome Project, will lead to
    unlocking the mysteries of diseases, such as diabetes, Parkinson's,
    schizophrenia, and common forms of cancer. That in turn will allow new
    approaches to prevention based on each individual's disease risk
    factors. And we can, a few years hence, predict a host of new gene-
    based therapies specifically designed to fit an individual's genetic
    makeup.
        Mr. Chairman, and members of the committee, it has truly been a
    privilege to be a part of this historic effort, known as the Human
    Genome Project. At the beginning of the new millennium, genetics has
    come to encompass nearly every aspect of health research and will
    surely transform how we diagnose and treat disease in the future. It
    will enhance our concepts of shared humanity, regardless of racial or
    ethnic identity.
        My colleagues and I will be happy to respond to any questions you
    may have.
                                     ______

                Prepared Statement of Dr. Judith L. Vaitukaitis
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the National Center for
    Research Resources (NCRR) for fiscal year 2001, a sum of $602.7 million
    which reflects an increase of $33.6 million over the Fiscal Year 2000
    appropriation. Including the estimated allocation for AIDS, total
    support requested for NCRR is $714.2 million, an increase of $39.1
    million over the fiscal year 2000 appropriation. Funds for the NCRR
    efforts in AIDS research are included within the Office of AIDS
    Research.
        It is a pleasure once again to have the opportunity to present the
    accomplishments of NCRR-supported investigators and future directions
    for NCRR programs. Before the recent turn of the millennium, doomsayers
    predicted the end of the world as we know it, and in some respects they
    were right. Advances in computer technology, bioengineering, imaging
    technologies, neuroscience and genomics will revolutionize biomedical
    research in the 21st century. The NCRR mission is unique among the NIH
    institutes and centers. While the other NIH components focus on
    particular diseases, organ systems, or categories of research, NCRR
    alone has a trans-NIH mandate--to develop and maintain the research
    infrastructure that enables all lines of biomedical inquiry. This
    effort transcends both clinical and basic research. NCRR's nationwide
    networks for basic and clinical research discern the molecular causes
    of disease, develop new preventive strategies, and assess novel
    therapies for diseases that affect majority as well as minority
    populations across this Nation. By providing scientists access to
    advanced technologies and sophisticated research facilities for
    collaborative clinical and basic research, NCRR serves as a
    facilitator--or catalyst--for biomedical discovery.
        One of NCRR's main objectives is to utilize scarce or expensive
    resources to the fullest by sharing them among many investigators. This
    strategy is efficient and cost effective. Each year more than 20,000
    investigators, supported by more than $2.5 billion in competitive grant
    support from the other NIH components, use NCRR-supported research
    resources. To meet the needs of biomedical investigators for access to
    costly technologies, NCRR collaborates with the Department of Energy
    and the National Science Foundation (NSF) to provide access for
    biomedical investigators to high-energy x-rays at the synchrotron
    facilities operated by those two agencies. In addition, NCRR provides
    access to advanced computing for health-related research by partnering
    with the NSF-supported San Diego Supercomputer Center, one of the two
    National Partnerships for Advanced Computational Infrastructure
    currently supported by the NSF.
        NCRR-funded resources have been critical to numerous projects that
    advance biomedical science. Many NCRR-supported discoveries have
    immediate benefits for patients; others help basic research move
    forward toward this ultimate goal. For example, separate groups of
    scientists, using NCRR-supported beamlines for x-ray crystallography,
    have determined the three-dimensional structure of ribosomes--our
    cells' protein factories--in unprecedented detail. These studies may
    expedite discovery of newer, more effective antibiotics. Animal studies
    conducted at an NCRR-supported primate center have shown that it is
    possible, by gene therapy, to reverse the brain cell destruction that
    is characteristic of Alzheimer's disease; and NCRR-supported clinical
    investigators have developed methods to assess changes in particular
    areas of the brain of depressed patients. The identification of these
    specific brain areas is fundamental to designing improved treatments
    for depression. According to the National Institute of Mental Health,
    depression affects more than 19 million American adults and costs
    society more than $30 billion in 1990.
            bioengineering, computers, and advanced instrumentation
        The ongoing technological revolution has made it abundantly clear
    that biomedical science is no longer the sole province of physicians,
    biochemists, and biologists. Engineers, physicists, and computer
    scientists are essential partners for developing and adapting new
    instruments and technologies for health-related research. For example,
    improved imaging systems are needed to investigate the pathophysiology
    of human disease by studying patients as well as small animals and
    nonhuman primates as disease models. To obtain the same resolution as
    in humans, these imaging systems must have sensitivities that are up to
    2,500 fold greater. NCRR proposes to support further technological
    development of high resolution imaging tools that include computed
    tomography, magnetic resonance imaging (MRI), and positron emission
    tomography.
        Functional MRI imaging has provided investigators a powerful
    technology for studies of the human brain and has contributed
    significantly with other complementary technologies to a virtual
    revolution in neuroscience research. To further take advantage of these
    imaging and related technologies, NCRR proposes to support the
    establishment of regional MRI imaging resource centers where experts in
    developing and using functional MRI can work with neuroscientists to
    study brain disorders and also explore novel therapies, including stem
    cell therapy to arrest, reverse, or even cure neurodegenerative
    diseases. NCRR plans to functionally link those NCRR-supported
    Biomedical Technology Research Resource Centers equipped with
    sophisticated imaging capabilities with General Clinical Research
    Centers at the same host institution in order to accommodate patients
    from across this country for studies of neurodegenerative and other
    brain disorders, supported by NIH categoric institutes.
        The use of high-level computers and advanced computer programs are
    essential components of today's biomedical research, but many
    biomedical scientists are not sufficiently familiar with
    bioinformatics, a key enabling technology. To help alleviate this
    urgent need, NCRR proposes to establish bioinformatics centers that
    will advance research in particular areas of biomedical investigation,
    as part of the Biomedical Information Science and Technology Initiative
    (BISTI). Those centers will create homes for interdisciplinary teams
    that will establish nurturing environments for exploration and
    research. Biomedical investigators are generating data in profuse
    quantities. For example, a single biomedical laboratory can produce up
    to 100 terabytes of information a year--about the same as the
    information in one million encyclopedias. In order to be useful, the
    data must be indexed and stored, analyzed and abstracted. To facilitate
    analysis of this data, NCRR proposes to establish another program that
    will foster development of tools to design future studies.
        Synchrotron resources--which produce the high-energy x-rays used
    for determining the 3-D structures of molecules--have an enormous
    impact on structural biology and drug design. The number of NIH users
    at NCRR-supported synchrotron beamlines doubled between 1995 and 1997,
    and requests for access to these facilities are increasing at an
    exponential rate. NCRR proposes to alleviate the projected substantial
    shortfall for access to beamtime by adding more technical staff so that
    technical support is available around the clock. New beamlines at the
    Advanced Photon Source at the Argonne National Laboratory may allow
    investigators to address more advanced structural biology grand
    challenges. In addition, several new beamlines must be built at the
    Advanced Light Source at the Lawrence Berkeley National Laboratory and
    designed for high throughput studies of less complex structures to meet
    the anticipated high volume of need for this approach. This effort will
    combine new developments in beamline design, x-ray detectors,
    cryocrystallography, robotics, and computational software.
                                genetic medicine
        Manifestations of gene action are explored through phenotypic
    assessment of genetically altered animals and biologic characterization
    of macromolecules expressed by both normal and altered genes. NCRR
    proposes to support regionally-linked resource centers for phenotypic
    studies of genetically altered research animal models. These resource
    centers will provide a critical infrastructure for analysis of gene
    function in animal models of human diseases. NCRR must provide those
    regional resources and several other biorepositories for genetically
    altered biologic collections and additional funding for more technical
    staff to help maintain the rapidly expanding biologic collections.
    Additional staffing is also needed to curate and standardize the
    genetic databases for those important research models--including flies,
    fish, and worms. Without continuous updating and editing, databases
    quickly become useless and as a result, unnecessary duplication of
    research results.
                               health disparities
        NCRR proposes to help alleviate health disparities for several
    diseases that disproportionately affect minority populations by
    competitively establishing several Comprehensive Centers on Health
    Disparities (CCHD). Those centers are to be hosted by medical schools
    located at universities that have an NCRR-supported Research Centers in
    Minority Institutions (RCMI) facility for clinical research. The NCRR
    CCHD initiative will focus on diabetes, AIDS, and infant mortality, but
    initially will place increased emphasis on cancer screening and
    management of cardiovascular disease and stroke. This effort will be in
    partnership with appropriate categoric NIH institutes and with nearby
    General Clinical Research Centers.
                               research capacity
        NCRR proposes to continue support for construction or renovation of
    biomedical research facilities to assure that state-of-the-art research
    laboratories are available to conduct the most sophisticated research.
    According to a 1998 National Science Foundation survey, at least 65
    percent of biomedical research laboratories are inadequate to host
    sophisticated research. Grant awards for construction or renovation
    through NCRR's Research Facilities Improvement program are not intended
    to be the major source for institutional funding of research laboratory
    construction or renovation.
        NCRR proposes to expand its Animal Facility Improvement program to
    meet institutions' needs nationally to upgrade animal research
    facilities to perform genetic research with rodents, nonhuman primates
    and other animal models. To assist research-performing Historically
    Black Colleges and Universities and other minority-serving institutions
    in bringing their animal research facilities up to AAALAC standards,
    NCRR proposes a special initiative to address this problem.
                               career development
        Over the past several years, fewer young physicians have pursued
    research careers. To help address that problem, NCRR has initiated
    programs to increase the number of young physicians in the clinical
    research pipeline. NCRR proposes to extend that effort in fiscal year
    2001. That effort includes expanded support for a year-long medical
    student mentored clinical research training program. The intent of this
    program is to serve as a catalyst for young physicians to pursue
    careers in patient-oriented research. The institutional GCRC or the
    RCMI-funded Clinical Research Center will serve as a focal point for
    patient-oriented research, through mentored didactic training and
    ``hands-on'' research. This new program will support up to 90 students
    per year. NCRR also proposes to increase the number of Mentored
    Patient-Oriented Research Career Development Awards to physicians and
    dentists at GCRC sites. This very successful program was formerly known
    as the Clinical Associate Physician (CAP) program.
        A serious shortage exists of trained veterinary pathologists to
    meet the collaborative research needs of scientists to assess the
    phenotypic manifestations of genetically altered animal models of human
    disease. To enhance the pipeline, NCRR proposes to initiate a one-year
    program for veterinary students that will provide a mentored biomedical
    research experience at research-intensive institutions. In addition,
    NCRR proposes to increase the number of Special Emphasis Research
    Career Award to train veterinarians in health-related research as
    pathobiologists. The NCRR programs are intended to address the
    inadequate number of research-trained veterinarians who participate in
    biomedical research.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    which compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        My colleagues and I will be happy to respond to any questions you
    may have.
                                     ______

                  Prepared Statement of Dr. Stephen E. Straus
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget request for the National Center for
    Complementary and Alternative Medicine for fiscal year 2001, a sum of
    $71,362,000, which reflects an increase of $3,381,000 over the
    comparable fiscal year 2000 appropriation. Including the estimated
    allocation for AIDS, total support requested for the National Center
    for Complementary and Alternative Medicine is $72,392,000, an increase
    of $3,381,000 over the fiscal year 2000 appropriation. Funds for the
    National Center for Complementary and Alternative Medicine efforts in
    AIDS research are included within the Office of AIDS Research budget
    request.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    Prominent in the performance data is NIH's first performance report
    that compares our fiscal year 1999 results to the goals in our fiscal
    year 1999 performance plan. As our performance measures mature and
    performance trends emerge, the GPRA data will serve as indicators to
    support the identification of strategies and objectives to continuously
    improve programs across the NIH and the Department.
        At the outset, I should note that NCCAM's work reflects the growing
    public interest in complementary and alternative medicine (CAM) and the
    belief that various CAM therapies may play a role in improved public
    health. Approximately 42 percent of U.S. healthcare consumers spent $27
    billion on CAM therapies in 1997. CAM enjoys particular popularity
    among baby boomers. A number of practices, once considered unorthodox,
    have proven safe and effective and assimilated seamlessly into current
    medical practice. Diet and exercise are today commonly used to prevent
    and control disease. Acupuncture is routinely applied to manage chronic
    pain and nausea associated with chemotherapy. Some of our most
    important drugs--digitalis, vincristine, and taxol--are of botanical
    origin.
        Additional CAM practices have the potential to prevent and treat
    chronic disease, to improve understanding of how healing works and to
    be integrated into the routine practice of medicine. Absent definitive
    evidence of effectiveness, however, alternative practices may impart
    untoward consequences for large numbers of people.
        As the NCCAM's first permanent director, I am excited by the
    challenge afforded me to help provide the American public the guidance
    it deserves. As CAM use by the American people has steadily increased,
    many have asked whether reports of success with these treatments are
    valid. It is critical that untested but widely used CAM treatments be
    rigorously evaluated for safety and efficacy. It is similarly important
    to identify promising new approaches worthy of more intensive study.
    The promising areas for future investments are numerous.
        In order to best seize these opportunities, the NCCAM's strategy
    must differ from that used by other NIH Institutes and Centers. Others'
    projects are usually driven by basic science discoveries. In contrast,
    the NCCAM must focus first on definitive clinical trials of widely
    utilized modalities that, from evidence-based reviews, appear to be the
    most promising. Credible, not anecdotal, data must be provided to the
    public, and we must educate conventional medical practitioners about
    the panoply of effective CAM practices, so they can be integrated into
    patient care. In recognition of these needs, Congress responded in 1998
    by elevating the NIH Office of Alternative Medicine (OAM), expanding
    its mandate, creating the NCCAM, and affording it administrative
    authority to design and manage its own research portfolio. The Congress
    continued to reflect the growing interest in CAM by further increasing
    funding for the Center in fiscal year 2000 to $68.4 million. We are
    indeed appreciative of this support. The Congress vested the NCCAM with
    a broad statutory mandate to conduct and support CAM research, support
    research training, and disseminate information on validated CAM
    therapies. Accordingly, the NCCAM is currently developing a strategic
    plan to ensure that our continued growth, development and research
    directions are consistent with these responsibilities. Five strategic
    areas have been identified as: Investing in research; training CAM
    investigators; expanding outreach; facilitating integration; and
    practicing responsible stewardship.
        In seeking to fulfill its mandate, the NCCAM has undertaken a
    number of initiatives, established critical contacts with CAM
    practitioners, and begun to fashion the scientific underpinning that
    will enable future research discoveries.
        Before describing these activities, I want to share with the
    Subcommittee my vision of where I expect complementary and alternative
    medicine to be in the years to come. As a result of rigorous scientific
    investigation, several therapeutic and preventative modalities
    currently deemed elements of CAM will prove effective. Therefore, in
    future years, these interventions will be integrated into conventional
    medical education and practice, and the term ``complementary and
    alternative medicine'' will be superseded by the concept of
    ``integrative medicine.'' The field of integrative medicine will be
    seen as providing novel insights and tools for human health, and not as
    a source of tension that insinuates itself between and among
    practitioners of the healing arts and their patients. Advances in
    neurobiology will reveal more about ancient practices such as
    acupuncture and meditation, as well as the phenomenon of ``the placebo
    effect'' as we tap the healing power of the mind. The medical basis for
    effectiveness of selected herbal and nutritional supplements will be
    clarified, leading to their standardization and routine use. Other
    modalities will be found unsafe or ineffective, and an informed public
    will reject them.
        My vision is an optimistic one. However, I am confident that, as it
    is realized, the NCCAM will have not simply expanded in those ways
    required to meet its research mission. Rather, owing to a tradition of
    superb science and consumer service, the NCCAM will become the leader--
    and recognized as such--within a vibrant, and global, CAM research
    community.
        Already, I have begun to recruit key experts to join me in
    developing our programs in intramural research, clinical research,
    international and traditional health studies, and traditional medicine
    and indigenous systems. We will continue to grow our intellectual
    capital and research capacity. Setting these cornerstones in place will
    enable us, together with our partners in CAM research, to provide
    definitive answers regarding CAM treatments.
                            current research studies
        In its first year, NCCAM has developed a diverse research portfolio
    in partnership with the other NIH Institutes and Centers. I am pleased
    to highlight for you our support of some of the largest, and certainly
    the most definitive Phase III clinical trials ever undertaken for a
    range of CAM therapies.
        For centuries, extracts from the leaves of the Ginkgo biloba tree
    have been used as Chinese herbal medicine to treat a variety of medical
    conditions, including age-related decline in memory. A new NCCAM study,
    in collaboration with the National Institute on Aging (NIA), may help
    resolve these questions. This study includes four clinical centers and
    will enroll almost 3,000 participants who will receive either Ginkgo
    biloba or a placebo.
        Arthritis is a major public health problem for older Americans.
    Accordingly, in collaboration with NIAMS, NCCAM has mounted two
    critical clinical trials for the treatment of osteoarthritis. One is
    the first U.S. multi-center study to investigate the dietary
    supplements glucosamine and chondroitin sulfate--two natural
    substances, found in and around joint cartilage. The other study is an
    evaluation of acupuncture for the treatment of pain associated with
    osteoarthritis.
        I am pleased to report that our study of St. John's wort for
    depression is nearing completion. This study, sponsored by the NCCAM,
    NIMH, and the NIH Office of Dietary Supplements (ODS), represents the
    largest and most rigorous assessment of the effectiveness and safety of
    St. John's wort. Investigations of St. John's wort illustrate the
    complex challenges afforded by some CAM modalities. A recent study
    reported in The British Medical Journal showed that St. John's wort is
    more effective than placebo in treatment of depression, and perhaps as
    effective as an older generation anti-depressant drug Imipramine.
    NCCAM's study, which is considerably larger than the European trial,
    compares St. John's wort with placebo and with Zoloft, currently one of
    the most commonly used anti-depressants. However, the therapeutic
    promise of St. John's wort and of botanical products like it, is
    accompanied by risks that the public has largely ignored. An NIH study
    published February 12th in the Lancet found that St. John's wort, when
    taken together with the important HIV protease-inhibiting drug,
    Indinavir, increased the rate at which Indinavir was eliminated from
    the bloodstream, to the extent that blood levels fell below the
    acceptable level for effective AIDS treatment.
        NCCAM continues support for four Specialized Research Centers
    (cardiovascular disease, substance abuse, pediatrics and chiropractic)
    funded originally by the Office of Alternative Medicine. By the end of
    fiscal year 1999, NCCAM made five additional Specialty Research Center
    awards. The nine Center grants total approximately $63 million. Each
    focuses on one of several areas, including pediatrics, addiction,
    cardiovascular disease (CVD), minority aging and CVD, aging,
    neurological disorders, craniofacial health, arthritis, and
    chiropractic medicine. In addition to these nine Centers, NCCAM and ODS
    jointly established two Dietary Supplements Research Centers to advance
    the science of botanicals, including issues of their composition,
    safety, and biological action. Another request for Center grant
    applications focusing on asthma and cancer recently was released for
    fiscal year 2000. This, coupled with our anticipated solicitation of
    one more botanical center in fiscal year 2000, will likely bring our
    total number of NCCAM-supported centers to as many as 15.
        Benign prostatic hyperplasia (BPH), or non-cancerous enlargement of
    the prostate, is the most common benign tumor found in men. Anecdotal
    reports suggested that the botanical product saw palmetto decreases
    prostate swelling. To determine the validity of these observations,
    NCCAM, in collaboration with National Institute on Diabetes and
    Digestive and Kidney Diseases (NIDDK), is supporting the first
    rigorously designed, placebo-controlled study to evaluate the effect of
    saw palmetto extract on symptoms and quality of life in men.
                      future scientific plans and projects
        Because of the dearth of credible scientific evidence on CAM
    practices, there is unprecedented opportunity for determining the
    efficacy and safety of CAM modalities. We have developed the following
    initiatives to address them:
        NCCAM has planned a collaboration on the treatment of liver disease
    with the NIDDK and the National Institute of Allergy and Infectious
    Diseases (NIAID). The project will examine the efficacy of milk thistle
    extract--Silybum marianum--when used to treat Hepatitis C and other
    hepatic diseases.
        NCCAM has already begun a number of activities that will serve to
    facilitate the integration of validated CAM therapies into conventional
    medical practice. The NCCAM plans to make awards to foster
    incorporation of CAM information into the curricula of medical and
    allied health schools and continuing medical education programs. Also,
    the NCCAM must educate eager medical students about CAM so that they
    may knowledgeably guide an avid patient base toward safe and effective
    CAM applications. We must also work to overcome the reluctance of
    conventional physicians to consider validated CAM therapies and to
    assimilate proven ones into their practice. The Center has established
    a Clinical Research Curriculum Award (CRCA) to attract talented
    individuals to CAM research and to provide them with the critical
    skills that are needed.
        A majority of the CAM modalities practiced in this country have
    arisen from the traditional healing practices of other nations. Some of
    the practices have ``evolved'' or been adapted to work within the
    context of our society, and often in parallel with conventional medical
    practices. Moreover, most of these practices are not well documented
    within the context of their native cultures or understood within the
    context of our own. Unraveling these issues will provide some important
    insights into how these CAM modalities are practiced and impact upon
    the health of U.S. minority populations--new immigrants like Hmong
    (from southeast Asia) and established groups like the Navajo. Likewise,
    the development of culturally sensitive studies will enable NCCAM to
    establish methodological feasibility and strengthen the scientific
    rationale for proceeding to full-scale, randomized, clinical trials on
    the application of traditional, indigenous systems. The ability to
    validate some of these therapies will also expand healthcare options
    for those who are primarily consumers of convention medicine. The
    international character of CAM necessitates that the NCCAM develop a
    broad-based international research program that reaches out to CAM
    practitioners across the world. Therefore, in collaboration with
    several other ICs, NCCAM is committed to support locally-based,
    traditional, indigenous research projects in countries where the
    opportunities for promising CAM research are greatest. That process
    will ensue with the forthcoming appointment of a Director for
    International and Traditional Medicine Studies, who will develop a
    long-range plan for the pursuit of studies on a global scale.
    Foreshadowing this appointment, I have already authorized NCCAM
    support, in collaboration with the NICHD, for international studies of
    traditional medical approaches to the health of women and children.
        The NCCAM will establish an Intramural Research Program that will
    develop a critical mass of CAM research to stimulate collaboration in
    the NIH Clinical Center with other Institutes and Centers, our Federal
    research partners, and others. The intramural program will serve as a
    focus for training future CAM researchers. Last month I formed a search
    committee to identify the Director of this program.
                           information dissemination
        Specific statutory authority enables the NCCAM to disseminate
    information regarding the safety and effectiveness of CAM therapies to
    health care providers and the public. A focal point for information
    about NCCAM programs and research findings, the NCCAM Information
    Clearinghouse develops and disseminates fact sheets, information
    packages, and publications to enhance public understanding about CAM
    research supported by the NIH. Its quarterly newsletter, Complementary
    & Alternative Medicine at the NIH is distributed to 6,000 subscribers.
    The NCCAM's award winning World Wide Web site, first established two
    years ago, reflects the NCCAM's growth in size and stature. Averaging
    more than 460,000 hits per month, the site includes links to NCCAM
    program areas, news and events, research grants, funding opportunities,
    and resources. Assembled by NCCAM from the National Library of
    Medicine's (NLM) MEDLINE database, the CAM Citation Index (CCI) affords
    the public access to approximately 175,000 bibliographic citations
    searchable by CAM system, disease, or method. Also, in February 1999,
    NCCAM joined the federally supported Combined Health Information
    Database (CHID), which includes a variety of health information
    materials not available in other government databases, including nearly
    1,000 CAM citations not available elsewhere.
        To facilitate our outreach to the general public, I have initiated
    a series of town meetings; the first will be held on March 15 in
    Boston, in conjunction with the Center for Alternative Medicine and
    Education of Beth Israel Deaconess Medical Center.
        I am now happy to take your questions about these or any other of
    NCCAM's activities and plans.
                                     ______

         Prepared Statement of Dr. Gerald T. Keusch, Director, Fogarty
                              International Center
        Mr. Chairman and Members of the Committee, I am pleased to present
    the President's non-AIDS budget request for the Fogarty International
    Center (FIC) for fiscal year 2001, a sum of $32,532,000, which reflects
    an increase of $3,620,000 over the comparable fiscal year 2000
    appropriation. Including the estimated allocation for AIDS, the total
    support requested for the FIC is $48,011,000, which is an increase of
    $4,683,000 over the fiscal year 2000 appropriation. Funds for the FIC
    efforts in AIDS research are included within the Office of AIDS
    Research budget allowance.
        I am delighted to relate our progress over the past year and our
    proposed plans for fiscal year 2001. The FIC has taken a lead role in
    formulating and implementing biomedical research and policy. The
    programs of the FIC, developed in close consultation with this
    Committee, reflect our Nation's enduring commitment to global health
    equity. But disparities in health still exist. While one-fifth of the
    world's population enjoys an average life expectancy approaching 80 and
    a life comparatively free of disability, two-thirds of the world's
    population, living in the least well-off countries of Africa, Asia, and
    Latin America, suffer overwhelmingly from the world's burden of illness
    and premature death. According to statistics compiled by the World
    Health Organization (WHO), each year in the developing world 15 million
    children die from infection and malnutrition--40,000 children per day--
    and the toll in sickness and life-long disability has even greater
    social, economic, and political consequences. Arguably, reversing this
    deepening disparity is a public health urgency in the new decade that
    demands increasingly creative actions from the scientific community.
        Disparities in health are not limited by national boundaries.
    Research on conditions related to poverty in resource-poor nations have
    universal applications. Most recently, this has been demonstrated by
    the development of short-course treatment regimens for tuberculosis,
    field tested initially in Tanzania and now applied by public health
    authorities throughout the United States. Adapting research advances in
    biomedicine to populations at home and abroad requires a continuing
    commitment to basic science as well as rigorous clinical and applied
    studies. Our mandate at FIC is to serve as NIH's international catalyst
    by enabling U.S. institutions to extend the geographic scope of
    research and training. FIC supports over one hundred U.S. institutions
    that collaborate with more than ninety nations. These efforts are
    multidisciplinary, embracing clinical, epidemiological, basic
    biomedical and behavioral research. They are multisectoral, coordinated
    with our sister institutes at NIH and with international organizations
    with health and development mandates, including the World Health
    Organization and World Bank.
        One principal strategy of the FIC is to create the human capital
    and institutional capabilities in developing nations necessary for a
    productive research enterprise. FIC places priority in four foundation
    disciplines: First, information science and technology, as both an
    analytical tool and a means to create global laboratories without
    walls; second, epidemiological and clinical methodologies necessary to
    characterize disease burdens and devise and evaluate therapeutic or
    preventive interventions; third, human genetics and genomics, so that
    developing nations may contribute to and benefit from international
    efforts to apply genetic discoveries to clinical practice and
    therapeutics; and fourth, ethical principles and practice in patient-
    oriented research, with the intent of ensuring the depth and
    transparency of the process of ethical review and the involvement of
    co-investigators and study volunteers as equals in accordance with
    international guidelines as well as local norms.
        The selected examples that follow characterize several of our
    leading priorities in global health research and training.
              developing cost-effective methods of preventing hiv
        Over ninety percent of the world's estimated 33 million persons
    infected with HIV live in developing countries (UNAIDS). Within the
    next five years, 61 of every 1,000 children born in southern Africa
    will not reach their first birthday due to AIDS and increasing
    longevity gains will be reversed. Progress in preventing future
    infections is dependent on rigorous scientific links with developing
    nations. This is the objective of FIC's AIDS International Training and
    Research Program, the most extensive HIV research and training network
    among U.S. schools of medicine and public health and counterparts in
    developing nations. In partnership with the National Institute of
    Allergy and Infectious Diseases, FIC provided training and
    infrastructural support for Ugandan-based trials to prevent perinatal
    HIV transmission through regimens of the anti-retroviral drug
    nevirapine. A single oral dose given to an HIV-infected women in labor
    and another given to her infant within three days of birth reduced the
    transmission rate by half at a cost of $4.00 per mother-infant pair. If
    implemented widely in developing nations, this intervention could
    prevent some 400,000 newborns per year from beginning life infected
    with HIV.
       novel approaches to treatment and control of emerging infectious
                                    diseases
        Coupled with the AIDS crisis, parasitic and other infections
    continue to compound the burdens of mortality and chronic illness as
    well as impede economic growth in affected regions. According to WHO,
    malaria kills close to 2 million people each year, most are children
    under the age of five, and an estimated \1/2\ to 1 billion cases of
    malaria occur, and this is closely associated with poor economic
    performance in the affected countries. Progress will require a new
    public health paradigm: An integrated approach to prevention and
    control, incorporating improvements in case management, rational drug
    use to limit the spread of resistance, monitoring and evaluation of
    control measures, and development of new diagnostic tools, drugs and
    vaccines. Moreover, the spread of HIV is hastened through the use of
    unscreened blood to treat the life-threatening anemia that often
    develops in malaria-infected individuals. This reinforces the need for
    operational strategies to ensure the safety of the blood supply and
    transfusion practices for the anemia of malaria, a major complication
    of the infection. The Multilateral Initiative on Malaria (MIM), an
    alliance of scientific and development agencies and African partners,
    was launched with major support from FIC and NIAID to address these
    critical needs. FIC now serves as the worldwide focal point for the
    MIM. To promote the agenda to reduce the burden of malaria, FIC has
    initiated a new research and training program to link U.S. and, in
    particularly, African institutions. The MIM constitutes a maturing
    model--a paradigm of cross-sectoral cooperation that FIC hopes to adapt
    to other global health urgencies.
        The field of malaria and other tropical infections has reached a
    watershed, demonstrating the potential for application of tools of
    molecular and cell biology to render formerly intractable problems
    approachable. For example, dengue fever and its most severe form,
    dengue hemorrhagic fever/dengue shock syndrome, are considered among
    the most important and widespread reemerging infectious diseases in the
    developing world, including the Caribbean. Global warming impacts on
    mosquito vectors that makes this a threat to the U.S. mainland as well.
    To date, existing methods to diagnose and characterize dengue viruses
    have been costly and complicated to perform, particularly in developing
    countries with limited capabilities and resources. Under FIC support,
    the University of California at Berkeley and the Ministry of Health in
    Nicaragua have developed a new technique to rapidly, accurately, and
    inexpensively define the virus responsible for dengue in Central
    America. This method is known as restriction site-specific PCR
    (polymerase chain reaction). Using this new information, local health
    authorities now are able to track the movement of the dengue virus from
    Asia and Africa to the Americas, which is the start of control efforts.
        Dengue is among more than thirty-five infectious diseases that have
    emerged or reemerged around the world in the past twenty-five years.
    Most recently, the outbreak of encephalitis in the New York region was
    attributed to the West Nile Virus, its first known introduction into
    the Western hemisphere. Although it is not clear how the virus migrated
    to the United States, this outbreak is representative of the continual
    challenge that newly emerging microbes present for U.S. citizens.
    Emerging infectious diseases are infections that are new in the
    population, rapidly increasing in incidence or expanding in geographic
    range. Most are caused by ``microbial traffic''--that is, the
    introduction and dissemination of existing agents into human
    populations either from other species or from smaller populations,
    often precipitated by rapid ecological and environmental change. To
    better comprehend the consequences of changes in terrestrial and marine
    ecosystems on human health, the FIC, in partnership with several NIH
    Institutes, the National Science Foundation, and other U.S. agencies,
    initiated an interdisciplinary research program to elucidate the
    underlying biology of habitat and biodiversity changes that may lead to
    increased disease prevalence in humans and, thus, fill an important gap
    in our understanding of these interrelated dynamics. With this
    information, we will be able to develop data and predictive models to
    anticipate future outbreaks and devise corrective actions before the
    disease strikes.
    taking steps to address emerging epidemics of noncommunicable disease:
                          fiscal year 2001 initiatives
        The classic burdens of infectious diseases in developing nations
    are now joined by a new class of epidemics. According to the Global
    Burden of Disease Study commissioned by the World Bank, over the next
    twenty-five years as populations age and risk exposures shift, non-
    communicable diseases will become the leading source of disability and
    premature death in developing nations. Both the pace of these changes
    and the sheer numbers affected will exceed the Western experience. By
    working in partnership with scientists in low- and middle-income
    nations, risk factors may be evaluated and interventions developed that
    will be of benefit to both industrialized and developing nations. The
    emerging epidemics of chronic disease in developing nations constitute
    FIC's major programmatic thrust for fiscal year 2001.
        In cooperation with the WHO Tobacco Free Initiative and multiple
    NIH partners, FIC will establish a research and training program to
    improve international efforts to control the tobacco epidemic. Among
    other objectives, the program will address large gaps in our knowledge
    relating to the burden of death and disability associated with tobacco
    use in developing nations, such as behavioral determinants of smoking
    uptake in youth. The Center also will launch a similar effort directed
    at prevention and management of mental health disorders--an unseen
    epidemic in most developing countries. At any give time, an estimated
    10 percent of the population in developing nations suffers from severe
    anxiety, depressive disorders and other psychosocial problems (World
    Mental Health: Problems and Priorities in Low-Income Nations, Oxford
    University press, 1995). Through international partnerships, we hope to
    begin to rectify the shortfall of well-trained clinical investigators
    and epidemiologists in mental health fields in developing nations.
    Moreover, we will begin to generate epidemiological data on the
    incidence of mental health disorders and risk factors, including
    sociocultural determinants of mental health in societies undergoing
    transition to industrialized economies.
        In fiscal year 2001, the FIC also proposes to create new linkages
    with developing nations in the field of molecular medicine, emphasizing
    research and training related to the complex interplay between genes
    and the environment. The genetic maps, physical maps and technologies
    that have emerged from the human genome sequencing effort have enabled
    the research community to accelerate dramatically the discovery of
    genes underlying disease or risk factors for disease. We are now
    positioned to advance understanding of population genetics and dynamics
    for chronic conditions that affect industrial and developing nations
    alike, such as hypertension, type 2 diabetes, asthma, and breast
    cancer. FIC's long-range goals are to define some of the genes involved
    in multigenic disorders of global priority and then test the predictive
    strength of these particular polymorphisms in prospective, community-
    based studies. Ultimately, diagnostic, therapeutic, and prevention
    strategies will evolve.
        Our current efforts in this field already have yielded promising
    leads. Scientists at the University of Washington have teamed with
    scientists from Tel Aviv University in Israel and Bethlehem University
    in the Palestinian Authority to map and clone the genes responsible for
    different types of inherited deafness--both progressive and early-
    onset. The incidence of preverbal deafness is an estimated five to ten
    percent in this region, among the highest in the world. Loss of hearing
    may be due to environmental factors or to genetic mutations in any one
    of a large number of genes. These genes encode proteins crucial for the
    proper development, structure and function of the inner ear. There may
    be more than 100 such genes, however only a fraction have been
    identified. Identifying these genes and defining the mutations that
    cause deafness through these novel studies will lead to a better
    understanding of the biology of hearing.
                                   conclusion
        These programs and initiatives are representative of a broad
    spectrum of international research and training efforts supported by
    FIC. The programs of FIC recognize a deeper philosophic purpose and
    vision. Advances in biology over the past decades have demonstrated
    social and global interdependence. This is a condition of health for
    the biosphere as much as it is an imperative of societal well-being.
    There is a deepening consensus that individuals and nations share an
    inherited and acquired sense of social altruism--an understanding of
    common fate and a shared set of social obligations. The pursuit of
    health through international scientific cooperation is an inherently
    global enterprise and one that ultimately improves the public health of
    this Nation as well.
        The NIH budget request includes performance information required by
    the Government Performance and Results Act (GPRA) of 1993. Prominent in
    the performance data is NIH's first performance report, which compares
    our fiscal year 1999 results to the goals in our fiscal year 1999
    performance plan. As our performance measures mature and performance
    trends emerge, the GPRA data will serve as indicators to support the
    identification of strategies and objectives to continuously improve
    programs across the NIH and the Department.
        Thank you, Mr. Chairman. I will be pleased to answer any questions.
                                     ______

                 Prepared Statement of Dr. Donald A.B. Lindberg
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's non-AIDS budget for the National Library of Medicine
    for fiscal year 2001, a sum of $224,942,000, which reflects an increase
    of $14,806,000 over the comparable fiscal year 2000 appropriation.
    Including the estimated allocation for AIDS, total support requested
    for NLM is $230,135,000, an increase of $16,067,000 over the
    appropriation for fiscal year 2000. Funds for the NLM's efforts in AIDS
    research are included within the Office of AIDS Research budget
    request.
                       health information for the public
        In the best tradition of American enterprise, NLM has within a few
    short years re-engineered its information services to benefit directly
    both health professionals and the public. The public has always been
    the ultimate beneficiary of NLM's services. But today's consumer now
    has the same access as doctors and scientists to the Library's immense
    databanks. NLM has also created new services aimed directly at the
    general public that are proving popular with Web users. These changes,
    encouraged by this Committee and supported by Congress, have been
    endorsed by NLM's Board of Regents.
        The NLM has a two-step strategy to maximize the utility of its
    services. The first is to respond to the needs of the Web-using public.
    It is estimated that 40 to 50 percent of Americans are connected to the
    Internet, and health information is a popular topic for searching. In
    three years the Library has seen the number of searches on its MEDLINE
    database rise from 7 million searches a year to 250 million. The
    Library estimates that 30 percent are done by the members of the public
    for themselves and their families. That a database of 10 million
    references and abstracts to medical journal articles would prove to be
    so popular is remarkable and demonstrates an eagerness for
    authoritative health information by the public.
        The Library has created for consumers a new service, MEDLINEplus,
    to complement its databases of scientific literature. MEDLINEplus has
    grown rapidly in little more than a year, and provides links to
    information on 350 diseases and medical conditions. This information,
    reviewed and selected by highly trained medical librarians, originates
    from such trusted sources as the Institutes of NIH and professional
    societies. NLM constantly scans these and other organizations for up-
    to-date information and the links are checked daily. MEDLINEplus
    contains a feature unique in the world of Web-based information for the
    public: carefully pre-formulated searches of the MEDLINE database that
    will return references and abstracts deemed especially useful for the
    average consumer.
        A new service, ClinicalTrials.gov, was introduced by NLM on behalf
    of NIH in February 2000. This database, accessible through MEDLINEplus,
    contains vital information about thousands of clinical trials sponsored
    by the NIH and other Federal agencies. Now patients, families, and
    members of the public can find out about cutting-edge research being
    conducted around the U.S. and whether they are eligible to join a
    study. ClinicalTrials.gov contains a statement of purpose for each
    clinical research study, together with the recruiting status, the
    criteria for patient participation in the trial, the location of the
    trial, and specific contact information. The database will be expanded
    to include clinical trials sponsored by private industry and in other
    countries.
        Not all Americans, however, can search the Internet. Thus, NLM's
    second strategy is to improve access for this group by encouraging
    medical libraries to work with local public libraries and other
    community organizations. In 1999 NLM completed a pilot project with
    public libraries in nine states and the District of Columbia. The
    purpose was to evaluate whether these libraries, using the Internet,
    could help meet the needs of the public for good health information.
    The project revealed that MEDLINEplus is an excellent place for
    consumers to begin their search and that public librarians need
    training in answering health reference questions and in finding and
    evaluating health information on the Web. Building on what we learned
    in this project, the NLM made awards in February 2000 to fund 49
    electronic health information projects in 34 states that will increase
    Internet access in many settings, from middle schools serving low
    income and educationally underserved students to shopping malls and
    senior centers. These imaginative and well-targeted projects will
    stimulate medical libraries, local public libraries, and other
    organizations to work together to provide electronic health information
    services for all citizens in a community. Crucial in this effort is the
    Regional Medical Libraries and members of the National Network of
    Libraries of Medicine.
                               health disparities
        The NLM has in place a number of programs that in recent years have
    been directed toward remedying the disparity in health opportunities
    experienced by segments of the American population. One of these
    programs deals with toxic waste sites and other environmental and
    occupational hazards that are much more likely to occur near homes in
    poor neighborhoods than where affluent Americans live. The Library has
    a program to train health professionals, community leaders, and others
    in minority neighborhoods to use the NLM's databases of information
    about hazardous waste information. The Library provides minority
    schools with state-of-the-art equipment, software, and free access to
    computerized information sources, including NLM's own toxicology and
    environmental health information databases. Other Federal agencies have
    joined with NLM and the project has grown from 9 participating minority
    institutions to more than 60.
        Similar to the program for toxicology and environmental health, the
    Library has been working with institutions that serve minority
    populations to encourage the use of NLM information services relating
    to HIV/AIDS. These include the databases AIDSLINE (references and
    abstracts), AIDSTRIALS (clinical trials), AIDSDRUGS (drugs being
    tested), and DIRLINE (organizations that provide health information to
    the public). The NLM has in place a program to train health
    professionals, community organizers, information professionals, and
    patient advocates in the use of these resources. Requests for this
    training have been strong and sustained, and NLM has responded to the
    extent its resources permit. In addition to the programs mentioned
    above, NLM grants and contracts have been targeted to support health
    information programs for African Americans, Latinos, and Native
    American populations in the south; rural hospitals in the Midwest;
    Native Americans in Alaska and the Pacific Northwest; African American
    and Latino populations in the Pacific Southwest; and Puerto Rico. To
    illustrate, telemedicine in rural Alaska is being tested as a strategy
    for controlling costs and for raising the quality of health care for a
    minority population that is scattered across a vast area.
        The NLM is a key participant in the Multilateral Initiative on
    Malaria Research effort in Sub-Saharan Africa. Scientists in many
    developing countries are unable to communicate easily with other
    scientists, search biomedical databases, or collaborate with colleagues
    in industrialized countries. This results in poor coordination and
    monitoring of research, redundancy of effort, and a growing disparity
    in research productivity. The Library is supporting the implementation
    of high end communications hardware and software in remote malaria
    research sites in Mali, Kenya, Cameroon, Ghana, and Tanzania. Since
    Internet connections can effectively carry voice, data, and video image
    transmissions, the Library is helping to bring them to scientists in
    those countries. The Ghana sites, for example, are engaged in malaria
    vaccine development and testing readiness.
                              medical informatics
        A recently released report recommends that the NIH invest heavily
    in computer and information technology so as to be able to manage data
    and model biological processes. It also observes that there is an acute
    need for training specialists competent in computational biology. This
    recommendation falls within the scope of the NLM's medical informatics
    training program under which the Library supports 12 programs at U.S.
    universities to train experts to carry out research in general
    informatics and in the genome-related specialty of bioinformatics. NLM
    plans to augment some of these training programs with additional
    resources so that they can make use of the advantages they already
    enjoy: experienced faculty, curricula, sanctioned university status,
    and ready access to potential candidates. NLM envisions expanding the
    program beyond 12 centers with the addition of training awards to new
    institutions.
        To ensure that the Internet will continue to support the health
    sciences, the NLM is a strong supporter of the Next Generation Internet
    (NGI), a partnership of industry, academia, and government agencies
    that seeks to provide affordable, secure information delivery at rates
    thousands of times faster than today. Advanced medical imaging, for
    example, requires more bandwidth than is currently available. Other
    applications require a guaranteed level of service (for example no data
    loss, or assured privacy protection) that today's Internet cannot
    provide. To help the health sciences prepare to use the capabilities
    the next few years will bring, the Library is supporting the
    development of innovative medical test-bed projects that demonstrate
    the application and use of the capabilities of the Next Generation
    Internet. Spread out over three phases, the support includes a variety
    of telemedicine-related projects, advanced medical imaging, and
    patient-controlled personal medical records systems. In the last phase
    there will be a scale-up of especially promising projects to regional
    or national level.
        The Visible Human Project is an example of a program that requires
    both advanced computing techniques and the capability of the Next
    Generation Internet. The two very large datasets of anatomical data
    represented by the Visible Human Male and Female are being used
    (without charge) by 1,240 licensees in 41 countries, and at four mirror
    sites in Asia and Europe. In addition to the varied uses to which these
    licensees are applying the data (for example, recyclable cadavers,
    virtual colonoscopies, and brain surgery rehearsal), the Library is
    seeking to create a public software ``toolkit'' that will allow anyone
    to use the data to ``create'' any anatomical object. A collaborative
    project of the NLM, in partnership with several NIH Institutes and the
    National Science Foundation, is extending the Visible Human Project by
    developing an extremely detailed atlas of the head and neck.
                              genetics of medicine
        As a result of the accelerating pace of research, the GenBank
    database of DNA sequence information maintained by NLM's National
    Center for Biotechnology Information is growing to gargantuan sizes. It
    now contains some 5 million sequences with a total of nearly 5 billion
    base pairs, and the NCBI Web site, where GenBank is made freely
    available, receives some 800,000 queries per day from 120,000
    scientists and others around the world. In addition to academic
    institutions, major biotechnology and pharmaceutical firms are among
    the heaviest users of the NCBI Web site. They not only search GenBank,
    but use NCBI-created computational tools such as that which allows
    researchers to use the growing body of known 3-dimensional structures
    to infer approximate 3D sequence structure from similarity
    relationships. NCBI scientists have also collaborated with 64
    colleagues from government, university, and commercial laboratories
    around the world to produce a new ``gene map'' that pinpoints the
    chromosomal locations of almost half of all human genes. This milestone
    in the Human Genome Project, available on the Internet, will expedite
    the discovery of human disease genes and by extension, contribute to
    advances in detection and treatment of illnesses.
                                 basic services
        Despite the NLM's extensive involvement with computer and
    communications technology, the staff is ever mindful of its
    responsibility to maintain the integrity of the world's largest
    collection of medical books and journals. Increasingly, this
    information is in digital form, and the NLM, as a national library
    responsible for preserving the scholarly record of biomedicine, is
    developing a strategy for selecting, organizing, and ensuring permanent
    access to digital information. Regardless of the format in which the
    materials are received, ensuring their availability for future
    generations remains the Library's highest priority. The expanding NLM
    collection and research and development programs continue to put
    pressure on current NLM storage capacity. The issue of NLM space needs
    will be considered as NIH revises its Master Plan. In the meantime, NIH
    has assigned NLM space in the Natcher Building, located adjacent to the
    NLM Building to address the immediate needs as longer term options are
    developed and evaluated.
        The NIH budget request includes the performance information
    required by the Government Performance and Results Act (GPRA) of 1993.
    As our performance measures mature and performance trends emerge, the
    GPRA data will serve as indicators to support the identification
    strategies and objectives to continuously improve programs across the
    NIH and the Department.
        My colleagues and I will be happy to respond to any questions you
    may have.
                                     ______

                    Prepared Statement of Dr. Neal Nathanson
        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the AIDS research programs of the
    National Institutes of Health for fiscal year 2001, a sum of
    $2,111,224,000, an increase of $105,041,000 above the comparable fiscal
    year 2000 appropriation. NIH budget request includes the performance
    information required by the Government Performance and Results Act
    (GPRA) of 1993. Prominent in the performance data is NIH's first
    performance report which compares our fiscal year 1999 results to the
    goals in our fiscal year 1999 performance plan. As our performance
    measures mature and performance trends emerge, the GPRA data will serve
    as indicators to support the identification of strategies and
    objectives to continuously improve programs across the NIH and the
    Department.
        The Office of AIDS Research (OAR) is responsible for setting the
    scientific agenda for the large and diverse NIH AIDS research program.
    To this end, we develop the annual AIDS research plan and budget, based
    on the most compelling scientific priorities that will lead to better
    therapies and prevention for HIV infection and AIDS. Those priorities
    are established through a collaborative process involving the NIH
    institutes and non-government experts from academia and industry as
    well as the full participation of the AIDS-affected community.
        Mr. Chairman, at our hearings here last year initiated
    unprecedented attention on the international dimension of the AIDS
    epidemic. Your support and attention to critical global needs at those
    hearings were a catalyst for efforts that have increased throughout the
    year. In January, the United Nations Security Council declared that
    AIDS is now a national security issue, representing a new kind of
    threat to political stability. AIDS in Africa is killing ten times as
    many people as war, sabotaging economic development, leading to massive
    social breakdown, and creating a generation of orphans. Ambassador
    Richard Holbrooke called AIDS ``a direct, cancerous growth on the
    political, social, and economic security of Africa.''
                            the unrelenting pandemic
        By every definition, AIDS is the great plague of the 20th century--
    an epidemic of biblical proportions. (Chart 1) AIDS already has killed
    more than 16 million people, surpassing tuberculosis and malaria as the
    leading infectious cause of death worldwide, according to recent data
    from the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the
    World Health Organization (WHO). In 1999, a record 2.6 million people
    died from AIDS--more than in any prior year. UNAIDS estimates that in
    India between 3 and 5 million people are infected, with new infections
    doubling every 14 months. New epidemics are rapidly increasing in
    Russia, Eastern Europe, and in China. AIDS remains a serious threat in
    Latin America and the Caribbean. Africa (Chart 2) remains the epicenter
    of the pandemic, bearing the largest disease burden, with 70 percent of
    people living with AIDS worldwide, 83 percent of global AIDS deaths,
    and 95 percent of the world's AIDS orphans. HIV-infected women aged 15
    to 49 outnumber infected men. In Harare, the capital of Zimbabwe, 40
    percent of adults are HIV-infected. The impact of AIDS on developing
    nations and many former communist countries is staggering, with even
    greater potential disaster to come. AIDS is reversing decades of
    progress from important public health efforts, lowering life
    expectancy, and significantly affecting international businesses. Lost
    productivity and profitability, the cost of sickness and death
    benefits, and the decline in a skilled workforce in the developing
    world will have economic effects worldwide. AIDS is affecting the
    military capabilities of some countries as well as the international
    peacekeeping forces.
                   the evolving epidemic in the united states
        In the U.S., the incidence of new AIDS cases has declined, thanks
    largely to expanded use of new antiretroviral therapies that prevent
    progression of HIV infection to AIDS. The previous decline in death
    rates has now leveled off. The state of Illinois just announced a 24
    percent increase in AIDS cases in 1999. Most significantly, the annual
    incidence of new HIV infections has not declined since 1990 (Chart 3).
    This means that although therapeutic interventions are delaying death,
    at least for a time, we have not slowed the epidemic. Chart 4 shows
    that HIV infection rates are continuing to climb in two major groups--
    women and minorities. Rates are also increasing in young homosexual men
    and people over 50 years of age. AIDS affects the disenfranchised in
    our society--the poor, the homeless, and those with addictive or mental
    disorders. Further, drug resistant strains of HIV present a serious
    public health concern.
        These data forebode an epidemic of even greater magnitude ahead,
    and shape our most urgent research priorities. These priorities (Chart
    5) address two critical populations--those living in developing
    countries, and the minority populations of the U.S.--with a two-pronged
    agenda: therapeutic research to treat those who are already infected;
    and prevention research to reduce HIV transmission. Our prevention
    agenda includes both vaccine and non-vaccine strategies, such as
    behavioral research, development of topical microbicides, and
    prevention of perinatal transmission.
                        priority: international research
        We are increasing our international AIDS research porfolio. As more
    than 90 percent of new infections occur in developing countries, where
    therapeutic interventions are unaffordable and undeliverable, NIH is
    pursuing interventions that can be implemented in these resource--and
    infrastructure-deprived nations. I will cite just a few examples. A
    recent NIAID-sponsored clinical trial in Uganda demonstrated that
    nevirapine, an antiretroviral drug costing less than $4, given once to
    the mother and once to the baby at birth, could reduce mother-to-child
    transmission by 50 percent. The NIH vaccine research effort underscores
    the crucial role of NIH in addressing prevention needs worldwide.
    Clinical trials within both the new NIAID Vaccine Trials Network and
    Prevention Trials Network are expected to involve international sites.
    The OAR is supporting the first international conference on
    microbicides to stimulate new research initiatives in this critical
    area. To further our efforts and enhance international collaboration,
    the Fogary International Center is expanding its research and training
    programs in many developing nations. The OAR fiscal year 2002 annual
    plan, which we are now developing, includes a special section for
    international research, and we have established an International AIDS
    Research Collaborating Committee to bring together all of the
    Departments of the U.S. government conducting AIDS research, along with
    international partners such as the UNAIDS and the World Bank.
               priority: health disparities in the united states
        The disproportionate impact of the HIV/AIDS epidemic on U.S.
    communities of color is demonstrated graphically on Chart 6. AIDS
    remains the number one cause of death among young African American men.
    OAR established a new group, the Ad Hoc Working Group on Minority
    Research, to advise us on the scientific priorities in this critical
    research area, and we added a new section to our plan on research
    targeting minorities. We are directing increased resources toward new
    interventions that will have the greatest impact on these groups,
    including those that address co-occurrence of other STDs, hepatitis,
    drug abuse, and mental illness, and interventions that consider the
    role of culture, family, and other social factors in the transmission
    and prevention of these disorders in minority communities. NIH is
    making significant investments to improve research infrastructure and
    training opportunities for minorities, and we will continue to assure
    the participation of minority subjects in AIDS clinical trials as well
    as natural history, epidemiologic, and prevention studies. In
    accordance with the Congressional Black Caucus initiative, the OAR has
    provided additional funds to projects aimed at: increasing the number
    of minority investigators conducting behavioral and clinical research;
    targeting the links between substance abuse, sexual behaviors and HIV
    infection; increasing outreach education programs targeting minority
    physicians and at-risk populations; and expanding our portfolio of
    population-based research. We estimate that with this budget request,
    NIH will devote approximately $427 million to research targeting AIDS
    in minority community communities.
                           priority: better therapies
        The development of protease inhibitors has had a significant impact
    on the length and quality of life for many HIV-infected people in the
    U.S. But the news in this area is not good. At the recent scientific
    meeting on retroviruses, the overriding theme was the long and serious
    list of problems for patients receiving these HIV therapies, including:
    (1) failure to obtain a satisfactory reduction in viral load even for
    patients who comply with treatment regimens; (2) expensive and
    complicated regimens that make compliance difficult; (3) drug
    toxicities; (4) metabolic and cardiac complications, including
    diabetes; and 5) drug resistance. We must develop and test new,
    simpler, less toxic, and cheaper anti-HIV drugs. Chart 7 summarizes our
    key priorities to accomplish that goal: (1) develop new targets for the
    design of new antiviral drugs; (2) conduct clinical trials to answer
    key questions such as: At what point in the disease process should
    therapy be initiated and which combination of drugs should be used? At
    what point should the drugs be switched and to which drugs? How can
    toxicities and drug resistance be prevented? How can regimens be
    simplified and compliance improved? and (3) translate research results
    into clinical practice information that is useful to caregivers and
    their patients, particularly in minority communities.
                            priority: hiv prevention
        NIH supports a comprehensive approach to HIV prevention research
    that includes contributions from the biomedical, behavioral, and social
    sciences. The OAR prevention science research agenda (Chart 8) targets
    interventions to both infected and uninfected at risk individuals to
    reduce HIV transmission. In addition, different strategies must be
    applied to each subepidemic in the US and around the world. Our
    biomedical prevention research priorities include areas such as the
    development of topical microbicides for women; perinatal prevention
    strategies, including understanding of breast-feeding risk; and
    management of sexually transmitted diseases that enhance risk of HIV
    transmission. NIH also supports behavioral research strategies,
    including prevention interventions related to drug and alcohol use. We
    are focusing efforts on infected individuals who may not know they are
    infected, but in addition, data suggest that some HIV-infected
    individuals successfully responding to therapy believe that they are
    less infectious and that they cannot be reinfected. As a result, they
    may re-engage in risky behaviors. Thus NIH is supporting research to
    develop HIV prevention interventions targeted to HIV-infected
    individuals.
                               priority: vaccines
        A safe and effective vaccine is the critical missing element in our
    armamentarium. In 1997, the President challenged the nation to develop
    an AIDS vaccine. Consistent with this challenge, NIH has moved forward
    aggressively to build a comprehensive vaccine research enterprise.
    Funds in this request represent more than a 100 percent increase in NIH
    vaccine research since fiscal year 1997. These funds will provide new
    grants to foster innovative HIV vaccine research and allow the
    invigoration and reorganization of the NIH vaccine clinical trials
    effort. The new Dale and Betty Bumpers Vaccine Research Center will be
    occupied this summer. Dr. David Baltimore continues to chair the AIDS
    Vaccine Research Committee which advises the NIH on the overall vaccine
    program. In February 1999, NIH-supported investigators initiated the
    first AIDS vaccine trial in Africa. In collaboration with industry
    partners, NIH has now tested 28 different HIV vaccine candidates,
    individually or in combinations, in over 3000 uninfected volunteers.
    Several new vaccines, including vaccines designed to induce mucosal
    immunity, novel DNA vaccines, and more complex vaccines presenting
    several viral proteins, have entered phase I trials. In addition,
    recent studies of ``therapeutic vaccines'' that do not prevent
    infection, but can prevent or delay disease progression in animal
    models has offered opportunities for additional vaccine strategies.
        There have been significant incremental advances in the development
    of an AIDS vaccine. A number of candidate vaccines have been formulated
    for use in rhesus monkeys where they can be tested for their ability to
    protect against a ``challenge'' with a simian immunodeficiency virus
    that has been shown to produce AIDS in these animals. This permits the
    rapid testing of the potential protective efficacy of vaccine concepts.
    The left part of Chart 9 shows the blood levels of two groups of
    monkeys, one vaccinated and one given a placebo control. The vaccinated
    monkeys had a much reduced infection, with a much better survival than
    the control group. Protection of this magnitude has been seen with
    several candidate vaccines. The right part of the chart shows one of
    the most recent vaccines that has been tested in humans for its ability
    to produce immune responses. Both versions of the vaccine induced the
    production of antibodies and cellular immune responses (CTLs), but only
    in a proportion of immunized subjects. Although this was not a trial of
    effectiveness, the subjects were followed for HIV infections. There
    appeared to be about half as many infections in the immunized subjects,
    although the numbers were too small to be statistically significant.
    Results of this kind are encouraging and lead us to hope that full
    scale trials of vaccine effectiveness may begin in humans in the next
    few years.
                       benefits to other disease research
        AIDS research is unraveling the mysteries surrounding many other
    infectious, malignant, neurologic, autoimmune and metabolic diseases.
    AIDS research has provided an entirely new paradigm for drug design and
    development to treat viral infections. One example this year was the
    development of the new flu drug, Relenza, which directly benefited from
    AIDS research. The drug known as 3TC, developed to treat AIDS, is now
    the most effective therapy for chronic hepatitis B infection. Drugs
    developed to prevent and treat AIDS-associated opportunistic infections
    also provide benefit to patients undergoing cancer chemotherapy or
    receiving anti-transplant rejection therapy. AIDS is also providing new
    understanding of the relationship between viruses and cancer.
                                    summary
        The transmissible nature of HIV--between individuals and across
    borders and populations--makes it radically different from non-
    transmissible diseases such as heart disease and cancer. There is the
    potential for unlimited spread, and also the possibility for a dramatic
    reduction in new infections--and thus ultimate control of the
    pandemic--in a way that can never be possible for noninfectious
    diseases. The impact of an intervention that reduces the probability of
    transmission, breaking the link in the epidemic chain, extends far
    beyond the treated or protected individual.
        We have made enormous strides in our fight against this horrible
    disease, but these were only small skirmishes in a major global war. As
    this Committee clearly recognizes, our progress will be meaningless
    unless we can make the benefits of our research findings available to
    populations desperately in need both here in our own country and around
    the world. The worldwide human and economic toll of this insidious
    disease is profound, and we will never solve the problem of AIDS for
    our own citizens without controlling the epidemic in the rest of the
    global village. We cannot afford to leave anyone behind.
        We are deeply grateful to the Committee for your steadfast support.
    I would be pleased to respond to any questions you may have.

                               President's budget

        Senator Specter. Well, thank you very much, Dr.
    Kirschstein. You say you are happy to present the President's
    budget. You are honored to present the President's budget.
    Well, what was the increase he requested?
        Dr. Kirschstein. 5.6 percent.
        Senator Specter. How much of that is in dollars?
        Dr. Kirschstein. The increase in dollars is $1 billion.
        Senator Specter. So you are honored to present a request
    for an increase of $1 billion.
        Dr. Kirschstein. Yes, sir.
        Senator Specter. I am just kidding with you a little here.
        Dr. Kirschstein. I know.
        I also said I was honored to appear before you.
        Senator Specter. Would you be more honored to receive an
    increase of $2.7 billion?
        Dr. Kirschstein. I certainly would.
        Senator Specter. I mean, if it is just a question of honor,
    I want to get the issue straight.

                                Research Grants

        What percentage of applications are recipients and grants?
        Dr. Kirschstein. We will fund the largest total of research
    grants we have had ever. But the percentage that we will be
    funding varies between institutes, but will be an overall of
    about 26 percent.
        Senator Specter. Well, the percentage of grants then has
    not increased in the past, say, 3 years as more than $5 billion
    has been added to the NIH budget. Is that correct?
        Dr. Kirschstein. It has increased somewhat over the last 3
    years. It was less than the level that I gave you several years
    ago.
        Senator Specter. Well, I heard several years ago, 3, 4
    years ago, a figure of 28 to 34 percent. And now you are saying
    that there are 26 percent. And of course the question is: Are
    you getting a lot more grant applications?
        Dr. Kirschstein. We are getting a lot more grant
    applications, but there are other reasons as well.
        Senator Specter. What are those reasons?
        Dr. Kirschstein. Well, in the years during which the NIH
    budget was constrained, the level of funding for each
    individual grant was constrained as well.
        And we felt, as our funds were increased, that it would be
    important for us to try to provide each investigator all of
    whom are being funded to do and are doing superb work, and that
    is why we are funding them, an amount of money closer to what
    their peers in the review process had suggested that they are
    able to use appropriately. And so we have tried to provide, as
    much as possible with the increased funds, full funding for the
    research grants.
        In addition, we know by the way science has been changing
    that it is very important to begin to provide our
    investigators, and they have actually asked us, with certain
    resources that are not necessarily required in each individual
    grant budget: Databases; banks of nucleic acids and proteins
    from which they can draw from to enhance their own research;
    information systems; instrumentation; very large instruments
    which they can share.
        So we have used our funds not only to provide individual
    investigators with the ability to do work, but provide them
    with the resources that are needed.
        Senator Specter. When you say that 26 percent of the
    applications receive grants, can you give us an estimate, a
    judgment, on how many of the balance of 74 percent which do not
    receive grants are meritorious and, under ideal circumstances,
    should receive grants?
        Dr. Kirschstein. In the past, we considered that about one-
    third of all the grants, 33, 34, 35 percent, would be an
    appropriate number to strive for. However, recently the
    institute directors and I have discussed this. And in many
    cases, we feel that the number could go even higher, up to 40
    or so percent, and meritorious science would continue to be
    funded.
        Senator Specter. What would it take by way of NIH budget to
    fund, say, 40 percent of the applications?
        Dr. Kirschstein. It would take about $2 billion more, not
    quite.
        Senator Specter. $2 billion on top of your current budget?
        Dr. Kirschstein. Not quite, but almost.
        Senator Specter. So if we come in with $2 billion more----
        Dr. Kirschstein. No. $2 billion more on top of the 2000
    budget.
        Senator Specter. On top of the 2000 budget.
        Dr. Kirschstein. Yes.
        Senator Specter. The 2000 budget is right at $17.9 billion.
        Dr. Kirschstein. Yes. The 2000 budget is $17.9 billion. You
    are correct.
        Senator Specter. So if we gave you $2 billion more, you
    could increase grant of applications from 26 percent to 40
    percent.
        Dr. Kirschstein. Closer to one-third.
        Senator Specter. Well, OK. Now answer my 40 percent
    question.
        Dr. Kirschstein. I think that would take more, and I am not
    absolutely sure. I will try to work that out.
        Senator Specter. Well, the subcommittee would like as
    precise an evaluation as you can give us on how many of those
    applications are meritorious. We always talk about opening up
    those closed doors. And then we would like to know what it
    would cost to do that.
        My own sense is that the potential for medical research is
    phenomenal, life saving. The most important asset we have is
    our health. So we would like to know what the maximum is and
    see if we cannot do something about that.
        Dr. Kirschstein. Each of the institute directors has
    provided information to that effect. And we will ask them to
    provide even more for you. And we will try to provide it in
    total.
        Senator Specter. Well, maybe we will just take the time to
    go around the room, giving you a little notice. And the
    questions I would like to have answered are: Current budget,
    what percent of the applications are granted? How many are
    meritorious, would you like to grant? And what would that cost?
        Sometimes we do not really get the answers later in
    writing. And sometimes when we get the answers, we do not read
    them.
        So let us try that this morning.
        I want to yield now to my distinguished ranking member,
    Senator Tom Harkin.
        In your absence, I was saying good things behind your back,
    Tom. So beware.
        Senator Harkin. I have to be careful about that now.

                    OPENING STATEMENT OF SENATOR TOM HARKIN

        Senator Harkin. Thank you very much, Mr. Chairman. And
    thank you for your great leadership on this committee, but
    especially as it deals with NIH funding. I was proud to join
    you last year in your great effort to secure a historic
    increase for NIH. And I am proud to join you again this year,
    hopefully for another historic increase in NIH funding.
        I also want to thank Dr. Kirschstein for her leadership at
    NIH, for always being there when we needed someone to take the
    helm, especially one--as I figure, you have been there 44
    years.
        Dr. Kirschstein. That is correct.
        Senator Harkin. And I want to thank you for 44 years of
    service to our country and beyond that, I guess, service to all
    humankind in terms of biomedical research. I think you are a
    great example, I hope, to a lot of young people today as to
    what research affords and what it can mean in terms of
    contributions they could make, if they were to stay in
    research.
        That is one of the reasons that I hope that we can continue
    to increase this funding for NIH and get it doubled in 5 years,
    as Chairman Specter has set the course to do, and that is to
    let a lot of young people know today that they can have a
    career in research, a good career in research.
        So I compliment you for that and, through you, to all of
    the institute directors who are here today and to thank each
    one of them, each one of you, for all of your work and your
    leadership in the area of medical research.

                               prepared statement

        With that, I would just ask that my statement be made a
    part of the record, Mr. Chairman.
        Senator Specter. It will be made a part of the record
    without objection.
        [The statement follows:]
                    Prepared Statement of Senator Tom Harkin
        Mr Chairman, I want to thank you for holding this hearing today and
    I want to welcome Dr. Kirschstein and her colleagues from NIH who are
    testifying before us today. NIH is the premier medical research
    institution in the world--research funded by NIH is key to maintaining
    the quality of our health care and key to finding preventive measures,
    cures and the most cost effective treatments for the major illnesses
    and conditions that strike Americans.
        But I must say that the timing of this hearing is interesting.
    Yesterday, the Senate Budget Committee marked up a budget resolution
    that cuts nondefense discretionary spending from last year. Nondefense
    discretionary spending is cut by $7 billion from a freeze! Last year,
    this subcommittee was able to secure a $2.3 billion increase for NIH--
    the second year in an effort to double NIH funding over five years. Mr.
    Chairman, as you know, you and I introduced legislation earlier this
    year calling for a $2.7 billion increase for NIH in fiscal year 2001--
    building on last year's increase for NIH as we move to doubling funding
    for NIH over a five-year period.
        But, it is going to be next to impossible to find that money with a
    cut in our allocation this year. But, Mr. Chairman, I know you will
    find a way--it's times like this that I'm glad you are the Chairman.
        One, but certainly not the only, reason that we must continue this
    support for medical research at NIH is the truly awe-inspiring
    potential benefits of stem cell research. This Subcommittee has held a
    number of hearings on the issues surrounding stem cell research. At
    those hearings, I have had the opportunity to express my support for
    this research. Now it is time to move forward. Dr. Kirschstein, I
    understand that the comment period has closed on the stem cell research
    guidelines--I expect that you will keep me updated on how you intend to
    encourage and support quality, ethically-sound research in this area
    over the coming months.
        I am also excited about the progress made on the Human Genome
    project. I see from Dr. Collins' testimony that scientists will
    complete the human genome sequence in 2003, two years ahead of the
    original schedule. I really believe that effort will results in a
    number of scientific breakthroughs in over the next ten years.
        Thank you, Mr. Chairman--I look forward from hearing from our
    witnesses.

        Senator Harkin. I do have several questions. I hope we have
    another round, because I am not going to get them all in in 5
    minutes, Mr. Chairman.
        Senator Specter. Sure.

                               Stem Cell Research

        Senator Harkin. There are about three areas I want to
    cover. One is stem cells. I want to cover Francis Collins with
    the genome research. And the other one is with the National
    Institute of Drug Abuse, NIDA, on methamphetamine. And maybe
    one other question on complementary and alternative medicine.
    Those are basically the areas I want to cover.
        Let us start with stem cells first, Dr. Kirschstein. I
    understand that NIH has issued draft guidelines for the funding
    of stem cell research. And the comment period on those
    guidelines ended on February 22.
        Can you give us some idea of when you will be finished
    reviewing those comments and be ready to issue a final
    regulation? And do you think there will be any changes to the
    proposed guidelines?
        Dr. Kirschstein. Mr. Harkin, first of all, thank you for
    your very kind remarks.
        The comment period, as you said, did close on February 22.
    And the staff is working very hard now to analyze all the
    comments--there were a considerable number--and to decide what
    needs to be changed about the guidelines. They will be revised.
    And we are working on that at the present time.
        In addition, once the guidelines are published, we also
    want to have an oversight group in place to be able to review
    all the proposals related to the use of stem cells.
        And so what we propose is that we put out the final
    guidelines at the same time as we have such an oversight group
    in place. And then we would be ready to go. We would anticipate
    doing so sometime in the early summer.
        Senator Harkin. Well, I am a little--I appreciate the time
    frame. Early summer, I hope that means--when does summer start,
    in June? June 21.
        But I am a little concerned about what I thought I heard
    you say, and that is that there would be some revisions to the
    proposed guidelines. And that has raised my level of concern.
        Dr. Kirschstein. No. The revision is based on the comments
    and what we think are in the comments that could clarify and
    refine what the guidelines will say. The basic aspects of the
    guidelines will remain the same.

                        Stem Cell Research and Diabetes

        Senator Harkin. OK. I appreciate that. Then my concern has
    been alleviated.
        I understand that at the University of Alberta in Edmonton
    seven individuals with juvenile diabetes have remained free of
    insulin injections for close to a year after receiving
    transplants of insulin-producing cells.
        I use that only as an example, but how does NIH plan to
    capitalize on this potential breakthrough? And what role might
    stem cells play in the future of this kind of research?
        Dr. Kirschstein. Senator Harkin, if I may, I would like to
    ask Dr. Spiegel, the new director of the National Institute of
    Diabetes, Digestive and Kidney Diseases, to answer that
    question.
        Senator Harkin. That would be great.
        Dr. Spiegel. Thank you, Dr. Kirschstein.
        The protocol you referred to, Mr. Harkin, the Edmonton
    Protocol, has indeed been successful for this period of 1 year.
    In collaboration with the National Institute of Allergy and
    Infectious Diseases' Immune Tolerance Network, that protocol
    will be expanded to multiple centers, which in turn hope to
    derive the islets that need to be produced at the NCRR harvest
    centers. NIDDK has also funded about $3.5 million worth of new
    trials on other protocols for islets transplants.
        As far as stem cells are concerned, it is clear that if
    this is, as we hope, successful, there will be a tremendous
    need for additional sources of insulin-secreting beta cells.
        Recent work in mice, published in Nature, indicated that
    one can harvest such stem cells from the pancreas and that they
    can cure diabetes. We will have a workshop of stem cell experts
    on April 10 through 11, which will explore all the possible
    avenues.
        And we are optimistic that there will be real opportunities
    for breakthroughs that will bring these clinically exciting
    trials, as well as stem cell technology, together.
        Senator Harkin. Can you elaborate a little bit more? This
    has been one year that they have. Is there any indication that
    there is any kind of rejection or that they may have to fall
    back on insulin injections? What can you enlighten me about the
    present state of that protocol?
        Dr. Spiegel. I would like to put it in historical
    perspective. Dr. Lacey at Washington University was a pioneer
    in this area and over 20 years ago made the first attempts at
    islet transplants in humans.
        Unfortunately, only perhaps 1 out of 300-and-some-odd
    patients in the world remained insulin independent after
    treatment. So there were dismal failures up to now. This is why
    this is so promising.
        And it relates both to the better methods of harvesting the
    islets from donor pancreases, as well as novel techniques which
    derive from basic immunology research. They are using a
    monoclonal antibody that targets a particular T-cell receptor
    and a drug called Rapimycin.
        Now, unfortunately, this is still not what we want to
    achieve. We would like to achieve complete absence of
    immunosuppressive drugs, be able to have the patient treated
    during the transplant and then need no further medication. And
    indeed, there are studies both in mice and in nonhuman primates
    indicating this can be achieved.
        Currently, these individuals in Edmonton have not had their
    medications removed. So it is too early to tell if they will be
    able to achieve a state of immune tolerance. But we are very
    optimistic that that could be the case.
        Senator Specter. Let us return to this in just a moment,
    because Senator Cochran has to chair another hearing. And we
    want to hear from him.

                   OPENING STATEMENT OF SENATOR THAD COCHRAN

        Senator Cochran. Well, thank you very much, Mr. Chairman. I
    want to join you in welcoming Dr. Kirschstein and the directors
    of the NIH who are appearing here today. It is good to see Dr.
    Klausner and to thank him for his trip to my State.
        I appreciate what Dr. Kirschstein and the NIH do for our
    Nation's health. The NIH has excelled in the stimulation and
    support of medical research. Their efforts have involved both
    the basic scientific research needed to understand disease and
    treatment, and the translational research needed to support
    clinical practice, and to reach the ultimate goal of improving
    the treatment of, and achieving the prevention of disease.

                               prepared statement

        There are other comments that I have prepared as an opening
    statement and some questions, which I ask, Mr. Chairman, be
    printed in the record and submitted for answering for the
    record. And I apologize for having to go to chair another
    meeting and not being able to stay for the full period of this
    hearing.
        Thank you all for what you do.
        Senator Specter. Well, Senator Cochran, thank you very much
    for joining us. We know you are chairing another hearing. And
    your full statement and questions will be in the record and
    submitted for responses. Thank you.
        [The statement follows:]
                   Prepared Statement of Senator Thad Cochran
        Mr. Chairman, I want to thank Dr. Kirschstein and the directors of
    the NIH's institutes for appearing here today. It is good to see Dr.
    Klausner and thank him for his trip to my state. I what all of you do
    for our nation's health. The NIH has excelled in the stimulation and
    support of medical research. Their efforts have involved both the basic
    scientific research needed to understand disease and treatment, and the
    translational research needed to support clinical practice, and to
    reach the ultimate goal of improving the treatment of and achieving the
    prevention of disease.
        The NIH has invested in the future of our nation's health by
    addressing areas of need including chronic diseases and health outcome
    disparities among minorities, those who live in rural communities and
    other under served populations. Some of these initiatives have taken
    place in Mississippi. The NIH continues to invest in the Jackson Heart
    Study, one of most significant cardiovascular studies of the African-
    American population.
        I am also very interested the ongoing efforts of NIH to increase
    opportunity and expand funding for projects like the Jackson Heart
    Study, in states such as Mississippi, that have not been traditional
    NIH research centers and that have lacked NIH research funding are also
    the areas with a high prevalence of chronic diseases.
        I applaud the efforts of NIH to address not only the issues of
    today, but also the issues of tomorrow. Only through foresight and
    planning can we avert the epidemics of the future. For example, the NIH
    has been alert to problems such as infectious disease research and the
    growing problem of antimicrobial resistance.
        NIH has also had the foresight to address diseases that are
    sometimes overlooked. One of those areas is Parkinson's Disease, a
    disease sometimes overshadowed by other more high profile diseases. In
    fact, I am hosting a briefing next week to support the National
    Institute of Neurological Disorders and Stroke strategic plan to
    develop a cure for Parkinson's.
        I appreciate your efforts in each of these areas. I look forward to
    assisting you as you continue your important work.

        Senator Specter. Senator Feinstein.
        Senator Feinstein. Thank you very much, Mr. Chairman.
        And I would like to say welcome to all of you.
        Particularly for Dr. Klausner, you know this last year on
    the National Cancer Dialogue has been very interesting to me.
    And I have learned a great deal.
        I have a statement, if I may, Mr. Chairman, to be entered
    into the record.
        Senator Specter. Without objection, it will be made a part
    of the record in full.
        Senator Feinstein. Thanks very much.
        [The statement follows:]
                 Prepared Statement of Senator Dianne Feinstein
        Thank you, Mr. Chairman, for holding this important hearing.
        The American people put a great deal of hope and faith in the
    National Institutes of Health. NIH is truly a symbol of our national
    strength and the world's leading medical research institution. NIH has
    produced 93 Nobel Prize winners and I come from a state that has world-
    renowned research entities that work closely with NIH.
        I have been pleased to work with NIH and this subcommittee to
    increase NIH funding in recent years, including the 15 percent increase
    we were able to provide each year for the past two years. It is a sad
    commentary that NIH can only fund around 32 percent of grant
    applications. Fortunately, that ``success rate'' has gone up since 1994
    when it was only 25 percent, but still, the many unfunded grants leaves
    a vast wealth of scientific knowledge unexplored and hundreds, if not
    thousands of diseases and disorders, uncured or untreated.
        The challenges facing our nation are huge.
      --By 2010, the incidence of cancer will reach ``staggering
            proportions,'' with an increase of 29 percent in incidence and
            25 percent in deaths, at a cost of over $200 billion per year.
      -- AIDS is now the leading cause of death among Americans ages 25 to
            44.
      --Rates of diabetes and asthma are rising.
      --Seven to 10 percent of children are learning disabled. Forty
            thousand babies die each year from devastating diseases.
      --Our aging population presents formidable challenges, from
            understanding overwhelming diseases like Alzheimers to helping
            people have quality of life as they have a longer life.
        I am sure the decision to fund one area means not funding another
    and that NIH decision-makers must feel pulled in every direction.
                               cancer challenges
        As a co-chair of the Senate Cancer Coalition, I have been working
    closely with the national cancer community for several years and would
    like today to raise some of the concerns that are brought to my
    attention. I hope everyone will understand that these are not intended
    as criticism of NIH or any institute or individual, but are challenges
    for our nation as identified by experts.
        The Discovery to Delivery Disconnect.--Dr. Harold Freeman, Chairman
    of the President's Cancer Panel, on March 8 made a presentation in
    which he expressed his concerns about a disconnect between the fruits
    of research and routine medical practice. He explained that we have
    made great strides in understanding disease origins, but said we must
    do better in incorporating research findings into routine practice. Can
    we do better? If so, how?
        The National Cancer Institute is a research institution. It is not
    a HCFA or Medicare or health care delivery agency. It was never
    designed to be a delivery system for health care. Even so, can't we do
    better in connecting this disconnect?
        The Unequal Burden of Cancer.--The Institute of Medicine last year
    issued a report on disparities in cancer care concluding, ``Despite
    scientific gains, not all segments of the U.S. population have
    benefitted to the fullest extent from advances in the understanding of
    cancer.'' In October, the New England Journal of Medicine reported on a
    study of 11,000 lung cancer patients which found that blacks are less
    likely than whites to get surgery for early stages of lung cancer. The
    study ruled out reasons like socioeconomic status, insurance, and
    access to care and implied that the reason could be a breakdown in the
    doctor-patient relationship.
        Unevenness of Cancer Care.--The Institute of Medicine also reported
    last year that ``there is a wide gulf between what could be construed
    as the ideal and the reality'' of cancer care, that some patients do
    not get care that is proven to be effective and the problem is
    ``substantial.'' The study said that having health insurance improves
    access, but it does not guarantee good care.
        The Declining Investigator ``Pipeline.''--The number of physician-
    scientists in oncology is diminishing at a time when knowledge and
    discovery are expanding rapidly. Funding at NCI for investigator
    training was only 3.1 percent of NCI's budget in 1999. The number of
    postdoctoral M.D. trainees in all fields funded by NIH overall has
    declined 51 percent of 6 years according to a study in Science. This is
    exacerbated by the growth in managed care plans that do not contract
    with academic medical centers where the bulk of research and training
    are conducted.
        ``This tragic phenomenon is jeopardizing the future of cancer
    research discovery and translation and the future of an America in
    which cancer is a treatable, beatable disease,'' says the National
    Coalition for Cancer Research.
        The Salary Cap.--Since the early 1990s, Congress has placed a
    ``salary cap'' on extramural researchers, those scientists in
    laboratories, like the University of California. The cap is a top
    salary limit of $141,300, even though senior scientists on the NIH
    Bethesda campus can earn up to $157,000. This cap has the effect of
    driving talented researchers to the private sector. We should be trying
    to attract and retain talented researchers to our universities, not
    create incentives that drive them away.
        Clinical Trials.--Only two percent of cancer patients are enrolled
    in clinical trials and of those, only 25 percent are elderly, even
    though cancer is disproportionately a disease of aging and the median
    age of cancer diagnosis is 68, according to the Cancer March of 1998.
    Last year, this committee asked NIH to send us a report on identifying
    barriers to participation in trials and recommendations for eliminating
    barriers. I hope you have good news for us today on that report.
        The American people have said they would contribute another $1.00
    per week in taxes for medical research. The public is behind NIH. This
    is indeed encouraging and I pledge to help NIH meet the many medical
    challenges that face our society.
        I look forward to working with you to address these challenges to
    improve the health and quality of life of millions of Americans.

                          Bench to Bedside Application

        Senator Feinstein. One of the things that I have become
    increasingly concerned about is the kind of disconnect that
    exists between discovery and application from the laboratory to
    the bedside. Some say it takes 5 years to get from a mouse to a
    human.
        Somebody you know well, Dr. Helene Brown of the UCLA Cancer
    Center, points out that the pap smear was ready for widespread
    use in 1940, but was not really used until 1960. 20,000 women's
    lives a year were unnecessarily claimed over the 20 years of
    this delay.
        My first question to any who care to answer is: How can we
    shorten this disconnect? How can we get things from the
    laboratory to the patient more quickly?
        Dr. Kirschstein. I think Dr. Klausner will start.
        Dr. Klausner. Thank you.
        First of all, Senator Feinstein, I want to thank you for
    your leadership in the bringing together of the disparate
    components of the cancer community. You have been very helpful.
        Senator Feinstein. It has been interesting.
        Dr. Klausner. I think--while I can comment about some NCI
    programs, I think one of the characteristic changes of the last
    few years has been an acceleration of translation of basic
    research into the clinic. Now the speed with which that happens
    varies tremendously, depending upon what it is you are trying
    to translate.
        For example, the discovery of a genetic alteration that
    predisposes an individual to a particular disease, for example
    cancer, can translate rapidly into a useful and useable
    clinical test.
        In my own work with a tumor suppressor gene for
    predisposing an individual to kidney cancer, it took about a
    year from discovery for it to be widely used in clinics to help
    predict predisposition and to help families make decisions
    about surveillance and what to do about this particular
    predisposition syndrome.
        For the development of new therapies, it often takes a long
    time. But I think many of the programs that have been developed
    with the new funding over the last few years are actually being
    developed to speed that transition.
        Let me give you an example. We established a program about
    a year and a half ago called RAID for Rapid Access to
    Interventional Development. It is sort of a virtual national
    drug development system that reaches out to academic
    laboratories and funds new promising agents to move, we hope,
    within 12 months out of the laboratory into phase one clinical
    trials. And this is really very rapid.
        We have now a little over a year's experience with the
    program. Thirty-two novel agents have been funded. Four of them
    have actually already made it out of the laboratory, basic
    laboratories, into clinical trials, each costing less than
    about $1 million per drug.
        It is these sorts of programs that allow us to move things
    much more rapidly than we had before. And I think there are
    many other examples that all of us can give.
        But I think it really is a characteristic of the new
    technologies and new programs we are all developing that are
    aimed specifically at speeding that transition.

                              state of Cancer Care

        Senator Feinstein. Second question--and I thank you for
    that. And I think you yourself pointed out the amazing
    extension of life that has been achieved through the pediatric
    model with cancer, where a child with cancer can in fact really
    be assured throughout the Nation of state-of-the-art cancer
    care. The same is not true for an adult.
        And what we have found is that the state of cancer care
    throughout the Nation is extraordinarily erratic. The need for
    every cancer patient to have a quarterback physician, for
    example, I think preferably an oncologist, somebody who is able
    to go through the options with them, see that for their case
    they have the best possible options, there is no real state-of-
    the-art care for the adult cancer patient.
        What is the institute doing to try to bring that about? And
    how might we be helpful in that regard?
        Dr. Klausner. Yes. I see the red light is on. Do I have
    time to answer this?
        Senator Specter. Yes, Dr. Klausner.
        Dr. Klausner. Thank you.
        Well, Senator, you are right. I think pediatric oncology,
    again, is one of the real success stories of NIH, of actually
    linking research to practice.
        Sixty-five percent of children in this country who are
    diagnosed with cancer, regardless of their economic status or
    ethnicity or race, are treated on NCI-funded clinical trials.
    And 90-odd percent are treated on NCI-developed protocols. When
    I say NCI, I mean the protocols are not developed by the
    institute, but by our funded investigators. This is as opposed
    to 2 to 3 percent of adults being treated on NCI-funded
    clinical trials.
        We believe that part of the reason there has been such
    progress in cure rates for childhood leukemia and childhood
    cancers, even without the development of major new drug
    advances, is due to improving protocols.
        One of the things that we have been doing to try to expand
    this to the adult is to revamp our clinical trial system, to
    turn it into a truly national system with a single web-based
    informative structure that allows any physician to access any
    of the 1,500 open adult clinical trials that we have in the
    country. This is new and is just coming on line this summer
    with a new national clinical trials organizational unit.
        But there is a lot that we need to do to try to open this.
    Funding is limited but with recent increased funding, there has
    been a significant increase in accrual just this past year of
    adult patients to clinical trials.
        What does that mean? One example, in a recent adjuvant
    breast cancer trial, it was predicted to take 38 months just to
    finish the accrual. It took 14 months. That means we can ask
    more questions more quickly. It is a direct reflection of the
    funding.
        There are other issues, and that is whether patients have
    access to clinical trials; the issue of whether, for the
    clinical care associated with clinical trials, patients can
    obtain reimbursement.
        Senator Feinstein. Can I just quickly----
        Dr. Klausner. Yes.
        Senator Feinstein. Are you saying then that the only way to
    assure that every cancer patient in the United States has
    state-of-the-art care is by access to clinical trials?
        Dr. Klausner. No. I am sorry.
        Senator Specter. Dr. Klausner, you may answer that, but
    please do so briefly.
        Dr. Klausner. I do not think that is the only way, but I do
    think we need to expand the clinical trials to generate more
    answers more quickly.
        And I think there is a variety of ways that we can make
    sure that the results of the clinical trials and the protocols
    that are generated, the expert protocols by which patients are
    treated on clinical trials, are more disseminated, whether it
    was within or without a clinical trial.
        Senator Feinstein. OK.
        [The information follows:]
                               Stem Cell Research
        As an introduction to the answers from the individual Institute and
    Center Directors, I would state that the potential scientific and
    medical benefits that may result from research using human pluripotent
    stem cells, funding and oversight of human pluripotent stem cell
    research by the Federal Government has become increasingly important.
    The participation of government in this research will help ensure that
    any research utilizing human pluripotent stem cells is conducted within
    the federal regulations and very importantly, that the results will be
    accessible to the public. If pluripotent stem cells are available to
    researchers, we expect that scientists will be able to pursue important
    research in the areas described below.
                           national cancer institute
        Since stem cells have the ability to divide without limit and give
    rise to many specialized cells in an organism, there are several
    reasons why may be important to cancer research and to reducing the
    cancer burden. First, pluripotent stem cells may be used to treat the
    tissue toxicity brought on by cancer therapy. Bone marrow and
    peripheral blood multipotent stem cells (which are more committed stem
    cells) are used already to restore patients' hematopoietic and immune
    systems after high dose chemotherapy. Pluripotent stem cells may have
    greater potential for returning the complete repertoire of immune
    response to patients undergoing bone marrow transplantation, thus
    contributing to the development of other treatments such as immune/
    vaccine therapy. Other tissues damaged by cancer therapy also may
    benefit by replenishing their stem cell pools, e.g., injection of
    pluripotent stem cells into the heart may permanently reverse
    cardiomyopathy caused by certain chemotherapeutic agents; injection of
    pluripotent stem cells that have been differentiated into neural cells
    may restore brain function after cancer treatment.
        A second reason why stem cells may be important to cancer research
    is based on the finding that cancer cells may have certain stem cell
    properties, specifically, the ability to renew themselves. The
    isolation and characterization of stem cells and in depth study of
    their molecular and cellular biology may help scientists understand why
    cancer cells survive despite very aggressive treatments. Once the
    cancer cell's ability to renew itself is understood, scientists can
    develop strategies for circumventing this property.
        A third and final reason for studying stem cells lies in the field
    of gene therapy, by which a gene that provides a missing or necessary
    protein is introduced into an organ for a therapeutic effect. One of
    the most difficult problems in gene therapy studies has been the loss
    of expression (or insufficient expression) following introduction of
    the gene into more differentiated cells.
        Introduction of the gene into stem cells to achieve sufficient long
    term expression would be a major advance. In addition, the stem cell is
    clearly a more versatile target cell for gene therapy, since it can be
    manipulated to become theoretically any tissue. A single gene transfer
    into a pluripotent stem cell could enable scientists to generate stem
    cells for blood, skin, liver, or even brain targets. Applications to
    cancer might include engineering replacement cells that are resistant
    to chemotherapeutic assault or that express antibodies against cancer
    targets.
                   national heart, lung, and blood institute
        Research using human pluripotent stem cells represents an important
    opportunity to understand numerous processes in human biology and
    provides enormous potential for designing new therapies and screening
    candidate drugs for various diseases. Establishment of human
    pluripotent stem cell lines for the characterization of the biological
    properties and markers of stem cells will allow us to identify various
    stem cell populations and develop models/assays to predict successful
    replacement of tissue in disease or traumatic injury settings. The
    identification of factors that control these important processes holds
    great promise to ultimately treat numerous diseases that result in
    human suffering.
             national institute of dental and craniofacial research
        The results from using pluripotential stem cells are enormously
    important towards developing innovative solutions to complex human
    diseases such as Parkinson's disease and a number of chronic pain
    syndromes. The capacity for pluripotential stem cells to differentiate
    into many different cell types is remarkable and has opened scientific
    inquiry into a number of approaches to regenerate damaged neural and
    muscular tissues. In addition, stem cell biology in general has opened
    new approaches for a number of therapeutic challenges such as soft and
    hard tissue regeneration. For example, mesenchymal stem cells found in
    bone marrow are being used to treat human bone diseases such as McCune-
    Albright syndrome here at the NIH.
        These benefits are but a superficial glance at the possibilities
    for both pluripotential as well as totipotential stem cell biology. The
    scientific foundations are being established and we need critical
    support to rapidly advance our basic science of stem cell biology into
    preclinical and clinical trials to address the significant suffering of
    so many American people. Stem cell therapies could profoundly reduce
    the burden of many dental and craniofacial diseases and disorders such
    as cleft lip and cleft palate, oral and pharyngeal cancer, and a number
    of chronic facial pain syndromes. In addition, pluripotential and
    totipotential stem cell research will also produce specialized cells
    such as cartilage and salivary cells, which can be used as replacement
    for tissues damaged by disease or injury. Examples include the
    treatment of temporomandibular joint disorders (TMDs), the replacement
    of skeletal elements lacking or damaged in diseases such as fibrous
    dysplasia of bone, the use of cells grown in special natural or
    synthetic scaffolding materials, and the replacement of salivary cells
    damaged by autoimmune diseases (Sjogren's Syndrome) or radiation for
    head and neck cancer.
        national institute of diabetes and digestive and kidney diseases
        Human embryonic stem cells hold great promise for advances in
    health care because they can give rise to many different types of
    specialized cells that may be used to replace or repair damaged tissues
    and organs and for other therapeutic purposes. They can also be used to
    enhance the development of new medications to slow or arrest disease
    processes, and to aid fundamental research that can provide important
    insights into developmental processes important to the understanding,
    treatment and ultimate prevention of disease. These ``pluripotent''
    cells have the unique capability of limitless division and self-
    renewal, and thus can be maintained indefinitely in cell culture.
        Human embryonic stem cells offer the potential for treating a
    number of chronic diseases that are within the NIDDK research mission.
    For example:
        Type 1 Diabetes.--There is an intense effort under way to
    understand the genetic rules by which an undifferentiated cell becomes
    a beta cell of the islet of the pancreas, which is capable of secreting
    insulin. Human embryonic pluripotent stem cells offer great hope for
    providing an unlimited supply of insulin-producing cells for
    transplantation once the rules of differentiation are known.
        Liver Diseases.--Attempts at cellular therapy to replace diseased
    liver tissue are under way. In this case, a cell would need to
    differentiate along the lines of a functional liver cell. Again, a
    similar set of rules are necessary for this to happen, but again the
    plasticity of the human pluripotent stem cell would form an excellent
    base for this to occur.
        Kidney and Bladder Diseases.--Various forms of kidney cells or
    potential bladder cells also offer the potential to differentiate into
    highly important tissue specific cells. At the present time, there are
    a number of studies underway in an attempt to grow bladder cells that
    could be used to reconstruct a human bladder.
        Developmental Biology.--There are other examples in addition to
    diabetes, liver failure, kidney failure, and urologic diseases in which
    human pluripotent stem cells may have a major therapeutic role. It
    would also be important to try and understand the genetic rules of
    development so that these important cells may be applied to important
    therapeutic uses.
             national institute of allergy and infectious diseases
        Transplantation.--Research on embryonic stem cells could lead to
    cures for diseases that require treatment through transplantation,
    including autoimmune diseases such as multiple sclerosis, rheumatoid
    arthritis, systemic lupus erythematosus, and type-1 diabetes.
        The most feasible example in the short term is to treat type-1
    diabetes by transplanting pancreatic islet cells or beta cells produced
    from autologous embryonic stem cells--that is embryonic stem cells that
    are removed from an individual, differentiated ex vivo to become
    functioning islets or beta cells, and then transplanted back into the
    same individual. Although there are questions about our ability to
    identify stem cells, obtain them in sufficient numbers from older
    children or adults, and produce differentiated cells, tissues or organs
    from such stem cells, this technique holds great promise to cure
    disease. Autologous transplants would obviate the need for
    immunosuppressive agents in transplantation, reduce the risks of
    transmitting infectious agents within transplanted materials, and
    eliminate the risks of post-transplant infection due to global immuno
    suppression. Moreover, such embryonic stem cells might be used to
    create a myriad of transplantable cells, tissues, and organs. This
    would address problems ranging from the supply of donor organs to the
    difficulty of finding acceptable matches between donors and recipients.
        Primary Immunodeficiency Diseases.--Embryonic stem cells might be
    used to treat virtually all primary immunodeficiencies. There are more
    than 70 different forms of primary (congenital and inherited)
    deficiencies of the immune system, which are characterized by an
    unusual susceptibility to infection and are sometimes associated with
    anemia, arthritis, malabsorption and diarrhea, and certain
    malignancies. Almost all of these diseases are rare, and can involve
    considerable pain and suffering, numerous hospitalizations, high
    medical costs, and even death. Because these diseases are genetic, gene
    replacement is an important area of investigation in the search for an
    effective treatment. Transplanting stem cells that have been
    reconstituted with a normal gene might result in developing healthy
    cells of the types affected by the missing or damaged genetic material
    in the immunodeficiency disease. Based on research with animals, there
    is reason to believe that using embryonic stem cells as a mechanism to
    replace damaged or missing genes will have proliferative advantages
    over currently available alternatives, such as peripheral blood or bone
    marrow derived hematopoietic stem cells. Other hypothetical advantages
    include greater susceptibility to genetic transduction. Ultimately, the
    hope is for greater success in transplantation, long-term survival and
    reconstitution of normal cellular functions.
        HIV/AIDS.--Research on pluripotent embryonic stem cell transplants
    could make restoration of immune function a viable option for treating
    HIV disease. Such transplants could regenerate all the components of
    the immune system that have been damaged by HIV infection. This
    includes repairing HIV-induced damage done to the cells and tissues
    that support immune system development, which would be a required
    prerequisite for T-cell repopulation. While there are many questions to
    be answered, experiments in animal models point to significant
    advantages with the use of these cells. Primarily, the embryonic stem
    cells are easily transduced with new genetic material, such as anti-HIV
    genes, so that the daughter cells are resistant to HIV infection. Thus,
    this combination of gene therapy and stem cell research could result in
    the immune reconstitution of AIDS patients with cells that are
    resistant to HIV.
            national institute of neurological disorders and stroke
        The logic arguing for NIH funding of embryonic stem cell research
    is straightforward from the perspective of nervous system disorders.
    Put simply: (1) Stem cells have enormous potential for treating
    disorders of the nervous system. (2) Research on embryonic cells is
    necessary to realize these possibilities.
        To elaborate:
        1. Stem cells have enormous potential for treating neurological
    disorders. The wide range of possibilities arises because these
    versatile cells can be used in several different ways. Plausible
    applications of neural stem cells include replacing lost nerve cells,
    replacing glial (supporting) cells, restoring complex nervous tissue,
    supplying cell sustaining chemicals, delivering substances widely
    throughout the brain, serving in tests for drug screening, and
    advancing fundamental studies of the brain and brain development.
    Although much research is needed before human trials can be safely
    attempted, animal experiments have already begun to demonstrate the
    feasibility of stem cell strategies for Parkinson's disease, spinal
    cord injury, demyelinating diseases such as multiple sclerosis, and
    enzyme deficiency disorders such as Tay-Sachs. Stem cell based
    strategies have also been proposed for several other neurological
    disorders such as stroke, epilepsy and brain tumors.
        2. Embryonic stem cells are necessary to realize these
    possibilities. Although stem cells are present in adult brains, the
    adult stem cells may not have the versatility of their embryonic
    counterparts. There is experimental data showing that embryonic stem
    cells can produce not only many types of neural cells, but also muscle,
    blood, bone, and other tissue. There is strong evidence that embryonic
    cells can survive when transplanted and can migrate widely in the adult
    brain. Embryonic stem cells have the potential to divide for indefinite
    periods in culture and offer the possibility of a renewable source of
    replacement cells and tissue, but stem cells in the adult brain are
    characterized by limited availability and accessibility. Therefore,
    research on all types of stem cells must be done to compare their
    properties and find those most suitable for each of the several
    different potential therapeutic applications.
                 national institute of general medical sciences
        Studies of embryonic stem cells would speed important medical
    advances. For example, NIGMS has supported research devoted to the
    development of ``artificial skin.'' Such a biomaterial would enjoy wide
    application in the field of burn therapy. Initial studies, begun in the
    early 1980s, has led to the development of a model for cultivating skin
    cells from burn patients. The method, which is being tested in patients
    today, consists of combining a biopolymer sponge made of collagen with
    actual skin cells from burn patients. Conceivably, human pluripotent
    stem cells could also be used as a source of ``skin'' to build such a
    graft, especially for severely burned patients with limiting amounts of
    remaining intact skin.
            national institute of child health and human development
        The fundamental question in biology is how a single fertilized egg
    develops into a complex adult organism with many different specialized
    cell types performing specific functions. This development follows a
    program directed by precisely timed turning on and off of many genes.
    Learning how this process works is basic to the mission of NICHD in
    promoting the birth of healthy offspring through research on human
    reproduction and development. Since pluripotent stem cells can develop
    into many different cell types, the study of how pluripotent stem cells
    can develop into many cell types may provide new knowledge of how
    fertilized eggs develop into organisms. Also pluripotent stem cell
    research will allow scientists to, among other things, direct the
    development of these stem cells along a certain path to become liver,
    blood, brain, or any type of cells which then can be used in
    transplantation and for other purposes. Within NICHD's area of
    interest, these cells could be used to replace organs or tissues that
    are defective as a consequence of birth defects. For example, one such
    condition is biliary atresia, in which part of the liver does not
    develop correctly. Human embryonic stem cells could potentially be
    directed to form liver tissue or to replace the damaged organ and save
    the life of the affected infant.
                             national eye institute
        Research into the treatment of retinal degenerations has
    demonstrated some promising results by transplanting retinal cells and
    tissues in an effort to ``treat'' animal models of retinal
    degeneration. However, the results have been mixed and many questions
    remain. The immunologic issues governing transplant survival are
    complex and only partially understood. Possible strategies for
    overcoming these problems are suggested from ongoing investigations of
    the development and maturation of the normal retina. Use of pluripotent
    stem cells could provide an additional avenue of research to overcome
    the immunological or other potential problems that may be encountered.
        There is also a significant clinical need for improved techniques
    to promote conjunctival and corneal healing during disease or after
    injury. Conventional surgery or standard corneal transplantation
    procedures are not consistently successful in treating persistent
    corneal ulcers, chemical or thermal injury, and other diseases that
    damage or scar the cornea. Recent results involving transplantation of
    corneal ``stem'' cells from the limbus region have shown some promise,
    but many practical and technical problems are presented by this
    approach. Transplantation procedures with pluripotent stem cells could
    provide an additional avenue of research for facilitating
    epithelialization of the ocular surface, reducing inflammation,
    vascularization, and scarring.
              national institute of environmental health sciences
        Human pluripotent stem cell research offers powerful new research
    approaches for clarifying the complex association of environmental
    agents with human disease processes. It also makes possible a powerful
    new means of conducting detailed investigations of the underlying
    mechanisms of the effects of environmental chemicals or mixtures of
    chemicals. The use of human pluripotent stem cell cultures may allow
    the identification of the specific early cell types at greatest risk of
    adverse effects from exposure to such developmental toxicants as lead,
    mercury, and polychlorinated biphenyls, as well as the mechanism of the
    toxic effect(s) and the temporal nature of future adverse effects in
    the subsequent cells and tissues established from these stem cells.
    There are often subtle effects of toxic exposures on the developing
    embryonic and fetal development tissue systems, yet these systems are
    responsible for maintaining strong post-natal health. For example, the
    human embryo and fetus may be very susceptible to long-terms
    impairments of immune or nervous system functions from the in utero
    effects of toxicant exposure.
        Parkinson's disease, according to most recent findings, has a
    strong component related to environmental exposure component for one
    form of the disease. The nature of the agents and the timing of the
    exposure remain unknown at present. The use of human pluripotent stem
    cell cultures will permit screening for the subtle effects of candidate
    environmental toxicants and toxicant mixtures on specific cell types in
    the developmental stages of the cell lineage comprising the nervous
    system cells and tissue associated with the brain region compromised by
    the disease. Such explorations may yield powerful insight into the
    biological mechanism(s) underlying human susceptibility to the
    epigenetic form of this disease with onset after age 50, as well as the
    genetic-based ``early'' onset form of the disease.
        It is possible that the opportunities afforded by human pluripotent
    stem cell research will lead to molecular markers or surrogate or
    combinations of both that can be utilized for population-based studies
    of gene-environment interaction in disease etiology. By using the
    toxicity screening, by human pluripotent stem cell coupled with DNA
    micro-array technology and gene expression profiling, it may be
    possible, within a decade, to construct complex data matrices of gene
    expression that constitute for each possibly toxic chemical a
    ``signature'' that could provide information by relating that chemical
    to others of known toxicity. Human pluripotent stem cell research
    offers great promise for use in testing the beneficial and toxic
    effects of biologicals, chemicals and drugs. Such studies will lead to
    fewer, less-costly, better-designed and more specific diagnostic
    procedures as well as more effective systemic therapies, not to mention
    the contribution of enhanced understanding to the development of
    strategies for prevention of disease.
                            national aging institute
        Human pluripotent embryonic stem (ES) cells hold enormous potential
    for cell replacement or tissue repair therapy in many degenerative
    diseases of aging. For disorders affecting the nervous system, such as
    Alzheimer's and Parkinson's diseases, amyotrophic lateral sclerosis,
    and spinal cord and brain injury, transplantation of neural cell types
    derived from human ES cells offers the potential of replacing cells
    lost in these conditions and of recovery of function. Human ES cells
    could provide a model for studying fundamental molecular and cellular
    processes important in the understanding of aging and age-related
    diseases. However, before the full medical potential of ES cells can be
    realized, much research needs to be done on the basic biology of human
    ES cells.
        Pluripotential and self-renewal capacity of human ES cells.--The
    potential use of ES cells in human medicine hinges on the possibility
    that ES cells can be grown in large numbers and that they can be
    induced to form all human cell types. Factors controlling the self-
    renewing ability of human ES cells must be explored and compared to
    self-renewal properties of fetal and adult stem cells. Factors that
    control the pluripotent nature of ES cells, that is, their ability to
    form various cell types when grown in culture or when transplanted into
    human tissue must be studied. The role of telomerase and other gene-
    regulating proteins in self-renewal, cell fate determination, and
    senescence could be examined.
        ES cells for transplantation and tissue repair.--Human ES cells
    could be used in tissue regeneration therapy in, for example, age-
    related neurological, cardiovascular, musculoskeletal, and immune
    system problems. Work in animal models of human nervous system
    diseases, such as demyelinating disorders and spinal cord injury, has
    provided evidence that mouse stem cells can survive, differentiate, and
    give some degree of functional recovery following transplantation to
    the affected region of the nervous system. The ability to use human ES
    cells in research would allow validation of such a cell replacement and
    repair strategy in animal models of human diseases. This could lead to
    potential transplantation of human ES cells into the brains of
    Alzheimer's and Parkinson's disease patients to replace lost or
    dysfunctional cells in the affected brain regions. ES cells also could
    be genetically modified to express certain proteins, such as neuronal
    growth factors, and then transplanted into affected brain regions in
    which locations they could provide local delivery of the critical
    therapeutic factor(s). ES cells could be used to effect bone and
    cartilage repair in osteoporosis and osteoarthritis, to reconstitute
    the immune response in age-related or genetic disorders, and to promote
    muscle regeneration in age-related progressive muscle wasting &
    strength decline. The ability of human ES cells to generate an immune
    response following transplantation could be assessed and compared to
    fetal or adult stem cells to see if they could be used to reduce the
    problem of rejection following cell therapy.
        The ability to use human ES cells in research would allow intensive
    studies to be performed to understand factors leading to optimum
    therapeutic benefit, including determining the best type of cells
    (embryonic, fetal, or adult stem cells) for transplantation and what
    happens when cells are transplanted into hosts of different ages or
    into hosts with different or multiple diseases. A better understanding
    of the fundamental, biological properties of human ES cells could lead
    to their successful use in cell transplantation and tissue regeneration
    therapies in age-related disorders.
       national institute of arthritis musculoskeletal and skin diseases
    Generation of replacement cells and tissue to treat diseases
        Because stem cells constitute a self-renewing population of cells,
    they can be cultured to generate greater numbers of bone, cartilage,
    muscle and skin cells than could be obtained from a tissue sample.
    Equally important, if a self-renewing population of new stem cells can
    be established in a transplant recipient, it could effect long-term
    correction of many diseases and degenerative conditions in which bone,
    cartilage, muscle and skin cells are deficient in numbers or defective
    in function, such as in osteogenesis imperfecta and various
    chondrodysplasias.
        national institute on deafness and other communication disorders
        Pluripotent stem cells research has tremendous potential for
    developing therapeutic strategies for regenerating selected populations
    of cells the degeneration or loss of which causes debilitating disease.
    Several clear examples include degeneration of insulin-producing cells
    in the pancreas which causes Type 1 diabetes mellitus, and degeneration
    of a subset of neurons in the brain which results in Parkinson's
    Disease.
        By age 70, it is estimated that as many as one third of all
    Americans have significant hearing impairment that compromises human
    communication using spoken language. Many of these individuals also
    have problems with balance, which leads to falls and limits their
    mobility. The cause of this loss of hearing and balance is most often
    degeneration or loss of hair cells, which are the specialized cells in
    the inner ear that detect sound and provide sensory input needed for
    balance.
                      national institute of mental health
        Human embryonic stem cells are a critical resource for studies of
    biological and disease processes, and for the creation of disease
    models. Human stem cells provide a model to study the factors that
    regulate differentiation, migration, and survival of neurons and glia
    in the brain. Because developmental factors are implicated in the
    pathophysiology of mental disorders (e.g., schizophrenia, autism, etc),
    it is important to understand the factors regulating critical
    developmental events that control stem cell fate in the central nervous
    system. Stem cells hold tremendous promise for the discovery and
    development of novel therapeutic targets such as growth factors and
    other signaling molecules. Stem cells also represent the most promising
    source of cells for use in transplantation therapy. Ultimately, stem
    cell research may provide important insights into the pathophysiology
    and treatment of mental disorders.
                        national institute on drug abuse
        Stem cells can be a valuable resource to drug abuse researchers,
    particularly those investigating the effects that drugs of abuse have
    on development. Stem cells can be potentially used to replace cells
    damaged by neurotoxic drugs. Using stem cells can also allow us to
    better determine the more subtle effects of drugs on the developing
    embryonic and fetal development tissue systems.
               national institute on alcohol abuse and alcoholism
        The value of pluripotent stem cell research would be in elucidating
    mechanisms of cellular differentiation. With this knowledge, scientists
    would have the potential to selectively differentiate cells into
    various tissues.
        Alcohol is a major source of damage to organs, such as the liver
    and brain, that may or may not regain function with abstinence from
    drinking. Development of medications that accelerate recovery in organs
    damaged by alcohol would be a major breakthrough. Such an advance would
    lessen human suffering and the economic burden associated with alcohol-
    induced organ damage. For cases of irreversible organ damage, stem cell
    research could be used to facilitate generation of new organ tissue.
    The following examples demonstrate the potential utility of this type
    of research to the alcohol field:
        Reversal of cognitive deficits in alcoholics: Treatment of memory
    problems as a result of long-term drinking can be problematic because
    patients have difficulty remembering instructions from therapists.
    Although in less severe cases recovery is possible after 3-5 years of
    abstinence, initial treatment is less effective, and patients are more
    likely to relapse. In the case of Korsakoff's syndrome, deficits can
    require lifetime institutionalization of patients. Transplantation of
    stem cells using appropriate growth factors may reverse the
    neurochemical and behavioral deficits induced by chronic ethanol
    administration. This approach might ultimately reduce the costs of
    long-term care.
        Organ transplantation: Alcoholic liver disease ranks second as the
    cause of end-stage liver disease necessitating liver transplantation.
    Given the scarcity of organs for transplantation, in vitro stimulation
    of pluripotent stem cells into liver cells and other specialized cells
    offers the extraordinary possibility of replacement cells and tissues
    for treatment.
        Fetal Alcohol Syndrome (FAS) cognitive deficits: Pluripotent stem
    cells would provide investigators with a tool to study how alcohol
    disrupts cellular differentiation at various stages of embryonic
    development. Findings from this research would contribute to the design
    of potential interventions for FAS.
                     national institute of nursing research
        The NINR does not perform research involving embryos or stem cells.
    However, nursing research will benefit from the technological advances
    resulting from such research. When embryo or stem cell clinical
    applications involve patient care, nursing research studies will
    contribute to the science base for health care professionals,
    especially nurses.
                     national center for research resources
        1. Potential for stem cell cure of Type 1 Diabetes versus the
    present insulin injection treatment.
        2. Potential cures for Parkinson's and Alzheimer's Diseases through
    embryonic stem cells.
                    national human genome research institute
        The Division of Intramural Research at the National Human Genome
    Research Institute is using the tools produced by the Human Genome
    Project, supported by the Institute's extramural research program, to
    study the fundamental mechanisms of development and the contributions
    of genetic factors to disease. NHGRI investigators have identified the
    following as potentially promising areas of study involving pluripotent
    stem cells:
        Gene Expression.--The differentiation potential of pluripotent stem
    cells make them important candidates for studies of alterations in gene
    expression profiles. Being able to examine the genes that are turned on
    and off during the differentiation process of these cells, using newly
    developed microarray technology, could supply very useful information
    about normal and abnormal cell development. This information could have
    promising application to a whole host of disease areas.
        Parkinson's Disease (PD).--PD is caused by degeneration of neurons
    in the region of the brain, the substantia nigra, leading to severe
    abnormalities in movement. The cause is largely unknown, although in a
    few rare families with early onset disease, mutations in the gene for
    alpha synuclein are known to be responsible. As with other
    neurodegenerative disorders, replacement of damaged nerve cells with
    stem cells is one avenue of possible therapy. Current experiments using
    fetal cells for replacement have provided very mixed results,
    especially for the long term. One possible explanation for the less
    than complete replacement is that the cells being transplanted are too
    far along in path of development and differentiation to be able to take
    up residence in the substantia nigra, make all the correct connections,
    and replace the damaged cells. Using even less differentiated cells,
    such as embryonic stem cells, is a possible alternative.
        Gene Therapy.--Almost any genetic disease for which cell and tissue
    transplantation protocols exist could potentially benefit from the
    application of embryonic stem cells in gene therapy. For example,
    patients with genetic disorders of the immune system might benefit
    greatly from studies involving gene transfer using specially derived
    pluripotent stem cells. Studies involving these cells also may be
    useful in immune reconstitution or in engineering immunologic
    resistance by HIV infected individuals.
        Blood Disorders/Sickle Cell Disease.--The epsilon globin gene is
    expressed only in embryonic red blood cells. This gene recently has
    been shown to block the sickling of red blood cells by hemoglobin.
    Research involving embryonic stem cells could help answer questions
    about how to turn on the epsilon globin gene in adult blood cells and
    thereby halt the disease process. Stem cell research may also help
    produce transplantable cells that would not contain the sickle cell
    mutation.

        Senator Specter. Thank you very much, Senator Feinstein.
        Coming back to the stem cell issue, because that is going
    to be the subject of major floor debate on legislation which we
    have introduced to eliminate the restriction on NIH doing
    funding on embryos, there has been substantial resistence to
    eliminating that restriction on the, I think, misguided ground
    that we are dealing with potential human life, when in fact
    these are discarded human embryos. It is going to be a real
    battle, though. And I would like to explore it for a moment or
    two.
        I know Senator Harkin is going to go back to Dr. Spiegel
    about the potential for juvenile diabetes.
        But what substance is there to the argument that there are
    alternatives, such as umbilical cords or other avenues of
    approach to get adequate numbers of stem cells for research?
        Who is the best person to answer that, Dr. Kirschstein?
        Dr. Kirschstein. I think many of my colleagues could, maybe
    Dr. Fischbach, Dr. Spiegel----
        Senator Specter. Dr. Fischbach, we will start with you,
    since my red light will be on momentarily, too.
        Dr. Fischbach. I will be brief. There are many sources of
    stem cells. And I am optimistic about stem cells from adult
    animals, but I think stem cells from embryos will also be
    extremely important. And I would be reluctant to rule out any
    source.
        The devastating illnesses that are going to be treated by
    these stem cells demand that we explore every possibility.
        Senator Specter. Well, Dr. Fischbach, beyond being
    unwilling to eliminate any source, that really does not
    directly answer the question as to whether there would be an
    adequate supply of stem cells other than from human embryos.
        What is it about the embryo which requires its availability
    for stem cell research to get the maximum benefit, to----
        Dr. Fischbach. At the present time, embryonic stem cells
    can divide and grow outside the body for an unlimited period of
    time. So by geometric multiplication, they can provide enormous
    stores of cells that can be used medically.
        It is a matter of research in the future to try and
    transform stem cells from adults, because adult stem cells at
    the present time do not have that capability of unlimited
    growth and expansion for medical use.
        Senator Specter. I would request that everyone submit to us
    a written response as to the utility of eliminating that
    funding limitation. We are going to have a knock-down, drag-out
    floor battle in the Senate.
        We put into our appropriations bill last year the
    elimination of that prohibition in order to bring the matter to
    a head. But we knew that we could not get the appropriation
    bill through without a filibuster if that remained for floor
    action. So we removed it with an agreement with the majority
    leader to bring up a free-standing bill this year.
        And I have talked to Senator Lott, and he is prepared to do
    it shortly. But we will need all the evidence we can get as to
    why that prohibition ought to be eliminated.

                                 youth violence

        Dr. Hyman, I am interested to know what progress has been
    made on our allocation of almost $900 million to school
    violence. We took that up, as you know, and you attended one of
    three lengthy sessions where we brought people in from various
    disciplines to try to treat school violence--as Dr. Koop said
    in 1982 as surgeon general, that it is a national health
    problem. And you have a very leading role in it.
        Could you give the subcommittee an update as to what has
    been done in furtherance of your work and, perhaps to the
    extent you know, by the other people we met with where we had
    that very substantial funding allocation?
        Dr. Hyman. I will be brief, and I will give you a complete
    answer for the record. But I will answer in two regards. First,
    in regard to the research that has been initiated at NIH,
    including NIMH, and then in some of the cooperation across
    government agencies, which I think has actually been almost
    unique in my experience, in terms of research at NIMH, we have
    been focused on two areas.
        One is interventions before somebody goes down the wrong
    road. We have recognized that children with either mood
    disorders or attention deficit hyperactivity disorders that are
    not optimally treated are at much higher risk for subsequent
    violent behavior and incarceration.
        And we have completed several clinical trials and are
    initiating new clinical trials in areas to help us understand
    the best and safest ways to intervene early for these children.
        For children who are already engaged in violent behavior,
    we have also initiated research on optimal ways of diverting
    them off this path.
        And one--just to be very brief, one very important insight,
    although it sounds almost like common sense, is that the final
    common pathway for a lot of children into either violent or
    criminal careers has to do with aggregation of antisocial peer
    groups. And yet it is the practice in the United States to
    literally create graduate schools for delinquency by having
    group detentions, alternative schools, and incarcerating young
    children often with hardened criminals.
        There are interesting data and new clinical trials looking
    at something called therapeutic foster care in which foster
    parents are supported by professionals. And one of the
    linchpins of this intervention is to make sure that these
    youngsters do not associate with other antisocial peers. And we
    have evaluations from some initial trials.
        And, of course, I do not have answers for you yet, because,
    based on new funding, we have just initiated some new
    replication trials.
        Just to give you a flavor of the cooperation, we have been
    cooperating with SAMSA, especially the Center for Mental Health
    Services, also with the Departments of Education and Justice.
    We have had several meetings.
        The Safe Schools/Healthy Schools Program has representation
    from multiple agencies and I think has some really superb
    demonstrations. It is too early to evaluate, but NIMH is
    actually supporting sort of a research evaluation to make sure
    that these collaborations actually do some good that we can
    quantify and demonstrate.
        Senator Specter. OK. Thank you, Dr. Hyman. We will look for
    a more complete response in writing.
        [The information follows:]
                                 Youth Violence
        Youth violence is a complex problem that requires complex
    solutions. NIMH has long supported and conducted research to generate
    information about risk factors, experiences, and processes that are
    related to the occurrence, during childhood and adolescence, of
    aggressive, antisocial, and violent behavior, and associated mental
    health problems. Broad lessons drawn from this research underscore the
    importance of a nurturing social environment in childhood, good early
    education and success in academic areas; the prominent influence of
    peers, whether positive or negative, on adolescent development; and the
    potential risks of policies that endorse or require intervention
    programs that house or otherwise group troubled adolescents. This
    overview highlights what is known about risk factors for the
    development of antisocial and problem behavior, and describes various
    early prevention and intervention strategies.
        Risk Factors.--Tragic events like the shootings at Columbine High
    School are not typical of youth violence. Most adolescent homicides are
    committed in inner cities and outside of school. They most frequently
    involve an interpersonal dispute and a single victim. On average, six
    or seven youths are murdered in this country each day. Most of these
    are inner-city minority youths. Such acts of violence are tragic and
    contribute to a climate of fear in schools and communities. Many
    studies indicate that a single factor or a single defining situation
    does not cause child and adolescent antisocial behavior. Rather,
    multiple factors contribute to and shape antisocial behavior over the
    course of development. Some factors relate to characteristics within
    the child, but many others relate to factors within the social
    environment (e.g., family, peers, school, neighborhood, and community
    contexts) that enable, shape, and maintain aggression, antisocial
    behavior, and related behavior problems.
        NIMH-supported research on risk for aggressive, antisocial and
    violent behavior encompasses multiple aspects and stages of life,
    beginning with interactions in the family. Weak within-family bonding,
    ineffective parenting (poor monitoring, ineffective, excessively harsh,
    or inconsistent discipline, inadequate supervision), exposure to
    violence in the home, and a climate that supports aggression and
    violence put children at risk for being violent later in life. At
    particular risk for violence are children who are exposed to the
    contributors listed above and who have mental disorders such as
    depression and anxiety and problem behaviors such as early conduct and
    attention problems, and lower cognitive and verbal abilities. Outside
    of the home, a major factor contributing to youth violence is peer
    influence. In the early school years, a good deal of mild aggression
    and violence is related to peer rejection and competition for status
    and attention. More serious behavior problems and violence are
    associated with smaller numbers of youths who are failing academically
    and who band together, often with other youth rejected by prosocial
    peers. Successful early adjustment at home increases the likelihood
    that children will overcome such individual challenges and not engage
    in behaviors that place them on a trajectory leading to violence.
    However, exposure to violent or aggressive behavior within a family or
    peer group may influence a child in that direction.
        Longitudinal research has begun to identify broad categories of
    young people who progress to adolescent antisocial behavior, the
    multiple pathways through which such behavior develops and persists,
    and the multiple factors that shape this risk. Two specific life course
    trajectories, called life course persistent, which is viewed as a form
    of psychopathology, and adolescence limited, which is identified only
    in select social situations--offer a useful distinction both as a way
    of thinking about developmental knowledge and as a tool for targeting
    the right interventions for antisocial youth.
        Life course persistent individuals begin antisocial behavior early
    in childhood and continue into adulthood, after their adolescence
    limited counterparts stop. Life course persistent behavior has been
    correlated with neurological deficits and pathological behaviors,
    (e.g., impulsivity) which are exacerbated when they are combined with
    stressful home situations. In one study of 13 year olds, individual
    differences--such as deficits in sensory, perceptual, and cognitive
    abilities, including the use of language--were shown to predict
    participation in crime five years later. One study found, for example,
    that boys with poorer neuropsychological functioning, especially verbal
    functioning at age 13, were more likely to have committed crimes at age
    18 than were their counterparts with better neuropsychological
    functioning at age 13.
        Gender Differences.--From about 4 years of age on, boys are more
    likely than girls to engage in both aggressive and nonaggressive
    antisocial behavior. Much remains to be learned about the causes of
    gender differences in antisocial behavior, but experts have suggested
    that it might be necessary to define antisocial behavior somewhat
    differently for boys and girls. Research has shown, for example, that
    girls are more likely to demonstrate social aggression by damaging peer
    relationships rather than by boys' overt aggression that inflicts harm
    through physical damage or the threat of such damage. NIMH currently is
    funding research on the antecedents and consequences of aggression for
    girls and boys as an essential step toward developing empirically-based
    interventions for aggressive children of both sexes.
        Antisocial Behavior Co-Occurring with Child Psychopathology.--There
    is strong evidence for the co-occurrence of two or more syndromes or
    disorders among children with behavioral and emotional problems. An
    obviously angry adolescent has other conditions such as anxiety
    disorders and depression (as seen in the quiet withdrawn young person)
    more often than would occur by chance. Research in this area indicates
    that very young children with conduct problems and anxiety disorders or
    depression display more serious aggression than youths with only
    conduct problems. Although some available data suggest that conduct
    problems often precede problems of depression, the sequencing of these
    concerns is not entirely clear for youth. Whether depression
    precipitates acting out, whether impairments and predispositions for
    acting out lead to depression, or whether there are underlying causal
    factors that are responsible for the joint display of such problems are
    unresolved questions.
        It is very common for youth with conduct problems to also display
    symptoms of attention deficit hyperactivity disorder (ADHD), the most
    commonly diagnosed behavioral disorder of childhood. The diagnosis is
    made by the presence of persistent age-inappropriate inattention and
    impulsivity, often coexisting with hyperactivity. This co-occurrence is
    often associated with an early onset of aggression and impairment in
    personal, interpersonal, and family functioning. Furthermore, academic
    underachievement is common in youth with early onset conduct problems,
    ADHD, and adolescents who display delinquent behavior.
        Individual Liability and Genetic Factors.--Although understanding
    of the nature of genetic influences on antisocial behavior is
    incomplete, research on differences in the magnitude of genetic and
    environmental influences on different kinds of conduct problems will
    contribute to elucidating the developmental origins of antisocial
    behavior. Twin and adoption studies indicate that child and adolescent
    antisocial behavior is influenced by both genetic and environmental
    factors, suggesting that genetic factors directly influence cognitive
    and temperamental predispositions to antisocial behavior. These
    predisposing child factors and socializing environments, in turn,
    influence antisocial behavior. Research suggests that for some youth
    with early onset behavior problems, genetic factors strongly influence
    temperamental predisposition, particularly oppositional temperament,
    which can affect experiences negatively. When antisocial behavior
    emerges later in childhood or adolescence, it is suspected that genetic
    factors contribute less, and such youths tend to engage in delinquent
    behavior primarily because of peer influences and lapses in parenting.
    The nature of the child's social environment regulates the degree to
    which heritable early predisposition results in later antisocial
    behavior. Highly adaptive parenting is likely to help children who may
    have a predisposition to antisocial behavior. Success in school and
    good verbal ability tend to protect against the development of
    antisocial behavior, pointing to the importance of academic
    achievement.
        Parent and Family Factors.--Research has demonstrated that youths
    who engage in high levels of antisocial behavior are much more likely
    than other youths to have a biological parent who also engages in
    antisocial behavior. This association is believed to reflect both the
    genetic transmission of predisposing temperament and the maladaptive
    parenting of antisocial parents. The importance of some aspects of
    parenting varies at different ages. The impact of inadequate parental
    supervision, for example, tends to be more pronounced in late childhood
    and adolescence than in early childhood. Evidence from many studies
    indicates that parental use of physical punishment may play a direct
    role in the development of antisocial behavior in their children. Other
    researchers have observed that parents often do not define antisocial
    behavior as something that should be discouraged, including such acts
    as youths bullying or hitting other children or engaging in ``minor''
    delinquent acts such as shoplifting.
        Research examining the mental health outcomes of child abuse and
    neglect has demonstrated that childhood victimization places children
    at increased risk for delinquency, adult criminality, and violent
    criminal behavior. Findings from early research on trauma suggest that
    traumatic stress can result in failure of systems essential to a
    person's management of stress response, arousal, memory, and personal
    identity that can affect functioning long after acute exposure to the
    trauma has ended. One might expect that the consequences of trauma can
    be even more profound and long lasting when they influence the
    physiology, behavior, and mental life of a developing child or
    adolescent.
        Peer Influences.--Antisocial children with earlier ages of onset
    tend to make friends with children similar to themselves. Consequently,
    they reinforce one another's antisocial behavior. Children who display
    age-inappropriate levels of impulsivity and hyperactivity (core
    symptoms of ADHD) are often rejected and thus are more likely to
    associate with other rejected and/or delinquent peers. The influence of
    delinquent peers on later onset antisocial behavior appears to be quite
    strong. Association with antisocial peers has been shown to be related
    to the later emergence of new antisocial behavior during adolescence
    among youths who had not exhibited behavior problems as children.
        Socioeconomic Factors.--An inverse relationship of family income
    and parental education with antisocial behavior has been found in many
    population-based studies. Across gender and ethnicity, much of the
    inverse relationship between family income and antisocial behavior is
    accounted for by less parental monitoring at lower levels of
    socioeconomic status.
        Studying the impact of communities and neighborhoods on children,
    researchers have examined three major features: (1) structural and
    demographic features, (2) exposure to situations or events, and (3)
    community-level processes and forms of social control.
        In terms of structural and demographic features, research on the
    extent to which neighborhoods are characterized by deteriorating
    housing, overcrowding, greater population density, and greater numbers
    of female-headed households consistently shows strong correlations with
    neighborhood crime rates and violence.
        By living in deteriorating neighborhoods with higher crime rates,
    children and youth are more likely to be exposed to and witness
    robberies, assaults, and murders. Experiencing their neighborhood as
    dangerous, young people are at increased risk for becoming anxious,
    depressed, defiant, and/or aggressive. Children who have seen or been
    the victim of violence are more likely to join gangs and report
    carrying weapons to school.
        A newer line of research has begun to examine how community-level
    processes and forms of social control may be important factors related
    to youth delinquency. Studies which have examined the extent to which
    members of the community share collective willingness to intervene in
    youth misbehavior have shown these forms of collective social control
    to correlate with decreased rates of delinquency and problem behaviors.
        Prevention and Intervention.--NIMH-supported investigators have
    developed and tested several effective programs and strategies to
    prevent youth violence at different stages of childhood, including
    programs for pre-school children, which are not discussed in this
    report. In light of the Subcommittee's interest in inter-agency
    collaborations, however, it is noteworthy that the Administration on
    Children, Youth and Families (ACYF) and the NIMH have awarded several
    research grants as the core component of a new young children's mental
    health research initiative designed to develop and test applications of
    theory-based research or state-of-the-art techniques for the
    prevention, identification and/or treatment of children's mental health
    disorders within a Head Start context. Among these are projects to
    develop screening tools for identifying behavior problems in preschool
    children, to test the effectiveness of research-based classroom
    interventions for very young children with serious disruptive behavior
    problems, and to assess the mental health needs of this vulnerable
    population.
        School-Age Children.--Research has found that between 70 and 80
    percent of children with diagnosable mental disorders who receive
    services are served within the school system, primarily by school
    psychologists and guidance counselors. The NIMH has supported many
    projects designed to develop, establish, and improve school-based
    mental health service delivery systems. These projects range from broad
    programs intended to enhance the social and problem solving skills of
    all students, to highly specific programs designed to treat children
    already showing symptoms of mental health problems. Programs also range
    from those that intervene at multiple levels, including the child,
    parents, peers, and teachers, to those that focus solely on the child.
    For example, research is developing techniques for teachers to manage
    disruptive students.
        The Families and Schools Together (FAST) Track Program is a multi-
    faceted, multi-year program designed for aggressive children in
    kindergarten, starting at age 6. A four-site study in North Carolina,
    Pennsylvania, Tennessee, and Washington, FAST Track involves working
    with the child, the family in their home, and school system, including
    teachers. Preschool children at high risk were identified at 55
    different schools. These children were randomly assigned for
    intervention or no intervention. The children initially enrolled in the
    study are now young adolescents. An evaluation of FAST Track found that
    by the third grade, students who took part in the program showed less
    oppositional and aggressive behavior and were less likely to require
    special education services than students who did not take part.
        The Linking the Interests of Families and Teachers (LIFT) Program
    is a 10-week intervention created for children and families who are at
    risk for the development of conduct problems due to residence in
    neighborhoods characterized by high rates of juvenile delinquency. The
    LIFT Program is a multi-component intervention that includes parent
    training, social skills training, a playground behavioral program, and
    regular communication between teachers and parents. Following program
    participation, students engaged in significantly fewer aggressive
    behaviors on the playground, parents demonstrated fewer negative
    behaviors during family problem-solving activities, and teachers
    reported improved student social behavior and peer interactions. Three
    years following the intervention, LIFT program students were less
    likely than their non-LIFT counterparts to engage in consistent alcohol
    use, to have troublesome friends, to have been arrested for the first
    time, or to demonstrate inattentive, impulsive, overactive, and
    disruptive behaviors in the classroom.
        Research-based programs also have been initiated to enhance the
    skills and knowledge of all children in order to decrease their risk of
    future emotional and behavioral problems. NIMH has sponsored the
    Promoting Alternative Thinking Strategies (PATHS) Curriculum, based in
    Washington State, which teaches children about self-control,
    understanding emotions, and problem solving. The PATHS curriculum has
    been evaluated using students in both regular education and special
    education classrooms. Students who received the PATHS curriculum
    demonstrated better knowledge of emotions than children who did not
    receive the curriculum. This emotional knowledge is thought to underlie
    the development of necessary social skills such as friendship
    development and maintenance, anger management, conflict resolution, and
    appropriate problem solving.
        The research highlighted above is, for the most part, sponsored by
    NIMH. In addition, numerous components of the National Institutes of
    Health (NIH) along with other Federal agencies have been active in
    responding to the Subcommittee's expressed interest in research
    concerned with developing and evaluating the effectiveness and
    sustainability of programs aimed at prevention, early recognition, and
    intervention for depression and youth suicide in school and community
    settings.
        On October 28 and 29, 1999, a meeting of investigators with
    extensive and recognized expertise in youth violence research was held
    at the National Institutes of Health Neuroscience Center in Bethesda.
    This meeting was organized in response to a request from former NIH
    Director Dr. Harold Varmus to convene a trans-NIH expert panel on youth
    violence intervention research. It was co-sponsored by the Office of
    Behavioral and Social Sciences Research (OBSSR), the NIMH, the National
    Institute of Child Health and Human Development (NICHD), the National
    Institute on Drug Abuse (NIDA), the National Institute of Nursing
    Research (NINR), and the National Institute on Alcohol Abuse and
    Alcoholism (NIAAA). The Expert Panel observed that much research has
    been and continues to be devoted to identifying the multiple risk
    factors that contribute to antisocial behavior as well as the
    mechanisms by which they operate. The Panel noted that several, often
    co-morbid, youth behavior problems (aggression and violence, high risk
    sexual behavior, and drug abuse) share common risk factors in their
    development. They pointed out that a number of these shared risk
    factors reliably predict behavioral problems and can be successfully
    changed through interventions. The Panel also observed that many other
    factors have been identified as important in understanding risk for
    behavior problems but have not been the target of focused
    interventions. The meeting participants identified future research
    needs that are informing research activities of the Institutes.
        In January, 2000, NIMH joined the OBSSR and several other NIH/IC's
    to co-sponsor a new RFA (OD 00-005) on developing and testing new
    interventions to prevent and/or reduce youth violence. In excess of 150
    letters signaling intent to respond to the April 14, 2000 application
    due date have been received.
        NIMH and the Center for Mental Health Services, Substance Abuse and
    Mental Health Services Administration (CMHS, SAMHSA) are issuing a
    joint program announcement (PA) to encourage research grant
    applications on services delivered to children, adolescents and their
    families through the CMHS's Comprehensive Community Mental Health
    Services for Children and Their Families Program initiative. Conducting
    the proposed research at one of the Children's Services Program sites
    is a prerequisite for funding under this PA. This PA encourages studies
    of the effectiveness of treatments or services delivered at these
    sites, the nature and impact of routine clinical practice, and factors
    related to successful implementation of treatments or services,
    including interventions targeting violent behavior and related
    problems.
        On March 30, NIMH staff met with members of the Working Group on
    Youth Violence Research, a component of the White House Council on
    Youth Violence. Members of the Working Group include representatives
    from the Departments of Health and Human Services, Justice, Labor,
    Education, and other Federal entities. The Working Group is refining an
    inventory of federal activities addressing youth violence; to make
    information on violence prevention and other interventions available to
    families, teachers, administrators and others involved in designing and
    implementing programs; and to develop a coordinated federal research
    agenda on youth violence.
        Staff of NIMH and the Centers for Disease Control and Prevention
    (CDC) are working closely to coordinate new CDC and NIMH efforts to
    develop new interventions and to implement effective prevention and
    treatment programs. This coordination has enabled NIMH and CDC to
    cross-reference and link research announcements issued by each agency,
    which already is enhancing the efficient use of federal research
    resources in this area of science.
        Finally, NIMH, CDC, and the Substance Abuse and Mental Health
    Services Administration (SAMHSA) are collaborating in a major effort to
    develop a Surgeon General's Report on the topic of youth violence. The
    report, planned for release early in fiscal year 2001, will examine
    advances in research regarding the occurrence and prevention of
    violence and interventions for those who engage in violent behavior. In
    order to raise public awareness about the critical issues surrounding
    youth violence, the report will provide useful information to help
    parents, schools and communities by identifying potentially effective
    strategies for ameliorating the risk of violence among youth. In
    addition, attention will be given to identifying approaches to
    intervention that may be contributing to problems rather than reducing
    them. This report will be an effective and highly credible means of
    educating policy makers and the public about the interaction of mental
    disorders and youth violence.

        Senator Specter. Senator Harkin.

                        treatment for Juvenile Diabetes

        Senator Harkin. Thank you, Mr. Chairman. I just want to get
    back to Dr. Spiegel one more time on juvenile diabetes and stem
    cells.
        Again, enlighten me again on what role stem cells could
    play in the further progress of what has happened at the
    University of Alberta. And then give me some idea of maybe some
    time frames that we are looking at.
        Just from my reading, my non-scientific reading, of it, it
    seems that this may be one of the earliest breakthroughs if, in
    fact, the data that I see from Alberta is correct, in terms of
    using stem cells to--and this is where my scientific expertise
    lacks--using the stem cells to regenerate the kind of cells
    that we need to replace the insulin-deficient cells in those
    who are suffering from juvenile diabetes. I think I am within
    the ballpark of scientific terminology there.
        Dr. Spiegel. Let me try to be concise. To be clear, in the
    Edmonton protocol, stem cells have not been used.
        Senator Harkin. I understand that.
        Dr. Spiegel. So they are using harvested inlets containing
    insulin-secreting cells from donor pancreas.
        Senator Harkin. Yes, sir.
        Dr. Spiegel. What we are both enthusiastic and cautiously
    optimistic about is that we hope this will be successful,
    because if it is, it represents a long-sought cure for Type I
    diabetes, juvenile diabetes.
        But it will then create an enormous demand and need for
    sources of insulin-secreting cells, which cannot possibly be
    supplied at current donor rates. And that is why stem cells are
    so absolutely critically important.
        Because research into stem cells, both the pluripotent type
    of embryonic stem cells that Dr. Fischbach alluded to, as well
    as ones that are further along, such as stem cells from the
    part of the embryo that would ultimately lead to both liver and
    pancreas, understanding those developments are critical to be
    able to provide a source for these kinds of transplantation
    experiments.
        And one final point: Basic stem cell research could also be
    important in teaching us ways to intervene in individuals with
    Type I diabetes to get regeneration of their existing stem
    cells. And this is potentially an important modality of
    treatment as well, which would be an alternative or complement
    to transplantation.
        Senator Harkin. I appreciate that, Dr. Spiegel. Could you--
    I hate to ask for more paperwork. But with regard to this area
    and the answer you just gave, if you could reduce that to
    writing for me and just get that to me, I sure would appreciate
    it.
        Dr. Spiegel. I would be pleased to.
        [The information follows:]
                        Stem Cell Research and Diabetes
        Type 1 diabetes is a disease for which stem cell research holds
    great promise. Research on islet cell transplantation and stem-cell
    biology offers compelling opportunities for the development of new,
    innovative approaches for treating and ultimately curing this disease.
    Type 1 diabetes is characterized by the inability of the body to
    produce insulin, a hormone necessary for glucose metabolism. It arises
    when the body's immune system attacks and destroys its own insulin-
    producing beta cells in the islets of the pancreas. The result of this
    ``autoimmune'' disease process is high levels of blood glucose, which
    are difficult to control with insulin injections. Moreover, although
    treatment with insulin sustains the patient's life, it does not prevent
    the devastating complications of the disease. These include kidney
    failure, blindness, amputation, heart attack and stroke. Clinical
    trials have shown that these complications can be prevented or
    significantly delayed by maintaining blood glucose levels as close to
    normal as possible. However, achievement of such intense blood glucose
    control requires multiple daily injections of insulin or use of an
    insulin pump--an extremely difficult regimen to follow, especially for
    children and teenagers, and one that always poses a risk of dangerously
    low blood sugars.
        To address these problems, researchers have pursued alternative
    approaches to restoring insulin-producing capacity--including research
    to develop an artificial pancreas, research on whole pancreas
    transplantation, and studies of islet cell transplantation. Formidable
    bioengineering problems attend development of an artificial pancreas,
    and while researchers are working diligently to overcome them, a time
    frame for success cannot be predicted. Whole pancreas transplantation,
    while successful in some patients, is an extremely difficult surgery.
    It requires lifelong treatment with immunosuppressive drugs that can
    have toxic side effects. Moreover, whole pancreas transplantation does
    not have as high a rate of graft survival as kidney transplantation.
    This surgery is typically performed only in adults, often in
    conjunction with a needed kidney transplant for which immunosuppressive
    drugs would already be required.
        Islet cell transplantation has several potential advantages. For
    example, insulin production could be restored with islets alone, which
    would be a much simpler procedure than pancreatic transplantation.
    Ideally, islet cell transplantation could be achieved with one or two
    infusions of cells on an outpatient basis without the need for chronic
    immunosuppressive drugs. Until very recently, serious technical
    problems have been a major impediment to rapid progress in islet
    transplantation research. The two key challenges have been: (1) to keep
    the body's immune defense system from rejecting the transplanted
    islets, and/or causing recurrence of autoimmune destruction of islets,
    and (2) to ensure that there is a sufficient supply of islet cells for
    transplantation. To date, only about five percent of people with
    diabetes who have received transplanted islets along with
    immunosuppressive drugs have been able to stay off insulin longer than
    one year. Recent scientific developments offer the potential to
    overcome these obstacles and have propelled researchers to focus more
    intense efforts on islet cell transplantation. This therapy is now
    viewed as a highly promising means of curing type 1 diabetes,
    especially for children and young adults whose disease has not yet
    progressed to the point of debilitating complications.
        The renewed promise of islet cell transplantation derives from two
    complementary research opportunities that could overcome the challenges
    that have stymied progress in this field. The first opportunity is the
    development of new methods for modulating the immune system to both
    preserve residual insulin-producing capacity and to keep the body from
    rejecting transplanted islet cells. The second opportunity is the
    prospect that stem cell research could ensure the needed supply of
    islet cells for transplantation. Together, these opportunities offer
    unprecedented hope for curing type 1 diabetes. They are also highly
    consistent with major recommendations of the Strategic Plan of the
    congressionally directed Diabetes Research Working Group.
        The first new opportunity, the development of novel immune-
    modulating methods, is the focus of multiple research initiatives
    across the NIH, including NIDDK, NIAID and NCRR. Scientists are making
    progress in finding ways to both halt the attack of the immune system
    on its own tissue and to prevent the body's rejection of transplanted
    organs and tissues--without the lifelong need for immunosuppression.
    Following promising preliminary results in experimental animals,
    clinical investigators are pursuing studies of novel biologic agents
    that offer the prospect of modulating the immune system in such a
    manner that transplanted organs and tissue are indefinitely accepted by
    human recipients. Initial clinical studies applying immune modulation
    therapy are being performed in patients receiving a kidney transplant
    for end-stage renal disease. Later this year, researchers plan to
    transplant insulin-producing pancreatic islet cells into patients with
    selected forms of type 1 diabetes.
        Of particular promise are studies currently under way by a team of
    researchers at the Unversity of Alberta, Edmonton, Canada. These
    researchers have developed and are following a revolutionary protocol
    for islet cell transplantation in patients with type 1 diabetes. This
    protocol involves treatment with an antibody to a cytokine receptor;
    rapamyacin; and a low dose immunosuppressant. It is particularly
    noteworthy that this protocol did not use glucocorticoid steroids as an
    immunosuppressive agent. In addition to having well-known side effects,
    such as growth retardation and increased risk of osteoporosis, these
    steroids are also toxic to islets. The researchers expect to report on
    their results in a scientific journal in the very near future. The
    Juvenile Diabetes Foundation International (JDF) provided support for
    the initial research in Edmonton. Now, plans are under development to
    replicate this approach, with support from the NIAID, NIDDK and the
    JDF, at several transplant centers that harvest their own islets.
        To the extent that islet transplantation therapy proves successful,
    there will be a great need for more islet cells. Currently, the NIH is
    working to perfect methods to increase the yield of these cells from
    pancreatic tissue; however, the ultimate solution will be to obtain
    them from other sources, such as stem cells. In this regard, it is
    vitally important to pursue simultaneous research on two fronts of stem
    cell biology: embryonic stem cells and adult stem cells.
        Embryonic stem cells offer the greatest promise of providing a
    limitless source of islet cells for treating and curing type 1
    diabetes. Embryonic stem cells are called ``pluripotent,'' because they
    have the ability to develop into most of the specialized cells or
    tissues in the human body. These stem cells can be derived from embryos
    that were intended for in vitro fertilization, were not used, and are
    donated for research purposes. Because embryonic stem cells mark the
    earliest stages of human development, they have not yet differentiated
    into specific types of organs and tissues. Thus, the possibility exists
    that these cells could be made to differentiate into specialized tissue
    needed for transplantation therapy, such as islet cells. Because
    embryonic stem cells have the unique property of being capable of
    limitless division and self-renewal, they can be maintained
    indefinitely in tissue culture. Thus, their potential benefits for
    research and medicine are enormous.
        Another potential source of islet cells for transplantation are
    stem cells found in the tissues of adults. Although these cells do not
    have the same capabilities as embryonic stem cells, they could prove
    useful in islet cell transplantation. Adult stem cells undergo
    asymmetric division, with some becoming stem cells capable of
    replenishing the tissue in which they are located, while others are
    capable of specialization into different tissue. Thus, adult stem cells
    are at an intermediate point in the differentiation process--beyond the
    embryonic stage, but not irrevocably committed to a final cell or
    tissue type. If researchers were able to identify and isolate
    pancreatic stem cells from adult tissue, it might be possible to direct
    these cells to differentiate into islet cells. This possibility could
    come to fruition as more is learned about the genes regulating cellular
    development and differentiation.
        The ability to use embryonic and adult stem cells as a means of
    providing islets for transplantation therapy in type 1 diabetes will be
    critically dependent upon a fundamental understanding of the
    developmental pathways that lead to the formation of pancreatic islets.
    A workshop on ``Stem Cells and Pancreatic Development'' held at NIH
    provided evidence of impressive progress in identifying a cascade of
    genes responsible for differentiation of cells from precursors in the
    embryonic foregut to pancreatic islet and specifically beta cells.
    Scientists at this workshop also reported on progress in
    identification, growth, and transplantation of hematopoietic, neural,
    muscle, liver, and pancreatic stem cells. Major recommendations for
    further research to permit application of stem cell technology to
    treatment of type 1 diabetes included:
        1. Identification of molecular `signatures' of stem cells and
    progenitors in the endocrine pancreas. Identifying all the genes
    expressed in the mouse and human pancreas throughout development is a
    goal of a major new NIDDK initiative on the ``Functional Genomics of
    the Endocrine Pancreas.'' It is conceivable that some of the genes may
    regulate cellular differentiation and thus could be used to direct stem
    cells down the specialization pathway to become islet cells;
        2. Generation of monoclonal antibodies to proteins expressed on the
    surface of islet beta cells and islet cell precursors to use in
    identification and isolation of pancreatic stem cells.
        3. Identification of growth conditions that permit the
    proliferation and differentiation of lineage-specific stem cells both
    inside and outside the body;
        4. Exploration of the potential use of embryonic stem cells, and
    tissue-specific stem cells, in the formation of pancreatic islets; and
        5. Use of animal models to examine the role of stem cells in the
    regeneration of the endocrine pancreas.
        Applying basic knowledge obtained from research in developmental
    and stem cell biology will enable the production of progenitor stem
    cells and the rational design of cellular therapies for human diseases
    such as diabetes. It is essential to underscore that studies of stem
    cells and the genes that regulate their development could be important
    as ways to intervene in type 1 diabetes, even beyond their use in islet
    cell transplantation. For example, a more precise understanding of stem
    cell biology could lead to methods to activate stem cells and to
    regenerate beta cells of the pancreas. Coupling immune modulation
    treatment to halt further autoimmune destruction of the islets with
    treatments to activate stem cells to regenerate beta cells would offer
    a powerful approach to prevention and treatment of patients at risk for
    development of type 1 diabetes.
        Thus, researchers have attained a very encouraging benchmark with
    respect to developing new clinical approaches to type 1 diabetes. They
    are currently pursuing a two-pronged approach involving both immune
    tolerance and stem cell biology to overcome previous impediments to
    successful islet cell transplantation. Inducing immune tolerance can
    halt or reduce the autoimmune attack on the insulin-producing cells of
    patients and help them retain some insulin reserve. In essence, this
    approach provides a ``shield'' to block the autoimmune attack and
    protect the residual insulin-producing cells from further destruction.
    The second prong of therapy is islet transplantation-based on novel
    methods of immunomodulation to prevent graft rejection, coupled with
    research on stem cell biology to provide a limitless source of islets
    for transplantation.

                              Human Genome Project

        Senator Harkin. Dr. Collins, on the human genome project,
    could you again enlighten me, and perhaps the press who is here
    and the public, there has been this big debate about Celera and
    you and this race to the finish and their patenting the gene
    and all that.
        A lot of people have asked me, well, wait, if you, the
    human genome project, is mapping and sequencing the human gene,
    and it is going to be here in another 1\1/2\ years or 2----
        Dr. Collins. We expect to have the finished sequence in
    2003, but a working draft will be done in the next 2 or 3
    months.
        Senator Harkin. OK. So 2003. And that is going to be
    available to the public?
        Dr. Collins. Yes.
        Senator Harkin. All the knowledge, everything, all the
    mapping, all the sequencing you have done on the human genome.
        Dr. Collins. Every 24 hours.
        Senator Harkin. All day long. So if a private company has
    already done that, and they have tried--why would a researcher
    then feel it necessary to go to a private company to get that
    kind of information, when they can go to NIH and get that
    information? So why do I care if Celera does whatever they are
    doing? As long as it is done in NIH, why should I care? I mean,
    it would be available to researchers all over. What is the
    problem?
        Dr. Collins. Well, Senator, I appreciate the question, and
    I appreciate this subcommittee's support of the Human Genome
    Project over the last 10 years. You had the vision of this
    project even before some of the rest of the scientific
    community had caught on. That vision is clearly paying off.
        We are at a very exhilarating time. Just yesterday we
    announced that we have crossed the 2 billion base pair mark.
        Senator Harkin. Wait a minute. I was just at the 1 billion
    base----
        Dr. Collins. Well, there you go.
        That is right. We appreciated your attending the ceremony
    in November to celebrate 1 billion. And yesterday we got to 2
    billion. It was T, by the way. The second billion bases were
    capped off by a T.
        And since the genome is only 3 billion, you can see that
    this working draft is coming along very quickly. It will
    require the course over the next 2 or 3 years to close the gaps
    and deal with the ambiguities that still remain in this draft
    version. But for many scientific applications, this will be
    enormously useful. And it is useful to anybody with an Internet
    connection.
        I think the parallel that I might try to draw for you is
    one that is perhaps familiar to people within these halls, and
    that is the Thomas System for keeping track of what is going on
    with regards to congressional legislation and other hearing
    transcripts and so on.
        There is this system, which citizens can go to if they are
    seeking information about what is happening in the U.S.
    Congress. And it is available for free to anybody who needs to
    find it out.
        There are other more elaborate systems, of course, that you
    can pay to subscribe to, such as Lexus Nexus or Congressional
    Quarterly Search Service, which for the sophisticated user who
    has the wherewithal to pay for them, are also useful.
        We think of ourselves as the Thomas System for the human
    genome project, where the basic information, the raw
    fundamental sequence of the genome, and some basic information
    about what it means, which our colleagues at the National
    Library of Medicine are putting together, is available to
    anybody in any country, whether in the private sector, the
    public sector, wherever. As long as they have an Internet
    contact, they can find out what we know right now, as of today.
        But there will undoubtedly be uses of the genome sequence
    that require a sophisticated level of annotation, of melding
    together a lot of additional information in order to try to add
    value to that basic information. We see that as a golden
    opportunity for the private sector to set up, hopefully not
    one, but many different competing databases that interested
    subscribers can check out and decide if they think those are
    worth their while to pay for.
        I think that is the solution to what has been a sort of
    tumultuous enterprise here, that we have the Thomas System, but
    then we have these other available, highly annotated versions
    that people who want to use them can subscribe to, if they find
    that that meets their needs.
        Senator Specter. Let me come back to you, Senator Harkin.
    Senator Feinstein had some more questions.
        Senator Feinstein.

                            AIDS Vaccine Development

        Senator Feinstein. Thank very much, Mr. Chairman.
        I would like to ask a question, if I might, about AIDS. The
    President's budget includes a 12-percent increase in 2001 for
    AIDS vaccine research. I was wondering if you could describe
    NIH's plan for developing the vaccine and, given this increase,
    if you could possibly be specific as to when a vaccine might be
    available.
        Dr. Kirschstein. Senator Feinstein, I am going to ask Dr.
    Nathanson, the Director of the Office of AIDS Research, and Dr.
    Fauci, the Director of the National Institute of Allergy and
    Infectious Diseases, to share their response to that question.
        Senator Feinstein. Thank you very much.
        Dr. Nathanson. Yes. So let us talk first about the way we
    are going about developing a vaccine, which I think was your
    first question. And the second was when we would expect to
    reach that goal.
        We have a series of sequential approaches which start off
    with some basic laboratory work on the virus, its proteins and
    its genes, and then move into animal experiments. And we are
    particularly using a rhesus monkey model of AIDS with a simian
    virus, simian immunodeficiency virus, very similar to human.
    And that can be rapidly used to improve the speed of this
    translation, to test concepts much more quickly than we can do
    in humans.
        And then we move into a further translational effort where
    we start first with phase one trials, which are safety trials
    on a small scale in humans, and then phase two, immunogenicity
    trials and extended safety trials, and phase three, efficacy
    trials.
        And we are expanding at all levels and basically pursuing a
    number of concepts about how to make an effective and safe
    vaccine in parallel because of the urgent need.
        We have made considerable progress with some of those
    concepts in animals. And at the present point in humans, there
    is a phase two trial that is an immunogenicity trial of a
    potential vaccine. It involves what is called a prime to start
    the immune response and a boost of an additional protein. And
    the results of that phase two trial will determine whether that
    is going to be advanced to a phase three trial.
        And I think Dr. Fauci might like to comment about that and
    maybe add something to my comments.
        Senator Feinstein. As to when we might----
        Dr. Nathanson. Well, as to when we will get to the
    potential phase three trial, this particular product could
    start within about a year, if we decide to move forward. It is
    a product the efficacy of which is somewhat marginal. And
    therefore, there is some debate within the scientific
    community.
        In fact, my council happens to be meeting today. And last
    night we did debate that somewhat. There are different views.
    And I think Dr. Fauci might like to enlarge on that.
        Dr. Fauci. The question really is twofold. When will we
    engage in a trial that will ask the question if a vaccine is
    effective? And then a much broader question that is much more
    difficult to answer is: When will we have an effective vaccine?
        Because one of the things we need to appreciate is,
    particularly with HIV, in contradistinction to other vaccine
    studies for other microbes, it is highly unlikely that the
    first vaccine trial that we do will be a home run, where we
    will have a highly effective vaccine.
        The situation is a little bit different with HIV/AIDS. When
    we deal with most of the vaccines that we deal with, namely for
    childhood diseases, we will not accept anything less than a 90
    or so percent effectiveness, because we want to make sure that
    virtually each and every one of the children that we vaccinate
    will be free of getting infected with the organism in question.
        With HIV/AIDS, we will probably have step-wise gradation of
    relatively more effective vaccines where the first one that is
    available might be in a range of effectiveness that would be
    unacceptable, for example, if it were a polio vaccine or a
    rubella vaccine. And those kinds of successes would probably go
    a long way to interrupting the kinetics of the epidemic,
    particularly in developing countries.
        For example, if you have a 35- to 45-percent efficacy of
    vaccine that would be unacceptable for a vaccine that we would
    use for a childhood disease, whereas that might, if given to
    populations with a very accelerated rate of infection, might
    interrupt the kinetics of the epidemic to the point that we
    would have a major positive impact.
        So it is really a complicated question and a complicated
    answer. We will probably within the next year or so be going
    into larger trials to ask a question, ``Is this at least
    partially effective?''
        But as Dr. Nathanson mentioned, while we are doing that, we
    will be building up a pipeline of candidates that might in 4,
    5, 6, or 7 years from now be much better than the candidates
    that we are dealing with now.
        Senator Feinstein. Thank you.
        Thank you, Mr. Chairman.
        Senator Specter. Thank you, Senator Feinstein.
        Senator Kohl.
        Senator Kohl. Thank you, Senator Specter.

                               Epilepsy research

        Dr. Fischbach, I am pleased that today NINDS is sponsoring
    a conference on epilepsy. I am hopeful that the discussions at
    the conference will lead to a clearer strategy for research
    into this disease. With that goal in mind, I have two
    questions.
        Report language last year discussed curing epilepsy, not
    just finding new treatments for it. What is NINDS doing
    differently to change its focus from finding new treatments to
    finding a cure to stop epilepsy?
        Dr. Fischbach. Thank you, Mr. Kohl. There is a wonderful
    conference which is beginning this morning and continuing for 2
    days, titled ``Curing Epilepsy,'' because the problem is that
    all of the drugs currently on the market merely reduce
    symptoms. More than a third of the patients in this country
    remain burdened with seizures at one time or another. There is
    no single therapy that completely eliminates them.
        We have expanded our ADD Program, our Anti-epilepsy Drug
    Development Program, looking for new medications with novel
    targets, new ways that drugs may interfere with the epileptic
    process that have not been explored before.
        We have developed methods for new modalities of therapies,
    such as brain stimulation, by stimulating outside the brain and
    even with electrodes placed inside of the brain, in an attempt
    to disrupt and cure epilepsy, defined as complete freedom from
    seizures and complete absence of side effects. So those are
    just two of the ways that we have approached it.
        A third and extremely promising strategy is to make use of
    resources now emerging from the genomic efforts to understand
    the mutant genes underlying more than 50 percent of the cases
    of epilepsy, which should lead to new and better diagnostic and
    therapeutic approaches.
        Senator Kohl. What is NINDS's strategy for focusing on the
    population with intractable epilepsy?
        Dr. Fischbach. This is the most difficult of all. And I
    simply would say that the three approaches I just mentioned--
    new targets for medicines, electrical stimulation to manipulate
    circuits in the brain, and more molecular genetic approaches
    will be beneficial to those patients. That is our hope.

                              Alzheimer's research

        Senator Kohl. Thank you.
        Dr. Hodes, it is my understanding that some research has
    shown that Alzheimer's disease begins to destroy the brain
    cells of its victims 10 to 20 years before outward symptoms
    appear. Do we currently have the tools to diagnose Alzheimer's
    disease in its earliest stages? And if not, what research is
    being done to develop that capability?
        Dr. Hodes. Senator, you are correct in that a number of
    studies have shown that a combination of parameters, including
    imaging, have been able to identify individuals who are at high
    risk of developing Alzheimer's disease a decade or two later.
        More recent studies, including some to be published this
    week, have taken a step further in refining these imaging
    techniques in particular, and have been extremely good at
    predicting which individuals are likely, over the course of a
    3- to 5-year follow-up, to develop Alzheimer's disease.
        This has not yet reached the stage of practicality as an
    intervention per se, but has an enormous impact in terms of
    identifying individuals at high risk. The importance of
    identifying individuals of high risk is particularly tied to
    current studies to test an intervention designed to prevent
    progression of disease.
        So by identifying a population likely, if no intervention
    is used, to develop Alzheimer's, we have an opportunity to
    carry out the critical studies now beginning, to see if we can
    interfere with that process.

                               Juvenile Diabetes

        Senator Kohl. Thank you. Last summer, 9-year-old Lenisha
    Patterson of Germantown, WI, testified before this subcommittee
    on what it is like to live with juvenile diabetes.
        I also have a short statement, which I would submit for the
    record and a statement from 14-year-old, Rachel Malz of
    Wisconsin, describing how diabetes has affected every day of
    her life. Both of these children have asked the subcommittee to
    promise to remember them and all the children who live with
    juvenile diabetes. I am one of 55 Senators who are trying to do
    just that.
        [The statements follow:]
                    Prepared Statement of Senator Herb Kohl
        Thank you, Mr. Chairman. And I'd like to welcome you, Dr.
    Kirschstein, and all of your colleagues who have agreed to appear
    before the Subcommittee today.
        As we all know, over the past several years, Congress has provided
    unprecendented funding increases for the NIH. I commend Chairman
    Specter and Senator Harkin for their leadership in ensuring that NIH
    has the resources it needs to achieve one of our nation's most
    important goals: curing disease and alleviating human suffering.
        It is both our hope and also our expectation, that this strong
    investment will result in new treatments and cures for diseases. Not
    only will this improve the quality of life of all Americans, it will
    reduce the need for expensive treatments in the future by keeping our
    nation's health care costs down.
        I strongly support biomedical research and agree that Congress
    should continue to provide the funds necessary to make this a reality.
    However, in addition to providing the dollars, Congress also has the
    responsibility to ensure that these funds are spent wisely. We have
    provided these increases as part of a balanced budget--but we must not
    forget that we have accomplished this by making some tough choices
    between other health and education programs. It is critical that these
    trade-offs can be justified by ensuring that research targets our
    nation's most pressing health needs.
        Again, I thank you, Mr. Chairman, for your support of NIH. I look
    forward to the question period, when we will have a chance to explore
    these priorities and results in more detail.
                                     ______

                 Prepared Statement of Rachel Malz, Madison, WI
        Good morning. My name is Rachel Malz and I am from Madison, WI. I
    am fourteen years old and I was diagnosed with Juvenile Diabetes when I
    was only 21 months old. I do not remember even one day when diabetes
    was not a part of my life. My diabetes has been very difficult to
    control. I was placed on an insulin pump when I was ten to help control
    all the ups and downs. However, at the age of twelve, my kidney tests
    showed some problems, so my doctor started me on an Ace--Inhibitor
    medication. Studies have shown these drugs may help keep my kidneys
    working. As you can see, I am doing all I can to stay as healthy as
    possible until a cure is found. I need all of you in that room today to
    do your part and work together so it will happen soon. Thanks to you
    and to Senator Kohl for the opportunity to share my story.

        Senator Kohl. Earlier this year we sent a letter asking you
    to fund more research into this area. I was pleased to learn
    that NIH is planning to implement the scientific
    recommendations of the Diabetes Research Working Group.
        However, it is my understanding that doing so would cost
    $827 million in fiscal year 2000, while NIH projects to spend
    only $525 million.
        I would appreciate knowing from you how NIH will be able to
    implement these recommendations, given the fact that the
    resources are presently lacking.
        Dr. Kirschstein. NIH strongly endorses the scientific
    recommendations of the Diabetes Research Working Group. And Dr.
    Spiegel and I have had many conversations about this.
        Within the constraints of the President's proposal for
    fiscal year 2001, which was a 5.6-percent increase overall, we
    provided to the Diabetes Institute a 5.9-percent increase. We
    will work hard with the funds that are available and funds that
    are given to us, to do the best and most important research
    possible.
        I think you heard from Dr. Spiegel how he is deeply
    involved in some of the studies on juvenile diabetes. He and I
    both understand the problems of that disease and feel deeply
    for those children. And I would like to ask him to expand on
    the discussion.
        Senator Kohl. Thank you.
        Dr. Spiegel. Thank you, Dr. Kirschstein.
        And, Senator Kohl, I appreciate the opportunity. It brings
    me back to the chairman's question. The Diabetes Research
    Working Group suggests that NIDDK, for example, in 2001 should
    increase its spending by $387 million. And within the budget
    constraints of the President's budget, we expect to increase
    from $313 million to $338 million. So you see that that falls
    very substantially short.
        Nonetheless, it is clear that there are some extraordinary
    opportunities, specifically in genetics, genomics and in
    clinical trials for Type I, Type II diabetes and obesity, all
    significant problems.
        So we are going to do the best that we can within the
    constraints of the budget, but it is clear that there are
    extraordinary opportunities which we would seize upon, if there
    were additional resources.
        Senator Kohl. Thank you, Mr. Chairman.
        Senator Specter. Thank you very much, Senator Kohl.

                                  NCI'S Budget

        Let us try a round to see how this works on the questions
    that I have posed. We will start with you, Dr. Klausner. You
    and I have talked about this on a number of occasions. Question
    one: What is the total funding for your institute?
        Dr. Klausner. The proposed total funding----
        Senator Specter. No. What is the current total funding for
    your institute?
        Dr. Klausner. $3.32 billion.
        Senator Specter. And what percent of grants do you award?
        Dr. Klausner. The success rate for grants will be 30 to 31
    percent this year.
        Senator Specter. And what is the total number of
    applications you have?
        Dr. Klausner. The total number of applications we have had
    this year is a little less than 4,000.
        Senator Specter. And what percentage would you like to
    grant, or do you think are meritorious?
        Dr. Klausner. I think what we would shoot for is about 40
    percent.
        Senator Specter. And what would the total funding be
    necessary to make the grants that you would like to make?
        Dr. Klausner. In order to achieve that level of funding
    and--and I think this is important--at the same----
        Senator Specter. You do not have to repeat the question. We
    would just like the answer, because I would like to go around
    the room.
        Dr. Klausner. OK. We would require about a 20-percent
    funding increase for the Institute to achieve the above success
    rate.
        Senator Specter. OK. Would you see if you could sharpen
    that up a little for me on all those questions?
        Dr. Klausner. Yes.
        Senator Specter. I know we are catching you sort of off
    guard here.

                                 NHLBI's Budget

        Dr. Lenfant, Heart, Lung and Blood Institute, what is your
    total funding?
        Dr. Lenfant. It is--including the AIDS component $2.025
    billion.
        Senator Specter. And how many grants have you made, are you
    making?
        Dr. Lenfant. In this year, it will be 1,050.
        Senator Specter. And what percentage is that of the
    applications?
        Dr. Lenfant. It is 27 percent.
        Senator Specter. And what percent grants would you like to
    make, if you had adequate funding?
        Dr. Lenfant. I will be consistent, and I will say 35
    percent is really what we should support.
        Senator Specter. And what kind of budget would you need to
    do that?
        Dr. Lenfant. That would require an increase of
    approximately 16 percent.

                                 NIDCR'S Budget

        Senator Specter. Dr. Slavkin, dental, what is your total
    funding?
        Dr. Slavkin. Our current funding for fiscal year 2000 is
    $269 million, including the AIDS budget.
        Senator Specter. And how many grants have you made?
        Dr. Slavkin. We project making 157 competing awards this
    year. In the year that closed, our total was 131. And we
    anticipate next year it will be 127.
        Senator Specter. And what percent of the applications will
    you be making grants to at the higher figure?
        Dr. Slavkin. We will struggle to meet a success rate of 19
    percent for fiscal year 2001. And so our----
        Senator Specter. And what percent would you like to make?
        Dr. Slavkin. Well, we have been hoping to reach at least a
    33-percent success rate.
        Senator Specter. And what total funding would that require?
        Dr. Slavkin. For us, that would require an additional $41
    million in funds for the competing research project grant line.

                                 NIND'S Budget

        Senator Specter. Dr. Fischbach, what is your total funding?
        Dr. Fischbach. $1.03 billion.
        Senator Specter. And how many grants have you awarded?
        Dr. Fischbach. 2,000.
        Senator Specter. And what percentage is that to the number
    of applications?
        Dr. Fischbach. It is 35. We are close to 35 percent.
        Senator Specter. And what percent would you like to award?
        Dr. Fischbach. 40 percent.
        Senator Specter. And how much more money would that take?
        Dr. Fischbach. That would require approximately a 20-
    percent increase above the $1.03 billion.

                            possible Accomplishments

        Senator Specter. What do you think you could accomplish
    with that extra money, Dr. Fischbach?
        Dr. Fischbach. I think we would do a significant amount
    more in neuro-degenerative disorders--ALS, Huntington's
    disease, Parkinson's disease, and Alzheimer's disease
    especially. We would fund more consortial arrangements for
    sharing of resources.
        Senator Specter. We heard that as to Parkinson's, the
    answer may be as close as 5 to 7 years. Would you confirm that?
        Dr. Fischbach. That is the hope, and I am optimistic about
    that.
        Senator Specter. How about Alzheimer's?
        Dr. Fischbach. That is an also extremely promising area of
    research, as I am sure Dr. Hodes would expand on. But with new
    discoveries about enzymes responsible for amyloid deposition,
    there is renewed hope for new therapeutic targets.
        Senator Specter. Could you give us a projection on time, if
    you got the extra money?
        Dr. Fischbach. On Alzheimer's disease, I think it is
    difficult to project that. That is such a complex disorder
    involving so many different systems within the brain that I
    would hope that even prolonging useful cognitive life by 1 or 2
    years in the next 10 would be an extreme advance.
        Senator Specter. Well, would you all write down the
    questions and provide--I am going to observe the time signals--
    the total funding each of your units gets, the number of grants
    you are able to award with that amount of funding, what percent
    the awards are from the total number of applications, what
    percent you would like to award, and what that would cost?
        [The information follows:]
                           Institute/Centers Budgets
        The following table summarizes the total funding levels requested
    for each institute and center (IC) in the fiscal year 2001 President's
    Budget request. It also provides the number of new and competing
    research project grants (RPG) that each IC funds and the success rate
    or percent of RPG applications each IC could fund within the fiscal
    year 2001 President's Budget request.
        The table also summarizes the success rates by IC associated with
    funding all new and competing RPGs in fiscal year 2001 at the
    professional judgment (PJ) level, as well as total costs associated
    with funding at the PJ level. Professional judgment budgets, which
    reflect each IC's best judgment of scientific opportunities available,
    are formulated by each IC without consideration of competing pressures
    or budgetary constraints or Administration priorities. NIH believes
    that each IC's PJ budget represents the IC's judgment of scientifically
    meritorious research.
        As I have noted, the RPG success rate varies among ICs. This
    variation reflects the difficulty of predicting total numbers of
    applications as well as the importance of many other mechanisms in
    funding each IC's best judgment of scientific opportunities available
    for support in fiscal year 2001.

                   NATIONAL INSTITUTES OF HEALTH ADDITIONAL COSTS TO FUND PROFESSIONAL JUDGMENT BUDGET
                                                  [Dollars in millions]
    ----------------------------------------------------------------------------------------------------------------
                                                                           Fiscal year 2001
                                                --------------------------------------------------------------------
                                                        President's budget           Funding professional judgement
                                                --------------------------------------------------------------------
                                                                                              Additional  Additional
                                                             Number of   Success    Success     amount    amount for
                                                    Total    competing    rates      rates     competing   IC total
                                                                RPGs    (percent)  (percent)     RPGs     PJ budgets
    ----------------------------------------------------------------------------------------------------------------
    NCI........................................    $3,505.1      1,271         30         42      $154.5      $629.9
    NHLBI......................................     2,136.8        811         29         43       146.9       193.6
    NIDCR......................................       284.2        127         19         33        40.9        74.0
    NIDDK......................................     1,209.2        715         34         50       107.0       160.5
    NINDS......................................     1,084.8        487         25         39       115.3       151.2
    NIAID......................................     1,906.2        831         31         39       110.4       159.9
    NIGMS......................................     1,428.2        882         26         33        81.3       128.8
    NICHD......................................       904.7        332         20         35       110.3       160.1
    NEI........................................       474.0        237         34         45        41.6        69.2
    NIEHS......................................       468.6        181         23         27        12.2        59.4
    NIA........................................       725.9        315         17         33       116.5       155.0
    NIAMS......................................       368.7        216         24         35        33.4        46.1
    NIDCD......................................       278.0        140         21         37        30.3        47.3
    NIMH.......................................      1031.3        485         23         33        67.0       138.3
    NIDA.......................................       725.5        262         21         32        46.9       113.4
    NIAAA......................................       308.7        123         23         48        43.1       102.6
    NINR.......................................        92.5         50         14         26        12.1        17.5
    NHGRI......................................       357.7         43         32         42        11.2        72.5
    NCRR.......................................       714.2         57         13         22        10.0       319.3
    NCCAM......................................        72.4         18         26         40        27.6        40.2
    FIC........................................        48.0         58         27         47         6.1        22.0
                                                --------------------------------------------------------------------
          Total................................    18,124.7      7,641         26         38     1,324.7     2,861.0
    ----------------------------------------------------------------------------------------------------------------
    Notes.--Because the question specifically focuses on RPGs and success rates, this table does not include
      information on the National Library of Medicine, the Office of the Director, and Buildings and Facilities
      activities.
    May not add due to rounding.

        Senator Specter. I am glad that Senator Stevens, the
    chairman of the full committee has--Senator, if I may have
    Senator Stevens' attention.
        He came in just at the point where we were inquiring of
    this distinguished group of scientists what funding they would
    like to make awards on the meritorious grants. And that is a
    good place for the chairman of the full committee to come in.
        We do not have the answers, but I will provide them to you,
    Senator Stevens. And I will also give you the floor at this
    time.

                    OPENING STATEMENT OF SENATOR TED STEVENS

        Senator Stevens. Well, thank you very much. And I am sorry
    to just barge in. We have a whole series of subcommittees
    meeting today, and I do like to stop in on each one and thank
    the people involved for their participation.
        I do think that we have a very tight budget this year. But
    I also think--and I have been making speeches throughout the
    country on the conclusion I have reached, really.
        And that is that this group, NIH, represents an investment
    in the future that, from a strictly conservative point of view,
    we ought to increase the investment now to assure that you
    are--that we are capable of dealing with the vast problems that
    will come to our country when the baby-boomer generation
    retires.
        If we have the same degree of diseases in their generation
    as exist in my generation, there is going to be a skyrocketing
    cost that the budget just cannot absorb.
        Though we are on the verge of so many breakthroughs, I
    think the number one and most important investment we can make
    this year--and I am chairman of the Defense Subcommittee--is
    not in defense, but is in accelerating the research and
    bringing about the developments and perfecting the application
    of some of the breakthroughs we already have.
        And I am--once again, Mr. Chairman, I am still ready to do
    battle. We are going to continue to be on the course that we
    are on, and that is: We are going to try to continue our
    process that will, within 5 years, double the amount of money
    that is available for research in NIH.
        Now, that is the commitment you made and, I think, we all
    made when we voted on that resolution. I take this resolution
    very seriously.
        Having said that, though, I do think that we have to find
    some way to really make certain that this money is really going
    to research and not necessarily to bricks and mortar. I am a
    little slow about the bricks and mortar side of the budget.
        I think the most important thing we can do now is
    accelerate this research and put it in the hands of our most
    competent people, and make sure that we get, to the maximum
    extent possible, the breakthroughs we need so we can reduce
    those future costs. That is the investment that I think we
    should make.
        And I thank you, Mr. Chairman.
        Senator Specter. See how good Senator Stevens' timing is?
    He came in at just the right moment. That is a pretty good
    commitment from the chairman.
        Senator Stevens. Thank you.
        Senator Specter. Thank you for that, Senator Stevens.
        Senator Harkin.

                                Gene Sequencing

        Senator Harkin. That is a good commitment. I appreciate
    that, Mr. Chairman.
        Dr. Collins, I just want to wrap up this issue on the
    genome. I read the statement put out by Prime Minister Blair
    and President Clinton, statements made at the following press
    conference by you and Dr. Lane.
        I just want to make it clear. Since I have been involved in
    this from the beginning, I just want to make it clear again
    where I think we ought to be headed in this. And I want to make
    it clear to the press that is here, too.
        That raw fundamental data on the sequencing of the human
    gene or any parts thereof should never be patentable. If a
    private sector company wants to get patents, I believe that
    company should take that raw available data, conduct
    experiments like they would for any other drug, and if
    experiments prove that it has application that a certain piece
    of gene would produce a disease-related protein, for example,
    and they can prove that through experimentation, and valid
    experimentations, then I have no problem with a patent at that
    point.
        But it is my belief that we have put a lot of public money
    into this globally, and that this raw data ought to be
    available to any researcher anywhere free of charge.
        And if companies want to seek to try to influence the
    Patent Office, well, we have something to say about that here
    legislatively, too. The Patent Office is a creature of the U.S.
    Congress. I know that they have had their comment period closed
    on March 22. And I am hopeful that they will be issuing
    guidelines along that pathway.
        But I have been quite upset, quite frankly, at some of the
    private companies who have indicated by filing thousands of
    patent requests, thousands of them, and they have not conducted
    one experiment, and they have tried to get a patent on those. I
    think that is not in the public interest. And I believe that--I
    do not think that those patents ought to be issued.
        So I just wanted to state for the record where I hope this
    is headed. If you have any further comments, I would welcome
    it. If not, you do not have to make a comment.
        Dr. Collins. Senator, I think you have expressed the issue
    very clearly. NIH has taken a position on the patenting issue,
    which is quite close to yours, namely that sequence information
    in the absence of any functional data about what that
    particular gene does ought not to be the subject of----
        Senator Harkin. Functional data means data based upon
    adequate experimentation.
        Dr. Collins. That is right. Whereas a circumstance where
    such data does exist and is compelling, that puts this sort of
    a gene patent application in the same category as other types
    of patent applications and ought to be seriously considered.

                                Methamphetamine

        Senator Harkin. I appreciate that. I said I had a couple of
    other questions here, but I may have to ask for those in
    writing. One had to do with methamphetamine because of the big
    problem in the Midwest. Methamphetamine, not only can we cut
    the supply, but the demand is a problem. And we find that this
    is a very addictive drug.
        I just wanted to ask Mr. Millstein what the Institute is
    doing on research on meth and possible treatment options. I
    have looked at this quite a bit, and it just seems like we are
    not getting very far. But maybe you have some knowledge that I
    do not know about.
        Mr. Millstein. Thank you, Senator Harkin. As you are well
    aware because you personally were involved in the town meeting
    that NIDA sponsored in 1998 in Des Moines----
        Senator Harkin. Right.
        Mr. Millstein [continuing]. We used that as the kickoff for
    the methamphetamine initiative. Our community epidemiology work
    group, which is an early alert system, had shown tremendous
    increases in use in rural areas, including Iowa.
        We had that kickoff specifically in Des Moines with your
    involvement, with the Governor's involvement and State health
    department, to talk about what we know, about public education,
    prevention and treatment.
        Since that time, we have made methamphetamine research
    supplements. We have already found out more about
    methamphetamine and violence, methamphetamine and heart
    disease, methamphetamine and brain damage.
        Because methamphetamine is a stimulant, we were able to
    pick up on some of the clinical trials that we have been
    conducting for cocaine in methamphetamine-using individuals,
    and currently are conducting clinical trials on five different
    potential medications, Tyrosine, Fluoxitine, Asertraline,
    Desipramine, and Isridapine.
        We are really hopeful that because we were able to move
    quickly, that soon we will have some kind of answers and be
    able to use that knowledge to apply to treatment populations,
    as well as in prevention.

                     Complementary and Alternative Medicine

        Senator Harkin. I appreciate that, because it seems that--
    well, my time is up.
        Just one last thing I would ask Dr. Kirschstein--Dr.
    Klausner, I wanted to talk to you about some things.
        But there is a list I have here from NIH talking about the
    total number of dollars spent in complementary and alternative
    medicine, not just in NCAM but in all of the institutes. It
    totals about $160.7 million estimate for fiscal year 2000; NCI,
    $38.4 million; and others.
        I would like to have a little bit further breakdown about
    what that all is for, what is happening in these areas, and how
    these different offices are correlating with NCAM on this type
    of research. I will not bore you, but just if you could give it
    to me.
        Dr. Kirschstein. We would be pleased to provide that.
        [The information follows:]
               Funding for Complementary and Alternative Medicine
        Each NIH Institute and Center (IC) has designated a liaison for
    complementary and alternative medicine (CAM) to provide scientific
    input to, and facilitate coordination with the National Center for
    Complementary and Alternative Medicine (NCCAM). NCCAM established the
    Trans-Agency CAM Coordinating Committee, which serves as a forum for
    facilitating research collaboration and coordination, not only across
    the NIH, but across other major Federal health research entities as
    well. The committee met on May 20, 1999; November 16, 1999; and April
    6, 2000. Membership of the committee includes:
      --the NIH IC CAM liaisons;
      --representatives of several OD Offices [Office of AIDS Research
            (OAR), Office of Behavioral and Social Sciences Research
            (OBSSR), Office of Dietary Supplements (ODS), Office of Rare
            Diseases (ORD), Office of Research on Minority Health (ORMH),
            and Office of Research on Women's Health (ORWH)]; and
      --liaisons from a number of other Federal Agencies [Agency for
            Healthcare Research and Quality (AHRQ), Centers for Disease
            Control and Prevention (CDC), Food and Drug Administration
            (FDA), Health Resources and Services Administration (HRSA),
            Indian Health Service (IHS), Substance Abuse and Mental Health
            Services Administration (SAMHSA), U.S. Department of
            Agriculture (USDA), U.S. Department of Education (ED), U.S.
            Department of Defense (DOD), U.S. Department of Veterans'
            Administration (VA), and the White House Commission on
            Complementary and Alternative Medicine Policy].
        Prior to the establishment of NCCAM, the ICs collaborated with the
    NIH Office of Alternative Medicine (OAM) on a number of activities,
    which included administration of OAM-supported research projects.
    Below, each of the ICs have provided examples of their current research
    collaborations with NCCAM and descriptions of their own CAM research
    portfolios.
                           national cancer institute
        NCI's research portfolio includes diverse activities performed in
    many venues including: Comprehensive Cancer Centers, clinical trials
    performed by the Cooperative Group and Community Clinical Oncology
    Programs and research projects performed by scientists at a variety of
    other academic institutions and corporations. Following are examples of
    research activities supported by NCI in complementary and alternative
    medicine:
    Examples of CAM Clinical Trials
        1. Phase III randomized trial of patients with prostate cancer to
    study the effect of a diet low in fat and high in soy, fruits,
    vegetables, green tea, vitamin E and fiber on prostate-specific antigen
    (PSA) levels.
        2. Phase II trial of patients with prostate cancer to study the
    effects of dietary soy on biomarkers of prostate cancer.
        3. Phase I and II trials using formulations of the active
    components from green tea. Patient accrual began in December, 1999.
    Examples of CAM Grants supported by NCI
        1. Dietary Tomato Products and Experimental Prostate Cancer
        2. Cohort Study of Dietary Supplements and Cancer Risk
        3. Inhibition of Prostate Cancer Cell Growth by Vitamin D
        4. Feasibility of Physioacoustic Therapy in Cancer Care
        5. Mechanisms of Dietary Modulation of Melanoma Invasion
        6. Menopausal Symptom Relief for Women with Breast Cancer
    CAM Practice Assessment Program
        1. Best Case Series Program--solicits and reviews case report data
    of complementary and alternative medicine therapies that are felt by
    their practitioners to be effective cancer therapies, and presents case
    series to the Cancer Advisory Panel for Complementary and Alternative
    Medicine.
        2. Practice Outcomes Monitoring and Evaluation (POMES) projects--a
    process used to follow-up on promising Best Case Series reviews. In the
    pilot project, we will evaluate outcomes at the P Banerji Homeopathic
    Research Foundation clinics in Calcutta, India using contract support
    to monitor new lung cancer patients and obtain documentation and
    follow-up of 30-50 new lung cancer patients for 12-18 months.
        CAM Citation Database.--A project to explore the feasibility of
    augmenting the cancer component of the existing NCCAM CAM Citation
    Index versus establishing an independent NCI controlled cancer CAM
    research database. This database will become a resource for NIH and
    extramural investigators interested in CAM research and will include
    articles and abstracts from many databases including Medline or Web of
    Science. The database will serve as a resource for NIH and extramural
    investigators interested in CAM research.
        The Director of NCI's Office of Cancer Complementary and
    Alternative Medicine (OCCAM) meets with the Director of the NCCAM every
    two weeks to discuss ongoing and new collaborative projects. Also
    several other projects funded by the NCI (e.g. the OCCAM Website, the
    Practice Outcomes Monitoring and Evaluation System project in Calcutta
    India, the NCI's Best Case Series Program) are discussed at these
    meetings.
        The Cancer Advisory Panel for Complementary and Alternative
    Medicine (CAPCAM) was jointly constructed by the NCCAM and the NCI to
    (1) review and evaluate summaries of evidence for CAM cancer claims
    submitted by practitioners, (2) make recommendations to the NCCAM on
    whether and how these evaluations should be followed up, and (3) be
    available to observe and provide advice about studies supported by the
    NCCAM and NCI, and about communication of the results of those studies.
    The Panel's membership is drawn from a broad range of experts from the
    conventional and CAM cancer research and practice communities. The
    organization meeting for the CAPCAM was held November 1998. The panel
    was subsequently chartered and is authorized to meet at least twice a
    year. The first meeting of the chartered panel was held July 1999. For
    fiscal year 2000, one CAPCAM meeting was held in December 1999 and a
    second one is scheduled for late summer, 2000.
                   national heart, lung, and blood institute
        NHLBI has had a long standing interest in complementary and
    alternative medicine for heart, lung and blood diseases and has been
    collaborating with the Office and now the National Center for
    Complementary and Alternative Medicine since its inception. Because of
    the elevation of NCCAM to the Center status, most research grants
    initially funded by NCCAM and managed by NHLBI, have been reassigned to
    NCCAM. Currently, NHLBI has a few primary applications, but has
    secondary assignment on most new applications related to heart, lung
    and blood diseases. In addition to grant support, NHLBI has been
    involved in the following joint activities:
        1. NHLBI is a co-sponsoring Institute for a PA ``Acupuncture
    Clinical Trial Pilot Grants'', issued by NCCAM in 1998. Several grants
    have been funded by NCCAM.
        2. A workshop on the ``Complementary & Alternative Medicine in
    Cardiovascular, Lung and Blood Research'', jointly sponsored by NHLBI
    and NCCAM, is scheduled for June 12-13, 2000, to be held in Bethesda.
        3. NHLBI and NCCAM jointly sponsor an RFA to encourage studies to
    assess the efficacy of CAM, including acupuncture, herbal remedies,
    homeopathy and magnesium supplement, in allergic disease and asthma.
        4. NHLBI cosponsors an RFA on the Ginkgo Evaluation of Memory Study
    with NCCAM and plans to provide funding in fiscal year 2000.
        5. NHLBI continues to serve on a Trans-NIH Coordinating Committee
    on Complementary & Alternative Medicine. This group reviewed planned
    activities, helped to prioritize initiatives, and offered other
    possible scientific directions to consider.
             national institute of dental and craniofacial research
        In fiscal year 1999, NIDCR funded a variety of research classified
    as ``Complementary and Alternative Medicine''. The majority of this
    funding was associated with research projects that addressed treatment
    of pain associated with temporomandibular joint disorders.
        NIDCR has worked with NCCAM to help develop their research
    portfolio. For example, Institute staff participated with NCCAM in the
    development of the Request for Applications for CAM Centers, which
    stimulated the project P50 AT/DE00076 (White/Kaiser Research
    Foundation-Craniofacial Complementary and Alternative Medicine Center).
    In addition, NIDCR staff vigorously encouraged oral health researchers
    to prepare CAM Center proposals, through contacting investigators,
    suggesting potential collaborations, and disseminating information on
    the CAM Center RFA at scientific meetings and in newsletters.
        Similarly, NIDCR staff identified opportunities to stimulate
    acupuncture research within pain research activities being conducted at
    the University of Maryland, where several physicians and
    neurophysiologists originally trained in China were initiating their
    scientific careers under the mentorship of a world-recognized
    neurophysiologist-dentist. The resulting project, funded by NCCAM, used
    a dental (third molar extraction) pain model to compare patients' post-
    operative pain relief after being given standard analgesics, sham
    acupuncture, or real acupuncture.
        national institute of diabetes and digestive and kidney diseases
        The NIDDK is supporting research on several alternative or
    complementary medicine strategies and has interest in their efficacy
    and safety and in understanding their mechanisms of action and
    interaction. Work on biofeedback is supported. There is close
    collaboration with the NIH National Center for Complementary and
    Alternative Medicine (NCCAM). Some specific examples include: (1)
    Herbal Therapy for Benign Prostatic Hyperplasia (BPH): The NIDDK and
    the NCCAM are jointly funding a clinical trial on the efficacy of saw
    palmetto, over the period of August 1999 through July 2002; (2) Placebo
    Effect: A trans-NIH workshop initiated by NIDDK, and jointly with the
    NCCAM, is planned for November 20-21, 2000. The purpose of this
    workshop is to develop a research agenda for placebo studies, and
    prepare background papers summarizing the current status; (3) Herbal
    Therapy for Liver Disease: The NIDDK and NCCAM will co-sponsor a
    Request for Applications (RFA) that would develop a standardized
    preparation of milk thistle for clinical studies of liver disease. In
    addition, the NIDDK held a workshop on ``Complementary and Alternative
    Medicine in Chronic Liver Disease,''on August 22-24, 1999, with support
    from the NCCAM and the Office of Dietary Supplements (ODS). (4)
    Chromium and Vanadium in Diabetes: In November 1999 the NIDDK co-
    sponsored a meeting with the ODS on ``Diabetes and Chromium:
    Formulating a Research Agenda.'' The workshop concluded that trials to
    assess efficacy and studies to define cellular mechanisms are needed.
    In 1992 the NIDDK issued an RFA to solicit research on vanadium;
    several laboratories are investigating its effect on glucose
    metabolism. (5) Botanical Research Centers: The Nutrition Branch of
    NIDDK has indicated interest in participating in a Request for
    Applications for Botanical Research Centers.
            national institute of neurological disorders and stroke
        NINDS funds 3 research grants in the area of complementary and
    alternative medicine (CAM) research. These include a clinical trial on
    vitamin intervention for stroke prevention and two grants on the
    ketogenic diet as a treatment for epilepsy.
        Brief summaries of these grants follow:
        Vitamin Intervention for Stroke Prevention.--This is a multi-center
    double-blind randomized controlled clinical trial to determine whether
    the administration of a multivitamin with high dose folic acid,
    pyridoxine, and cyanocobalamin, together with best medical management
    and risk factor modification, can reduce the incidence of recurrent
    stroke and myocardial infarction (MI) in patients with a first
    nondisabling stroke who also have elevated homocyst(e)ine levels. This
    is based on evidence that homocyst(e)ine is a risk factor for
    atherothrombotic disease (and may be involved in the disease etiology),
    and that elevated homocyst(e)ine levels can be reduced by vitamin
    supplementation. Such an intervention has the potential to be an
    inexpensive and safer alternative for preventing recurrent stroke and
    MI, as compared to current warfarin or ticlopidine therapy.
        Efficacy of the Ketogenic Diet--A Blinded Study.--This is a blinded
    placebo-controlled study of the high-fat-low-carbohydrate ketogenic
    diet to treat children with Lennox-Gastaut Syndrome, a refractory form
    of epilespy characterized by atonic-myoclonic seizures. Preliminary
    evidence suggests that the ketogenic diet is highly effective in
    reducing seizure frequency. The study will test both the initial
    efficacy of the diet (after 5 days) and whether seizure reduction can
    be maintained over a longer period of time (after 6 months on the
    diet).
        Ketogenic Diet and Brain Amino Acid Metabolism.--This study is
    investigating the mode of action of the ketogenic diet in a rat model.
    The hypothesis is that the ketone bodies produced as part of the diet
    reduce the rate of transamination of glutamate to aspartate. This has
    the effect of reducing brain concentrations of aspartate, which is
    excitatory, while increasing brain concentrations of GABA, which is
    inhibitory. This is being studied in rat pups being fed the ketogenic
    diet. In addition, the efficacy of the ketogenic diet to reduce
    seizures in a rat model of epilepsy is also being studied.
        NINDS is a member of the newly formed trans-NIH CAM Coordinating
    Committee, which meets regularly to identify opportunities for trans-
    Institute collaboration on activities and initiatives related to CAM.
    In addition, NINDS staff have worked closely in the past with NCCAM
    staff on several joint initiatives, including a Request for
    Applications (RFA) for Centers for Mind/Body Interactions and Health,
    and another RFA for Centers for Complementary and Alternative Medicine
    Research. An NINDS staff liaison also regularly attends study section
    (i.e., peer review) meetings of neurology related CAM grants.
             national institute of allergy and infectious diseases
        The NIAID supports complementary and alternative research efforts
    in areas that coincide with its own research priorities. The Institute
    expects to spend $8 million in this area in fiscal year 2000, and the
    following research examples reflect NIAID's interest in pursing
    research advances in its own targeted areas of research, with the help
    of complementary and alternative medicine.
      --The NIAID is supporting research on Siberian Ginseng at the
            University of Iowa. Investigators are examining the use of
            Siberian Ginseng for the treatment of chronic fatigue syndrome,
            and evaluating whether subjects with idiopathic chronic fatigue
            will respond to Siberian Ginseng, a widely recommended herb for
            the treatment of fatigue.
      --The NIAID is supporting research at the University of Cincinnati to
            determine the impact of dietary supplements on kidney graft
            survival and incidence and severity of post-transplant adverse
            events. To date, this pilot study has enrolled 20 patients and
            has shown a 77 percent reduction in the number of recipients
            having an acute rejection, leading to a 50 percent reduction in
            the number of biopsies for renal dysfunction. In addition, a
            significant reduction in the number of post-transplant
            infectious complications was also observed.
      --An international workshop, The Importance of Omega-3 Fatty Acids in
            the Attenuation of Immune-Mediated Diseases, will be co-
            sponsored by the NIAID, the NIH Office of Dietary Supplements
            and the National Center for Complementary and Alternative
            Medicine, and will be held in fiscal year 2000. The primary
            goal of this workshop is to establish research plans for
            definitive, mechanisms-based, preclinical studies and clinical
            trials to elucidate the mechanisms whereby omega-3 fatty acids
            attenuate immune-mediated diseases. Fish and other marine life
            are rich sources of a special class of polyunsaturated fatty
            acids known as the omega-3 or n-3 fatty acids. Reports suggest
            that dietary omega-3 fatty acids may have potent anti-
            inflammatory activities in inflammatory disorders such as
            transplant rejection, autoimmune and allergic diseases. The
            workshop will include investigators from the United States and
            other countries, who will participate in the discussions to
            review the current knowledge and clinical trial results.
            Further discussions will focus on setting research priorities
            and formulating research plans to accelerate focused studies in
            this area. The workshop proceedings will be published, and
            proposed initiatives for new preclinical studies and clinical
            trials will be developed for funding consideration by NIH
            Institutes and Centers.
      --The NIAID is providing funds to the University of California,
            Davis, to develop the Asthma-Alternative Medicine Center. The
            Center will serve as a U.S. and international resource to
            assist alternative medicine practitioners and researchers in
            identifying potential treatments and for developing protocols
            to evaluate the efficacy of unconventional medical practices
            using nutrition, ethnomedicine, and immunopharmacology for the
            treatment of asthma. The Center will include studies on: the
            effect of vitamin C on pulmonary function and quality of life
            on patients with mild asthma; oral immunotherapy of grass
            pollen allergy using wheatgrass juice; and the influence of
            botanical and glandular extracts on cytokine biosynthesis and
            cytotoxicity.
        It is customary for staff at the NIAID to interact with staff at
    the NCCAM on complementary and alternative medicine disciplines. For
    example, the NIAID program staff will consult with the NCCAM program
    staff about grant applications that cut across both the Institute and
    the Center.
            national institute of child health and human development
        The National Institute of Child Health and Human Development
    (NICHD) sponsors a variety of research projects to study complementary
    and alternative medicine (CAM). These span the life cycle, and include
    studies to: investigate the use of yoga to improve the pulmonary
    function in asthmatic women during pregnancy; evaluate the use of
    supportive birth companions and soft infant carriers to foster
    parenting skills and maternal/infant attachment; and test the
    hypothesis that muscle strength improvement in the elderly depends more
    on mental effort than training intensity. The latter has implications
    in rehabilitation of stroke victims. Other studies focus on pain
    management. One such study evaluates cognitive-behavioral treatments
    for pain reduction (relaxation training, parent education, stress
    management and thermal biofeedback) in children with recurrent
    migraines or abdominal pain. Another looks at the effects of manual
    therapies combined with specific exercises to treat chronic back pain.
    A third studies the effects of antioxidants (Vitamins C and E) on the
    pathogenesis of endometriosis, a disorder that inflicts pain and may
    cause infertility in women.
        The NICHD has a representative on the NCCAM Trans-Agency
    Coordinating Committee, who attends NCCAM's regular meetings,
    participates in discussions of joint initiatives, strategic planning
    and collaborative workshops. In addition, the NICHD staff administers
    several large center grants in collaboration with NCCAM to evaluate the
    effectiveness of CAM therapies, for conditions within the mission of
    the NICHD, and teach research methods and provide clinical research
    training and mentoring programs to clinicians who employ CAM.
                             national eye institute
        In fiscal year 1999 NEI-supported complementary and alternative
    medicine research that was principally focused on the role of nutrition
    and dietary supplements on prevention and treatment of progressive
    blinding eye diseases such as macular degeneration and cataract.
    Specifically, researchers are investigating the role glutathione, an
    antioxidant, has for protecting the retinal pigment epithelium from
    oxidative stress. This research may advance our understanding of the
    pathogenesis of Age-Related Macular Degeneration (ARMD) and provide
    information for the development of treatments for ARMD. Researchers
    supported by the NEI are also conducting an epidemiological study to
    evaluate the relationship between nutritional factors and ARMD in the
    United States, and the results of this research will be useful for the
    development of future clinical trials on nutritional intervention of
    this blinding disease. The NEI also supported research on the
    biochemistry and pharmacology of macular carotenoids. This research
    will investigate the biochemical processes responsible for the specific
    deposition of lutein and zeazanthin in the macula with special emphasis
    on the search for potential carotenoid-binding proteins. The results of
    this study will provide new insights on the uptake of lutein and
    zeazanthin into the macula, and may lead to the development of
    therapies that take advantage of these uptake systems to retard or
    prevent blindness resulting from macular and other retinal degenerative
    diseases. The NEI also funded research on the use of antioxidant
    supplements on the prevention of cataract progression. Additionally,
    the NEI reports to NCCAM on studies of the impact of dietary
    supplements on vision and visual disorders. NEI staff participate in
    NCCAM workshops.
              national institute of environmental health sciences
        The National Institute of Environmental Health Sciences (NIEHS) has
    several objectives regarding complementary and alternative medicine:
      --Assess toxicity of common herbal preparations, particularly their
            ability to cause reproductive, neurological and immunological
            toxicity
      --Assess the health consequence of long-term, chronic use of herbal
            preparations.
      --Define herb/herb and herb/drug interactions, particularly in
            sensitive subpopulations.
      --Identify the molecular basis of herbal efficacy and toxicity.
        Furthermore, the NIEHS, in conjunction with the National Toxicology
    Program (NTP), will design and initiate studies to identify and
    characterize possible adverse health effects that may be associated
    with prolonged use or higher doses of some of the most popular
    medicinal herbs, including aloe vera, comfrey tea, androstenedione,
    Ginkgo biloba, echinacea, and Panax quinquefolius (American ginseng).
        The NIEHS sponsored a workshop called International Workshop to
    Evaluate Research Needs on the Use and Safety of Medicinal Herbs with
    the NTP; NIH's Office of Dietary Supplements and its Office of Research
    on Women's Health; the Department of Health and Human Services' Office
    of Disease Prevention and Health Promotion; the Food and Drug
    Administration's Office of Special Nutrition; and the Society for the
    Advancement of Women's Health Research.
        Currently, medicinal herbs are not subject to testing requirements
    for effectiveness or safety. This workshop succeeded in bringing
    together an international panel of experts to discuss necessary
    research to address public health concerns related to their use. In
    follow-up to this workshop, the NIEHS and NTP are working with NCCAM,
    the NIH Office of Dietary Supplements, FDA, the academic community, and
    others to further define and implement research that addresses
    deficiencies in our knowledge about herbal medicines and their
    potential toxicities.
                          national institute on aging
        In fiscal year 1999, NIA funded a variety of areas related to
    complementary and alternative medicine including: investigations of the
    effects of culture and ethnicity on health care practices and treatment
    choices for diseases such as cancer and HIV infection; the use of
    phytoestrogens instead of estrogen replacement therapy for the
    prevention of menopausal symptoms and bone loss; the use of vitamin E
    to prevent atherosclerosis, cognitive decline in women, and infection;
    the effects of religion on health; and the use of tai chi to prevent
    falls.
        The Director, NCCAM has met with the Director, NIA, individually,
    and with NIA senior scientific program staff at a special meeting to
    discuss areas of potential scientific collaboration. An NIA staff
    person serves as an official NIA liaison to NCCAM to work on
    collaborative activities including the development of a conference on
    the placebo effect. Other specific areas of collaboration that are
    being pursued in fiscal year 2000 include the addition of a set of
    questions on the use of complementary and alternative medicine to the
    NIA Health and Retirement Survey; an ongoing program announcement on
    medication use by the elderly; and a randomized, controlled trial of
    ginkgo biloba in preventing Alzheimer's disease.
     national institute of arthritis and musculoskeletal and skin diseases
        There is substantial interest on the part of the American public in
    alternative therapies, particularly for people with chronic diseases of
    bones, muscles, joints and skin. For example, scientists have reported
    that green tea products show anti-inflammatory activity in mouse
    models. Rheumatoid arthritis is an example of an inflammatory condition
    affecting joints, resulting in pain and, over time, destruction of
    joints. Results of recent research suggest that identification of
    common dietary substances, such as green tea products, capable of
    affording protection or modulating the onset and severity of arthritis,
    may be used in the future to treat or prevent rheumatoid arthritis.
    Another promising area of alternative medicine being pursued by NIAMS-
    funded scientists is an evaluation of the effects of acupuncture on
    carpal tunnel syndrome.
        NIAMS has enjoyed substantial collaboration with NCCAM since the
    inception of the OAM at NIH in 1992. For example, NIAMS co-funded with
    OAM three of the original Centers on Alternative Medicine--the Center
    of Alternative Medicine for Pain Research and Evaluation at the
    University of Maryland, the Center to Assess Alternative Therapy for
    Chronic Illness at Beth Israel Hospital, and the Complementary and
    Alternative Medicine Research Center at Stanford University. In
    addition, the NIAMS and OAM jointly established the Chiropractic
    Consortium at the Palmer College of Chiropractic in Iowa. Furthermore,
    we have teamed with our colleagues in alternative medicine to fund
    several conferences in this area, including the NIH Consensus
    Development Conference on Acupuncture in November 1997, and the NIH
    Pain Consortium symposium ``New Directions in Pain Research'' in
    November 1997. Finally, the NCCAM and NIAMS have jointly issued a
    number of solicitations to stimulate research in alternative medicine.
    These include an RFA on Acupuncture Treatment for Osteoarthritis; and
    very recently, a solicitation and contract award to study the efficacy
    of glucosamine and chondroitin sulfate in osteoarthritis. This is a
    significant area of interest and concern for the American public, and
    the NIAMS and NCCAM staff have launched a study to provide a solid
    scientific basis in determining the value of these widely-used
    compounds in people with osteoarthritis.
        national institute on deafness and other communication disorders
        The NIDCD is currently supporting one research project involving
    alternative and complementary approaches to communication and sensory
    disorders. The long term goals of this study are to understand the
    epidemiology of otitis media (OM) and hearing loss among Native
    Americans from birth to age two and to define the relative importance
    of known and new risk factors in this population. Native Americans have
    a high prevalence of chronic otitis media, but prospective studies of
    OM among infants and young children, of this group are sparse. The risk
    factors under study include both environmental factors such as smoking
    by parents as well as genetic factors that may be specific to Native
    Americans.
        Questionnaires are one mechanisms used in the study to collect
    information. The questionnaires ask if pregnant mothers are taking
    ``traditional'' Native American medicines. Such medicines include:
    sage, tea from medicine man, swamp tea; sweet grass; cedar tea; bear
    root; blue spruce; pregnancy tea; sumac; echinacea tea; and raspberry
    leaf tea. Mothers are also asked whether their children have been given
    any ``traditional'' Native American medicines, but the specific types
    are not asked for in the questionnaire. The answers on the
    questionnaire will eventually be used to determine if there is any
    correlation between the frequency of otitis media and the use of
    ``traditional'' Native American medicines. Approximately 5 percent of
    the project is devoted to the determination of possible effects of
    Native American traditional medicines.
        The NIDCD is currently planning a workshop with the National Center
    of Complementary and Alternative Medicine (NCCAM) for fiscal year 2001
    to explore the use of T'ai Chi (TC) and other alternative therapeutic
    modalities (e.g., Chi Kung, yoga, dance therapy) in the treatment of
    balance disorders. The collaboration of other Institutes, including the
    National Center of Medical Rehabilitation Research (NCMRR) of NICHD and
    the NIA has also been sought. There are reports in the literature
    suggesting that TC is effective in maintaining or improving balance in
    unstable individuals and in improving falls in the elderly. This
    workshop will explore the promise of such approaches as efficacious and
    low-cost alternatives to conventional physical rehabilitation and
    sensory substitution programs, the latter oftened termed, ``vestibular
    rehabilitation.'' It will shed light on a long-standing question in the
    balance rehabilitation field: Should balance be trained as an isolated
    function or within the context of ``acts of daily living.''
        The NIDCD has a representative serving on the Trans-agency
    Complementary and Alternative Medicine Coordinating Committee (TCAMCC).
                      national institute of mental health
        The National Institute of Mental Health (NIMH) supports research
    that explores the potential usefulness of complementary and alternative
    medicine approaches to the treatment of mental disorders and to mental
    and behavioral aspects of other serious illnesses. In fiscal year 1999,
    NIMH CAM research included:
    CAM approaches to treatment of depression
        Saint John's Wort (SJW), or hypericum, a popular naturotherapy for
    depression in Germany, is being widely used in the UnitedStates.
    Previous controlled trials have indicated SJW does reduce symptoms of
    depression in adults, although definitive data on its efficacy are
    lacking and there are no scientific reports of the effectiveness,
    safety, and tolerability of SJW in children or adolescents. NIMH is
    collaborating with the NCCAM in the conduct of a three-arm, placebo-
    controlled, clinical efficacy study of a standardized extract of
    hypericum in major depression. This trial is designed to test the acute
    efficacy and safety of hypericum compared to placebo. In another pilot
    study, NIMH-supported researchers are exploring the benefits of SJW as
    a possible non-pharmaceutical treatment for depression in youths ages
    6-16.
        Exposure to light appears to offer promise for the treatment of
    winter depression (Seasonal Affective Disorder, or SAD), although the
    mechanism of the effect or the optimal scheduling of light exposure
    with respect to an individual's circadian phase has not been
    determined. NIMH-supported researchers are studying the mechanisms and
    timing of light therapy for best results. Other investigators funded by
    NIMH are determining if therapeutic sleep deprivation (TSD) can
    accelerate the response of depressed geriatric patients to an
    antidepressant (paroxetine). In other work, investigators are examining
    the relationship of exercise to depression in a general population, and
    the efficacy of exercise as a treatment for people with mild-to-
    moderate depressive disorder.
    CAM approaches to other mental and medical disorders
        For mental disorders other than depression, NIMH-supported
    researchers are assessing the efficacy of Eye Movement Desensitization
    and Reprocessing (EMDR) for treatment of post-traumatic stress disorder
    (PTSD) and the efficacy of hypnosis as an adjunct to traditional forms
    of psychotherapy. NIMH-supported ethnographic research aims to
    understand the therapeutic change processes in three forms of religious
    healing in Navajo society. For serious medical disorders, researchers
    are exploring the ability of peer support to enhance adherence to
    treatment for HIV/AIDS and the ability of cognitive-behavioral stress
    management (CBSM) to reduce acute stress responses in HIV-positive
    individuals, focusing on low socioeconomic status minority and
    substance-abusing individuals. Additional research evaluates the
    benefits of psychosocial and psychoeducational interventions to cancer
    patients both for pre-surgical stress reduction for men undergoing
    surgical treatment of prostate cancer and on survival for women
    recovering from metastatic breast cancer.
        NIMH collaborates closely and actively with NCCAM on those CAM
    studies of interest to the Center, such as the Saint John's Wort
    clinical trial. For more exploratory CAM studies focused on limited-
    scope aspects of mental health research, communication with NCCAM is
    encouraged by NIMH at all times.
                        national institute on drug abuse
        The National Institute on Drug Abuse estimates that it spent $0.4
    million on complementary and alternative medicine grants in fiscal year
    1999. NIDA plans to encourage more research on this important and often
    cross-cutting topic area. NIDA is interested in determining the
    efficacy of treatments for substance abuse, including those that take
    on a more ``complementary or alternative'' approach to treating the
    complex problem of addiction. Currently NIDA has two research grants
    that focus on alternative therapies, specifically the role that
    acupuncture plays in treating addiction. One of NIDA's grantees is
    looking at the role that auricular acupuncture can play in reducing
    cocaine use among HIV-positive patients in methadone-maintenance
    programs. The other grant is researching the role that electro-
    acupuncture can play in alleviating pain.
        NIDA has had a relationship with the staff from the former NIH
    Office of Alternative Medicine for several years. In fact, NIDA was one
    of the co-sponsors for the NIH Consensus Development Conference on
    Acupuncture that was held in November 1997. NIDA staff continues to
    collaborate with NCCAM staff in a variety of formal and informal ways
    including through NIDA representation on the NCCAM Trans-agency CAM
    Coordinating Committee. NIDA is also collaborating with the National
    Center for Complementary and Alternative Medicine (NCCAM) and the
    Office of Dietary Supplements (ODS) to sponsor a meeting later this
    summer to examine intervention modalities (chemo and alternative) in
    drug abuse and HIV/AIDS.
                     national institute of nursing research
        The National Institute of Nursing Research (NINR) funds a number of
    research studies in the area of complementary or alternative medicine.
    Two studies are co-funded with NCCAM. One addresses the use of
    melatonin for sleep disorders in patients with Parkinson's disease. The
    other study addresses whether the setting of a breast cancer support
    group for African-American women can trigger self-transcendence to
    enhance quality of life.
        Other studies supported by NINR include a model of wellness circles
    for Native American Indian families to promote prevention of disease;
    the effects of relaxation therapy on the immune system and quality of
    life of caregivers of patients with Alzheimer's disease; the effects of
    relaxation and music on postoperative pain; the benefits of
    acupuncture, massage therapy, vitamins, herbs and nutritional
    supplements, in addition to traditional care, on those at the end of
    life; and the effects of cancer pain interventions that include guided
    imagery, attention diversion, and relaxation.
        NINR research initiatives for fiscal year 2001 include self-
    management strategies and end-of-life palliative care. Future CAM areas
    of interest could involve evaluation of mind-body interventions for
    patients with chronic illness or who are at the end of life stage.
        In addition to collaborations with NCCAM on research projects, NINR
    serves on the NCCAM Trans-Agency CAM Coordinating Committee, which
    meets three times a year to discuss initiatives and projects of mutual
    interest.
                     national center for research resources
        The NCRR creates, develops, and provides a comprehensive range of
    human, animal, technological, and other resources to enable biomedical
    research advances. The NCRR serves as a ``catalyst for discovery'' for
    NIH-supported investigators by supporting resources in four areas:
    Biomedical Technology, Clinical Research, Comparative Medicine, and
    Research Infrastructure. Three of these areas currently support
    research resources that enable multidisciplinary collaborations and
    discoveries in many areas of health relating to CAM.
    Clinical Research
        The Clinical Research area, through its national network of 77
    General Clinical Research Centers (GCRCs), supports CAM related
    clinical investigations such as biofeedback in advanced heart failure
    (Ohio State University); effects of melatonin in human sleep behavior
    (Massachusetts Institute of Technology); and, soybean diets and breast
    cancer prevention in women (University of Texas at Galveston). Other
    studies include the use of hypnosis as an adjunct to periodontal
    therapy, acupuncture for the treatment of HIV associated diarrhea and
    the effect of therapeutic back massage on the immune function of cancer
    patients.
        The GCRC Program encourages funded investigators from NCCAM
    supported Centers such as the CAM Centers at the University of Michigan
    and the Addictions Center at Minneapolis to utilize the resources of
    the GCRCs. Many other NCCAM funded investigators are co-located with,
    or nearby, GCRCs such as the GCRCs at the University of Virginia,
    University of Washington Seattle, Brigham Women's Hospital, University
    of California San Diego, and the University of Indiana, just to name a
    few.
    Biomedical Technology
        The Biomedical Technology area of NCRR supports state of the art
    technologies and methodologies that create, develop, and provide a wide
    range of complex technological capabilities. Examples are studies of
    acupuncture in humans using magnetic resonance imaging (MRI) and
    magnetic resonance spectroscopy (MRS) at the University of Pennsylvania
    and the characteristics of antioxidant compounds from natural products
    at Michigan State University. NCCAM currently supports an Intramural
    fellow (Dr. Joannie Shen) to study the effects of acupuncture for the
    treatment of alcoholism using functional MRI. This topic, or others
    similar to it, could potentially be supported by the regional imaging
    centers funded by Biomedical Technology and the GCRC Program. Dr. Shen
    is now performing her studies at the NIH Clinical Center.
    Research Infrastructure
        The Research Infrastructure area, through its Research Centers in
    Minority Institutions (RCMI) Program, supports research at the
    University of Hawaii in the use of energy healing in very low birth-
    weight infants as well as the use of distant healing in breast and
    prostate cancer patients receiving radiation. The University of Hawaii,
    as well as some other RCMI institutions, such as Drew and the
    University of Puerto Rico have been applicants to NCCAM for a variety
    of grants including Center support.
                          fogarty international center
        FIC's longstanding Biodiversity and AIDS programs support
    complementary and alternative medicine in the form of research on
    herbal therapies utilized by indigenous peoples in several nations,
    including Nigeria, Mexico, Chile, and Laos. Herbal medicines used for a
    variety of indications relevant to infectious diseases, cancer, pain,
    and Alzheimer's disease are explored for efficacy and safety in
    laboratory studies in developing countries and in the United States,
    including those of industrial pharmaceutical partners.
        Given that CAM is used extensively abroad as well as in the United
    States, the FIC Director (who also serves as the NIH Associate Director
    for International Research) and the Director of NCCAM have discussed on
    several occasions common interests and the possibility of future joint
    initiatives examining the international role and resources available
    for study of CAM. In addition, FIC staff work to facilitate
    international dialogue between NCCAM and foreign counterparts,
    including those in China. Also, the FIC program director for
    Biodiversity works with the staff of NCCAM to ensure that relevant
    information is shared among interested groups.

        Senator Harkin. Thanks.
        Senator Specter. On the questions which I have asked, I
    would like two additional answers in writing. One is what you
    have been able to accomplish with the increases in funding over
    the last 3 years, which for the total number of institutes,
    aggregate more than $5 billion. Of course, it breaks down to
    different figures.
        I would like to have the increase actually for each of the
    institutes over the 3 years, what you have been able to
    accomplish with that extra, and what you would look forward to
    accomplishing if you got your wishes on the funding to have the
    total number of grants that you would like to see.
        [The information follows:]

                        Past and Future Accomplishments

        The following table reflects each institute and center budget
    increases over the last three years, to include fiscal years 1998-2001.

                                                  NATIONAL INSTITUTES OF HEALTH FUNDING BY INSTITUTE AND CENTER
                                                                    [In thousands of dollars]
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Fiscal year
                                                               ---------------------------------------------------------------------------------------------
                             Institute                                  1998                   1999                    2000                    2001
                                                               ---------------------------------------------------------------------------------------------
                                                                  Actual     Change     Actual      Change     Estimate     Change     Estimate     Change
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    NCI.......................................................   2,551,281   162,240   2,891,570    340,289    3,311,687    420,117    3,505,072    193,385
    NHLBI.....................................................   1,526,276    94,455   1,774,827    248,551    2,026,430    251,603    2,136,757    110,327
    NIDCR.....................................................     210,172    13,109     238,001     27,829      269,185     31,184      284,175     14,990
    NIDDK.....................................................     896,686    83,622   1,021,006   12,4,320    1,141,415    120,409    1,2D9,173     67,758
    NINDS.....................................................     778,432    49,183     896,921    118,489    1,029,743    132,822    1,084,828     55,085
    NIAID.....................................................   1,352,119    94,326   1,570,530    218,411    1,796,631    226,101    1,906,213    109,582
    NIGMS.....................................................   1,061,505    66,116   1,202,800    141,295    1,353,943    151,143    1,428,188     74,245
    NICHD.....................................................     672,073    40,811     752,179     80,106      859,258    107,079      904,705     45,447
    NEI.......................................................     354,153    22,566     395,604     41,451      450,101     54,497      473,952     23,851
    NIEHS.....................................................     328,711    21,156     387,640     58,929      442,688     55,048      468,649     25,961
    NIA.......................................................     517,082    32,764     599,720     82,638      687,861     88,141      725,949     38,088
    NIAMS.....................................................     273,879    17,687     305,976     32,097      349,480     43,504      368,712     19,232
    NIDCD.....................................................     199,786    11,569     230,803     31,017      263,661     32,858      278,009     14,348
    NIMH......................................................     748,329    47,572     854,184    105,855      974,673    120,489    1,031,353     56,680
    NIDA......................................................     536,852    37,539     617,409     80,557      687,376     69,967      725,467     38,091
    NIAAA.....................................................     226,224    15,031     259,258     33,034      293,234     33,976      308,661     15,427
    NINR......................................................      63,340     3,789      69,851      6,511       89,539     19,688       92,524      2,985
    NHGRI.....................................................     218,340    29,431     283,638     65,298      335,862     52,224      357,740     21,878
    NCRR......................................................     452,193    38,144     560,716    108,523      675,054    114,338      714,192     39,138
    NCCAM.....................................................  ..........  ........      50,531     50,531       69,011     18,480       72,392      3,381
    FIC.......................................................      28,190     1,690      35,164      6,974       43,328      8,164       48,011      4,683
    NLM.......................................................     161,606    11,499     181,770     20,164      215,199     33,429      230,135     14,936
    OD........................................................     295,194     9,331     255,635    (39,559)     282,000     26,365      308,978     26,978
                                                               ---------------------------------------------------------------------------------------------
        Subtotal..............................................  13,452,423   903,630  15,435,733  1,983,310   17,647,359  2,211,626   18,663,835  1,016,476
    B&F.......................................................     234,436    12,458     197,456    (36,980)     165,376    (32,080)     148,900    (16,476)
                                                               ---------------------------------------------------------------------------------------------
        Total.................................................  13,686,859   916,088  15,633,189  1,946,330   17,812,735  2,179,546   18,812,735  1,000,000
    --------------------------------------------------------------------------------------------------------------------------------------------------------

        In response to the second part of your question, listed below are
    descriptions of Institutes and Centers current accomplishments and what
    could be accomplished with with additional resources.
                           national cancer institute
        The National Cancer Institute (NCI) conducts, coordinates and funds
    cancer research, and provides vision and leadership for the cancer
    research community both in the United States and abroad.
    Accomplishments
        The incidence and death rates for all cancers combined declined
    between 1990 and 1996, reversing an almost 20-year trend of increasing
    cancer cases and deaths in the U.S.
        To date, we have catalogued approximately 70,000 genes that are
    expressed in the development of cancers; of these, about 30,000 are
    previously unknown genes.
        Scientists uncovered evidence, using the new science of cancer
    genomics, that diffuse large B-cell lymphoma is actually two distinct
    diseases. This has important implications for their treatment.
        Tamoxifen, a drug long used to treat breast cancer, led to a 49
    percent reduction in the incidence of primary breast cancer during the
    treatment period in women at high risk for the disease.
        Last year, NCI supported over 1,500 clinical trials in prevention
    and treatment, covering virtually all human cancers. The results of
    clinical trials over the past two years have set new standards for
    regimens to treat childhood cancers, leukemia, myeloma, breast cancer,
    and others.
    What Could Be Accomplished With Additional Funds
        Priority for new resources would be given to developing cancer
    prevention interventions for children under 10 years of age, when they
    are most receptive to parental and adult influences. Opportunities for
    prevention of cancer include tobacco use, sun exposure, and diet and
    nutrition.
        Additional funding will greatly enhance NCI plans to increase the
    number of clinical trials and the number of patients who enroll in
    trials.
        NCI's Tumor Gene Index will catalog the genetic characteristics of
    tumors at each stage of growth. NCI also hopes to change the system of
    tumor classification from a visual to a molecular basis.
        Today, NCI can support approximately only the top 30 percent of
    grants in the research project grant pool. More support for all types
    of investigator-initiated research remains a fundamental need.
        Additional resources are needed to expand NCI's Surveillance,
    Epidemiology, and End Results (SEER) database to enhance coverage of
    rural whites and blacks, non-Mexican Hispanics and Native Americans.
        New initiatives are aimed at training scientists that cross
    disciplinary boundaries to meet the complex challenge of cancer, at
    training physicians in the skills of clinical research, and at
    attracting increased numbers of minority students and young scientists
    into all aspects of cancer research.
                   national heart, lung, and blood institute
    Accomplishments
        A newly developed procedure called cardiac magnetic resonance
    imaging will allow cardiologists in hospital emergency rooms to make
    faster and more accurate assessments that could mean the difference
    between life and death when a person comes into the hospital with
    symptoms of a heart attack.
        Recently, the first totally implantable, mechanical heart-assist
    device was successfully placed in a patient who was no longer eligible
    to receive an organ transplant due to the advanced stage of his heart
    disease.
        A recent study showed the benefits of teaching children early about
    eating a healthy diet and getting plenty of physical exercise. Three
    years afterward, children in the study continued to eat healthier food
    and get more exercise than their peers. The researchers concluded that
    giving the children occasional, positive reinforcement will help them
    maintain their healthy lifestyles throughout junior high, high school,
    and beyond.
        A recent technological leap in blood testing called Nucleic Acid
    Testing, or NAT, screens donated blood to detect the presence of genes
    for the hepatitis and AIDS viruses. NAT detects even minute levels of
    virus, making the safest blood supply ever even safer.
        A breakthrough in ventilator management offers both better survival
    in patients with acute respiratory distress syndrome (ARDS) and
    substantial monetary savings due to faster recovery and less time spent
    in costly intensive care units.
        Two new ways have been found to determine who is at high risk for
    sudden cardiac death (SCD), which kills 300,000 Americans annually,
    often striking without warning in young, seemingly healthy people. The
    screening techniques can easily be incorporated into routine physical
    exams. Once a person is found to be at risk for SCD, appropriate
    preventive therapy can be prescribed.
    What Could Be Accomplished With Additional Funds
        Three phase I clinical trials are in progress to test the safety of
    using gene therapy to treat hemophilia, which affects 20,000 Americans.
        A new treatment can stimulate the development and growth of new
    blood vessels for the heart. This treatment may one day eliminate the
    need for the more invasive, risky, and costly angioplasty and bypass
    procedures currently used to treat heart disease.
        The Action to Control Cardiovascular Risk in Diabetes (ACCORD)
    trial aims to gain a better understanding of how to reduce risks of
    heart attack and stroke in patients with type 2 diabetes. The goal is
    to find the most effective ways to normalize blood sugar and improve
    blood pressure and cholesterol levels, thereby helping diabetics enjoy
    longer, healthier lives.
             national institute of dental and craniofacial research
        The National Institute of Dental and Craniofacial Research (NIDCR)
    seeks to improve and promote craniofacial, oral, and dental health
    through research.
    Accomplishments
        A recent NIDCR-sponsored study has revealed a mutation in the PAX9
    gene that results in the absence of molar teeth. This discovery brings
    scientists a step closer to understanding human tooth development.
        New studies sponsored by the NIDCR showed that the hormone estrogen
    can reverse problems associated with wound healing in the elderly.
        New studies have found mutations in the cathepsin C gene that cause
    Papillon-Lefevre syndrome, a genetic disorder that typically affects
    both the skin and teeth. In some cases, all primary teeth are lost by
    age 4 and all permanent teeth are lost by age 14. This research
    suggests possible future therapies.
    What Could Be Accomplished With Additional Funds
        What Could Be Accomplished With Additional FundsNIDCR recently
    issued a Request for Applications for Centers for Research to Reduce
    Oral Health Disparities for fiscal year 2001 funding. The centers will
    support research to investigate dental, oral, and craniofacial health
    disparities and design interventions to reduce them.
        Scientists have already identified a large number of genes
    associated with craniofacial-oral-dental diseases and disorders. NIDCR
    is poised to pursue the next phase of genetic research, which deals
    with the complex gene-gene and gene-environment interactions that
    control craniofacial development.
        NIDCR is exploring the suggested link between periodontal disease
    and the birth of preterm, low birth weight babies. It is also
    evaluating the benefits of periodontal disease treatment in women at
    high risk for delivering prematurely.
        NIDCR will support statewide models of oral cancer prevention and
    early detection, and collect the knowledge and opinions of health care
    professionals and the public about the disease. NIDCR will support
    statewide models of oral cancer prevention and early detection, and
    collect the knowledge and opinions of the public and health care
    professionals about the disease.
        In the future, testing saliva may be a simple way of obtaining
    medical diagnostic information. NIDCR scientists are investigating new
    ways to analyze saliva and incorporate saliva testing into trials and
    other clinical settings.
        The NIDCR biomimetics program aims to mimic biological processes to
    repair body parts and help fight infectious diseases and inherited
    disorders. It will promote new research into restoring oral, dental,
    and craniofacial structures, and into molecular technologies to deliver
    drugs and genes to combat infectious diseases, cancers, and
    craniofacial disorders.
        national institute of diabetes and digestive and kidney diseases
    Accomplishments
        Replacement of insulin-producing beta cells through regeneration or
    transplantation could offer lifelong treatment for type 1 diabetes.
    Recent studies in animals demonstrated a drug that led to long-term
    acceptance of these cell transplants, opening the possibility of new
    treatments for type 1 diabetes in humans.
        Genetic studies of type 2 diabetes have found single gene mutations
    that cause rare forms of the disease in the young.
        An NIDDK intramural scientist has recently discovered gene
    ``insulators'', which allow genes to be expressed without interference
    from surrounding genetic material. This discovery is of particular
    importance to the biotechnology industry.
        An obese child with a congenital leptin deficiency was treated
    successfully with leptin therapy, resulting in decreased appetite,
    increased physical activity, and significant weight loss.
        Scientists reported a treatment in an animal model of Polycystic
    Kidney Disease (PKD) that prevents cyst formation and dramatically
    enhances survival. This new finding has clear implications for treating
    human PKD, the fourth leading cause of end-stage renal disease.
        Scientists successfully demonstrated a genetically-engineered
    treatment called infliximab for Crohn's disease, an inflammatory bowel
    disease.
    What Could Be Accomplished in the Future with Additional Funds
        NIDDK is co-sponsoring a number of initiatives to develop new
    transplantation strategies to treat type 1 diabetes and improve the
    success of liver and kidney transplantation.
        NIDDK will support research to understand the differences in type 2
    diabetes and obesity among racial and ethnic groups, with a view toward
    developing interventions.
        Rates of hepatitis C infection are two to three times higher in
    African Americans than in Caucasians, and the response rate among
    African Americans to interferon therapy is far less than among
    Caucasians. NIDDK plans to expand research to address the causes of
    this ``resistant pattern''.
        NIDDK will encourage research into cell and tissue development, and
    into the use of stem cells to combat disease.
        NIDDK will expand its research on autoimmune diseases, including
    type 1 diabetes, autoimmune renal disease, autoimmune hepatitis,
    autoimmune thyroid disease, and inflammatory bowel disease.
            national institute of neurological disorders and stroke
        The National Institute of Neurological Disorders and Stroke (NINDS)
    seeks to reduce the burden of neurological disorders through research.
    Accomplishments
        Scientists identified a gene that causes narcolepsy in dogs, one of
    the few species besides humans susceptible to narcolepsy. This
    discovery may make it possible to design a drug to treat the condition.
        Scientists showed that reducing corticosteroid hormone levels in
    aged rats restored the rate of nerve cell growth in the brain's
    hippocampus region to nearly the same level as in young animals. This
    work suggests new avenues for preventing memory loss in aging.
        A study into the factors that influence the likelihood that an
    aneurysm will burst will allow some patients to avoid possibly
    dangerous surgical intervention.
        Scientists have found a chemical signal that helps brain cells
    tolerate ischemia, a loss of adequate blood supply to the brain that
    causes strokes. This chemical, ceramide, presents a new strategy to
    reduce the damage caused by stroke.
        Scientists gained new insights into a structure called the M
    channel, revealing the cause of one form of epilepsy. This finding
    opens the door for developing new epilepsy treatments.
    What Could Be Accomplished With Additional Funds
        A National Neuroscience Center will bring basic research findings
    to clinical application by promoting collaboration, communication, and
    shared resources.
        NINDS is developing initiatives to exploit new understanding of the
    nerve cell circuits in the spinal cord and of the cellular mechanisms
    that promote spinal regeneration.
        Tests must be developed to detect prions, which cause Creutzfeldt-
    Jakob disease and other neurodegenerative diseases, in the blood
    supply.
        Therapies using neural stem cells have shown tremendous promise in
    animal models of such human diseases as Tay-Sachs, Parkinson's, and
    spinal cord injury.
        Efforts to reduce health disparities will focus on HIV/AIDS and on
    preventing and treating stroke in minority populations. Supporting
    Specialized Centers for Neuroscience Programs at minority institutions
    will be vital in this endeavor.
        A multi-institute study of cognitive and emotional health over the
    life span will improve our ability to identify people who may benefit
    from early intervention or preventive measures to improve brain
    function and delay or prevent disease.
             national institute of allergy and infectious diseases
        The National Institute of Allergy and Infectious Diseases (NIAID)
    supports research to develop better ways to diagnose, treat and prevent
    infectious, immunologic and allergic diseases.
    Accomplishments
        A single oral dose of the relatively inexpensive ($4) drug
    nevirapine given to an HIV-infected woman at the onset of labor and
    another to her baby within three days of birth can reduce the
    transmission rate by half compared with AZT.
        NIAID is spearheading a $144 million initiative to develop new ways
    of controlling the human immune system to improve the success of organ
    transplants and develop treatments for autoimmune diseases such as
    lupus and rheumatoid arthritis.
        NIAID-supported investigators created, for the first time, live,
    replicating influenza A virus starting with its genetic blueprint. This
    research has far-ranging implications for understanding the way flu
    strains mutate and spread.
        Scientists found that highly active antiretroviral therapy (HAART)
    can help adult patients infected with HIV rally and produce new immune
    cells.
        An NIAID-led effort produced the first high-resolution genetic map
    of Plasmodium falciparum, the deadliest malaria parasite.
        The genome sequence of Chlamydia trachomatis has been completed.
    This bacterium can cause blindness, genital tract infections, infant
    pneumonia, and other diseases.
    What Could Be Accomplished With Additional Funds
        Research into preventing and controlling the global spread of AIDS,
    tuberculosis, malaria, influenza, and hepatitis are all in need of
    expansion.
        Future studies will focus on whole-genome approaches to emerging
    pathogen research, including large-scale sequencing, bio-informatics,
    and functional genomics.
        Mounting evidence suggests that infectious agents may be the
    underlying causes of chronic diseases such as coronary artery disease,
    diabetes, multiple sclerosis, autism, and chronic lung diseases. New
    studies will focus on identifying the infectious agents involved in
    these diseases.
        Increases in training funds would ensure that a sufficient number
    of talented investigators from diverse backgrounds enter immunology and
    infectious diseases research.
        There are unprecedented opportunities to expand vaccine discovery
    and development in a variety of areas within the next five years.
                 national institute of general medical sciences
        The National Institute of General Medical Sciences (NIGMS) supports
    basic biomedical research that is not targeted to specific diseases.
    Accomplishments
        New work explained how one of the B vitamins called folic acid
    lowers levels of homocysteine--a risk factor for heart attacks and
    strokes--by converting it to a harmless molecule the body needs to fuel
    essential chemical reactions.
        Scientists discovered structural details of a protein that helps
    regulate heart rhythm. The work may shed light on long QT syndrome, a
    genetic heart condition.
        Scientists gained new insight into how a molecule called a copper
    chaperone delivers copper to an enzyme that is defective in some cases
    of Lou Gehrig's disease. The work may offer insight into how to block
    this delivery in people with the disease.
        Test tube experiments revealed an enzyme that may reverse the
    damage seen in the brains of people with Alzheimer's disease. The
    enzyme untangled ``tau'' protein clumps, which are associated with
    memory loss and dementia.
        The discovery of molecular signals that prompt embryonic cells to
    become liver cells suggests ways to rebuild damaged organs or tissues,
    or make new ones from scratch.
        Scientists determined the three-dimensional structure of ribosomes,
    the cellular factories that manufacture all of the proteins required
    for life. Many antibiotic drugs target bacterial ribosomes, so this
    work may help scientists in antibiotic development.
        Scientists hunted down the molecule that triggers the body's
    response to painful heat. The discovery should help researchers find
    ways to treat pain.
    What Could Be Accomplished With Additional Funds
        NIGMS has launched two new initiatives to support pharmacogenetics,
    the study of individual differences in drug responses based on genetic
    variation.
        NIGMS initiated a program to support structural genomics, which
    will develop new, faster techniques to determine protein structures
    from their gene sequences.
        NIGMS has initiated a new program to train the next generation of
    scientists to develop computational approaches and associated databases
    for biology.
        NIGMS supports genomic studies of animals that include mice and
    zebrafish.
        NIGMS seeks to expand programs to increase the participation of
    under-represented minorities in the biomedical sciences.
            national institute of child health and human development
        National Institute of Child Health and Human Development (NICHD)
    fosters research on reproduction, development, and behavior to maintain
    the health of children and adults.
    Accomplishments
        NICHD-funded investigators discovered the gene responsible for Rett
    syndrome, a heartbreaking disease that robs healthy infant girls of
    their language, mental abilities, and ability to walk.
        Children born to mothers with hypothyroidism during pregnancy
    scored lower on IQ tests than children born to healthy mothers. When
    mothers were treated for the condition, their children scored almost
    the same.
        For certain types of infertility, induced ovulation combined with
    artificial intrauterine insemination is more successful and less
    expensive than many other infertility treatments.
        Computer imaging of the brain showed that estrogen, commonly
    prescribed to treat the symptoms of menopause, may also boost memory in
    postmenopausal women.
        High doses of vitamin A reduced chronic lung disease in extremely
    low birth weight infants.
        Researchers discovered that the absence of a protein called CC10 in
    premature infants placed the infants at risk for lung disease. Efforts
    are underway to manufacture the protein for further testing.
    What Could Be Accomplished With Additional Funds
        The rate of Sudden Infant Death Syndrome (SIDS) among African
    Americans is still more than twice that of whites. NICHD is
    intensifying the campaign to stress the importance of placing infants
    to sleep on their backs.
        NICHD-funded researchers will explore how children learn and how
    best to help them when they have learning difficulties. Research
    initiatives will also focus on overcoming reading disabilities,
    improving mathematics skills, and on how Spanish-speaking children best
    learn English.
        An NICHD initiative seeks to improve therapies for childhood trauma
    victims.
        An NICHD initiative will investigate the causes of childhood
    violence.
        NICHD will launch an array of initiatives focusing on early human
    development.
                             national eye institute
        The National Eye Institute (NEI) supports research, training, and
    other programs to address diseases of the eye and disorders of vision.
    Accomplishments
        A new drug called PKC 412 may be important in preventing vision
    loss in humans from diabetic retinopathy or macular degeneration.
        Scientists detected estrogen receptors in eye tissue from young
    women, but not from men or postmenopausal women, that may account for
    gender-based differences in some eye diseases and may offer a
    therapeutic target for the treatment of dry eye syndromes.
        Scientists have recently found that animals with induced detached
    retinas experienced less damage when given oxygen treatment. Further
    research in this area may lead to a new approach to minimizing retinal
    damage in humans with retinal detachment.
        Scientists have shown a connection between the molecule nitric
    oxide (NO) and damage to retinal nerve cells in the eye. Research is
    now being aimed at exploiting this knowledge to develop a new class of
    neuroprotective glaucoma drugs.
        NEI recently launched studies to determine the extent of eye
    disease among Latinos and a clinical trial to determine whether low
    intensity laser treatment can prevent the advanced complications of
    age-related macular degeneration, the leading cause of severe vision
    loss in those over 65.
    What Could Be Accomplished With Additional Funds
        Nerve cells in the retina can now be purified and grown in the
    laboratory. This provides an opportunity to study the mechanisms of
    cell survival and injury response.
        A number of promising approaches--using growth factors,
    transplantation, and molecular and genetic technologies--aim to prevent
    or slow down degenerative eye diseases.
        Identifying and sequencing genes in the visual system will lead to
    a better understanding of the molecular and genetic bases for visual
    disorders and diseases, and will ultimately lead to improved treatment
    or prevention.
        The NEI will continue to fund the Ocular Hypertension Treatment
    Study (OHTS), a clinical trial of medications designed to prevent
    vision loss from glaucoma. Because glaucoma is the number one cause of
    blindness in African Americans, a high percentage of African Americans
    are participating in this study.
              national institute of environmental health sciences
    Accomplishments
        NIEHS found that some fatty acids may prevent heart attacks,
    strokes: Using mouse models and cultured human cells from the lining of
    the arteries, NIEHS-supported scientists have shown that some naturally
    occurring fatty acid compounds called epoxyeicosatrienoic acids (EETs)
    and their metabolites suppress inflammation, a critical step in the
    development of atherosclerosis. This work offers a new therapeutic
    approach for preventing the arterial build-up that leads to heart
    attacks and strokes.
        Liver carcinogen blocked: An NIEHS study in China strongly suggests
    that administration of oltipraz would help reduce the risk of
    subsequent liver cancers in high risk populations exposed to aflatoxin
    and represents an important chemoprevention regimen in the avoidance of
    an environmentally-induced cancer.
        Learning how cells respond to stress, infection, injury: In times
    of stress, such as an infection or injury, the body's cells often
    respond with an inflammation. This phenomenon can lead to heart
    disease, autoimmunity, asthma, arthritis, neuronal degradation, and
    cancer. In a series of cutting-edge studies, NIEHS researchers have
    followed the molecular events which occur inside the cell--discovering
    molecular targets for potential treatments for these major human
    diseases.
    What Could Be Accomplished With Additional Funds
        The Sister Study Can Clarify Causes of Breast Cancer: NIEHS seeks
    to speed a study of the unaffected sisters of breast cancer cases . . .
    using questionnaires and a blood and urine samples to clarify the joint
    effects of environmental and genetic factors in the etiology of breast
    cancer . . . such factors as hormonally active environmental agents,
    growth factors, environmental contaminants of general public concern
    such as pesticides and solvents, as well as the role of with genes
    involved in their metabolic activation. With CDC, NIEHS has developed
    the capacity to measure biological markers for 70 new hormonally active
    agents, which can be used to analyze the samples.
        Children's Environmental Health Centers to Focus on Learning,
    Behavior: Following an initial emphasis on asthma and other respiratory
    diseases, NIEHS would plan a new phase that will concentrate on two
    other key areas in pediatric environmental health: learning and
    behavior, and growth and development. New research opportunities
    include the investigation of environmental effects on such outcomes as
    attention deficit hyperactivity disorder.
        Biomarkers for Safety: NIEHS can make important contributions, in
    collaboration with the NIH Office of Science Policy and Planning, in
    developing biomarkers for drug safety, and thus advancing not only drug
    safety but timely drug development.
        Comparative Mouse Genomics Center (Expansion of the Environmental
    Genome Project): NIEHS would support development of trans-NIH
    Comparative Mouse Genomics Centers resource centers that produce
    transgenic and knockout mice which will have variants of human
    environmental responsive genes found in the general human population,
    such as the genes controlling the metabolism of toxicants, for DNA
    repair pathways, for the cell cycle control system, for cell death and
    for the cell signaling or communication. The Centers' research will be
    used by the scientific community to learn the importance of these human
    variations, in order to better predict health risks and to develop
    environmental policies to protect the most susceptible of us. What is
    learned will advance not only the protection of people from
    environmental factors but from viruses, nutritional shortcomings, drug
    side-effects, and physical and chemical stresses.
        Linking Exposure to Human Disease: Using new computer imaging and
    computational advances, coupled with sensitive tools of analytic
    chemistry and gene expression/function, NIEHS proposes to dramatically
    enhance exposure assessment and its use to prevent human disease. In
    cooperation with CDC and EPA, NIEHS seeks to address issues of
    children's health, of low-dose chemical exposure risks, of environment-
    related health disparities, and of gene/environment interactions, as
    well as to prioritize chemicals for safety study by the NTP, and
    finally, with other agencies, to evaluate of the effectiveness of
    regulatory decisions and get the most bang from the buck.
        Advanced Research Cooperation in Environmental Health: NIEHS
    recently developed a new program called Advanced Research Cooperation
    in Environmental Health (ARCH), to link historically black colleges and
    universities in research partnerships with research intensive academic
    institution--thus expanding the Nation's base of scientists. NIEHS
    proposes to expand ARCH to include Hispanic serving institutions and
    tribal colleges and thereby establish groups of investigators at these
    institutions who can successfully compete for other NIEHS and other NIH
    grants.
                          national institute on aging
        The National Institute on Aging (NIA) leads a scientific effort to
    uncover the mechanisms of the aging process and to extend the healthy,
    active years of life for all Americans.
    Accomplishments
        NIA has launched a nationwide treatment study to assess the
    effectiveness of Vitamin E and donepezil (Aricept) in preventing
    Alzheimer's disease. Other clinical studies will look at using
    nonsteroidal anti-inflammatory drugs (NSAIDS) to treat Alzheimer's
    disease.
        Studies of the brain using magnetic resonance imaging (MRI) were
    able to predict the development of Alzheimer's disease (AD) within a
    three-year period, raising the hope of developing treatments to stop
    brain changes before clinical deterioration begins.
        Physical activity was found to increase nerve cell growth and
    survival in the region of the mouse brain involved in learning and
    memory. This study suggests that behavior modification might help
    alleviate the age-related decline in brain function.
        Transgenic mice without the ability to rebuild telomeres, the
    structures at the tips of chromosomes that become progressively shorter
    with age, had a shortened life span. When older, they also had an
    increased number of spontaneous cancers.
        In a long-term study of more than 6500 middle-aged men, low blood
    pressure, low blood sugar levels, and avoiding cigarette smoking and
    obesity were shown to predict healthy aging. The study also found that
    healthy habits or therapeutic interventions can have beneficial health
    effects when begun later in life.
    What Could Be Accomplished With Additional Funds
        Studies will help determine the genetic and environmental factors
    that allow centenarians to live to such an old age. Understanding the
    genetic, molecular and biochemical basis of aging will help us to
    combat aging problems and age-related disease.
        NIA will lead the trans-NIH Alzheimer's Disease Prevention
    Initiative to make a concerted assault on this disease's development
    and progression.
        Potential causes of disparities in adult health across race,
    gender, and socioeconomic status will be studied in order to reduce
    health inequalities.
        Carefully designed national studies will examine the prevalence of
    elder abuse and the risk factors for elder abuse.
        More research is needed into stem cells, which hold enormous
    potential for therapy in many degenerative diseases of aging, including
    Alzheimer's disease, Parkinson's disease, stroke, myocardial
    infarction, mascula-skeletal disorders, immune system dysfunction, and
    diabetes.
     national institute of arthritis and musculoskeletal and skin diseases
    Accomplishments
        Improved hormone replacement therapy for older women at risk for
    osteoporosis includes lower doses of estrogen and progesterone, in
    combination with calcium and vitamin D.
        Researchers reported on a transcription factor that is required to
    establish the barrier function of the skin. These findings provide
    insights into how the skin performs its critical environmental
    protective function.
        Researchers have successfully used the antibiotic gentamicin to
    restore the function of the gene that encodes for the protein
    dystrophin in mouse models of Duchenne muscular dystrophy (DMD).
        Gene therapy to treat limb girdle muscular dystrophy in animals
    made muscles five fold less likely to be damaged during forceful
    contractions than untreated muscles.
        Optical coherence tomography (OCT) is an advanced new method of
    imaging capable of detecting small structural changes in tissues during
    the earliest stages of disease.
        Researchers found that people who did more than 4 hours of heavy
    physical activity per day were 7 times more likely (13 times, if obese)
    to develop knee osteoarthritis than people who did no heavy physical
    activity. Walking and light physical activities did not increase the
    risk.
        An international research team showed that the obesity gene leptin,
    which helps maintain body weight, also plays a role in controlling bone
    density by telling the brain to slow down the rate of bone formation.
    This study suggests a new strategy to increase bone density and treat
    or prevent osteoporosis.
    What Could Be Accomplished With Additional Funds
        A public-private partnership is being explored to identify
    biomarkers, biological warning signs, for osteoarthritis that would
    allow earlier intervention therapies.
        A recent workshop identified research opportunities into treatment
    approaches for osteogenesis imperfecta, a disease that typically
    strikes young children whose bones are very brittle and vulnerable to
    many fractures.
        NIAMS is planning an initiative with NHLBI to explore promising
    research into the roles of vascular calcification and bone cell
    regulation in osteoporosis.
        Members of the NIAMS intramural research program are designing an
    outreach program targeted toward minority communities.
        NIAMS is enthusiastically participating in the new NIH K23 and K24
    initiatives to stimulate careers in clinical research.
        national institute on deafness and other communication disorders
        The National Institute on Deafness and Other Communication
    Disorders (NIDCD) supports and conducts research into diseases and
    disorders of human communication.
    Accomplishments
        A study of twins and triplets revealed a possible genetic component
    to prolonged and recurrent episodes of middle ear infections. Once the
    genes are identified, doctors may be able to recognize which children
    and siblings are at risk and improve treatment.
        An investigational vaccine that targets bacteria causing middle ear
    infections was shown to be safe and to provide protection against
    infection in animals, which may lead to use in humans.
        Scientists have located more than 50 genes that can cause hearing
    impairment. Ten have been cloned and the nature of the problems causing
    the hearing loss discovered. With the ability to predict who is at
    increased risk, better strategies can be developed to minimize or delay
    hearing loss.
        More than 10,000 children have received cochlear implants, a
    prosthesis that converts sound into electrical impulses that can be
    interpreted much like sound. Scientists found that children with
    cochlear implants had better language skills than children who used
    hearing aids.
        A large study of children who stutter showed a strong genetic
    component to the condition. NIDCD has begun a study to identify the
    genes that predispose an individual to stutter.
        Dramatic findings this year demonstrated that individual odor
    receptors are not dedicated to specific odors. An odor is distinguished
    by the unique combination of receptors that respond to it.
    What Could Be Accomplished With Additional Funds
        NIDCD hopes to identify with precision the early, sensitive periods
    for developing speech and language skills.
        More research is needed to identify the molecular pathways that may
    lead to regeneration of auditory hair cells, a possible strategy for
    reversing hearing loss.
        A working group will examine studies of the molecular mechanisms of
    middle ear infections in the hope of developing novel therapies.
        Based on promising recent research advances, NIDCD will
    aggressively continue its investigations into the hereditary basis of
    hearing impairment.
                      national institute of mental health
        The mission of the National Institute of Mental Health (NIMH) is to
    diminish the burden of mental illness through research.
    Accomplishments
        A White House Conference on Mental Health, the release of the
    first-ever Surgeon General's Report on Mental Health and the Surgeon
    General's Call to Action on Suicide Prevention this past year were all
    made possible by advances in science. There is no longer doubt that
    mental illnesses such as schizophrenia, depression, bipolar disorder
    and anxiety disorders are disorders of the brain, and that they are
    diagnosable and treatable.
        The largest and longest study ever of children with attention
    deficit hyperactivity disorder (ADHD) found that methylphenidate
    (Ritalin) was safe and effective, particularly when coupled with
    intensive behavioral treatments.
        Scientists showed that primate brains make new cells for the brain
    region involved in higher cognitive function. This research gives new
    hope for the repair of brain injuries.
        NIMH has initiated large-scale clinical trials to learn the best
    treatments for bipolar disorder, depression in adolescents, depression
    that is unresponsive to initial treatment, schizophrenia, and
    Alzheimer's disease.
        NIMH research has found that many people have seen their doctors
    the month, day, or even hours before they commit suicide, and that many
    suffer from depression. This knowledge raises the hope that one day the
    majority of these deaths may be prevented.
        NIMH research has shown that many risk factors for violence occur
    early in a child's life, including child abuse and neglect.
    What Could Be Accomplished With Additional Funds
        Ongoing clinical trials in neuroscience, behavioral science,
    genetics, and clinical investigation will provide solid information
    about the best treatments for many mental illnesses including
    schizophrenia, depression and bipolar disorder.
        Several new clinical trials will focus on children's mental
    disorders.
        Research on school safety to be initiated this year will improve
    our understanding of the social and emotional factors involved in
    violent behavior by children.
        NIMH is using a broad array of scientific approaches to examine the
    patterns of use of psychotropic drugs in young children.
                        national institute on drug abuse
        The National Institute on Drug Abuse (NIDA) conducts and supports
    over 85 percent of the world's research on the health aspects of drug
    abuse and addiction.
    Accomplishments
        NIDA launched the National Drug Abuse Treatment Clinical Trials
    Network (CTN), which will include not only a wide array of research
    centers but also some 250 community-based treatment programs.
        NIDA-supported research has demonstrated a potentially powerful new
    treatment approach for heroin addiction known as Bup-Nx. FDA approval
    is expected soon.
        Scientists are finding that abuse of some drugs such as
    methamphetamine and MDMA, or ecstasy, can cause long-lasting damage to
    the brain.
        Using neuroimaging techniques, scientists have discovered that the
    amount of dopamine D2 receptors an individual has may predict whether
    they will find a drug pleasant.
        In animal tests, a new compound, DIPP-NH2 , was found to be three
    times more potent at reducing pain than morphine and did not show signs
    of physical dependence.
    What Could Be Accomplished With Additional Funds
        NIDA would increase its research portfolio investigating the link
    between drug abuse and various diseases that predominantly affect
    minority populations.
        NIDA has launched an initiative to understand the role of genetic
    and environmental factors in addiction, but it has only been able to
    fund half of the excellent proposals received.
        Given the increasing use of ``club drugs'' such as ecstasy, GHB,
    ketamine, and others, NIDA will increase its efforts to develop
    effective new treatments.
        Little is known about the short- and long-term effects of chronic
    drug abuse on the body. NIDA hopes to increase its efforts to
    understand these consequences, especially as drug-using populations
    continue to age.
        NIDA would launch a Neurobiology of Development Initiative to
    determine the effects of drugs on brain development at all ages,
    especially those prenatally exposed.
        State-of-the-art technologies such as functional magnetic resonance
    imaging (fMRI) scanners enable scientists to pose a whole new series of
    questions and provide analyses at an even more sophisticated level.
    Expanding access to and refining these costly technologies is a high
    priority for NIDA.
           national center for complementary and alternative medicine
        The National Center for Complementary and Alternative Medicine
    (NCCAM) is playing a key role in validating unconventional approaches
    to health care by supporting rigorous scientific research.
    Accomplishments
        NCCAM supports the largest, most definitive Phase III clinical
    trials ever undertaken for a range of unconventional therapies,
    including studies of:
      --Ginkgo biloba to prevent dementia (with NIA).
      --acupuncture for osteoarthritis pain (with NIAMS).
      --glucosamine and chondroitin sulfate for osteoarthritis (with
            NIAMS).
      --shark cartilage for lung cancer treatment (with NCI).
      --saw palmetto extract for enlargement of the prostate (with NIDDK).
      --St. John's Wort for treatment of depression (with NIMH).
        Five new Specialty Research Center bring the number of research
    centers supported by NCCAM to 11. The new centers focus on aging and
    women's health, arthritis, craniofacial disorders, neurological
    disorders, and cardiovascular disease in African Americans.
    What Could Be Accomplished With Additional Funds
        The Clinical Research Curriculum Award (CRCA) would support
    instruction in complementary and alternative medicine (CAM) clinical
    research. NCCAM plans to make awards that help incorporate CAM
    information into medical and allied health school curricula.
        NCCAM has formed a search committee to recruit a recognized
    authority in clinical research to develop an intramural research
    program. NCCAM intramural research will be primarily clinical in focus.
        NCCAM would like to support studies examining the use of:
      --echinacea to treat upper respiratory infections and ear infections.
      --massage to speed the development of preterm infants.
      --feverfew as a treatment for migraine.
      --valerian root for the treatment of insomnia.
      --milk thistle extract to treat Hepatitis C and other liver diseases.
        NCCAM hopes to support studies of indigenous health systems,
    exploring promising traditional therapies for their potential
    applicability in the U.S. Examples include Native American medicine and
    traditional Chinese medicine.
               national institute on alcohol abuse and alcoholism
        Approximately 14 million American adults are dependent on alcohol
    or abuse it. The direct and indirect costs to the nation are almost
    $185 billion annually.
    Accomplishments
        NIAAA-supported scientists found that the brains of human
    alcoholics produced less of a crucial nervous-system protein, myelin,
    than those of non-alcoholics. This new finding will help scientists to
    pinpoint gene activity that results in damage to alcoholics' brains.
        NIAAA's Collaborative Studies on the Genetics of Alcoholism (COGA)
    has found the likely chromosomal locations of several genes involved in
    alcoholism.
        NIAAA-supported studies showed that the new medication nalmefene is
    at least as successful in preventing relapse among recovering
    alcoholics as naltrexone, the recently FDA-approved drug of choice.
    Nalmefene may have advantages over naltrexone, including less liver
    toxicity. A Finnish company plans to seek FDA approval.
        NIAAA-supported researchers have found that people who drank
    heavily during early and middle adolescence score significantly lower
    on neuropsychological tests. Heavy drinking in the young may inflict
    unique and potentially lasting damage.
    What Could Be Accomplished With Additional Funds
        NIAAA proposes to establish an Integrative Neuroscience Initiative
    on Alcoholism (INIA) that would incorporate the efforts and findings
    from various scientific disciplines.
        Microarray technology, a recently developed genetics technique,
    will give alcohol researchers a clearer picture of the changes in the
    brain caused by chronic alcohol exposure and reveal potential
    therapeutic targets.
        At least nine promising medications for alcoholism treatment await
    further testing, but require a faster mechanism for moving from the
    laboratory to clinical trial.
        NIAAA could conduct the first national, representative sample of
    drinking among adolescents and college-age youth. This study is crucial
    to estimate treatment needs.
        Research is needed to identify the biological, genetic, and
    sociocultural factors that contribute to increased risk of fetal
    alcohol syndrome in some minority populations.
        Recovery rates among alcoholics need to be improved. Clinical
    trials that identify biological factors influencing recovery will
    enable scientists to work toward this goal.
        Researchers could better address the public health threat from
    hepatitis C by investigating how alcoholic liver disease and hepatitis
    C interact to cause unexpectedly high damage.
                     national center for research resources
        The National Center for Research Resources (NCRR) provides the
    critical research tools and infrastructure necessary for scientists to
    conduct top-notch health-related research.
    Accomplishments
        Scientists used powerful high-field nuclear magnetic resonance
    (NMR) spectrometers to identify the crucial parts of the prion protein
    that can change and cause degenerative brain conditions such as mad cow
    disease, scrapie in sheep and goats, and Creutzfeldt-Jakob disease and
    kuru in humans.
        Postmenopausal women with hip fracture were found to show signs of
    vitamin D deficiency, which can be prevented with proper nutrition and
    vitamin supplements.
        Researchers uncovered the three-dimensional structure of the cell's
    tiny protein factories known as ribosomes in unprecedented detail using
    high-energy x-rays.
        Scientists have found that most babies with severe combined
    immunodeficiency (SCID), a rare and sometimes fatal syndrome marked by
    a lack of immune system cells, can survive if given a bone marrow
    transplant from a family member within 14 weeks of birth.
        By evaluating monkeys with a specially made contact lens over one
    eye, scientists discovered that visual development in one eye could be
    significantly altered by modifying vision in the other. These findings
    may point to new avenues for treating and preventing visual problems in
    infants and young children.
    What Could Be Accomplished With Additional Funds
        Improved imaging systems are needed to investigate the cause,
    progression and treatment of brain pathologies.
        NCRR proposes to establish informatics centers that will facilitate
    research in areas such as genomics that generate very large data sets
    requiring high-end computation.
        NCRR proposes to establish state-of-the-art resource centers for
    analyzing gene expression, which will in turn facilitate defining gene
    function.
        NCRR proposes to increase support for synchrotron facilities, which
    produce the world's most brilliant x-rays and are crucial to structural
    biology and drug design studies.
        NCRR proposes to help alleviate health disparities among racial and
    ethnic minorities by establishing several Comprehensive Centers on
    Health Disparities at minority medical schools. The centers will focus
    on cancer screening and management, cardiovascular disease, and stroke.
                     national institute of nursing research
        The National Institute of Nursing Research (NINR) supports clinical
    and basic research to establish a scientific basis for the care of
    individuals.
    Accomplishments
        The transitional care model, with follow-up in the home by advanced
    practice nurses, was shown to improve the health of older adults with
    common medical and surgical problems at a 48 percent savings to the
    healthcare system. Widespread use of this model could improve the
    quality of patient care and save significant healthcare dollars.
        NINR has tested the effectiveness of a 6-week arthritis self-
    management course in Spanish to help Hispanics control this widespread,
    painful condition. Four months after the course was completed,
    participants showed notable improvements in their arthritis and better
    overall health.
        Very low birthweight infants require procedures that are probably
    painful to them. To avoid the use of drugs and their possible side
    effects, investigators tested three non-medication interventions in an
    effort to ease pain in these tiny babies. Pacifiers with sucrose or
    sterile water were found to significantly reduce pain.
        Researchers have found that a carefully designed educational
    program for teens who select to use the insulin infusion pump rather
    than multiple insulin injections enables them to achieve excellent
    control of their diabetes.
    What Could Be Accomplished With Additional Funds
        More funds would allow an intensive focus on research for improving
    end-of-life symptom management of pain, nausea, and weight loss.
        Increased resources would focus on helping minorities, who have a
    high rate of diabetes, manage their condition effectively.
        A new initiative would support in-depth research on promising self-
    management strategies for patients with such chronic illnesses as
    diabetes, arthritis, and congestive heart failure.
        Research would be undertaken to investigate the effectiveness of a
    wide range of telehealth interventions, especially in rural and other
    underserved areas.
        NINR would support multidisciplinary clinical trials to improve
    adherence to treatment, help patients make decisions about therapy, and
    manage the symptoms of chronic illness.
        NINR would broaden the training opportunities for nurse researchers
    in the field of genetics, including an expansion of the new Summer
    Genetics Institute.
                    national human genome research institute
        The National Human Genome Research Institute (NHGRI) aims to
    characterize the genomes of human and selected model organisms through
    complete mapping and sequencing of their DNA.
    Accomplishments
        Human Genome Project scientists have deciphered 2.25 billion of the
    3 billion chemical units of human DNA. Planners expect to complete a
    working draft of 90 percent of the genome by this spring and to finish
    the human sequence by 2003.
        NHGRI-supported scientists deciphered an entire human chromosome,
    Chromosome 22, for the first time.
        The public database GenBank has accumulated over 3.8 billion base
    pairs of DNA sequence. Scientists find this information invaluable--
    there are approximately 5 million searches of the GenBank data daily.
    What Could Be Accomplished With Additional Funds
        The roles of human genes are often discovered by comparing their
    DNA sequences to that of other organisms. Publication of the complete
    sequence of the fruit fly Drosophila melanogaster is expected in early
    2000. Having the genome sequences of other organisms will be critical
    for improving the speed and accuracy of understanding gene function and
    disease.
        A catalogue of the places in the genome where the DNA sequence
    differs among individuals will help in the effort to discern the
    genetic factors associated with many common diseases. Alterations in
    our genes are responsible for an estimated 3,000 to 4,000 hereditary
    diseases, including Huntington's disease, cystic fibrosis, and
    polycystic kidney disease. Genetic factors also interact with lifestyle
    and environmental factors like diet and cigarette smoking to influence
    the development of many common illnesses. In the future, an individual
    might be screened for hereditary predispositions to diseases and
    counseled on steps to prevent these diseases or delay their onset.
        Supporting the fundamental research needed to develop new
    sequencing technology will continue to be important, even after the
    reference human genome sequence is finished. Faster and cheaper
    sequencing machines are vital to the identification of sequence
    variations associated with disease, to understanding gene function, and
    to the incorporation of new genetic technologies into patient care.
        In the future, an individual may be able to take a credit card size
    DNA ``chip'' containing his or her personal DNA profile, along with a
    drug prescription, to a pharmacy, where the medication will be tailored
    to the individual's genes. The result will be fewer side effects and
    more effective treatment.
                          fogarty international center
        The Fogarty International Center (FIC) supports research and
    research training to address global health challenges.
    Accomplishments
        Fogarty collaborators in Uganda have helped show that single doses
    of the anti-retroviral drug nevirapine prevent mother-to-infant
    transmission of HIV, and are more effective and much cheaper than AZT.
        FIC-supported researchers have developed a new technique to more
    easily identify the virus that causes dengue fever, a reemerging
    infectious disease in the developing world.
        FIC has developed a collaborative program to combat tuberculosis
    (TB) with NIAID, CDC and USAID. Early results show progress with two
    drugs: prednisone and isoniazid.
        An FIC-supported health survey shows that people exposed to
    unprocessed cooking fuels in their homes are at a substantially
    increased risk of having active tuberculosis.
        FIC supports an International Training in Medical Informatics
    Program to train people from the developing world to apply state-of-
    the-art information and communication technologies to research and
    health surveillance activities.
    What Could Be Accomplished With Additional Funds
        FIC would establish an international research and training program
    to address tobacco prevention and control as well as research capacity
    in developing countries.
        FIC would develop a cadre of mental health experts in low- and
    middle-income nations by promoting programs to provide researchers with
    relevant scientific training.
        Efforts would be devoted to train scientists in molecular biology
    and molecular epidemiology techniques of relevance to developing
    countries.
        FIC would expand its clinical research and training programs to
    support professionals from developing nations. Clinical trials of drugs
    and vaccines of mutual benefit to the United States and host countries
    will form a major part of this activity.
        FIC would establish a program designed to reduce malnutrition and
    to support research to prevent and treat diseases through nutritional
    intervention.
        FIC would establish a program designed to strengthen epidemiology
    research and clinical trials capacity to evaluate candidate vaccines
    for parasitic, bacterial, and viral disease in low- and middle-income
    nations.
                          national library of medicine
        The National Library of Medicine (NLM), the world's largest medical
    library, uses computer and communication technologies to improve the
    organization and use of biomedical information.
    Accomplishments
        ClinicalTrials.gov, a new database developed by NLM, has just been
    made public. It is an easy-to-use system that provides the public with
    information on more than 4,000 federal and private scientific studies
    involving human subjects.
        MEDLINEplus, the Web-based consumer-oriented health information
    service, is now delivering more than a million documents each month.
    The service links users to extensive data about 350 diseases and
    conditions, and most recently to the NIH ClinicalTrials.gov database.
        NLM made awards to fund 49 electronic health information
    ``outreach'' projects in 34 states that will increase Internet access
    in a variety of community-based settings.
        Another new information resource developed by NLM is ``PubMed
    Central,'' the just-released Web-based repository that provides
    barrier-free access to primary reports in the life sciences.
    What Could Be Accomplished With Additional Funds
        ClinicalTrials.gov plans to expand to include studies not funded by
    the Federal Government. With additional support, PubMed Central
    eventually will contain peer-reviewed reports from journals and reports
    that have been screened but not formally peer reviewed.
        NLM is planning to provide access to extensive information about
    prescription drugs as the next major improvement to MEDLINEplus.
        Additional resources would be needed to expand the current outreach
    campaign through public libraries and other community organizations.
        Additional support will allow NLM to augment the medical
    informatics training programs at its 12 centers and to make training
    awards to new institutions.
        NLM is supporting the development of the Next Generation Internet.
    Additional funds will support a projected Phase III.
        NLM's National Center for Biotechnology Information (NCBI)
    collects, analyzes, and distributes molecular biology data related to
    genomic analysis. NCBI manages the GenBank database. These
    sophisticated information tools and resources must be improved,
    expanded, and made even more widely available.

        Senator Specter. We have given you a fair amount of work to
    do, but we are going to have a lot of work to do on this end in
    trying to get this funding.
        This will be the third round and I think our concluding
    round. I will call now for the final question.
        Senator Feinstein.

                                Budget Increases

        Senator Feinstein. Thanks very much, Mr. Chairman.
        I was wondering if you could tell me how the various
    institutes apply an increase in budget across the board. And
    what I mean by this, in the past 2 years, there has been a 15-
    percent increase. But apparently these increases are not
    applied equally across the board, for example, in lupus or
    diabetes. Could you tell me how this figure gets applied across
    the board, or if it does?
        Dr. Kirschstein. It gets applied based on a number of
    factors that the institute directors use to make decisions.
    Each institute has a mission statement and has developed a
    strategic plan to relate to all the diseases, dysfunctions,
    organ systems that are under the purview of that institute.
        In addition, the institutes seek advice very, very broadly
    from the statutorily mandated advisory councils, as well as
    other review groups of experts in the various fields. And over
    that large assemblage of advice and over a period of time and
    in discussion with their colleagues and with the Director of
    NIH, Dr. Varmus over the past years, final decisions are made
    as to what might be possible to do in a particular field.
        Certain scientific areas, certain diseases are more ready
    for a great expansion in funds to move them forward than are
    others. Others need nurturing in a different way, small
    workshops or large conferences, to prepare the field to be able
    to do more research. And then the institutes make decisions as
    to what types of allocations go to each area.
        The decisions also include how burdensome the disease can
    be, the quality of life with the disease, whether it affects
    one population, a majority population, a minority population,
    whether it affects women versus men. And all those factors are
    taken into consideration along with the scientific judgments of
    all these outstanding directors, to make the final decisions.
        And I would offer my colleagues, any one who might wish to,
    to add to the answer.
        Senator Feinstein. Could I just follow up on that? Are you
    saying effectively that money goes based on how ready the
    science community is to advance the ball up the field, or are
    you saying the money goes based on the presence of viable
    projects? Your answer was unclear in this area.
        Dr. Kirschstein. The answer is that it is both, and many
    other factors, as well. There is not one way, I do not think,
    that any institute or any entity decides, ``I shall spend,'' or
    ``We shall spend' X' amount on a particular disease.''
        It is indeed projects that are ongoing that can be expanded
    because new developments have occurred. There may be an
    emergency situation.
        Recently, for example, over the last several years, as
    tuberculosis reemerged as a disease that had not been of as
    much significance in the previous years, it was felt that it
    was an emergency of such a nature that a considerable amount of
    money had to be put into it.
        So there are varying reasons to do this. And each institute
    director uses the best expertise from the community, from
    outstanding scientists, from the advisory and advocacy groups,
    and then comes to the best decisions possible.
        Senator Feinstein. Thank you very much, Doctor.
        Senator Specter. Thank you very much, Senator Feinstein.
        Well, we very much appreciate you all coming in today. As I
    have said in the past, we are reluctant to interrupt your
    research to have you come to these hearings, but it is a very
    impressive group. And we will be working hard to provide the
    funding which will enable you to continue to serve America and
    the world.

                              Cancer Group Letters

        That concludes the hearing.
        Senator Feinstein. Mr. Chairman, before you adjourn, I have
    some letters from major cancer groups that deserve a response.
    May I ask that they be submitted for response?
        Senator Specter. They will be made a part of the record for
    response.
        Senator Feinstein. Thank you very much.
        [The information follows:]

                     Letter From Marin Breast Cancer Watch

                                     Marin Breast Cancer Watch,
                                     San Rafael, CA, February 22, 2000.

        Dear Senator Feinstein: I am very appreciative of your continuing
    efforts on behalf of the breast cancer stamp. As I told you in our
    phone conversation, we love the stamp and feel it has helped heighten
    awareness of the epidemic. However, we do want to know exactly where
    the money is going, and if it is not going into researching the causes,
    we would like to know why not.
        Donna Shalala said in her letter to you that the Insight Awards
    program received 400 applications, with 20 percent related to
    environmental causes of breast cancer. How much money would it cost to
    fund all 80 applications related to environmental causes?
        We would also like to know who is on the panel of scientists and
    who are the patient/advocate representatives? Who is on the
    presidentially appointed National Cancer Advisory Board? How can we
    influence the awards decision? To whom can Marin Breast Cancer Watch
    members write? Call? E-mail?
        Shalala's letter says ``Environmental factors have long been
    suspected as playing a causal role in breast cancer, and both NCI and
    the National Institute of Environmental Health Sciences already support
    many studies specifically addressing the role of the environment in
    breast cancer.'' We are unaware of these studies. How can we get more
    information on them?
        I, personally, am delighted to have you as an ally in this struggle
    to stop the epidemic of breast cancer. I believe, with all of us
    working together it will happen.
                Sincerely,
                                                Fracine Levien,
                                            Founder/Executive Director.
                                     ______

                       Letter From The Breast Caner Fund

                                        The Breast Cancer Fund,
                                      San Francisco, CA, March 7, 2000.
    Re Request to redirect Breast Cancer Stamp Funds to NIEHS.

    Senator Dianne Feinstein,
    Washington, DC.

    Attn: Glenda Booth

        Dear Senator Feinstein: As you know, The Breast Cancer Fund (TBCF)
    is very concerned about the dearth of funding for research that
    investigates linkages between environmental factors and breast cancer.
    I am therefore writing to request that you consider redirecting the
    funds raised by the Breast Cancer Stamp to the NIEHS in the re-
    authorization bill scheduled for this summer.
        In Secretary Donna Shalala's letter to you dated February 14, 2000,
    she stated that of the 400 grant applications for breast cancer stamp
    revenues, 20 percent are related to environmental causes of breast
    cancer, ``an area of major concern to many breast cancer advocates.''
    The 20 percent number is low and most likely will result in less than
    20 percent of the awards. However, an even greater problem exists with
    the definition of environmental factors.
        Advocates use environmental research to mean studies about the
    effect of chemicals and radiation on the development of breast cancer,
    while Federal agencies like the NCI include in the concept diet,
    exercise, genetics, alcohol use, pharmaceuticals and hormones, as well
    as chemicals and radiation. With this expanded definition, NCI always
    appears to be doing more than it actually is with regard to research
    into the effect of environmental toxins, including pesticides,
    industrial chemicals and pollutants, and radiation.
        TBCF has done extensive oversight to determine how much funding
    from two other important allocations for ``environmental research''
    actually went to studies into the connections between breast cancer and
    environmental toxins. We report as follows:
                     (1) 1997 emergency supplemental budget
        The first incident occurred in 1997, in the Emergency Supplemental
    Budget to which Representative Nancy Pelosi added a $15 million
    appropriation to study breast cancer and environmental toxins in areas
    of high breast cancer incidence. TBCF worked closely with Congresswoman
    Pelosi to draft the appropriation language and waited patiently to
    learn about the allocation of these funds. No action or reporting from
    the NIH was forthcoming, until, finally, in 1998, TBCF filed a Freedom
    of Information Act (FOIA) to find out whether all the groups named in
    the legislation were consulted and what the disposition of the funding
    was.
        TBCF has compiled a chronology of events that the FOIA disclosed,
    which we are enclosing with this letter. As you will see, first, $3
    million was allocated for air pollution research, and the remaining $12
    million appears to have ended up in three RFAs. However, it is
    difficult to determine exactly what funds were related to the original
    appropriation, as the addition of all funding amounted to $8.25 million
    out of the original $12 million allocation.
        As a follow-up, Representative Pelosi wrote a letter Dr. Harold
    Varmus at the NIH (12/99) requesting clarification on the RFAs and
    their relationship to the study of environmental toxins and breast
    cancer risk factors in the high incidence areas enumerated in the
    legislation. No reply has come as yet.
     (2) nci extramural research on breast cancer and environmental factors
        For several years, TBCF and other advocates wrote to Dr. Varmus
    requesting that the NIEHS budget be doubled since the mandate of that
    agency is to investigate the connections between environmental factors
    and disease. In the initial correspondence with Dr. Varmus, we were
    told that there were 40 extramural projects in 1997-98 that related to
    ``Breast Cancer and the Environment.'' Once again, our analysis reveals
    that Dr. Varmus and the NCI were including topics like exercise and
    diet in their interpretation of ``environment.''
        Of the 40 cited projects, TBCF looked for those related to
    environmental chemicals, radiation and EMFs. Our use of the term
    ``environmental factors'' was done in the most generous way. For
    example, we included as environmental research the creation of the New
    York Cancer Registry which is necessary for any future study of
    environmental factors. With numbers rounded to the nearest thousand,
    our analysis revealed the following results:
              Total funding for all projects: $11,967,000
              Total environmental projects: 12
              Total funding for environmental projects: $4,228,000 or 35
            percent of total funding.
        It should also be noted that the funding for environmental research
    cited by Dr. Varmus represents a pittance of the total NIH budget of
    $15.6 billion and that the NIEHS budget was $382 million or 2.4 percent
    of the NIH budget for the period in question.
        As a next step, TBCF plans to obtain a detailed description of
    total intramural breast cancer research funding at NCI for the 1997-98
    period to determine what percentage of those funds went to research on
    breast cancer and environmental factors, as we define them. We hope you
    will consider the two incidents described above as you consider whether
    we will actually get research into the environmental causes of breast
    cancer by allowing the NCI to continue using the Breast Cancer Stamp
    funds as described by Secretary Shalala.
        As you know, The Breast Cancer Fund has been and will continue to
    be a major supporter of the Breast Cancer Stamp. Not only is the
    funding raised by the stamp vital, but it gives the public a welcome
    opportunity to contribute to much needed research into a disease about
    which we are all concerned. We believe that the stamp revenues can have
    an even greater impact, however, if they are specifically directed to
    research into the causes of the disease. Identifying environmental
    toxins that are contributing to the disease and that can be reduced or
    eliminated would give us the first step toward real prevention.
        Thank you for considering this request, and please do not hesitate
    to contact us if we may be of further assistance in this matter.
                Sincerely,
                                              Andrea R. Martin,
                                        Founder and Executive Director.

    Enclosure.
     Chronology of Freedom of Information Act (FOIA) Request Regarding $15
      Million Emergency Appropriation for Breast Cancer and Environmental
                                Factors Research

                          (By the Breast Cancer Fund)

        Congresswoman Nancy Pelosi inserted a section in the FY 1997
    Emergency Supplemental Budget that called for a special $15 million
    appropriation, as follows:

        ``. . . for the purpose of supporting multicenter research studies
    on environmental risk factors associated with breast cancer and factors
    related to regional variations in breast cancer incidence and
    mortality. The Committee understands that there may be a significant
    link between toxics and other chemical substances present in the
    environment and the high rate of breast cancer among women in certain
    areas of the country.''

        Several States were listed, including California, where high breast
    cancer incidence and mortality has been recorded. In line 12, Chapter
    7, language was included mandating ``consultation'' with other agencies
    in the distribution of the funds:

        ``These funds will be made available on a competitive basis and
    through mechanisms determined by the Secretary, in consultation with
    the Directors of the National Institutes of Health, the National Cancer
    Institute, the National Institute of Environmental Health Sciences, the
    Centers for Disease Control and Prevention, and the Deputy Assistant
    Secretary for Women's Health.''

        The Breast Cancer Fund (TBCF) has a copy of a letter from Secretary
    Shalala to Senator Tom Harkin (12/19/97) which explained that the
    Emergency Supplemental Budget bill had passed and of the $15 million
    appropriated, $3 million was to be spent on air pollution studies that
    related to cancer and respiratory diseases. This proposal was puzzling
    since the funds were slated for breast cancer studies.
        One year after this emergency budget bill was law (Public Law 105-
    18), no information or requests for proposals had come forth from the
    National Institute of Health. TBCF has taken the following steps to
    determine the disposition of the $12 million and which agencies.were
    consulted in the disposition.
        10/14/98.--TBCF sent a FOIA to the Department of Health and Human
    Services (DHHS) Secretary Shalala requesting written proof that all the
    groups listed in the consultation mandate had been involved.
        10/21/98.--A postcard was received by TBCF from the DHHS with a
    note that consideration of our request was underway and that all future
    contact should refer to case number 99-54W.
        10/29/98.--A postcard was also received by TBCF from the Centers
    for Disease Control and Prevention (CDC) that consideration of our
    request was underway and in the future to refer to case number 99-151.
        01/21/98.--Rosario Cirrincione from the DHHS Office of Public
    Affairs, on behalf of the Executive Secretariat, sent 62 pages of
    records to TBCF in response to our FOIA request.
        03/31/98.--Ioana Petrou, Esq., TBCF General Counsel and Board
    member sent Rosario Cirrincione a letter indicating that none of the 62
    pages related to the disposition of the $12 million in Public Law 105-
    18. The request for appropriate records was repeated.
        06/28/99.--A letter was sent to TBCF from Beatriz Flores, FOI Clerk
    at the Public Health Service of DHHS, accompanied by a half inch of
    documentation \1\ which answered our consultation questions and some
    issues about how the requests for research proposals were drafted. The
    Flores cover letter stated clearly that CDC had no records regarding
    this appropriation, which means CDC was not consulted. No evidence was
    submitted that the Office of Women's Health was consulted either. The
    additional documentation concerned the specifies of the Request for
    Proposal Applications (RFA) as follows:
    ---------------------------------------------------------------------------
        \1\ Document Summary: The $12 million allocation was spread over a
    four-year period which would have resulted in a maximum of $3 million
    per year. However, $0.5 million of these funds was taken away to do
    occupational research and another $0.25 million was applied to some
    risk exposure work, neither of which allocations appears to relate
    directly to breast cancer and environmental toxins. In addition, funds
    were allocated to the NCI/NIEHS ``Exposure Assessment in Cancer
    Epidemiology'' amounting to $2.5 million a year for 3 years. The total
    funds to be awarded amounts to $8.25 million out of a $12 million
    allocation.
    ---------------------------------------------------------------------------
        (1) Regional Variation in Breast Cancer Rates in the U.S. RFA: CA-
    98-017  Application Receipt Date: 8/25/98
        (2) Interdisciplinary Studies in the Genetic Epidemiology of Cancer
    RFA: CA-98-018  Application Receipt Date: 11/17/98
        (3) Implementation of the National Occupational Research Agenda
    RFA: OH-99-002  Application Receipt Date: 6/10/99
                                     ______

                        Letter From Breast Cancer Action

                                          Breast Cancer Action,
                                     San Francisco, CA, March 10, 2000.
    Re Breast Cancer Stamp Re-authorization.

    Hon. Dianne Feinstein,
    U.S. Senate,
    Washington, DC.
        Dear Senator Feinstein: We write on behalf of the undersigned
    organizations and the thousands of people we represent to urge you to
    consider changing the language of the bill to re-authorize the breast
    cancer stamp.
        While we think this is a creative and important program, we
    strongly believe that the funds generated need to be spent in a way
    that might make a significant difference in the breast cancer epidemic.
    That will not happen if the current structure of the stamp program is
    maintained. The 70 percent of stamp proceeds that are allocated to the
    National Institutes of Health (NIH) should be directed by law to the
    National Institute of Environmental Health Sciences (NIEHS). Leaving
    the allocation of funds to the discretion of the NIH means more of the
    same kind of research that has done little to uncover the causes of
    breast cancer.
        We know that you share our concern about how the portion of the
    stamp funds that are directed to the National Institutes of Health are
    spent. Your office has shared with us the letter dated February 14 in
    which Secretary Shalala responds to your questions regarding
    expenditure of the funds. That letter reveals precisely why it is
    important to change the structure of the stamp program. Secretary
    Shalala states that the stamp funds have been allocated by the NIH to
    the National Cancer Institute (NCI), which, in turn, has created a new
    awards program for the funds. The letter states that, of the 400 grant
    applications received, twenty percent relate to environmental causes of
    breast cancer. Notably, the letter does not indicate how many of those
    grants the NCI expects to fund. And, based on the NCI report,
    ``Charting the Course: Priorities for Breast Cancer Research,'' which
    is the impetus for the grant program, it is unlikely that many of those
    applications will be funded.
        However, an even greater problem is the definition of
    ``environmental factors.'' When advocates use this phrase. they mean
    chemicals and radiation, while the NIH and NCI mean diet, exercise,
    alcohol use, hormones, as well as chemicals and radiation. By using
    this expanded definition, the NCI always appears to be doing more than
    it actually does with regard to research on ``the environment'' and
    cancer.
        As even a brief review of the ``Charting the Course'' report
    reveals, the NCI continues to focus its attention primarily on the
    molecular biology of breast cancer and on so-called ``chemoprevention''
    strategies. The work being done to identify what in the environment
    might be causing the increased incidence of breast and other cancers is
    not being done at the NCI. If that work is being done at NIH, it is
    being done at the NIEHS.
        As you know, the funds generated by the stamp are small in the
    scheme of what is directed toward and needed to solve the breast cancer
    problem. In light of that, it is all the more important to make sure
    that the funds are spent in a way that at least has a chance of
    addressing some aspect of true prevention. If we are ever to truly
    solve the problem of breast cancer by preventing the disease, we will
    need to discover and eradicate the causes of the disease.
        We look forward to working with you to make the breast cancer stamp
    program as effective as it can possibly be, and we believe that this
    will occur by making the NIEHS the designated recipient of the stamp
    funds allocated to the NIH. We also believe that the stamp will gain
    even more popular support when the public is made aware that the funds
    will be directed into research on possible preventable causes of the
    disease.
        Thank you for attention to these concerns, and for all you do to
    address the concerns of the growing population of people touched by
    breast cancer.
                Sincerely,
                        Barbara A. Brenner, Executive Director, Breast
                                Cancer Action, and on behalf of Francine
                                Levien, Executive Director, Marin Breast
                                Cancer Watch; Catherine Porter, Esq., Legal
                                Services and Public Policy Coordinator,
                                Women's Cancer Resource Center; Andrea R.
                                Martin, Founder and Executive Director, The
                                Breast Cancer Fund; Sharon Batt, Breast
                                Cancer Action Montreal; Nora Cody, DES
                                Action; Judy Norsigian, Boston Women's
                                Health Book Collective.
                                     ______

                              cancer group letter
        The importance of lifestyle and other environmental exposures as
    contributing factors of cancer is unquestionable. The pivotal role of
    the environment is reflected in the substantial variation in cancer
    incidence around the world. Furthermore, epidemiologic research has
    succeeded in identifying a wide range of cancer-causing exposures,
    including tobacco use, dietary components, sunlight, ionizing
    radiation, environmental chemicals, infectious agents, obesity,
    exercise, hormones, and reproductive factors. Indeed, the largest
    source of variability in cancer risk is due to behavior. Nevertheless,
    the causes of many cancers remain elusive. While better approaches to
    measuring exposures will provide new insights, it is clear that the
    environment represents only part of the equation in determining who
    will get cancer.
        NCI, as the Nation's leading institute in supporting and conducting
    cancer research, has placed a special focus on breast cancer research.
    NCI has a portfolio of over 1400 individual NCI-funded projects having
    relevance to breast cancer. In fiscal year 1999, NCI expended over $387
    million in research related to breast cancer, and for fiscal years 2000
    and 2001, this figure is expected to be about $425 million and $450
    million respectively.
        To support the full range of research activities necessary to
    conquer cancer, including breast cancer, NCI uses a complex and dynamic
    process to set our scientific and funding priorities. This process is
    driven by several principles:
      --Strive for a balanced portfolio of research in behavior,
            epidemiology, control, etiology, prevention, detection,
            diagnosis, treatment, survivorship, rehabilitation, and end of
            life issues;
      --Link all pieces of the cancer research enterprise through
            translational research;
      --Rely on our diverse constituencies--including scientific, medical,
            advocacy and other public communities--to help us identify new
            opportunities, gaps, and barriers to progress, create new
            programs, and improve existing ones.
        From a strategic level, we integrate priority setting into all of
    our strategic planning activities. For breast cancer research planning,
    NCI established a Progress Review Group (PRG) in 1997 to assess the
    status of breast cancer research and to provide recommendations on
    direction and priority to speed the progress. The Breast Cancer PRG was
    composed of prominent members of the scientific, medical and advocacy
    communities and their report, published in August 1998 and entitled,
    ``Charting the Course: Priorities for Breast Cancer Research,'' is the
    framework NCI uses to support a balanced portfolio of breast cancer
    research (http://wwwosp.nci.nih.gov/planning/prg/
    bprgtableofcontents.htm).
        From the research application level, we integrate priority setting
    into the funding of individual research applications based on
    scientific merit. NCI, like the rest of NIH, uses scientific peer
    review panels to competitively determine the technical validity,
    soundness and ranking of the individual grant applications. However,
    NCI has increasingly used lay reviewers/consumer advocates in our
    scientific review panels to provide a consumer perspective. These
    consumer advocates actively participate in discussions, present the
    patient perspective, and vote on the applications. During the last 18
    months, consumers have participated in almost 60 reviews, including the
    panel currently reviewing the applications for the program announcement
    ``Insight Awards To Stamp Out Breast Cancer,'' the program that will
    use the funds contributed by consumers in support of the 1997 Stamp Out
    Breast Cancer Act.
        The Insight Awards are a new initiative designed to support
    innovative pilot studies that are likely to generate new understanding
    about breast cancer and to advance underdeveloped areas of research as
    identified by the Breast Cancer PRG's 1998 report. The focus of this
    initiative is to support innovative high risk/high payoff research that
    would not be funded under normal circumstances. Over 400 applications
    have been received and are being competitively reviewed by a peer
    review panel for the available funds. The role of the peer review
    process is to judge the likelihood that the proposed research will have
    a substantial impact on the pursuit of the initiative's goals. The
    applications are being judged solely on the basis of scientific merit,
    with attention given to a balanced research portfolio as articulated in
    the Breast Cancer PRG's report. To preserve the integrity of the peer
    review process, names of individuals participating on review panels
    must remain confidential until the selection of awardees is made.
        Finally, in regard to the question on the status of the breast
    cancer research funds provided by the 1997 Emergency Supplemental
    Appropriations Act (Public Law 105-18), I am submitting a letter sent
    to The Honorable Nancy Pelosi, dated 15 March 2000, along with the
    enclosures that describe the disposition of the funds and the vital
    research it is supporting.
                                     ______

                      Letter From Dr. Richard D. Klausner

                 Department of Health & Human Services,
      National Institutes of Health, National Cancer Institute,
                                          Bethesda, MD, March 15, 2000.
    Hon. Nancy Pelosi,
    House of Representatives,
    Washington, DC.
        Dear Ms. Pelosi: Thank you for your letter of December 2, 1999, to
    the Director of the National Institutes of Health. It has been
    forwarded to the National Cancer Institute (NCI) for reply. Your letter
    addressed the disposition of the funds designated for the Department of
    Health and Human Services (DHHS) Office of the Secretary, and
    subsequently to the NCI, in the 1997 Emergency Supplemental
    Appropriations Act (Public Law 105-18, enclosed). I appreciate this
    opportunity to provide for you descriptions of our activities relating
    to this appropriation and the vital research it is supporting.
        The language contained in the Act directed the Secretary to use the
    funds appropriated ``For expenses necessary to support high-priority
    health research'' and the Conference Report (105-119, enclosed), which
    superseded the original Senate Report, provided the further direction
    that the Secretary consult with the Directors of the National
    Institutes of Health (NIH) and the Centers for Disease Control and
    Prevention (CDC), and the Deputy Assistant Secretary for Women's Health
    to determine the most appropriate mechanisms for distribution of the
    funds. The conferees stipulated that the funds should be competitively
    awarded and further requested that the Secretary consider dedicating
    the funds to cancer research, ``especially research investigating the
    environmental factors that may be associated with breast cancer in
    communities with high incidence of the disease,'' and asked for a
    report on the Secretary's plan for allocating the funds.
        After designing a strategy to invest in the best opportunities for
    advancement, several initiatives were identified that reflected the
    vision of the conferees about the disposition of these funds. Dr.
    Harold Varmus, Director of the National Institutes of Health (NIH) sent
    a report (enclosed) to Congress describing the plan. The appropriation
    was divided into two parts: NCI is coordinating the disposition of $12
    million allotted for the study of the role of environmental factors in
    cancer; and National Heart, Lung, and Blood Institute (NHLBI) is
    coordinating the disposition of $3 million for the study of health
    effects of air pollution. Air pollution studies were included in the
    research package at the request of the Secretary of the Department of
    Health and Human Services in response to the President's call for more
    research on the health effects of air pollution exposure as part of his
    implementation plan for the Environmental Protection Agency's (EPA)
    revised regulation on air quality standards. To date two projects have
    been identified for funding.
        To administer the cancer research portion of the funds, the NCI, in
    collaboration with National Institute of Environmental Health Sciences
    (NIEHS), National Institute on Aging (NIA), National Institute for
    Occupational Safety and Health (NIOSH) at CDC and the National Center
    for Environmental Research and Quality Assurance at EPA, prepared and
    issued Requests for Application (RFA) to solicit proposals from
    interested investigators. Proposals were reviewed and selected for
    funding based on a rigorous evaluation of scientific merit. This peer
    review process is arduous, but necessary to ensure that money the
    Congress and the American people have entrusted to us is used wisely.
    The initiatives envisioned in the plan and their subsequent
    implementation, including the funding allotted to each project, are
    outlined in Table 1 (enclosed).
        The RFA entitled ``Regional Variation in Breast Cancer Rates in the
    United States'' launched 5 new projects in which investigative teams
    are using statistical and epidemiologic methods to investigate factors
    that may influence, contribute to, or account for the reported
    differences in breast cancer incidence and mortality rates across
    different geographic regions. Data on women residing in California,
    Connecticut, Georgia, Hawaii, Iowa, Massachusetts, Michigan, New
    Mexico, Washington, Wisconsin, and Utah will be analyzed. An additional
    award supplemented an ongoing study in New York that is evaluating the
    effect of electromagnetic field radiation (EMF) on breast cancer risk.
        Five new grants were awarded under the RFA entitled
    ``Interdisciplinary Studies in the Genetic Epidemiology of Cancer''.
    These projects, operated together as a consortium with three related
    NCI-funded projects, will be working to understand the way genes
    interact with environmental factors in cancer development. Although
    only one of these projects addresses breast cancer specifically, each
    of them promises to contribute knowledge about the impact of the
    relationship between genetic and environmental elements in cancer
    incidence and survival, an extremely important area of cancer research.
    Since research on environmental exposures alone cannot bring us all the
    information we need, we must also address the synergistic effects of
    genes and environmental factors to understand how a normal cell becomes
    cancerous.
        In response to the RFAs entitled ``Implementation of the National
    Occupational Research Agenda'' and ``Mechanistic-Based Cancer Risk
    Assessment Methods'' four new grants were awarded to develop and/or
    improve methods for assessing past environmental and occupational
    exposures that could be associated with geographic patterns for some
    cancers including breast cancer. Research of this type (called exposure
    assessment) is important in understanding breast cancer for two
    reasons: First, we must be able to link breast cancer development to a
    carcinogen exposure that occurred years before the diagnosis; and
    second, we must be able to obtain environmental data for assessing the
    role of gene-environment interactions in the etiology of breast cancer.
        In May 1999, NCI awarded a $4.87 million 5-year contract ($2
    million from the fiscal year 1997 supplemental funds) to develop and
    implement the prototype geographic information system for health (GIS-
    H) for breast cancer studies on Long Island. The GIS-H, the first of
    its type, will provide a new tool for researchers to investigate
    relationships between breast cancer and the environment, and to
    estimate exposures to environmental contamination. The GIS-H data
    layers will include geographic data for general mapping purposes and
    demographic data. Data on health care facilities, health care surveys,
    breast cancer, and the environment will also be included. The
    environmental data will include information on contaminated drinking
    water, sources of indoor and ambient air pollution, including emissions
    from aircraft; EMFs; pesticides and other toxic chemicals; hazardous
    and municipal waste; and radiation. The system will rely chiefly on
    existing databases obtained from Federal, State, and local governments,
    as well as private sources, with emphasis placed on high-quality data.
    It is expected to be available for pilot studies in mid-2001. A Web
    site is available where the public and researchers can follow the GIS-
    H's progress and obtain summary information about the databases: http:/
    /www.healthgisli.com.
        The important work supported by the Public Law 105-18 funds is part
    of our continuing commitment to a broad research agenda that promotes
    discovery of the ways that environmental exposures to carcinogens lead
    to the development of cancer. A new RFA will be issued this year to
    direct the remaining funds toward promising studies of this nature (see
    Table 1) and NCI sponsors many other projects in this research area. In
    accordance with our own strategic plan and the intentions of the
    conferees, the funds are being used to capitalize on scientific
    opportunities that continue to provide significant new information and
    that will advance our knowledge of cancer processes.
        I hope this information is useful for you and your constituents.
    Please feel free to contact me if you have additional questions or
    concerns.
                Sincerely,
                                     Richard D. Klausner, M.D.,
                                   Director, National Cancer Institute.

    Enclosures.

                               Public Law 105-18

                                   CHAPTER 6

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                            Office of the Secretary

                public health and social services emergency fund
        For expenses necessary to support high priority health research,
    $15,000,000, to remain available until expended: Provided, That the
    Secretary shall award such funds on a competitive basis.
                                     ______

                           Conference Report 105-119

        LABOR, HEALTH AND HUMAN SERVICES, EDUCATION AND RELATED AGENCIES

                            Office of the Secretary

                public health and social services emergency fund
        The conference agreement modifies language proposed by the Senate
    which would have appropriated $15,000,000 to the Public Health and
    Social Services Emergency Fund within the Office of the Secretary for
    competitively awarded research on the environmental links to breast
    cancer. The Senate language designated the funding as an emergency
    appropriation. The House bill had no similar provision.
        The conferees agree that $15,000,000 is appropriated to support
    high priority biomedical research. These funds will be made available
    on a competitive basis and through mechanisms to be determined by the
    Secretary, in consultation with the Directors of the National
    Institutes of Health and the Centers for Disease Control and
    Prevention, and the Deputy Assistant Secretary for Women's Health. The
    conferees request that the Secretary provide a report to both
    Committees on the research plan and allocation methodology accompanying
    these additional funds by July 1, 1997. Among the priorities the
    conferees encourage the Secretary to consider is cancer research,
    especially research investigating the environmental factors that may be
    associated with breast cancer in communities with high incidence of the
    disease. The conferees have removed the emergency designation for these
    funds, offsetting the cost elsewhere within the bill.
                                     ______

                 Department of Health & Human Services,
          Public Health Service, National Institutes of Health,
                                       Bethesda, MD, February 23, 1998.
    Hon. John Edward Porter,
    Chairman, Subcommittee on Labor, Health and Human Services, Education,
            and Related Agencies, Committee on Appropriations, House of
            Representatives, Washington, DC.
        Dear Mr. Porter: On December 19, 1997, in response to the
    Conference Report accompanying the Fiscal Year 1997 Emergency
    Supplemental Appropriations Act (Public Law 105-18), the Secretary of
    Health and Human Services submitted to you our research plan for using
    the $15 million appropriated in the Act for high-priority health
    research. However, after further internal discussion, we have notified
    the Secretary and are now notifying you that we believe we can improve
    upon our original project design for the $12 million we intend to use
    to study gene-environment interactions in the cause of breast cancer in
    high-risk areas of the United States. Our updated research plan is
    enclosed. Please note that this revision still conforms with the
    legislative requirement that all of these funds be awarded on a
    competitive basis.
        Instead of a single, multi-year, multi-center, case-control study
    as originally envisioned, we have determined it would be more
    appropriate to break out the funds into four types of projects, with
    most of these funds awarded in fiscal year 1998. The first project
    would be a contract for a Geographic Information System for the Long
    Island Breast Cancer Study to identify potential environmental risk
    factors for breast cancer. The National Cancer Institute (NCI) plans to
    issue a Request for Proposals for this contract in late winter or early
    spring of 1998 for award in fiscal year 1998. The second and third
    projects would include research grants in the specific areas of
    ``Addressing Environmental Factors and Breast Cancer in High-Risk
    Areas'' and ``Interdisciplinary Collaborative Studies of Gene-Gene and
    Gene-Environment Interactions in Breast and Other Cancers.'' Requests
    for Applications (RFAs) for grants in these two areas are expected to
    be issued in the spring of 1998 and awarded in fiscal year 1998. A
    third RFA for research grants on developing and testing accurate
    exposure assessments for breast cancer epidemiology is still being
    developed and will be advertised and awarded in fiscal year 1999. We
    expect to find many different research grants with a multiplicity of
    study designs through each of these RFAs. Both NCI and the National
    Institute of Environmental Health Sciences will contribute the
    expertise of their staffs to these projects, with NCI to have the lead
    responsibility for oversight of the project.
        The portion of the original research plan related to spending $3
    million for research on the adverse health effects of exposure to air
    pollutants, such as ground level ozone and particulate matter, has not
    been revised in this update. Specific announcements regarding the award
    of funds for this project are still under development.
        Thank you for your continuing strong support for medical research.
                Sincerely,
                                           Harold Varmus, M.D.,
                                                              Director.

    Enclosure.

       A Study of Gene-Environment Interaction in the Etiology of Breast
                Cancer, in High-Risk Areas of the United States

                              [February 23, 1998]

        The special legislation (Fiscal Year 1997 Emergency Supplemental
    Appropriations Act) directing research on the environmental causes of
    breast cancer provides a remarkable opportunity to better understand
    the determinants of that disease through an innovative,
    interdisciplinary initiative that encompasses the expertise of the
    National Cancer Institute (NCI) and the National Institute of
    Environmental Health Sciences (NIEHS). Decades of research have
    established that the causes of breast cancer may involve environmental
    factors and genetic elements that are also likely to be highly
    interactive in producing the disease. However, the identification of
    the specific exposures and array of genes involved has proven elusive.
    Recent profound innovations in assessment of exposure to environmental
    contamination and molecular genetic technology have raised the
    expectation that we now have the tools to gain major new insights into
    potentially preventable causes of many diseases such as cancer, and
    into breast cancer in particular. It is clear that the time is ripe for
    studies focused on gene-environment interactions in the risk of breast
    cancer. Identification of environmental influences on genetic effects
    should clarify the biologic mechanisms involved, and discovery of genes
    that modify such effects should help identify the specific
    environmental agents and host factors responsible for breast cancer.
        All of the studies funded through this initiative will be
    accomplished via extramural competitive research funding. These studies
    will expand the existing portfolios of both Institutes in environmental
    causes of breast cancer. Studies will be funded for a variety of
    scientific approaches, including the development and application of
    geographic information systems for the identification of potential
    environmental risk factors for breast cancer, the development and
    testing of accurate exposure assessment in breast cancer epidemiology,
    the study of environmental factors for breast cancer in high risk
    areas, as well as molecular and genetic epidemiology studies of gene-
    environment interaction in breast cancer. A multiplicity of study
    designs is envisioned. Such a breadth of approaches will provide truly
    new and innovative opportunities not only to clarify genetic and
    environmental determinants that are currently under suspicion as
    causative of cancer, but also to establish bio-specimen resources
    within epidemiologic infrastructures which can be revisited to evaluate
    etiologic questions as they will arise in the future. The selection of
    meritorious projects through the peer review process will assure that
    the most scientifically excellent programs, totaling $12M, will be
    selected, thus assuring that such studies will provide an important,
    productive and efficient way to exploit our rapidly expanding
    scientific and biotechnology knowledge base to identify preventable
    causes of breast cancer. Investment in new approaches to studying gene-
    environment interactions as they relate to breast cancer, if
    successful, will provide a paradigm for new programs of
    interdisciplinary studies into the origins of other cancers, as well as
    many chronic diseases.
        Total project cost: $12 million
                                     ______

     A Study of the Adverse Health Effects of Air Pollutants, Particulate
                                Matter and Ozone

                              [February 23, 1998]

        The Fiscal Year 1997 Emergency Supplemental Appropriations Act also
    provides an opportunity to elucidate further the adverse heath effects
    of exposure to air pollutants and particulates and the role of such
    exposure in the causation of diseases such as asthma, lung cancer and
    respiratory distress syndrome. The National Heart, Lung and Blood
    Institute (NHLBI), the National Institute of Environmental Health
    Sciences (NIEHS), the National Cancer Institute (NCI), and the National
    Institute of Allergy and Infectious Diseases (NIAID) all have
    portfolios of competitively awarded grants which study the underlying
    causes of asthma, emphysema, hyperresponsiveness of the airways and the
    premalignant and malignant changes in the cells of the lining of the
    airways. Building on this knowledge base, new awards will focus on the
    roles of a single exposure or multiple exposures to ground level ozone,
    of exposure to particulate matter, and the combination of such
    exposures along with other predisposing factors to respiratory
    problems. After a national competition and peer review of applications,
    awards will be made to the most scientifically meritorious applications
    and will place emphasis on new molecular diagnostic and therapeutic
    techniques which clarify the influence of these environmental
    pollutants on genetic factors and other biologic mechanisms which
    predispose the population of this country, particularly the young, and
    the socio-economically disadvantaged to diseases such as asthma, lung
    cancer, emphysema and other respiratory distresses. These awards will
    maintain a separate identification so that they can be tracked to this
    initiative.
        Total Project Cost: $3 million to be shared by NCI, NHLBI, NIEHS,
    and NIAID dependent on the number and size of individual grant awards.
                                     ______

                                DISPOSITION OF 1997 EMERGENCY SUPPLEMENTAL APPROPRIATIONS
                                                  [Dollars in millions]
    ----------------------------------------------------------------------------------------------------------------
                                                                                                              Fiscal
                Plan initiative                 Actual initiative          Resulting projects      Funding     year
    ----------------------------------------------------------------------------------------------------------------
    Geographic Information System.........  Geographic Information     Contract awarded to             $2       1999
                                             System NO2-PC-95074.       Averstar, Vienna, VA.
    Addressing Environmental Factors and    Regional Variation in      5 new grants (UO1).......        1.6     1999
     Breast Cancer in High Risk Areas        Breast Cancer Rates in    EMF study /LIBCSP                 .4     1999
     (RTA).                                  the United States RFA:     (supplemental funds for
                                             CA-98-017 (reissue of CA-  U01).
                                             93-024) (with NIEHS).
    Interdisciplinary Collaborative         Interdisciplinary Studies  5 grants (U0I)...........        5       1999
     Studies of Gene-Gene and Gene-          in the Genetic
     Environment Interactions in Breast      Epidemiology of Cancer
     and Other Cancers (RIA).                RFA: CA-98-018 (with
                                             NIA).
    Exposure Assessment Techniques (RIA)..  Implementation of the      3 grants (R01)...........         .6     1999
                                             National Occupational
                                             Research Agenda KRA: OH-
                                             99-002 (with NIOSH/CDC
                                             and NIEHS).
                                            Mechanistic-Based Cancer   1 grant (ROI)............         .2     1999
                                             Risk Assessment Methods
                                             RFA: OH-99-003 (with
                                             NIOSH/CDC, NIEHS, and
                                             EPA).
                                            New RFA for 2000 (with       .......................    \1\ 2.2     2000
                                             NIEHS).
    ----------------------------------------------------------------------------------------------------------------
    \1\ Estimate.

    Environmental Factors and Cancer--$12 million set aside (Coordinated by NCI).
    Adverse Health Effects of Air Pollutants--$3 million set aside (Coordinated by NHLBI).

        Senator Specter. Thank you.
        Dr. Kirschstein. Thank you.

                         Additional committee questions

        Senator Specter. Thank you very much. There will be some
    additional questions which will be submitted for your response
    in the record.
        [The following questions were not asked at the hearing, but
    were submitted to the Department for response subsequent to the
    hearing:]
                  Questions Submitted by Senator Arlen Specter
                       nih doubling: future implications
        Question. What happens after doubling? What are NIH's plans to
    maintain the ``doubled'' NIH after the 5th year--how will we avoid
    large cuts in the number of new grants, and even the total number of
    grants, as NIH funding moves to a maintenance level of some sort? Can
    you prepare some grant-funding scenarios for us so we can see what the
    implications would be of maintaining NIH at biomedical inflation, as
    well as some higher levels, in the years beyond 2003?
        Answer. We recognize that Congress has stated its intention to
    double NIH's budget by fiscal year 2003 and appreciate the support the
    Congress has provided in the past three years. For responsible
    management, we have begun to consider the impact of similar increases
    in fiscal years 2002 and 2003 on NIH activities and biomedical research
    in general, and to consider scenarios for support of research in the
    years beyond fiscal year 2003. Any specific proposals for future NIH
    budgets, whether for overall budget requests or specific grant-funding,
    would be determined through the normal Executive branch budget process
    that considers overall fiscal constraints and competing priorities.
    Although at this time we cannot outline any specific proposals for
    NIH's future activities, for the purposes of answering this question,
    below are some preliminary grant funding scenarios.
        For the purposes of answering this question, we have assumed
    increases of 15.2 percent in fiscal year 2001 over fiscal year 2000,
    and increases of 15.4 percent each in fiscal year 2002 and fiscal year
    2003 that would complete a five-year doubling effort begun in fiscal
    year 1999.
        Using these assumptions, NIH estimates that by fiscal year 2003, we
    would fund nearly 12,000 competing RPGs, with average cost increases of
    5 percent provided each year for these awards. In answering this
    question, NIH assumed that Research Centers, Other Research, and
    Research and Development (R&D) Contracts would increase by 16 and 18
    percent in fiscal year 2002 and fiscal year 2003. NIH would maintain
    full-time training positions (FTTPs) at a level of 16,446, with
    inflationary increases provided for stipends, tuition allowances, etc.
        NIH funding would need to continue to increase in real terms if the
    number of competing RPGs were to be maintained at the fiscal year 2003
    level. For the three years following fiscal year 2003, if the NIH
    budget in total were maintained with increases equal to the Biomedical
    Research and Development Price Index, currently estimated at
    approximately 3.6 percent, then the number of competing RPGs NIH could
    fund would likely decrease by over 20 percent, or approximately 2,500
    grants, from nearly 12,000 in fiscal year 2003 to 9,500 in fiscal year
    2004. With the exception of those mechanisms requiring payraises, other
    mechanisms would be held flat. In fiscal year 2005, numbers of grants
    would continue to decrease, dropping by over a thousand to 8,200. This
    would be nearly 3,800 and 32 percent fewer competing RPGs than in
    fiscal year 2003. In fiscal year 2006, numbers of competing RPGs would
    increase by 1,400 to 9,600, still well below the fiscal year 2003 level
    of 12,000 competing RPGs.
        Alternatively, if NIH were to receive total increases ranging from
    8 percent in fiscal year 2004, to 10 percent in fiscal year 2005, and 7
    percent in fiscal year 2006, we could maintain the number of competing
    awards at the fiscal year 2003 level and avoid the increases and
    decreases described above. Inflationary average cost increases are
    assumed for RPGs and all other mechanisms.
        If, under a third scenario, NIH were to receive increases of
    approximately 10 percent, 11 percent, and 9 percent, respectively,
    between fiscal years 2004-2006, the number of competing RPGs could be
    maintained at the fiscal year 2003 level of nearly 12,000 and small
    increases above inflation would be provided in both competing RPGs and
    other research mechanisms. Average cost increases greater than
    inflation for competing RPGs would recognize that future investigators
    will increasingly use scientific databases, sources of specialized
    animals and sophisticated instrumentation to achieve scientific
    advances. NIH believes that sustained, stable support is vital to
    optimize the benefits of the long-term investment needed for progress
    in biomedical research.
        More and more, we find that multidisciplinary teams are needed to
    solve big problems in research. The laboratory of the future will
    almost assuredly be driven by computer applications and technologies.
    While recognizing the importance of RPGs, we see that other mechanisms
    offer unique opportunities to bring together multiple disciplines and
    centers to pursue research questions, and this scenario also provides
    modest program growth for these other mechanisms. Under this approach,
    we have also assumed continued expansion of clinical research programs
    in all mechanisms, including the Clinical Research Career Development
    programs, Clinical Research Centers, Cooperative Clinical Groups, and
    intramural clinical research in order to speed medical breakthroughs at
    the bedside that will lead to improvements in treatments and
    interventions to decrease mortality and morbidity, and improve the
    quality of life. In addition, we have assumed in the third scenario the
    same number of FTTPs in our research training program as in fiscal year
    2003, with inflationary increases for stipends.
        Modern facilities are required for molecular medicine and genetic
    research. Continuing support of such infrastructure elements would also
    be a key component of our overall strategy for sustaining capacity for
    world class medical research. Furthermore, it will be important for NIH
    to have sufficient capacity to manage research portfolios and to ensure
    appropriate stewardship of funds. Consequently, NIH's Research
    Management and Support activity and the Office of the Director would
    receive adequate increases to enable NIH to continue to assure the
    public that its trust is well founded.
        The fiscal year 2001 President's Budget proposed a strategy of
    providing average cost increases of 2 percent over fiscal year 2000 for
    RPGs, to control the growth of continuing commitments and support
    planned new and expanded initiatives. If NIH continues on the doubling
    path, then we can consider different approaches for managing funding
    increases in the best interest of scientific progress and long-term
    budgetary discipline.
        The pace of new discoveries in the biomedical sciences is now
    occurring at a breathtaking rate. The explosion of new knowledge that
    has resulted from our explorations of the human genome and the biology
    of the cell is providing new opportunities to further understand
    disease, as well as new and innovative ways of treating, diagnosing,
    and preventing illness. Untapped resources for developing and testing
    new ideas--in other words, unused capacity--will remain available in
    the research enterprise in the future. The more new ideas that are
    explored and the more rapid the effort, the sooner these findings will
    be available for translation into medical practice.
        NIH looks forward to working with Congress to ensure that NIH's
    funding increases support the highest quality research in a fiscally
    manageable and responsible manner.
                                   stem cells
        Question. When will you begin funding research grants involving
    embryonic stem cells provided they meet peer review?
        Answer. NIH will consider requests for new funds, supplemental
    funds or use of ongoing grant or intramural funds as soon as the NIH
    Guidelines are finalized and there is an oversight process in place.
        Question. What do you think has been the negative impact on stem
    cell research from the year and half long delay we have had waiting for
    the NIH guidelines to be put in place?
        Answer. As soon as it is possible to use federal funds for this
    research, more researchers will be able to participate and contribute
    to this new arena of biomedical investigation. As more people are
    involved, it is conceivable that progress may proceed more quickly.
        Question. Some have raised concerns about fetal tissue research and
    possible violations of the law concerning profiting from the sale of
    fetal tissue research. Do NIH funded scientists spend more than the
    appropriate funds charged for fetal tissue? Or do they pay a flat fee
    that simply covers the cost of processing and transporting the tissue?
        Answer. All NIH funded researchers are required to follow the
    local, state and Federal laws governing fetal tissue research. There is
    a Federal law that prohibits an individual or entity from profiting
    from sale of human fetal tissue. It also prohibits any individual or
    entity from knowingly acquiring fetal tissue from another entity for
    ``valuable consideration.'' According to this law, ``valuable
    consideration'' does not include reasonable payments associated with
    the transportation, implantation, processing, preservation, quality
    control, or storage of human fetal tissue. Violation of this statute
    carries criminal penalties. There is no evidence that NIH funded
    researchers spend more than appropriate charges. Appropriate charges
    for processing and transportation of fetal tissue may or may not take
    the form of a ``flat fee.''
        Question. How would stem cell research be impacted if fetal tissue
    research were restricted?
        Answer. If Federally funded researchers were no longer permitted to
    conduct research using fetal tissue, they would not be able to either
    derive human pluripotent stem cells from fetal tissue or conduct
    research using human pluripotent stem cells derived from fetal tissue.
                             grants review process
        Question. This Subcommittee receives many complaints from advocacy
    groups that certain fields of research are underfunded because of the
    current structure of the grant review system. What are you doing to
    address the concerns of researchers and advocates in those underfunded
    fields?
        Answer. The Center for Scientific Review (CSR) conducts the review
    of approximately three-fourths of the grant applications submitted to
    NIH, including almost all investigator-initiated applications. The
    study sections that review these applications were established over a
    period of many years. Although the content of the science reviewed in
    CSR's study sections has evolved as the research enterprise developed,
    there had never been a systematic assessment of whether the current
    study sections are appropriate for the review of today's (and
    tomorrow's) scientific opportunities in the health-related research
    areas.
        In 1998, CSR convened a distinguished panel (the Panel on
    Scientific Boundaries for Review) of scientific leaders from diverse
    fields of biomedicine to conduct an overall assessment of the structure
    and functions of its peer review system, and to propose changes needed
    to better align the system with the current research landscape and
    scientific opportunities. The Panel engaged in extensive outreach to
    the broad research community so as to solicit input and encourage
    dialogue. The Phase 1 recommendations were posted on the web for
    several months, and over 800 comments from professional societies and
    individual researchers were received and considered. Numerous meetings
    and teleconference calls were held among Panel members, the director of
    CSR and her staff and concerned representatives from advocacy groups
    and professional societies. A revised Phase 1 report was presented and
    accepted by the CSR Advisory Committee in January, 2000. The thrust of
    the proposed reorganization involves the distribution of research grant
    applications for review to a group of committees that form a cluster
    focused on a particular disease or organ systems, in order to stimulate
    the identification of the best scientific approaches to such a unit.
        The second phase of the Panel's activity has just begun and will
    define the boundaries of the individual study sections that will
    populate the new clusters of review groups. Again, this will be
    accomplished with extensive participation by the relevant research
    communities, which will ensure that new directions and newly-emerging
    scientific areas will be accommodated and that all types of research
    approaches will receive a fair and appropriate review. An
    implementation plan for Phase 2 has been developed and posted on the
    NIH website, and CSR is currently beginning work on the first new
    cluster of study sections.
        In addition to the major re-structuring of CSR, individual
    Institutes have responded to advocacy groups by (1) organizing
    workshops to identify potential research opportunities for the
    development or refinement of diagnoses, and therapies and the further
    understanding of specific diseases, and (2) issuing specific requests
    for applications (RFAs) that address areas that are recognized to
    require stimulation. Responses to these RFAs are reviewed by special
    review committees convened specifically for that purpose by the funding
    Institutes.
        Question. Some institutes are taking steps to involve members of
    the public on certain scientific peer review panels. How are these
    efforts working out? What contributions can lay reviewers make to the
    process?
        Answer. The National Cancer Institute, the National Institute of
    Allergy and Infectious Diseases, the National Institute of Mental
    Health, and the National Institute on Drug Abuse involve members of the
    public on their peer review panels. A description of their involvement
    follows:
    National Cancer Institute
        The NCI has increasingly involved consumers on Institute-based
    scientific peer review panels for grant applications and contracts
    proposing clinical trials of new cancer treatments. NCI has expanded
    the involvement of members of the public to include lay reviewers/
    consumers on all NCI scientific peer review panels for clinical and
    population based research. This includes review panels for Cancer
    Centers, Cooperative Clinical Trials Groups, Specialized Programs of
    Research Excellence (SPOREs), clinically oriented Program Projects, and
    projects submitted in response to Requests for Applications (RFAs).
    Most Cancer Center, Cooperative Group, and Program Project applications
    require a site visit to the applicant institution prior to the formal
    review committee meeting, and consumers participate in the site visit
    as well as in the subsequent review committee for these applications.
    NCI review staff worked with the NCI Office of Liaison Activities (OLA)
    and the NCI Director's Consumer Liaison Group (DCLG) to develop
    criteria for selecting consumer reviewers. In response to input from
    consumers, NCI developed a Consumer's Guide to Peer Review and a
    Consumer's Cancer Dictionary for Peer Review to facilitate
    participation of lay members on review panels. Consumers have been used
    in almost 60 reviews during the past 18 months.
        Consumers participate actively in discussions, present the patient
    perspective in discussion, and vote on the applications. Consumers
    provide an important additional perspective on the proposed research in
    the following areas: factors that may affect study design; feasibility
    of plans for patient recruitment, retention and follow up of subjects;
    feasibility of protocols in regard to specific populations (e.g.,
    complexity, compliance); clarity and patient acceptability of
    protocols; feasibility of protocols in the context of total patient
    care; cultural and socioeconomic aspects of protocol implementation;
    outreach and special challenges (e.g., need for multi-cultural research
    staff, composition and role of the Community Advisory Board, etc); and
    ethical issues, including human subject protection, adequacy of
    informed consent forms and inclusion of women, minorities, and children
    in clinical research. In addition, as they review applications, they
    may consider whether the proposed research is applicable to cancer in
    terms of prevention, cause, detection, treatment, care, quality of
    life, and/or other pertinent issues. Feedback to NCI from both
    consumers and scientific reviewers is obtained and indicates that the
    system is working very well.
        One striking effect of use of consumers in the peer review process
    has been its effects on applicants. There has been a noticeable
    increase in documented consumer input in research proposals as
    evidenced by the participation of consumers in various structural and
    advisory capacities within applicant organizations.
    National Institute of Allergy and Infectious Diseases
        The use of members of the public on NIAID review committees, where
    they can contribute essential insights to the overall evaluation, is a
    thoroughly considered and well-precedented practice that NIAID
    considers to be an important component of the responsible conduct of
    the peer review of patient oriented research. Public members make
    important contributions and can bridge the communication and knowledge
    gap between scientists and the patient base they serve. The NIAID has
    been actively involving members of the public on certain scientific
    peer review panels over the last ten years, and the following data
    summarize some of the experiences:
      --Public members bring very unique multi-faceted perspectives of the
            disease/condition/subject to the review group resulting in
            better decisions.
      --They have a very high interest in the research and the process of
            thorough evaluation of applications to determine which have the
            best scientific merit.
      --Their knowledge of certain diseases and the people affected by
            those diseases enables the public members to provide valuable
            input and expertise as reviewers and to raise important
            questions in several aspects of the research, for example,
            clarity of protocols, consent forms, and the feasibility of
            complicated protocols for certain patients.
      --Since at least 1991, the NIAID special review committees have
            included patient and lay representatives of the target
            populations for selected large clinical efforts including: the
            AIDS Clinical Trials Groups (ACTG), the Pediatric ACTG, the
            Women's Interagency HIV Study, the Multi-center AIDS Cohort
            Study, and the AIDS Vaccine Evaluation Group. However, the
            NIAID does not include members of the public on committees in
            which patient recruitment and retention is not an issue, for
            example, basic science initiatives.
      --The NIAID believes that proposed research efforts, the overall
            success of which depends upon the successful recruitment and
            retention of patient populations, must be evaluated on the
            quality, appropriateness, and feasibility of the proposed plans
            for recruitment and retention. So important is this aspect of
            the plans that the review criteria specifically include
            recruitment, retention, and related community outreach issues.
      --As with selection of any reviewer, special care needs to be taken
            to select individuals with the appropriate expertise.
        The NIAID also believes the review committees need to include all
    types of expertise relevant to making an informed assessment of the
    merit of the applications, and that patients or members of the public
    provide insights regarding the quality, appropriateness, and
    feasibility of plans for recruitment, retention, and community
    outreach. This is viewed as one of the essential types of expertise
    that should be brought to bear upon the overall judgement.
        Public members of the NIAID review committees have review
    assignments in which they are asked to comment on the recruitment,
    retention and outreach aspects of the proposals. Their contributions
    are generally valued and appreciated by other (scientific) reviewers.
    They are full-scoring participants in the review meeting and constitute
    a small percentage of the voting members of any of these review
    committees.
        Like all reviewers, the public members are asked to comment on
    aspects of the applications related to their personal expertise, and to
    score the applications on overall merit as best they can, having
    listened to the discussion of all other reviewers. In our experience,
    the scores assigned by the public members have been remarkably
    consistent with scores assigned by other reviewers.
        In summary, the NIAID applauds the efforts of members of the public
    on peer review committees, and recognizes that additional members may
    contribute a perspective that is perhaps sometimes difficult for a
    scientific specialist to appreciate.
    National Institute of Mental Health
        Public participant reviewers have successfully served for a year on
    the NIMH's service and interventions review committees. Public
    reviewers included individuals who have suffered from mental disorders,
    family members of those suffering from mental disorders, policymakers
    in the mental health care arena, and mental health care providers. All
    committee members were asked for their assessment of how well the
    process worked. The most common feedback was that the inclusion of
    public reviewers was useful and that the public reviewers had done an
    excellent job. The public reviewers, many of whom experienced the
    committee process for the first time, were impressed with the efforts
    of the committee members and the serious and objective nature of the
    deliberations. NIMH will continue to request feedback from all
    reviewers to help inform and improve the process of public
    participation in its review meetings. Future plans are to help public
    reviewers focus on the review issues to which they can best contribute
    such as determining public health importance and human protection
    issues, and to continue adding and training new public reviewers to
    ensure a broad diversity of opinions and experiences.
    National Institute on Drug Abuse
        NIDA is in the process of planning the recruitment and training of
    public consumers to act as reviewers for the treatment and services
    review panels. These public members will provide an important point of
    view, commenting on issues such as feasibility of the research,
    practicality of the proposed intervention, and appropriateness of human
    subjects protections.
                          nih buildings and facilities
        Question. Dr. Fischbach and Dr. Hyman, the Budget requests funding
    for a new National Neurosicence Research Center, at a cost of $73.3
    million. How will this ``integrated neuroscience program'' enhance
    neuroscience research at the NIH? Will the broader research community
    benefit from this?
        Answer. The most significant feature of the integrated neuroscience
    program is that it will speed the translation of scientific discoveries
    into new, clinically useful strategies for disease prevention and
    treatment. Sustained interactions between basic and clinical scientists
    are needed so that each group can be better informed about the
    opportunities offered by the other. In the more typical academic model,
    basic neuroscientists are segregated in one or more preclinical
    departments, quite removed from colleagues in clinical departments of
    neurology, psychiatry, neurosurgery, medicine, and anesthesiology.
    Input from the engineering, mathematics and physical sciences is
    minimal. This new integrated neuroscience program has a rare
    opportunity to set a high standard for the entire nation by ``putting
    the brain back together'' without regard to the artificial boundaries
    of Institute or medical school organization. Beyond the obvious medical
    disciplines, we will integrate bioengineering, computational science
    and bioinformatics as more equal partners in research in the
    neurosciences. In so doing, we will support and enhance the patient-
    oriented research that will be conducted in the new Mark Hatfield
    Clinical Research Center.
        Each of the Institutes that will participate in this program was
    created with a distinct patient population in mind, and they fund
    research that is of special interest to their different constituencies.
    However, they share many areas of neuroscience research. For example
    common mechanisms of nerve cell degeneration probably underlie
    Alzheimer's disease, vascular dementia, blindness, hearing loss, and
    stroke. Common alterations in the actions of neurotransmitters, such as
    dopamine, probably underlie thought disorders such as schizophrenia,
    movement disorders such as Parkinson's disease, substance abuse
    problems including alcoholism, and the suffering due to chronic pain.
    Thus, the mission of each Institute would be better served by a
    coordinated effort on the NIH campus.
        We plan to bring together, under one roof, NIH scientists who are
    now isolated from one another simply because of outdated historical
    precedents. Research will be organized, and resources allocated,
    according to scientific themes, not Institute identity. We will also
    cooperate in filling gaps in our research programs by recruiting the
    very best new scientists to the NIH campus.
        The broader research community will benefit in many ways. One of
    the most exciting elements of this plan is the opportunity to attract
    and train the most talented young scientists, many of whom will return
    to the extramural community. We also envision enhanced opportunities
    for intramural-extramural collaboration, both on specific projects and
    through mechanisms that will allow the appointment of academic
    scientists to short-term positions at NIH. In addition to bringing
    individuals and teams of scientists together, the program will provide
    unprecedented opportunities for extramural scientists to take advantage
    of resources such as animal models, genetic tools, and state-of-the-art
    imaging devices. Perhaps most importantly, our program will serve both
    as a model to reinforce similar efforts in the broader community and as
    a template for developing strong neuroscience research programs in
    institutions that do not presently have them.
        Question. Is this $73 million the total cost of the entire project,
    or is there another phase to come later, and if so, how much is the
    total cost?
        Answer. The B&F request includes $47.3 million in fiscal year 2001
    and requests advance appropriations of $26 million in fiscal year 2002
    for the initial phase of construction to replace Building 35. In fiscal
    year 2000 the NIH plans to request a reprogramming of $5 million from
    other B&F projects to fund the design/construction documents for the
    initial phase of construction. We are considering a second phase to the
    NNRC project. A decision on the scope and cost of any potential phase
    will be made through the normal Executive branch budget formulation
    process.
        Question. What types of research will you be able to conduct in the
    new center that you are unable to do with your present facilities?
        Answer. As noted earlier, we believe the planned center will
    provide an optimal environment for translational research. However, its
    distinguishing feature will not be research on specific topics so much
    as an innovative process and environment for conducting
    interdisciplinary, collaborative research without regard to
    organizational boundaries. The importance of this can hardly be
    overstated in the context of what modern neuroscience is teaching us
    about the brain and its disorders.
        Question. Are other important activities needing B&F funds being
    put on hold in order to undertake this project?
        Answer. The fiscal year 2001 B&F request provides a level of
    funding to initiate or continue support for three of the highest
    priority projects of the National Institutes of Health (NIH): the
    National Neuroscience Research Center (NNRC), the Central Vivarium, and
    the Modernization of Building 6. The remaining funds in the request are
    sufficient to maintain continuity of essential and enabling projects in
    support of the research facilities infrastructure of the NIH.
                           national cancer institute
        Question. Dr. Klausner, shortly after you became NCI Director, you
    began a new research initiative called the Cancer Genome Anatomy
    Project to identify all of the genes involved in cancer. Can you tell
    us whether that project has produced any results?
        Answer. This project has been extremely successful, identifying
    tags for the vast number of human genes, annotating what types of cells
    and cancers express those genes, developing catalogues of chromosomal
    changes in cancer and discovering common genetic variations that will
    help to explain why individuals are different in their risk of getting
    cancer, their sensitivity to diet and the environment and their
    responses to therapy. CGAP has become one of the most widely used
    sources of information and reagents in the research world
    (www.ncbi.nlm.nih.gov/ncicgap/).
        In the past three years, the CGAP Tumor Gene Index has discovered
    more than 40,000 previously unknown expressed human genes, representing
    about one-half of all known human genes and has produced more than
    900,000 DNA sequences. CGAP has discovered approximately 3,800
    previously unknown genes expressed in the breast, colon, lung, ovary,
    and prostate and has now extended this analysis to all major forms of
    cancer. These new genes are already the subject of follow-up studies to
    assess their potential for defining molecular signatures for normal,
    precancer, and cancerous tissue.
        We expect that having these molecular signatures of cancer will
    afford new opportunities to catalyze all areas of cancer research
    including cancer predisposition, development, prevention, detection,
    prognosis, and therapy. For example, CGAP discoveries may provide the
    platform for molecular signatures of the earliest stages of cancer
    development, thereby facilitating prevention research.
        In the area of therapy, understanding the molecular nature of
    cancer will spur efforts to develop new drugs with improved
    effectiveness and reduced side effects because the drug design will be
    based the precise molecular profiles of tumors and the patients. In
    addition, identifying early molecular events in cancer will afford new
    opportunities to therapeutically target earlier stages of cancer
    development. NCI is working actively to build a strong interface of
    CGAP with the basic and clinical research communities in academia and
    industry to assure that these new resources are effectively utilized.
        In addition, the NCI will continue to build additional
    infrastructure (data, technology, informatics tools) to assure that
    maximal value is obtained from the CGAP project. Toward that end, the
    NCI has implemented several CGAP inter-related components designed to
    provide an information and technology infrastructure for the biomedical
    research community. One of these components, the human tumor gene index
    (TGI), was fully implemented in May 1997 with the initial goal of
    identifying genes expressed during development of tumors in five major
    cancer sites--breast, colon, lung, ovary, and prostate. For breast
    cancer, the TGI has produced more than 17,000 DNA sequences from 11
    cDNA libraries derived from human breast tissue and tumors, resulting
    in the categorizing of about 5,700 genes expressed in human breast
    cancer.
        Active efforts in the research community are being directed at
    assessing the potential value of these newly discovered genes as
    markers for cancer development. These projects include laboratory
    studies of how environmentally-induced genetic alterations leading to
    altered function of a mutant protein contribute to the abnormal growth
    pattern which characterizes tumors. Epidemiologic studies too are
    focusing on the role of genetic variations possibly induced by
    environmental agents. Of particular interest are studies of the enzymes
    which metabolize environmental agents or steroid hormones, and
    alterations in the genes which code for these enzymes.
        Question. What is NCI's/NIH's role in international cancer
    research? Please describe for the committee what NCI's role has been in
    the development of the historic All-Ireland Cancer Center.
        Answer. NCI, in cooperation with extramural institutions and the
    Fogarty International Center of the NIH, supports international health
    research through bilateral agreements, grants, and contracts. The
    Institute supports some 1,000 Visiting Scientists and Exchange
    Scientists. The work of outstanding scientists throughout the world is
    supported through fellowships, cooperative projects, exchanges of
    personnel and materials, and workshops. During fiscal year 1999, NCI
    obligated approximately $45 million for foreign grants and contracts,
    the NIH Visiting Program, bilateral scientist exchanges, workshops, and
    international dissemination of cancer information. NCI's international
    effort, coordinated by the Office of International Affairs (OIA) within
    the Office of the NCI Director, works in conjunction with programs
    within NCI's divisions, at other NIH Institutes and the Fogarty
    International Center.
    The All Ireland--National Cancer Institute Cancer Consortium
        The NCI has recently embarked on an international partnership with
    the developing Cancer Programs on the Island of Ireland (Northern
    Ireland and the Republic of Ireland) in an attempt to improve the
    quality and range of cancer services available for patients in Ireland.
    This Transatlantic Partnership, called the All Ireland-NCI Cancer
    Consortium seeks to strengthen cancer treatment, education and research
    programs as the cancer communities from both the Republic of Ireland
    and Northern Ireland prepare to join in a unique agreement with the US
    National Cancer Institute. I and several members of my staff had worked
    closely with Chief Medical Officers of both Irish governments and other
    key Ireland officials to develop this concept, and we were greatly
    facilitated in this endeavor by our Irish ex-colleagues at the NCI.
        Cancer is a significant cause of mortality and morbidity on the
    Island of Ireland with Northern Ireland and the Republic of Ireland
    having one of the highest incidence and mortality rates for cancer in
    the Western World. Currently there are approximately 28,000 new cases
    and approximately 11,000 deaths from cancer each year. Therefore, the
    development/improvement of services for cancer patients has been a top
    priority for both Northern Ireland and the Republic of Ireland. Given
    the NCI's leadership in the cancer field, the leadership of Northern
    Ireland and the Republic of Ireland felt it was timely to bring
    international expertise such as the NCI on board as partners in an
    effort to fuel the further development of cancer services in Ireland.
    The major components of the NCI Ireland Agreement include the
    following:
    Education and exchange of scholars
        Education forms one of the major platforms of this Agreement
    through the support of educational programs for Medical, Nursing and
    Scientific Staff. These programs will include the exchange of scholars,
    including Ph.D., M.D., and nursing students. Particular emphasis will
    be given to the exchange of medical and nursing trainees focused on
    clinical research. This will have an immediate clinical impact and will
    naturally extend the support that has already been given to the
    training of medical and scientific trainees from the Island of Ireland.
    Further exchanges would include Ph.D. students, laboratory based M.D.s
    in training, clinical visiting professors and investigators from the US
    wishing to extend their studies in Ireland.
    Clinical Trials
        Another major area for partnership will be the enhancement of
    clinical trials infrastructure and clinical trial development.
    Modernization of cancer care requires placing cancer delivery in the
    context of evidence based medicine. This requires a vigorous and
    contemporary clinical trials infrastructure that will center around the
    clinical trials infrastructure already established at the Northern
    Ireland Cancer Center and also the Clinical Trials organization in the
    Republic of Ireland. The NCI has already commissioned the development
    of a new Clinical Trials Information System (CTIS) which seeks as its
    goal to implement international standards in institutionally based
    clinical trials processes and has already committed significant
    resources to its implementation. The outcome of this element of
    partnership will be that clinical trials performed in these
    institutions will immediately be compatible for collation, analysis and
    presentation with studies performed in the United States. Moreover,
    this system will allow participating centers to immediately conform to
    international standards. This proposal therefore permits participating
    institutions in Northern Ireland and the Republic of Ireland to quickly
    achieve data management standards, which will exceed that of many
    institutions.
    Teleconferencing
        Some teleconferencing capabilities and linkages are already
    established between both partners in Ireland and the NCI. The further
    investment in this infrastructure will facilitate cooperative clinical
    trial development, education programs, patient services development and
    exchange of clinical and scientific ideas. Communications will be
    essential to the success of this partnership.
    Tumor Registries
        Another area for major collaboration and partnership will be in the
    use of the Cancer Tumour Registries in both Northern Ireland and the
    Republic of Ireland. The monitoring of improvements in cancer care can
    only be a success with a reliable tumor registry that tracks population
    based cancer incidence and mortality. These registries are now
    available in both Northern Ireland and the Republic of Ireland, and
    both Governments recognize their importance. The NCI will assist both
    tumor registries by developing a common data base that can assist in
    consultation, informatic tools and quality control. The consolidation
    of the Registries in both the North and South will improve the overall
    quality of data collection and provide information on a genetically
    stable population. This will also act as a major tool for major
    epidemiological investigations and development.
    Developments in Cancer Clinical Services
        The NCI Ireland partnership assists in the further development of
    cancer clinical services programs on the Island of Ireland. This
    includes the improvement and standardization of Radiation Oncology
    practice and the development of a consolidated Radiation Oncology
    program for research. There are a limited number of radiation
    facilities on the Island of Ireland and there are significant needs in
    terms of linking practice elements and the implement of uniform
    standards of practice. The assistance in standardizing and driving the
    development of clinical services will also extend to elements of
    Medical and Surgical Oncology Practice as well as Palliative Care. The
    development of Palliative Care Services is already at a very advanced
    stage on the Island of Ireland and is one that the National Cancer
    Institute will benefit from in terms of its own developing programs.
    The NCI-All Ireland Cancer Conference
        The NCI-All Ireland Cancer Conference held in Belfast in October
    1999 was an important event that highlighted the commencement of this
    special relationship. This Conference touched on clinical, laboratory,
    epidemiological, and political issues that are pertinent to the care of
    cancer patients. It highlighted important work by Irish, American and
    European Scientists coupled with input from well-known international
    academic and biotechnology investigators from across the world. This
    international expertise was asked to discuss their areas of expertise
    and comment on clinical and scientific programs that may help improve
    North and South interaction and Transatlantic collaboration. All NCI
    investigators were invited to participate in this conference.
        Finally, the Conference punctuated the start of a very special
    interaction on the Island of Ireland focused on the overall development
    of cancer services for patients and also signaled the start of an
    important partnership between the NCI and the practicing cancer
    community in Ireland.
        Question. What process does NCI use to set priorities? How does
    this relate to the Bypass Budget initiatives?
        Answer. To support the full range of research activities necessary
    to conquer cancer, NCI uses a complex and dynamic process to set our
    scientific and funding priorities. This process is driven by several
    principles. Support the full range of research activities necessary to
    conquer cancer:
      --Strive for a balanced portfolio of research in behavior,
            epidemiology, control, prevention, detection, diagnosis,
            treatment, survivorship, rehabilitation, and end of life
            issues;
      --Give attention to the spectrum of distinct diseases we collectively
            refer to as cancer and the various populations that experience
            these diseases differently;
      --Link all pieces of the cancer research enterprise through
            translational research;
      --Rely on our diverse constituencies to help us identify new
            opportunities, gaps, and barriers to progress, create new
            programs, and improve existing ones.
        We integrate priority setting into all of our strategic planning
    activities. These activities include identifying high priority
    scientific opportunities, determining what is needed to build and
    maintain our research infrastructure, and examining what is being done
    and what needs to be done to tailor broadly applicable research to
    specific cancers. All planning activities involve significant
    participation from our advisory groups and the advocacy community.
    Extraordinary Opportunities for Investment--Identifying Extraordinary
            Scientific Opportunities
        ``Extraordinary Opportunities'' are areas where focused efforts and
    increased resources could produce dramatic progress toward reducing the
    burden of cancer. NCI identifies and prioritizes, with formal input
    from cancer scientists, educators, advocates, and other cancer
    community leaders, opportunities that:
      --Respond to important recent developments in knowledge and
            technology;
      --Offer approaches that go beyond the size, scope, and funding of our
            current research activities;
      --Can be implemented with specific, defined investments;
      --Can be described in terms of achievable milestones, with clear
            consequences for investing; and
      --Promise advances and progress against all cancers.
    NCI Challenges--Building Critical Research Infrastructure
        NCI plans for and supports research through a variety of
    mechanisms, many of which provide funds tailored to specific research
    processes. As part of an ongoing process of review and revitalization,
    NCI has instituted a series of external reviews to guide us in
    strengthening our major research support programs. In the past few
    years, we have completed in-depth reviews of several programs: Cancer
    Centers, Cancer Control, Clinical Trials, Cancer Prevention, and the
    Development Therapeutics Program. We prioritize and plan to ensure a
    research infrastructure that:
      --Provides the vision, creative environments, and diverse resources
            needed to increase the number of discoveries and advances in
            cancer research and the scientific community's ability to apply
            these findings to prevent and treat the many forms of cancer;
      --Promotes and rewards innovative thinking, cross-fertilization of
            ideas, and enhanced collaborations among government, academia,
            and industry; and
      --Develops and maintains the cadre of scientists required to
            undertake the cancer research challenges of the future.
    Tailoring to specific cancers
        NCI must apply new discoveries and advances to specific forms of
    cancer. The primary mechanism for cancer site-specific research
    planning at the NCI is the Progress Review Group (PRG). Each Progress
    Review Group is composed of prominent members of the scientific,
    medical, and advocacy communities who know the state of the science
    intimately and can provide a thoughtful, considered assessment of our
    portfolio and recommend activities that will speed our progress. PRG
    recommendations give the NCI a framework to determine whether or not
    existing initiatives and programs are sufficient to aid the research
    community in addressing priority areas. Where gaps are identified, NCI
    modifies its plans to address unmet needs and encourages the research
    community to undertake projects in key areas by clearly indicating
    where NCI's priorities lie.
    Participation from advisory groups and the advocacy community
        NCI actively seeks out expert advice from a variety of advisory
    bodies both within and outside the Institute. Scientific experts and
    consumer advocates on the Presidentially appointed National Cancer
    Advisory Board advise NCI's Director on issues related to the National
    Cancer Program. The Board of Scientific Counselors and Board of
    Scientific Advisors provide advice to NCI leadership on the progress
    and future direction of NCI's Intramural and Extramural Research
    Programs respectively. The NCI Executive Committee, which includes NCI
    Division directors and other key advisors to the Director, meets
    regularly to make major policy and operating decisions. The Director's
    Consumer Liaison Group (DCLG) serves as a primary forum for discussing
    issues and concerns and exchanging viewpoints important to the broad
    development of NCI program and research priorities. The DCLG also helps
    develop and establish processes, mechanisms, and criteria for
    identifying appropriate consumer advocates to serve on NCI program and
    policy committees; and establishes and maintains strong collaborations
    between NCI and the advocacy community.
        The annual Bypass Budget request is a key tool that NCI uses to
    articulate the results of our on-going planning and prioritizing
    process. Due to new scientific discoveries, advances in technology, and
    the related changes in scientific thought, the Bypass Budget request
    represents a snapshot, good for a relatively short time, of where NCI's
    planning and prioritizing process indicates we need to go to take
    advantage of new scientific opportunities in cancer research. As a
    result, the Extraordinary Opportunities and NCI Challenge initiatives
    outlined in the fiscal year 2001 Bypass Budget request represents the
    focus of where NCI would put available funds. For example, with the
    $420.4 million increased funding NCI received for fiscal year 2000, we
    seized the opportunity to implement many of the initiatives identified
    in the Bypass Budget request. 83 percent of the funding increase, or
    $349.7 million of the $420.4 million increase, directly supported
    initiatives in the Bypass--$124.9 million supported Extraordinary
    Opportunities initiatives and $224.8 million supported NCI Challenges
    initiatives (see figure below).
    [GRAPHIC] [TIFF OMITTED] T07MA30.005

                         clinton/blair joint statement
        Question. What was the significance of the joint statement issued
    by the President and Prime Minister Tony Blair? Was this statement
    intended to undermine research efforts in the private sector?
        Answer. The President and Prime Minister Tony Blair agreed that it
    was important to take notice, at the the highest levels of their
    governments, of the progress the two countries have made in human
    genomics and of the era of new opportunities unfolding before us. For
    that reason, they issued a joint statement of position to help ensure
    that human genomic discoveries are used as effectively as possible for
    the advancement of human health throughout the world. The statement
    consisted of two equally important, complementary principles, designed
    to maximize scientific opportunities to understand the human genome, as
    well as medical and economic opportunities for the development of
    health care products.
      --First, the statement reiterated the principle that raw fundamental
            sequence data from the human genome--the ordering of the A's,
            T's, C's, and G's that make up DNA--should be distributed as
            broadly as possible, in an unencumbered manner, for use by
            scientists around the world. This principle has been a
            condition of funding by the Human Genome Project, which makes
            genomic sequence data freely available over the Internet in a
            public database called GenBank. New sequence data are deposited
            daily by Human Genome Project participants.
      --Second, the statement makes clear that intellectual property
            protection for gene-based inventions will play an important
            role in stimulating the development of health care products,
            which will in turn allow the public to realize the full medical
            benefits of the fundamental scientific discoveries. As a new
            generation of medical discoveries begins to rely on gene-based
            technologies, it is essential that we afford these technologies
            the kind of intellectual property protection that has enabled
            the development of every other wave of medical innovations.
        No. The complementary principles described in the statement are
    beneficial to both the private sector and the public. They reinforce
    the public-private partnership that has fueled the genomics and
    biotechnology enterprises, by enabling fundamental biological
    discoveries as well as the entrepreneurship that can capitalize on
    those discoveries and bring innovations to market. Key companies
    involved in genomics were quick to issue statements endorsing the joint
    statement.
                              human genome project
        Question. Why did talks breakdown between the public Human Genome
    Project negotiators and Celera Genomics? Do you see any way the public
    Human Genome Project can maximize research dollars through
    collaborating with private sector companies?
        Answer. Representatives of The Human Genome Project, Doctors Martin
    Bobrow, Francis Collins, Harold Varmus and Robert Waterston, met with
    representatives of Celera Genomics Corporation on December 29, 1999, to
    discuss a possible collaboration to sequence the human genome. At that
    meeting Celera and Human Genome Project (HGP) representatives presented
    quite divergent terms for such a collaboration. In a February 28, 2000,
    letter to Celera, HGP representatives summarized the December 29, 1999
    discussion and described how specific terms for collaboration presented
    by Celera would conflict with the underlying principles of the Human
    Genome Project to make sequence data rapidly and freely available to
    all. On March 7, 2000 Celera Genomics President, J. Craig Venter
    responded that Celera Genomics continues to be interested in pursuing
    good faith discussions toward collaboration. On March 9, Dr. Collins
    sent a letter to Celera indicating that he had received its letter and
    would discuss possible next steps with the other HGP representatives.
                                  human genome
        Question. What are the likely developments in medicine over the
    next 10 years that will result from unraveling the human genome?
        Answer. The Human Genome Project will reveal all the human genes
    and many of the variations in DNA that make individuals unique and
    affect our susceptibility to disease. Scientists will understand the
    genetic factors that influence the development of complex diseases--
    like heart disease, diabetes, Alzheimer's disease, and cancer--that are
    caused by several genes in interaction with each other and
    environmental influences. Detailed understanding of the molecular
    causes of disease will suggest new treatments.
        In the next decade, predictive genetic tests will become available
    for a few dozen complex diseases. If you find you are at high risk for
    various ailments you will be able to adopt strategies (like changes in
    diet, lifestyle, medical surveillance, and treatment with drug therapy)
    to reduce your risk of becoming ill.
        If you fall through that preventive medicine safety net and get
    sick anyway, new treatments will begin to be available. Some likely
    will be gene therapies. Others will be drug therapies designed on the
    basis of an understanding of gene function. These therapies will be
    more precisely tuned for the problem that you have and, because of
    early diagnosis, will be available at an earlier stage in the disease
    process. This new generation of preventive and therapeutic
    interventions based upon your genetic information, which likely will
    come along first for cancer, will revolutionize medicine and improve
    our ability to prevent, diagnose, and treat the diseases that afflict
    us and our families.
        While both parties are open to continued discussions about the
    terms of a possible collaboration, it remains unclear whether the
    specific terms that meet the distinct goals of each of the two sectors
    are possible.
        Several productive public-private collaborations have marked the
    Human Genome Project during its short history. For example, several
    years ago, Merck & Company, Inc. decided to fund the generation of a
    public collection of human EST (Expressed Sequence Tag or gene snippet)
    sequences. More recently, on January 19, 1999 a memorandum of
    understanding (MOU) was signed between Celera Genomics and the Berkeley
    Drosophila Genome Project Group, a consortium of research groups
    working at the University of California at Berkeley, Lawrence Berkeley
    National Laboratory, Baylor College of Medicine and Carnegie
    Institution of Washington. The group is funded by the NIH, the
    Department of Energy and the Howard Hughes Medical Institute. The MOU's
    stated purpose was to produce a complete, annotated, and publicly
    accessible sequence of the Drosophila genome at a reduced cost and an
    accelerated pace. The DNA sequence of the fruitfly, Drosophila
    melanogaster was published in Science on March 24, 2000.
        Presently, the National Human Genome Research Institute (NHGRI) is
    working with a consortium of groups to develop a plan to identify an
    estimated 700,000 single nucleotide polymorphisms (SNPs) (common areas
    in the human genome where the sequence varies by a single letter) over
    the next two years. The SNP Consortium (TSC) is a unique group of 10
    pharmaceutical companies, IBM, Motorola and the Wellcome Trust of the
    United Kingdom, in partnership with leading HGP academic centers.
    Variant SNPs, that are identified, will be placed in the public domain
    for all to use. Many of the variants will be responsible for traits
    that distinguish one person from another. Others will be found to
    contribute to an individual's risk of developing complex diseases such
    as cancer, heart disease, and diabetes. The NIH and TSC have been
    coordinating efforts since TSC's inception. For example, efforts by
    both the NIH and TSC to discover SNPs are using DNA samples from the
    NIH SNPs resource so that data from the two efforts will be comparable.
    In addition, the SNP data generated from both projects are deposited in
    the public database, dbSNP. Finally, NIH and TSC investigators
    participate in joint scientific and technical meetings to share
    information and coordinate strategies.
        Each of these collaborations combine public and private resources
    to generate genomic information that is freely accessible, without
    restriction, to both public and private sector scientists. As a result,
    more information has been available to the scientific community more
    rapidly than expected. The NIH welcomes these opportunities by which
    workable models for collaboration between the public and private
    sectors can be achieved.
                                  mouse genome
        Question. Why is it important to sequence the mouse genome if you
    already have the human genome?
        Answer. The human genome is a very complex structure that will take
    decades or even centuries to understand fully. One of the best tools
    for understanding it is to compare it with other genomes. For example,
    if a certain region in the mouse genome is almost identical to the same
    region in the human genome, this is a clue that the region codes for an
    important function. If the function of such a region of the mouse
    genome is known, it can be deduced that the function of the human
    region is the same or is similar. Because we have been studying on mice
    for many years, we know a great deal about the biology of mice and
    mouse genes, an area that is difficult to study in humans. As a result,
    the ability to compare mouse and human sequence is expected to provide
    a tremendous boost for understanding human genetics. For this reason,
    having the sequence of the mouse is critically important.
                         sequencing of the human genome
        Question. A working draft is useful, but what are your plans for
    finishing the sequence of the human genome to high accuracy?
        Answer. The Human Genome Project is committed to finishing the
    human sequence to a level of high accuracy. This has been the goal from
    the beginning of the project and it has not changed. The current plan
    is for each group to finish those sections that it has sequenced to the
    working draft status. An international working group has been
    discussing the details of strategy for finishing the sequence over the
    last few months and has come up with a plan that all have endorsed. The
    goal is to complete this by 2003, but it may well be possible to finish
    earlier.
                                  human genome
        Question. What plans does your institute have to encourage research
    on understanding the genome, once the sequence is in hand? What role
    will computers play in this next phase?
        Answer. NHGRI has been supporting technology development for
    research on functional genomics for some time. Recently we have
    intensified our efforts by supporting two new initiatives. The first is
    the Mammalian Gene Collection in collaboration with the NCI. This
    project will assemble a catalogue of cloned and sequenced human genes
    and make them available to researchers. This collection will be a
    critical tool for understanding the human genome. In addition, NHGRI
    will shortly issue a request for applications for Centers of Excellence
    in Genomic Science. These centers will focus on novel approaches to
    studying genomic questions. We expect that they will become centers for
    technology development and computational biology, whereby new
    methodologies are created that assist scientists in understanding the
    human genome sequence and how it functions.
        Databases, using computers, will store the information on DNA
    sequence, DNA variants, and a large amount of information on gene
    structure and function. Researchers will be able to access this
    information from their lab computers. Using computers, they will be
    able to analyze the data to discover more about how genes work, for
    example, by comparing human with mouse sequence to find genome regions
    important for gene regulation. They will also be able to use computers
    to make discoveries by combining the genomic information with their own
    research results, such as mapping genes for diseases.
                            children and depression
        Question. Children and depression--Dr. Hyman, you have often said
    that a depressed child is at quite a disadvantage in terms of ability
    to learn, form relationships, and develop overall in a healthy way. It
    is critical that each child in distress have the best possible chance
    of being noticed and evaluated in a thorough, competent way. What
    effect might failure to do this have on the apparently increasing
    incidence of violence among children and adolescents?
        Answer. We can only speculate on this, as studies which would
    unravel the effects of untreated depression in children, for ethical
    reasons, have not been undertaken. We agree that children who are
    depressed can be identified, that valid assessment approaches are
    available, and that some treatments and preventive strategies,
    including school-based programs specifically for these children, have
    been rigorously tested. A major problem is that too often these
    treatments and preventive approaches are not available to children who
    need them. Instead unevaluated programs are offered under the guise of
    providing a ``service.''
        There have been several longitudinal studies of children with
    different patterns of risk, and these studies indicate that there is a
    cumulative and negative effect to ignoring such risks. Children with
    certain patterns of risks may go on to exhibit serious behavior
    problems in adolescence. Many of these behavior problems can be avoided
    by early detection, careful assessment, and implementation of well-
    established intervention programs.
        Question. Suicide--To what do you attribute rising suicide rates
    among young people? What can we do about this?
        Answer. In addition to a possible increase in the likelihood of
    reporting youth suicides, the rising youth suicide rates have been
    linked to increased substance use among the nation's youth. For
    example, an association between lower state drinking age and higher
    youth suicide rates has been shown.
        So far there are no proven prevention efforts shown to reduce youth
    suicide rates, and some school-based awareness programs have actually
    caused distress in vulnerable youth. NIMH and NIDA just released a
    program announcement encouraging researchers to submit applications
    that test various approaches to preventing youth suicidal behavior.
        Question. Dr. Hyman, can you tell us what you are doing to address
    the legal and ethical issues that may interfere with the need to do
    critical research on depression and suicide? Should people who are (or
    who may be) suicidal be allowed to participate?
        Answer. NIMH staff, and experts in (1) clinical research with
    suicidal patients, (2) bioethics, and (3) legal issues pertaining to
    liability risks with suicidal patients have developed a draft document,
    Safety and Ethical Issues to Consider for Persons at High Risk for
    Suicidal Behavior in Intervention Trials. Its purpose is to propose
    ways to minimize risk and consider the ethical issues unique to
    conducting research on suicidal behavior, in order to promote more
    research on effective interventions to reduce suicidal behaviors.
    Currently, the draft is being circulated to OPRR staff, representatives
    from the National Advisory Mental Health Council, professional and lay
    advocacy communities, Institutional Review Boards (IRB) and Data Safety
    Monitoring Boards (DSMB) members, and former research participants, for
    comment.
        As the draft was being developed, the audience in mind included
    researchers conducting clinical trials designed to reduce the rate of
    suicidal behaviors, and the IRBs and DSMBs that must review and monitor
    them. However, the document is also intended to be useful for
    researchers conducting any type of treatment trials aimed at reducing
    symptomatology in disorders known to carry a high risk for suicidal
    behavior. The adequate incorporation of plans to increase safety,
    minimize risk, and consider the ethical issues pertaining to
    individuals who may become suicidal in treatment trials, could allow
    more individuals who are at risk for becoming suicidal to participate
    in a greater number of treatment trials.
            national institute of neurological disorders and stroke
        Question. Dr. Fischbach, your Institute recently undertook a major
    effort to produce a five-year research plan for Parkinson's disease
    research. How can this kind of initiative advance the research into
    Parkinson's disease and should this kind of process be duplicated for
    other disease research areas?
        Answer. The Parkinson's disease research agenda proposes a
    comprehensive approach--understanding the disease, developing
    treatments, creating research capabilities, and enhancing the research
    process. We are optimistic that such an approach will result in
    significant progress against Parkinson's and other neurodegenerative
    disorders. It may prove to be a good model for many diseases. We were
    particularly pleased by the enthusiastic participation of leaders from
    the Parkinson's research community, from other fields that can
    contribute to the effort, and from the patient advocacy groups.
        NINDS embarked on a strategic planning process last year, and we
    continue to refine it in terms of next steps and procedures for
    implementation. The strategic plan is based on broad, cross-cutting
    themes (such as neurodegeneration), each one of which touches on many
    disorders. The plan has already produced many initiatives that address
    both basic neuroscience and specific disease problems. We plan to
    complement this approach with additional plans focused on specific
    disorders, and began with Parkinson's disease. Using a slightly
    different approach, we are collaborating with the National Cancer
    Institute to develop a plan for brain tumor research. We plan to
    proceed with other disease-specific plans at the rate of two or three
    per year.
        Our view is that there are several useful models that can be
    employed (including the more traditional but highly effective approach
    of sponsoring workshops), depending on specific disease issues and the
    state of the science. In general, however, we do not favor the
    inclusion of funding proposals in long-range plans. We are concerned
    that a proliferation of such budget-oriented plans would decrease our
    ability to take advantage of new, unexpected opportunities, both in
    terms of the specific disease being reviewed and more broadly in other
    disease areas of interest.
                      consensus conference on osteoporosis
        Question. Dr. Katz, I understand that a Consensus Development
    Conference on Osteoporosis will be held at the NIH. What are the
    specific issues that this conference will examine?
        Answer. NIH held a Consensus Development Conference on Osteoporosis
    Prevention, Diagnosis, and Therapy on March 27-29, 2000. The NIAMS was
    the primary organizer of this conference. Fellow sponsors included the
    NIH Office of Medical Applications of Research, nine other NIH
    Institutes and Offices, and the Agency for Healthcare Research and
    Quality. Well over 1,000 people attended presentations during the 3-day
    conference.
        Osteoporosis occurs in all populations and at all ages. About 10
    million people in the United States have osteoporosis, and an
    additional 18 million individuals are at increased risk for the
    disorder.
        The consensus panel was charged with addressing the following five
    questions: (1) What is osteoporosis and what are its consequences? (2)
    How do risks vary among different segments of the population? (3) What
    factors are involved in building and maintaining skeletal health
    throughout life? (4) What is the optimal evaluation and treatment of
    osteoporosis and fractures? (5) What are the directions for future
    research?
        In general, the panel found that nutrition, exercise, and medicines
    can play important roles in the prevention and treatment of
    osteoporosis. The panel noted that maintaining optimal bone health is a
    lifelong process that should begin in childhood. Bone mass attained
    during childhood is perhaps the most important determinant of life-long
    skeletal health. At all ages, physical activity and good nutrition,
    particularly adequate calcium and vitamin intakes, aid in developing
    and maintaining strong bones. Exercise can also reduce the risk of
    falls, a major cause of fractures in people with osteoporosis.
        While hormone replacement therapy remains a common treatment and
    prevention option; the panel suggested that more information is needed
    as to how estrogen reduces the incidence of fractures. There are new
    medicines for preventing and treating osteoporosis, such as
    bisphosphonates and selective estrogen receptor modulators. New
    technologies have improved the detection of loss of bone mineral, a key
    predictor of osteoporotic fracture, although the panel recognized that
    no standard exists for comparing different screening devices.
        The panel's recommendations for future research included
    identifying and intervening in disorders that can impede the
    achievement of peak bone mass in children of ethnic diversity;
    improving diagnosis and treatment of secondary causes of osteoporosis,
    such as that resulting from the use of glucocorticoids (for example,
    prednisone); collecting data necessary to establish testing guidelines
    for osteoporosis; developing quality-of-life measurement tools that
    incorporate gender, age, and race/ethnicity; conducting randomized
    clinical trials of combination therapies to prevent or treat
    osteoporosis; and developing a paradigm for the management of
    fractures.
                      screening and treating osteoporosis
        Question. Do we have good screening mechanisms for osteoporosis?
    And once we diagnose an individual with osteoporosis are there adequate
    treatment protocols?
        Answer. Fortunately, research over the last decade has led to some
    very reliable methods for assessing bone mass/bone mineral density.
    Dual energy x-ray absorptiometry (DXA) has been developed and used in
    some large studies that confirm the association of low bone mineral
    density with high fracture risk. This technology can assess the bone
    mineral density of two important sites of fracture in the body--the hip
    and the spine. The results of this test can be used to identify
    individuals at high risk of fracture who may profit from interventions
    designed to slow bone loss.
        There are several medications available to treat osteoporosis.
    Estrogen has the longest history in the prevention/treatment of
    osteoporosis. Two newer medications called bisphosphonates are approved
    by the FDA for osteoporosis--alendronate and risedronate. These
    medications are bone-specific and have been shown to reduce fractures
    in clinical trials. Another approach to osteoporosis has been the
    development of Selective Estrogen Receptor Modulators (SERMs). These
    drugs mimic the positive effects of estrogen in the bone but have been
    modified to diminish some of the deleterious effects of estrogen on the
    breast and the uterus. Currently, there is one SERM that has been
    approved by the FDA for osteoporosis--raloxifene. However, this is an
    active area of research. NIH is sponsoring a workshop on Selective
    Estrogen Receptor Modulators April 26-28, 2000, to develop a research
    agenda in this important area.
                            osteogenesis imperfecta
        Question. I understand that in 1999 you supported a workshop on the
    development of new strategies for Osteogenesis Imperfecta, also known
    as brittle bone diseases. Can you summarize the outcome of that
    workshop? And please tell us how your 2001 budget reflects these
    recommendations?
        Answer. In September of 1999 the NIAMS partnered with the
    Osteogenesis Imperfecta Foundation, the Children's Brittle Bone
    Foundation, and the NIH Office of Rare Diseases to sponsor a meeting on
    Osteogenesis Imperfecta (OI). The goal was to stimulate new clinical
    approaches to OI by calling attention to recent findings in several
    areas of basic biology and model systems. These areas include stem cell
    manipulation and gene therapy strategies, cell-matrix interactions, and
    the role of growth factors and cytokines in bone turnover. The workshop
    also assessed recent advances toward the ultimate goal of developing
    techniques for correcting the underlying genetic defects in OI. In
    addition, recent observations suggest that the metabolic consequences
    of collagen defects, such as effects on the activities of osteoblasts
    and osteoclasts, play an important role in the pathogenesis of OI.
    Exploring these new findings could lead to therapeutic approaches, such
    as pharmacological interventions, that could have an significant impact
    on the clinical management of OI. A number of research recommendations
    resulted from the workshop, and the NIAMS is currently assessing future
    research directions.
        The opportunities for basic research advances to move the field
    forward seem to be particularly promising. NIAMS is planning an
    initiative in fiscal year 2001 to capitalize on the opportunity to
    better understand how the bone cells in patients with osteogenesis
    imperfecta are programmed and can be re-programmed by therapeutic
    intervention.
                                  osteoporosis
        Question. With the aging of the population is osteoporosis becoming
    a problem for men, as well as women? And if so, do you recommend that
    men over 65 take advantage of bone density screening?
        Answer. Although American women are four times as likely to develop
    osteoporosis as men, an estimated one-third of hip fractures worldwide
    occur in men. Studies have shown that men tend to develop osteoporosis
    about 10 years later in life than women. This difference has been
    attributed to a higher peak bone mass in men at maturity and to a more
    gradual reduction in sex steroid influence in aging men. The lifetime
    risk of older men for fractures of the hip, spine, or wrist is
    considerable, and the Institute is committed to providing a particular
    focus on osteoporosis in men, in addition to its extensive portfolio of
    research on osteoporosis in women. In fiscal year 1999, the NIAMS
    launched a major study of osteoporosis in men. This is a 7-year study
    that will enroll and then follow 5,700 men 65 years and older for an
    average of 4 to 5 years, and will determine the extent to which the
    risk of fracture in men is related to bone mass and structure,
    biochemistry, lifestyle, tendency to fall, and other factors. The
    study, which is supported in part by the National Institute on Aging
    and the National Cancer Institute, will also try to determine if bone
    mass is associated with an increased risk of prostate cancer.
        As mentioned above, men tend to develop osteoporosis somewhat later
    than women. It is not clear that it would be advantageous to screen all
    men over 65. Rather physicians should be aware of some of the factors
    that place men at high risk of an osteoporotic fracture such as
    previous low impact fractures, especially spine fractures that may be
    manifest by a loss of height, the use of certain drugs like prednisone,
    and the diagnosis of primary hyperthyroidism. In addition, low body
    weight and diseases that lead to malabsorption of food, or a family
    history of low impact fractures, may raise suspicion of low bone mass.
                           medicare and osteoporosis
        Question. Given the aging of our population, do you see the
    problems of treating bone diseases, which is paid for by the Medicare
    program, as one that will consume a large portion of the Medicare money
    in the next 20 years?
        Answer. The aging of the American population will certainly add to
    the number of individuals at risk of fractures. It is estimated that
    one out of two women will develop an osteoporotic fracture in her
    lifetime. Men have a lower risk but are increasingly living to an age
    when their fracture risk is also high. Serious efforts at the
    prevention of bone loss need to be directed to reducing the number of
    individuals affected. Efforts directed at the young can be particularly
    important as the development of an adequate bone mass at maturity is
    important protection against fractures later in life. These efforts
    need to be focused on increasing physical activity, maintaining a
    healthy body weight and adequate calcium intake. The recent Consensus
    Development Conference on Osteoporosis estimated that only about 25
    percent of boys and 10 percent of girls ages 9 to 17 meet the calcium
    intake recommendations of the Institute of Medicine.
        However, the seniors of the next few decades are already adults and
    there is a great deal that can be done to prevent bone loss in adults.
    In fact, some of the same preventive measures that are effective in
    building bone mass in adolescence are effective in maintaining bone
    mass later in life. Low physical activity in older populations is a
    significant factor in bone loss but also affects the balance and
    coordination that protect against falls. Active seniors have fewer
    falls and less serious ones. Calcium and vitamin D can also prevent
    bone loss, and their intake in senior adults are seriously below the
    recommended levels. In some individuals at high risk of fracture,
    medications directed to slowing bone loss can be a cost-effective
    strategy.
                                  osteoporosis
        Question. If the treatment of bone diseases is going to be a major
    expense to the Medicare program, do you think you and your fellow
    institute directors are investing enough money in bone research in
    order to improve the quality of life for our seniors and to reduce the
    cost to Medicare?
        Answer. I am pleased to tell you that bone research is indeed a
    major priority for the NIH. A number of NIH components plus
    representatives from other agencies participate in the Federal Working
    Group on Bone Diseases--a collaboration that helps to coordinate
    research activities across the Federal government and provide
    recommendations for future research efforts. NIAMS supports bone
    research across the full spectrum from basic studies on how bone is
    normally built up and how bone breaks down in disease to clinical
    studies to improve our diagnostic and therapeutic abilities; and to
    prevention studies, especially those that target young people in their
    prime years for building strong bones. We also support major clinical
    trials that are looking at the value of combining some of the available
    drugs for treating osteoporosis, to determine the enhanced value that
    combinations of drugs may have against osteoporosis. In addition, we
    have recently supported a Consensus Development Conference at the NIH
    on osteoporosis, and experts identified a number of promising avenues
    for the NIH to consider and pursue. Finally, in the area of information
    dissemination, the NIAMS and other ICs fund the NIH Osteoporosis and
    Related Bone Diseases National Resource Center that provides
    comprehensive and timely information to patients, their families, and
    their health care providers. While there are always opportunities for
    funding additional research, I believe that the NIH research efforts in
    bone--those already underway as well as those planned for the future--
    reflect the major priority we give to this area of research.
                               muscular dystrophy
        Question. Why has NIAMS been unable to provide as many muscular
    dystrophy related single investigator grants as other institutes?
        Answer. The NIAMS, together with the National Institute of
    Neurological Disorders and Stroke (NINDS), considers research on the
    muscular dystrophies to be a priority area. We will continue to work
    with the extramural muscular dystrophy research community, as well as
    interested patient organizations, to stimulate and support promising
    studies in this area. In fiscal year 1999, the NIAMS invested nearly
    $5.4 million in muscular dystrophy projects, an increase of over 40
    percent from the previous fiscal year.
        A number of exciting studies with implications for our
    understanding of the muscular dystrophies have been supported by the
    NIAMS in recent years. One such investigation used gene therapy to
    restore muscle function in a hamster model of limb-girdle muscular
    dystrophy (LGMD). In another NIAMS-funded study, researchers
    successfully used the common antibiotic gentamicin to restore the
    function of the gene that encodes for the protein dystrophin in mouse
    models of Duchenne muscular dystrophy (DMD). In a third project, NIAMS-
    supported researchers used gene therapy in mice to give the body a
    boost in fighting the effects of aging on muscle, and to help repair
    the damage caused by injury and muscle-wasting disorders such as
    muscular dystrophy. These projects underscore the potential of treating
    human forms of LGMD, DMD and other muscular dystrophies with gene
    therapy approaches.
        Another area of excitement relates to a new protocol developed with
    support from the NIAMS that makes it possible to obtain an almost
    unlimited number of a special class of adult stem cells from a small
    sample of bone marrow. These adult stem cells have the ability to
    develop into cells of muscle, nerve, bone, cartilage and fat. Because
    of their vast potential for differentiation, they may be excellent
    therapy vectors for a number of skeletal diseases, including muscular
    dystrophy.
        Next month, the NIAMS--in partnership with the NINDS and the NIH
    Office of Rare Diseases--will support two research meetings on muscular
    dystrophy. The first is an international scientific conference centered
    on clinical and molecular studies of facioscapulohumeral dystrophy
    (FSHD). The meeting will bring together researchers who are already
    involved in FSHD projects, as well as scientists who are working in
    related fields and may be able to contribute to progress on FSHD. The
    second meeting will focus on therapeutic approaches for DMD. This
    workshop is aimed at addressing key questions in improving treatments
    for DMD, identifying areas of needed scientific knowledge, and the
    critical next steps to promote effective therapy. The NIH expects to
    build on the insights from these two meetings to develop new program
    initiatives related to the muscular dystrophies. Such initiatives would
    complement on-going efforts to stimulate research in this area,
    including the currently active program announcement on the pathogenesis
    and therapies of the muscular dystrophies.
        Question. Why is there no separate study section for muscle
    biology? Would a separate study section enhance research and integrate
    efforts?
        Answer. The NIH Center for Scientific Review (CSR), which conducts
    the peer review process, is currently involved in a comprehensive
    assessment of its study section structure, led by Dr. Bruce Alberts,
    the President of the National Academy of Sciences. The purpose of this
    assessment is to ensure that CSR provides a rigorous, unbiased review
    system that facilitates the advance of all areas of biomedical
    research, including muscle biology. Indeed, muscle disease review
    issues are being considered as part of the assessment. CSR will also be
    meeting with scientists at the Duchenne muscular dystrophy workshop in
    May to discuss this and other review concerns. The outcome of these
    discussions will help guide future decisions about the review of
    muscle-related research grant applications.
        There is no simple answer to the question of whether a dedicated
    study section would enhance the success of muscular dystrophy research
    applications or otherwise improve coordination of muscle-related
    research. It is important to consider that the NIH receives a broad
    range of research applications on muscle functioning and disease, and
    diverse areas of scientific expertise are required to review those
    applications. Whether it is desirable--or, indeed, even feasible--to
    cluster all muscle research proposals into a single study section is
    one of the questions being explored by the CSR assessment described
    above.
                                magnetic therapy
        Question. Has the use of magnets been proven scientifically?
        Answer. Todate, there have been only a few, rigorous, double-
    blinded, randomized trials investigating the efficacy of magnet therapy
    (e.g. Vallbona et al., 1997, Weintraub, 1998; Taylor et al, In press).
    Although the results of these trials suggest that magnet therapy is
    more effective than placebo for pain management, a definitive statement
    on magnet therapy's efficacy awaits completion of a large, multi-site
    randomized controlled trial. The research portfolio of the National
    Center for Complementary and Alternative Medicine (NCCAM) includes
    rigorous studies of magnet therapy.
        Question. Are there any dangers in using magnets like sleeping on a
    magnetic pad or magnets in your shoes? I heard somewhere that they are
    not recommended for people with heart problems--they cause problems
    with electrical currents.
        Answer. Static magnetic fields appear to be safe. In 1987, the
    World Health Organization reported that ``the available evidence
    indicates the absence of any adverse effects on human health due to
    exposure to static magnetic fields up to two Tesla.'' Given that the
    typical static magnet used to treat disease produces a magnetic field
    of only a few thousands of a Tesla in strength, there is little
    intrinsic danger to using magnet therapy. Supporting this contention,
    the few well-designed clinical trials investigating static magnets have
    not reported any severe adverse events associated wit the intervention
    (e.g. Vallbona et al., 1997, Weintraub, 1998; Taylor et al, In press).
    Although no cause and effect was established, there has been one case
    report of a person who developed a myeloma after sleeping on a magnetic
    mattress for five years (Burns 1994). Concerning the use of static
    magnets by individuals with heart disease, there is conflict evidence
    whether low level electromagnetic fields produce changes in heart rate
    (Cook et al., 1994; Korpinen and Partanen, 1994) and blood pressure
    (Korpinen and Partanen, 1996). Until these issues are addressed for
    static magnetic fields, caution might be suggested for individuals
    suffering from severe hypertension. Caution may also be advised for
    individuals with cardiac pacemakers or wearing cardiac infusion pumps.
                                     ______

                  Questions Submitted by Senator Thad Cochran
                               infectious disease
        Question. The NIH has invested heavily in infectious disease
    research. We have done a good job of developing vaccines to combat many
    infectious diseases, including HIV. However, one area that is of
    concern to me is that of drug resistance in infectious diseases. We now
    have bacteria that are becoming resistant to our last lines of
    antibiotic treatment.
        What is the NIH doing to insure appropriate use of antibiotics?
    What is the NIH doing to stimulate the development of new antibiotics
    to combat drug resistant bacteria?
        Answer. The NIH co-chairs with the Food and Drug Administration
    (FDA) and the Centers for Disease Control and Prevention (CDC) an
    Interagency Task Force on Antimicrobial Resistance. The initial public
    activities of this Task Force were announced in the Federal Register,
    Vol. 64, No. 123, Monday, June 28, 1999. This was in conjunction with a
    July 1999 public meeting organized by ten Federal agencies (the CDC,
    the FDA, the NIH, the Health Care Financing Administration, the Health
    Resources and Services Administration, the Agency for Health Care
    Research and Quality, the Environmental Protection Agency, the
    Department of Defense, the U.S. Department of Agriculture, and the
    Department of Veterans' Affairs) to coordinate Federal programs
    relating to antimicrobial resistance. The purpose stated in the
    preceding notice was ``To solicit input from invited consultants
    regarding items to be included in a Public Health Action Plan that,
    when published, will serve as a blueprint for activities of Federal
    agencies to combat antimicrobial resistance. The Plan is being
    developed by a Task Force composed of Federal personnel from several
    Federal agencies and departments, co-chaired by the CDC, the FDA, and
    the NIH.'' It should also be noted that the fiscal year 2000
    appropriations report language for CDC mentions this existing Task
    Force and the recommendation that a report be done within a year of
    enactment of the legislation--the above mentioned Public Health Action
    Plan is in response to this report language. Accordingly, four focus
    areas were selected for grouping the discussions and outcome:
    Surveillance, Prevention and Control, Research, and Product
    Development. The issue of appropriate use of antimicrobials, including
    antibiotics, is within the purview of Prevention and Control, and is
    addressed in the connotation of ``judicious use.'' The NIH is
    collaborating in the overall development of the Action Plan in the role
    of Co-Chair, and also plans to collaborate with the appropriate
    agencies coordinating any resulting actions relating to judicious use
    of antimicrobials, principally the CDC and the FDA, for any action
    items that fall within the scope of the NIH mission.
        The NIH funds a diverse portfolio of grants and contracts to study
    antimicrobial resistance in major viral, bacterial, fungal, and
    parasitic pathogens. The National Institute of Allergy and Infectious
    Disease (NIAID) has a lead role in many of these activities, but
    numerous other Institutes and Centers at the NIH also support and
    participate in research related to antibiotic resistance.
        The NIH-funded projects include basic research on the disease-
    causing mechanisms of pathogens, host-pathogen interactions, and the
    molecular mechanisms responsible for drug resistance, as well as
    applied research to develop and evaluate new or improved products for
    disease diagnosis, intervention, and prevention. Numerous genome
    projects seek to identify new gene targets for the development of drugs
    and vaccines. Other NIH-sponsored activities with relevance to
    antimicrobial resistance include physician and researcher training and
    education. In addition, the NIAID supports a number of clinical trials
    networks with the capacity to assess new antimicrobials and vaccines
    with relevance to drug-resistant infections. Among these are the AIDS
    Clinical Trials Groups, the Mycoses Study Group, the Collaborative
    Antiviral Study Group, the Vaccine and Treatment Evaluation Units, and
    the Tuberculosis Research Unit. The NIAID supports contracts that
    screen for novel anti-tuberculosis drugs by testing in vitro and in
    animal models. The candidate drugs are selected for screening from
    submissions by academic and private sector researchers worldwide and
    from the National Cancer Institute's (NCI) chemical repository.
        With regard to other NIAID-specific projects, the Institute funds a
    diverse portfolio of grants examining antimicrobial resistance among
    the major nosocomial bacterial pathogens, for example, multi-drug
    resistant Staphylococcus aureus, enterococci, and Escherishia coli.
    Current research support is aimed at:
      --Identifying new diagnostic techniques, novel therapeutics, and
            preventive measures to minimize infection with resistant
            pathogens, prevent the acquisition of resistance traits, and
            control the spread of resistance factors and resistant
            pathogens in hospital settings;
      --Understanding the molecular biology and genetics of resistance gene
            acquisition, maintenance, and transmission;
      --Exploring novel approaches to combat resistance through passive or
            active immunization;
      --Identifying natural antimicrobial peptides that may prove useful as
            new classes of antibiotic-like drugs; and
      --Through the use of molecular characterization, continuing efforts
            to determine the degree of spread of multi-resistant
            international clones of Streptococcus pneumoniae in the United
            States and the rest of the world.
        The NIAID is also creating a Bacteriology and Mycology Study Group
    to design and conduct multi-center clinical studies of interventions
    for serious fungal and healthcare-associated resistant bacterial
    infections. Key aspects of the effort will be to: formulate and
    implement a scientific research agenda; establish a multi-center
    clinical studies group; establish a clinical studies coordinating unit;
    provide leadership and organization of the study group; and conduct,
    complete, and report the results of the clinical studies. This project
    will be funded in the spring of 2001.
        Finally, the NIAID recently released a Request for Applications
    (RFA), ``Challenge Grants: Joint Ventures in Biomedicine and
    Biotechnology.'' The purpose of this initiative is to support research
    and development efforts whose outcomes could significantly reduce the
    impact of infectious diseases nationally and worldwide. The RFA was
    issued in response to the fiscal year 2000 Public Health and Social
    Services Emergency Fund appropriation of $20,000,000 designated for
    ``NIH Challenge Grants and Partnerships.'' This new initiative is
    intended ``to promote joint ventures between the National Institutes of
    Health and the biotechnology, pharmaceutical, and medical device
    industries'' and involves a ``one-on-one matching of federal dollars by
    qualified organizations that are conducting R&D activities in
    biomedical research or biotechnology with commercializable potential or
    conducting research in promising therapies.''
        The NIAID has identified areas of high importance where it believes
    successful product research and development combined with existing
    infrastructures and federal challenge grant funding could significantly
    impact a major health or medical problem. Bacterial drug resistance is
    an evident area of focus in this solicitation in two specific areas:
    tuberculosis (TB), and emerging and resistant infections, including
    drug resistant staphylococci and enterococci.
        It is the intention of these challenge grants to encourage the
    private sector to develop new TB drugs, including: identification of
    potential new drug targets and novel classes of drugs (making use,
    where appropriate, of the Mycobacterium tuberculosis genome sequence
    and high throughput approaches); preclinical development of novel
    classes of drugs and optimization of lead compounds; and clinical
    testing of potential new therapies. The NIAID also seeks to encourage
    the private sector to increase its commitment to TB vaccine development
    through these challenge grants. In particular, it encourages the use of
    whole genome approaches for the identification of promising protective
    antigens, and the development of both pre-exposure and post-infection
    candidate vaccines from pre-clinical through clinical testing.
        Similarly, through the challenge grants mechanism, the NIAID seeks
    to interest the private sector in pursuing preclinical and clinical
    studies of passive or active immunization candidates to protect against
    resistant staphylococcal infection, first in the most vulnerable
    populations such as severely-ill hospitalized patients and patients
    facing major surgery and at risk for infection, and then also for
    potentially broader application to community situations. Novel
    therapies, such as bacteriophage therapy, will be considered as
    candidates for study for enterococci.
                              parkinson's disease
        Question. The committee just received the Parkinson's Disease
    Research Agenda from your office.
        Do you agree with the report that a cure for Parkinson's is now a
    comprehensive goal if a comprehensive approach is pursued?
        Answer. A cure for Parkinson's is a realistic goal, given what is
    known about the disease and the research tools now available to us. The
    research agenda proposes a comprehensive approach--understanding the
    disease, developing treatments, creating research capabilities, and
    enhancing the research process. We are optimistic that such an approach
    will result in significant progress against Parkinson's and other
    neurodegenerative disorders.
        Question. Is the NINDS sufficiently staffed to implement such a
    plan?
        Answer. The plan reflects our best professional judgment as to what
    could be accomplished if funding were available to implement all
    aspects of the research agenda, but without taking into account fiscal
    constraints or other competing priorities of NIH and the rest of the
    Federal government. In order to do this, more staff would be required
    to develop the necessary initiatives and work collaboratively with the
    research and patient communities.
                                    diabetes
        Question. One of NIH's initiatives for 2001 deals with genetics
    research and exploiting genomic discoveries. One area where genetics
    research could be essential is in the area of diabetes, especially
    juvenile diabetes.
        Do genomic discoveries show promise in the area of juvenile
    diabetes and is funding sufficient to do this?
        Answer. Type 1 diabetes has a strong genetic determinant, in which
    more than one gene is believed to play a role. These genes make some
    individuals more susceptible to developing diabetes than others. In
    addition, genetic factors may cause some individuals with diabetes to
    be more prone to developing the serious and life-threatening
    complications associated with type 1 diabetes. Knowledge of the genetic
    defects underlying diabetes will be critical not only for identifying
    individuals at risk for diabetes and its complications, but also for
    identifying targets for effective treatment and prevention.
        The NIDDK is attempting to provide cutting-edge genetics and
    genomics resources to our investigators. We have already begun to move
    in this direction, with a biotechnology initiative on microarray
    technology that will be useful to diabetes researchers and other NIDDK
    investigators, and with a major effort planned for a Diabetes Genome
    Anatomy Project (DGAP) to locate and analyze the function of genes in
    all the various types of tissue relevant to diabetes. Start up of the
    DGAP initiative is currently slated for fiscal year 2001.
        The NIDDK envisions DGAP as a trans-NIH effort involving several
    Institutes with a research interest in diabetes and its complications.
    This project would collect genomic information on the spectrum of genes
    expressed in all tissues relevant to diabetes and its complications. It
    would build upon an ongoing NIDDK initiative on the functional genomics
    of the developing pancreas. While our ongoing effort supports the
    production and sequencing of complementary DNA libraries based on
    multiple stages of pancreatic development, the DGAP would be much
    broader. Objectives would be to obtain full length cDNAs from tissues
    relevant to diabetes; to discover novel genes in tissues affected by
    diabetes; to conduct expression profiling to determine patterns of gene
    expression in disease; and to perform functional phenotyping of
    expressed products in tissues affected by diabetes. More importantly,
    this initiative--if undertaken at a full-scale level--would allow for
    the cataloging of all information obtained in a diabetes relational
    database with automated data mining and query support. This database
    would be developed and offered as a resource for all diabetes
    investigators and could be used in the development of new assays,
    identification of potential therapeutic agents, and points of departure
    for new studies into diabetes and its complications. Information
    obtained through an initiative such as this has the potential to
    further our understanding of the causes and mechanisms of diabetes, to
    identify targets for effective treatment and prevention, and to serve
    as a springboard for the development of future investigator-initiated,
    hypothesis-driven research. The degree to which we can undertake all
    components of this initiative and the timeline for implementation will
    be dependent on resource availability.
                                     ______

                   Questions Submitted by Senator Tom Harkin
                             mental health research
        Question. In several recent Mental Health Advisory Council reports
    you have recommended improving the relevance of prevention research
    into early interventions, clinical research to actual practice, and of
    behavioral research to serious mental illnesses. Could you please
    discuss some of the difficulties you've encountered in your efforts to
    change the institute's course toward the greatest public health needs?
    Where does NIMH stand relative to other NIH institutes on the rate of
    grants submitted and funded? Is the relative quality of the science in
    the grant submissions and proposals received NIMH rising or declining?
        Answer. Mental disorders and suicide together account for over 15
    percent of the burden of disease in established market economies such
    as the United States. The mission of the National Institute of Mental
    Health is to reduce the burden of mental disorders. NIMH also takes the
    lead in understanding the impact of behavior on HIV transmission and
    pathogenesis, and in developing effective behavior preventive
    interventions in areas such as violence. These collectively constitute
    an enormous area of responsibility. Over the past several years, NIMH
    has systematically examined its overall research portfolio and
    conducted even more in-depth reviews of selected programs, areas of
    science, and disorders, all with the objective of refocusing programs
    to bring the best science to bear on areas of greatest disease burden:
    depression; schizophrenia, bipolar disorder, obsessive compulsive
    disorder, and childhood autism, to name a few. In particular we have
    tried to ensure that knowledge gained is relevant to the full range of
    patients: from children to the aged; both sexes; all genders, races,
    ethnic groups; and to individuals with co-occurring conditions. This
    refocusing process has encountered significant challenges. One has been
    the need for extensive reorganization of programs within the
    Institute's intramural and extramural research programs. On the
    intramural side, certain laboratories and clinical units have been
    phased down or terminated in order to permit new growth and
    initiatives. Extramural staff and program realignments have been even
    more extensive and, often, difficult. It also has been quite
    challenging to shift the direction of the larger extramural community--
    for example, to motivate basic behavioral researchers to examine and
    revise many time-tested research paradigms in order to make research
    more relevant to clinical questions, or to encourage investigators to
    take a potentially risky step outside a given area of expertise into
    uncharted areas such as translational research. Although we have
    encountered some resistance and doubts about the need for change, these
    efforts are paying off.
        Since we rejoined the NIH in 1993, the ratio between competing
    research project grant applications submitted and awards funded, or
    success rates, has been consistently lower by 3-5 percent from the
    aggregated average for all NIH Institutes and Centers. The functional
    consequence of this differential for scientists is that an application
    for funding to the NIMH had a 16 percent lower chance of success than
    for NIH in the aggregate. This was also true for the most recent 1999
    fiscal year when the success rate for NIMH was 27 percent in comparison
    to the aggregate NIH success rate of 32 percent. Most NIMH applications
    are reviewed in committees with applications from several different NIH
    Institutes, and NIMH applications have been consistently judged
    somewhat better than average by those committees.
        Although precise data is not available, it is my opinion that since
    joining NIH, NIMH science is stronger than it has ever been. The
    science has been kept sharp by strong competition within NIH review
    committees and the new seriousness of scientific review within the
    intramural research program. As indicated in the paragraph above, NIMH
    scientists have performed well in review comparisons with scientists of
    other institutes.
                 research on children's mental health disorders
        Question. As I understand it, research on children's mental
    disorders at NIMH still lags behind so much other research, with few
    treatments available that work for obsessive-compulsive disorder (which
    often begins in childhood) and bipolar disorder (which increasingly is
    seen as beginning in childhood and adolescence). What is NIMH's plan
    for strengthening this research and assuring the development of more
    effective treatments for children?
        Answer. NIMH is actively planning a series of projects. A new
    program announcement is being crafted that will focus specifically on
    children with serious mental illnesses, including obsessive-compulsive
    disorders, bipolar disorders, eating disorders, schizophrenia, among
    others. The object of the announcement is to encourage a broad range of
    studies on the onset, course, risk processes, and treatments for
    serious mental illnesses in children and associated disabling
    impairments. In addition, next week NIMH is hosting a meeting to
    identify key research gaps in identification and treatments for
    children with bipolar illnesses, with the aim to further advance
    studies in these areas. Also, NIMH is currently supporting seven
    Research Units of Pediatric Psychopharmacology, several of which focus
    on bipolar illnesses in children.
                       research on minority mental health
        Question. The landmark 1998 Schizophrenia PORT study, found that
    the gap between science and accessible treatment has never been wider.
    Moreover, this lack of ``translation'' was at its worst in the African
    American community, leading to significant health disparities. African
    Americans with schizophrenia were more likely to experience
    overmedication with anti-psychotic medications, increased side-effects,
    and under-treatment of depression to a higher degree than other racial/
    ethnic groups. What is NIMH doing to improve the translation of
    scientific advances into real world treatment, in general, and
    especially in the African American community?
        Answer. Since the completion of the Schizophrenia PORT study, NIMH
    has funded additional studies to look, in depth, into reasons for the
    disparities in treatment. One study is designed to determine if
    adherence to treatment recommendations will lead to improved outcomes
    and whether minority status has an impact on what treatments are
    provided. In addition, the NIMH has issued a report, Bridging Science
    and Service, that calls for more research on improving the delivery of
    treatments in community populations, especially those who are
    traditionally underserved. NIMH also recently launched four new major
    clinical treatment studies that will provide data on how to treat some
    of the most severe mental illnesses in real-world settings. These
    studies are required to include minority populations so the results
    will be relevant to them.
        Currently, the NIMH Committee on Health Disparities is drafting a
    document delineating the specific research priorities for the next 5
    years. The report will focus on what the state of disparities is; why
    they exist and approaches to remedy the situation. In addition, the
    National Advisory Mental Health Council just issued a new report,
    Translating Behavioral Science into Action, which calls for research
    that takes into account the importance of individual, sociocultural,
    and organizational factors on the differences in help seeking,
    treatment, and outcomes from treatment.
        In the past, studies of treatment in schizophrenia tended to be
    small scale, industry sponsored, and focused on safety and short term
    efficacy. The data gathered were useful in obtaining regulatory (FDA)
    approval, but provided little guidance for practitioners on how best to
    treat patients in the community. Moreover, for a number of reasons,
    African Americans tended to be underrepresented in these treatment
    trials. The net result was that clinicians had to base many treatment
    decisions, particularly in minority patients, on prior experience,
    opinion, and their own experiences, rather than objective data. To
    remedy this situation, NIMH recently initiated a multie-year, multi-
    site, multi-million dollar project to study new antipsychotic drugs in
    people with schizophrenia (Clinical Antipsychotic Trials of
    Intervention Effectiveness, CATIE). One of the project's highest
    priorities is to include a representative sampling of patients with
    adequate representation of minorities and not be limited to middle
    class or upper class patients. There will be considerable outreach
    efforts to African Americans with schizophrenia, including recruitment
    of study sites in African American communities. Important
    characteristics of the trial are that all subjects participating in the
    trial will receive state-of-the-art care, and clinicians involved in
    the trial will be guided on best clinical practice and will have world-
    class experts available for consultation. While the number of patients
    treated in this trial will represent an insignificant fraction of the
    totality of people with schizophrenia, NIMH anticipates that the
    experience with patients and clinicians in African American communities
    gained through CATIE will greatly facilitate subsequent translation of
    CATIE's findings into that community as well as aid in dissemination of
    optimal clinical practices to mental health professionals providing
    care to African American people with schizophrenia.
                              nimh research agenda
        Question. A recent National Advisory Mental Health Council report
    notes that the behavioral science portfolio at NIMH has not been well-
    focussed on the areas of greatest public health need and makes a number
    of recommendations to improve the relevance of this portfolio. Could
    you discuss some of the factors which contributed to this lack of
    attention to many of our serious mental illnesses, what you think
    behavioral research can contribute, and how you can redirect existing
    research resources to develop more relevant behavioral research?
        Answer. Until recently, NIMH has focused relatively little
    organized effort to bridge basic behavioral science and severe mental
    illness. In part this has reflected the Institute's encouragement of
    investigator-initiated research, which, in turn, reflects academic
    traditions within psychiatry and psychology that often place a higher
    value on basic research than on clinically oriented (or applied)
    research. In addition, clinical and basic behavioral scientists have
    traditionally operated in separate academic departments unfamiliar with
    the language, concepts and problems of each other's disciplines.
    Because clinical populations have not been accessible to basic
    researchers, they have often focused on normal or less ill populations.
    Academic incentive systems and the segmentation of funding and outlets
    for publication have not promoted cross-disciplinary studies. Training
    programs in basic behavioral science often discourage exposure to
    clinical problems and clinical settings so that behavioral scientists
    may be unaware of basic research issues and opportunities posed by
    research on mental illness.
        Finally, when NIMH has attempted to encourage targeted research
    that can bridge between basic behavioral research and severe mental
    illness, relatively few researchers have responded. This lack of
    interest in certain types of behaviorally oriented translational
    research indicates the necessity for more specific targeted efforts to
    stimulate interest in these areas.
        Basic behavioral science will contribute to understanding and
    solving otherwise intractable public health problems related to serious
    mental illness in a number of areas:
    Understanding Symptoms of Illness
        The symptoms of serious mental illness involve attention, abstract
    thinking, social interaction, motivation, and emotion. Behavioral
    science should offer new ways of assessing these behavioral processes
    that will: (1) help link them to underlying neurobiologic processes;
    (2) allow their evaluation as indicators of risk prior to the
    development of full-blown illness; and (3) facilitate the objective
    assessment of response to targeted treatment interventions.
    Encouraging Behavior Change
        Theory-driven behavior-change interventions are highly successful
    in HIV/AIDS, yet remarkably, behavioral theory has rarely focused on
    health behaviors related to serious mental illness. More than half of
    all schizophrenia relapses can be attributed to lack of adherence with
    treatment recommendations. The application of theory-based behavior-
    change principles to the problem of adherence should result in
    effective approaches to substantially reduce morbidity in schizophrenia
    and other serious mental illness.
    Improving Treatments
        Learning theory should guide new treatment development for mental
    illness as well as treatment dissemination. Despite advances in
    psychopharmacology, patients with serious mental illness must learn
    ways of adapting to deficits and disabilities; learning theory should
    inform the development of new cognitive-behavioral interventions for
    skills training and illness self-management. At the same time, because
    research advances are very slow to influence everyday care, we need a
    better understanding of physician and provider behavior as related to
    the diffusion of innovations.
    Encouraging Help-Seeking
        Evidence indicates that delay in seeking treatment contributes to
    morbidity at the onset of serious mental illnesses including major
    depression, bipolar disorder and schizophrenia. Behavioral science
    should contribute to our understanding of the psychological and social
    processes, including the influence of social norms and stigma, that
    impede timely symptom recognition and help-seeking for serious mental
    illness.
    Helping Families Cope with Mental Illness
        Mental illness in a child or spouse can have a profound effect on
    family relationships, which in turn influence both the ill individual
    and other family members. Relationship research should explicate the
    adaptive responses of families that influence treatment outcome for the
    ill family member, including adherence to treatment recommendations. At
    the same time, better ways of characterizing and alleviating the family
    burden created by serious mental illness must be developed. The
    presence and severity of symptoms alone cannot account for the
    disabilities associated with mental illnesses. Behavioral science
    should contribute to a better understanding of the multidimensional
    nature of social, vocational and instrumental functioning to refine the
    choice of rehabilitation interventions. It should also aid in
    identifying the different treatment needs of individuals who are
    grouped within a single diagnostic category.
    Understanding the Inheritance of Mental Disorders
        Evidence indicates that defining mental disorders in terms of
    behavioral dimensions rather than specific diagnoses may more closely
    approximate inherited phenotypes. Behavioral science may aid in finer
    characterization and measurement of these behavioral phenotypes to
    facilitate the linkage of behavioral diseases to specific sets of risk
    genes.
        ``Translating Behavioral Science into Action,'' the report of the
    National Advisory Mental Health Council's Behavioral Science Workgroup,
    provides a wealth of specific recommendations for redirecting existing
    research resources. Measures commenced or soon to begin include:
      --A Request for Applications (RFA) with set-aside funds that focuses
            on basic behavioral processes in mental illness is under
            development to jump start cross-disciplinary collaborations
            between basic behavioral researchers and clinical
            investigators.
      --Simultaneously, a new Program Announcement (PA) will outline a
            trajectory of research support to include both developing and
            mature translational research centers to provide an
            infrastructure for new research, speed the translation of
            findings, and encourage interaction across basic, clinical and
            services research. These efforts will signal a serious and
            ongoing commitment on the part of NIMH to apply behavioral
            science methods to the problems of mental illness.
      --An ancillary study PA encourages behavioral scientists to access
            the patient populations and infrastructure developed as part of
            the NIMH clinical trial initiatives.
      --Workshops bringing together behavioral and clinical scientists have
            been initiated in the areas of (1) adherence in serious mental
            illness; (2) informed consent and clinical research; (3)
            research ethics; and (4) integrating behavioral science with
            public health.
      --Staff have worked with current behavioral scientist grantees to
            encourage redirection into areas more closely dealing with
            mental disorders.
      --Training activities are being examined to identify ways to overcome
            barriers to cross-disciplinary training experiences that are
            required to facilitate translational research.
                                 schizophrenia
        Question. Given the many changes underway at NIMH in terms of the
    funding of clinical research and the clinical research centers, how are
    you moving to assure that the research base studying schizophrenia is
    strengthened and expanded?
        Answer. NIMH is strengthening and expanding its research base with
    regard to schizophrenia in the following ways: (1) initiating a large,
    sustained effort in the area of clinical trials of typical and atypical
    antipsychotics for treatment of schizophrenia, and supporting Centers
    and other grants addressing a large number of schizophrenia treatment
    issues; (2) bolstering our program for the Silvio O. Conte Centers for
    the Neuroscience of Mental Disorders in the area of schizophrenia (2
    Centers to date); (3) undertaking major, innovative new efforts to
    investigate genetic contributions to schizophrenia; these efforts
    include a centralized, international respository for genetic samples
    and for services to genetics investigators; (4) funding a large number
    of R01-type grants focused on the neurobiology of schizophrenia, using
    methods such as brain imaging, electrophysiology,
    electromagnetoencephalography, etc.; (5) funding an extensive portfolio
    of basic neuroscience research relevant to schizophrenia and other
    mental disorders, (6) initiating new epidemiological and other efforts
    to understand non-genetic risk factors for schizophrenia and to
    characterize, in more insightful ways, the very early stages of the
    disorder; (7) continuing to support a large intramural research program
    targeting a number of aspects of schizophrenia.
                             advocates on comittees
        Question. NIMH was a leader in asking members of the general
    public--often consumers with severe mental illnesses or their family
    members--to serve on scientific peer review committees looking at
    treatment research. As you know, there was a good deal of skepticism
    about the wisdom of including non-scientists on the committees. Could
    you provide us with your assessment of how that innovative project has
    turned out?
        Answer. Public participant reviewers have successfully served for a
    year on the NIMH's service and interventions review committees. Public
    reviewers included individuals who have suffered from mental disorders,
    family members of those suffering from mental disorders, mental health
    care policymakers, and mental health care providers. All committee
    members were asked for their assessment of how well the process worked.
    The most common feedback was that the inclusion of public reviewers was
    useful and that the public reviewers had done an excellent job. The
    public reviewers, many of whom experienced the committee process for
    the first time, were impressed with the efforts of the committee
    members and the serious and objective nature of the deliberations. NIMH
    will continue to request feedback from all reviewers to help inform and
    improve the process of public participation in its review meetings.
    Future plans are to help public reviewers focus on the review issues
    about which they can best contribute such as determining public health
    importance and human protection issues, and to continue adding and
    training new public reviewers to ensure a broad diversity of opinions
    and experiences.
                            human subject protection
        Question. NIMH has been dealing with ethical issues in research on
    mental illnesses for a number of years and has instituted a new Mental
    Health Advisory Council review process to examine human subjects
    protections before grant approval. Has this new review process been
    useful? Is it helpful to have non-scientists on the review panel?
        Answer. The NIMH Human Subject Research Council Workgroup has been
    in existence for a year and will meet next on May 3, 2000. It has
    helped assure that applications considered for funding meet the highest
    scientific and ethical standards, and that proper protections for human
    research volunteers are in place. Having bioethicists and consumers on
    this group has been particularly useful in considering research risks,
    benefits, alternatives, and informed consent issues.
                             co-occurring disorders
        Question. NIAAA's strategic plan hardly mentions the problem of co-
    occurring disorders. What plans does NIAAA have to address co-occurring
    disorders--and in particular, is the institute sponsoring any research
    to help establish the most effective treatment approaches when
    alcoholism and a mental disorder occur together?
        Answer. The strategic plan of the National Institute on Alcohol
    Abuse and Alcoholism (NIAAA) is a blueprint of the Institute's major
    goals and objectives and the strategies for achieving them. Many
    elements of this plan were developed with input from the National
    Advisory Council, with significant input from scientists in alcohol-
    related areas as well as other research areas. The plan also reflects
    advice from a broad spectrum of sources--researchers, health care
    providers, over 250 liaison organizations, policymakers, people
    recovering from alcoholism and their families, and others. It is a
    ``live'' document that the Institute will be updating periodically.
    While researchers interested in the causes of disease will differ on
    whether studying the patient with co-occurring disease is a promising
    research strategy, the NIAAA is addressing the issue of co-occurring
    disorders throughout the strategic plan and the research portfolio.
        Alcohol's effects on the human body are ubiquitous,both physically
    and psychologically. For example, chronic alcohol use is associated
    with a range of diseases, from liver damage to depression. In terms of
    psychological comorbidity, the challenge for alcohol investigators is
    to determine whether specific diseases occur regardless of alcoholism,
    are the result of alcoholism, or contribute to the development of
    alcoholism. Numerous studies in this regard are underway. For example,
    topics of studies on depression range from delivery of services for
    depressed substance abusers to observing the outcome of treating
    depressed alcoholics for depression alone, alcoholism alone, or both
    conditions. The Institute's research on co-occurring psychiatric
    disorders also includes studies of alcoholics with post-traumatic
    stress syndrome and bipolar disorder and clinical trials of alcoholics
    with social phobia and depression. Neuroscience contributes vital
    information to studies of treatment for alcoholism and co-occurring
    disorders, since they identify the biological mechanisms that underlie
    these conditions. The NIAAA conducts numerous neuroscience studies on
    mental health, from research on alcoholism and schizophrenia to
    research on development of alcohol use and abuse in adolescents with
    attention-deficit hyperactivity disorder.
               treatment options for dually diagnosed individuals
        Question. Drug abuse and psychiatric disorders frequently occur
    together and these ``dually-diagnosed'' individuals pose special
    treatment problems. I understand that NIDA's ambitious Clinical Trials
    Network will address this issue. Could you please review for us what
    the existing research says about the most effective treatment
    approaches for these dually-diagnosed individuals and discuss why these
    approaches have generally not been adopted by the drug abuse and mental
    health treatment communities?
        Answer. Data from the Epidemiological Catchment Area Study showed
    that 53 percent of individuals with substance use disorders met
    criteria for one or more mental disorder, and that about one-third of
    individuals who have a mental disorder also experience alcohol and
    other drug abuse disorders in their life. In the National Comorbidity
    Study, 47 percent of individuals with a past year substance use
    disorder diagnosis had a comorbid mental disorder. Affective, anxiety,
    personality and psychotic disorders were most commonly comorbid with
    substance abuse or addiction disorders.
        Among treatment-seeking substance abusers and addicts, psychiatric
    comorbidity has been found to be commonplace. In a recent study in
    Baltimore, psychiatric comorbidity was detected in 47 percent of heroin
    addicts one month after stabilization on methadone. Antisocial
    personality disorder (25 percent) and major depression (16 percent)
    were the most common diagnoses. Psychiatric comorbidity was associated
    with increased severity of drug use and severity of associated social
    problems. In other studies increased psychiatric symptoms have been
    associated with increased HIV risk behaviors.
        Clinical studies have shown that people who have comorbid mental
    and addictive disorders tend to have poorer treatment outcomes, to
    relapse more frequently, and are less responsive to psychiatric
    medications during continued use. Furthermore, studies have
    demonstrated that treatment of a comorbid mental disorder with
    appropriate psychiatric and drug addiction medications and
    psychotherapy and drug addiction counseling is important to the
    effective treatment of the addictive disorder and results in better
    outcomes and reduced relapse rates.
        Several studies have now shown that integrated treatment programs,
    which combine mental health and substance abuse interventions, offer
    much greater promise than the totally separate programmatic approaches
    found in many communities. In addition to a comprehensive integration
    of services, successful programs include assessment, assertive case
    management, motivational interventions for patients who do not
    recognize the need for substance abuse treatment, behavioral
    interventions for those who are trying to attain or maintain
    abstinence, family interventions, housing, rehabilitation, and
    pharmacotherapy.
        Since the late 1980's new models of treatment for the dually
    diagnosed--with a primary aim of integrating services----have been
    evolving. This integration is accomplished through the use of
    multidisciplinary teams that include both mental health and substance
    abuse professionals who are cross-trained. However, despite the
    encouraging research findings regarding the effectiveness of integrated
    treatment for this population, implementation continues to be slow
    because of problems related to the organization and financing of
    programs. Organizational guidelines have been developed for dual
    diagnosis programs, but few large systems have successfully integrated
    services.
        It appears that more research needs to be done on the organization
    and financing of integrated treatment programs (health services
    research). In addition, many of the basic components of integrated
    treatment (family psychoeducation; motivational interventions;
    behavioral treatments for substance abuse; integrating
    pharmacotherapies, etc.) are still being developed and refined.
    Research is needed to address the effectiveness of the appropriate
    combination of these components.
        Of course, another major barrier to successful implementation of
    this integrated approach is the lack of cross-training for health
    substance abuse and mental health professionals.
        In summary, research has informed us that it is important to
    diagnose both substance abuse and mental disorders when they are
    comorbid and provide fully effective treatments for both disorders.
    Several studies have demonstrated the significant benefits of
    integrated substance abuse and psychiatric services in the same
    treatment setting rather than separate and parallel treatment. Benefits
    included increased engagement and retention in treatment, decreased
    addiction severity and decreased psychiatric symptomatology. For the
    most psychiatrically severe patients, these integrated interventions
    must include Assertive Community Outreach, which fosters continuous
    engagement and re-engagement in treatment, provides crisis intervention
    and other community-based services, and supports medication compliance
    and attendance at both psychiatric and drug treatment services.
    Research is continuing on the refinement of the components of treatment
    services and their effectiveness in combination therapy.
        NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN)
    will also serve as a potential vehicle for treating dually diagnosed
    patients. Since the CTN will be testing efficacious therapies in real
    life settings with diverse patient populations, dually-diagnosed
    patients will be included in some treatment protocols with appropriate
    analyses of these patients conducted to improve the treatment strategy
    even more. Additionally, the CTN will develop protocols to test
    therapies specifically targeted to co-morbid patients. For example,
    this may include using antidepressants as an adjunct to behavior
    therapies for depressed drug addicts.
                               autoimmune disease
        Question. What is the status of the NIH's report on autoimmune
    disease research? What is the timing on submission of that report?
        Answer. The Report of the NIH Autoimmune Diseases Coordinating
    Committee summarizes recent basic and clinical research programs
    supported by NIH and non-Federal organizations, highlighting
    coordination and collaborative activities in ten thematic areas; recent
    and ongoing activities of the NIH Autoimmune Diseases Coordinating
    Committee; and emerging opportunities to improve treatment and develop
    preventive approaches for autoimmune diseases. Twenty-two NIH
    Institutes, Centers, and Offices; the U.S. Food and Drug
    Administration; the Centers for Disease Control and Prevention; the
    Veterans' Administration; and ten private organizations with an
    interest in autoimmune diseases are represented on the Committee. The
    research programs supported by these groups comprise a broad range of
    basic, pre-clinical, and clinical endeavors addressing many different
    diseases, organ systems, and aspects of autoimmune disease.
        The Committee will submit the report to the Office of the Director,
    NIH, for clearance and hopes to release the report in the very near
    future.
        Question. What is the total amount that NIH is spending for
    research on all autoimmune diseases?
        Answer. The NIH spent $393.2 million on autoimmune disease research
    in fiscal year 1999, and expects to spend $434.6 million in fiscal year
    2000, and $456.9 million in fiscal year 2001.
        Question. What are some research initiatives NIH is funding to
    develop better treatments for these diseases?
        Answer. Autoimmune diseases are immune-mediated disorders in which
    the immune system attacks the body's own tissues. Treatment of these
    diseases depends largely on immunosuppressive agents that have many
    side effects, for example, steroids and cytotoxic therapies. However,
    more specific and less toxic immune therapies have shown efficacy in
    animal studies. As highlighted below, the NIAID, in collaboration with
    many other federal and private organizations, has developed new
    programs to assist in moving these promising therapies to clinical
    practice.
        Immune Tolerance.--The induction of immune tolerance is a major
    therapeutic goal for the treatment of many immune-mediated diseases, as
    it will eliminate or reduce the life-long dependence of many patients
    on costly and toxic immunosuppressive drugs. Tolerance induction
    strategies seek to modify or block deleterious immune responses, such
    as those responses that cause the body to attack its own organs and
    tissues in autoimmune disorders, or the immune responses that result in
    the rejection of transplanted organs, tissues, and cells. A number of
    promising reagents for the induction of immune tolerance are being
    developed and can now be tested in clinical trials.
        In September 1998, the NIAID published a long-term plan, now
    available on the web (http://www.niaid.nih.gov/publications/immune/
    bookcover.htm) to accelerate research on immune tolerance, particularly
    in the clinical setting. In September 1999, the NIAID, with co-
    sponsorship of the National Institute of Diabetes and Digestive and
    Kidney Diseases (NIDDK) and the Juvenile Diabetes Foundation
    International (JDFI), established one of the major research programs
    emanating from this plan, the Immune Tolerance Network (http://
    paramount.bsd.uchicago.edu/frameset.html). Leading investigators from
    more than 40 institutions in the U.S., Canada, Western Europe, and
    Australia are participating in the design and evaluation of clinical
    trials of tolerance induction therapies for autoimmune diseases, asthma
    and allergic diseases, kidney transplantation, and islet
    transplantation for type 1 diabetes. In the six months since the
    inception of this major clinical research program, the Network has
    initiated the development of clinical trials for a variety of immune-
    mediated disorders, including islet transplantation for systemic lupus
    erythematosus, and multiple sclerosis. The Network is also implementing
    a study to assess the immune status of kidney transplant recipients who
    have voluntarily discontinued immunosuppressive therapy yet maintained
    a functioning transplant over long periods of time. Network-supported
    scientists are also designing studies of several approaches to measure
    the induction, maintenance, and loss of tolerance in humans in
    conjunction with these clinical trials. Examples include the use of new
    biotechnologies, such as the complementary ``gene chip'' microarray
    technology, which will profile changes in gene expression associated
    with tolerance induction therapies, and the ELISPOTR assay that will
    enable scientists to analyze the expression of immunomodulatory
    proteins during treatment with tolerogenic therapies. In order to
    stimulate new insights that will lead to wider application of
    tolerogenic approaches, all Network-supported clinical trials will
    include studies of the underlying mechanisms of immune regulation as an
    integral part of the protocols.
        The NIDDK, with the NIAID and the National Institute of Child
    Health and Human Development (NICHD), is cosponsoring a clinical trial
    to test the ability of subcutaneous or oral insulin by inducing immune
    tolerance to prevent or delay the development of type 1 diabetes in
    relatives of patients with the disease who are at risk for development
    of the disease in the next five years. The JDFI and the American
    Diabetes Association are also sponsoring this multi-center, nationwide
    trial.
        The program, Human Islet Transplantation into Humans, will support
    clinical studies using new methods to induce immune tolerance, to
    prevent reoccurrence of the autoimmune destruction of beta cells in the
    islet, and to prevent transplant rejection. The NIDDK, the NIAID, and
    the JDFI support this program.
        Immune Modulation.--Traditional immunosuppressive and cytotoxic
    therapies used to treat autoimmune diseases have many serious side
    effects, including a decreased ability to fight infection, tissue and
    bone fragility, and malignancy. In contrast, immunomodulatory
    approaches seek to modify immune injurious responses without the need
    for global immunosuppression. Examples include recently approved drugs
    that target the tumor necrosis factor, an important mediator of
    inflammation in rheumatoid arthritis and inflammatory bowel disease.
    This targeted approach appears to be more potent and less toxic than
    the use of cytotoxic agents or cortocosteroids in treating these
    disorders.
        In fiscal year 1999, the NIAID, with co-sponsorship of the NIDDK,
    the National Institute of Arthritis and Musculoskeletal and Skin
    Diseases (NIAMS), and the Office of Research on Women's Health (ORWH)
    of the National Institutes of Health, established the Autoimmunity
    Centers of Excellence to design and conduct pilot clinical trials of
    the safety and potential efficacy of new strategies for immune
    modulation in multiple autoimmune diseases. Three clinical trials of
    promising approaches are under development: prevention of kidney damage
    in systemic lupus erythematosus through interruption of a specific
    immune pathway, the complement pathway; induction of remissions in
    systemic lupus erythematosus through removal of a specific immune cell,
    the B cell; and prevention of the development of autoantibodies in
    children at risk for type 1 diabetes through the use of insulin. These
    Centers will also conduct pilot clinical trials of tolerance induction
    strategies and provide important safety and efficacy data for further
    evaluation by the Immune Tolerance Network.
        Another new research program will focus, in part, on the
    development of novel treatments for the many rare immune-mediated
    diseases, some of which affect less than 200,000 people. NIH support in
    this area is particularly important due to limited industrial interest
    in diseases with a small market potential. A fiscal year 2000 NIAID
    research initiative, Clinical Trials and Clinical Markers of Immune
    System Diseases, will support the testing of new therapeutic approaches
    for certain rare immune-mediated disorders, including primary
    immunodeficiency diseases and autoimmune diseases. Under this
    initiative, the development of new biological markers and surrogate
    endpoints to measure disease risk, activity, stage, and therapeutic
    response will be encouraged. The availability of specific and easily
    measured biological markers will facilitate the design and evaluation
    of new therapeutic strategies.
        In fiscal year 1998, the NIAID initiated a program called the
    Hyperaccelerated Award/Mechanisms in Immunomodulation Trials to support
    investigator-initiated research applications for mechanistic studies to
    be conducted in conjunction with clinical trials for immune-mediated
    diseases. The applications focus on utilization of patient samples to
    define: mechanisms of disease pathogenesis; immunological mechanisms
    underlying the clinical intervention; and surrogate/biomarkers markers
    of disease activity and therapeutic effect. The ``parent'' or ``core''
    clinical trial must have independent financial support, either from
    industry, private foundations, or a federal agency. This program,
    cosponsored by the National Institute on Aging (NIA), NIAMS, NIDDK, the
    National Heart, Lung and Blood Institute (NHLBI), the National
    Institute of Neurological Disorders and Stroke (NINDS), and the ORWH,
    has been highly successful. In the 18 months since its inception, the
    NIH has received 29 applications and funded eight projects in
    autoimmune diseases, allergy and asthma, and transplantation in
    collaboration with six industry partners. Through a number of steps to
    expedite peer review and award, applications are accepted monthly and
    awards are made within 13 weeks of receipt.
        In fiscal year 2000, the NIDDK, the NIAID, and the NICHD will begin
    a new program, New Strategies for the Treatment of Type 1 Diabetes,
    supporting clinical studies to test new approaches to treat type 1
    diabetes, including studies of immunomodulation.
        Other Therapeutic Approaches--Another approach to the treatment of
    immune-mediated diseases involves ``replacing'' the immune system
    through transplantation of hematopoietic stem cells. In many cases, the
    patient's own stem cells are used to ensure that the transplanted cells
    do not react against the body's own tissues. Stem cell transplantation
    is currently being used for the treatment of several autoimmune
    diseases, and anecdotal reports suggest that this approach holds
    promise for inducing remission or decreasing disease severity. However,
    well-controlled clinical trials of efficacy have not yet been
    conducted. Therefore, in fiscal year 1999, the NIAID implemented a
    research initiative, Stem Cell Transplantation for Autoimmune Diseases,
    to design and conduct rigorous clinical trials of the safety and
    efficacy of this new therapeutic strategy.
        In fiscal year 1999, the research initiative, Pilot Clinical Trials
    on Innovative Therapies for Rheumatic and Skin Diseases, was
    implemented under the leadership of the NIAMS to develop innovative
    therapies for the treatment of rheumatic and skin diseases. Awards were
    made for research on Wegener's granulomatosis, rheumatoid arthritis,
    scleroderma, systemic lupus erythematosus, and ankylosing spondylitis.
        In fiscal year 1999, the NHLBI began an investigator-initiated
    clinical trial of Cyclophosphamide in the treatment of the pulmonary
    fibrosis associated with systemic sclerosis. In systemic sclerosis,
    interstitial pulmonary fibrosis is frequent (80 percent) and is now the
    leading cause of death. The mortality rate of patients with impaired
    pulmonary function is 40-45 percent within 10 years of onset.
    Uncontrolled studies suggest that cyclophosphamide may stabilize or
    improve lung function in systemic sclerosis patients. The study is a
    five-year, 13-center, parallel-group, double-blind, randomized,
    controlled, phase III clinical trial of oral cyclophosphamide versus
    placebo to assess the efficacy of cyclophosphamide in stabilizing or
    improving the course of pulmonary disease in scleroderma. NIAMS also
    contributes to the support of this study.
        In fiscal year 2000, the NIDDK with the NIAID and the JDFI will
    sponsor new Diabetes Centers of Excellence to support basic research
    into the pathogenesis of type 1 diabetes and to develop new therapeutic
    approaches to this autoimmune disease.
        Question. How does NIH intend to increase coordination of research
    on the family of autoimmune diseases?
        Answer. In fiscal year 1998, both the Senate and the House
    Appropriations Committee Reports addressed the importance of
    coordination of NIH-supported research activities relating to
    autoimmune diseases. The NIH recognized the need for coordination and
    collaboration in this area and in fiscal year 1998 established the
    Autoimmune Diseases Coordinating Committee under the direction of the
    NIAID. Twenty-two NIH Institutes, Centers, and Offices, the U.S. Food
    and Drug Administration, the Veterans Administration, the Centers for
    Disease Control and Prevention, and private organizations that sponsor
    research in this area are represented on the Committee. Some of the
    private organizations include the Juvenile Diabetes Foundation
    International, the Arthritis Foundation, the National Multiple
    Sclerosis Society, the Systemic Lupus Erythematosus Foundation, the
    Sjogren's Foundation, and the American Autoimmune Related Diseases
    Association.
        Since its initial meeting in June 1998, the Committee has collected
    and analyzed information on current research activities and funding
    levels and established multi-Institute collaborative working groups in
    areas of common interest and relevance to multiple autoimmune diseases.
    In addition, the Committee's efforts have facilitated a variety of
    other activities to further enhance coordination of research and
    increase partnerships between public and private organizations.
    Examples include:
      --Extensive collaboration among many NIH Institutes, Centers, and
            Offices in planning and cosponsoring several new research
            initiatives in fiscal year 1999;
      --Establishment of public-private research partnerships between the
            NIH and the Juvenile Diabetes Foundation International, the
            Arthritis Foundation, and the Crohn's and Colitis Foundation of
            America;
      --Cosponsorship of workshops and scientific symposia by the NIH, the
            Juvenile Diabetes Foundation International, the Arthritis
            Foundation, and the Crohn's and Colitis Foundation of America;
      --Participation of NIH staff in scientific planning activities of
            non-Federal organizations, such as the National Multiple
            Sclerosis Society, the Alliance for Lupus Research, and the
            Juvenile Diabetes Foundation International.
        The Autoimmune Diseases Coordinating Committee was instrumental in
    the development, coordination, and implementation of several new
    initiatives in fiscal year 1999. The guiding principles of this
    planning process included an emphasis on: cross-disciplinary research
    addressing multiple autoimmune diseases; support for a mechanism-based
    approach, encompassing fundamental investigations of disease
    pathogenesis and clinical trials involving new diagnostic and
    therapeutic approaches; and selected research programs focusing on
    specific diseases, new technologies, and/or extraordinary scientific
    opportunities.
        Several new trans-NIH initiatives emerged from this process, and
    nine previously planned activities in later stages of development
    received increased support. Support was provided for the following
    initiatives, the majority of which involved joint sponsorship by
    multiple NIH components:
      --New Imaging Technologies in Autoimmune Diseases
      --Environment/Infection/Gene Interaction in Autoimmune Diseases
      --Autoimmunity Centers of Excellence
      --Multiple Autoimmune Disease Genetics Consortium
      --Target Organ Damage in Autoimmune Disease
      --Stem Cell Transplantation for Treatment of Autoimmune Diseases
      --Immune Tolerance Network
      --Non-human Primate Transplantation Tolerance Cooperative Study Group
      --Human Immunology Centers of Excellence
      --Clinical Trials and Clinical Markers for Immunologic Diseases
      --Rat Autoimmune Disease Genetic Resource
      --Rat Autoimmune Model Repository
      --Pilot Trials on Innovative Therapies for Rheumatic and Skin
            Diseases
      --Immunological Phenotyping of Mouse Mutants
      --Human Rheumatic Diseases Registries
      --Hyperaccelerated Award/Mechanisms in Immune Disease Trials
      --Rheumatic Diseases Registries
        In November 1999, the Autoimmune Diseases Coordinating Committee
    established Collaborative Working Groups to encourage NIH, other
    federal agencies, and private organizations to prospectively develop
    jointly sponsored initiatives in areas of overlapping interest. Several
    initiatives are likely to be published in the coming year from this
    collaborative process.
        The major challenges facing autoimmune diseases research today are
    the: development of a mechanism-based, conceptual understanding of
    autoimmune disease; translation of this knowledge into new, broadly
    applicable strategies for treatment and prevention of multiple
    diseases; and development of sensitive tools for early and definitive
    diagnosis, disease staging, and identification of at-risk individuals.
    Through the collaborative programs outlined above, NIH-supported
    scientists are vigorously pursuing these goals.
                                     ______

                    Questions Submitted by Senator Herb Kohl
                                    epilepsy
        Question. Dr. Fischbach, I am very pleased that today NINDS is
    sponsoring a conference on curing epilepsy. I am hopeful that the
    discussions at the conference will lead to a clearer strategy for
    research into this debilitating disease. With that goal in mind, I have
    several questions:
      --Report language last year discussed curing epilepsy, not just
            finding new treatments for it. What is NINDS doing differently
            to change its focus from finding new treatments to finding a
            cure to stop epilepsy dead in its tracks?
      --What is NINDS's strategy for focusing on the population with
            intractable epilepsy?
        Answer. Our approach to curing epilepsy is reflected in the title
    of a major, White House-initiated conference we sponsored last month--
    ``Curing Epilepsy: Focus on the Future.'' In light of recent science
    advances, and with the enthusiastic support of the research and patient
    communities, we are defining ``cure'' as the prevention of epilepsy
    before it occurs in people at risk, and the total elimination of
    seizures without treatment side effects in those who develop the
    disease. Our approach is threefold. We want to pursue innovative
    approaches to medical treatment, including the identification of new
    targets for drugs and new methods such as high throughput screening to
    identify useful medicines. We want to improve existing surgical
    treatments and develop new ones aimed at modifying the circuitry of the
    brain and take advantage of new methods such as various types of
    stimulation to prevent or interrupt the destructive cascade of seizure
    activity. And we want to harness the power of genomic information to
    understand how the mutant genes responsible for many forms of epilepsy
    lead to disease so that we can identify ways to prevent or reverse that
    process.
        ``Intractable epilepsy'' is a term that we hope will become
    obsolete as our research strategies bear additional fruit. The approach
    I have just outlined for epilepsy in general is really the same we hope
    to apply to those for whom existing treatments have failed--better
    drugs, more effective surgery, and application of what we already know
    and expect to learn about the role of genes in epilepsy.
                              alzheimer's disease
        Question. It is my understanding that some research has shown that
    Alzheimer's Disease begins to destroy the brain cells of its victims 10
    to 20 years before outward symptoms appear. Do we currently have the
    tools to diagnose Alzheimer's Disease in its earliest stages and, if
    not, what research is being done to develop that capability?
        Answer. Alzheimer's disease (AD) is a degenerative disorder of the
    central nervous system where neuropathological changes may begin
    several decades before the disease is recognized clinically. Therefore,
    the most cost-effective therapies will prevent the onset of AD before
    it ever manifests itself clinically. These preventative therapies can
    only be developed if we can understand and predict the initial stages
    and events in the brain that lead to the development of AD.
        Targeting early pathological processes necessitates development of
    biochemical, neuropsychological, neuroimaging and genetic markers that
    are sufficiently sensitive and accurate to identify at-risk individuals
    along the spectrum from normal aging through mild cognitive impairment
    (MCI) (a condition characterized by memory deficit without dementia) to
    AD. Most recently, diagnostic research has focused on people with MCI.
    These people are at increased risk of developing AD since 15-20 percent
    annually convert to AD versus 1-2 percent in the general population
    over the age of 65. A number of ongoing imaging studies are evaluating
    persons who exhibit early pre-clinical or clinical signs of AD and
    comparing their neuroimaging and biochemical measures to those of older
    individuals who are not cognitively impaired in an attempt to identify
    the earliest biochemical and imaging markers that distinguish AD from
    normal age-related changes.
        Current neuroimaging studies are assessing whether it is possible
    to measure aspects of brain function and/or structure to identify
    individuals who are at-risk for AD before they develop the symptoms of
    the disease. Structural and functional imaging have been shown to be
    useful in identifying diagnostic markers of AD; however, in the past,
    most imaging studies have been cross-sectional and designed to
    demonstrate differences between older controls and patients who were
    already demented. Recently published research has conducted magnetic
    resonance imaging (MRI) studies in longitudinally followed individuals
    diagnosed with MCI who were at increased risk of AD. The studies
    measured two areas of the temporal lobe of the brain, the hippocampus
    and the entorhinal cortex, because these brain structures play a
    central role in memory function and are the sites of the earliest
    pathology in AD. The studies found that in older individuals with MCI,
    hippocampal and entorhinal cortex atrophy were predictive of an
    increased risk of subsequent conversion to AD; that is, the smaller the
    brain volumes, the greater the risk. The implication of these studies
    is that it may be possible to identify people who are beginning to
    develop the brain structural changes associated with the disease prior
    to the clinical diagnosis of AD.
        Recognition and characterization of brain changes prior to the
    clinical symptoms or diagnosis of AD has important implications for
    improving the timing and effectiveness of interventions. If diagnostic
    procedures can be developed to detect early changes in the brain, it
    may be possible to develop treatments that will stop the
    neuropathological and biochemical lesions of AD before clinical
    deterioration begins.
        Improved diagnosis of AD could also improve the design of drug
    trials. Focusing drug trials on persons at highest risk for disease is
    more efficient and less costly, and, among highest risk persons with
    minimal or no clinical symptoms, has the added benefit of testing the
    effectiveness of preventing progression of symptoms to a clinical
    diagnosis of AD. Finally, earlier and more accurate diagnosis provides
    patients and families important information allowing them to better
    plan for future care needs and management of their personal affairs.
                          duchenne muscular dystrophy
        Question. As you know, 1 in 3,500 boys worldwide will be stricken
    with Duchenne Muscular Dystrophy, the most common fatal childhood
    genetic disease. There is no treatment. Each day, two boys in the
    United States die from this disease. After hearing the stories of these
    boys, I am very concerned about the lack of research being done at NIH
    on Duchenne and Becker Muscular Dystrophy--as well as on neuromuscular
    disorders generally. The dystrophin gene was discovered through NINDS-
    sponsored research in 1987; yet no new treatments have emerged. In
    1999, less than 1 percent of NIH funds were spent on over 40 different
    forms of neuromuscular disorders.
        It is my understanding that there are currently only 17 active
    research grants for muscular dystrophy research. Do you believe that is
    sufficient? What is NIAMS doing to encourage and fund more research
    grants in this area?
        Answer. The NIAMS, together with the National Institute of
    Neurological Disorders and Stroke (NINDS), considers research on the
    muscular dystrophies to be a priority area. We will continue to work
    with the extramural muscular dystrophy research community, as well as
    interested patient organizations, to stimulate and support promising
    studies in this area. In fiscal year 1999, the NIAMS invested nearly
    $5.4 million in muscular dystrophy projects, an increase of over 40
    percent from the previous fiscal year.
        A number of exciting studies with implications for our
    understanding of the muscular dystrophies have been supported by the
    NIAMS in recent years. One such investigation used gene therapy to
    restore muscle function in a hamster model of limb-girdle muscular
    dystrophy (LGMD). In another NIAMS-funded study, researchers
    successfully used the common antibiotic gentamicin to restore the
    function of the gene that encodes for the protein dystrophin in mouse
    models of Duchenne muscular dystrophy (DMD). In a third project, NIAMS-
    supported researchers used gene therapy in mice to give the body a
    boost in fighting the effects of aging on muscle, and to help repair
    the damage caused by injury and muscle-wasting disorders such as
    muscular dystrophy. These projects underscore the potential of treating
    human forms of LGMD, DMD and other muscular dystrophies with gene
    therapy approaches.
        Another area of excitement relates to a new protocol developed with
    support from the NIAMS that makes it possible to obtain an almost
    unlimited number of a special class of adult stem cells from a small
    sample of bone marrow. These adult stem cells have the ability to
    develop into cells of muscle, nerve, bone, cartilage and fat. Because
    of their vast potential for differentiation, they may be excellent
    therapy vectors for a number of skeletal diseases, including muscular
    dystrophy.
        Next month, the NIAMS--in partnership with the NINDS and the NIH
    Office of Rare Diseases--will support two research meetings on muscular
    dystrophy. The first is an international scientific conference centered
    on clinical and molecular studies of facioscapulohumeral dystrophy
    (FSHD). The meeting will bring together researchers who are already
    involved in FSHD projects, as well as scientists who are working in
    related fields and may be able to contribute to progress on FSHD. The
    second meeting will focus on therapeutic approaches for DMD. This
    workshop is aimed at addressing key questions in improving treatments
    for DMD, identifying areas of needed scientific knowledge, and critical
    next steps to promote effective therapy. The NIH expects to build on
    the insights from these two meetings to develop new program initiatives
    related to the muscular dystrophies. Such initiatives would complement
    on-going efforts to stimulate research in this area, including the
    currently active program announcement on the pathogenesis and therapies
    of the muscular dystrophies.
        Question. What, if any, coordinated strategy exists between NIAMS
    and NINDS to focus research on Duchenne and integrate scientific
    discoveries from related research? Would a consensus conference on
    Duchenne/Becker Dystrophies be beneficial in creating that focus?
        Answer. NIAMS and NINDS share the lead for Duchenne/Becker muscular
    dystrophy research. NIAMS brings to this role a perspective as the lead
    institute for basic studies of muscle biology and most muscle diseases.
    NINDS leads in the study of the many neurological disorders that affect
    neuromuscular control. Since the discovery of the muscular dystrophies,
    neurologists have played a major role in diagnosis and care of children
    and in research on these disorders. Interactions among medical
    professionals from several disciplines are increasingly important in
    studying and treating the muscular dystrophies, and the involvement of
    several components of NIH in muscular dystrophy research reflects this.
        Some have expressed concern that no single component of NIH is
    responsible for all muscular dystrophy research. The division of
    responsibilities for muscular dystrophy research among components of
    NIH reflects the biological complexities of the disease, and there are
    substantial benefits from bringing a coordinated approach from multiple
    perspectives focused on muscular dystrophy. This issue in general is an
    important one for NIH. Biology does not abide by administrative
    divisions. Most disorders, including the muscular dystrophies, affect
    many aspects of physiology, benefit from a wide range of fundamental
    biological research, and require that we explore diverse strategies for
    treatment. It is therefore essential to bring to bear expertise and
    resources from all parts of NIH, as appropriate. The need for
    coordination is very real, and we must be vigilant. For muscular
    dystrophy, NIAMS and NINDS together take the lead and have initiated
    joint solicitations, scientific workshops and other activities,
    involving other components of NIH.
        As noted earlier, the NIAMS and NINDS are presently partnering with
    the NIH Office of Rare Diseases to sponsor a workshop on therapeutic
    approaches for DMD. A number of scientific questions will be explored
    at this meeting with the goal of moving currently studied therapies
    toward human trials. Institute staff have worked closely with the DMD
    research community, as well as patient advocates, to develop the agenda
    for this workshop. At present, an NIH consensus conference on DMD may
    be premature--as the primary goal of such conferences is to develop a
    report evaluating state-of-the-art scientific information on a given
    biomedical technology with the purpose of resolving a particular
    controversial issue in clinical practice. However, it is our
    expectation that the meeting we are sponsoring this spring on DMD will
    provide an important focus for new approaches to this disorder, and
    will serve as the basis for future programmatic efforts.
        Question. Concerns have been raised that there is no separate study
    section for muscle biology within any of the institutes of NIH. Why is
    this the case? Do you believe the NIH is properly organized to evaluate
    and coordinate muscle biology-related research--specifically related to
    Duchenne/Becker Muscular Dystrophy?
        Answer. The NIH Center for Scientific Review (CSR), which conducts
    the peer review process, is currently involved in a comprehensive
    assessment of its study section structure, led by Dr. Bruce Alberts,
    the President of the National Academy of Sciences. The purpose of this
    assessment is to ensure that CSR provides a rigorous, unbiased review
    system that facilitates the advance of all areas of biomedical
    research, including muscle biology. Indeed, muscle disease review
    issues are being considered as part of the assessment. CSR will also be
    meeting with scientists at the Duchenne muscular dystrophy workshop in
    May to discuss this and other review concerns. The outcome of these
    discussions will help guide future decisions about the review of
    muscle-related research grant applications.
        There is no simple answer to the question of whether a dedicated
    study section would enhance the success of muscular dystrophy research
    applications or otherwise improve coordination of muscle-related
    research. It is important to consider that the NIH receives a broad
    range of research applications on muscle functioning and disease, and
    diverse areas of scientific expertise are required to review those
    applications. Whether it is desirable--or, indeed, even feasible--to
    cluster all muscle research proposals into a single study section is
    one of the questions being explored by the CSR assessment described
    above.
                               diabetes research
        Question. Over 175,000 adults in Wisconsin were diagnosed with
    diabetes in 1996. In addition to the physical and life-threatening
    complications diabetes sufferers face, the costs of diabetes in
    Wisconsin total nearly $2.3 billion annually.
        I realize that funds for trans-NIH diabetes research are estimated
    to increase by 15.7 percent in fiscal year 2000, with a 14.7 percent
    increase for NIH overall. In recent years, NIH has recommended to
    Congress allocations among institutes that generally spread the funding
    increase evenly among Institutes.
        Do you think that across-the-board allocations adequately fund all
    new scientific opportunities equally? How does this across-the-board
    approach square with the assertion by NIH that allocations should be
    made on the basis of scientific opportunity, the greatest need, and the
    greatest potential for breakthroughs?
        Answer. NIH recommendations to Congress regarding allocations to
    the Institutes and Centers (ICs) vary each year to reflect many factors
    and consultations. The NIH solicits advice from a large number of
    individuals and groups, including the members of the scientific
    community, patient advocacy groups, Congress, the Administration, and
    NIH staff. Each IC convenes meetings of its national advisory council
    or board to review a broad range of policies and sponsors many
    workshops and conferences to gather opinions on specific areas of
    science. The efforts of the ICs to seek external advice are further
    augmented by those of the NIH Director through meetings of the Advisory
    Committee to the Director and the Council of Public Representatives.
        Also, last year, for the first time, the NIH held a Budget Retreat
    to develop its research priorities and to establish areas of research
    emphasis in preparation of the President's 2001 budget. Retreat
    participants included ten external advisors in addition to the NIH and
    IC leadership. As reflected in the fiscal year 2001 budget request,
    proposed increases by IC range from 10.8 percent for the Fogarty
    International Center to 3.3 percent for the National Institute on
    Nursing Research.
        The final fiscal year 2000 appropriation, incorporating NIH
    recommendations, also provided a range of funding levels across the
    NIH. Increases ranged from 36.6 percent for the newly-established
    National Center for Alternative Medicine, to 14.4 percent for the
    National Institute of Diabetes and Digestive and Kidney Diseases, with
    other ICs receiving an increase in the range of 12-13 percent. By any
    measure, the amount the NIDDK received in fiscal year 2000 was
    substantial and unprecedented and will allow a major commitment of
    resources to new diabetes initiatives. We will increase our diabetes
    research efforts by over 17 percent--more than two percentage points
    over the fiscal year 2000 increase provided to the NIDDK as a whole.
    This increase will permit new and significantly expanded research on
    type 1 and type 2 diabetes and diabetes complications. Some examples
    include: expanded support for studies of islet transplantation in
    humans, including support of six new research projects and the
    establishment of an islet transplant registry; increased support of the
    type 2 diabetes genetic linkage consortium; identifying and
    characterizing the genes involved in pancreatic endocrine development
    and function; funding of two new Diabetes Endocrinology Research
    Centers; novel approaches to imaging functional islet beta cells;
    understanding and combating the increase of type 2 diabetes in
    children, especially from minority groups; approaches to diabetic foot
    complications--a major cause of amputations particularly affecting
    minority populations; studies of the cause and treatment of diabetic
    neurologic complications; and, together with the NHLBI, support of two
    major clinical trials relating to cardiovascular complications of
    diabetes.
        Question. Can you tell us how you plan to allocate the increases
    you have been receiving as a result of Congress' commitment to doubling
    NIH spending overall? For example, what will be the breakdown of
    expenditures applied to existing programs and research projects,
    compared to money provided to exciting new research initiatives
    identified by the Diabetes Research Working Group (DRWG)?
        Answer. Over 70 percent of our approximate $150 million increase
    over fiscal year 1999 will be used to meet commitments for non-
    competing continuations in fiscal year 2000. Much of the remaining
    fiscal year 2000 increase will be directed toward congressional
    emphases in diabetes and prostate disease. We are making a major
    commitment of resources to new diabetes initiatives, by increasing our
    diabetes research efforts by over 17 percent--more than two percentage
    points over the 15 percent increase provided to the NIDDK as a whole.
        The increase provided to NIDDK in fiscal year 2000 will permit new
    and significantly expanded research on type 1 and type 2 diabetes and
    on diabetes complications. Some examples include: expanded support for
    studies of islet transplantation in humans, including support of six
    new research projects and the establishment of an islet transplant
    registry; increased support of the type 2 diabetes genetic linkage
    consortium; identifying and characterizing the genes involved in
    pancreatic endocrine development and function; funding of two new
    Diabetes Endocrinology Research Centers; novel approaches to imaging
    functional islet beta cells; understanding and combating the increase
    of type 2 diabetes in children, especially from minority groups;
    approaches to diabetic foot complications--a major cause of amputations
    particularly affecting minority populations; studies of the cause and
    treatment of diabetic neurologic complications; and, together with the
    NHLBI, support of two major clinical trials relating to cardiovascular
    complications of diabetes.
        Question. What amount of funds would it take for the NIDDK to fully
    implement its share of the recommendations of the DRWG? Can you find
    the money to meet the DRWG recommendations in the context of a doubling
    of the overall NIH budget if NIDDK is generally increased by the same
    percent as the overall NIH increase each year, give or take a percent?
        Answer. The DRWG Strategic Plan made both scientific and funding
    recommendations for fiscal year 2000 through fiscal year 2004 for each
    Institute and Center of the NIH, as well as for the NIH as a whole. For
    the NIDDK specifically, the DRWG recommended that diabetes research
    funding reach $501.1 million in fiscal year 2000; $654.8 million in
    fiscal year 2001; and continue to rise to $989.7 million in fiscal year
    2004. For the entire NIH, the DRWG recommended that diabetes research
    funding reach $827 million in fiscal year 2000; $1.074 billion in
    fiscal year 2001; and continue to rise to $1.6 billion by fiscal year
    2004.
        Diabetes research is receiving significant funding increases across
    the NIH--rising from a funding level of $457.6 million in fiscal year
    1999, to an estimated $525.1 million in fiscal year 2000 and an
    estimated $561 million for fiscal year 2001. However, the NIDDK cannot
    fully implement all of the recommendations of the DRWG, even in the
    context of a doubling of the NIH budget, assuming that its percentage
    funding increase generally matches the overall percentage increase for
    the NIH proper. In fiscal year 2000, for example, even if the NIDDK had
    been able to apply the entirety of its funding increase of $150 million
    to diabetes research, it would still have fallen substantially short of
    the target funding level of $501.1 million set for it by the DRWG.
        The five-year funding trajectory recommended by the DRWG for NIDDK
    and NIH diabetes research, respectively, would represent an increase in
    excess of 3.5 times fiscal year 1999 funding levels. Thus, even if its
    budget doubled in five years, it would not be possible for the NIDDK to
    implement all of the DRWG recommendations in the time frame specified
    without seriously harming research programs on other diseases of
    national concern that are within the NIDDK's research
    responsibilities--and the DRWG itself recommended against the diversion
    of funds from other programs.
        Question. Can you give us your opinion of the DRWG report? To what
    extent do you agree that it provides a serious outline for the
    direction in which our diabetes research portfolio ought to go?
        Answer. The Diabetes Research Working Group (DRWG) Strategic Plan
    serves as an important guidepost which the NIH is using to help frame
    its diabetes research agenda. The Strategic Plan represents a year-long
    deliberative planning process conducted by twelve eminent scientific
    leaders in diabetes research and four lay representatives, including
    representatives from both the Juvenile Diabetes Foundation
    International and the American Diabetes Association. The DRWG also
    solicited advice from many ad hoc scientific experts and public
    commentary. The Working Group evaluated all aspects of diabetes health
    issues, as well as the state-of-the-science, in an effort to develop a
    comprehensive plan. Thus, the recommendations of the DRWG Strategic
    Plan reflect the consensus of many talented scientists and concerned
    patients about the most promising avenues we can pursue to achieve
    greater understanding and more effective treatments for diabetes and to
    realize means to prevent and cure both forms of the disease and its
    complications. The NIH has already undertaken many new initiatives
    related to the extraordinary opportunities and special needs identified
    by the DRWG and will continue to use the DRWG Strategic Plan as a
    scientific framework for additional new initiatives in the years ahead,
    along with advice from our National Advisory Council and emerging
    scientific leads from conferences, workshops and other sources of
    external advice.
                                multiple myeloma
        Question. As you well know, this committee and our colleagues in
    the House both addressed research for multiple myeloma in our
    respective reports last year. I especially want to thank the chairman
    of this committee, Senator Specter for his leadership on this issue.
        It is my understanding that you decided to include multiple myeloma
    in next month's scheduled Progress Review Group (PRG) for leukemia and
    lymphoma. Will this, in your opinion, fulfill the intent of the report
    language requesting a consensus conference or scientific workshop on
    multiple myeloma? Do you think the PRG will fundamentally change the
    NCI's multiple myeloma research program?
        Answer. The Leukemia, Lymphoma and Myeloma (LLM) PRG will be an
    excellent way to address the report language requesting a consensus
    conference/scientific workshop on multiple myeloma. It will undoubtedly
    have an impact on the direction of NCI's myeloma research program.
    There are nevertheless some issues that need explanation:
        The PRG process may be a more useful approach for scientific
    planning than either a consensus conference or a scientific workshop.
    Like a consensus conference, a PRG identifies a set of recommendations
    upon which all group members agree. However, a PRG goes well beyond a
    consensus conference by identifying research needs and opportunities
    that experts in the field agree are the most important. PRG
    participants do this by reviewing many research needs and opportunities
    and then prioritizing them. Consequently, a PRG also goes well beyond a
    scientific workshop, which also can involve a large number of
    participants but rarely results in a list of research priorities and
    recommendations.
        In order that each of the three cancers receives sufficient
    attention during the PRG process, NCI has named three co-chairs, one
    for each cancer type. This arrangement will provide leadership for each
    cancer being reviewed by the PRG. In addition, NCI is committed to
    sufficient advocate participation throughout the PRG process. Clinical
    and scientific experts, however, will often have interests in more than
    one of these diseases, and therefore it makes sense to combine these
    cancers within one PRG .NCI is confidant that a combined PRG will have
    a great impact on the direction of the Institute's myeloma research
    program, since prior PRGs have resulted in substantial adjustments to
    the Institute's breast cancer and prostate cancer programs. It is
    likely that there will be some recommendations/actions that serve all
    three groups of cancers as well as some recommendations/actions that
    serve the unique needs of each disease and community.
        The Leukemia, Lymphoma, Myeloma PRG is already well underway. The
    PRG leadership team will meet in June 2000 to select the PRG membership
    and to begin planning the PRG's agenda.
        Question. Although multiple myeloma is a hematological cancer--
    according to NCI SEER data, it is the second fastest growing
    hematologic cancer in the United States--it's most obvious effects are
    in the bone destruction caused by the plasma tumors. Are there any
    plans to increase collaboration between NCI and NIAMS on the issue of
    bone disease and multiple myeloma?
        Answer. NCI is currently collaborating with NIAMS in a multi-center
    epidemiologic study, entitled ``Osteoporotic Fractures in Men
    (MR.OS).'' A major goal of this study is to assess the relationships
    among risk factors of osteoporotic fractures and prostate cancer in
    older men (>65 years old). A total of 5,700 men will be recruited in
    six diverse geographical areas and will be followed for seven years.
    MR. OS will provide a unique perspective on prostate cancer occurrence
    influenced by the skeletal, hormonal, and lifestyle determinants
    associated with osteoporosis. Findings could provide avenues for
    additional research leading to preventive strategies for prostate
    cancer.
        Another NCI-NIAMS collaboration involving studies of bone disease
    is the long-term support of the ``Rochester Epidemiology Project'' at
    the Mayo Foundation. Data have been collected during the past 34 years
    on the population of Rochester and Olmsted Counties, Minnesota, and
    several studies within the Project have published results on bone
    fractures associated with chronic disease and osteoporosis in the
    elderly. Investigators have also reported the incidence and trends in
    rates of multiple myeloma in Olmsted County during 1978 through 1990.
        As scientific advances and new technologies increase research
    capabilities to explore associations between bone disease and multiple
    myeloma, the NCI and NIAMS look forward to collaborating in this
    endeavor.
        Question. Does the NCI have any plans, or would it consider,
    establishing a working relationship with the CDC to develop more
    comprehensive epidemiological and occupational health statistics to
    support myeloma research activities?
        Answer. NCI investigators currently collaborate with several
    investigators at the CDC on epidemiologic and surveillance studies of
    multiple myeloma and other hematopoietic malignancies. One study with
    CDC's National Center for Environmental Health, includes multiple
    myeloma and collects biological specimens needed to analyze
    occupational and environmental exposures in the general population. In
    another study, NCI investigators found a relationship between risk of
    multiple myeloma and exposure to solvents among workers at a U.S. Air
    Force base. NCI supports the continuation and expansion of
    collaborative activities with the CDC to explore and develop new
    methods and approaches to better understand the origins of multiple
    myeloma and the reasons for the unusually high rates in certain
    populations such as African-Americans.
        NCI and the CDC have recently established a Memorandum of
    Understanding (MOU) for implementing an enhanced and more coordinated
    national cancer surveillance effort. NCI and CDC share a vision for a
    federally integrated comprehensive national cancer surveillance system.
    This system will build upon and strengthen the existing infrastructure,
    improve the availability of high quality data used to measure the
    nation's cancer burden, and advance the capacity for surveillance
    research. The scope of this coordinated cancer surveillance system
    includes coverage of the entire U.S. population using high quality data
    to measure cancer risk and health behaviors, incidence, treatment,
    morbidity, mortality, and other outcomes. As leaders and catalysts in
    federal cancer control activities, NCI and CDC enter into this
    agreement to enhance cancer surveillance at national, state and
    regional levels. This includes developing ways of looking at each
    cancer site nationally. Geographic Information Systems (GIS)
    methodologies will enable researchers to link environmental exposures
    with unusually high occurrences of cancer on a geographic basis. The
    SEER registry and the CDC Cancer Surveillance System, especially
    working in collaboration, can help identify new hypotheses for causal
    studies in multiple myeloma.
        In addition, the NCI coordinates and supports many epidemiological
    studies conducted intramurally and extramurally, on multiple myeloma
    and other lymphoproliferative diseases. Intramural investigators are
    collaborating with investigators participating in the SEER program in a
    large case-control study of non-Hodgkin's lymphoma to which a multiple
    myeloma component has recently been added. Under analysis is a multi-
    centered case-control study of multiple myeloma in blacks and whites in
    the United States. It is designed to identify the risk factors for this
    tumor. A new study linking total population registries, cancer
    registries, and hospitalizations for auto-immune diseases is in the
    planning phase in an effort to clarify the risk of familial occurrences
    of multiple myeloma and other hematopoietic malignancies. Also,
    analyses of existing case-control data are being conducted as novel
    occupational, geographic, and environmental hypotheses arise.
                                     ______

               Questions Submitted by Senator Barbara A. Mikulski
                       workplace environment of nih's oeo
        Question. What is Acting NIH Director Dr. Ruth Kirschstein
    personally doing to address concerns about the workplace environment of
    the NIH Office of Equal Opportunity (OEO) and the OEO Director's
    treatment of OEO employees?
        Answer. Dr. Kirschstein has been deeply concerned and personally
    involved in the issues related to the workplace environment of the NIH
    Office of Equal Opportunity (OEO). She has discussed these issues with
    all the persons involved and after such discussions did not appear to
    improve matters, she assigned the NIH Ombudsman the task of resolving
    the issue. The Ombudsman with the services of a mediator, experienced
    in this area, developed a process of a series of meetings, some
    separately with individual or groups of employees, at which they have
    had the opportunity to raise specific concerns privately and some
    separately with the Director, OEO. In addition, the two mediators have
    held joint meetings between the employees and the Director, OEO, at
    which views were exchanged. It has become clear that the issues of
    which you are aware, raised by some OEO employees do not represent
    those of all OEO employees. Nevertheless, it is clear that the issues
    are real and must be and are being settled.
        A good deal of progress has been made. The Director, OEO has been
    responsive to the concerns raised by the employees, and has undertaken
    certain necessary steps to address the most pressing matters. In
    addition, the NIH has resolved the specific concerns of two OEO
    employees, and has entered into agreements with them that fully satisfy
    their concerns. Other actions are in progress and we are optimistic
    that a satisfactory outcome will result.
                            minority representation
        Question. Please specify what specific steps NIH is taking to
    address the following items, providing specific timetables for actions
    that NIH will take to:
      --ensure that NIH has sufficient representation at all levels of
            African Americans, Native Americans, Latinos/Hispanics, Asian
            Pacific Americans and how NIH Institute and Center Directors
            will be held accountable for meeting established goals (OEO)
      --retain African Americans at NIH (OEO)
      --improve the tenure rate of African American scientists at NIH (OIR)
        Answer. While no Federal agency can legally assure that its actions
    will result in complete representation of all minority groups based on
    their availability in the work force, including persons with
    disabilities, many proactive steps are underway by the NIH to achieve a
    diverse organization. Under the auspices of the NIH Affirmative Action
    Planning Program (AAP), each Institute and Center (IC) has the
    flexibility to set annual hiring goals. Based on an annual analysis of
    underrepresentation that is conducted of the various occupational
    series, goals are then established, based upon projections of
    anticipated hiring need. Individually tailored recruitment strategies,
    necessary to address the specific underrepresented EEO groups within
    its organization, are targeted for each vacancy. At the end of each
    fiscal year, the ICs report their accomplishments.
        IC recruitment strategies vary, according to the targeted audience
    and the vacancies under consideration. They may include the use of:
    Career Opportunity Training Agreements, the Student Temporary
    Employment Program, advertising of vacancies on the Internet, exhibits
    at conferences such as those of the Association of American Indian
    Physicians (AAIP), the American Council on Education, the American
    Indian Science and Engineering Society (AISES), the National Hispanic
    Medical Association, the Student National Medical Association, the
    Hispanic Association of Colleges and Universities (HACU), and the
    Society for the Advancement of Chicanos and Native Americans (SACNAS).
    Additional recruitment activities are held at other professional
    meetings as well, including those of the Mexican-American Engineers and
    Scientists (MAES), the Association of Minority Health Professions
    Symposium (AMHPS) on Careers in Biomedical Professions, the League of
    United Latin American Citizens, the National Council of LaRaza, and the
    National Black Nurses Association. Additionally, EEO Officers attend
    local career fairs at George Washington University, Morgan State
    University, University of Maryland-Baltimore Campus, and Bowie State
    University.
        Responsibilities for Equal Employment Opportunity Programs are
    included as an integral part of managerial performance elements to
    establish accountability. The OEO guidance to IC Directors on specific
    areas for inclusion in their annual accomplishment reports, as required
    for SES managers, serves to maintain consistency across IC lines. All
    SES managers have a separate element which is reviewed by their
    respective IC Director. All IC Directors' annual accomplishments and
    accompanying proposed ratings are reviewed by a subgroup of the NIH
    Performance Review Board. The Director, OEO, is a voting member of that
    group. Additionally, the NIH requires a performance appraisal covering
    EEO Program accomplishments for supervisors and managers through the
    use of either the stand alone critical EEO performance element or an
    overall supervisory or management element that incorporates EEO
    responsibilities. An EEO Program element is also part of the annual
    Commissioned Corps performance review mechanism and is one of 18
    critical elements that comprise an officer's annual rating.
        In June 1999, the NIH established a Corporate Recruitment Task
    Force designed to develop global trans-NIH recruitment strategies
    including those needed to address barriers to minority representation
    in the NIH work force. Its members include IC EEO and Personnel
    Officers as well as Office of Equal Opportunity(OEO) staff members.
    Common goals include the development of a unified corporate approach to
    recruitment and related issues such as relocation matters, recruitment
    techniques, and targeted occupations common to all or most ICs.
    Implementation of the Task Force's objectives is scheduled to begin in
    fiscal year 2001.
        The recruitment of minority and women scientists is extremely
    competitive both within the Federal government and private enterprise.
    NIH continues to use the pay flexibility provisions of Title 42 and
    Title 38 to attract candidates to the NIH campus. Additionally, the NIH
    AIDS Research, Clinical Research, and General Research Loan Repayment
    Programs are used as recruitment incentives for minority and women
    scientists. The NIH Undergraduate Scholarship Program offers
    competitive scholarships to students from disadvantaged backgrounds who
    are committed to careers in biomedical research. In 1999, 10
    scholarships were awarded to African American (1), non-minority (4),
    Asian/Pacific Islander (1), and Hispanic (4) students.
        To foster an environment that attracts and retains minority
    employees, the OEO sponsors Workforce Diversity Initiative (WDI)
    activities. These activities promote equal opportunity goals, engender
    respect for the similarities and differences that employees bring to
    the workplace and assist managers and supervisors in learning how to
    capitalize on those similarities and differences while promoting
    quality, fairness and efficiency. For example, the OEO sponsored an
    educational project entitled the ``NIH Diversity Book Bridge Project.''
    This project took a fresh approach of using literature as a tool to
    discuss diversity issues. Guidance is regularly provided to the IC
    Diversity Catalysts to supplement the Catalysts Implementation Manual
    which was designed to identify specific duties for the newly appointed
    Catalysts in the ICs. The OEO staff provided a second document,
    ``Guidelines for OEO Diversity Program Managers'' (DPMs), for the OEO
    staff in their role as consultants to the ICs in the implementation of
    the WDI. Sharing the guidelines on DPM roles with the ICs was meant to
    reinforce the value of developing long term strategies and processes to
    promote the WDI throughout the NIH. In November of 1999, Vice President
    Gore's Special Diversity Task Force recognized the NIH diversity
    process as a best practice, referencing in particular, the unique
    appointing of Diversity Catalysts in each of the ICs. Some of the ICs
    have incorporated the Quality of Work Life Plans into their diversity
    initiatives as a method of creating a healthy work environment for
    employees.
        The NIH is also deeply involved in several ongoing Departmental
    Minority Initiatives. For example, the employment aspects of the
    Departmental Hispanic Agenda for Action and other minority initiatives
    related to annual recruitment activities are addressed. During fiscal
    year 1999, there was a significant increase in the number of HACU
    interns as compared to the participation rate of 10 during the previous
    fiscal year. Total participation during fiscal year 1999 numbered 21: 7
    during the Spring Semester and 14 during the Summer. There were 7
    students enrolled in the Washington Internship for Native American
    Students (WINS) Program, and 10 African American interns from the
    National Association for Equal Opportunity in Higher Education (NAFEO)
    Program.
        Data shows that NIH needs to continue its efforts to address the
    retention of African Americans, particularly African American males in
    the scientific occupations. Several years ago, an exit interview
    program was established and a questionnaire was administered to all
    employees leaving the Agency. Based on the low response rate to the
    questionnaire, however, the program was discontinued. Lacking the
    ability to clearly identify a pattern of the reasons employees left the
    NIH, other actions have been taken to try to improve the NIH work
    climate as much as possible. For example, the Center for Cooperative
    Resolution has been shown as an effective alternative to the
    traditional methods of conflict management. Headed by an Ombudsman, the
    Center regularly evaluates new approaches to conflict resolution and
    encourages employees to develop new and more effective ways to deal
    with issues they face in the workplace. The Center has addressed more
    than 400 cases with a resolution rate of better than 80 percent. The
    Center offers a variety of alternative dispute resolution processes,
    including facilitation, mediation, shuttle diplomacy, and systems
    change. Within the past year, the Center has begun other initiatives
    such as the implementation of a seminar series on conflict for
    executives, utilization of Peer Panels, as well as preparation of
    preliminary plans for partnering agreements for scientific
    collaborations. More and more employees are becoming informed of the
    availability of the Center from briefings, publicity, and its
    reputation for efficiency, confidentiality, and neutrality. At the same
    time, the Federal discrimination complaint processing mechanism is
    communicated to all employees who may wish to utilize its provisions in
    seeking redress of employment related concerns.
        As reflected above, the objectives of the NIH AAP have served to
    identify and recruit minority members, women, and persons with
    disabilities into the work force. Once recruited, additional
    initiatives mentioned above, such as the WDI, have been taken to create
    and maintain a healthy work environment for employees.
        Tenure at the NIH is granted to outstanding scientists who have
    made major contributions to biomedical research and includes both
    salary support and commitment of research resources subject to rigorous
    review every fouryears. Tenure differs from permanent appointment in a
    civil service position since it includes research support as well as
    salary. Tenure policy and procedures at NIH were completely revamped in
    1993 with additional modifications made in 1996. A major intent of the
    new tenure policy was to provide equality of access and opportunity for
    all individuals qualified for tenure-track positions. Tenure-track
    positions are the principal point of entry for investigators to achieve
    tenure at the NIH. The specifics of the policy and procedures may be
    viewed at the following websites:
        The Tenure-Track Program at http://www1.od.nih.gov/oir/sourcebook/
    irp-policy/tenure-track.htm
        Tenure in the NIH Intramural Research Program--Modifications to
    Policy at http://www1.od.nih.gov/oir/sourcebook/irp-policy/tenure.htm
        Search Process for Tenure and Tenure-Track Investigators at http://
    www1.od.nih.gov/oir/sourcebook/irp-policy/search.htm
        All tenure-track positions are advertised nationally using an
    advertisement that must be approved by the Deputy Director for
    Intramural Research (DDIR). A Search Committee must be established for
    every tenure-track position that becomes available. The composition of
    the Search Committee must also be approved by the DDIR and each
    committee must have as voting members a scientist who is an under-
    represented minority, a woman scientist and a scientist selected by the
    DDIR to serve as his representative.
        Despite these efforts to attract and recruit to NIH under-
    represented minority scientists, from January 1999 through March 2000,
    NIH hired a total of 34 tenure-track investigators, of whom 1 (2.9
    percent) is African American. From January 1999 through March 2000, 34
    total investigators successfully achieved tenure, of whom 2 (5.9
    percent) are African Americans. This number represents 100 percent of
    African American candidates considered for tenure.
        To increase the pool of qualified candidates for tenure-track and
    tenured positions at the NIH, the NIH intramural program continues to
    increase efforts to attract under-represented minorities into research
    training programs early in their biomedical research careers, to
    provide training in biomedical research and to acquaint trainees with
    the career opportunities available at NIH. It is expected that research
    training opportunities such as the Summer Internship Program for high
    school, college and graduate students (http://www.training.nih.gov/
    student/internship/internship.asp), the Undergraduate Scholarship
    Program (UGSP) for undergraduate students from a disadvantaged
    background (http://ugsp.info.nih.gov/), the Postbaccalaureate
    Intramural Research Training Award for students that have obtained
    their Bachelor's degree and fully intend to pursue doctoral degrees in
    the biomedical sciences (http://www.training.nih.gov/student/Pre-IRTA/
    previewpostbac.asp), and the newly created NIH Academy for
    postbaccalaureates interested in domestic health disparities (http://
    www.training.nih.gov/student/Pre-IRTA/irtamanualpostbacAcademy.asp)
    will help increase the pipeline of under-represented minorities who can
    successfully compete for tenure-track and tenure positions at the NIH.

                             CONCLUSION OF HEARINGS

        Senator Specter. Thank you all very much for being here,
    that concludes our hearing. The subcommittee will stand in
    recess subject to the call of the Chair.
        [Whereupon, at 10:53 a.m., Thursday, March 30, the hearings
    were concluded, and the subcommittee was recessed, to reconvene
    subject to the call of the Chair.]

      DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
              RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2001

                                  ----------

                                           U.S. Senate,
               Subcommittee of the Committee on Appropriations,
                                                        Washington, DC.

                           NONDEPARTMENTAL WITNESSES

        [Clerk's note.--The subcommittee was unable to hold
    hearings on nondepartmental witnesses. The statements and
    letters of those submitting written testimony are as follows:]

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                               General Healthcare

    Prepared Statement of Persons United Limiting SubStandards & Errors in
                             Healthcare of Colorado

        Mr. Chairman and Members of the Committee: Thank you for allowing
    me this opportunity to submit written testimony to request funding for
    public education to help reduce Medical Errors. As a consumer advocate,
    I feel that it is imperative to budget funding for public education,
    consumer Hotlines and an Federal agency that will oversee all state
    medical boards and create national standards of care that will be
    communicated to the consumer. It is ludicrous to believe that the many
    problems in the present system will be remedied anytime soon.
    Therefore, the consumer must know exactly what their responsibility is
    as an informed and savvy patient to reduce the incidence of medical
    errors.
        I lost my mother in February of 1995 under similar circumstances to
    those that Debra Malone lost her father, Dr. Karl Shipman. A
    combination of inexperienced and overworked hospital nurses, an inept
    and arrogant physician, misdiagnosis and medication errors caused my
    mother to suffer a myocardial infarction as an inpatient. She was in a
    coma for seven weeks before she died. Had she presented at an emergency
    room with the same symptoms that were ignored on the floor, emergency
    protocol would have taken the necessary tests to determine what was
    going on and may have saved her life. I found it nearly impossible to
    get any answers, and was appalled to learn that what my mother
    experienced was common. Nothing was reported by anyone but myself and
    by my own perseverance. I did not sue, had I gone forward with a civil
    suit, Colorado tort reform laws would have limited any award or
    settlement to less than the cost of pursuing the case. I filed
    complaints with the medical and nursing boards. Both agencies initially
    dismissed my complaints. The nursing board dismissed the original
    complaints at a lunch. Several local nurses assisted me in preparing
    the original complaints. After the luncheon dismissal, I spoke with the
    nursing board administrator. She indicated that if one of the nurses
    who helped me write the complaints would simply write her a letter and
    sign it, she would reopen the complaints process. I asked the nurses to
    do this, they all refused. Having become an advocate and networking
    with other states advocacy groups, I found two out of state nurses with
    impeccable credentials willing to review the records. I did not know
    either of them, but they were both sympathetic to the cause and
    reviewed the records for free. Paying for the review would have hurt
    the credibility with the regulatory agency. Both nurse's letters said
    precisely what the local nurses told me to include in the original
    complaints. The administrator did keep her word, an investigation was
    opened that resulted in disciplinary action for two of the three nurses
    I filed complaints on. It is disturbing that the outcome was based on
    the two out of state letters, not my original complaints. The medical
    board told me that they would reevaluate the physician complaint if I
    had a physician review the records. Unfortunately, I could not find one
    anywhere in the United States willing to do this for free.
        Peer review should be reporting these things to the regulatory
    agencies, they are not. The regulatory agencies investigate nearly 100
    percent of all peer review complaints filed. Sadly, the regulatory
    agencies dismiss the majority of all consumer complaints, without
    checking their validity. This is not due to lazy medical boards, it is
    another facet of the present ailing system of healthcare delivery.
        In our society, most of us see our doctors as family. We seem to
    have a parent child like relationship with them. We hear stories of
    medical errors or problems, yet we feel that our own private physician
    has our care under total control and nothing like that could ever
    happen to us. We regard our doctor as a child regards a parent, the all
    knowing, all seeing omnipotent super hero who protects us from all
    adversity. Most medical errors that occur are far from the control of
    our private doctors. When we are exposed to the adversities, we become
    confused and angry. The present system as it now exists does not allow
    our personal physicians to communicate the entire story to us. We then
    lose faith, hope and trust, we search for answers and find none. It is
    then, and only then, that we seek out legal counsel, searching for
    answers, truth and justice. I cannot imagine how difficult it must be
    for our personal physicians to know that something went wrong, yet not
    be able to comfort us, nor have a place to report the incident without
    fearing the consequences of doing so. What agony it must be for our
    doctors. These physicians, like us, are victims of a severely impaired
    system that must change.
        Medicine is not an exact science, yet we expect perfection, when we
    don't get perfection, we expect compensation. How puzzling it is that
    less than 2 percent of all victims of medical errors seek legal
    counsel, yet the fear of lawsuits barricades voluntary reporting of
    errors in medical care. Those who work inside of medicine are bound by
    this code of silence. The present system has the consumer under a false
    sense of security. The public must be told the absolute truth, yes,
    some will do without surgical procedures that they would have had not
    knowing the full risks. The public must be told when they are being
    treated by doctors in training, and that the risks of this lack of
    experience may be harmful to them. Yes, some will refrain. The public
    must be told at once when an error occurs, most victims would walk away
    with this simple explanation. But, it does not work that way. The
    threat of litigation prevents medical boards from doing their jobs
    effectively because they fear that their hard work will become free
    discovery for less then 2 percent of all incidents. It is a vicious
    cycle that leads to nowhere.
        Imagine how plaintiffs feel years after the incident when their own
    attorney tells them to accept a modest out of court settlement, and
    sign a document prohibiting them from discussing the case indefinitely.
    Imagine how consumers feel when they read the release that they must
    sign that states that the defendants admit no guilt. These settlements
    are reported to the NPDB, but what good does it do for the peace of
    mind of the plaintiff? What good does it now do for future victims of
    the same incident when nothing is admitted?
        Both the medical profession and the consumers are programmed to
    believe a lie, we have been sold a bill of goods that simply is not
    true. It is a no win situation for everyone involved. In Colorado,
    there have been only 63 plaintiff verdicts in medical malpractice cases
    in our courts in seventeen years. The odds of going to trial and
    winning are not in the favor of the plaintiff. Why?, because, when all
    is said and done, and the truth is finally forced, it is usually in
    favor of the provider, because, ``Medicine is not an exact science,
    there will be adverse outcomes, and when a physician uses due care,
    diligence and does make a mistake, he or she is not accountable for it
    in civil court''. Now, if this simple truth were told from the
    beginning, think of how much grief, anguish and suffering could be
    avoided, on all sides. That is what is wrong with the present system.
    It does not work, and as long as we allow this sham to go on, we are
    doing a grave injustice to society.
        One member of our organization who lost her child because of poor
    medical care found out there was a previous board action against the
    doctor involved for using poor judgment in another death of a child.
    This physician was grossly overworked, seeing too many patients per
    day. She had taken her child to see this doctor several times a week
    before he died. At one point she took him to an emergency room and the
    other doctors ``did not want to get involved''. The doctor in question
    also missed important signs of trouble with several other patients.
    However, this physician also did a great deal of good for other
    patients. Our town, and our organization were heavily spilt over the
    Medical Board's decision to suspend his license. This doctor was a
    victim too, a victim of a savage system that, even though local peer
    review knew of adverse outcomes that were preventable, they were silent
    and did not report them to the medical board, nor did anyone help this
    doctor with his patient load. The controversy and rumors surrounding
    this doctor was that he truly loved the children he was treating, he
    and his partner were the only ones in town who wanted to provide care
    for Medicaid children, other doctors sent Medicaid children to him. The
    local medical community made no effort to bring in other doctors
    interested in Medicaid reimbursements. Knowing that this doctor would
    be up all night at local hospitals with families of sick children, the
    local medical community did nothing when this doctor would barely have
    time to shave before returning to his office the following morning to
    see other children. How can someone deprived of sleep use good
    judgment? Yet, when the medical board suspended this man's license
    based on evidence that they had gathered from many consumer complaints,
    the medical community remained silent, some other doctors rallied
    around this doctor and encouraged him to not take responsibility for
    his mistakes. They allowed this to go on for so long and finally when
    the state attempted to intercede, the local medical community closed
    ranks, cried sour grapes, got political and told the state to stay out
    of local affairs. This made it very difficult for the board, the nurses
    and consumers who were brave enough to act. The doctor and the board
    came to an agreement where he will retire early, and of course, have a
    clean record. How will this effect future care by this provider in
    another state?
        Why is it that only 2 percent of all consumers affected by medical
    errors seek legal counsel? Could it be that the rest of us tirelessly
    go from one attorney to another with our tales of grief but none seem
    interested in our cases? Not because we were attempting to file
    frivolous lawsuits but because the attorneys know the usual outcome of
    a trial. They know the high percentage of verdicts are found for the
    defendant, not the plaintiff. They know most settlements would barely
    cover court costs and fees, expert testimony etc.. The reason for this
    needless heartache for those who believe that they have already been
    violated or betrayed by medicine is this code of silence, the lack of
    an honest explanation when something goes terribly wrong. The time has
    come for the secrets of medicine to be shared with the consumer, in
    easy to understand language. All too often the elusive ``standard of
    care'' for a particular malady is virtually untouchable by the consumer
    until the case gets to trial in civil court. At that time ``expert
    witnesses'' explain to the non medical people of the jury what happened
    to the patient in plain terms. These explanations are why most doctors
    are found not guilty of medical malpractice in our nations courts. Only
    at this time are the errors or mistakes made public, yet most consumers
    know little about researching court documents. These errors again go
    unreported, instead of being addressed, usually get lost in the
    shuffle. Admitting the error from the beginning would have avoided the
    costly ordeal for both the plaintiff and the defendant.
        If there were a National Patient Safety Board, designed much like
    the National Transportation Safety board, Federal standards would then
    be in place and any deviation from such standards would be addressed
    and dealt with for the sake of public safety.
        Medical errors are at an all time high, people from all walks of
    life are affected. Things have gotten so out of control that medical
    errors resulting in preventable deaths now even touch the lives of
    physicians themselves. Inefficient health care delivery has become a
    way of life and must no longer be tolerated. Many providers ask how
    have things gotten this bad? In every other consumer related industry,
    there are standard safety guidelines, this is not true in medicine. It
    appears that if there are no real standards to follow, no consequences
    due to lackadaisical behavior, and no rewards for creating
    accountability and dealing with problems, why strive for excellence? We
    must then depend on pure conscience of the brave insiders who blow the
    whistle risking all, or others who learn through personal loss that
    things must change. Unfortunately, it is unrealistic to believe that
    this very small inside minority can police this huge and affluent
    industry.
        Most of us are under a false blanket of security that civil justice
    and government agencies are our protectors. Nothing could be further
    from the truth. Colorado recently made it illegal for a physician to
    lie to the medical board in his confidential response to a complaint.
    Civil justice no longer exists, instead the remnants of what once may
    have once been civil justice, have been replaced by a great theatrical
    and costly fiasco that sucks everything from both sides of the case at
    hand. The medical industry does not own up freely to mistakes nor does
    it do anything to correct them, thus leaving the American people with
    the shadows of a long gone system of honor, truth and justice.
    Voluntary reporting of medical errors already exists, it has for a long
    time. Voluntary reporting of errors was the reason the National
    Practitioners Data Bank was created. Why then did the IOM study reveal
    such startling results? Why do we want to reinvent the wheel? We must
    have mandatory reporting and public education to seek excellence.
        Public education is the only way to help consumers be better
    patients and take more responsibility for our own healthcare. As is
    being pursued in other areas, there must be a national media campaign
    to educate consumers on taking more responsibility and not being so
    dependent on the healthcare system to take care of them. As early as in
    middle school, public education programs must begin, teaching
    individuals responsible receivership of healthcare. Monthly meetings
    for senior citizens could be taught in public places by volunteer
    health care providers. Consumers would be encouraged to learn from
    information already available on the illness or disease that they have
    been diagnosed with. All would be encouraged to ask questions. Hotlines
    would be established for questions and answers. All information on
    credentials will be available and providers would encourage consumers
    to use these resources. Public Service announcements on television
    would provide consumers with a toll free number and web site
    information for many rich resources already available for those of us
    of seek them out. All informed consent forms would be given to all
    scheduled surgical candidates a minimum of one week before surgery for
    review to insure the consumer knows exactly what they are signing.
    There would be a consumer advocate employed by the hospital or out
    patient facility to explain the consent form to anyone having
    questions. Consumers must do their part to insure safety in medicine.
    Providers must allow consumers to do this without offense.
        Consumers must be taught how to better communicate with all
    providers. They must know more than they presently do about their own
    bodies, conditions, and illnesses. Consumers must know how to recognize
    an error in the making and personal physicians must be permitted to
    advocate for their patients when the patient is in a hospital
    situation. Consumers who are elderly or mentally impaired must have
    someone else available to advocate for them at all times. Excellence in
    medicine will come about only after crossing into a new frontier where
    physicians and consumers work together as a real team.
        Thank you for allowing me to submit written testimony. I am
    available to testify before the committee if need be. I can supply you
    with additional documents and information upon request.
                                     ______

             Prepared Statement of the American Medical Association

        On behalf of its 300,000 physician and medical student members, the
    American Medical Association (AMA) would like to share three of its
    most pressing concerns with the Administration's fiscal year 2001
    budget proposal submitted to Congress on February 7, 2000. We hope that
    you will take our concerns into account and look forward to working
    with you as the Committee begins the appropriations process for the
    fiscal year 2001 budget.
                                   user fees
        Through its budget proposal, the Administration has once again
    proposed user fees for physicians who submit claims on behalf of their
    patients. As background, several years ago, Congress enacted
    legislation requiring that physicians treating Medicare patients submit
    these claims to the Medicare program on behalf of their patients.
    Congress has repeatedly rejected the Administration's attempts to shift
    Medicare program costs onto physicians through user fees. These user
    fees are nothing but a tax on the physician/provider community, and we
    urge you to again reject them once again.
        First, the budget proposal would also tax physicians $1 for each
    paper claim submission. The Administration admitted last year that this
    would have impacted 21 percent of all Part B Medicare claims and 4
    percent of Part A Medicare claims at a cost of $495 million over five
    years. This would be an extraordinary cost for physicians to bear
    simply because their offices have not been linked to an electronic
    network. This tax is especially unwarranted since many physicians may
    feel more comfortable submitting hard copies of claims to their
    carriers given the negative experiences that some physicians have had
    with their carriers and the issues surrounding confidentiality of
    patient records.
        Second, the budget proposal would penalize physicians for
    resubmitting claims even when payment was seriously overdue or when the
    contractor had rejected the claim for trivial or inappropriate reasons.
    The AMA strongly objects to requiring a physician to pay to resubmit
    claims to the Medicare program.
        The AMA believes that physicians are already bearing an extremely
    heavy regulatory burden, which increases exponentially as the Health
    Care Financing Administration (HCFA) issues each new Medicare billing
    requirement. Physicians should not have to bear the additional cost of
    administering the Medicare program through new and unjustified user
    fees.
                          physician education efforts
        Several weeks ago, the Department of Health and Human Services
    Office of the Inspector General (OIG) released the latest version of
    the Chief Financial Officer (CFO) audit. The audit and its resulting
    rhetoric refocused attention on billing and alleged fraudulent
    activities in the Medicare program. However, by OIG's own admission,
    auditors have not been able to separate inadvertent billing errors from
    fraud. The CFO audit includes all types of improper payments including
    inadvertent billing errors, which may involve subjective decisions open
    to honest disagreement. According to the OIG's own spokesperson, ``We
    don't know how much Medicare fraud there is.'' (Washington Times, 3/11/
    00) The AMA has been asking since the inception of the audit for
    details regarding types of billing problems uncovered related to
    specialty, geographic region, and particular coding issues so that we
    could educate our members on the issues uncovered. The AMA has never
    been able to obtain such information.
        We urge the federal government and the Congress to stop using such
    a broad-brush approach and to start being more precise with its
    language and its responses to these numbers. Since the advent of the
    first CFO audit, Congress and the Administration have emphasized
    enforcement as the way to eliminate inadvertent billing errors from the
    Medicare program. The AMA urges policymakers to begin to focus on
    prevention and to start implementing effective and innovative education
    programs for physicians. Physicians want to comply with Medicare
    billing regulations, and the AMA believes that federal resources should
    be devoted to supporting extensive education efforts for physicians.
        The AMA has advocated to implement systematic reforms in situations
    when a carrier identifies a widespread billing problem in a physician
    community. The AMA has asked HCFA to require the carriers to work with
    the appropriate medical state and specialty societies to educate
    physicians about a billing problem and to help them understand how to
    address it in the future. We would also like to see HCFA implement
    education efforts for individual physicians when the carrier identifies
    that a physician has a billing problem. Physicians overwhelmingly agree
    that physician-specific education in the field is not occurring.
        The AMA believes that HCFA's current education efforts present
    overly general directions that fail to aid individual physicians in
    learning specific Medicare coding and billing requirements. The AMA
    strongly urges the Appropriations Committee to specify that HCFA and
    its carriers will conduct general physician education and provide
    education specific to coding and billing procedures that are
    encountered during pre and post payment audits. The AMA also believes
    that the Committee should require HCFA to use the billing errors
    identified in the most recent CFO audit to carry out billing and coding
    education efforts.
        The Administration has proposed in its fiscal year 2001 budget to
    allocate $15.8 million in funding for Provider Education and Training
    out of a total Medicare contractor budget of $1.3 billion. The funding
    level for provider education and training in fiscal year 2000 was also
    $15.8 million. This funding level, which represents approximately one
    percent of the carriers' budget, is woefully inadequate to ensure that
    physicians and health care providers learn about new changes to
    Medicare laws and billing and coding requirements. The AMA urges the
    Committee to significantly increase funding for physician/provider
    education to ensure that fewer widespread and physician specific
    billing errors occur and that the relationship between HCFA and
    physicians becomes less adversarial.
                                toll free lines
        The Administration has eliminated funding for two types of toll-
    free lines during the past several years. The first type of toll-free
    lines allowed physicians to call their local carrier for answers to
    billing and coding questions regarding Medicare claims submissions.
    This ``penny-wise pound-foolish'' approach to the Medicare contractor
    budget process eliminated a ready source of information and advice that
    physicians depended upon when billing the Medicare program. The AMA is
    pleased that the Administrator has now indicated that she intends to
    restore that capability, and we urge the Committee to ensure that this
    funding is continued for fiscal year 2001.
        The second type of toll-free lines were used by physicians who
    submitted electronic claims to their Medicare carriers. Instead of
    proposing to tax physicians for not submitting electronic claims, the
    AMA believes that HCFA should provide proper incentives for those
    physicians who employ this preferred method of claims submission. As
    such, the AMA requests that the Appropriations Committee instruct HCFA
    to reinstitute these toll-free lines to encourage electronic claim
    submissions.
                 overwhelming regulatory burdens for physicians
        The AMA believes that the Congress should recognize that Medicare
    regulations are complicated, burdensome and are in need of
    simplification. Princeton Professor Uwe Reinhardt described the
    situation in a January 21, 2000, Wall Street Journal editorial, stating
    that Medicare ``regulations have become just too complicated to
    understand.'' There are more than 100,000 pages of Medicare rules and
    guidances with which a physician must comply--more than the Internal
    Revenue Code. Furthermore, Medicare billing frequently involves
    understandable differences of opinion in clinical judgments or the
    level of service provided. Much of Medicare billing is subjective and
    honest people can, and do, disagree. In fact, a 1995 OIG report found
    that even carriers had difficulty selecting codes.
        HCFA has also acknowledged that Medicare is complex. However, the
    AMA believes that the agency's commitment to reducing administrative
    burdens is questionable. More than a year ago, HCFA assembled an
    internal committee named the Physicians Regulatory Initiative Team
    (PRIT) to review the multitude of rules, regulations and instructions
    with which physicians must comply in order to treat Medicare patients.
    Ultimately, PRIT was to make recommendations about how to streamline
    existing regulations. More than a year and a half has passed, and PRIT
    has still not finished its work.
        The AMA has had some positive discussions with HCFA regarding
    physician education. However, Congress has not dedicated sufficient
    resources to education, and the AMA remains concerned that education
    for physicians will not be a priority. For instance, in recent years,
    the federal government has been holding physicians to a zero tolerance
    for errors standard, while not even providing a mechanism to answer
    physicians' questions. There have been numerous discussions during
    MedPAC meetings regarding Medicare's complexity, and the AMA was
    heartened that Congress has asked MedPAC to study the issues
    surrounding Medicare regulatory reform. Regulatory reform in the
    Medicare program is long overdue.
                              oig/carrier activity
        When there is true fraud, the AMA supports federal efforts to
    prosecute such acts. However, the AMA implores the Congress to
    distinguish between inadvertent billing errors and fraudulent activity.
    In addition, we urge Congress to consider a proactive approach to
    ensure compliance by simplifying regulations and significantly
    increasing funding for physician and provider education.
        Placing OIG agents in carriers' offices would only further compound
    the problems faced by the nations' physicians. Carriers already
    understand the message coming from Washington and are working
    diligently to recoup Medicare program money. Spending federal funds to
    check the checkers does not add up, but rather, would serve only to
    construct additional bureaucracies. These funds should be directed
    towards HCFA's efforts to simplify the Medicare program and towards
    carriers for direct physician education.
        We stand ready to assist your Committee during the appropriations
    process and look forward to working with you on these and other issues.
    Thank you for the opportunity to submit this testimony.
                                     ______

               Prepared Statement of Santa Rosa Memorial Hospital

        Mr. Chairman, and Members of the Subcommittee, thank you for the
    opportunity to submit testimony to the hearing record regarding the
    proposed Northern California Telemedicine Network. This network will
    consist of a hub located at Santa Rosa Memorial Hospital in Santa Rosa,
    California and will serve over 11 hospitals, health centers and clinics
    in Sonoma, Napa, Mendocino, and Humbolt counties.
        Santa Rosa Memorial Hospital is moving aggressively to build a
    permanent telemedicine infrastructure to expand health care services,
    as well as education and prevention programs into these currently
    underserved areas. The core of this initiative will be located at the
    Santa Rosa Memorial Hospital Emergency Department that will serve as
    the ``hub,'' for this regional telemedicine network, providing access
    to primary, specialty and trauma care services.
        The Northern California Telemedicine Network will work with other
    institutions to develop twelve ``spoke'' sites throughout northern
    California during the initial years of the project including:
      --St. Joseph's Hospital, Eureka, California
      --Redwood Memorial Hospital, Fortuna, California
      --Mendocino Coast District Hospital
      --Petaluma Valley Hospital
      --Rohnert Park Healthcare Center
      --Redwood Coast Medical Services
      --Anderson Valley Health Clinic
      --Mendocino Coast Clinics
      --Potter valley Community Health Center
      --Long Valley Health and Dental Center
      --Mendocino Community Health Clinic
        The growth of this network will enable a telemedicine program to
    achieve maximum cost effectiveness by serving multiple spoke sites from
    a single hub. In addition, it is anticipated that the spoke sites will
    develop some synergies as a result of their telemedicine technology
    that will allow them to communicate more effectively with each other
    and, importantly, with the communities most urgently in need of those
    services through the use of telemedicine technologies.
        As I am sure that you are aware, rural America is experiencing a
    shortage of primary care physicians and specialist care providers.
    Primary care physicians are the keys to meeting the basic health care
    needs of patients in these areas because they are able to provide a
    wide variety of basic health services and identify medical problems
    needing further attention. Twenty-nine percent of rural residents live
    in Health Professional Shortage Areas (HPSA) compared to only nine
    percent of urban residents. Statistics from the Office of Statewide
    Health Planning and Development in California show that in northern
    California alone, all of Del Norte county and portions of Sonoma,
    Mendocino, Lake and Humboldt Counties are all experiencing Primary Care
    Health Professional Shortages.
        People living in remote areas struggle to access timely, quality
    medical care. Residents of these areas often have substandard access to
    specialty health care, primarily because specialist physicians are more
    likely to be located in areas of concentrated population. Because of
    innovations in computing and telecommunications technology, many
    elements of medical practice can be accomplished when the patient and
    health care provider are geographically separated. This separation
    could be as small as across town, across a state, or even across the
    world.
        Many areas in California, specifically Northern California are
    medically underserved areas. The United States Department of Health and
    Human Services has classified portions of Sonoma, Mendocino, Humboldt,
    Del Norte counties and all of Lake county as federally designated
    medically underserved areas. Access to medical care, especially
    specialty and trauma care is limited and episodic at best.
        Often, these communities have been medically underserved due to the
    concentration of specialty care and health education in urban and
    suburban neighborhoods. The use of Telemedicine serves to provide
    California's underserved patients with the medical services they need.
    Instead of the patient being forced to travel long distances to reach a
    specialized provider, the patient, instead, could see their local
    provider and receive specialized care via telemedicine saving time,
    improving safety and providing a much needed service for the patient.
    Additionally, the need for emergency transport of patients would be
    significantly decreased due to the ability of telemedicine to assist in
    the diagnosis of a trauma patient on site. California could
    significantly benefit from the development of telemedicine due to its
    large geographical area with a population located in big cities,
    smaller towns and isolated rural regions.
        Telemedicine has the potential to improve the delivery of health
    care in America by bringing a wider range of services to underserved
    communities and individuals in both urban and rural areas. In addition,
    telemedicine can help attract and retain health professionals in rural
    areas by providing ongoing training and collaboration with other health
    professionals.
        Santa Rosa Memorial Hospital is grateful for the initial funding
    that your subcommittee provided in fiscal year 2000. This funding will
    enable us to establish the first like. We look forward to working with
    you to secure additional funds which will enable us to link the
    remaining 10 sites throughout California's north coast.
        Mr. Chairman, we believe that Santa Rosa Memorial Hospital's
    Northern California Telemedicine Network creates a national model for
    providing access to primary, specialty and trauma care services for
    remote and at-risk populations. Our desire is to provide a much needed
    service--primary and specialty care--to these underserved communities.
    Therefore, Santa Rosa Memorial Hospital is seeking $2 million in
    continued federal support in fiscal year 2001 for the implementation of
    the final phases of its Northern California Telemedicine Network. The
    federal investment will enhance our nation's commitment to protecting
    the health of our citizens. Your support for this effort will improve
    the quality of health care and contribute to the saving of lives for
    thousands of individuals in Northern California.
        Thank you for your interest.
                                     ______

                Prepared Statement of the Condell Medical Center

        Mr. Chairman, thank you for the opportunity to present this
    testimony for the record regarding the proposed Regional Center for
    Cardiac Health Services at Condell Medical Center, in Libertyville,
    Illinois.
        As you may know, in the United States today, cardiac diseases are
    the number one killer of men and women. Everyday, more than 2,600
    Americans die of cardiovascular disease, an average of one death every
    33 seconds. Among both men and women, and across all racial and ethnic
    groups, cardiovascular disease is the number one killer in the United
    States. More than 960,000 Americans die of cardiovascular disease each
    year, accounting for more than 40 percent of all deaths nationally. In
    1998, cardiovascular diseases cost the nation an estimated $274 billion
    in medical expenses and lost productivity, including more than $50
    billion in direct Medicare and Medicaid expenditures. It is expected
    that that figure has increased to $286.5 billion in 1999.
        Over the last 20 years there has been a dramatic increase in the
    indicators of prevalence of heart disease and stroke, particularly
    among Americans over age 65--an age group that is now about 13 percent
    of the U.S. population and will constitute over 20 percent by year
    2010. Currently, almost 10 million Americans aged 65 years and older
    report disabilities caused by heart disease. Of the nearly 5 million
    patients afflicted with heart failure, 75 percent are older than 65
    years of age.
        Cardiovascular diseases are the most common cause of death in
    Illinois, accounting for an even higher mortality rate than on the
    national level. According to the National Center for Health Statistics,
    Illinois had the 10th highest 1995 death rate for heart attacks, stroke
    and other cardiovascular diseases in the nation, accounting for 101.7
    deaths per 100,000 population. Illinois also had the 12th highest rate
    of total cardiovascular diseases in the nation, at 203.7 deaths per
    100,000 population.
        In Lake County, IL, these statistics have even more profound
    implications. Today, the County has a higher incidences of heart
    disease, cardiovascular disease and chronic obstructive pulmonary
    disease than the State of Illinois as a whole. In fact, Lake County had
    4.6 deaths per 100,000 population from congenital anomalies versus
    Illinois' 4.2 deaths per 100,000.
        With a total population of 640,000, Lake County has a potential for
    5,312 cardiac catheterizations annually. Currently, there are four
    institutions with catheterization labs in Lake County with a combined
    total volume of only 1,700 or 32 percent of the potential volume,
    leaving a distinct cardiac health service need in the region. A primary
    reason for this discrepancy is that many patients are referred out of
    Lake County for interventional services currently unavailable anywhere
    in the County. In fact, some patients are forced to travel 90 minutes
    and more to obtain appropriate cardiac care.
        With the region experiencing a 35 percent population growth through
    2010, the need for an expanded primary and specialty health services
    infrastructure, including comprehensive cardiac care, is evident.
        We here at CMC are taking steps to do identify the risk factors and
    implement a comprehensive program that will provide, education,
    prevention, diagnosis, specialty care, surgical care and rehabilitative
    cardiac care for our patients.
        Since 1927, Condell Medical Center (CMC) has been a highly
    respected comprehensive community health care, prevention and education
    resource for Lake County, Illinois. The Medical Center has grown from
    its origins as a 12-bed country hospital to a technologically
    sophisticated 190-bed acute care medical center with affiliated health
    care and educational service facilities strategically located
    throughout Lake County.
        Condell Medical Center was the first institution in Lake County to
    establish a cardiac rehabilitation program in 1978. Since then, the
    Medical Center has run a basic cardiology program including diagnostic
    and rehabilitative services at its main campus in Libertyville, IL. It
    has also provided emergency cardiac care at its main campus and its
    affiliated acute care centers located throughout the northwestern Lake
    County region. Currently, acute care centers are located in Buffalo
    Grove, Vernon Hills, Gurnee and Round Lake Beach. Condell affiliated
    medical offices are located in these centers in addition to other
    medical office buildings located in Lake Villa, Grays Lake and
    Mundelein. A focus on primary care physicians has enabled CMC to manage
    the medical needs of a large population of patients which has
    contributed to the success of its entire cardiovascular program.
        Condell offers comprehensive care to area residents from the
    initial onset of the disease through recovery and return to daily
    routine, including:
        Diagnostic Care.--Opened in 1996, Condell's new centralized
    Cardiology Department began to offer diagnostic cardiac catheterization
    services to area residents. One of the first fully-digital cardiac
    catheterization facilities in the nation, the laboratory aids Condell
    cardiologists in making a more thorough diagnosis of a patient's heart
    status. This permits faster clinical decisions, increased continuity of
    care and less patient stress.
        Intensive Cardiac Care Center.--CMC currently operates an Intensive
    Care Unit with staff trained to provide optimal patient care to those
    with life-threatening illnesses. Monitoring equipment links patients
    with nursing staff. The Total Care Team, through its interdisciplinary
    cooperative efforts, handles the most critical situations in an
    efficient, well-organized manner to produce the most effective results
    for the patients.
        In the cardiac care program at CMC is primarily comprised of non-
    invasive diagnostic and rehabilitative care. The Medical Center
    referred patients in its primary and secondary service areas to other
    outlying hospitals for specialty cardiac surgical services. In 1997,
    1998 and 1999 a total of 240, 343 and 376 patients respectively were
    referred directly from Condell for interventional cardiac procedures.
        The practice of referring patients for care interrupted the
    continuity of care, increased the health risk to the CMC patient,
    inconvenienced the patients and their families and broke the chain of
    care between the patient and their primary care physician.
    Additionally, the cost of care for those patients who are referred
    increases significantly due to transport costs, repetition of certain
    diagnostic tests, physician and nursing assessment during the patient
    admission to the tertiary hospital.
        In 1996, CMC established its Cardiac Catheterization Lab providing
    diagnostic cardiac catheterization services as the first step in the
    establishment of a regional center for cardiac health services. The
    catheterization lab established a quality care program with
    comprehensive peer review process and outcomes measurements.
        With the establishment of the catheterization lab in 1996 and the
    resulting increases in demand for services in 1997, 1998 and 1999, it
    became very apparent that the patients of Lake County have chosen CMC
    as the hospital-of-choice for their cardiac care.
        Today, cardiovascular disease represents 20 percent of all CMC's
    hospital admissions. In 1998, CMC ended the year with 697
    catheterizations, the largest market share in Lake County. In addition,
    the Medical Center referred 191 patients to other facilities for open-
    heart surgery in 1998. When the proposed cardiac care center opens, it
    is expected that the number of cardiac care patients will increase
    significantly placing additional stress on Condell's ICU, surgical and
    ED infrastructure.
        The addition of a comprehensive cardiac health program including an
    open-heart surgery and angioplasty program will enable CMC to fulfill
    its mission of providing a full spectrum of cardiac care.
      the regional center for cardiac health services at condell medical
                                     center
        In response to the critical need for comprehensive cardiac health
    services in Lake County, Illinois and the surrounding region, Condell
    Medical Center has established the ``Regional Center for Cardiac Health
    Services'' (RCCHS).
        The Regional Center for Cardiac Health Services at Condell Medical
    Center is being developed as a dynamic, multi-faceted facility designed
    to bolster the Lake County region's ability to deal with the numerous
    faces of the cardiac threat in an innovative and integrated fashion.
    The RCCHS will provide a full suite of cardiovascular services
    including emergency, surgical, diagnostic, education, prevention and
    rehabilitation.
        This Center, which is part of Condell Medical Center's planned
    institution wide expansion project, will build upon existing cardiac
    expertise at the Medical Center and create a full service regional
    center that will include:
      --Cardiac Catheterization Lab (diagnostic and interventional cardiac
            cath)
      --Echocardiography
      --Stress Testing
      --Cardiac Rehabilitation
      --Cardiac outpatient monitoring
      --EKG
      --Pediatric Cardiology
      --Cardiac ICU
      --Surgical
      --Prevention and Education
      --Rehabilitation
        The new Center will accommodate increased volume expected from the
    expanded cardiac programs, the Emergency Department and the primary and
    secondary service areas.
        The proposed program will:
      --Be clinically effective, using an interdisciplinary approach with
            input from surgeons, cardiologists, ancillary professionals,
            nurses, administration and importantly, patients.
      --Facilitate continuity of care from admission through discharge and
            after-care in the home and rehabilitation.
      --Enable cardiologists to maximize patient care through decreased
            morbidity and mortality through the use of interventional
            cardiac procedures and on-site open-heart surgery services.
      --Provide additional suites for use in open-heart surgeries.
      --Reduce referrals out of CMC and Lake County, allowing closer ``home
            care.''
      --Provide comprehensive cardiac care 7 days a week, 24 hours per day.
      --Locate all cardiac services adjacent to one another for increased
            patient convenience and improved medical efficiency.
        Key components of the proposed Regional Center for Cardiac Health
    Services include:
                                    surgical
        Condell Medical Center will provide for the first time in Lake
    County open heart surgery capability. It will provide suites for use
    solely as open heart surgery suites which will co-exist within the
    expanded surgical center.
                             education & prevention
        Another aspect of the proposed Regional Center for Cardiac Health
    Services at Condell Medical Center will be the education and prevention
    programs. This will entail expansion of the existing Health Promotions
    Program and Cardiac Rehabilitation Program. In addition, opportunities
    for the development of specialty services will be evaluated and
    implemented.
                              rehabilitative care
        A key element of the Regional Center for Cardiac Health Services at
    CMC will be an expanded Cardiac Rehabilitation Program, conducted at
    Centre Club. The Centre Club is the on-campus health and fitness
    facility at CMC. This program helps cardiovascular patients return to a
    safe, healthy and active lifestyle. This two-phase program combines
    education with individualized exercise prescriptions, which are closely
    monitored by highly trained staff members.
        As a key part of this initiative, CMC is also in the process of
    adding a second rehabilitation program off campus at its Gurnee
    facility.
        The establishment of this center is also a critical component in
    the Medical Center's goal to become the County's first tertiary care
    center. Other components of that goal will be becoming a level I
    emergency department, becoming a level I intensive care unit (ICU), and
    becoming a level III OB/GYN facility.
        Condell Medical Center is seeking $5.5 million in fiscal year 2001
    two years for the final phase of its Regional Center for Cardiac Health
    Services. This proposed federal partnership in conjunction with the CMC
    financial commitment of $72.8 million will provide significant returns
    on the federal investment through faster and more effective treatment
    while helping to reduce the significant costs associated with cardiac
    related illnesses in the area.
        The proposed Regional Center for Cardiac Health Services will serve
    as a national model for the provision and effective management of
    comprehensive cardiac care in a single location for an at-risk
    population. This partnership, supported by CMC's financial commitment
    of $72.8 million, will provide significant returns on the federal
    investment through faster and more effective treatment while helping to
    reduce the significant costs associated with cardiac related illnesses
    in the area. It will also help to reduce the very real costs associated
    with cardiac related illnesses in the region.
        Again, Mr. Chairman thank you for the opportunity to submit this
    testimony for the record. We look forward to working with the
    subcommittee as it strives to implement an effective system for
    addressing the complex issue of cardiac care.
                                     ______

          Prepared Statement of the National Treasury Employees Union

        Chairman Specter, Members of the Subcommittee: My name is Colleen
    M. Kelley and I am the National President of the National Treasury
    Employees Union (NTEU). On behalf of the more than 140,000 federal
    employees represented by NTEU throughout the Federal Government, thank
    you very much for this opportunity to share our views concerning the
    fiscal year 2001 budget.
        NTEU represents employees in many HHS agencies who will be directly
    affected by funding decisions made by your Subcommittee. NTEU
    represents employees in the Health Resources and Services
    Administration, Indian Health Service, Substance Abuse and Mental
    Health Services Administration, Agency for Healthcare Research and
    Quality, Administration for Children and Families, Administration on
    Aging, Office of the Secretary, Office for Civil Rights, Program
    Support Center and the National Center for Health Statistics. In
    addition, NTEU represents employees in the Social Security
    Administration's Office of Hearings and Appeals.
        As the Chairman knows, spending has been severely constrained at
    most federal agencies over the past several years. These funding
    shortfalls have resulted in hiring restrictions and delayed and
    canceled employee training which have made it difficult for employees
    to do their best. With the deficit finally behind us and surpluses
    predicted for the immediate future, we have an opportunity to provide
    adequate resources to federal agencies. Doing so will enable federal
    employees to carry out their agencies' missions to the best of their
    abilities and provide first class service to agency customers.
        The Administration's fiscal year 2001 budget request for program
    management at the Health Resources and Services Administration (HRSA)
    is $131 million. HRSA's goal is to bring health care services to some
    of our most neediest populations, including those in underserved rural
    communities, people living with HIV/AIDS, and those who are uninsured.
    There is little question that HRSA provides essential services that are
    desperately in need of expansion. This agency can truly no longer do
    more with less.
        The employees represented by NTEU at the Agency for Healthcare
    Research and Quality (AHRQ) are committed to improving the quality of
    patient care in our health care system. This agency's goal is to both
    cut the number of medical errors and explore ways to better use
    research to improve medical care in our country. The Administration's
    budget proposal includes $3 million for program support at the AHRQ, an
    increase over the prior fiscal year which reflects the important work
    accomplished by this agency.
        President Clinton's budget proposes $60 million in funding for
    program management at the Substance Abuse and Mental Health Services
    Administration (SAMHSA). This agency is at the forefront of efforts to
    provide early intervention programs designed to discourage young people
    from trying drugs as well as playing a critical role in insuring that
    mental health and drug abuse services are widely available. The Office
    of National Drug Control Policy estimates that as many as 5 million
    Americans need substance abuse treatment, yet, they report, less than
    half actually receive services. If SAMHSA is to adequately respond to
    the substance abuse and mental health needs in this country, the
    President's budget recommendation is the minimum that must be approved.
        The Indian Health Service (IHS) is slated to receive $2.7 billion
    for its health services programs in fiscal year 2001 under the
    President's budget. This budget request reflects the Administration's
    continuing commitment to improve health care for the millions of
    American Indians and Alaska Natives that belong to federally recognized
    Tribes. These additional funds will permit the employees of IHS to
    continue to make a difference in the health status of the groups served
    by the IHS.
        The fiscal year 2001 budget request for federal administration at
    the Administration for Children and Families (ACF) is $165 million. As
    the Chairman knows, ACF is one of the government's premiere agencies
    for promoting the health and welfare of America's children. Programs
    under its jurisdiction include Head Start as well as projects that
    promote and support child care, foster care and adoption efforts. The
    budget request will permit ACF to hire additional staff in key areas
    such as monitoring child welfare, expanding access to quality child
    care and overseeing the critical Head Start Program. Funding
    restrictions in past years have hampered ACF's ability to fulfill its
    mission and on behalf of the dedicated employees of this agency, I urge
    the Subcommittee to fully fund this request.
        For fiscal year 2001, the budget request for program administration
    at the Administration on Aging (AoA) is $17 million. Since the turn of
    the last century in 1900, it is estimated that the population of
    Americans age sixty-five and older has grown from 3 million individuals
    to more than 34 million. Helping older Americans remain independent and
    productive is one of the key goals of AoA. The employees of AoA operate
    nutrition programs, disseminate information and are active in the
    Alzheimer's programs. The budget recommendation for AoA is the minimum
    that should be approved for this important agency.
        NTEU also represents employees in the Office of the Secretary of
    HHS. The President's budget request for departmental management is $330
    million for fiscal year 2001. As you know, the employees in the Office
    of the Secretary help support those activities associated with the
    overall operation of the department. In addition, the fiscal year 2001
    budget request includes funding to support research on significant
    policy issues including welfare reform, at-risk children and youth and
    improved access to health care being conducted in the Office of the
    Secretary.
        The President's budget request for the Office for Civil Rights
    (OCR) for Fiscal 2001 is $24 million. The important work of OCR
    includes enforcing the Nation's civil rights statutes that prohibit
    discrimination in health and social service programs. Moreover, OCR
    plays a central role in efforts to prohibit discrimination against
    individuals with disabilities in programs under HHS's purview. In the
    past several years, the funding levels OCR has received have not
    reflected OCR's critical mission and we urge this Committee to
    carefully consider the President's fiscal year 2001 request.
        For the National Center for Health Statistics (NCHS), the
    Administration has requested $110 million for program support in fiscal
    year 2001. This budget request is intended to support NCHS's health
    survey and data collection activities. One of NCHS's primary
    responsibilities is to follow changes in health and health care, assess
    the effectiveness of health care programs and identify health and
    disease patterns and risk factors in our country. The budget request
    reflects the critical work done by this agency.
        As the name implies, the Department's Program Support Center (PSC)
    provides support services to HHS as well as to other agencies. These
    services include efforts in three areas, including human resources,
    financial management and administrative operations. For fiscal year
    2001, the Administration has recommended a funding level of $326
    million for PSC, a small increase over the division's fiscal year 2000
    budget.
        NTEU also represents employees in the Office of Hearings and
    Appeals (OHA) of the Social Security Administration. As I have brought
    to this Committee's attention in past years, OHA is once again the
    subject of reorganization efforts. NTEU has several concerns regarding
    the latest reorganization effort called the Hearing Process Improvement
    (HPI) plan.
        As the Chairman knows, the process at OHA is judicial in nature and
    is focused around the due process hearing. Disability claimants who
    have not been found eligible for disability are entitled to a timely
    and fair adjudication at the hearing office level. The OHA hearing
    procedure permits the dissatisfied claimant to personally interact, to
    personally argue his/her position directly to the decision maker. The
    decision he/she receives is comprehensive and specific; it deals with
    his/her situation in great detail.
        One particularly innovative and successful program stands to be
    eliminated if HPI is implemented. The Senior Attorney Program as
    originally operated, involved approximately 475 of OHA's experienced
    Staff Attorneys who in addition to drafting ALJ decisions, reviewed
    those disability cases most likely to result in a fully favorable
    decision before they were assigned to the disability que for an ALJ
    hearing. If the evidence indicated that the case was likely to result
    in a finding of disability, the Senior Attorney would complete
    development of the case, including securing additional medical evidence
    and appropriate medical and vocational expertise. If after such
    development the case was not likely to be favorably decided without a
    hearing, the case was forwarded to an ALJ for a hearing. However, if
    the record established that the claimant was in fact disabled, the
    Senior Attorney would draft and issue under his/her authority a fully
    favorable decision.
        The average processing time for Senior Attorney decisions was just
    over 100 days. This was at a time when processing time at the OHA
    hearing level was 386 days--more than an entire year. As a result of
    the Senior Attorney Program, disabled claimants received their benefits
    nearly 9 months earlier than otherwise would have been the case. From
    its inception until the Program was sharply curtailed in 1999, the
    Senior Attorney Program resulted in approximately 50,000 fully
    favorable decisions per year.
        In every respect the Senior Attorney Program has been a resounding
    success. It materially improved the quality of service provided to the
    public, especially those individuals who are disabled and entitled to
    timely granting of their benefits. Despite its success, the Senior
    Attorney as an independent adjudicator is being eliminated as part of
    the HPI Plan.
        NTEU is profoundly skeptical that the Hearings Process Improvement
    Plan will materially improve disability adjudication at the hearings
    level. In fact, the failure to retain the decisional authority of
    Senior Attorneys would seem to doom HPI to failure. NTEU urges this
    Subcommittee to carefully review the Hearing Process Improvement
    initiative and urges the Chairman to carefully review the shortsighted
    plan to eliminate the Senior Attorney Program. Without this program,
    and the additional 50,000 to 75,000 decisions it will help generate
    each year, there is little question that a serious degradation of in
    the quality of service will result.
        Mr. Chairman, thank you again for this opportunity to share our
    views on the fiscal year 2001 needs of the agencies within the
    jurisdiction of your Subcommittee.
                                     ______

              Prepared Statement of the Montefiore Medical Center

        Mr. Chairman and Members of the subcommittee, thank you for the
    opportunity to submit this testimony for the record on the Montefiore
    Medical Center in the Bronx, New York and the exciting new Children's
    Hospital at Montefiore that we are developing.
                                   the bronx
        The Bronx has a population of 1.2 million residents, placing it
    among the top 10 largest cities in the United States. Approximately
    400,000 of those residents are children. Neighborhoods in the Bronx
    rank among the poorest in the nation. Thirty percent of residents in
    the Bronx are on some form of public assistance and/or Medicaid (31
    percent). Over one-quarter of the residents have incomes under $10,000
    annually and sixty percent have annual incomes below $30,000.
        The Bronx population is largely composed of historically
    underserved and uninsured minorities. Three-quarters of the Bronx
    population are non-white--28 percent African American and 50 percent
    Hispanic. The Bronx is among the nation's most underserved urban areas
    with sociodemographic and health status indicators that underscore its
    need for health services. Those health and social indicators include:
      --An infant mortality rate which is among the highest in the nation;
      --Rates of teenage pregnancy and low birth weights that are higher
            than the proportions for the City and nation;
      --The incidence of asthma is six times greater than the national
            average;
      --Bronx children living with AIDS in 1996 represented 28.5 percent of
            all New York City pediatric AIDS cases, and 5.5 percent
            nationwide.
      --The lack of industry and a strong economic base leaves the borough
            with extreme housing problems, drug abuse and crime, all
            underlying problems of poverty and unemployment.
                           montefiore medical center
        Established over 100 years ago as a chronic care hospital,
    Montefiore Medical Center has become a critical resource in addressing
    the health and social needs of the residents of the Bronx. MMC was the
    first hospital to create a community-oriented care program in the late
    1960s and early 1970s to meet the needs of underserved residents in the
    Bronx. This comprehensive public/private health system provides more
    than one-third of all inpatient acute care, over 42 percent of all
    tertiary care, and $50 million in uncompensated care annually.
        The Medical Center strives for excellence in patient care, medical
    education, scientific research and community services. Staff and
    faculty at MMC practice ``family-centered care,'' working with families
    to promote health, prevent diseases, and alleviate the burden of
    illness.
        In 1995, Montefiore Medical Center performed an extensive review of
    the health of their population, specifically children. The study
    revealed that children in the Bronx are among the City's most needy,
    with some of the City's highest rates of low birth weight, infant
    mortality, HIV infections and other reportable diseases. It also
    revealed that hospitalization rates for children (0-19 years) in the
    Bronx are excessive at 65 admissions for every 1,000 persons--nearly
    twice the average of more affluent areas.
        The study also demonstrated that child health programs at MMC are
    at great risk for the future. While MMC offers a comprehensive array of
    child health, prevention and education services through a network of
    inpatient, outpatient, and community programs and facilities, these
    programs are fragmented and uncoordinated. The four-site program is
    hard to sustain, and utilization declines (due to managed care)
    threaten the viability of the system. It was determined that many
    inadequacies exist due to the limitations of the physical environment.
    Existing programs and services at MMC lack focus for the specific needs
    of children and lack child and family-friendly elements.
        Among the four hospitals, inpatient services for children are
    inadequate and fragmented. Ambulatory services for children are
    scattered throughout the system and are not well housed, and primary
    and specialty ambulatory services are not adequately articulated to
    meet the health and related needs of children. In addition, there are
    no existing ancillary services specifically designed for children.
    Finally, the fragmented nature of existing children's services makes it
    increasingly difficult to staff the four-site program. Rather than
    having a critical mass of pediatric primary and specialty care in one
    location, this expertise is dispersed throughout the multi-site system,
    making departmental cooperation and consultation difficult and staff
    retention very challenging.
        It is clear that a restructuring and consolidation of services for
    children at MMC must take place to ensure the livelihood of the
    hospital as well as the longevity of children's health services in the
    Bronx. In response to this crisis Montefiore has embarked on a
    comprehensive initiative to tackle the daunting task of consolidating
    all of our children's services into a central location--the Children's
    Hospital at Montefiore. The new Children's Hospital will serve as a
    ``hub'' of our child health initiative--eliminating fragmentation
    within the existing child health network, enabling the provision of
    services in a more direct, cost-effective manner and enabling MMC to
    better and more efficiently address the ever growing health needs of
    the children in the Bronx.
                     the montefiore child health initiative
        The traditional model of children's hospitals is designed for and
    focuses on chronic care. There has been very little preventive,
    supportive or specialty care at children's hospitals. With the more
    sophisticated understanding of childhood illness, the resulting need
    for advanced care, and with the increased understanding of the
    connection between an individual's health status and his/her lifestyle
    and family life--a new model of children's hospitals has emerged.
        The Montefiore Child Health Initiative, comprised of both the child
    health services within the existing Ambulatory Care Network and the
    Children's Hospital, is a unique example of a modern and aggressive
    approach to the provision of comprehensive children's primary and
    specialized health care services.
        The Montefiore Child Health Initiative proposes a unique model of
    care that will assure MMC's continued leadership in the provision of
    health care and related services to children in the Bronx and
    surrounding areas. That proposal includes:
    An Integrated Child Health Network
        The establishment of a child health network, which builds on the
    existing services available through the Ambulatory Care Network, is a
    necessity in the rapidly changing environment in the Bronx. The
    Montefiore Child Health Initiative will ensure that the Integrated
    Child Health Network provides each child with access to high quality
    primary and specialty care; effective connections and communication
    between existing primary and specialty care services/providers;
    cohesion among the different parts of the network to ensure a full
    spectrum of child health and related services; and access to the
    secondary and tertiary services at the Children's Hospital so that
    children and families will have the option of receiving care in an
    organized, cost effective and accountable system of care.
        The Montefiore Child Health Initiative will provide the
    consolidation and coordination necessary to effectively and efficiently
    provide a full range of services for the children and families of the
    Bronx.
        The network aspects of the Initiative will play a key role in
    ensuring that a full continuum is and remains available for children
    and their families through the existing array of services throughout
    the Bronx, including:
      --3 hospital outpatient departments, providing primary care,
            specialty care and special programs for children;
      --30 ambulatory care sites--receiving over 300,000 visits annually;
      --21 school-based health clinics--providing services to over 11,000
            children annually;
      --The New York Children's Initiative--an innovative outreach care
            program for homeless children providing care to over 6,300
            children annually;
      --An extensive base of privately practicing pediatricians throughout
            the Bronx and Westchester County.
        The ``front door'' to the planned Children's Hospital, the core of
    the Montefiore Child Health Initiative, is through any one of the
    affiliated ambulatory care sites in our network. Within the network
    each child will have an identifiable primary care provider responsible
    for their care. Any site in the system will have the ability to assess
    the need for specialty services and to provide those services and
    consultations on-site or through referral. There will be constant
    communication between the primary care providers in the community and
    the specialty care providers at the Children's Hospital or in the
    community.
        The network currently offers specialty services specifically geared
    to meet the unique health and social service needs of children in the
    community. It is critical to note that these programs do not simply
    target health needs. They also address some of the underlying economic
    and social issues that cause illness in children by providing
    prevention and education services for at-risk youth and families in the
    Bronx. Those existing special services include:
      --Child Abuse Center;
      --Pediatric Resource Center;
      --Child Health and Safety Initiative;
      --Ambulatory care to adolescents with HIV infection;
      --A nationally recognized mobile lead screening and safe house
            program;
      --School-based health program providing direct medical services at 21
            schools in the community;
      --A drop out prevention program;
      --Outreach to and prenatal/child care services to pregnant women who
            are either HIV infected or at-risk for infection; and,
      --Community redevelopment/commercial revitalization.
    Pediatric Asthma Center
        A dedicated center for the diagnosis and treatment of childhood
    asthma is a major focus of the Montefiore Child Health Initiative. The
    concept of the Pediatric Asthma Center stemmed from the disturbing
    statistics about childhood asthma in the Bronx:
      --Almost 15 percent of children in the South Bronx have asthma (6
            percent nationally).
      --African American children are three times more likely than white
            children to be hospitalized for asthma, and four to six times
            more likely to die from it. Rates for Latino children are also
            higher than those for white children.
      --More than five times as many children in the Bronx are hospitalized
            for asthma compared with national rates.
      --In the South Bronx, the rate is 7.5 times the national rate, and
            more than twice the rate of New York City overall.
        The Pediatric Asthma Center will establish a state-of-the-art
    clinical and educational resource center as well as a community-wide
    network of services for children and families linked directly with
    schools and day care programs. The Center's services will provide
    school-based education and pediatric care for children with asthma, and
    will serve as a hub for a network of diagnostic and clinical services
    located in Montefiore's Integrated Child Health Network. Schools and
    day care centers will be linked to the Pediatric Asthma Center as well
    as a local network primary care site for services, training and
    educational programs. State-of-the-art technology, including diagnostic
    equipment and computer links for clinical evaluation, and support for
    school-based health care and education, will be key components of the
    Pediatric Asthma Center.
    A New Children's Hospital
        The Children's Hospital will provide the critical connection
    between the providers of children's health services in the Ambulatory
    Care Network. It will serve as the hub of the entire Montefiore Child
    Health Initiative.
        The new hospital will not stand alone but will be connected to a
    tertiary care center. The hospital will be programmed and staffed
    specifically with the special needs of children and families in mind.
    Those special features and services include:
      --State-of-the-art pediatric emergency room;
      --Medical and surgical subspecialty ambulatory clinical modules
            designed specifically for children;
      --A short stay ``Day Hospital'';
      --Family support services;
      --Diagnostic and treatment services;
      --Age appropriate units specifically designed to care for the
            individual needs of infants, school age children, and
            adolescents;
      --A state-of-the-art Pediatric Critical Care Unit, with specialized
            activities such as dialysis and transplant technologies,
            designed with adequate space for parents to stay with their
            child;
      --All single occupancy rooms will have parent sleep-in
            accommodations;
      --A playroom on each unit with age appropriate toys, staffed with
            child life professionals to assist in the developmental needs
            of children;
      --School facilities specially designed to meet the needs of each age
            group;
      --Liaison child psychiatry services;
      --Medical information stations on each unit.
                                   conclusion
        The implementation of the Montefiore Child Health Initiative will
    elevate the quality and scope of primary and specialty health care
    services to children and their families in the Bronx.
        Montefiore Medical Center, with our 100 year tradition of community
    service and community-based health care programs, is uniquely qualified
    to implement and operate the Montefiore Child Health Initiative which
    could serve as a national model of how complete health systems can
    adapt to and address the very unique health and social needs of today's
    inner-city, minority, children.
                             funding/budget sources
        The new Children's Hospital and related facilities will cost $116
    million for capital construction. The Medical Center is seeking $5
    million in fiscal year 2001 for this critical children's hospital and
    child health initiative. In fiscal year 1999 and fiscal year 2000
    respectively, Montefiore received $2 million and $500,000 respectively
    for this initiative. Montefiore Medical Center looks forward to
    developing relationships with the Federal Government to make this plan
    a reality and to serve as a model to other cities and hospital systems.
        Thank you for your consideration.
                                     ______

           Prepared Statement of St. Joseph's Hospital Health Center

        Mr. Chairman, thank you for the opportunity to submit this
    testimony and for the support that this Subcommittee gave to St.
    Joseph's Hospital Health Center last year. St. Joseph's, located in
    downtown Syracuse, New York, is a non-profit 431-bed hospital and
    health care network providing services to Onondaga County and to
    patients from 15 surrounding counties. St. Joseph's is best known for
    its ranking as the #1 hospital in New York State for open-heart surgery
    in terms of lowest overall mortality rate. We are very proud of this
    ranking, which we have held for four consecutive years. What many
    people do not know is that we are also the largest hemodialysis center
    outside metropolitan New York. My statement is focused on these two
    areas of expertise at St. Joseph's and how we plan to initiate a
    chronic disease management model that will benefit our current patients
    with heart and kidney disease and enhance the quality of life for at-
    risk patients in the region. We see this initiative as one with not
    only health enhancement benefits but also with significant positive
    economic implications for the community and the region.
        St. Joseph's provides over $7 million in bad debt and charity care
    to our service region. This comes to about 4 percent of our operating
    budget. This number has steadily risen over the years and we feel it
    will continue to do so unless some dramatic steps are taken. In order
    to increase access to patients who are underserved and at-risk for
    disease, we have implemented a program of ``patient-centered care.'' We
    believe we achieved our #1 ranking for cardiac care through this
    process, which employs a secondary prevention model for disease
    management. By applying a multidisciplinary team approach to heart
    disease and preparing patients before surgery and rehabilitating them
    after, we have reduced mortality rates as well as the number of second
    hospitalizations. We have done this to improve the overall health of an
    underserved and underinsured patient base, but also for practical
    financial reasons. While our rehabilitation and education programs for
    our cardiac patients are largely unreimbursed, we are rewarded by
    having to perform less expensive charity care on patients who would
    typically end up back in the hospital without disease management.
        Recognizing that early assessment is important to reducing the
    number of expensive treatments required later in life, St. Joseph's
    instituted a Wellness Place at a local mall so that people could stop
    in at their convenience. The Wellness Place provides free, general
    health screenings such as blood pressure readings, cardiac and diabetes
    risk assessment, counseling and patient education and seminars. Last
    year, approximately 15,000 people used the Wellness Place. Nearly 1000
    of these people were determined to be at risk for heart disease,
    diabetes, or vascular problems. These individuals were offered follow-
    up services intended to change lifestyle, such as nutritional
    counseling, smoking cessation, exercise programs and other similar
    regimens. They were also offered a choice of primary care physician if
    none was identified. This is all done at considerable unreimbursed
    expense to St. Joseph's but with the knowledge that a great deal of
    money will be saved in the long run--for the patient, the Medicare
    system and the hospital. The most dramatic economic implications I
    mentioned are encompassed within this concept--but not all. At risk
    patients are working people who may lose jobs if their disease
    progresses. It is important to realize, however, that patients with
    diagnosed diseases or who have congestive heart failure, may still work
    and lead productive lives if an effective disease management program is
    initiated at the earliest stage possible. The other economic benefits
    come in the form of the support required for this program. I will
    detail those later in this statement.
        Assessment is the first line of defense in chronic disease
    management; but, there are many other factors involved after this step
    is taken. A program for management of disease must adequately educate
    patients and then foster a sense of individual responsibility for the
    importance of following prescribed regimens. This takes a great deal of
    initial monitoring and time spent with patients by telephone, at
    community health centers, and in the home. This also requires
    coordinated community participation by physicians, nurses, pharmacists,
    physical therapists, educators, behavioral specialists and even
    employers.
        Diabetes, leading to kidney disease and kidney failure, is the most
    expensive disease in the country. The second most expensive, and #1
    admitting diagnosis for Medicare, is congestive heart failure. The U.S.
    spends more than $7 billion annually in Medicare dollars for these
    diseases. The clinical relationship between chronic kidney failure and
    heart disease (e.g., high blood pressure) requires similar early
    intervention techniques as well as later management, treatment, and
    rehabilitation. Utilizing resources already developed and in place for
    our cardiac rehabilitation program, St. Joseph's is proposing to
    further develop a chronic disease management program focused on
    hemodialysis. Combining resources in this way will be cost effective
    and has the potential to radically change the management of kidney
    disease.
        The specific objectives of the program will begin with early
    identification. Timely referrals to a nephrologist can be improved so
    that more aggressive treatment can be initiated to prolong kidney
    function and allow better preparation of the patient for dialysis.
    Second, we will identify, investigate, evaluate, and implement
    technology that will promote in-center self care and home hemodialysis
    modalities. The Aksys Corporation has developed a product that has the
    potential of achieving this objective. Third, we will utilize the St.
    Joseph's Cardiac Rehabilitation Model for the renal patient. This model
    will emphasize education and exercise with the goal of improving the
    percentage of patients that stay employed, reduce frequency and length
    of hospitalizations, and improve patient acceptance of and control over
    disease processes. Finally, we will apply our disease management
    techniques to our overall goal of reducing the percentage of candidates
    for kidney transplantation. The ultimate goal of the renal patient and
    the health care industry is to have renal patients lead a ``normal''
    life. Currently, kidney transplantation is the modality that is most
    associated with that goal.
        Our history of service and specialization in the areas of cardiac
    and kidney disease has proven that there is a demonstrable need for a
    chronic disease demonstration in these areas for the Central New York
    region. The demonstration will involve relationships and initiatives in
    Dialysis, Cardiac Care, Home Care, and Wellness. What we lack at this
    point, is a facility that can be shared by both cardiac and dialysis
    patients. Our current dialysis facility, the largest outside the New
    York Metropolitan area, is woefully inadequate in every way. The
    facility was originally built as a modular, temporary, unit over 20
    years ago. We now treat our overload of patients in the hallways and
    have legitimate safety concerns that come with overcrowding and
    questions as to the future structural integrity of the plant itself. We
    have not replaced this facility for financial reasons but, fortunately,
    have been able to treat patients satisfactorily. We have three
    satellite clinics in the region that are also operating at capacity.
    Our goal is to implement our demonstration program in an on-campus
    facility that will provide the space needed for dialysis, exercise
    facilities, classrooms, meeting rooms, examination rooms, an acute
    kidney unit, and nurse and allied professional training space. Training
    of personnel is an important aspect of implementing an innovative
    chronic disease model.
        In terms of economic development for the region, we believe that
    keeping our patients healthy and productive will have the most dramatic
    impact on the economy albeit in the long term. For the shorter term, we
    believe the training programs that we currently provide and will expand
    in areas such as home care, nursing, rehabilitation specialists, and
    counseling, to name a few, will bring employment opportunities to
    people in and around Syracuse. As we expand our efforts, we will likely
    train people outside the immediate area to be able to serve the
    outlying areas where our satellite clinics are and in homes in more
    remote locations. The facility we envision will also provide many
    construction jobs over the next couple of years. The two-story
    facility, equipment and program operation will cost approximately $13.2
    million. St. Joseph's has requested Federal partnership grant funding
    of $5.8 million that will also cover start-up operating costs. Our
    partnership funding request has increased over the past two year's by
    $300,000 due to our current need to upgrade our Acute Kidney Unit as
    part of our overall initiative. We estimate, based on our current
    services, that our operating budget will exceed $5.5 million per year.
        As you know, St. Joseph's received $2 million in fiscal year 2000
    from this Subcommittee to begin the planning and site preparation
    necessary for the new Center. We are very grateful for this support and
    urge you to complete this investment with an additional $2 million in
    fiscal year 2001 toward our total requested federal share for the
    initiative. Having made this request, which we realize is considerable,
    we would like to assure the Subcommittee that St. Joseph's will
    provide, through private sources, the remainder of the estimated total
    for this effort or $7.4 million.
        We recognize the magnitude of this request but believe
    wholeheartedly that this facility, and the implementation of our
    chronic disease management model will repay this initial investment
    many times over in terms of Medicare savings and in terms of providing
    a national model for replication across the country.
        Thank you.
                                     ______

          Prepared Statement of the American Public Power Association

        The American Public Power Association (APPA) is the service
    organization representing the interests of the more than 2,000
    municipal and other state and locally owned utilities throughout the
    United States. Collectively, public power utilities deliver electric
    energy to one of every seven U.S. electric consumers (about 45 million
    people) serving some of the nation's largest cities. The majority of
    APPA's member systems are located in small and medium-sized communities
    in every state except Hawaii. APPA member systems appreciate the
    opportunity to submit this statement in support of fiscal year 2001
    appropriations for the Low Income Home Energy Assistance Program
    (LIHEAP).
        APPA urges the Committee to support funding of $1.4 billion in
    fiscal year 2001 for LIHEAP. APPA also supports the request for $300
    million in emergency funds in fiscal year 2001 and supports a funding
    level of $1.5 billion in advanced funding for fiscal year 2002. Because
    the majority of LIHEAP monies are needed during a short period of time
    in the winter months, advanced funding for LIHEAP is critical in
    enabling states to effectively plan for and administer the program.
    Moreover, a severe winter and escalating home heating oil prices in the
    Midwest and Northeast have depleted fiscal year 2000 emergency funds
    and highlight the important role LIHEAP plays for the elderly and
    working poor during winter months.
        Funding cuts since LIHEAP's reauthorization in fiscal year 1995
    have forced a tightening of eligibility standards and, in some cases,
    significant reductions in benefit levels. According to the National
    Energy Assistance Directors' Association (NEADA), the primary
    educational and policy organization for state LIHEAP directors, the
    number of recipients has been cut by over one million households during
    the recent past and average benefits have declined by about 10 percent.
    Prior to the dramatic reduction in LIHEAP funding in fiscal year 1995,
    the program was serving 20 percent of the eligible population, with
    one-half of the recipients being elderly or disabled Americans living
    on fixed incomes. Without the assistance provided by LIHEAP, many would
    be forced to choose between paying their home energy bill or purchasing
    other necessities of life, such as food.
        As the debate over restructuring of the electric utility industry
    and the issue of providing and funding ``public benefits'' programs
    continues, some have stated their belief that electric utilities should
    assume the entire burden of energy assistance for low income customers
    as a cost of doing business. As these restructuring efforts take place
    at both the federal and state levels, the risks become greater that
    bills for residential customers, especially those with low incomes,
    will increase as retail markets are opened to competition. The need for
    full funding of LIHEAP remains critical in ensuring that all those in
    need of energy assistance receive help. APPA believes that any public
    benefits programs should not replace or supersede existing programs,
    such as LIHEAP, that are funded by federal appropriations.
        As evidence of their commitment to low income assistance, public
    power systems across the country support a variety of programs
    providing help to low and fixed income customers. A survey conducted by
    the National Fuel Funds Network (NFFN) shows that publicly-owned
    utilities raised 14 to 26 cents more per customer than other utilities
    in their efforts to assist low income and needy customers in paying
    their bills. Many public power systems provide special rates for low-
    income households and some have residential conservation and demand
    side management programs designed to reduce energy consumption.
        In addition, the impact of welfare reform on energy assistance is
    just beginning to be felt and LIHEAP is likely to play an important
    role in the transition. Persons leaving the public assistance rolls are
    entering lower paying jobs and continue to be confronted with large
    energy bills. These families remain at risk.
        LIHEAP is one of the outstanding examples of a successful state-
    operated program. The requirements imposed by the Federal Government
    are minimal and most important decisions are left to grantees.
        APPA urges this Subcommittee's favorable consideration of fiscal
    year 2001 funding for LIHEAP. Again, thank you for this opportunity to
    present our views.
                                     ______

     Prepared Statement of Denise Roberts, Board Member, PULSE of Colorado

        Mr. Chairman and Members of the Committee: Thank you for the
    opportunity to submit written testimony regarding this very important
    issue, Medical Errors.
        My testimony concerns a series of errors that occurred as my son
    was under the care of a pediatrician in Pueblo, Colorado. This doctor
    already had a long history of providing substandard care to other
    children. Unfortunately, this information was not public knowledge nor
    was it reported by this doctor's peers. In early 1999, the Board of
    Medical Examiners suspended this doctors license in hopes of protecting
    the children of Pueblo. The decision was an unusual one since it was
    based solely on consumer complaints. The board felt that it had
    substantial evidence to act upon regarding this physician who was
    seeing far too many patients per day. In the grandest of public
    relations campaign the wealthy physician gained momentum within the
    community, and eventually the Board had a major conflict with local
    political leaders, hospitals and the peer review committees who did not
    initially go forward to protect the public. Several local doctors
    publicly sided with the physician, placing blame on the parents of the
    dead and injured children. The others remained silent. Parents and
    nurses came to the advocacy group that I belong to and informed us of
    this problem. The parents assumed that the new doctors would report the
    problems, they were wrong. Many symptoms were ignored and not charted
    by the doctor in question, the other physicians treated them without
    reporting the incidents.
        In a historic decision, this doctor was given back his license
    several months after suspension as the board continued to pursue the
    case. The local medical community closed ranks on the board, making it
    very difficult for the suspension to remain effective until the
    hearing. In exchange of that costly process, the doctor and the board
    agreed to an early retirement in exchange for a clean record with the
    medial board. This doctor can go and practice in any other state after
    he retires here and the same problems could happen there.
        My son Taylor Michael Roberts passed away on Feb. 25, 1998 at 14
    months. He was a healthy baby until he was prescribed medicine on 9/22/
    97. I would like to give you a brief history of the medical care my son
    received during his illness.
        It all started around the end of October 1997 when my son got sick.
    I took him to Dr. Kuna's office numerous times. (10-27-97, 10-30-97,
    11-12-97, 11-14-97, 11-18-97, 12-13-97, 12-22-97). It was the Friday
    after Christmas, on Dec. 26, 1997, when I took him to Dr. Kuna's office
    again. Dr. Rao, Dr. Kuna's partner saw us and sent us to get some test
    taken to find out what was wrong with Taylor. I brought the test back
    to Dr. Rao and he told me that Taylor had pneumonia and bronchitis, and
    to take him home and bring him back Monday. When I took Taylor home he
    was very sick all day. The next morning I took him to my personnel
    physician, and was told to get him over to the emergency room
    immediately. I am not a medical doctor, but a few things occurred at
    the hospital that I found disturbing: (1) They only took a blood test
    of my child after I demanded one be taken. (2) It was Dr. Derrington,
    another pediatrician on call, not Dr. Kuna or Dr. Rao, that ordered
    blood cultures. The results confirmed that my son was septic and this
    was the reason he was not getting better. (3) Dr. Kuna wanted to
    discharge my son days earlier from the hospital reasoning that he would
    be better off at home and more comfortable there. He stated other
    children had the same symptoms and were at home. (4) Dr. Kuna lied to
    us saying that all the tests; blood, and other wise, were all normal
    upon his release. (5) Dr. Kuna said on the discharge summary (1/5/98)
    that ``I will monitor the CBC carefully'', yet, no further blood test
    were taken until Feb. 22, 1998 when my son was diagnosed with
    meningitis. (6) I was never aware of the fact that Taylor had staph
    infection only that he was septic.
        I find it most unsettling that a Doctor would lie to us about the
    care of our child. This only leads me to believe that he must not
    comprehend or understand how much a parent could love a child and the
    lengths they would take to keep a child safe. Does he think that the
    results of the blood test are irrelevant to the life of my child?
        I brought my son back to Dr. Kuna for his follow up appointment on
    1/16/98. Dr. Kuna stated, that he was fine, but, to continue the neb
    treatments. Again, No tests were taken, or results mentioned. I took
    Taylor back to Kuna's office on 2/3/98 because he and my daughter had a
    runny nose and a cough. There again in his records he shows that Taylor
    had bronchitis. This was never mentioned to me during my visit. Then I
    took him back and on 2/7/98 Dr. Rao said he has a viral infection. I
    called Dr. Kuna on Sunday morning (2/22/98), and told him that Taylor
    was very sick and that he needed to be seen immediately. Dr. Kuna
    agreed to meet me at his office between 9:00 and 9:30. I told him
    Taylor had the following symptoms: (1) Fever on Friday night of 99
    degrees (2) Fever on Saturday night of 103.8 and not very controllable
    with the baths and switching Advil and Tylenol (3) Vomited once after
    the Advil (4) Heavy breathing. (5) Bumps on the back of his neck. (6)
    Was given Tylenol right before our visit.
        He informed me that Taylor had a virus infection and was prone to
    high fevers. I was not satisfied with this diagnosis, and asked him to
    do a throat culture. He said he had seen one lesion in Taylors throat.
    Then Kuna checked to see what his oxygen level would register. The
    machine showed a level under 90; Kuna then squeezed the monitor around
    his finger. I asked him if this would make the monitor reading high. He
    said it would have a misleading reading of three to four degrees which
    would make Taylors oxygen level okay. I still insisted that he should
    give me some medicine for Taylor. My son did not look very good at all.
    Later on in the afternoon I called Dr. Kuna and explained to him that
    my child was still very sick. Once again, I was told not to worry it
    was just a virus. I noticed on the records of my visit (2/22/98) that
    Kuna noted Taylor had a questionable dull left eardrum. This was not
    reported to me during this visit. Kuna then stated in the discharge
    summary `` I requested medicine because I was afraid of him getting an
    ear infection as in the past''. I have no idea how Kuna come up with
    this conclusion, as I was never informed of the ear infection. This is
    a great example of the deceptive practice that Dr. Kuna used in his
    diagnosis of Taylor.
        I took my son to the hospital on Monday morning around 6:00 a.m.,
    and told them to call Dr. Kuna immediately. I called the hospital
    before I left, and was informed that Kuna was scheduled to be on the
    pediatric floor that morning. My child was not very well at all on
    arrival at the hospital. I explained to them that I thought that he was
    breathing heavier than usual, and that his eyes seemed strange to me.
    The doctor writes in her report that he appears well hydrated and is
    taking fluids well. She only spent at the most 15 minutes with us. She
    also writes in her report that she checked Taylors neck. During the 15
    minutes she never checked his neck. They poked my son numerous times
    trying to take the 2nd blood test. After the first blood test they told
    us the results were fine. They further stated that they could not
    believe that results turned out to be OK. Because he looked ill they
    were going to recheck the initial blood test. Taylor barely responded
    to the numerous times that he poked in the arms while they were trying
    to obtain blood. They actually had to send in another lab person to
    take blood, because the second one could not draw any. They continued
    to ignore my requests to have Dr. Kuna come look at him. But only in
    the reports does it show that indeed he knew we were there at 8:50. My
    husband carried my son upstairs to be admitted to the pediatric floor.
    The nurses once again kept poking him numerous times in the arms to put
    the IV in. I went over to Dr. Kuna's office to talk to him about Taylor
    since he never showed up. His nurse told me that he was too busy to
    talk to me at this time, and I should come back at 12:00. When I went
    back to his room, my husband and I noticed that he was rocking and
    acting like he was not looking at us. We kept asking the nurse to call
    Dr. Kuna. One of the nurses stated that she noticed his eyes looked
    funny upon his arrival to the pediatric floor, but, she did not say
    anything. Dr. Kuna finally came over on the request of the nurse. He
    checked his neck and Taylor cried. Then he took Taylor into get a
    spinal tap. Immediately after the spinal tap, they had my husband carry
    him back to his room. Dr. Kuna told us that our son had meningitis. He
    left us standing there with just the nurse to take care of him. This is
    the part I now find so disturbing. How could he just leave us there? He
    stated he was in a hurry to get back to the office to take care of his
    patients. Moments after Dr. Kuna departed, Taylor went into a seizure
    that lasted 35 minutes. Dr. Kuna did not reappear until the last
    minutes of the seizure. I questioned why we were being transferred to
    St. Lukes hospital instead of Children's hospital. Dr. Kuna than
    informed me that the same doctors were available at St. Lukes. Upon
    arrival at St. Lukes, the staff fought for Taylors life until we
    decided to take him off the machines and medicine on Feb. 25, 1998.
        Dr. Kuna lied on the discharge summaries and he lied to the medical
    board. There is great concern on his ability to provide quality care
    for his patients. I am in great concern for the safety of other
    children under this sort of care. After reviewing some of the records
    and noting some of the mistakes, I am feeling tremendous guilt, because
    I listened to Dr. Kuna against my better judgment. How could I be so
    ignorant to trust this doctor with the life of my child? I thought that
    he would watch out for my child knowing how they misdiagnosed him the
    first time.
        After Taylor's death I learned that there had been a letter of
    admonition from the medical board regarding Dr. Kuna and the death of
    another child. This letter really hit home for me. I wish that these
    letters could be posted in the doctors office for patients to see. In
    this instance, I feel that the letter could have made a big difference.
    I also learned that he had been named in several lawsuits and many
    other consumers had filed complaints with the medical board against
    him. Had I known that he had gotten in trouble before, I would have
    gone someplace else. Since joining PULSE, I know now that this problem
    is nationwide, and many other children have died and been injured like
    Taylor was due to medical errors, misdiagnosis, etc. I hope someday
    that full disclosure will exist helped by mandatory reporting of
    medical errors as I feel that there are children's lives at at stake.
    Had I been informed, I know in my heart that there would have been a
    much different outcome.
        Thank you for allowing me to give you this written testimony.
                                     ______

             Prepared Statement of the National Consumer Law Center

                                  introduction
        Mr. Chairman and Members of the Committee, the National Consumer
    Law Center appreciates the opportunity to submit written testimony
    regarding appropriation of funds for the Low Income Home Energy
    Assistance Program for fiscal year 2001. This testimony is submitted on
    behalf of our low income and elderly clients who face going without
    food or medicine to avoid disconnection due to an inability to afford
    utility service.
        The National Consumer Law Center (NCLC) is a nonprofit corporation
    dedicated to the interests of low-income consumers. Founded in 1969,
    NCLC provides specialized legal support and consulting services to low-
    income consumers, their advocates, government agencies and private
    attorneys in all aspects of consumer and utility law. NCLC has helped
    utilities, regulatory commissions and advocates design low-income
    affordability programs and has published leading manuals and reports on
    related law.\1\
    ---------------------------------------------------------------------------
        \1\ Manuals and reports relating to utility service include Access
    to Utility Service, Cap the Gap: Assuring Residential Customers Share
    Benefits of Electric Industry Restructuring, The Regulation of Rural
    Electric Cooperatives, A Guide to Low-Income Energy Efficiency and
    Energy and the Poor: The Crisis Continues.
    ---------------------------------------------------------------------------
        NCLC is a strong supporter of the Low Income Home Energy Assistance
    Program (LIHEAP), as it is the primary safety net between low-income
    consumers and disconnection of utility service. LIHEAP is designed to
    target energy assistance to households most in danger of losing that
    vital service. However, without adequate regular appropriations, LIHEAP
    cannot get the job done. On behalf of our low-income clients, we urge
    the restoration of LIHEAP funding to at least $1.5 billion in regular
    appropriations for fiscal year 2001. This level of funding is slightly
    less than the level appropriated for this program in fiscal year 1988
    and far from the $2 billion level authorized to be appropriated for
    this program in prior and upcoming years.\2\
    ---------------------------------------------------------------------------
        \2\ 42 U.S.C. 8621(b).
    ---------------------------------------------------------------------------
        We also support additional emergency contingency funding of $300
    million and advance LIHEAP appropriations for fiscal year 2002 of at
    least $1.6 billion. This amount is still below the pre-1987 regular
    appropriations levels, but would enable states to cover a larger
    portion of the energy burden for eligible customers and increase energy
    efficiency efforts to move households closer to energy self-
    sufficiency.
        While emergency funds are critical for responding to life-
    threatening, brutal winters and summer heat waves, increasing the
    regular appropriations for LIHEAP will allow the states to design more
    solid programs for the upcoming year. This includes proactive, timely
    and appropriately designed responses to crisis situations, as opposed
    to reactive and potentially ill-timed responses due to the lag time
    that comes with the dependence on the release of emergency contingency
    funds. Delays in responding to heating and cooling crisis needlessly
    jeopardize the health and safety of those Americans eligible for
    assistance.
                  the need for restored regular liheap funding
        Those that cannot afford to pay their winter heating bill often
    face desperate choices. A 1999 survey of LIHEAP recipients in Iowa
    revealed that when the heating bills were unaffordable, almost 21
    percent went without medical care, 12.3 percent went without food and
    19 percent went to bed early with lots of blankets.\3\ Analysis of
    recent data from the U.S. Department of Energy, Energy Information
    Administration show that in 1997, about 2.1 million households suffered
    from loss of heat. All but 154,000 of the households were LIHEAP
    eligible.\4\ The average period without heat was 3.3 days.\5\ The
    consequences of disconnections include, health and safety risks
    associated with alternative heat and lighting sources, such as kerosene
    and candles; hunger and malnutrition; hyperthermia and hypothermia and
    eviction and increased homelessness.
    ---------------------------------------------------------------------------
        \3\ Preliminary results of a survey by the Department of Human
    Rights, Community Action Agencies, Des Moines Iowa. The final results
    are expected in May 2000.
        \4\ Derived from 1997 Residential Energy Consumption Survey (RECS),
    database files, Energy Information Administration, U.S. Department of
    Energy, Washington, DC. 1999.
        \5\ Id.
    ---------------------------------------------------------------------------
        Census statistics also show a widespread need for the LIHEAP
    program.

    HOUSEHOLDS ELIGIBLE FOR LIHEAP OUT OF 91,993,582 TOTAL HOUSEHOLDS IN THE
                                  UNITED STATES
    ------------------------------------------------------------------------
                                                                    Percent
                     Proverty level                   Number of      total
                                                      households  households
    ------------------------------------------------------------------------
    Greater of 60 percent SMI \1\ or 150 percent of   24,136,925        26.0
     poverty.......................................
    150 percent poverty or below...................   18,718,748        20.0
    125 percent poverty or below...................   14,796,445        16.0
    110 percent poverty or below...................   12,335,430        13.4
    ------------------------------------------------------------------------
    \1\ State Median Income.

    Source: Compiled from U.S. Dept. of Health and Human Service, LIHEAP
      Division of Energy Assistance/OCS/ACF table on number of all low-
      income households, by census region and state based on 1990 Census
      data.

        At its peak, regular, non-emergency, funding for LIHEAP was $2.1
    billion in 1985. Since then, regular block grant funding has been cut
    back to $1.1 billion in fiscal year 1999 and 2000. Consistent with the
    cutback in funding is the reduction of the number of households served.
    According to the Administration for Children and Families, U.S.
    Department of Health and Human Services, the number of federally
    eligible households using LIHEAP assistance dropped from 7.5 million
    households in 1981 to 4.4 million households in 1996.\6\
    ---------------------------------------------------------------------------
        \6\ U.S. Department of Health and Human Services, Administration
    for Children and Families, September 1999, ``LIHEAP Home Energy
    Notebook for fiscal year 1997'', p. 27.
    ---------------------------------------------------------------------------
        At the same time, the percent of LIHEAP recipients' home heating
    bills covered by LIHEAP has been diminishing as the amount of
    recipients' total heating bills has been increasing. In 1981, LIHEAP
    covered around 23 percent of the total bills and since 1987, this
    percentage has steadily dropped from 19 percent in 1987 to 8 percent in
    1996.\7\ At the same time total home heating bills have increased in
    current dollars from $7.0 billion in 1981 to $7.9 billion in 1987 to
    $10.6 billion in 1996.\8\
    ---------------------------------------------------------------------------
        \7\ Id at 29.
        \8\ Id at 29.
    ---------------------------------------------------------------------------
        Who is hit hardest by the reduction in LIHEAP funding? It is
    estimated that 43 percent of LIHEAP eligible households have
    children.\9\ A recent survey by the National Energy Assistance
    Directors Association released in September 1997, showed that of the
    1.2 million households that lost LIHEAP assistance between fiscal year
    1995 and fiscal year 1997, 313,000 had at least one elderly member and
    156,000 had at least on disabled member.
    ---------------------------------------------------------------------------
        \9\ Oak Ridge National Laboratories, ``The Scope of the
    Weatherization Assistance Program: Profile of Population in Need''
    March 1994. p. xii.
    ---------------------------------------------------------------------------
        LIHEAP recipients also tend to be on the low-end of the poverty
    scale. For example, in fiscal year 1995, around 40 percent of
    households that received assistance were under 75 percent of the
    poverty level.\10\ The proportion of energy costs to household income
    is called the energy burden. In 1995, NCLC completed a study that
    illustrated the disparity in energy burden between average residential
    and low-income households. We found the burden for the average
    residential household is 3.8 percent, while low-income households pay
    far more. Households receiving welfare assistance paid an average of 26
    percent of their income on energy, Social Security recipients paid
    around 14 percent and minimum wage households paid around 12
    percent.\11\
    ---------------------------------------------------------------------------
        \10\ U.S. Dept of Health and Human Services, Report to Congress for
    fiscal year 1995: Low-Income Home Energy Assistance Program, p.30,
    Table 12.
        \11\ National consumer Law Center, ``Energy and the Poor: The
    Crisis Continues,'' January 1995, chpt. II.
    ---------------------------------------------------------------------------
               liheap can move households toward self-sufficiency
        LIHEAP is a block grant that targets assistance to low-income
    households who pay a high proportion of household income on home
    energy, assists eligible families in crisis situations, and among other
    things, provides low-cost weatherization to reduce household energy
    costs.\12\ Increased funding for LIHEAP could work towards reducing
    dependence on energy assistance in the first place. As noted by Vicky
    Mroczek, Chief of the Office of Community Services, Ohio Department of
    Development and the Director of Ohio's LIHEAP program: Reduction in
    energy assistance dependence over time is self-evident with respect to
    weatherization, but I think it's also true on the bill assistance side.
    When someone goes into debt to maintain utility service, there are
    costs or other needs that go unmet. When someone owes the utility money
    over a long period, ratepayers bear that expense, too. An unpaid final
    utility bill on a credit report impinges on a person's ability to buy
    or rent housing; sometimes it can show up when a potential employer
    does a background check. Loss of utility services also affects
    education performance due to excessive moving or unhealthy conditions
    in the home.
    ---------------------------------------------------------------------------
        \12\ 42 U.S.C. section 8624(b).
    ---------------------------------------------------------------------------
                       emergency contingency liheap funds
        Emergency contingency funds are a critical resource in times of
    crisis, but should not be counted as part of the overall amount of
    funding a state has to plan a program. Emergency contingency funds are
    released only after the emergence of a full-blown crisis, which may
    arise after the program has shut down for the season. Maintaining
    current funding levels for LIHEAP regular and emergency contingency
    funding in lieu of restored regular funding will continue to place
    vulnerable low-income and elderly households in potentially life-
    threatening situations time and time again. A more rational approach
    would be to increase the current level of the regular funding so that
    programs can effectively plan ahead for crisis situations to mitigate
    the danger to safety and health.
                               the private sector
        Fuel funds, a form of non-federal energy assistance, play an
    important role in helping those Americans in dire need of energy
    assistance; however, these funds are only a small fraction of the
    LIHEAP. The National Fuel Funds Network estimates that in 1998, around
    $88 million in non-federal energy assistance was raised nationally.
    These private sector funds are critical, but simply not large enough to
    provide the amount of energy assistance to eligible Americans as the
    LIHEAP and cannot fill the gap left by reduced levels of regular LIHEAP
    funding.
                                   conclusion
        We urge the restoration of LIHEAP assistance to, at a minimum, $1.5
    billion in regular appropriations for fiscal year 2001 and $1.6 billion
    in advance appropriation for 2002. Restored levels of regular funding
    will enable state agencies design a stronger program for the upcoming
    fiscal year. Finally, the need for LIHEAP assistance continues,
    especially as states implement welfare reform and, as demonstrated this
    past winter with the home heating oil price crisis, inadequate funding
    levels place the health of financially vulnerable families in jeopardy.
                                     ______

        Prepared Statement of the National Alliance for the Mentally Ill

        Chairman Specter, Senator Harkin and members of the Subcommittee, I
    am Jim McNulty, of Bristol, Rhode Island, a member of the Board of
    Directors of the National Alliance for the Mentally Ill (NAMI). I am
    pleased today to offer NAMI's views on the Subcommittee's fiscal year
    2001 bill that are of tremendous concern to people with serious brain
    disorders and their families.
                                  who is nami?
        NAMI is the nation's largest national organization, 210,000 members
    representing persons with serious brain disorders and their families.
    Through our 1,200 chapters and affiliates in all 50 states, we support
    education, outreach, advocacy and research on behalf of persons with
    serious brain disorders such as schizophrenia, manic depressive
    illness, major depression, severe anxiety disorders and major mental
    illnesses affecting children.
        Like so many NAMI members, mental illness has directly affected my
    life. In 1986, I was first diagnosed with bipolar disorder, also known
    as manic-depressive illness.
        Mr. Chairman, for too long severe mental illness has been shrouded
    in stigma and discrimination. These illnesses have been misunderstood,
    feared, hidden, and often ignored by science. Only in the last decade
    have we seen the first real hope for people with these brain disorders
    through pioneering research that has uncovered both a biological basis
    for these brain disorders and treatments that work. From NAMI's
    perspective, this progress was confirmed for all Americans through two
    watershed events in 1999--the White House Conference on Mental Health
    on June 7 and the release of the Surgeon General's Report on Mental
    health on December 13. Taken together, these two events brought
    together national leaders and the most comprehensive scientific report
    ever to substantiate what we have been saying for years--that severe
    mental illnesses are brain disorders that are treatable. As the Surgeon
    General noted, current success rates for treating schizophrenia are
    near 60 percent. Likewise, the success rate for bipolar disorder has
    risen in recent years and now approaches 80 percent. For major
    depression, the rate has climbed to nearly 65 percent. These recent
    advances would not have been possible without substantial investment in
    biomedical research directed to the most complex organ in the human
    body, the brain.
                   severe mental illness research at the nih
        The year 2000 marks the end of the Decade of the Brain--an
    initiative that grew out of the leadership of your colleagues former
    Senator Mark Hatfield of Oregon and the late Senator and Governor
    Lauton Chiles of Florida--it is important for us to put into
    perspective the gains we have witnessed in brain science that have
    benefited people with serious brain diseases such as schizophrenia and
    other severe mental illnesses. We also need to plan for the future
    gains that are so necessary.
        I noted earlier that severe mental illnesses are often quite
    effectively treated. In fact, tremendous advances in treatment of
    severe mental illnesses occurred during the last ten years, the Decade
    of the Brain, from the introduction of Prozac and Clozapine and other
    new drug discoveries that have virtually revolutionized mental illness
    treatment. Today, many more consumers, patients with serious mental
    illnesses, stand able to take charge of their lives, to be productive,
    to enjoy recovery, because of these treatment advances.
        But we should not underestimate how much more must be learned about
    the brain regions involved in these serious mental disorders, the
    molecules at the roots of the terrible symptoms, and the genes that
    lead to vulnerability to these illnesses. The Decade of the Brain has
    really only brought us to the threshold of discovery when it comes to
    brain diseases such as schizophrenia, manic-depressive illness,
    obsessive-compulsive disorder, childhood mental illnesses and others.
    We are only now poised to fully probe and finally understand the
    biological underpinnings of the most serious mental illnesses.
        Treatment for mental illnesses, while impressive and comparable to
    some of the best treatments in all of medicine, are still unacceptable
    for patients, families, and our society. Many people with severe mental
    illnesses find only incomplete relief from their symptoms; disability
    is still all too commonly associated with these illnesses. In my case,
    treatment for bipolar disorder has proven effective, but never for all
    of the symptoms. Individuals with obsessive-compulsive disorder, a
    brain disorder which has been pinpointed to specific higher regions of
    the brain, still often fail to achieve much gain in treatment. For
    children matters are worse because we know so little about the
    illnesses as they emerge during development, and we know even less
    about how to effectively and safely treat them.
        The national need for severe mental illness research is most
    starkly demonstrated by particularly terrible statistics. Our nation
    stands in the midst of a virtual catastrophe: a suicide epidemic.
    Suicide is the eighth most common cause of death in this country and
    the fourth most frequent cause of life lost under age 65. Rates are
    increasing among young men and the elderly. As it stands, 30,000
    Americans will die by suicide this year, most of whom have a serious
    mental illness. The most severe mental illnesses--schizophrenia and
    bipolar disorder-disproportionately lead to suicide. Ten percent of the
    2,000,000 U.S. citizens with schizophrenia are take their lives; about
    half will make a suicide attempt at some point. Fifteen percent to 20
    percent of the approximately 2,000,000 Americans with bipolar illness
    will die by suicide.
        That severe mental illness research ought to be a priority for our
    nation is also demonstrated by data from the World Bank and World
    Health Organization. Severe mental illnesses--major depression, bipolar
    disorder, schizophrenia, and obsessive-compulsive disorder--account for
    four of the top 10 most disabling illnesses in the world. These brain
    disorders account for an estimated 20 percent of total disability
    resulting from all diseases and injuries.
        Mr. Chairman, the public health burden to our nation from severe
    mental illnesses requires that research on these diseases be a high
    priority, especially given the scientific opportunities that exist in
    the brain sciences. Let me concentrate now on what we think are sound
    goals for NIH and NIMH, respectively, so that we can bring the full
    force of our research to bear on this most important health emergency.
        nih investment: a call for increased funding and accountability
        NAMI applauds your leadership in supporting increases for the NIH.
    We urge the Subcommittee to follow the recommendations of the
    scientific community and the Ad Hoc Group for Medical Research Funding
    and increase overall funding for NIH by $2.7 billion (a 15 percent
    boost) for fiscal year 2001, up to $20.5 billion. Such an increase
    would keep Congress on pace to reach the bipartisan goal of doubling
    NIH funding by 2003.
        But increased resources are not the only important objective for
    NIH: better accountability is also essential. NAMI applauds your
    efforts to fairly boost NIH funding and limit disease-of-the week
    approaches to appropriations. Nonetheless, we urge you to press NIH to
    invest their resources according to public health need as well as
    scientific opportunity, as the 1998 Institute of Medicine (IOM) report
    on NIH priority setting called for. NIH must balance its investment
    among diseases so that increases in the budget go preferentially to
    address illnesses that are disabling and costly and have been
    underfunded in the past.
        It is obvious to NAMI that severe mental illnesses would, and
    should be, a top research priority if public health burden is the
    principal criteria by which public research dollars are allocated. Yet,
    based on NIH's own recent estimates, $1.00 is invested in research for
    every $6.86 in costs of AIDS, $9.96 in costs of cancer, $65.65 in costs
    of heart disease, and $161.26 costs in schizophrenia. In other words,
    15 cents is spent on AIDS research per dollar of costs, compared with
    10 cents for cancer, two cents for heart disease, and less than one
    cent for schizophrenia. This is obviously not a wise research
    investment strategy for the United States.
             nimh: the key to the cure for severe mental illnesses
        For NIMH, we also applaud this Subcommittee's leadership,
    demonstrated by your boosting its appropriations significantly in the
    past few years and by nearly 15 percent in fiscal year 2000, up to its
    current level of $978.4 million. For fiscal year 2001, NAMI urges the
    Subcommittee to fund the NIMH up to the ``professional judgment''
    recommendation of $1.169 billion. While NAMI applauds the President's
    request to increase NIMH's budget by 5.9 percent, up to $1.031 billion,
    we believe that the ``professional judgment'' recommendation needed in
    order to increase the agency's success rate for reviewed grants to at
    least 750 new and competing grants. NIMH is currently attracting more
    research grant applications than any other institute due to the
    leadership of the institute and the tremendous research opportunities
    that exist in the neuroscience's and in severe mental illness research.
    NAMI believes that we must ensure that this time of interest, strong
    leadership, and research opportunity is taken--so that people with
    serious brain diseases have the best hope for the future, for
    themselves and for their families and future generations.
        We urge you, Mr. Chairman, to help ensure that NIMH continues its
    move to spend its taxpayer dollars wisely, with investments in basic
    neuroscience and molecular biology that will undergird the new
    treatment frontier for severe mental illnesses and also with strong
    commitments to serious brain disorders directed towards pre-clinical,
    clinical, and services research. NIMH should continue its efforts to
    identify genes linked to severe mental illnesses; to fund and expand
    clinical research into psychotic illnesses, serious disorders in
    children, and in mood disorders; to continue the probe of the biology
    of serious mental disorders including schizophrenia, mood, and anxiety
    disorders.
        NIMH should also use the tools of behavioral science to better
    understand the expression and best treatment of severe mental
    illnesses. However, NAMI strongly recommends that research in
    prevention and psychosocial research should be redirected in order to
    address problems associated with serious mental illnesses, consistent
    with the recommendations of NIMH's own National Advisory Mental Health
    Council. We agree with the recommendations of the Council that the
    prevention research portfolio has all but excluded serious mental
    illness research and instead focused on basic behavioral science issues
    and or social problems such as adolescent relationships, divorce or
    poor self-esteem. NAMI believes that we cannot let another five years
    go by studying children who misbehave while we know so little about
    serious mental illnesses in children and how to effectively treat these
    disorders.
        What research issues are most compelling for our members, the more
    than 210,000 Americans facing a serious brain disorder? (1) More basic
    research on the brain and higher brain functioning. (2) More pre-
    clinical research on the genes, molecules, and brain regions involved
    in severe mental illnesses. (3) More clinical research aimed at
    understanding the best treatment for these serious disorders and
    translating that research into practice. (4) More research aimed at
    better understanding and treating these brain disorders in children.
    (5) Research aimed at diminishing relapse and disability in severe
    mental illnesses. (6) More research on how people with severe mental
    illnesses best receive treatment and services. (7) An accountable and
    responsible research investment strategy that will help the nation's
    individuals with severe mental illnesses and their families, as well as
    the country at large, which must shoulder the burden and costs of these
    illnesses.
        Finally, Mr. Chairman, NAMI would like to urge that NIMH's
    colleague institutes, the National Institute on Drug Abuse (NIDA) and
    the National Institute on Alcohol and Alcoholism (NIAAA) be directed to
    work cooperatively with NIMH and the pressing public health crisis
    posed by persons diagnosed with a severe mental illness who have a co-
    occurring substance abuse problem. NAMI believes that a large and
    growing body of scientific evidence is making clear that integrated
    treatment, as opposed to parallel and sequential treatment, is the most
    effective means of treating these co-morbid disorders. NAMI urges that
    NIMH, NIDA and NIAAA should work in partnership to ensure that progress
    continues in our efforts to better understand co-occurring mental
    illness and chemical dependency.
                                samhsa and cmhs
        Mr. Chairman, in addition to urging the Subcommittee to support
    increased funding for brain research, I would also like to note the
    importance of federally funded mental illness services through the
    Center for Mental Health Services at SAMHSA. Federal support for
    community-based care is a critical resource for people with the most
    severe mental illnesses. With many states reducing their psychiatric
    hospital beds and a growing number moving toward managed care systems,
    the federal investment in community-based care continues to grow in
    importance. For example, funding for the Mental Health Block Grant
    (MHBG) now constitutes as much as 40 percent of all non-institutional
    services spending in some states.
        In the President's fiscal year 2001 budget proposal, a $60 million
    increase is proposed for the MHBG (up from its fiscal year 2000
    appropriation of $356 million, to $416 million). While NAMI is
    extremely grateful for the $68 million increase that the Subcommittee
    enacted for fiscal year 2000, the reality is that this boost in
    resources is not enough to keep pace with the continued widening of
    gaps in the public mental illness treatment system in many states. The
    consequences of these emerging cracks in the service system are readily
    apparent, not just to NAMI's consumer and family membership, but also
    to the public: the growing number of homeless adults on our nation's
    streets who receive no treatment services, well publicized tragic
    incidents involving individuals with severe mental illness who are not
    accessing adequate treatment services and the growing trend of
    ``criminalization'' of mental illness and the stress it is placing on
    state and local jails and prisons.
        The causes of these growing gaps in the services are varied and
    complicated: the trend toward privatizing state Medicaid programs
    through contracting with private managed care firms, cuts in Medicaid
    Disproportionate Share Hospital (DSH) funding and expansion of the
    mission of public mental health programs beyond serving the most
    severely disabled consumers. Moreover, in recent years state mental
    health agency budgets have been under increasing pressure as a result
    of forces beyond their control. Among these forces are restrictions on
    eligibility for SSI and SSDI for people whose disability is based in
    part on drug abuse or alcoholism and a 1997 U.S. Supreme Court decision
    allowing states to commit sexually violent predators to state
    hospitals.
        In addition to supporting the Administration's proposed increase,
    NAMI further recommends that the Subcommittee target all additional
    funds for the MHBG in fiscal year 2001 to state and local evidence-
    based, outreach-oriented service-delivery models for persons with
    severe mental illness in the community. In particular, NAMI urges that
    any increase in MHBG funding be directed to assertive community
    treatment, including the Program of Assertive Community Treatment, or
    PACT. PACT programs use a 24-hour, seven day-a-week, team approach that
    delivers comprehensive treatment, rehabilitation and support services
    in community settings. High-quality PACT programs are typically
    implemented at a cost that is significantly less than placing an
    individual in a jail, a residential treatment program or a hospital.
    PACT is especially effective in serving persons who are the most
    treatment resistant, persons with a co-occuring mental illness and
    substance abuse disorder and persons who are high users of inpatient
    hospitalization services.
        In addition, NAMI recommends that the Subcommittee consider
    requiring states to report an unduplicated count of persons served by
    diagnosis, age and services consumed using the targeted initiative MHBG
    funds. NAMI is also concerned that the Substance Abuse Treatment and
    Prevention Block Grant is not currently supporting programs serving
    persons dually diagnosed with mental illness and addictive disorders.
    As I noted above, evidence-based research, as confirmed by the NIH,
    verifies that integrated treatment, as opposed to parallel
    collaborative or sequential approaches, is the most effective model for
    serving persons with a dual diagnosis. NAMI therefore recommends that
    the Subcommittee direct SAMHSA to allow states to use funding from both
    programs to promote integrated treatment services for persons with co-
    occuring mental illness and addictive disorders.
        NAMI is pleased that the President's fiscal year 2001 budget
    proposes another $5 million increase for the PATH program (up from its
    current $30 million, to $35 million). PATH is a formula grant program
    to the states to support local programs serving homeless persons with
    severe mental illness. This increase in PATH funding will help
    communities all across the country increase access to treatment and
    supports for the growing number of homeless with severe mental
    illnesses.
        Mr. Chairman, as you know, the President's fiscal year 2001 budget
    proposes a new unauthorized line-item as part of the CMHS's programs--
    Targeted Capacity Expansion (TCE). According to CMHS's own
    justification for this request, this new $30 million is for undefined
    prevention and early intervention services for persons who are not
    diagnosed with a severe mental illness who receive services in ``non-
    mental health settings.'' While NAMI recognizes that such a new program
    could offer benefit to many communities, we believe a more pressing
    public health concern is the alarming trend of ``criminalization'' of
    severe mental illness.
        NAMI therefore urges that instead of establishing a new TCE line
    item within the CMHS budget, the Subcommittee instead direct these
    funds to a new initiative within the agency's Knowledge, Development
    and Application (KDA) program on criminalization. Such a program should
    be directed toward innovative state and local programs that (1) divert
    mentally ill, non-violent criminal defendants and convicts into
    treatment programs, (2) replicate successful models such as mental
    health courts, and (3) train police officers in how to appropriately
    interact with suspects with severe mental illnesses. NAMI is making a
    similar request to your colleagues at the Commerce-Justice-State
    Appropriations Subcommittee for a program of similar scope and purpose
    at the Bureau of Justice Assistance.
        In January, The Charlotte Observer ran a five-part investigative
    series that reported since 1994, at least 35 people with mental or
    developmental disabilities have died under questionable circumstances
    while under the care of public and private mental health facilities in
    North Carolina. Deaths were attributed to suicide, murder, neglect,
    scalding, and falls, and most went unnoticed by the agencies authorized
    with investigating such deaths. NAMI recommends that resources be
    targeted to fund Protection and Advocacy agencies to investigate
    questionable deaths and serious injuries, like those deaths in North
    Carolina that have resulted from restraint abuse.
        Unfortunately, the Charlotte Observer series is just one of several
    investigative media reports over the last year that have exposed
    systemic failures to provide adequate treatments and services to
    individuals with severe and persistent mental illnesses. The Los
    Angeles Times, The New York Times, The Hartford Courant, and The
    Orlando Sentinel have revealed a pervasive pattern of neglect by state
    mental health systems. The need for further investigation, a system of
    accountability and mandatory reporting of deaths and serious injuries
    will help ensure that individuals with mental illnesses don't lose
    their lives in the very places designed to help them.
                                  dol and ssa
        Finally, beyond the NAMI's traditional concerns with NIMH and CMHS,
    I would like to note two other departments under the Subcommittee's
    jurisdiction that are of concern to NAMI--the Department of Labor (DoL)
    and the Social Security Administration (SSA). With regard to DoL, NAMI
    would like to go on record in support of the Administration request to
    establish a new Assistant Secretary position for disability policy. At
    SSA, NAMI would like to express our strong support for full
    implementation of the Ticket to Work and Work Incentives Improvement
    Act (TWWIIA) and fiscal year 2001 funding for the new work incentives
    planning and outreach program. NAMI would like to thank you for your
    strong support for TWWIIA last year. Enactment of both these proposals
    will help ensure that progress is made in addressing the barriers to
    work that still leave more than 80 percent of adults with severe mental
    illnesses unemployed and out of the economic mainstream.
                                   conclusion
        Mr. Chairman, thank you for the opportunity to offer NAMI's views
    on fiscal year 2001 funding for programs of critical importance to
    people with serious brain disorders. NAMI looks forward to working with
    you in the coming months to educate both the general public and your
    colleagues in Congress about the critical importance of investment in
    biomedical research and improved services for people living with severe
    mental illness.
                                     ______

      Prepared Statement of the American Public Transportation Association

        The American Public Transportation Association (APTA) appreciates
    this opportunity to testify on the fiscal year 2001 Labor, Health and
    Human Services, Education and Related Agencies Appropriations bill.
    About APTA
        APTA's 1,270 member organizations serve the public interest by
    providing safe, efficient and economical public transportation service,
    and by working to ensure that those services and products support
    national transportation, energy, environmental, community, and economic
    goals. APTA member organizations include transit systems; design,
    construction and finance firms; product and service providers; academic
    institutions, and state associations and departments of transportation.
    More than ninety percent of the people who use transit in the U.S. are
    served by APTA member systems.
        We submit testimony to this Subcommittee to make the point that
    public transportation can make a difference in how people get to jobs,
    health care, training, and other social services. According to the
    Federal Transit Administration (FTA), 32 million senior citizens rely
    on transit as their driving ability decreases with age; 27 million
    people with disabilities depend on transit to maintain their
    independence; 37 million people living below the poverty level often
    cannot afford a car and use transit to reach jobs. There are 56 million
    children under driving age, many of whom use transit to travel to and
    from school and for after-school activities. Transit ridership has
    grown by more than 15 percent over the past four years and annual
    ridership exceeds the 9 billion mark.
    Overview
        Mr. Chairman, we bring a message about the role public
    transportation can and does play in providing services to millions of
    Americans. We ask that the Subcommittee consider three issues of
    particular importance to public transit. First, APTA requests that the
    Subcommittee direct the Department of Transportation (DOT) and the
    Department of Health and Human Services (HHS) to complete joint
    coordination guidelines on human services transportation as soon as
    possible. Second, we urge the Subcommittee to highlight the role that
    public transportation can play in providing cost-effective access to
    health care and to work--made better by improved coordination. Finally,
    we urge the Subcommittee to continue to provide and encourage
    flexibility with regard to HHS funding being used to pay for the
    transportation costs of HHS clients--especially those individuals with
    special transportation needs. Transit agencies have the expertise and
    infrastructure to provide transportation, and we think that social
    service agencies could save money on transportation service by working
    with transit agencies. The Federal Government has already invested in
    public transportation. Let's not pay twice by allowing separate special
    purpose systems to be built and subsidized.
        Mr. Chairman, transit is delivering. U.S. transit ridership was up
    more than 4.5 percent in 1999.\1\ Ridership is on the rise in every
    mode, including a 5 percent increase in demand response service.
    Moreover, these vital services, which provide the only source of
    mobility for individuals with disabilities and our elderly population,
    are seeing a dramatic increase in areas all across America--both rural
    and urban. Demand response services are on the rise in places like
    Springfield, Illinois; Milwaukee, Wisconsin; Pensacola, Florida; Waco,
    Texas; Fort Myers, Florida; Dallas, Texas; Miami, Florida; and
    Baltimore, Maryland.
    ---------------------------------------------------------------------------
        \1\ APTA Transit Ridership Report, Fourth Quarter 1999.
    ---------------------------------------------------------------------------
    Background
        According to the U.S. General Accounting Office (GAO), federal
    efforts to streamline the delivery of human services transportation by
    DOT and HHS began as early as 1986 with the establishment of a
    Coordinating Council.\2\ Over a course of years, the Council
    successfully identified numerous barriers standing in the way of
    transportation coordination. However, due to jurisdictional problems,
    the Council was unable to fully respond to these barriers. Moreover,
    even when the Council reached out to the States in the mid 1990's, the
    majority of barriers that were identified were too general to be acted
    upon with any significant federal response.\3\
    ---------------------------------------------------------------------------
        \2\ TRANSPORTATION COORDINATION: Benefits and Barriers Exist, and
    Planning Efforts Progress Slowly. October, 1999. (Hereinafter, GAO
    Report).
        \3\ GAO Report, Page 3.
    ---------------------------------------------------------------------------
        In fiscal year 1997, report language first appeared in both the
    Transportation and Related Agencies and Labor, Health and Human
    Services Appropriations bills, calling for the development of joint
    planning guidelines to specifically address the use of public
    transportation in the delivery of human services transportation. APTA,
    having worked with Congress to encourage this collaboration, was
    pleased that the bills directed DOT and HHS to develop joint guidelines
    for coordination of transportation services, including joint
    identification of human services client transportation needs and the
    appropriate mix of transportation services to meet those needs; the
    expanded use of public transit services to deliver human services
    program transportation; and cost-sharing arrangements based on a
    uniform accounting system for HHS program recipients transported by
    paratransit systems.
        Although the joint guidelines have not yet been released, we are
    hopeful that DOT and HHS will be in a position to release a working
    draft in the near future. Nevertheless, we again urge this Subcommittee
    to direct HHS and DOT to complete their joint coordination guidelines
    as soon as possible, and to consider the feasibility of involving other
    federal agencies, such as the Department of Labor, in the process.
    GAO Report Cites the Value of Transportation Coordination
        The report issued by the GAO notes that transportation coordination
    can have numerous benefits. It also recommends a number of ways that
    DOT and HHS can better coordinate their activities. They include:
      --requiring the Coordinating Council to issue a prioritized strategic
            plan by a specific date.
      --charging the Council with developing an action plan with specific
            responsibilities.
      --requiring an annual report from the Council on its major
            initiatives and accomplishments.\4\
    ---------------------------------------------------------------------------
        \4\ GAO Report, Page 20.
    ---------------------------------------------------------------------------
        APTA fully agrees with the recommendations made in the GAO report.
    During this period of tight budget caps, every dollar dedicated to
    human services transportation by transit agencies can be stretched
    further if coordination is implemented at the federal level and
    encouraged at the State and local level. These joint guidelines will be
    invaluable in providing policy guidance for coordination activities by
    transportation agencies and human service providers at the local level.
    If we can't get the necessary guidance at the federal level, how can we
    expect coordination at the local level?
    TEA 21 Planning Provisions
        We are pleased to note that the principal federal surface
    transportation infrastructure investment law, the Transportation Equity
    Act for the 21st Century (TEA 21), includes numerous provisions that
    deal specifically with the importance of coordination of transportation
    activities. First, the bill requires DOT to encourage metropolitan
    planning organizations in developing local transportation plans to
    coordinate the design and delivery of transportation services by all
    entities receiving federal funds for transportation purposes. Another
    TEA 21 section requires government agencies and nonprofit organizations
    receiving assistance from government sources other than DOT for non-
    emergency transportation services to coordinate the design and delivery
    of transportation services. The law also requires transportation plans
    to be consistent with air quality goals under the Clean Air Act.
    Clearly, transportation services are coordinated with many federal
    programs to improve overall efficiency.
       public transportation provides affordable access to non-emergency
                                  health care
        Mr. Chairman, we continue to stress the importance of coordinating
    transit service with other government functions because of the great
    potential for saving tax dollars at all levels of government. To lower
    costs, non-driving outpatients may travel to health care by transit.
    The alternative may be expensive taxi or ambulance service. Rather than
    using paratransit services (which can cost 10 times the amount of
    traditional transit fares),\5\ physically able clients can save
    themselves and human services agencies significant money by taking
    other types of public transportation. For example, across the nation,
    transit vans carry thousands of people to and from dialysis treatment,
    saving as much as $200 to $400 per trip as compared to specialized
    medical transportation services.
    ---------------------------------------------------------------------------
        \5\ GAO Report, Page 7.
    ---------------------------------------------------------------------------
        During the past decade, transit systems have made it increasingly
    possible for transit services to be available to all Americans.
    Wheelchair accessible buses increased from 40 percent of the fleet in
    1990 to 77 percent of the fleet in 1999. Similarly, commuter rail
    operators reduced the number of non-accessible rail cars by more than
    half over the same period. Moreover, virtually all fixed route bus
    service is now accessible to individuals with disabilities.
        In 1997, the Health Care Financing Administration estimated that it
    was spending approximately $1.2 billion annually in non-emergency
    medical transportation. Since then, many state Medicaid offices have
    found waste, fraud and abuse within their transportation systems and
    have improved the delivery of transportation services at a reduced cost
    by coordinating with local public transit operators. In fact, 20
    percent of the nation's Medicaid rides are now on public transit.
    According to the FTA, in four major programs--Medicare, Medicaid, Food
    Stamps, and Unemployment Compensation--each dollar invested in low-cost
    mobility services reduces the transportation cost of these programs by
    approximately 60 percent.
           public transportation delivers people from welfare to work
    Transit Provides American's Access to Jobs; Employers Gain Access to
            New Talent
        During the late 1990's, Congress and the 50 States took positive
    steps to get people off welfare and into the workforce. At the same
    time, a healthy economy has created thousands of new jobs. However, due
    to America's changing landscape and the growth of suburban sprawl, many
    of these new jobs are located in the suburbs. How can we bring people
    who live in central cities, many of whom have no automobile, out to
    where the jobs are? Public transportation agencies, in coordination
    with State and local social service agencies and the private sector,
    have responded to the challenge.
        One of the best examples of a successful access to work program
    (and the value of coordination) is New Jersey Transit's ``WorkPass''
    Program--a comprehensive transportation service and educational program
    developed to assist public and non-profit agencies in their efforts to
    move people from welfare to work. The program has provided assistance
    to more than 50 public and non-profit organizations, including county
    welfare agencies, Medicare agencies, and other social service
    organizations who offer public assistance for transportation to jobs,
    medical assistance and childcare. Partnering with the New Jersey
    Department of Transportation as well as the State's human services
    agency, New Jersey Transit was able to have a working program within
    one month, and more than 5,000 monthly passes and one-way tickets are
    purchased by WorkPass members each month. The transit agency notes that
    the success of the program is due to the partnerships it has formed and
    its ability to adapt to the different agencies seeking its services.
        WorkPass is more than just a pass sales program--it has a
    comprehensive training program which has trained more than 500 welfare
    and other social service agency representatives. These representatives
    are taught to read schedules, determine fares and accessibility and
    provide special transportation services to their clients. New Jersey
    Transit provides each member with a resource center stocked with
    schedules, maps, fare charts and other transit information. WorkPass
    provides participants with access to job training and education,
    employment opportunities, medical visits, and childcare--all while
    learning the valuable commuting skills they need to succeed when
    employed.
        The cost savings as a result of this program have been tremendous.
    Under the WorkPass Program, instead of providing their clients with a
    $6 per diem, welfare agencies reduce transportation costs by using bus
    and rail monthly passes. County welfare agencies are saving between 50
    percent--60 percent on each WorkPass participant--an estimated $2
    million saved in transportation costs for its members.
    More Coordination Needed To Deliver People from Welfare to Work
        Mr. Chairman, the successful New Jersey program is representative
    of the commitment the entire U.S. transit industry has put forth in the
    effort to assist individuals making the difficult transition from
    welfare to work. In October 1998, an APTA Access to Jobs Task Force was
    created to help coordinate and assess APTA member welfare to work
    activities. New services include new routes to employment locations
    outside the existing service area; more direct service to reduce very
    long trip times; late night and early morning service; so-called
    reverse commute service; and shuttles from rail stations and the ends
    of bus routes to dispersed job locations. The negative impact that
    these extra efforts may have on transit budgets is easily outweighed by
    the changes the programs have made in people's lives.
        APTA believes that an awareness of problems encountered by
    organizations in their welfare to work activities may help other
    agencies avoid the pitfalls that could reduce the effectiveness of
    their welfare to work programs. Therefore, we asked our member
    organizations to describe some of the most common problems that they
    have encountered in implementing welfare to work activities. Not
    surprisingly, APTA's 1999 Access-To-Work Best Practices Survey Summary
    Report reveals that throughout America, the lack of coordination is the
    number one reason that some well intentioned welfare to work projects
    have fallen short of their goals.
        For example, lack of coordination has hampered programs in
    Missouri. In St. Louis, there has been a lack of meaningful cooperation
    with the training staffs of human services agencies. Also, City
    Utilities of Springfield has experienced difficulty in coordinating
    information from all the various social service agencies involved with
    their welfare to work program. In fact, in order for them to put
    together a comprehensive regional plan, the assistance of an outside
    consulting company was required to gather all information. Moreover, in
    Texas, transportation coordination with human services agencies is
    sorely needed in the Fort Worth Transportation Authority's (The T)
    attempt to identify employers willing to hire welfare recipients, and
    to find strong candidates for certain jobs. Moreover, the transit
    agency says that coordinating various funding sources has been quite
    difficult--local social services partners are burdened with the task of
    tracking separate data from separate Federal agencies, including DOL
    and HUD. This requirement has been a major barrier in streamlining
    funding for Tarrant County's welfare to work initiatives.
        Some 94 percent of welfare recipients attempting to move into the
    workforce do not own cars and must rely on public transportation to get
    to work. And while 60 percent of welfare recipients live in central
    cities, the majority of new jobs are in the suburbs. If we as a nation
    wish to continue the positive trends in getting more people into
    decent, productive employment, we must provide the necessary
    coordination and guidance at the federal level to get them there. In
    the TEA 21 section authorizing the Job Access and Reverse Commute
    Program, DOT is required to ``coordinate activities with related
    activities under programs of other federal departments and agencies.''
    Eligible Access to Jobs projects financed under that section must be
    ``part of a coordinated public transit-human services transportation
    planning process.'' \6\ Mr. Chairman, we need the help of the
    Coordinating Council's joint guidelines in order to fully implement
    this provision.
    ---------------------------------------------------------------------------
        \6\ TEA 21, Section 3037.
    ---------------------------------------------------------------------------
        Mr. Chairman, we've come so far in the last ten years with respect
    to providing people on public assistance with access to decent jobs.
    But without a concerted effort to improve coordination at the federal
    level, there's a limit on the amount of services our transit agencies
    and state DOT's can provide. Coordination is absolutely crucial to the
    future success of the welfare to work initiative.
       increased funds are required to maintain ada compliance standards
        Since the enactment of the Americans with Disabilities Act, transit
    agencies have made huge progress in their effort to ensure that all
    forms of public transportation are accessible to individuals with
    disabilities. But public investment for further on-vehicle lift, ramp
    and station improvements must keep pace in order for transit agencies
    to maintain Federal standards. More than 100 million trips were
    provided on demand responsive public transit in 1999, at an estimated
    total capital and operating cost of $1.4 billion. Accordingly, APTA
    urges this Subcommittee to continue to provide and encourage
    flexibility with regard to HHS funding being used to pay for the
    transportation costs of HHS clients. This is also an area where the
    joint guidelines would go far in ensuring HHS programs retain their
    commitment to making adequate transportation resources available.
                                   conclusion
        In closing, Mr. Chairman, we again thank you for this opportunity
    to convey our message about the critical role public transportation can
    and does play in providing services to millions of Americans. We ask
    that in developing the fiscal year 2001 Labor, Health and Human
    Services and Education bill, the Subcommittee direct the Department of
    Transportation and the Department of Health and Human Services to
    complete the joint coordination guidelines on human services
    transportation that have been requested by Congress. Second, we urge
    the Subcommittee to highlight the role that public transportation can
    play in providing cost-effective access to health care and to work--
    made better by improved coordination. Finally, we urge the Subcommittee
    to continue to provide and encourage flexibility with regard to HHS
    funding being used to pay for the transportation costs of HHS clients--
    especially those individuals with special transportation needs.
        Once again, we appreciate your consideration of our views. APTA
    would be pleased to provide you additional information to assist you in
    your deliberations.
                                     ______

        Prepared Statement of the National Council on Independent Living

        Chairman Specter and members of the Senate Appropriations
    Subcommittee on Labor, HHS and Education, the National Council on
    Independent Living (NCIL) thanks you for allowing us to provide written
    testimony regarding the great need to increase the funding in title
    VII, Part C of the Rehabilitation Act of 1973, as amended, by $75
    million over the next three years. This funding will allow states to
    strengthen and expand the network of centers for independent living
    throughout the country.
        The National Council on Independent Living (NCIL) is the national
    membership association of centers for independent living (CILs),
    statewide councils on independent living (SILCs), people with
    disabilities and organizations advocating for the rights of people with
    disabilities.
        CILs are community-based, non-profit corporations which are
    governed, managed and staffed by a majority of people with
    disabilities. CILs are non-residential organizations, advocating and
    providing services that support the efforts of people with significant
    disabilities to live more independently in their own homes, within our
    communities.
        Currently, there are 340 CILs, with more than 224 satellite
    locations. Of these, 229 CILs and 44 satellites are funded with the $45
    million dollars authorized through Title VII-Part C of the
    Rehabilitation Act of 1973. The balance are supported with state funds.
        A center's service area may be one county or a dozen. According to
    the Rural Institute on Disabilities, CILs cover an average of 5.7
    counties. Today, 60 percent (1,911) of our nation's counties receive
    service from a CIL. This figure is deceiving, however, because a single
    center may have the task of providing services to an area the size of
    Pennsylvania.
        NCIL is asking that the Senate Appropriations Committee make a
    strong commitment to independent living. You can do this by increasing
    funding for CILs by $75 million over the next three years.
        As described above, statewide independent living councils are
    joining in the effort to secure additional funds for CILs. SILCs are
    governor-appointed bodies which are directed by the Rehabilitation Act
    to design a network of CILs. Working in conjunction with the state
    vocational rehabilitation agencies, SILCs must develop plans which
    address the needs of our unserved and underserved communities. This
    plan is submitted to the Department of Education and summarized each
    year for your review. The following are some of the findings from 1998,
    when CILs were funded at about $40 million nationally. These figures do
    not include Massachusetts, Connecticut, and Minnesota because of their
    unique funding formulas.
    First, who did we serve?
        In 1998, CILs assisted 118,000 people with significant
    disabilities. Of these, 35 percent were from minority groups, which
    significantly exceeded the percentage of minorities in the nation as a
    whole (29.7 percent according to the Census Bureau). One might ask what
    would contribute to a success rate that makes CILs the envy of many
    service providers. Perhaps it is because over 28 percent of center
    employees are also members of minority groups.
        In the introduction, you were informed that CILs must be run by
    people with disabilities. In 1998, almost 66 percent of the staff were
    people with disabilities, including 72 percent of the decision-making
    positions. When we say 19consumer directed', we mean it.
    What about services?
        If we were VISTA, we might brag about our 2 million hours of
    community service. Or if we were a single services program, CILs would
    claim to provide services over 760,000 times. But that isn't who we
    are. CILs are about assisting people with disabilities so they can live
    more independently in their communities.
        In addition to responding to almost 340,000 requests for
    information and referral, CILs provided over 54,000 individuals with
    peer counseling services; 50,000 received assistance finding housing;
    34,000 acquired personal assistance services; 33,500 attained
    transportation services; over 54,000 individuals received independent
    living skills training, and over 6,000 became employed. In addition,
    literally tens of thousands of individuals received dozens of other
    services from CILs, including assistance in moving out of costly
    institutional settings such as nursing homes.
        In 1998, CILs helped over 1,400 people get out of nursing homes AND
    prevented over 14,500 from going into nursing homes. According to the
    1998 State Data Book on Long Term Care Program and Market
    Characteristics, the average cost of nursing home services across the
    U.S. is $34,938/person/year. As you can imagine, there is a wide
    variation in nursing home costs from state to state. In Washington, for
    instance, the annual cost was $42,340.
        Those who leave or avoid entering a nursing home are able to remain
    in their communities because they receive personal assistance and other
    community-based services. According to a 1999 report from the National
    Conference of State Legislatures, the average cost for community based
    services is $14,902 per person. In other words, when a center is able
    to help a person move from a nursing home to community-based services,
    they save taxpayers an average of $20,036. In 1998, CILs saved
    taxpayers over $318 million. Think of it: A savings of $318 million AND
    people remain in their own homes with their own families, as
    contributing members of their communities.
        Imagine the financial rewards in Alaska alone, where nursing homes
    cost $92,520 per year for each resident while home health costs $33,
    616. This amounts to a savings of $58,904 per person, per year.
        Investing in CILs for independent living makes sense.--If the
    federal CIL program were a seed or magnet project, it would claim that
    with the $39,955,310 CILs received in 1998, they were able to attract
    an additional $144 million outside of the funding from Title VII of the
    Rehabilitation Act. This includes a variety of government, private
    foundation, fundraising, and fee-for-service arrangements. In other
    words, CILs make the taxpayers' money work for us--and for their
    consumers.
        Here's another interesting fact.--The average cost for serving an
    individual at a CIL was $1,655. This amount is particularly startling
    when it is remembered that this number does not include the thousands
    of people who are served through information and referral, community
    education and systems change activities not counted in the case service
    records kept by CILs. These are individuals and groups who benefit from
    the information and referral services provided as a core service at
    every center and satellite, they are also individuals and groups served
    through community training and awareness activities, and through the
    systems change activities that result in sweeping improvements in the
    way the needs of people with disabilities are met in general.
        Thus far, this request has concentrated on statistics and data.
    NCIL doesn't want to lose track of the fact that this appeal for
    funding helps real people make real changes in their lives. Sometimes,
    in the course of advocating for change, both the fiscal and personal
    costs are lost.
        However, these things we know:
      --Additional stress will be put on our health care and housing
            systems as baby-boomers age.
      --Our nation is relying on institutions to address the needs of
            people who are elderly and/or with disabilities.
      --Institutions are expensive and much more restrictive than most
            people need.
      --Individuals, given a choice, will remain with their families and in
            their own homes, participating in community activities.
      --Oregon saved $278.3 million dollars between 1981 and 1996, by
            serving 73 percent of eligible elderly people and those with
            disabilities in the community.
      --The personal attendant services that Kansas offers under Medicaid
            waivers have saved the state $2,000 per person per year.
      --Wisconsin's Community Options program, which offers personal
            assistance and other services to keep people with disabilities
            in the community, has saved the state as much as 25 percent of
            the cost of nursing home placement for people at risk of
            institutionalization.
        In each of the above states, it is due to a strong independent
    living movement that community-based services have been as successful
    as the figures would indicate. This movement is initiated and fueled by
    strong CILs. In Oregon and Wisconsin, it was through the efforts of
    CILs that those states moved from the typical fragmentation of
    services, to a single point of entry, thus streamlining service
    delivery and significantly reducing costs.
        That's what CILs do. Here are some examples of the personal impact
    of their work:
        A man in Fulton, Mississippi was injured in an automobile accident
    and sustained a spinal cord injury. Like most who have this experience,
    this gentleman was told that he would need 24-hour care in a nursing
    home at a cost to the state of $30,000/year. A staff member from the
    satellite center in Tupelo helped him find a wheelchair, counseled him,
    and helped him get financial assistance from the state's Spinal and
    Head Injury Fund. Today, this man is living with his elderly mother and
    receiving four hours a day of personal assistance services at an annual
    cost of less than $8,000/year.
        A woman in New York was facing a life in a psychiatric center at an
    annual cost of $137,000 due to pressure from her family and her own
    lack of assertiveness. The center spent $212 to provide peer
    counseling, advocacy, and other services to help her work with her
    family and find her own apartment, where she now lives. She receives a
    HUD rent subsidy of $2,712 per year.
        The Hawaii Center for Independent Living has been helping a man who
    experiences quadriplegia return successfully to his community. In
    addition to providing independent living skills training and helping
    him access assistive technology, the center has been working with local
    vocational rehabilitation services and a small business called Custom
    Computer Consulting to tie his lights, fans, phones, and other
    appliances to his computer. Because of their efforts, he is going to
    make it!
        At the center for independent living in Hot Springs there was a
    consumer who used a power wheelchair due to paralysis, was deaf and
    visually impaired. This young woman was not very educated, had been
    labeled as having behavioral problems, and her vocational
    rehabilitation counselor had virtually given up on her. The center
    began working with her using very limited signing skills, and taught
    her typing and computer skills to improve her ability to communicate.
    Everything about her changed. Suddenly she could express herself and
    people understood her. She found a job that paid a competitive wage and
    offers benefits such as medical insurance. This woman, who had been on
    SSI all her life, is now a taxpayer. The center worked with her
    approximately two months for a total cost of less than $5,000--less
    than one year's worth of SSI payments.
        CILs keep families together. In Milwaukee, Independence First
    helped a single parent with quadriplegia. She contacted their assistive
    technology program for ideas on baby care adaptations while she was
    still pregnant. After her child was born she used the program to help
    her get an adapted baby carrier for trips into the community, and ideas
    for a lifting harness to help her get the baby onto and off of the
    floor. The technology coordinator worked with Sharon and several county
    agencies to assure that the child's care needs could be adequately met.
        In 1994, a rural nursing home contacted the center in Tulsa,
    Oklahoma. One of their residents was a young mother in her early
    thirties who had incurred a traumatic brain injury as the result of a
    car wreck. The injury had left the mother a paraplegic, with left-sided
    paralysis. The young mother wanted desperately to leave the nursing
    home and reestablish a relationship with her three small children. The
    woman's physician and her own family members refused to help relocate
    her to Tulsa. The woman didn't even have the $307 needed to pay for her
    monthly medications. Nor did she have money for food, rental or
    security deposits. After seven months, the center was successful in
    locating resources within the community and moved this mother out of
    the nursing home. Six years later, she is still living independently in
    her own apartment and enjoying being a mother.
        A young Maryland college student injured in an automobile accident
    at 24 had been discharged from a rehabilitation center into a nursing
    home in Hyattsville, Prince George's County, MD. A center for
    independent living contacted the young man who was, ``convinced I was
    going to be there forever.'' The center for independent living provided
    peer support and information about resources he could utilize to
    maximize his re-integration into the community. Today he is living in
    his own apartment, attending the University of MD, and majoring in
    computer science and graphic arts.
    Why do we need $75 million?
        Today, the CIL network reaches less than one percent of all people
    with significant disabilities in the United States. While not every
    person with disability needs a center's help, there remain vast areas
    of the U.S. where no center exists at all. Forty percent (40 percent)
    or 1,230 of our nation's counties receive no service whatsoever from a
    CIL. Hundreds more receive only superficial coverage.
        At the current rate of coverage (5.7 counties per center), The
    Rural Institute on Disabilities estimates that we need at least an
    additional 216 CILs. Some states have estimated that there should be at
    least one ``fully-funded'' center for every 500,000 persons, or an
    additional 185 CILs nationwide.
    What is a ``fully-funded'' CIL?
        Today, CILs are woefully underfunded. The average federally-funded
    CIL receives approximately $163,285 to support the operations of the
    center. Most statewide independent living councils believe that CILs
    need a strong base--anywhere from $200,000 to $500,000 per center per
    year--to do their job. The National Council on Independent Living
    (NCIL) believes a center needs at least $250,000 to support day-to-day
    operations, meet standards and assurances required by the
    Rehabilitation Act, and address the goals of the community. The
    Independent Living Research Utilization Program (ILRU) has found
    limited funding to be the most common reason for the fiscal collapse of
    CILs.
        A $25 million increase in each of the next three years will fill
    the gap. When we first raised this issue to you last year, several of
    you expressed concern that the current funding formula, based solely on
    population, would send most of the money to larger communities at the
    expense of rural areas. This year, we are suggesting that each $25
    million increment be divided roughly in half so that each state
    receives an flat allocation of $250,000, plus an allocation based on
    population.
        What will be the impact of a $75 million increase over the next
    three years? In Illinois, funding would increase from $1.5 million to
    $3.7 million. The Illinois SILC will recommend that the funds be used
    to address underserved inner-city people, as well as the unserved areas
    in the four southern counties bordering Indiana.
        Pennsylvania's funding would grow by $2.3 million over three years,
    making it possible for CILs which have been operating at less than half
    the recommended budget to finally reach their potential, and open long-
    needed CILs in Du Bois and Johnstown.
        In Florida, funding will increase from $1.8 to almost $4.4 million.
    The Florida SILC will use the additional funds to not only shore up the
    existing CILs, but also address the needs of the people in 27 of the
    state's 67 counties who are receiving virtually no service at all.
        In a rural state like Idaho, funding will grow from less than
    $700,000 to almost $1.6 million. This will allow us to strengthen the
    existing CILs, expand services to Coeur D'Alene and Caldwell, and set
    up a center on an Indian Reservation.
        Kentucky will increase it's budget from $490,000 to $1.7 million.
    There are four fledgling CILs in Bowling Green, Lexington, Harlan, and
    Covington which are operating on budgets of less than $70,000 each.
    This increase would make it possible for those CILs to add the staff
    they need to begin seriously addressing the independent living needs of
    people in these communities.
        In a large state like California, both urban and rural needs would
    be addressed. CILs in San Diego and San Francisco are responsible for
    such large populations (The San Diego center provides services to 11
    percent of the state's population) that they have consumers within
    their local communities who they cannot assist. This will greatly
    increase their capacity to serve those folks plus allow for the funding
    of satellites in the adjoining counties.
        Arizona is among the most underserved states in the country. With
    an additional $1.3 million, Arizona will be able to fully fund existing
    CILs in Phoenix, Tucson, Prescott, and Yuma, plus add new CILs in
    Flagstaff, Sierra Vista, and the Navajo Nation.
        The Texas SILC has identified 18 unserved and underserved areas
    throughout the state which they would cover with an additional $3.2
    million, and Mississippi would turn their satellites in Tupelo,
    Meridian, McComb and Greenville into CILs plus create a whole new set
    of satellites.
        In other words, an increase of $25 million over each of the next
    three years will make it possible to fill gaps in a service system
    which, in spite of proven success over the last twenty years, remains
    pitifully inadequate.
        Centers for independent living are a great bargain for America.
    They keep people active and involved in their communities. They save
    the taxpayer money. Given their track record, we know that CILs will
    use that $75 million to double or triple those dollars. However, even
    if they didn't, think of the changes and savings. At an average cost of
    $1,655 per consumer for comprehensive IL services, they will serve an
    additional 45,317 people. They will help another 1,630 individuals
    relocate from nursing homes--and prevent another 16,000 from entering.
        Funding centers for independent living makes sense: Common sense
    and dollars and cents.
      national council on independent living proposed incremental request
                                    summary
        The National Council on Independent Living proposes that there be
    three annual increases in Part C of $25 million rather than one of $75
    million. Each $25 million appropriation would be divided into two
    allocations.
        Approximately one-half of each year's appropriation would be
    granted to states in $250,000 increments. (Note that $250,000
    50 states = $12\1/2\ million. For appropriation purposes, the District
    of Columbia and Puerto Rico have traditionally been considered states
    and the territories have received somewhat less. For the purposes of
    discussion, we are using a figure of $125,000 for each of the four
    territories.) This means that each state, regardless of its size or
    population will receive a base increase of $750,000 over three years.
    Approximately one half of the $75 million will be appropriated to
    states in this manner.
        The remainder of each year's appropriation, an amount somewhat less
    than $12\1/2\ million because of the allocations to DC and the
    territories, will be granted to states based upon their percentage of
    the nation's population. For discussion and projection purposes, we are
    using the conservative figure of $11\1/2\ million.
        As part of the appropriation process, NCIL requests that Congress
    attaches spending authority language regarding the disbursal of these
    funds, as follows:
      --Each center for independent living (CIL) must have a base funding
            level of at least $250,000. Therefore, before any new centers
            are created, existing centers must receive at least $250,000 in
            operating funds from the state and/or Federal Government.
            Satellite centers may receive somewhat less based upon the
            recommendation of the statewide independent living council
            (SILC).
      --Receipt of the additional Part C funds is contingent upon
            maintenance of each state's funding effort. These additional
            funds are intended to supplement, not supplant existing funds
            generated in the state legislature for the operation of
            centers.
      --After each center is receiving an annual minimum base funding of at
            least $250,000, all Title VII funds shall be distributed
            following the directions set forth in the State Plan for
            Independent Living.
        Attached are two identical worksheets produced in Microsoft Excel
    and in Word Perfect which show how the $75 million will be distributed
    state-by-state over three years. The worksheet has seven columns:
      --A list of the states and territories;
      --Each state's annual distribution based upon its percentage of the
            nation's population. As explained above, we are using a
            conservative figure of $11\1/2\ million;
      --Each state's distribution of $250,000, which we call equity;
      --The 1 year total increase that each state is likely to be allotted
            if we receive an incremental increase of $25 million;
      --The 3 year total increase that each state is likely to be allotted
            if we receive three incremental increases totaling $75 million;
      --The funds currently allocated through Title VII Part C are in the
            1999 total column;
      --The 2003 total is each state's likely allotment if we are
            successful in our efforts. The 2003 total represents a
            combination of current (1999 total) and new (3 year total)
            funds.

                         CENTER FOR INDEPENDENT LIVING PROGRAM--NCIL INCREMENTAL REQUEST SUMMARY
    ----------------------------------------------------------------------------------------------------------------
                                                                       1 year      3 year
                     State                   Population    Equity       total       total    1999 total   2003 total
    ----------------------------------------------------------------------------------------------------------------
    ALABAMA................................    $183,507    $250,000    $433,507  $1,300,520    $505,225   $1,805,745
    ALASKA.................................      26,061     250,000     276,061     828,183     602,952    1,431,135
    ARIZONA................................     181,997     250,000     431,997   1,295,990     536,293    1,832,283
    ARKANSAS...............................     107,179     250,000     357,179   1,071,536     486,008    1,557,544
    CALIFORNIA.............................   1,362,989     250,000   1,612,989   4,838,968   4,016,347    8,855,315
    COLORADO...............................     161,674     250,000     411,674   1,235,022     697,758    1,932,780
    CONNECTICUT............................     141,308     250,000     391,308   1,173,925     486,008    1,659,933
    DELAWARE...............................      30,937     250,000     280,937     842,810     486,008    1,328,818
    FLORIDA................................     611,229     250,000     861,229   2,583,687   1,801,120    4,384,807
    GEORGIA................................     310,706     250,000     560,706   1,682,118     915,563    2,597,681
    HAWAII.................................      51,216     250,000     301,216     903,649     486,008    1,389,657
    IDAHO..................................      50,181     250,000     300,181     900,542     695,762    1,596,304
    IOWA...................................     122,625     250,000     372,625   1,117,876     486,008    1,603,884
    KANSAS.................................     110,674     250,000     360,674   1,082,021     566,935    1,648,956
    KENTUCKY...............................     166,550     250,000     416,550   1,249,649     490,775    1,740,424
    LOUISIANA..............................     187,347     250,000     437,347   1,312,041     552,059    1,864,100
    MASSACHUSETTS..........................     262,079     250,000     512,079   1,536,236     954,181    2,490,417
    MICHIGAN...............................     412,016     250,000     662,016   1,986,049   1,269,426    3,255,475
    MINNESOTA..............................     198,910     250,000     448,910   1,346,731     523,090    1,869,821
    MISSISSIPPI............................     116,369     250,000     366,369   1,099,107     486,008    1,585,115
    MISSOURI...............................     230,494     250,000     480,494   1,441,483   1,060,757    2,502,240
    MONTANA................................      37,538     250,000     287,538     862,615     486,008    1,348,623
    NEBRASKA...............................      70,633     250,000     320,633     961,898     789,481    1,751,379
    NEVADA.................................      66,016     250,000     316,016     948,047     486,008    1,434,055
    NEW HAMPSHIRE..........................      49,533     250,000     299,533     898,600     486,008    1,384,608
    NEW JERSEY.............................     342,808     250,000     592,808   1,778,423   1,010,158    2,788,581
    NEW MEXICO.............................      72,704     250,000     322,704     968,111     551,100    1,519,211
    NEW YORK...............................     782,525     250,000   1,032,525   3,097,575   2,305,881    5,403,456
    OHIO...................................     481,139     250,000     731,139   2,193,417   1,417,781    3,611,198
    OKLAHOMA...............................     141,438     250,000     391,438   1,174,313     672,259    1,846,572
    OREGON.................................     135,527     250,000     385,527   1,156,580     554,713    1,711,293
    PENNSYLVANIA...........................     520,878     250,000     770,878   2,312,633   1,534,881    3,847,514
    RHODE ISLAND...........................      42,716     250,000     292,716     878,148     709,848    1,587,996
    SOUTH CAROLINA.........................     158,481     250,000     408,481   1,225,443     486,008    1,711,451
    SOUTH DAKOTA...........................      31,455     250,000     281,455     844,364     486,008    1,330,372
    TENNESSEE..............................     226,784     250,000     476,784   1,430,351     668,268    2,098,619
    UTAH...................................      84,181     250,000     334,181   1,002,543     547,704    1,550,247
    WEST VIRGINIA..........................      78,874     250,000     328,874     986,621     904,979    1,891,600
    WISCONSIN..............................     221,045     250,000     471,045   1,413,135     651,358    2,064,493
    WYOMING................................      20,711     250,000     270,711     812,133     486,008    1,298,141
    D.C....................................      23,904     250,000     273,904     821,711     486,008    1,307,719
    PUERTO RICO............................     162,019     250,000     412,019   1,236,058     486,008    1,722,066
                                            ------------------------------------------------------------------------
          NATIONAL TOTALS..................  11,500,000  13,500,000  25,000,000  75,000,000  44,222,040  119,222,040
    ----------------------------------------------------------------------------------------------------------------

        fact sheet--increased funding for centers for independent living
    What is a Center for Independent Living (CIL)?
        A CIL is a non-profit corporation, which assists people with
    significant disabilities who want to live more independently. CILs are
    managed and staffed by people with disabilities, are always located in
    the communities they serve, and assist people with all types of
    disabilities.
    How do CILs assist people?
        The foundation of CIL services is the peer relationship--people
    with disabilities assisting other people with disabilities as role
    models, mentors, and counselors. Each center is unique because it
    offers services based upon the particular needs of its community. At
    the same time, centers are alike in that they all offer core services:
    information and referral, peer counseling, individual and systems
    advocacy, and independent living skills training.
    How many centers are there in the U.S.?
        Currently, there are 340 centers for independent living, with more
    than 224 satellite locations. Of these, 229 centers and 44 satellites
    are funded through Title VII-Part C of the Rehabilitation Act of 1973
    (as amended). A center's service area may be one county or a dozen.
    According to the Rural Institute on Disabilities, CILs cover an average
    of 5.76 counties. Today, 60 percent (1,911) of our nation's counties
    receive service from a CIL.
    What role do satellites play in the CIL network?
        Satellites, sometimes called branch offices, are administered by an
    existing center and fill a critical need in the independent living
    network. Satellites make it possible for services and programs to be
    provided in outlying areas while avoiding the overhead of a
    freestanding, non-profit corporation. Some satellites have only one or
    two staff while others have more to address the needs of their
    communities. Costs for satellites vary, therefore, from state to state
    and community to community.
    What must CILs do to receive Title VII-Part C funds?
        In addition to submitting a viable application in a statewide
    competition, CILs must meet standards and assurances set by Congress,
    as well as goals and objectives, which address the needs of their
    communities. The assurances are fiscal and programmatic reporting
    requirement, while each standard has indicators of compliance which
    address the day-to-day operations of the center. Centers report
    annually on their progress and are visited periodically as part of a
    state and federal oversight process.
    What is the current funding level for federally funded centers?
        Current funding for Title VII-Part C of the Rehabilitation Act is
    $43,692,496. This is an average of $163,285 per center and $97,821 per
    satellite.
    Are CILs a good investment?
        You bet! Last year the Department of Education gathered information
    from 295 of the centers. In addition to responding to almost 340,000
    requests for information and referral, these centers provided over
    54,000 individuals with peer counseling services; 50,000 received
    assistance finding housing; 34,000 acquired personal assistance
    services; 33,500 attained transportation services; and over 54,000
    individuals received independent living skills training. In addition,
    literally tens of thousand of individuals received dozens of other
    services from centers, including assistance in moving out of costly
    institutional settings such as nursing homes.
    Why do we need more centers for independent living and satellites?
        Today, the CIL network reaches less than one percent of all people
    with significant disabilities in the United States. While not every
    person with a disability needs a center's help, there remain vast areas
    of the U.S. where no center exists at all. Forty percent (40 percent)
    or 1,230 of our nation's counties receive no service whatsoever from a
    CIL. Hundreds more receive only superficial coverage.
    How many more CILs do we need?
        At the current rate of coverage (5.7 counties per center), The
    Rural Institute on Disabilities estimates that we need at least an
    additional 216 centers. Some states have estimated that there should be
    at least one ``fully-funded'' center for every 500,000 persons, or an
    additional 185 centers nationwide.
    What is a ``fully-funded'' CIL?
        Today, CILs are woefully underfunded. As stated above, the average
    federally funded CIL receives approximately $162,285 to support the
    operations of the center. States have set funding targets ranging from
    $200,000 to $500,000 per center per year. The National Council on
    Independent Living (NCIL) believes a center needs at least $250,000 to
    support day-to-day operations, meet the standards and assurances, and
    address the goals of the community. The Independent Living Research
    Utilization Program (ILRU) has found limited funding to be the most
    common reason for the fiscal collapse of centers.
    What level of support is needed for CILs?
        Centers for independent living need an additional $75 million to
    build a strong nationwide network of centers. This increase will bring
    the total budget for Title VII-Part C to $120 million, a fraction of
    what is expended for other programs assisting significantly fewer
    persons. CILs have a proven record of accomplishment, distinguishing
    themselves among consumers, advocates, and providers alike. Support for
    CILs makes good sense!
                                     ______

                  Prepared Statement of the City of Newark, NJ

        Mr. Chairman: Thank you for giving me the opportunity to submit
    testimony on behalf of the City of Newark, New Jersey regarding two
    innovative projects that are of importance to us: (1) the Children's
    Health Care Services Center and (2) the Newark Museum Science Education
    Project.
                     children's health care services center
        The Children's Health Care Services Center will provide a
    coordinated approach to offering health and social services to
    uninsured/underinsured pregnant women and children between the ages of
    0 through 5. The City's Department of Health and Human Services will
    partner with other community organizations and hospitals to provide a
    full spectrum of health, social services and mental health services.
        There is a tremendous need in Newark for such comprehensive
    services. The City of Newark has been designated by the Centers for
    Disease Control and Prevention as a pocket of need for children. An
    analysis of trends in the City of Newark reveals that 1/5 of Newark
    resident births in 1996 were to teenage mothers (under age 20). Teenage
    mothers have accounted for 1 in 5 Newark resident births from 1989
    through 1996. Over one-half of Newark resident women who delivered in
    1996 began pre-natal care in the first trimester of pregnancy. In
    contrast three fourths of all New Jersey mothers giving birth in 1996
    began pre-natal care in the first trimester. Since 1989 the percentage
    of Newark mothers receiving pre-natal care in the first trimester has
    generally declined for all age groups. In fact, the rate of mothers
    giving birth in 1996 who received no pre-natal care was six times as
    high for Newark (8.3 percent) as for the State as a whole (1.3
    percent). By race, nearly 12 percent of black mothers in Newark and 3
    percent of white mothers received no pre-natal care.
        In 1996 the number of Newark resident infant deaths 80, a 14.3
    percent increase over the 70 infant deaths in 1995. Notwithstanding
    this one year increase, the number of resident infant deaths in Newark
    decreased from a high of 189 deaths in 1989 to the current level. Neo-
    natal deaths have been increasing over the past 8 years, from 52
    percent of the total infant deaths in 1989 to 58 percent in 1996. The
    leading cause of death for infants in Newark in 1996 is low birth-
    weight. The second leading causes of death were congenital anomalies
    and sudden infant death syndrome.
        Other ailments that affect the health of Newark children include
    pulmonary dysfunctions such as asthma and lead poisoning. As of
    December 31, 1998, Newark had a caseload of 1,613 children under age
    six with blood lead levels over 20 ug/dL. In 1998 an average of 25
    percent of nearly 2,000 children tested had blood lead levels over 20
    ug/dL.
        The objective of the Newark Children's Health Care Services Center
    is to positively impact on the health of Newark's children through the
    development of a coordinated health care system that will allow the
    City to bring health care services to the community.
        Through the use of focus groups, the DHHS will assess and re-
    evaluate Newark residents use of existing services. Focus groups will
    be conducted to analyze barriers to services and residents utilization
    rates. Based upon the analysis, the DHHS will design the Children's
    Health Care Services Center as a consumer friendly service center.
        At minimum, the Center will provide services that include, pre-
    conception counseling, early pregnancy testing, pre-natal care,
    substance abuse counseling and referral services, family counseling,
    pediatric practice with related services including WIC, immunization,
    nutritional counseling and case management services. Health education
    will be offered to develop parenting skills and managing households.
        Through the centralization of services, we believe that we can
    increase access to the array of health and social services needed by
    Newark residents to raise healthy children. The City seeks $2.5 million
    in Federal support for this initiative.
                                 newark museum
        Newark is truly at a crossroad--we are a City with all of the
    problems of many major urban centers, but we are also a City with vast
    potential. We have begun to turn the corner--there is a renewed
    vitality and sense of optimism in Newark.
        The Newark Museum seeks $2.0 million to support its new Science
    Initiative Education. The City of Newark has committed $1.7 million
    dollars to date toward the preparatory collections care necessary to
    make this initiative possible. Additionally, The Museum plans a $5
    million dollar operating endowment fund based upon a public/private
    partnership to assure adequate on-going support, of which $1.2 million
    has been raised to date. Research has shown that the ongoing
    maintenance cost of science galleries is several multiples of that of
    art galleries.
        The plan calls for the creation of a major permanent exhibition
    based upon its natural science collection. The exhibition, called
    Making Sense of the Natural World, will explore scientific phenomena
    through natural history specimens and live animals. Museum audiences
    will participate in mindful science learning through stimulating and
    engaging experiences that integrate the collections, Dreyfuss
    Planetarium and Mini Zoo. This gallery, along with the Museum's plan to
    institutionalize cohesive science education programs parallel to its
    distinguished art and culture programs, is the core of The Newark
    Museum Science Education Initiative.
        The cohesive science education at The Newark Museum will entail
    greater use and dissemination of their science gallery, planetarium and
    live animal resources, thus providing new learning opportunities for
    individuals, families, schools, and community organizations. This
    initiative also allows the Museum to safeguard the thousands of
    scientific specimens, so critical to its success, in proper housing
    both in the exhibition and in technologically advanced, environmentally
    appropriate behind-the-scenes storage.
        The Newark Museum is recognized as one of the nation's leading
    cultural institutions. It is located in Newark, New Jersey's largest
    city, and within Essex County, the State's most densely populated. The
    Museum's constituency is economically and ethnically diverse,
    reflecting the distinctive character of the city, northern New Jersey
    and the metropolitan region. In 1998, The Newark Museum served an
    audience of 462,000 children and adults.
        The Newark Museum's natural science collections of 74,000 specimens
    in the areas of geology, botany and biology are being utilized today in
    programs that allow for participatory and inquiry-driven experiences,
    to engage visitors in meaningful science learning. Science-related
    programs draw more visitors to The Newark Museum than any other
    offering, despite the fact that the science galleries have been closed
    for more than a decade. Realizing the opportunity to attract larger
    audiences and better serve Newark and New Jersey residents, the Museum
    has embarked on a new science initiative. It will enable the Museum to
    reopen the science galleries and builds upon the Museum's proven track
    record of excellence in interdisciplinary arts and humanities programs.
    The Newark Museum New Science Education Initiative: Reshaping Science
            Education
        In planning the new Science Initiative, Museum staff and Trustees
    have been guided by the principles contained in Goals 2000 and by New
    Jersey's recently adopted Core Curriculum Content Standards for K-12
    education. Critical thinking, mathematical, and scientific
    understanding will be fostered as visitors question, experiment,
    compare, and analyze real specimens from the Museum's science
    collections, and participate in planetarium and Mini Zoo programs
    designed to effectively communicate complicated and abstract science
    concepts.
        The science plan will also include a Science Resource Laboratory
    for teachers, which will provide them with a space to research and test
    curriculum ideas for hands-on activities in the natural and planetary
    sciences. Based on the results of research conducted with Newark
    educators, these monthly multi-session and one-time in-service teacher
    professional development workshops will provide teachers opportunities
    to become more comfortable teaching science and meet the state-mandated
    re-certification requirements. The same Science Labs will be used by
    school classes and in after school and weekend programs to reinforce
    science concepts that are introduced in Making Sense of the Natural
    World, the projected new exhibition.
        For high school students from Newark and other state urban
    districts, the Science Initiative calls for a Science Career Ladder.
    These innovative programs are designed to provide ``at-risk'' teens
    with critical exposure to careers in science and to teach workplace
    ethics and behavior. This builds upon an already successful YouthAlive
    program at the Museum. In addition, the plan will provide a Science
    Internship Program, which will offer students a year-long experience in
    scientific research, collections management, and the planetary sciences
    at The Newark Museum.
    The New Natural Science Exhibition, Making Sense of the Natural World
        This gallery, intended primarily for a family and elementary school
    audience, will be one of the few in the country to combine the best of
    natural history museums and science centers by marrying actual
    biological, geological and botanical specimens with hands-on, inquiry-
    driven activities.
        In this exhibit, visitors will experience the wonder of nature's
    diversity and then look at collections the way scientists look at them.
    They will begin to learn that natural history specimens individually
    and collectively provide volumes of information about science. They
    will understand how ordering the natural world led to the realization
    that the Earth is constantly changing and that life adapts to those
    changes. Moreover, they will appreciate that evidence of those changes
    is as close as their own backyard.
        Recurring throughout the exhibit will be the concepts of bio-
    complexities and dynamic geological forces as fundamentals of the
    natural world. The museum's striking collections will be the vehicle
    for explaining--making sense of- these concepts as they relate to
    living and non-living systems, globally and locally.
        The exhibition will be divided into five sections. The first is an
    Introductory Gallery, called the Diversity Arc, in which visitors will
    realize that by uncovering relationships within groups of specimens,
    scientists have been able to order and make sense of the diversity
    around them. Visitors will meet their video host at the first of
    several stations that are located throughout the exhibit. The host is a
    museum scientist who will guide visitors' observations and enhance
    their understanding of the exhibit's concepts. The host is one of the
    ways the exhibit will depict people as part of nature and interpreters
    of it. It will serve to put the exhibit components into context for the
    visitor.
        In the second gallery, The Dynamic Earth: Forces of Change, sound
    and light will give visitors the feeling of being present at the
    beginning of the Earth. A short video will elaborate on the formation
    of the planet, plate tectonics and climate. Video animation will be
    used to communicate abstract geological concepts. Specimens will be
    displayed that illustrate the products of geological activity, climate
    change and glacial activity. Mineral and rock specimens will be chosen
    for the stories they can tell. Fossils, such as Glossopteris, found on
    today's widely separated continents, will show how tectonic forces
    split the continent on which the fern once grew.
        Next, the visitor will encounter Life Adapts to Change, which will
    show the tremendous variety of environments on the Earth--the
    consequences of where continents and oceans are located today, and
    climate. Specimens from the African Savannah will show how different
    species have adapted to a unique biome, the grassland, through color,
    behavior and structure. The exhibit also contains an interactive
    natural selection component explaining the process. The remainder of
    the exhibit will illustrate two different kinds of adaptations to the
    environment: structural and behavioral.
        At this junction, visitors will have the choice of either
    continuing to Collections: Tools of Knowledge or Diversity in Your
    Backyard: New Jersey Highlands. In Collections: Tools of Knowledge,
    visitors will discover that science is a dynamic, ongoing activity that
    uses specimens and collections as tools to make sense of the natural
    world. In this section, visitors explore how science is actually
    conducted. Scientists will tell their own story of how they collect
    data and analyze it, and there will be equipment which visitors can
    manipulate in activities designed to mimic the work the scientists
    perform. For most of the population, science is an abstract art, almost
    like magic. This area of the exhibit will assign the tasks of the
    scientist to the visitor, making the process of science much more
    concrete.
        The final, and largest, section is called Diversity in Your
    Backyard: New Jersey Highlands, which will feature a re-creation, in
    the form of a walk-in diorama, of an oak-hickory forest biome of the
    New Jersey Highlands. It is a demonstration of how and why the
    interdynamics of geology and biology creates an ecosystem. Using New
    Jersey as a backdrop, this gallery will provide specific examples of
    Dynamic Earth and Adapting to Change in a recreated environment of the
    New Jersey Highlands. This will allow visitors to apply the complex
    ideas introduced earlier to examples familiar to them and to make sense
    themselves of the natural world. A tented ``field station'' will offer
    opportunities for hands-on activities.
        In closing, federal support is critical for each of these
    initiatives. It is my hope that the subcommittee will find them worthy
    of your support.
                                     ______

     Prepared Statement of the University of Medicine and Dentistry of New
                                     Jersey

        The University of Medicine and Dentistry of New Jersey (UMDNJ) is
    the largest public health sciences university in the nation. Our
    statewide system is located on five academic campuses and consists of 3
    medical schools and schools of dentistry, nursing, health related
    professions, public health and graduate biomedical sciences. UMDNJ also
    comprises a University-owned acute care hospital, three core teaching
    hospitals, an integrated behavioral health care delivery system, a
    statewide system for managed care and affiliations with more than 200
    health care and educational institutions statewide. No other
    institution in the nation possesses the resources which match our scope
    in higher education, health care delivery, research and community
    service initiatives with federal, state and local entities.
        We appreciate the opportunity to bring to your attention our
    priority projects that are consistent with the mission of this
    committee. These projects are statewide in scope and include
    collaborations both within the University system and with our
    affiliates. Our research projects also underscore UMDNJ's commitment to
    eliminating racial disparities in health care delivery. New Jersey,
    with its small geographic size and its large diverse population, is an
    idea site in which to conduct research and develop activities that will
    address this important issue. The first of our priority initiatives is
    the Child Health Institute of New Jersey:
        UMDNJ-Robert Wood Johnson Medical School (RWJMS) has developed the
    Child Health Institute of New Jersey as a comprehensive biomedical
    research center focused on the health and wellness of children. At this
    institute, biomedical researchers address the prevention and cure of
    environmental and genetic diseases of infants and children. The Child
    Health Institute is integral to the long-term plan for the enhancement
    of research at RWJMS in developmental genetics, particularly as it
    relates to disorders that affect a child's development and growth,
    physically and functionally. The program will enable the medical school
    to expand and strengthen basic research efforts with clinical
    departments at Robert Wood Johnson University Hospital, in particular
    those involved with the new Bristol-Myers Squibb Children's Hospital.
        The CHI will build on a current NIH funding base at RWJMS and its
    academic partners of more than $50 million with significant strengths
    in genetic, environmental and neurosciences research at the medical
    school and the associated joint research and advanced degree programs
    with academic institutions and the pharmaceutical industry.
        The Child Health Institute will focus research on the molecular and
    genetic mechanisms that direct the development of human form,
    subsequent growth, and acquisition of function. Broadly, the faculty
    and students will investigate disorders that occur during the process
    of development; to discover and study the genes contributing to
    developmental disabilities and childhood diseases; to determine how
    genes and the environment interact to cause childhood diseases; and to
    identify the causes and possible avenues of treatment of cognitive
    disorders found among conditions such as mental retardation, autism and
    related neurological disorders.
        Approximately half of the admissions to children's hospitals are
    for genetic disorders, and the majority of these are the result of
    genes interacting among themselves and with the environment.
        Examples include autism, heart defects, diabetes and cleft lip.
    Babies are five times more likely to have a cleft lip if their mother
    carries a particular gene and smokes during pregnancy. Mothers with
    this gene who don't smoke don't increase the risk for their child.
    Preventing this class of clift lips is now possible through testing
    mothers coupled with behavior modification.
        Despite new therapies, asthma-related problems have risen by 50
    percent over the past decade with hospitalization rates 4-5 times
    higher for African Americans. Effective prevention and treatment will
    require greater understanding of the molecular mechanisms that elicit
    asthmatic attacks, and more understanding of the molecular reactions
    mounted by cells once stimulated by environmental factors. Continued
    exploration of the basic molecular underpinnings of injury reactions
    will lead to more rational methods to prevent, minimize and treat
    asthmatic reactions and deaths. Urban academic medical centers such as
    RWJMS are at the epicenter of the current escalation in asthma and the
    Child Health Institute is well positioned to address this critical
    issue.
        Development of the Child Health Institute will fill a critical gap
    through the expansion, by new recruitment, of an intellectual base upon
    which basic molecular programs in child development and health will
    build. It is expected to cost almost $30 million for our building with
    an additional $10 million endowment for programs. We are requesting an
    appropriation of $5 million from the Federal Government to complement
    $3 million already received from the Federal Government, $18 million
    raised in the private sector and $10 million we expect to raise from
    the State.
        A second priority is the Gallo Prostate Cancer Center:
        The Dean and Betty Gallo Prostate Cancer Center (GPCC) was
    established at the Cancer Institute of New Jersey (CINJ) with the goal
    of eradicating prostate cancer and improving the lives of men at risk
    for the disease through research, treatment, education and prevention.
    GPCC was founded in memory of Rep. Dean Gallo, a New Jersey Congressman
    who died of prostate cancer diagnosed at an advanced stage. The purpose
    of the GPCC is to establish a multi-disciplinary center to study all
    aspects of prostate cancer and its prevention. The Cancer Institute of
    New Jersey is a partnership of UMDNJ-Robert Wood Johnson Medical School
    and hospital affiliates.
        Prostate cancer is particularly devastating in New Jersey. With the
    highest population density in the country, our state has one of the
    highest prostate cancer rates in the nation. African-Americans
    diagnosed with the disease are twice as likely to die from it. To help
    eliminate this health disparity, GPCC is collaborating with
    organizations such as ``100 Black Men'' in a prostate cancer initiative
    that will make educational programs and cancer screenings available in
    all 21 counties throughout the State.
        GPCC unites a team of outstanding researchers and clinicians who
    are committed to high quality basic research, translation of innovative
    research to the clinic, exceptional patient care, and GPCC efforts will
    be focused in four major areas: Basic, Clinical and Translational
    Research; Comprehensive Patient Care; Epidemiology and Cancer Control;
    and Education and Outreach.
        GPCC scientists will investigate the molecular, genetic and
    environmental factors that are responsible for prostate cancer
    initiation and progression. Our researchers will develop appropriate
    model systems that will facilitate the design and implementation of
    novel strategies for prevention and treatment. GPCC will foster multi-
    disciplinary efforts that will lead to the effective translation of
    basic research, improved patient care and novel clinical trials.
    Another goal of the GPCC is to understand the etiology of prostate
    cancer susceptibility and to find effective modalities for prevention
    of the disease.
        The Cancer Institute of New Jersey has received $5 million in
    federal funding over the last two years for the Gallo Prostate Cancer
    Center. This important funding has enabled us to establish a world-
    class program in prostate cancer research that includes publications in
    prestigious national journals. CINJ has used its findings to leverage
    additional research dollars for individual investigators from such
    agencies as CapCure, the Department of Defense and several private
    foundations. Top investigators have been recruited to initiate programs
    in prostate cancer research through our education and pilot grant
    programs.
        Additional federal funding is being sought this year to build on
    our basic research in prostate cancer and to support the development of
    technological approaches to test new methods of prevention and
    treatment. This additional funding will also allow us to enhance our
    treatment of patients with prostate cancer through several new clinical
    trials for patients at all stages of the disease. We seek $2 million in
    federal funding to enhance the research, education and cancer care
    programs of the Gallo Prostate Cancer Center at our New Brunswick
    facility and to expand these programs statewide.
        Another priority this year is to establish a statewide General
    Clinical Research Center:
        New Jersey is the most densely populated state in the nation and
    hosts some 175 healthcare companies within its borders. Yet, New Jersey
    has failed to attract large amounts of clinical research dollars
    because there is no General Clinical Research Center within the state.
        As a consequence, patients in the state lack adequate access to the
    latest in clinical research studies. UMDNJ is well positioned to
    reverse this trend and requests federal funding to provide the
    infrastructure to compete more effectively for both NIH and
    pharmaceutical research dollars.
        The UMDNJ-Robert Wood Johnson Medical School Clinical Research
    Center (CRC) is a 16-bed dedicated clinical research facility located
    in New Brunswick, New Jersey. New Brunswick is known as the ``health
    care city'' and is home to many of the state's major pharmaceutical
    firms. Robert Wood Johnson Medical School is consistently ranked among
    the most diverse in the nation.
        As such, the University can make significant contributions in the
    clinical research training of under-represented minorities enrolled in
    medical, nursing, dental, pharmacy, public health, dietary and other
    advanced degree programs across the state. The medical school is home
    to the Cancer Institute of New Jersey, the Child Health Institute of
    New Jersey and other nationally recognized centers of excellence. We
    are well positioned to uphold NIH policies regarding the inclusion of
    women, minorities and children in clinical research studies.
        Robert Wood Johnson Medical School has a well-established research
    environment that provides insight into the basic mechanisms of disease,
    innovative approaches to patient care that leads to the etiology and
    pathogenesis of disease, and patient care outcomes. Scientists in the
    basic and clinical departments continue to make nationally recognized
    contributions in their areas of expertise. Researchers within the
    medical school have been in the forefront of medical discoveries,
    including advances in Parkinson's disease, Lyme disease, disorders of
    sexual dysfunction, epilepsy, prostate cancer, psoriasis, cardiology,
    and obesity. In addition to broad-based programs at RWJMS' three
    campuses in Piscataway, New Brunswick and Camden, the CRC is committed
    to expanding its research programs by collaborating with other schools
    within the UMDNJ system as well as with affiliated institutions. This
    includes:
        The UMDNJ-New Jersey Medical School (NJMS) located in Newark is
    developing a Clinical Research Center on its campus. Once established,
    both Centers will work together to provide the infrastructure to
    optimize clinical research across the state. The UMDNJ-New Jersey
    Dental School (NJDS) has outstanding research in biomaterials and a
    nationally recognized dental training program. The UMDNJ-School of
    Health Related Professions (SHRP) has a research team in its nutrition
    program that currently collaborates with the CRC at RWJMS. The UMDNJ-
    School of Osteopathic Medicine located in Stratford in southern New
    Jersey, the UMDNJ-School of Nursing, with statewide nursing programs
    and the UMDNJ-School of Public Health provide additional opportunities
    for collaboration.
        Additionally, UMDNJ is affiliated with the Veterans Administration
    Health Care system in New Jersey and already collaborates with the VA
    on many initiatives. We would look forward to a partnership with the VA
    to provide clinical research studies to this large and diverse patient
    population.
        UMDNJ is requesting $1.7 million through an NIH grant to develop a
    General Clinical Research Center (GCRC) that will link all clinical
    research activities across our statewide campuses and allow us to
    expand these activities to affiliated partners such as the VA
    HealthCare System in New Jersey. The opportunity exists to build a
    clinical research organization that would be at the cutting edge of new
    medical practices. Collaborations will result in a powerful unit that
    can organize medical experts and patients in response to federally and
    industrially sponsored trials of new therapies. Federal participation
    is needed to support a single network of clinical research and training
    programs throughout the state that will provide the impetus for the
    designation of our statewide program as a General Clinical Research
    Center.
        Our final priority is the establishment of a Center for BioDefense:
        In considering the threat of biological weapons use, the New York/
    New Jersey area is a prime target. UMDNJ is well poised to expand
    several current areas of expertise in the national response to this
    threat.
        UMDNJ's Center for Education and Training (CET) is the nation's
    foremost program in education and training concerning chemical threats.
    The Center has provided hazardous materials training to more than
    175,000 individuals, including police, firefighters and health care
    personnel. Preparing emergency response personnel for chemical and
    biological incidents is an extension of the Center's existing
    expertise.
        UMNDJ has several Level I and Level II Trauma Centers within its
    statewide system. A crucial component of the trauma network is the
    state's helicopter trauma service linking the northern and southern
    regions of the State. Members of the UMDNJ Emergency Response Team
    participated in a federally-sponsored ``Weapons of Mass Destruction''
    education program last year.
        A number of laboratories in our system are engaged in rapid methods
    of detection of virulent agents with particular emphasis on the most
    dangerous multi-drug resistant species. The molecular basis of drug
    resistance is the focus of our laboratories, as well as the
    establishment of large libraries of clinical strains available for
    epidemiological and other studies.
        Many of our faculty are advisors to the U.S. Government and serve
    on various committees and advisory panels. Our researchers are studying
    the effects of exposure to a variety of chemical and organic agents.
    UMDNJ has considerable expertise in analysis of genotoxic effects of
    radiation, toxic chemicals and other agents.
        The University's Newark campus is an internationally renowned
    center for the identification, treatment, and basic research of TB and
    other emerging and re-emerging pathogens. UMDNJ is a founding partner
    in the International Center for Public Health in Science Park, Newark.
    The establishment of the Center for Emerging Pathogens at the UMDNJ-New
    Jersey Medical School will add another layer of expertise in the
    analysis of a number of pathogens.
        Gene chip technology is a recent, cutting-edge technology enabling
    the simultaneous analysis of thousands of DNA sequences. Recent state
    funding has led to the formation of the Center for Applied Genetics at
    UMDNJ. In the context of a biological weapons threat, new chips will be
    designed displaying sequences representing a panel of potential agents
    for rapid screening and identification.
        Additional funding of $2.5 milllion will enable UMDNJ to provide a
    comprehensive statewide program ranging from our nationally acclaimed
    training ability in the public health arena to internationally
    recognized expertise in infectious disease basic research.
                                     ______

                   Prepared Statement of New York University

        Mr.Chairman: Thank you for allowing me to submit this testimony for
    the Promoting healthy lifestyles, eliminating disparities in oral
    health on the basis of race and ethnicity, and removing barriers to
    health care access are important priorities for the New York University
    College of Dentistry. It is therefore a matter of urgency for the
    College to undertake major renovations to modernize its patient-care
    facilities.
        The NYU College of Dentistry has been in existence for 135 years.
    NYU educates more than eight percent of the nation's dental graduates,
    making it the largest dental school in the United States. It is also
    the nation's largest provider of comprehensive preventive, primary, and
    specialty oral health care at one site, as well as a major Medicaid
    provider and safety net for free or low-cost care to the uninsured and
    working poor.
        NYU also provides the nation's most extensive private dental health
    outreach, preventive education, and screening programs that serve
    public schools, day care centers, Head Start programs, handicapped
    facilities, hospitals, and homeless shelters. Indeed, last summer over
    1,000 New Yorkers took part in a College-sponsored free oral-cancer
    screening as part of a national effort to alert Americans about the
    dangers of oral cancer.
        With the heavy, 24 hour-a-day, 365 days-a-year usage of the NYU
    dental clinics and the need to keep pace with changing technologies and
    equipment, the NYU College of Dentistry has launched a major capital
    project to refurbish and upgrade its clinical facilities to ensure that
    patients will be treated in an environment that promotes their optimal
    health, safety, and comfort. With 565 clinical operatories (treatment
    facilities) serving the public on a daily basis, the College seeks to
    upgrade 256 of its most heavily used and antiquated operatories which
    are located on four floors of its eleven-story structure.
        Recognizing that the clinics are the heart of the institution, NYU
    is requesting $5 million over three years to renovate and modernize the
    clinics and labs on these four floors currently serving the oral health
    needs of a vast number of needy New Yorkers.
                             who are our patients?
        The NYU College of Dentistry has a long tradition of providing
    comprehensive, low-cost dental services to people who are unable to
    afford private dentistry, including many new immigrants. Each year
    NYU's dental clinics treat tens of thousands of poor and low-income New
    Yorkers who have no other place to turn for dental care. The NYU
    College of Dentistry draws the largest portion of its patient
    population from New York City's largely Hispanic Lower East Side, which
    is a federally-designated dental health professional shortage area
    (HPSA), and has many patients from other medical/dental HPSAs in
    Manhattan, including Chinatown, East Harlem, Central/West Harlem, and
    Washington Heights/Inwood, as well as shortage areas in Brooklyn.
        In all, the NYU dental clinics attract the most multiethnic,
    multicultural population in the nation, as evidenced by the fact that:
      --65 percent of patients are minority Americans, primarily African
            Americans, members of Hispanic subgroups, Asians, Pacific
            Islanders, and Native Americans;
      --30 percent of patients are senior citizens;
      --10 percent of patients are children;
      --70,000 of our 250,000 visits annually are made by Medicaid
            recipients;
      --15,000 people receive emergency care every year;
      --5,000 emergency patients are treated free of charge each year, and
            since the average cost of a routine visit to the NYU dental
            clinics is presently $43.00, compared to $360 to $1,100 for a
            typical hospital emergency room visit, this is extremely cost-
            efficient care;
      --10,000 school children annually visit the NYU pediatric dentistry
            clinic; and
      --2,500 children receive dental services annually through the Head
            Start program, both through a three day-a-week busing program
            which brings youngsters to the College and through on-site care
            in their neighborhoods, making the NYU College of Dentistry the
            largest Head Start provider of dental services in the nation.
        In addition to the Head Start busing program, the College buses
    children daily from local public schools to the College for care, and
    conducts a busing program for elderly adults in cooperation with local
    social service agencies. The College has also added, at its own
    expense, a state-of-the-art mobile dental van with four dental stations
    to expand its outreach effort on behalf of poor children who have been
    severely impacted by the dramatic decrease in the availability of
    publicly-funded, pediatric oral health resources.
        It is anticipated that the mobile dental clinic program will
    provide more than 1,500 patient visits each year, consisting of primary
    dental care and/or preventive services to preschool and school-age
    children ages 4-13 from poor, minority, and immigrant families.
    Additionally, staff members inform low-income families of their
    eligibility for the dental, prescription, and other health benefits
    available to their children through the Children's Health Insurance
    Program and Medicaid. Moreover, since the dental van is staffed in part
    by minority Americans, including an African-American pediatric dentist,
    children who visit the van are exposed to role models for health
    profession careers.
                           institutional recognition
        The NYU College of Dentistry's leadership in the health care arena
    has been recognized through grants for innovative pediatric dentistry
    programs, a Medicaid Managed Care Provider Grant from the New York
    State Department of Health to develop a model for school-based dental
    services, and significant funding from the National Institute of Dental
    and Craniofacial Research (NIDCR) of the National Institutes of Health
    (NIH).
        The latter includes major support, obtained in collaboration with
    the Forsyth Dental Center of Boston, to establish a Minority Oral
    Health Research Center at NYU to improve the oral health status of
    minorities and increase the number of minorities working in the health
    professions. In addition, the College has received widespread acclaim
    for initiating the Consortium for the Prevention and Early Detection of
    Oral Cancer.
              the cost of dental education at new york university
        The high cost of dental equipment and materials, combined with the
    lack of a hospital infrastructure, has long made the cost of dental
    education the highest of any profession. As a private dental school,
    the NYU College of Dentistry is often able to pursue newer, more
    effective therapeutic approaches and to transfer these advances to
    practice with more freedom and speed than is possible among some of our
    public counterparts. However, tuition for dental education is
    necessarily greater for an independent academic dental institution. For
    those of us who make our lives among students, it is therefore never
    easy to increase tuition. But although we have redoubled our efforts at
    cost containment, we recognize that there is a limit beyond which we
    cannot go without sacrificing the quality of our academic and patient
    care programs. As a result, NYU's tuition for the 1999-2000 academic
    year is $36,886 for each year in the four-year D.D.S. program, making
    tuition at the NYU College of Dentistry the highest in the nation.
        The irony is that although tuition at NYUCD is very expensive, it
    is nevertheless the most cost effective dental education in the nation.
    In fact, according to the American Association of Dental Schools, the
    amount of money it takes to educate a dental student for one year at
    NYU--approximately $40,000--is substantially below the national mean of
    $60,000, and less than half of that at some state-supported
    institutions.
        A chief reason for our high tuition is the prevailing poverty of
    the population we treat, which effectively results in NYU dental
    students subsidizing the charity care. We provide approximately $4
    million in free dental care annually--through tuition.
                  the infrastructure to care for our community
        The NYU College of Dentistry does not currently possess the
    infrastructure to support the treatment needs of its patient community,
    including the introduction of new technologies. To put it another way,
    current clinical facilities impede our ability to provide an optimal
    patient care environment for the thousands of patients who seek
    treatment daily.
        Physically, our clinics are bursting at the seams. Much of the
    existing clinical care space is over 35 years old and is cramped and
    out-of-date. To meet appropriate standards of care, this infrastructure
    must be redesigned immediately. The average size of an operatory is
    approximately 65 square feet. In order to provide optimal patient care
    involving a dentist and a dental assistant, each operatory should be
    100 square feet. Addressing these concerns will require extensive
    renovation and modernization of 256 of the existing 565 dental
    operatories and development of new space for additional clinical
    facilities to keep pace with the growth of our patient pool.
        New York University College of Dentistry's health promotion
    initiatives, its programs to expand access to mainstream oral health
    benefits for our neediest citizens, and its reputation as a force for
    social action in medically-underserved areas all place the College in
    an excellent position to advance the national agenda for health care.
    Accordingly, we believe that support for renovated and modernized
    patient care facilities at the College is an appropriate focus for
    Congress. The community care goals of the NYU College of Dentistry are
    entirely consistent with the commitment to make health care an equal
    opportunity, available to all, regardless of financial means, age, or
    racial or ethnic group. Our dental clinics also greatly relieve the
    pressure on an already over-burdened public health system, and in
    emphasizing early, preventive and comprehensive treatment, save health
    care costs down the road.
        With help in creating clinical facilities that foster the well
    being of our community, the NYU College of Dentistry can continue to
    meet the needs of new Americans and of native racial and ethnic
    minorities, and to alleviate the disproportionate oral health burden of
    poor and minority Americans.
        Thank you for your consideration.
                                     ______

     Prepared Statement of the University of Miami School and the Lovelace
                         Respiratory Research Institute

        Mr. Chairman and Members of the Subcommittee: I appreciate the
    opportunity to present testimony on behalf of the University of Miami
    School of Medicine, the Lovelace Respiratory Research Institute in
    Albuquerque, NM and our jointly proposed Tobacco Addiction Risk
    Assessment Research Center (TARARC) which will be devoted to the
    reduction of health risks associated with addiction to tobacco and
    other harmful substances. We deeply appreciate your leadership, Mr.
    Chairman. I fully understand and appreciate that you and your
    congressional colleagues face many constraints and challenges and we
    appreciate your willingness to devote special attention to the
    important public health issues related to tobacco addiction and its
    many harmful consequences. As the former campaign manager for Tom
    Luken, who served on the Hill for over 18 years, I was personally
    impressed by the dedication, commitment and hard work that all of you
    put into serving this great country of ours. We feel strongly that the
    unique challenges you face have never been greater than at this point
    in history, but there has also never been a greater opportunity to
    apply science-based solutions to solving the riddle of addiction and
    greatly improving public health by eliminating or reducing its negative
    health consequences.
        As you may know, approximately 20 percent of all deaths are
    associated with tobacco smoking. Tobacco kills more people than murder,
    AIDS, suicide, illicit drug use and automobile accidents combined. The
    medical consequences of tobacco addiction include the three leading
    causes of death: cardiovascular disease, cancer and cerebrovascular
    disease and its related medical costs are astronomical. For example, in
    Florida in 1996, tobacco-related Medicaid pay-outs were estimated to be
    between $264,000,000 and $365,000,000. However, tobacco use is also the
    most preventable cause of disease and death.
        We now know that nicotine is at least as addictive as cocaine or
    heroin. Recent studies even suggest that nicotine interacts with other
    drugs of abuse, that it reinforces craving and increases intake of
    cocaine and other drugs. However, nicotine is a special case of
    addiction because tobacco is legally sold and its use is not prohibited
    among adults. In spite of the evidence that nicotine is an addictive
    drug which affects the brain in the same way that illicit substances
    such as opiates and cocaine do, nicotine dependence has not been
    considered substance abuse.
        The University of Miami School of Medicine and the Lovelace
    Respiratory research Institute are uniquely qualified to address the
    issue of addiction to tobacco and other harmful substances. University
    of Miami faculty members have significant expertise and experience in
    many relevant areas including substance abuse, evaluation research,
    community research, behavioral medicine, disease prevention, treatment
    of tobacco-related diseases, basic science research, epidemiology and
    public health. The University of Miami's Tobacco Research Evaluation
    and Coordinating Center (RECC) has been responsible for the evaluation
    of Florida's Tobacco Pilot Program. Other strengths in the area of
    biomedical research and treatment include Pediatric Oncology and the
    Batchelor Children's Research Center, the Pediatric Environmental
    Respiratory Center, as well as the proposed Tobacco Addiction Risk
    Assessment Research Center (TARARC). The Batchelor Children's Research
    Center is currently under construction and will provide a state-of-the-
    art clinical and research facility that will be one of the nation's
    largest devoted to children's health. It is designed to foster
    collaboration among researchers and clinicians and will include a focus
    on cancer as well as many other diseases. It, along with the Pediatric
    Environmental Respiratory Center, will provide an appropriate and ideal
    setting for the study of tobacco-related, maternal-child health issues
    as well as a study of the impact of second-hand (environmental) smoke
    on the respiratory health of children. The Lovelace Respiratory
    Research Institute has undertaken some of the leading studies of animal
    models of smoking and the role of nicotine in immune function.
        The proposed Tobacco Addiction Risk Assessment Research Center will
    be devoted to the study of unrecognized health risks associated with
    addiction to tobacco products, predominantly in minority populations
    who may be uniquely susceptible to immune suppression, increased fetal
    HIV transmission, increased respiratory inflammation and infection,
    synergistic negative health effects with other abused substances and
    impaired immunological function of non-smoking family members exposed
    at home or in utero. The Center will use animal models to study disease
    processes prior to assessing the equivalent condition in human
    subjects. Finally, the Center will address the culturally relevant
    behaviors that underlie tobacco use in human populations. The
    importance of the Center lies in its bridging the use of animal models
    to the study of disease in people and the subsequent formulation and
    testing of medical and behavioral interventions to improve or eliminate
    the negative health consequences associated with tobacco use. Of
    further interest is the opportunity to compare two different Hispanic
    populations that differ in genetics and cultural characteristics
    (Mexican in new Mexican and Cuban in Florida) as well as characterizing
    African-American and Caucasian populations. Creating the Tobacco
    Addiction Risk Assessment Research Center represents a unique
    opportunity to build upon the rich diversity of Florida's population,
    the commitment of the University of Miami School of Medicine to the
    community and our experience with behavioral interventions,
    particularly related to tobacco use and substance abuse. Florida is an
    ideal location for the proposed Center, being a bellwether state for
    social, demographic and epidemiological changes that the rest of the
    nation is currently facing or will face in the near future. Our
    extensive experience working with traditionally hard-to-reach
    populations such as minority substance abusers will ensure that the
    interventions we develop will be culturally and linguistically
    appropriate and acceptable. We also have a means for rapid
    dissemination of effective prevention and intervention within minority
    communities through an already developed community health care
    coalition.
        The goals of the Tobacco Addiction Risk Assessment Research Center
    are to:
      --Identify risk behaviors which lead to tobacco use and substance
            abuse.
      --Reduce the incidence and prevalence of tobacco use and that of
            other addictive substances.
      --Reduce the development of and suffering from disease associated
            with tobacco and other addictive substances through research
            and interventions in the basic sciences, clinical medicine and
            epidemiological research.
      --Reduce exposure to environmental tobacco smoke.
      --Develop, test and apply science-based community interventions to
            achieve these goals.
        We know that intervention with effective prenatal programs saves a
    tremendous amount of money that otherwise would be spent on healthcare
    after birth. The same can be said for early intervention at other
    points in the life cycle. My own personal research experience with the
    early detection of breast cancer through the screening of over 30,000
    medically underserved women has demonstrated that early detection and
    intervention saves dollars as well as lives. As is true for cancer, we
    already possess a great deal of knowledge that could be used to develop
    interventions and prevention strategies for addiction to tobacco and
    other harmful substances. Applying this knowledge could effect savings
    of billions of dollars for state, local and national governments.
    Equally important, the quality of life will be improved for
    individuals, families and their communities as well as society at
    large. It is becoming ever more apparent that we, as a society, cannot
    afford to ignore prevention and early intervention strategies since
    crisis management is far too costly in terms of quality of life and
    unnecessary expenditures of dollars.
        By achieving our stated goals, the Tobacco Addiction Risk
    Assessment Research Center will be in a perfect position to (1) improve
    quality of life, (2) decrease morbidity and mortality, (3) increase
    survival and (4) significantly decrease health care expenditures by
    applying effective prevention and intervention. I thank you very much
    for your valuable time and stand ready to serve you in any way
    possible.
                                     ______

      Prepared Statement of the National Association for State Community
                               Services Programs

        The National Association for State Community Services Programs
    (NASCSP) thanks this committee for its continued support of the
    Community Services Block Grant (CSBG) and seeks an appropriation of
    $630 million for the state grant portion of the CSBG. The amount
    appropriated for the state grant portion in fiscal year 2000 was $530
    million. We are requesting an increase of $100 million in order to
    expand the efforts of the Community Services Network in assisting those
    families remaining on welfare with the intensive services they need to
    transition to work and to assist low-income workers in remaining at
    work through supportive services such as transportation and child care.
    These additional funds will also assist states in developing services
    in the four percent of counties that are not currently served by the
    CSBG.
        NASCSP is the national association that represents state
    administrators of the Community Services Block Grant (CSBG), and state
    directors of the Department of Energy's Low-Income Weatherization
    Assistance Program.
                                   background
        The states believe the Community Services Block Grant (CSBG) is a
    unique block grant that has successfully devolved decision making to
    the local level. Federally funded with oversight at the state level,
    the CSBG has maintained a local network of over 1,000 agencies which
    coordinate over $5 billion in federal, state, local and private
    resources each year. Operating in more than 96 percent of counties in
    the nation and serving over 9 million low-income persons, local
    agencies, known as Community Action Agencies (CAAs), provide services
    based on the characteristics of poverty in their communities. For one
    town this might mean providing job placement and retention services,
    for another developing affordable housing. In rural areas it might mean
    providing access to health services or developing a rural
    transportation system.
        Since its inception, the CSBG has shown how partnerships between
    states and local agencies benefit citizens in each state. We believe it
    should be looked to as a model of how the Federal Government can best
    promote self-sufficiency for low-income persons in a flexible,
    decentralized, non-bureaucratic and accountable way.
        Long before the creation of the Temporary Assistance for Needy
    Families (TANF) block grant, the CSBG was setting the standard for
    private-public partnerships that could work to the betterment of local
    communities and low-income residents. Family oriented, while promoting
    economic development and individual self-sufficiency, the CSBG relies
    on an existing and experienced community-based service delivery system
    of CAAs and other non-profit organizations to produce results for its
    clients.
            major characteristics of the community services network
        Locally Directed.--Tri-partite boards of directors guide CAAs.
    These boards consist of one-third elected officials, one-third low-
    income persons and one-third representatives from the private sector.
    The boards are responsible for establishing policy and approving
    business plans of the local agencies. Since these boards represent a
    cross-section of the local community, they guarantee that CAAs will be
    responsive to the needs of their community.
        Adaptability.--CAAs have demonstrated success in moving persons
    from welfare to work and in assisting low-income families in achieving
    self-sufficiency. CAAs provide a flexible local presence that governors
    have mobilized to deal with emerging poverty issues.
        Leveraging Capacity.--For every CSBG dollar they receive, CAAs
    leverage nearly $3.50 in non-federal resources (state, local, and
    private) to coordinate efforts that improve the self-sufficiency of
    low-income persons and lead to the development of thriving communities.
        Volunteer Mobilization.--CAAs mobilize volunteers in large numbers.
    In fiscal year 1997, the most recent year for which data are available,
    the CAAs elicited nearly 27 million hours of volunteer efforts, the
    equivalent of almost 13,000 full-time employees. Using the minimum
    wage, these volunteer hours are valued at more than $139 million.
        Emergency Response.--CAAs are utilized by federal and state
    emergency personnel as a front line resource to deal with emergency
    situations such as floods, hurricanes and economic downturns. They are
    also relied on by citizens in their community to deal with individual
    family hardships, such as house fires or other emergencies.
        Accountable.--The federal Office of Community Services, state CSBG
    offices and CAAs have worked closely to develop a results-oriented
    management and accountability (ROMA) system. Through this system,
    individual agencies determine local priorities within six goals for
    CSBG and report on the outcomes that they achieved in their
    communities.
        The statutory goal of the CSBG is to ameliorate the effects of
    poverty while at the same time working within the community to
    eliminate the causes of poverty. The primary goal of every CAA is self-
    sufficiency for its clients. Helping families become self-sufficient is
    a long-term process that requires multiple resources. This is why the
    partnership of federal, state, local and private enterprise has been so
    vital to the successes of the CAAs.
                            who does the csbg serve?
        National data compiled by NASCSP show that the CSBG serves a broad
    segment of low-income persons, particularly those who are not being
    reached by other programs and are not being served by welfare programs.
    Based on the most recently reported data,
      --67 percent have incomes at or below the poverty level; 44 percent
            have incomes below 75 percent of the poverty guidelines. In
            1997, the poverty level for a family of three was $13,330.
      --Only 38 percent of adults have a high school diploma.
      --37 percent of all client families are ``working poor'' and have
            wages or unemployment benefits as income.
      --25 percent depend on pensions and Social Security and are therefore
            poor, former workers.
      --23 percent receive cash assistance from TANF.
      --60 percent of families assisted have children under 18 years of
            age.
                        what do local csbg agencies do?
        Since Community Action Agencies operate in rural areas as well as
    in urban areas, it is difficult to describe a typical Community Action
    Agency. However, one thing that is common to all is the goal of self-
    sufficiency for all of their clients. Reaching this goal may mean
    providing daycare for a struggling single mother as she completes her
    General Educational Development (GED) certificate, moves through a
    community college course and finally is on her own supporting her
    family without federal assistance. It may mean assisting a recovering
    substance abuser as he seeks employment. Many of the Community Action
    Agencies' clients are persons who are experiencing a one-time
    emergency. Others have lives of chaos brought about by many overlapping
    forces--a divorce, sudden death of a wage earner, illness, lack of a
    high school education, closing of a local factory or the loss of family
    farms.
        CAAs provide access to a variety of opportunities for their
    clients. Although they are not identical, most will provide some if not
    all of the services listed below:
      --employment and training programs
      --transportation and child care for low-income workers
      --individual development accounts
      --micro business development help for low-income entrepreneurs
      --a variety of crisis and emergency safety net services
      --local community and economic development projects
      --housing and weatherization services
      --Head Start
      --nutrition programs
      --family development programs
        CSBG funds many of these services directly. Even more importantly,
    CSBG is the core funding which holds together a local delivery system
    able to respond effectively and efficiently, without a lot of red tape,
    to the needs of individual low-income households as well as to broader
    community needs. Without the CSBG, local agencies would not have the
    capacity to work in their communities developing local funding, private
    donations and volunteer services and running programs of far greater
    size and value than the actual CSBG dollars they receive.
        CAAs manage a host of other federal, state and local programs which
    makes it possible to provide a one-stop location for persons whose
    problems are usually multi-faceted. CAAs manage the Head Start program
    in many communities. Using their unique position in the community, CAAs
    recruit additional volunteers, bring in local school department
    personnel, tap into religious groups for additional help, coordinate
    child care and bring needed health care services to Head Start centers.
    In many states they also manage the Low Income Home Energy Assistance
    Program (LIHEAP), raising additional funds from utilities for this
    vital program. CAAs often administer the Weatherization Assistance
    Program and are able to mobilize funds for additional work on
    residences not directly related to energy savings that may keep a low-
    income elderly couple in their home. CAAs also coordinate the
    Weatherization Assistance Program with the Community Development Block
    Grant program to stretch federal dollars and provide a greater return
    for tax dollars invested. They also administer the Women, Infants and
    Children (WIC) nutrition program as well as job training programs,
    substance abuse programs, transportation programs, domestic violence
    and homeless shelters, food pantries, as well as gardening and canning
    programs.
                            examples of csbg at work
        CAAs in many states have been working diligently to support
    families receiving cash assistance through the Temporary Assistance for
    Needy Families (TANF) block grant. The CAAs and the state CSBG offices
    have been developing methods of creating an effective transition from
    welfare to work for families.
        In Illinois, all 36 Community Action Agencies are providing their
    outreach workers with training and certification in Family and
    Community Development. This is a joint effort of Iowa State University
    and Southern Illinois University (SIU) to develop certification
    standards. SIU provides three hours of course credits for persons who
    successfully complete this program. Illinois now has over 500 people
    certified within its 36 CAAs. These individuals will spend more staff
    time providing comprehensive assistance to each low-income person to
    help them become self-sufficient. At first this expanded effort will
    cost more, but will produce lasting results in the long-term.
        Additionally all 36 CAAs have entered into performance contracts
    with the Illinois Department of Public Aid to assist welfare recipients
    who are now ``on the clock'' as far as finding jobs before their
    welfare benefits lapse. When an agency places a welfare recipient in a
    job whose salary is above 125 percent of the official poverty
    guidelines and has benefits, the agency is paid $1,200. They are paid
    $1,000 for each successful placement in a job whether or not it has
    benefits or has a salary that is equal to 125 percent of the poverty
    guideline. The Community and Economic Development Association of Cook
    County (CEDA) is using these funds for job creation.
        In Pennsylvania, community development has been a major focus. For
    example, Montgomery County Development Commission opened the CADCOM
    Micro Enterprise Resource Center (CMERC). The purpose of the center is
    to nurture start-up and emerging small business. The center provides a
    six-week training course, hands-on management assistance, access to
    shared office equipment, flexible leases and expandable space. In its
    first year, the program successfully started three businesses.
        In New Hampshire, CSBG funds are being used for alcohol and drug
    rehabilitation programs for welfare recipients to assist them in
    staying drug free and in securing and keeping jobs.
        To recapitulate: The CSBG provides a community-based service
    delivery system. Each local organization, through its local board of
    directors, establishes priorities and serves its community and low-
    income residents through programs designed and delivered locally in
    partnership with state and local governments, businesses, civic and
    religious groups and others. The CSBG leverages resources that are far
    in excess of the appropriations it receives. Additionally, nearly 27
    million hours of volunteer services are contributed to CAAs annually.
    CSBG agencies have used the increased funds they received for the last
    two years to continue their activities that lead to self-sufficiency
    and have become integrally involved in the implementation of TANF in
    most states across the nation. Those families who remain on welfare
    have substantially greater impediments to successfully becoming self
    sufficient, an increase in the CSBG will make it possible to meet these
    special needs, while still helping working poor families remain in the
    workforce.
        NASCSP therefore urges this committee to provide an increase that
    factors in inflation and to fund the CSBG grant to the states at $630
    million.
                                     ______

       Prepared Statement of the American Academy of Physician Assistants

        On behalf of the nearly 38,000 clinically practicing physician
    assistants in the United States, the American Academy of Physician
    Assistants is pleased to submit comments on fiscal year 2001
    appropriations for Physician Assistant (PA) education programs that are
    authorized through Title VII of the Public Health Service Act.
        A member of the Coalition for Health Funding (CHF), the American
    Academy of Physician Assistants supports the CHF recommendation to
    appropriate $37.7 billion for the Public Health Service in fiscal year
    2001. The Academy is also a member of the Health Professions and
    Nursing Coalition (HPNEC) and supports the HPNEC recommendation to
    provide at least $335 million to support the Title VII and VIII
    programs in fiscal year 2001. The Academy believes that a 10 percent
    increase in funding for the Title VII health professions programs is
    well justified. The programs are essential to the development and
    training of primary health care professionals and contribute to the
    nation's overall efforts to increase access to care by promoting health
    care delivery in medically underserved communities.
        The Academy is very concerned that the Administration's fiscal year
    2001 budget request once again proposes to eliminate funding for the
    primary care medicine and dentistry programs, through which physician
    assistant educational programs receive support. We wish to thank the
    Members of this Subcommittee for your historical role in supporting
    funding for the health professions programs, and we hope that we can
    count on your support for these important programs in fiscal year 2001.
                 overview of physician assistant (pa) education
        As many Subcommittee Members are aware, PA programs provide
    students with a primary care education that prepares them to practice
    medicine with physician supervision. The first PA program was started
    at Duke University approximately 30 years ago, and today there are 120
    accredited PA educational programs.
        Physician assistant programs are located at schools of medicine or
    health sciences, universities, teaching hospitals, and the Armed
    Services. All PA educational programs are accredited by the Commission
    on Accreditation of Allied Health Education Programs upon
    recommendation by the Accreditation Review Committee for PA Education.
        Prior to admission, the typical PA student has a bachelor's degree
    and 45 months of health care experience. The most common prior health
    experience of PA students involves pre-hospital care, such as emergency
    medical technicians or paramedics. Other students come from backgrounds
    in nursing, allied health technologies, mental health fields, and
    social work.
        The typical PA program consists of 111 weeks of instruction. The
    first phase of the program consists of intensive classroom and
    laboratory study, providing students with an in-depth understanding of
    the medical sciences. More than 400 hours in classroom and laboratory
    instruction are devoted to the basic sciences, with over 70 hours in
    pharmacology, more than 149 hours in behavioral sciences, and more than
    535 hours of clinical medicine.
        The second year of PA education consists of clinical rotations. On
    average, students devote more than 2,000 hours or 50-55 weeks to
    clinical education, divided between primary care medicine and various
    specialties, including family medicine, internal medicine, pediatrics,
    obstetrics and gynecology, surgery and surgical specialties, internal
    medicine subspecialties, emergency medicine, and psychiatry. During
    clinical rotations, PA students work directly under the supervision of
    physician preceptors, participating in the full range of patient care
    activities, including patient assessment and diagnosis, development of
    treatment plans, patient education, and counseling.
        Physician assistant education is competency based. After graduation
    from an accredited PA program, the physician assistant must pass a
    national certifying examination jointly developed by the National Board
    of Medical Examiners and the independent National Commission on
    Certification of Physician Assistants. To maintain certification, PAs
    must log 100 continuing medical education credits over a two-year cycle
    and reregister every two years. Also to maintain certification, PAs
    must take a recertification exam every six years.
                          physician assistant practice
        Physician assistants are licensed health care professionals
    educated to practice medicine as delegated by and with the supervision
    of a physician. In all states except Mississippi, physicians may
    delegate to PAs those medical duties that are within the physician's
    scope of practice and the PA's training and experience, and are allowed
    by law.
        A physician assistant provides health care services that were
    traditionally only performed by a physician. Duties include, but are
    not limited to, performing physical examinations, diagnosing and
    treating illnesses, ordering and interpreting laboratory tests,
    suturing wounds, assisting in surgery, providing patient education and
    counseling, and making rounds in nursing homes and hospitals. Forty-six
    states, the District of Columbia, and Guam authorize physicians to
    delegate prescriptive privileges to the PAs they supervise.
        PAs are located in almost all health care settings and in every
    medical and surgical specialty. Fourteen percent of all PAs practice in
    rural areas where they may be the only full-time providers of care
    (state laws stipulate the conditions for remote supervision by a
    physician). Approximately twenty percent of PAs work in urban and inner
    city areas. The majority of PAs are in primary care. Nearly one-quarter
    practice in surgical specialties. Seventy percent of PAs practice in
    outpatient settings.
        In 1999 an estimated 154 million patient visits were made to PAs
    and approximately 196 million medications were prescribed or
    recommended.
      critical role of the title vii, public health service act, programs
        A growing number of Americans lack access to primary care, either
    because they are uninsured, underinsured, or they live in a community
    with an inadequate supply or distribution of providers. The growth in
    the uninsured U.S. population increased from approximately 32 million
    in the early 1990s to nearly 45 million today. Simultaneously, the
    number of medically underserved communities continues to rise, from
    1,949 in 1986 to 2,900 today.
        The role of the Title VII programs is to alleviate these problems
    by supporting access to quality, affordable, and cost-effective care in
    areas of our country that are most in need of health care services,
    specifically rural and urban underserved communities. This is
    accomplished through the support of educational programs that train
    more health professionals in fields experiencing shortages, improve the
    geographic distribution of health professionals, and increase access to
    care in underserved communities.
        The Title VII programs are the only federal education programs that
    are designed to address the supply and distribution imbalances in the
    health professions. Since the establishment of Medicare, the costs of
    physician residencies, nurses and some allied health professions
    training has been paid through Graduate Medical Education (GME)
    funding. However, GME has never been available to support PA education.
    More importantly, GME was not intended to generate a supply of
    providers who are willing to work in the nation's medically underserved
    communities. That is the purpose of the Title VII Public Health Service
    Act Programs, which support such initiatives as loans and scholarships
    for disadvantaged students, scholarships for students with exceptional
    financial need, centers of excellence to recruit and train minority and
    disadvantaged students, and interdisciplinary initiatives in geriatric
    care and rural health care.
                   title vii support of pa education programs
        Targeted federal support for PA education programs is currently
    authorized through section 747 of the Public Health Service Act. The
    program was reauthorized in the 105th Congress through the Health
    Professions Education Partnerships Act of 1998, Public Law 105-392,
    which streamlined and consolidated the federal health professions
    education programs. Support for PA education is now considered within
    the broader context of training in primary care medicine and dentistry.
        Public Law 105-392 reauthorized awards and grants to schools of
    medicine and osteopathic medicine, as well as colleges and
    universities, to plan, develop, and operate accredited programs for the
    education of physician assistants and faculty, with priority given to
    training individuals from disadvantaged communities. The funds ensure
    that PA students from all backgrounds have continued access to an
    affordable education and encourage PAs, upon graduation, to practice in
    underserved communities. These goals are accomplished by funding PA
    education programs that have a demonstrated track record of: (1)
    placing PA students in health professional shortage areas; (2) exposing
    PA students to medically underserved communities during the clinical
    rotation portion of their training; and (3) recruiting and retaining
    students who are indigenous to communities with unmet health care
    needs.
        The program works. A review of PA graduates from 1991-1999 reveals
    that 16.5 percent of students graduating from PA programs supported by
    Title VII are from underrepresented minorities, compared to 7.7 percent
    of graduates from programs that did not receive Title VII support.
    Similarly, 13.5 percent of the graduates who attended PA programs
    receiving Title VII support during the eight-year period practice in
    underserved communities, compared to 10.1 percent of graduates of
    programs not receiving such support during the same period.
        The PA programs' success in recruiting and retaining
    underrepresented minority and disadvantaged students is linked to their
    ability to creatively use Title VII funds to enhance existing
    educational programs. For example, a PA educational program in Iowa
    uses Title VII funds to target recruitment efforts to disadvantaged
    students, providing shadowing and mentoring opportunities for
    prospective students, increasing training in cultural competency, and
    identifying new family medicine preceptors in underserved areas. PA
    programs in Texas use Title VII funds to create new clinical rotation
    sites in rural and undersered areas, including new sites in border
    communities, and to establish non-clinical rural rotations to help
    students understand the challenges faced by rural communities. Several
    other PA programs have been able to use Title VII grants to leverage
    additional resources to assist students with the added costs of housing
    and travel that occur during relocation to rural areas for clinical
    training.
        Without Title VII funding, many of these special PA training
    initiatives would not be possible. Institutional budgets and student
    tuition fees simply do not provide sufficient funding to meet the
    special, unmet needs of medically underserved areas or disadvantaged
    students. Nevertheless, the need is very real, and Title VII is
    critical in meeting it.
         need for increased title vii support for pa education programs
        Increased Title VII support for educating PAs to practice in
    underserved communities is particularly important given the market
    demand for physician assistants. Without the Title VII funding to
    expose students to underserved sites during their training, PA students
    are far more likely to practice in the communities where they were
    raised or the communities in which they attended school. Title VII
    funding is a critical link in addressing the natural geographic
    maldistribution of health care providers by exposing students to
    underserved sites during their training, where they frequently choose
    to practice following graduation.
        The supply of physician assistants is inadequate to meet the needs
    of society, and the demand for PAs is expected to increase. A 1994
    report of a workgroup of the Council on Graduate Medical Education
    (COGME), ``Physician Assistants in the Health Workforce,'' estimated
    that the anticipated medical market demand and the estimated workforce
    requirements for PAs would exceed demand. Additionally, the Bureau of
    Labor Statistics projects that the number of available PA jobs will
    increase 47 percent between 1996 and 2002.
        Despite the increased demand for PAs, funding has not
    proportionately increased for the Title VII programs that are designed
    to educate and place physician assistants in underserved communities.
    Between fiscal year 1994 and fiscal year 1997, PA program funding went
    from $6.5 million down to $5.9 million and, as of fiscal year 1997, was
    restored to $6.376 million. PA program funding was slightly increased
    again for fiscal year 1998 at $6.398 million. The fiscal year 1998
    appropriation provided 42 awards to support the training of
    approximately 1600 PA graduates. The fiscal year 1999 allocation was
    $6.8 million; the fiscal year 2000 appropriation for the cluster
    assumes funding for the PA programs at the fiscal year 1999 level.
                  recommendations on fiscal year 2001 funding
        The American Academy of Physician Assistants urges members of the
    Appropriations Committee to consider the inter-dependency of all the
    public health agencies and programs when determining funding for fiscal
    year 2001. For instance, while it is important to fund clinical
    research at the National Institutes of Health (NIH) and to have an
    infrastructure at the Centers for Disease Control (CDC) that ensures a
    prompt response to an infectious disease outbreak, the good work of
    both of these agencies will go unrealized if the Health Resources and
    Services Administration (HRSA) is inadequately funded. HRSA administers
    the ``people'' programs, such as Title VII, that bring the cutting edge
    research discovered at NIH to the patients--through providers such as
    PAs who have been educated in Title VII-funded programs. Likewise, CDC
    is heavily dependent upon an adequate supply of health care providers
    to be sure that disease outbreaks are reported, tracked, and contained.
        The critically important programs administered by NIH, HRSA, and
    CDC are integral components within the nation's public health
    continuum. One component is not more important than another, and no one
    component can succeed without adequate support from each of the other
    elements. The Academy is particularly concerned that any increase for
    the NIH not be made at the expense of the health professions education
    program or other public health programs, as recommended this year by
    the Senate Budget Committee.
        The American Academy of Physician Assistants is particularly
    appreciative of the modest increase in funding for PA education
    programs that was appropriated during the 105th Congress. However, the
    increase has not been sufficient to meet the increasing demand for PA
    graduates in the growing number of medically underserved communities.
    Accordingly, the Academy respectfully requests that the Title VII
    health professions programs, including PA programs, receive a 10
    percent funding increase in fiscal year 2001.
        Thank you for the opportunity to present the American Academy of
    Physician Assistants' views on fiscal year 2001 appropriations.
                                     ______

     Prepared Statement of the National Jewish Medical and Research Center

        Mr. Chairman and Members of the Subcommittee, thank you for your
    support last year and the opportunity to present this testimony
    regarding the National Jewish Medical and Research Center's proposal to
    build an integrated Center for Environmental Health Research and
    Service (CEHRS). This Center will, under one roof, support research and
    provide clinical services for patients with respiratory and immune
    diseases with the mission of controlling or eradicating environmental
    and occupational illness in the Rocky Mountain Region. It will serve as
    a regional resource and national model for the delivery of
    environmental clinical health services, conduct both basic and field
    research on environmental illness, and ``translate'' new knowledge, to
    better inform the public and help guide rational environmental policy
    by government, at both regional and national levels.
        National Jewish Medical and Research Center is known worldwide for
    the diagnosis and treatment of patients with environmental,
    respiratory, immune and allergic disorders, and for groundbreaking
    medical research. For the past 20 years, this century-old nonsectarian,
    nonprofit medical center has earned an international reputation for its
    treatment of environmental illness and for research leading to the
    detection and prevention of environmental disorders including asthma,
    berylliosis, tuberculosis, and building-related illnesses.
        With funding from Federal agencies including the NIEHS, NHLBI,
    NIAID, EPA, DOE, and CDC/NIOSH, as well as foundations and private
    industry, National Jewish has become one of the leaders in the field of
    environmental health. National Jewish is deeply committed to providing
    accessible, affordable and high quality care for environmentally and
    occupationally exposed individuals, to consulting for government and
    industries in the region and nationally, and to educating medical
    professionals and the public on matters of environmental risk and
    health.
        Our nation faces a significant challenge for the 21st century--how
    to safeguard the health of the American public from environmental
    hazards. We are faced with the reality that many Americans,
    particularly the working poor, blue collar middle class, minorities,
    children and the elderly, are exposed daily to environmental toxins
    that may cause major lung, heart, immune and allergic diseases,
    disability and untimely death. We must find ways to better diagnose,
    treat and, most importantly, prevent environmental disease. In
    addition, federal agencies and corporations face the daunting task of
    cleaning up environmental ``sins of the past''--without unduly
    endangering the health of today's hazardous waste workers and the
    members of communities that surround them.
        The State of Colorado has historically been medically underserved,
    in environmental health services, with fewer than 40 medical
    practitioners in Colorado who are board certified to practice
    environmental and occupational health. While the Division of
    Environmental and Occupational Health Sciences at National Jewish
    provides consultation to industry, agriculture, community groups, and
    labor, its services are outstripped by the regional need for expertise.
    National Jewish is forced to turn away many patients and groups who
    have environmental concerns because of physical and staffing
    limitations at the Center. These needs range from community groups
    seeking advice on the hazards of radioactivity and of metal-
    contaminated soil, to industries needing help in the control of lead
    poisoning and biological hazard exposures, to regional agencies seeking
    aid in the investigation of disease outbreaks caused by airborne molds
    or tuberculosis-like organisms.
        National Jewish is uniquely positioned in the Rocky Mountain region
    to serve as a model health care institution for implementing innovative
    environmental health programs that reduce the risk of respiratory and
    immune system disease. Regionally and nationally, the diseases that are
    treated at National Jewish Medical and Research Center are on the rise,
    including asthma, diseases due to environmental tobacco smoke,
    building-related respiratory and allergic illnesses. National Jewish
    Medical and Research Center specializes in helping both small and large
    regional employers address practical issues of toxic exposure
    assessment, exposure control, medical management of occupational
    illness, and remediation. Employees and their employers, while aiming
    to make the workplace safer and more productive, often lack enough
    information about the toxic effects of airborne chemicals, metals, and
    organic matter that produce disability. Recent studies show that 1 in
    10-hospital admissions is related to a workplace injury or exposure.
    More than half of all patients seen in general medicine clinics in the
    central U.S. report past or ongoing exposure to one or more known
    toxin.
        The solutions to these environmental health dilemmas are to prevent
    exposures from causing disease and, if environmental exposures have
    already occurred, to detect disease earlier and to develop more
    effective treatments for disease.
        National Jewish can best increase our effectiveness by housing
    these major activities in a single, dedicated location. The CEHRS will
    be a showcase for the application of the most advanced environmental
    science and directly to the prevention of disease in groups of
    Americans at environmental risk. By showing how a multidisciplinary
    approach can help eradicate environmental respiratory and allergic
    diseases, our Center will be a model for other centers around the
    country who may address other forms of environmental illness, such as
    those linked to skin disease, neurologic disorders, liver disease, and
    cancer. National Jewish Medical and Research Center believes that by
    maintaining a tight focus of both clinical care and research in an area
    of great need--the respiratory and immune systems--its Center will be
    able to deliver long term solutions to the most important forms of
    environmental disease.
        The CEHRS will meet this need by integrating the following existing
    and new program components in the new Center:
        The Clinic for Environmental and Occupational Health Care.--A
    combined adult and pediatric outpatient clinical practice staffed by
    experienced environmental and occupational health physicians and nurses
    who diagnose and treat environmental disorders. Annually, this clinical
    group screens and evaluates more than 2,000 patients with suspected
    environmental or occupational lung and allergic disorders.
        The Environmental Disease Prevention and Research Service.--A
    multidisciplinary team of physicians, researchers, epidemiologists,
    industrial hygienists, and health educators, who conduct practical
    research aimed at ``real life'' problems solving by measuring airborne
    exposures to toxins and implementing innovative programs that detect
    the effects of chemicals in individuals and in the air. The goal is to
    devise practical, cost-effective solutions to reducing risks of cancer,
    lung fibrosis, and allergic lung disease.
        The Environmental Away-Team Consultation Service.--A mobile
    consultation service staffed by a team of environmental and
    occupational health experts who go anywhere in the country to measure
    environmental exposures, monitor for disease, and advise industrial and
    agricultural employers, labor, and private citizens on the management
    and control of environmental hazards. This service has gone on-site to
    more than 20 states.
        The Respiratory Protection Program.--A mobile service that helps
    individuals and corporations to educate and provide appropriate types
    of masks for people being potentially exposed to airborne hazards.
    Firefighters, hazardous waste workers, municipal employees, and others
    who encounter potentially lethal exposures to highly toxic materials
    call on this service.
        The Environmental Education/Community Outreach Service.--A risk
    communication service that utilizes the internet as well as more
    traditional educational approaches to deliver up-to-date, balanced,
    practical environmental information to civic groups, labor, industry,
    and local and Federal Government agencies.
        The Occupational and Environmental Medicine Training Program.--
    Based at National Jewish and the Department of Preventive Medicine and
    Biometrics at the University of Colorado School of Medicine, this is
    the only training program for environmental medicine in the State of
    Colorado.
        The Environmental Toxicology Section.--A research unit dedicated to
    understanding oxidative stress which is a natural process that produces
    disease when undesirable oxidant gases or dusts are inhaled, causing
    inflammation.
        The Environmental Immunology Laboratory.--A research unit dedicated
    to understanding how environmental toxins cause allergic diseases.
        National Jewish is the only academic research facility in Colorado
    that provides clinical care for patients with suspected environmental
    or occupational illnesses. Patients from the region as well as from all
    50 states come to National Jewish Medical and Research Center for
    medical diagnosis and care. Patients receive superior care without
    regard to their ability to pay. Each year $7 to $10 million of free or
    heavily subsidized care is provided.
        National Jewish was recently ranked as the best hospital in the
    nation for excellence in treating respiratory diseases in U.S. New and
    World Report's ``America's Best Hospitals.'' American Health magazine
    termed National Jewish one of the finest U.S. hospitals in allergy,
    immunology and pulmonology for both adult and pediatric patients. The
    Institute for Science and medicine rated National Jewish among the top
    10 independent biomedical research institutions--of any kind--in the
    world, and the only one that also provides patient care. It was ranked
    as one of the three most influential research institutions for
    immunology and as the number one private immunology research
    institution in the world.
        Partnerships with governmental agencies.--In addition to conducting
    research directly funded by several agencies, National Jewish faculty
    provide advice and consultation to local, regional and Federal
    Government offices, including: the Colorado Department of Health and
    the Environment, the Governor's Air Toxics Science Advisory Committee,
    the U.S. DOE Beryllium Standards Advisory Committee, oversight Boards
    for Hanford Reservation in Washington State, the Nevada Test Site, and
    Los Alamos National Laboratories, the EPA air pollution research
    advisory panel, and the OSHA Metalworking Fluids Standards Advisory
    Committee, and both CDC/NIOSH and NIH research advisory committees.
        Partnership with community health organizations.--Faculty members
    conduct community outreach, speaking at local hospitals on
    environmental health. Three of our faculty have served as presidents of
    the Rocky Mountain Academy for Environmental and Occupational Medicine,
    the regional society for all physicians practicing in this field.
        Partnership with regional industry and labor.--National Jewish has
    helped organize and conduct medical education and medical surveillance
    programs for many regional industries, helping them to protect
    employees from hazards in the workplace.
        National Jewish proposes to establish a public/private partnership
    with the Federal Government in support of the establishment of the
    ``Center for Environmental Health Research and Service.'' This
    partnership will cover the cost of the construction of a new, 50,000
    square foot, state-of-the-art facility which will house all basic and
    clinical environmental research, clinical care, outpatient services,
    training and consulting services affiliated with the Environmental
    Health Research and Sciences program.
        The total cost of the proposed facility is $14 million. National
    Jewish received a $1 million HRSA grant from this Subcommittee in
    fiscal year 1999 and $250,00 last year to carry out the initial phases
    for the construction of the CEHRS. National Jewish seeks $5 million in
    HRSA follow-on funding in fiscal year 2001 to help construct the new
    Center.
        Thank you.
                                     ______

                  Prepared Statement of Idaho State University

        Mr. Chairman and Members of the Subcommittee, thank you for the
    opportunity to submit testimony to the hearing record regarding an
    important initiative in rural health being undertaken by Idaho State
    University's (ISU) Institute for Rural Health Studies. Specifically,
    ISU has requested federal partnership assistance to establish the Idaho
    Telehealth Integrated Care Center to address the many health challenges
    faced by Idaho as a rural and frontier state where 90 percent of the
    geography and about one half of the population is outside of an urban
    area. The three main objectives of the Idaho Telehealth Integrated Care
    Center (ITICC) are to:
      --improve the quality and quantity of access to healthcare for people
            living in Idaho's rural and frontier areas,
      --promote professional development in telehealth for faculty and
            practicing professionals, and
      --provide professionals-in-training educational experiences in
            integrated care and telehealth.
        This integrative model meets many of the objectives for whole-
    person primary care outlined in Healthy People 2010. In addition to
    improving care and provider professional support, this integrated care
    program can serve as a national model for the integration of general
    medical, oral health, and mental health.
        The goal of this project is to build a comprehensive telehealth
    clinic providing consultation and technical assistance in a variety of
    fields to support care in rural and frontier areas. The concept is
    simple. By contacting the ITICC, facilities in rural and frontier areas
    can schedule assistance across the health care spectrum. For example,
    if a rural clinic determines they need support in audiology, they can
    call the ITICC and schedule an audiology consultation. Rural partners
    will be recruited from Tribal Nations, Indian Health Service, critical
    access hospitals, private and public clinics. Particular attention will
    be taken to provide care in culturally sensitive ways. In addition to
    supporting patients and caregivers in rural and frontier areas, the
    ITICC will serve as practice and training outlet for the university
    community.
        Idaho consists of 44 counties covering 83,574 square miles--
    geographically, the 14th largest state in the U.S. The 1998 population
    of the state was 1,228,684--only 9 states have a smaller population. Of
    the 208 towns in the state, 2 have populations over 50,000 and 16 towns
    have populations less than 100; 186 have less than 10,000 people. About
    40 percent of the population lives outside of an urban area,
    distributed over 9/10ths of the states geographical area. Idaho's per
    capita income was $18,170, ranking 43rd in the U.S. in 1997. The median
    household income was $32,000 in 1997. Idaho ranks in the upper 1/3
    (16th) of the states in number of persons employed, but 42nd in average
    annual pay. Just over 400,000 people in the state are employed, largely
    in the service industry. Forty-one thousand of those people are
    employed in health related fields.
        In Idaho, an estimated 150,000 people--60,000 of whom are
    children--live below the poverty level. Idaho ranks 3rd in the nation
    for number of persons under 18 years of age and 40th in persons over 65
    leaving the state with an abundance of children and a dearth of older,
    potentially wiser, elders. Twenty three percent (23 percent) of
    children under 5 live in poverty. In 1995, five counties had no full-
    time physician. In 1996, the physician to population ratio was 145 per
    100,000 placing Idaho in the unenviable position of having the worst
    patient to physician ratio in the United States. Access to mental and
    oral health is even more limited.
        The Office for the Advancement of Telehealth defines telehealth as
    the use of ``telecommunications technologies to support long-distance
    clinical health care, patient and professional health-related
    education, public health and health administration.'' The distribution
    of telehealth is irregular and largely explainable by an area's
    resources. According to a 1999 NTIA report on defining the digital
    divide, the more available resources, the more likely an area is to
    have access to telehealth. While telehealth has been seen as a panacea
    for improving health care in rural areas, the very rurality of these
    areas is preventing appropriate penetration of the proposed solution.
        Integrated telehealth combines two promising trends in healthcare
    to lower social and financial healthcare costs. Integrated telehealth
    uses telecommunication technology to combine physical and behavioral
    healthcare to deliver community-based whole-person care. It overcomes
    social, economic, geographical, and climatological barriers that hinder
    access. Training students in integrated telehealth care places Idaho as
    a leader in healthcare training innovation. Integrated telehealth
    should reduce medical error; improve recruitment and retention of
    healthcare students and providers; combat burnout and employee
    turnover; and improve healthcare in rural and underserved areas.
        The key to success for ITICC is building a collaborative network.
    While universities and communities have not traditionally enjoyed
    strong collaborative relationships, this trend has been reversed in
    telehealth. The majority of telehealth programs serving communities
    around the U.S. are based in academic centers. Initially, a working
    group will be founded composed of consumer, practice, student, and
    faculty representatives. Using implementation strategies based on other
    successful projects such as the Alaska Federal Health Care Access
    Network, East Carolina University, and the Telemedicine Research
    Center, the working group will development implementation strategies
    for the ITICC. Four telemedicine practice suites and up to eight rural
    clinics will be connected with up to an additional 27 rural clinics to
    follow bringing the total to 35. The ITICC system will interface with
    the Idaho Critical Access Hospital program that will wire up to 50
    hospitals. Between the two projects, up to 85 communities will have
    access to the ITICC.
        The areas of consultation available through Idaho State University
    include:
      --Geriatric Care
      --Family Medicine
      --Health Education
      --Healthcare Administration
      --Mental Health, Child & Adult
      --Nutrition Sciences
      --Nursing
      --Occupational & Physical Therapy
      --Oral Health
      --Pharmacy
      --Radiology
      --Rural Health Research
      --Speech Pathology & Audiology
        This project is designed to avoid the mistakes of other telehealth
    programs, which tend to focus on the technology and overlook the
    importance of maximizing human capital and the powerful effect of
    training on system change. The director of this project has been
    involved in designing, implementing, and evaluating telehealth programs
    for nearly a decade serving as a technology advisor to national and
    international groups and is the author of theory and evaluation papers.
    The clinical staff are mature in their fields. The ITICC team has
    intentionally chosen a smaller, scaleable project over a larger,
    riskier enterprise. Ongoing evaluation, using standardized measures, is
    built into the system design. During Year 3 there will be a special
    focus on refinement, sustainability, and dissemination of the program
    so other programs can benefit from the lessons learned by ITICC.
        Sustainability is always a concern for any program, especially one
    that is as heavily invested in equipment as telehealth must be. The
    core elements of this program are based on proven technology that can
    be sustained at minimum cost and frustration to users. Because the
    ITICC is connected with a training institution, ITICC money can be
    leveraged for other training and research grants. Moreover, because the
    ITICC target is health professions shortage area, most consultations
    will be reimbursable under HCFA rural telehealth reimbursement
    regulations.
        Mr. Chairman, ISU is seeking to establish a telehealth model for
    rural outreach. The 4 million dollars in federal partnership assistance
    requested will provide training benefits as well as improve the quality
    of care for Idaho's rural and frontier residents. We believe this will
    be an excellent investment of taxpayer funds that will be repaid many
    times over through local cost-savings and the provision of an
    integrative health model that can be replicated nationally. For
    example, it is well documented that local treatment usually results in
    cost savings. Receiving appropriate care when it is needed reduces the
    risk of hospitalization. It has been calculated that if each clinic
    prevents just one hospitalization through appropriate integrative care,
    there is the potential for 100 percent cost offset across the life of
    this project. Clearly the dollar cost offset is impressive but when
    added to the benefits of reduced medical error, better training, and
    recruitment and retention of providers in rural and frontier areas the
    benefits mount. Perhaps the most compelling case can be made by looking
    at the improvement to the quality of life for an individual person and
    his or her family and community when appropriate community based,
    whole-person care is finally possible.
        Thank you.
                                     ______

              Prepared Statement of Babyland Family Services, Inc.

        Mr. Chairman and Members of the Subcommittee, thank you for the
    opportunity to submit testimony to the Public Witness Hearing Record
    regarding a model educational program that will close the ``digital
    divide'' among minority inner city children and families. Babyland
    Family Services (BFS) is a major non-profit child and family service
    organization, founded in 1968 in Newark, New Jersey, that provides
    comprehensive child and family development services at 14 sites to
    1,500 at risk children and their families each year. The Annie E. Casey
    Foundation, a national leader in children's issues, highlighted
    Babyland in its annual 1998 Kids Count report as a model in community-
    based child and family development. BFS was also one of a select number
    of agencies that received a 1999 Century of Caring award, from the NJ
    Division of Youth and Family Services (DYFS), for its service to
    children and families. Babyland has also taken the lead on several
    community-wide initiatives: Success By 6, Family and Children Early
    Education Services (FACES), Abbott Preschool Family Worker Program, and
    the Pediatric Asthma Reduction Effort (PARE). These initiatives include
    collaborations with over 30 other child care centers, several public
    and parochial elementary schools, and several service providers.
    Together these initiatives serve over 5,000 children and families.
        BFS integrates its wide network of services in order to enable each
    child and individual to reach their potential--intellectually,
    emotionally, spiritually, socially, and physically. Babyland's holistic
    philosophy--integrating child, family, staff and community
    development--serves as a model and has been studied by other
    communities throughout the nation and as far away as South Africa.
    Babyland serves at-risk children (from infancy to 18 years old),
    parents striving to be self-sufficient, teenage parents (including
    young fathers), struggling families and distressed neighborhoods.
        BFS programs provide a continuum of educational services to
    individual children as well as multiple support services for family
    members. By virtue of this continuum, the agency is able to build
    extensive relationships with families and to provide follow-up care. As
    a result, BFS is in a unique position to launch and oversee a major
    computer and technology initiative that will provide extensive training
    and technology support for individual families having no other tangible
    means of becoming computer literate or of acquiring the requisite
    skills necessary to be informed and self-sufficient. This initiative
    would empower not only present clients but also those who will receive
    BFS services in the future.
        BFS services include:
      --Quality child care for children under three years old, through the
            Early Head Start Program;
      --Early childhood education for preschoolers;
      --After school and summer enrichment programs for school-age
            children;
      --Pediatric health services, including a pediatric AIDS and asthma
            program;
      --Parent education for teenage mothers and pregnant women, young
            fathers, severely distressed parents, foster parents, and
            grandparents;
      --Emergency shelter and counseling for battered women and children;
      --Foster care homes for boarder babies and sibling children;
      --Self-sufficiency services that include: life skills, family
            literacy, substance abuse and mental health counseling, and
            employment training/placement in conjunction with networking
            partners;
      --Training in the areas of child development, domestic violence,
            foster care, family support, health and parent leadership; and
      --Community organizing and neighborhood leadership training for
            parents and residents.
        Computer technology is transforming the economic and social
    landscape of this country by offering information and educational
    opportunities for individual growth and community development. Inner-
    city children and residents are inadequately prepared to take advantage
    of these growth opportunities. If the gap in information technology--
    the digital divide--is not bridged, a large segment of society will be
    further polarized and left without the tools needed for full
    participation in society. Specifically, BFS is seeking to establish the
    telecommunications linkages necessary for the educational development
    of 670 children and to provide computer and technology training for
    2,000 parents, teachers, and employees. As a result, this initiative
    will strengthen children's educational skills; promote the self-
    sufficiency of and enhance the educational skills of parents; enable
    the agency to better track child and family needs in order to enhance
    client services; and link the community to local and national resource
    centers. The proposed technological network will link center and home-
    based child care facilities; community resources and service providers;
    educational, economic and resource information sources; training
    centers and administrative offices. The establishment of this network
    will be a model for educating urban children and serve as a conduit for
    comprehensive family support services.
        The Specific Provisions of the BFS proposal include:
      --Computer hardware and software (technical assistance, installation
            and wiring, modems, printers etc.) for children, parents and
            residents, and teaching/social service staff in classrooms,
            homes and social service offices.
      --Technology Center, as part of a new multi-purpose community
            resource center, that will provide distance learning,
            professional development and training in basic and advanced
            computer and technology skills for low-income parents,
            neighborhood residents and entry-level employees.
      --Computer Training, Curriculum Development and Professional
            Development for children, parents and residents, educational
            and social services staff, as well as national and
            international community-based family service providers.
        The initiative will benefit:
      --Preschoolers (550) at eight centers and 120 school-age children
            (after school/summer enrichment programs) at five centers.
      --Parents and family members (1,750) at 13 Babyland sites with links
            to community resources;
      --Agency Staff (250) for client tracking purposes; training and
            professional development; and access to community resources to
            be provided through workstations and/or palm pilots for
            caregivers/teachers and social service staff.
      --Parents and children in the home for educational instruction and
            support, economic and resource information, links to other
            parents and teachers, parenting education (child and family
            health, child behavior and development, cultural sensitivity,
            etc) and professional education (ex. Certifications, GED,
            etc.).
      --Family day care homes with links to community resources,
            professional education, BFS child care centers and other child
            and family resource centers.
      --Child and family service providers throughout New Jersey, the
            nation and South Africa.
        The BFS digital divide initiative will seek specifically to greatly
    enhance:
      --Early childhood development and education for young children (three
            to 13 years old).
      --The ability of inner city residents, especially low-income parents
            and teenagers, to learn computer and technology skills.
      --Tracking of 1,500 children in center- and home-based child care
            facilities; teenage parents and victims of domestic violence;
            homeless families; foster children and families.
      --Provision and delivery of professional development for BFS staff
            and parent education programs and curriculum development
            efforts.
      --Delivery of clinical and therapeutic services to parents and
            children.
      --The ability to fulfill State and Federal reporting requirements.
      --The ability to provide consultation to international family service
            providers.
        Current BFS parent and staff training programs that will be
    continued and expanded through the implementation of this initiative
    include:
      --Foster parent training for over 300 candidates;
      --Domestic Violence training for nearly 40 community staff;
      --Family Worker training for over 50 Abbott Preschool family workers;
      --Child care training and accreditation for nearly 100 child care
            staff from 30 centers;
      --Parent leadership training for 30 parents from three public
            schools, through a grant from the Victoria Foundation;
      --Family literacy training for 40 parents; and
      --Family day care training for 20 family day care providers.
        Of particular note, Babyland established an international training
    program with the Goldfield Metropolitan Corporation, a community-based
    organization in South Africa, in order to exchange information on child
    care, community development and family services. In 2000, we are
    looking forward to providing distance learning for over 100 parents and
    staff at the Early Head Start Program.
        Mr. Chairman, as your Subcommittee deliberates funding requests
    from many qualified candidates coming to you for assistance this year,
    I urge you to review and consider our request for a $1 million 21st
    Century Learning Centers Grant to bridge the digital divide among
    inner-city families in Newark. We make this request in order to help us
    fulfill our mandate as a provider for thousands in our city but also,
    in return, to act as a model for other agencies in cities around the
    country who may also be able to help the technologically disadvantaged
    gain access to the resources and skills necessary to survive in the
    21st Century.
        Thank you.
                                     ______

                   Centers for Disease Control and Prevention

        Prepared Statement of the International Brain Injury Association

        The International Brain Injury Association (IBIA) respectfully
    requests $15 million in fiscal year 2001 for the Traumatic Brain Injury
    Act (TBI Act).\1\ IBIA is a non-profit organization dedicated to the
    support and development of medical and clinical professionals and
    others who work to improve opportunities and successes for persons with
    brain injury. Headquartered in Charlottesville, Virginia, IBIA is the
    only international association representing and convening brain injury
    professionals and specialists throughout the world.
    ---------------------------------------------------------------------------
        \1\ Reauthorization of the TBI Act is currently under consideration
    by the Congress. Funding must continue uninterrupted through fiscal
    year 2001.
    ---------------------------------------------------------------------------
        The TBI Act, Public Law 104-166, is the first nationwide attempt to
    discern the extent of brain injury in this country, to assist states in
    providing services to persons with brain injury, and to further
    research on brain injury rehabilitation. Like other medical research
    and treatment in the United States, the TBI Act serves as a model for
    the rest of the world. IBIA and its members, therefore, strongly urge
    your support for $15 million to continue the critical work being done
    under the relatively nascent law.
        The Act defines TBI as an insult to the brain, not of a
    degenerative or congenital nature but caused by an external physical
    force, that may produce a diminished or altered state of consciousness,
    which results in an impairment of cognitive abilities or physical
    functioning. TBI can also result in the disturbance of behavioral or
    emotional functioning.
        TBI is the leading cause of death and disability in young
    Americans. Motor vehicle crashes, sports injuries, falls, and violence
    (including shaken baby syndrome and other child abuse) are the major
    causes of traumatic brain injury. TBI can strike anyone--infant, youth,
    adult or elderly person--without warning, and often with devastating
    consequences. TBI affects the whole family and often results in huge
    medical and rehabilitation expenses over a lifetime.
        Approximately 2 million Americans experience TBI each year. About
    half of these cases result in at least short-term disability, and
    50,000 people die as a result of their injuries. Each year,
    approximately 230,000 persons require hospitalization for TBI (30
    percent of which show disabilities a year post injury), and over 1
    million people receive emergency medical care for TBI. The national
    cost is estimated at more than $48 billion annually. Every year about
    80,000 people sustain severe brain injuries leading to long term
    disability. Through the TBI Act, the Center for Disease Control and
    Prevention (CDC) has estimated that there are 5.3 million persons
    living with long term, severe disability as a result of brain injury
    and as many as 6.5 million persons living with some form of injury
    including mild and moderate brain injuries.
        The TBI Act was enacted ``to provide for the conduct of expanded
    studies and the establishment of innovative programs with respect to
    traumatic brain injury.'' Under the law, the Centers for Disease
    Control and Prevention (CDC) is responsible for activities related to
    assessing the incidence of traumatic brain injury, conducting
    prevention research and increasing awareness of TBI; the Maternal and
    Child Health Bureau (MCHB) under the Health Resources and Services
    Administration (HRSA), is responsible for implementing a TBI State
    Demonstration Program; and the National Institutes for Health (NIH) has
    been delegated the responsibility of conducting basic and applied
    research and holding a consensus conference.
                   cdc surveillance, education and prevention
        The TBI Act authorized CDC to support studies in collaboration with
    State and local health-related agencies to: (1) determine the incidence
    and prevalence of traumatic brain injury; and (2) develop a uniform
    reporting system under which States report incidents of traumatic brain
    injury. CDC has published TBI surveillance methods and guidelines for
    public health purposes and created and oversees a multi-state, uniform
    reporting system to provide nationally representative data to define
    groups at higher risk, causes and circumstances of injury, and outcomes
    of injury. This information is critical in the planning,
    implementation, and evaluation of programs for preventing TBI and any
    accompanying disabilities.
        CDC's population based surveillance activities have provided the
    data for the epidemiologists and statisticians to estimate the
    incidence and prevalence of brain injury in this country. As CDC's
    estimates become more refined, the numbers of persons sustaining long
    term disabilities as a result of brain injury are increasing
    tremendously. Improving the accuracy of these estimates by conducting
    surveillance in additional states is crucial to understanding the
    impact brain injury has on the nation's medical and rehabilitative
    systems and accompanying costs, educational institutions, lost income
    and productivity, and the immeasurable toll on persons sustaining brain
    injury and their families.
        The TBI Act also directed CDC to conduct research into identifying
    effective strategies for the prevention of brain injury, implementing
    public information and education programs for the prevention of brain
    injury, and broadening public awareness of the health consequences of
    such injury. CDC has drafted a brochure for persons with mild TBI who
    are treated in emergency departments, which discusses potential
    problems they may encounter and how to identify services. With
    additional funding the brochure can be widely distributed and other
    public awareness efforts can be initiated.
        For fiscal year 2000, approximately $3 million was appropriated for
    CDC's work under the TBI Act. CDC has used most of this funding on its
    incidence and prevalence studies. More money is needed for education
    and prevention initiatives. We, therefore, respectfully request an
    increase of $2 million for education and prevention programs. Funding
    of $5 million for fiscal year 2001 is necessary to continue CDC's
    surveillance work, as well as to implement effective education and
    prevention activities.
                   hrsa/mchb tbi demonstration grants program
        Under the TBI Act, HRSA directs the Maternal and Child Health
    Bureaus to provide and administer grants to States for demonstration
    projects to improve services for persons with TBI. The TBI
    Demonstration Grants are intended to help States implement statewide
    systems that ensure access to comprehensive and coordinated TBI
    services for the 5.3 million persons with long-term disabilities and
    their families. The projects are to involve all relevant disciplines,
    organizations and consumers.
    State Planning Grants
        Planning grantees are developing statewide TBI advisory boards;
    designating state agency and staff positions responsible for TBI
    activities; assessing statewide needs to address the full spectrum of
    care and services from initial acute treatment through community
    reintegration for individuals with TBI; and drafting statewide action
    plans to develop comprehensive, community-based systems of care that
    include physical, psychological, educational, vocational, and social
    aspects of TBI services.
    State Implementation Grants
        The implementation grants require states to establish interagency
    linkages; education and training for persons with TBI and their
    families; data collection to track programs, resources and enhance
    program evaluation; develop materials for low literacy and culturally
    or ethnically distinct populations; develop a pre-discharge model to be
    used in acute care sites in the development of long term resource plans
    for individuals with TBI; and develop a model to coordinate financial
    resources to provide services that most effectively meet the needs of
    persons with TBI.
        In fiscal year 2000, $5 million was appropriated for this program.
    To maintain the continuity of these projects, we request $5 million for
    fiscal year 2001.
             nih research on traumatic brain injury rehabilitation
        The TBI Act directed the National Institutes of Health (NIH) to
    conduct a consensus conference on TBI. In October 1998, the NIH held
    such a conference regarding managing traumatic brain injury and related
    rehabilitation concerns. The event was sponsored by the National Center
    for Medical Rehabilitation Research (NCMRR) within the National
    Institute of Child Health and Human Development (NICHD). Conference
    participants evaluated the scientific data concerning rehabilitation
    practices for persons with TBI. Particular emphasis was placed on
    rehabilitation of cognitive, behavioral, and psychosocial difficulties
    associated with mild, moderate and severe TBI. The conference brought
    together national and international biomedical researchers and
    clinicians, as well as person with TBI and their families.
        Participants undertook a detailed review of the evidence-based
    scientific evaluations of cognitive and behavioral rehabilitative
    interventions. In response to ``what research is needed to guide the
    rehabilitation of people with TBI,'' the conference statement listed
    the following priorities: \2\
    ---------------------------------------------------------------------------
        \2\ The National Institutes of Health Consensus Development
    Conference Statement on Rehabilitation of Persons with Traumatic Brain
    Injury, October 26-28, 1998.
    ---------------------------------------------------------------------------
      --Epidemiological studies on the risk factors and incidence of TBI
            are needed for different age groups, gender and race.
      --The relationship between substance abuse and TBI should be studied.
      --Existing CDC surveillance systems based on hospital discharge
            summaries or death records should be expanded to include
            emergency department encounters in order to augment the current
            database for research.
      --Studies of the placement of persons with TBI in nursing homes and
            psychiatric facilities are needed to clarify what constitutes
            appropriate placement.
      --The epidemiology of mild TBI should be studied.
      --The duration, natural history, and life-course manifestations
            (neurological, cognitive, social, psychological, economic,
            etc.) of mild, moderate, and sever TBI should be studied.
      --Gender differences in survival rates, patterns of severity, and
            long-term manifestations of TBI should be studied.
      --The consequences and effects of rehabilitation after TBI in the
            elderly should be studied.
      --The experience of minority group members with TBI should be
            studied.
      --Research training is needed in the areas of injury epidemiology and
            clinical research in order to enhance the quality of all
            research related to TBI.
      --The time course of TBI should be studied in animals with respect to
            injury severity, influence of age and gender and effects of
            interventions.
      --Research is needed on the appropriate timing of therapeutic
            interventions after TBI.
      --Research is needed on the effectiveness of pharmacological
            interventions for the cognitive, behavioral, and emotional
            consequences of TBI.
      --The neurobiology of TBI in humans should be studied with modern
            imaging techniques (e.g. positron emission tomography [PET] and
            functional magnetic resonance imaging [fMRI]) and correlated
            with neuropsychological findings.
      --Promising treatments of TBI derived from animal studies should be
            tested in humans.
      --The epidemiology and management of TBI in sports should be studied.
      --Well-designed and controlled studies of the effectiveness of
            rehabilitation interventions are needed.
      --Economic analysis of TBI including major determinants of costs, is
            needed.
      --Innovative rehabilitation interventions for TBI should be developed
            and studied.
      --The predictors of quality of life for persons with TBI, their
            families, and significant others should be studied.
      --Studies are needed to evaluate the relationship between specific
            cognitive deficits and global outcomes.
      --Validation of generic health-related quality of life assessment
            instruments for use in TBI is needed as well as the development
            and validation of TBI-specific instruments.
      --Uniform standards and minimal data sets to describe injury type,
            severity, and significant interacting variables, which could
            provide a total injury profile across a continuum of recovery,
            should be developed.
      --The relationship between the pathophysiology of TBI and the
            effectiveness of different interventions should be studied.
      --The long-term consequences of TBI of varying severity, including
            the consequences of aging for a person with TBI, should be
            studied.
      --The developmental impact of TBI in childhood with respect to the
            need for special education, mental health, and rehabilitation
            services should be studied.
      --The effectiveness of community-based rehabilitation of persons with
            TBI should be studied.
      --Severity risk-adjustment models for studies of persons with TBI
            should be established.
      --The effectiveness of peer support for persons with TBI, their
            families, and significant others should be studied.
      --Innovative study methodologies to assess the effectiveness of
            complex interventions for persons with TBI should be developed
            and evaluated.
        The NIH Consensus statement concludes that ``funding for research
    on TBI needs to be increased.'' IBIA therefore requests $5 million for
    brain injury research to be conducted by the National Institutes of
    Health through the National Center on Medical Rehabilitation Research
    and/or the National Institute on Neurological Disorder and Stroke.\3\
    ---------------------------------------------------------------------------
        \3\ The National Institute on Neurological Disorders and Stroke
    engages in numerous research studies, some of which could benefit
    traumatic brain injury research; NINDS has expressed an interest in
    undertaking TBI specific research.
    ---------------------------------------------------------------------------
                                   conclusion
        There are few conditions that can strike anyone at any age at any
    time. Traumatic brain injury is one of them, and as a result is often
    known as the ``silent epidemic.'' As the United States medical
    community perfects trauma care and rehabilitation, more individuals
    (who might have otherwise died) are living with brain injuries than
    ever before. CDC must keep track of the growth of this epidemic, devise
    public awareness campaigns and establish effective prevention programs.
    The states need to assess the needs of their communities and include
    persons with brain injury in their services. And as the National
    Institutes of Health conducts basic and applied research on the myriad
    of disorders that affect the brain, trauma to the brain and the
    resulting affects on the person and his/her life must not be excluded.
        IBIA respectfully requests $15 million in fiscal year 2001 for the
    Traumatic Brain Injury Act ($5 million for CDC, $5 million for HRSA,
    and $5 million for NIH).
                                     ______

                 Prepared Statement of the Epilepsy Foundation

        The Epilepsy Foundation is the national voluntary organization that
    works for people affected by seizures through research, education,
    advocacy and service. The national office together with its network of
    more than 60 affiliates across the country advocate for increased
    funding for medical research to find better treatment and an eventual
    cure for epilepsy, and works with Federal Government agencies and
    Congress to advance the interests of people with epilepsy.
        Epilepsy is a neurological condition characterized by recurrent,
    unprovoked seizures. It is an economic burden on individuals, families,
    communities, and society as a whole because of resultant increased
    health care costs. Epilepsy is a formidable barrier to normal life,
    affecting educational attainment, employment, and personal fulfillment.
    The stigma that comes from seizures and societal misconceptions about
    them remain as facts of life for many individuals with epilepsy.
        Epilepsy and seizures affect 2.3 million Americans of all ages.
    Approximately 181,000 new cases of seizure and epilepsy occur each
    year; 10 percent of all Americans will experience seizures in their
    lifetimes. According to the most recent data available, in 1995,
    300,000 children aged 14 and under had epilepsy; 1.4 million adults
    under age 64 and 550,000 aged 65 and over had epilepsy. Epilepsy is a
    chronic condition that usually requires a lifetime of continual medical
    treatment and education. As many as 44 percent of people with epilepsy
    continue to have seizures despite treatment; 56 percent have early or
    delayed seizure control with treatment. Currently, there is no cure for
    epilepsy.
                   the cost of epilepsy in the united states
        Epilepsy is a major, unsolved health problem affecting the lives of
    millions of Americans and their families. The economic impact in the
    United States is also tremendous. A three-year study sponsored by the
    Epilepsy Foundation to determine the financial costs of epilepsy to
    individuals and the nation was completed in 1999. Using data from
    actual cases as a basis for the estimate, the annual financial cost of
    epilepsy in the United States is approximately $12.5 billion. Of this,
    $1.7 billion (14 percent) are direct medical costs while $10.8 billion
    (86 percent) are indirect medical costs. The study also found marked
    divisions in costs among those people with epilepsy whose seizures are
    easy to control and those who continue to experience seizures, despite
    treatment.
        Indirect costs are primarily employment related. Individual men and
    women who continue to experience seizures despite treatment were
    estimated to lose hundreds of thousands of dollars in wages while also
    experiencing loss of productivity at home. Each man lost a total of
    $317,000 or 35 percent of his lifetime wages. Each woman lost a total
    of $140,000 or 25 percent of her lifetime wages.
        The high concentration of costs among those people with epilepsy
    who continue to experience seizures emphasizes the importance of
    seizure control in reducing the economic burden of epilepsy on society
    and the individual and also demonstrates the cost-saving potential of
    effective interventions that increase seizure control. Recent advances
    in medical, surgical, and vagal nerve stimulation therapies hold
    promise for reducing the frequency and severity of seizures in people
    with intractable epilepsy.
        Epilepsy research is an area largely under-funded compared to other
    diseases. The results of this cost study provide compelling evidence of
    the need for increased support in this area. The cure of intractable
    seizures and all forms of epilepsy must be a research priority for the
    nation.
                      curing epilepsy: focus on the future
        A White House-initiated conference sponsored by the National
    Institute of Neurological Disorders and Stroke was held March 30-31,
    2000 at the National Institutes of Health. The conference featured
    clinicians and scientists who discussed innovative discoveries likely
    to lead to the prevention and cure of epilepsy. Presentations on
    diverse topics included the prevention of epileptogenesis (how epilepsy
    begins), ameliorating the effects of epilepsy genes, monitoring
    epileptogenesis, developing new therapies and using surgery and other
    forms of technology.
        The primary message from the conference is that epilepsy treatment
    is due to undergo a fundamental change in direction from treating the
    seizures which are the symptoms of epilepsy to treatment of the
    underlying condition in the brain. The goals of treatment will be the
    prevention and cure of epilepsy, no seizures and no side effects for
    those who have already developed the condition and dramatic new ways of
    preventing epilepsy that is acquired from injury, infection or errors
    of development.
        Opportunities for further breakthroughs in epilepsy research
    identified at the conference are dependent upon increased funding to
    the National Institutes of Health and the National Institute of
    Neurological Disorders and Stroke and the development of a coordinated
    plan for pursuing these opportunities.
                         advances in epilepsy research
        In his testimony before the House Appropriations Subcommittee on
    Labor, Health and Human Services, Education and Related Agencies,
    Gerald D. Fischbach, M.D., Director, NINDS, described several major
    initiatives for fiscal 2001. These priorities include efforts to
    address developmental and degenerative disorders of children, such as
    epilepsy, that can result in a lifetime of disability. The severe
    epilepsy syndromes of childhood produce developmental delay and brain
    damage that can result in a life of dependence on others and
    continually accruing costs to the health care system and society.
    Research has led to the discovery of good predictors for remission or
    relapse of epilepsy in children. For the sake of these children and
    those others who will develop epilepsy, research focused on the
    prevention and treatment of epilepsy in our youngest citizens must be a
    national priority.
        One area of research that holds great promise is the identification
    of the genes responsible for predisposition to certain types of
    epilepsy. Research has identified several genes for childhood
    epilepsies in the last few years. During his recent testimony, Dr.
    Fischbach explained that the NINDS has emphasized gene discovery in
    epilepsy since even the most common forms, such as febrile convulsions,
    have a heritable component. Advances in genetic therapy, coupled with
    genetics research, will not only suppress seizures, but cure certain
    types of epilepsy.
        Another area of great clinical importance to people with epilepsy
    has been the development of new anti-epileptic drugs. The Foundation
    recommends research support from the NINDS for comparative trials of
    anti-epileptic drugs to assure that people with epilepsy receive the
    greatest possible benefit from these newly available medications. These
    medications have shown great promise but more research is needed to
    eradicate this disorder.
                  centers for disease control epilepsy program
        As directed by Congress in 1993, the CDC launched its epilepsy
    program within the National Center for Chronic Disease Prevention and
    Health Promotion. Focusing on early detection and effective treatment
    of epilepsy, the epilepsy program targets its outreach and education
    efforts on consumers, health professionals, and health systems. The CDC
    was appropriated an additional $1 million for fiscal year 2000 to
    expand epilepsy surveillance, public awareness activities, and public
    and provider education. The fiscal year 2000 funding is the first
    significant increase since 1993, illustrating Congress' and CDC's
    renewed commitment to epilepsy and the issues which surround it.
        Current CDC activities in the area of epilepsy include programs
    geared toward teens and adolescents, a population which struggles with
    the stigma associated with this disorder. The Foundation hopes to help
    teens, through a web based teen chat room, forums, and special events,
    to make more informed decisions about their behaviors and life plans,
    while at the same time educating the general public.
        Experts agree that timely recognition of seizures and effective
    treatment can reduce the risk of subsequent brain damage, as well as
    disability and mortality from injuries incurred during a seizure and
    from recurring seizures. With additional funding in fiscal year 2001,
    epilepsy activities can be expanded to include a broader public
    awareness and communication strategy including laying the groundwork
    for programs targeted at seniors and children and continued efforts for
    teens. Increased funding would allow for the implementation of local
    community activities; improved surveillance and prevention research;
    and more extensive provider education.
                      fiscal 2001 funding recommendations
        Epilepsy research funded by the National Institute of Neurological
    Disorders and Stroke is vital to continuing the fight against epilepsy.
    The promise of future breakthroughs in epilepsy research can only be
    achieved by increased funding for epilepsy research and prevention
    programs. The Foundation urges Congress to increase the federal
    commitment to epilepsy research by allocating sufficient funding for
    the NINDS and Centers for Disease Control.
        National Institutes of Health.--The Foundation supports
    Congressional efforts to double the NIH budget over 5 years and is
    seeking a 15 percent increase for fiscal 2001, resulting in a total NIH
    budget of $20.6 billion.
        National Institute of Neurological Disorders and Stroke.--The
    Foundation supports a 15 percent increase for NINDS in fiscal 2001,
    creating a total NINDS budget of $1.19 billion. This increase is
    consistent with efforts to double NIH research funding over 5 years.
        Epilepsy Research.--The Foundation urges Congress to support a
    major expansion of epilepsy research within NINDS. In 1999, NINDS spent
    approximately $74 million dollars on epilepsy research. We are seeking
    a commitment to triple that amount over the next few years.
        Centers for Disease Control Epilepsy Program.--The Foundation is
    seeking a $5 million increase in fiscal year 2001 support for the CDC's
    epilepsy program within its chronic and environmental account. With
    additional resources, the CDC and the Foundation can make great strides
    in combating the negative consequences associated with epilepsy and
    seizures.
                                     ______

                   Prepared Statement of Rotary International

        Chairman Specter, Senator Harkin, members of the Subcommittee,
    thank you for this opportunity to present written testimony on behalf
    of Rotary International in support of the polio eradication activities
    of the U.S. Centers for Disease Control and Prevention. As you know,
    2000 is a water shed year in the battle to eradicate polio. The
    penultimate goal of the international polio eradication initiative, the
    interruption of polio transmission, is within our grasp. We remain on
    track for our primary target: certification of eradication by 2005.
    This monumental effort, toward which countless millions have
    endeavored, has required the commitment and fortitude of a climb to
    Everest's peak. As we near our goal--a world free of polio--we cannot
    become complacent. We cannot allow the daunting challenges that lie
    before us to diminish our resolve. As with an expedition to scale
    Everest, the most difficult stage of our journey, the stage most
    fraught with the risk of failure, is the final push to the summit.
        I would like to take this opportunity to thank you Chairman
    Specter, Senator Harkin and members of the Subcommittee for your
    tremendous commitment to this effort. Without your support of the CDC's
    polio eradication activities, the battle against polio would be
    impossible.
        The global eradication strategy is working. In 1985, when Rotary
    began its PolioPlus Program, 100 nations around the world suffered
    under the burden of polio. The Western Hemisphere has now been polio-
    free for nearly 9 years, and today polio is confined only to Sub-
    Saharan Africa, parts of the Middle East, and South Asia.
        Thanks to the polio eradication efforts over the last decade,
    approximately three million children who might have been polio victims
    are walking and playing normally. Tens of thousands of public health
    workers have been trained to investigate cases of acute flaccid
    paralysis and manage immunization programs. Cold chain, transport and
    communications systems for immunization have been strengthened. A
    network of more than 140 polio laboratories has been established.
        Significant challenges lie before us. Continued political
    commitment is essential both in polio endemic countries, to support the
    acceleration of eradication activities, and in donor countries, so that
    the necessary human and financial resources are made available. Access
    to children everywhere is needed, particularly in countries affected by
    conflict. Truces must be negotiated if National Immunization Days are
    to proceed in these countries. The continued leadership of the United
    States is critical if we are to overcome these challenges.
        Rotary International is a global association of more than 29,000
    Rotary clubs, with a membership of over 1.2 million business and
    professional leaders in 160 countries. In the United States today there
    are some 7,500 Rotary clubs with 400,000 members. All of our clubs work
    to promote humanitarian service, high ethical standards in all
    vocations, and international understanding.
        Less than one year remains to defeat this disease in the nations
    where the poliovirus still causes death and disability. With your
    continued support, soon no child will ever be struck down by polio
    again.
                        fiscal year 2001 budget request
        For fiscal year 2001, we respectfully request that you provide $91
    million for the targeted polio eradication efforts of the Centers for
    Disease Control and Prevention, a $5 million increase from the fiscal
    year 2000 funding level, thereby meeting the President's budget
    request. This $5 million increase is necessary to meet the meet the
    need for additional oral polio vaccine resulting from the accelerated
    immunization schedule in 2000. In addition, we must continue to meet
    the enormous costs of eradicating polio in its final stronghold--sub-
    Saharan Africa. The underdeveloped and conflict-torn countries of
    Africa represent the greatest challenges to the success of the global
    Polio Eradication Initiative. This additional appropriation will allow
    the CDC to help African nations accelerate polio eradication
    activities, improve surveillance for polio and other diseases, and
    support peace-building cease-fires for NIDs. Without the additional $5
    million, we may not be able to eradicate polio in Africa by the Target
    2000 date, prolonging the need to continue expensive NIDs and routine
    immunization worldwide. The time for the final assault against polio is
    now.
      eradicating polio will save the united states at least $230 million
                                    annually
        In 1998 the Chairman of the House Committee on International
    Relations commissioned the General Accounting Office to investigate the
    soundness of WHO cost estimates for the eradication or elimination of
    seven infectious diseases. The United States was a major force behind
    the successful eradication of the smallpox virus, and the GAO concluded
    that the eradication of smallpox has saved the United States some $17
    billion to date. Even greater benefits will result from the eradication
    of polio.
        Although polio-free since 1979, the United States currently spends
    at least $230 million annually to protect its newborns against the
    threat of importation of the poliovirus, in addition to its investment
    in international polio eradication. Globally, over $1.5 billion U.S.
    dollars are spent annually to immunize children against polio. This
    figure does not even include the cost of treatment and rehabilitation
    of polio victims, nor the immeasurable toll in human suffering which
    polio exacts from its victims and their families. Once polio is
    eradicated and immunization against it can be discontinued, tremendous
    resources will be unfettered to focus on other health priorities.
               progress in the global program to eradicate polio
        Thanks to your leadership in appropriating funds, the international
    effort to eradicate polio has made tremendous progress.
      --Since the global initiative began in 1988, 3 million children in
            the developing world, who otherwise would have become paralyzed
            with polio, are walking because they have been immunized.
      --The number of polio cases has fallen from an estimated 350,000 in
            1988--of which 35,000 were reported--to approximately 6,000
            reported cases in 1999. More than 180 countries are polio-free,
            including 4 of the 5 most populous countries in the world
            (China, U.S., Indonesia and Brazil).
      --Almost 2 billion children worldwide have been immunized during NIDs
            in the last 5 years, including 147 million in a single day in
            India. During 74 National Immunization Days, 16 Sub-National
            Immunization Days and 7 Mopping-up activities conducted in
            1999, over 450 million children received oral polio vaccine.
            This represents nearly 75 percent of all the world's children
            under the age of five.
      --All polio-endemic countries in the world have conducted NIDs--most
            recently in Sierra Leone and Democratic Republic of the Congo.
            The achievement of successful NIDs and implementation of APF
            surveillance in Somalia and Sudan shows that polio eradication
            strategies can be implemented in all countries.
        the role of the u.s. centers for disease control and prevention
        Rotary commends the CDC for its leadership in the global polio
    eradication effort, and greatly appreciates your Subcommittee's support
    of the CDC's polio eradication activities. For 2000, you appropriated a
    total of $87.2 million for the CDC's global polio eradication
    activities. Because of Congress' unprecedented support, in 2000 the CDC
    is:
      --Supporting the international assignment of more than 110 long-term
            epidemiologists, virologists, and technical officers to assist
            the World Health Organization and polio-endemic countries to
            implement polio eradication strategies, and 10 technical staff
            to assist UNICEF and polio-endemic countries. This includes 30
            CDC staff provided directly on assignment to WHO and UNICEF.
      --Providing over $60 million to UNICEF for approximately 700 million
            doses of polio vaccine and operational costs for NIDs in some
            60 countries in Asia, Eastern Europe, the Middle East and
            Africa. Many of these NIDs would not take place without the
            assurance of the CDC's support.
      --Providing over $20 million to WHO for surveillance and NIDs'
            operational costs, primarily in Africa. As successful NIDs take
            place, surveillance has emerged as a critical need, to
            determine where polio cases are continuing to occur. Good
            surveillance can save resources by eliminating the need for
            extensive immunization campaigns if it is determined that polio
            circulation is limited to a specific locale.
      --The leading specialized polio reference lab in the world providing
            the largest volume of both operational (poliovirus isolation)
            and technologically sophisticated (genetic sequencing of polio
            viruses) lab support to the 148 laboratories of the global
            polio laboratory network.
      --Serving as the primary technical support agency to WHO on
            scientific and programmatic issues regarding: (1) laboratory
            containment of wild poliovirus stocks following polio
            eradication, and (2) when and how to stop polio vaccination
            worldwide following global certification of polio eradication
            in 2005.
                      other benefits of polio eradication
        Increased political and financial support for childhood
    immunization has many documented long-term benefits. Polio eradication
    is helping countries to develop public health and disease surveillance
    systems useful in the control of other vaccine-preventable infectious
    diseases. Already, much of Latin America is free of measles, due in
    part to improvements in the public health infrastructure implemented
    during the war on polio. As a result of this success, measles has been
    targeted for eradication in the Americas by the year 2000. The disease
    surveillance system--the network of laboratories and trained personnel
    built up during the Polio Eradication Initiative--is now being used to
    track measles, Chagas, neonatal tetanus, and other deadly infectious
    diseases. NIDs have been used as an opportunity to give children
    essential vitamin A, as well as polio vaccine. The campaign to
    eliminate polio from communities has led to increased public awareness
    of the benefits of immunization, creating a ``culture of immunization''
    and resulting in increased usage of primary health care and higher
    immunization rates for other vaccines. It has improved public health
    communications and taught nations important lessons about vaccine
    storage and distribution, and the logistics of organizing nation-wide
    health programs. Lastly, the unprecedented cooperation between the
    public and private sectors serves as a model for other public health
    initiatives.
            resources needed to finish the job of polio eradication
        The World Health Organization estimates that $1 billion is needed
    from donors for the period 2000-2005 to help polio-endemic countries
    carry out the polio eradication strategy. The estimated shortfall for
    the years 2000-2001 now stands at approximately $300 million. In the
    Americas, some 80 percent of the cost of polio eradication efforts were
    borne by the national governments themselves. However, as the battle
    against polio is taken to the poorest, least-developed nations on
    earth, and those in the midst of civil conflict, many of the remaining
    polio-endemic nations can contribute only a small percentage of the
    needed funds. In some countries, up to 100 percent of the NID and other
    polio eradication costs must be met by external donor sources. We are
    asking that the United States continue to take the leadership role in
    meeting this shortfall.
        The United States' commitment to polio eradication has stimulated
    other countries to increase their support. Belgium, Canada, Germany,
    and Italy are among those countries that have followed America's lead
    and have recently announced special grants for the global Polio
    Eradication Initiative. Japan has also expanded its support to polio
    eradication efforts in Africa. Germany has made major grants that will
    help India eradicate polio by the target year 2000. In December 1999
    the United Kingdom announced two grants totaling U.S. $94.6 million for
    polio eradication efforts in India and Africa. The Government of India
    will receive U.S. $62.6 toward its Pulse Polio Initiative over the next
    two years. In addition, the U.K. will grant a total of U.S. $32 million
    to African nations that are poliovirus reservoirs, affected by conflict
    or both. These nations include Nigeria, Ethiopia, Somalia, Sudan, DR
    Congo and Angola.
        By the time polio has been eradicated, Rotary International expects
    to have expended approximately $500 million on the effort--the largest
    private contribution to a public health initiative ever. Of this, $373
    million has already been allocated for polio vaccine, operational
    costs, laboratory surveillance, cold chain, training and social
    mobilization in 120 countries. More importantly, we have mobilized tens
    of thousands of Rotarians to work together with their national
    ministries of health, UNICEF and WHO, and with health providers at the
    grassroots level in thousands of communities.
        Polio eradication is the most cost-effective public health
    investment, as its benefits accrue forever. The world will begin to
    ``break even'' on its investment in polio eradication only two years
    after the virus has been vanquished.
        When we reach the summit, we will be able look out upon a world in
    which the scourge of polio is a thing of the past. This will be our
    gift to the children of the twenty-first century.
        Thank you for this opportunity to present written testimony.
                                     ______

          Prepared Statement of the American Society for Microbiology

        The American Society for Microbiology (ASM) is pleased to provide a
    written statement on the fiscal year 2001 appropriation for the Centers
    for Disease Control and Prevention (CDC). The ASM is the largest single
    life science society in the world with more than 42,000 members
    representing a broad spectrum of subspecialties, including
    microbiologists who work in clinical, public health, biomedical and
    industrial laboratories. The ASM appreciates the Subcommittee's ongoing
    support of the CDC, particularly for the CDC's National Center for
    Infectious Diseases (NCID), which funds programs, addressed in this
    statement, related to emerging and drug resistant infectious diseases,
    public health infrastructure, bioterrorism preparedness and food
    safety.
        The ASM endorses the recommendation of the CDC Coalition to
    increase the overall CDC budget to a level of $4.1 billion, an amount
    that exceeds the President's budget request by approximately $600
    million. The CDC requires additional new resources to respond to an
    array of continuing and new public health challenges. As the ``Nation's
    Prevention Agency,'' the CDC is charged with promoting health and
    quality of life by anticipating, identifying, preventing and
    controlling diseases and other public health threats. The CDC must have
    adequate resources to expect and be prepared for unexpected public
    health emergencies throughout the country and across the globe,
    including, for example, a bioterrorism event, a global influenza
    pandemic, a large scale environmental disease threat or an unforeseen
    public health danger.
        In the following statement, the ASM will focus on specific areas
    within the CDC budget which are of concern to the microbiological
    community.
    emerging and drug resistant infectious diseases: public health threats
                                   and needs
        The American people benefit from a well-funded and effective
    federal health system. In the past year, the rapid response by health
    officials identified an outbreak of West Nile encephalitis in New York,
    Connecticut and New Jersey; linked E. coli O157:H7 infection at an
    upstate New York county fair to contaminated water; and tied a multi-
    state outbreak of Listeria infections to contaminated hotdogs and cold-
    cut meats manufactured at a single plant. These successes are due to
    state-of-the-art molecular laboratory diagnostic tools, as well as to
    coordinated communications and disease reporting systems among health
    agencies. Initiated in 1995 by the CDC, the Epidemiology and Laboratory
    Capacity for Infectious Diseases cooperative agreements are helping to
    rebuild the nation's public health infrastructure at state and local
    levels, and making possible success against infectious disease
    outbreaks. In fiscal year 1999 CDC awarded more than $40 million to all
    states and four cities to boost preparedness against possible chemical
    and biological terrorism, and developed laboratory protocols for
    several of the possible bioterrorism agents to share with state and
    local laboratories. In 1999 the CDC also distributed nearly 300,000
    copies of recommendations for prevention and control of hepatitis C
    infection (HCV) infection and HCV-related liver disease to physicians
    and health care providers nationwide.
        The ASM recognizes and applauds the breadth of the CDC's
    contributions to these and other successful public health campaigns.
    Despite positive past experiences, however, the vigilance needed
    against disease will only intensify as we move through the 21st
    century. The blood-borne hepatitis C virus, for example, has infected
    more than 4 million persons in the United States, 3 million of whom
    remain chronically infected and therefore at risk for developing
    cirrhosis or liver cancer. In this country each year, 8000 to 10000 die
    from cirrhosis or primary liver cancer. The CDC is coordinating the
    Hepatitis C Public Information Campaign, aimed toward notifying all
    prior transfusion recipients at risk for HIV infection. It will
    continue ongoing investigations into various risk factors and modes of
    transmission, as well as collaborate with other groups like the
    American Liver Foundation to educate the public about HCV. Sufficient
    funding would strengthen and expand this multipronged effort against
    HCV infection. Like the hepatitis viruses, both ``old'' and newly
    emerging or reemerging infectious diseases will continue to challenge
    our society's well-being and productivity, and thus make even more
    imperative an adequately funded federal public health agency.
        The CDC is recognized the world over for its efforts to combat the
    threats of new, emerging and drug resistant infectious diseases.
    Infectious diseases are a crisis of global proportions which threaten
    gains in health and life expectancy and which are now the world's
    biggest killer of children and young adults. Substantial new funding is
    needed to enable CDC to fully implement its comprehensive plan,
    ``Preventing Infectious Diseases: A Strategy for the 21st Century.''
    The additional $25 million requested for this initiative in the
    Administration's fiscal year 2001 budget would not provide adequate
    resources needed to fully implement the next phase of the plan. The ASM
    concurs with other supporters of the CDC that an additional $162
    million would achieve in the appropriate time frame the CDC goals set
    forth in 1998 for emerging infections. These goals include a broad
    range of improvements to such critical functions as detection and
    prevention of emerging pathogens, communication among all levels of
    government health agencies, and integration of laboratory science with
    on-site epidemiology.
        Also targeted in the 1998 plan was the alarming trend toward
    antimicrobial resistance among pathogenic microorganisms. Approximately
    28 percent of bacteria that cause hospital-acquired infections in the
    United States, for example, are resistant to the specific antibiotic
    once considered most effective against that particular infection.
    Especially problematic is the reduced susceptibility of Staphylococcus
    aureus to vancomycin. The CDC has specific plans to address this
    problem which will require sufficient funding: improved clinical
    guidelines for antibiotic usage; better public education on the issue
    of overuse of antibiotics; research on antibiotic resistance genetic
    markers as monitoring devices; and a national surveillance system to
    assess the overall impact of antibiotic resistance.
                          public health infrastructure
        The ASM recommends that Congress increase the budget requested to
    modernize the CDC's outmoded, severely inadequate and deteriorating
    physical plant. CDC needs funding and authority to modernize existing
    laboratory and support facilities and construct new facilities
    according to its long range facilities master plan which addresses
    building and facilities needs through the year 2009. Almost all of
    CDC's laboratory capacity is currently dangerously antiquated, unsafe
    and unsuitable for modern scientific research activities related to
    CDC's public health role. CDC has experienced substantial program
    growth in recent years, and facilities have not kept pace with new
    programs created in response to an increasing number of dangerous
    threats from deadly pathogens. The ASM recommends that Congress provide
    at least the $127 million requested (an additional $70 million over
    fiscal year 2000) for CDC infrastructure needs and consider providing
    an even higher level of $175 million to fully meet the facilities needs
    and repairs at CDC and accelerate planned construction and upgrades.
                     bioterrorism preparedness and response
        The CDC has established a national effort to protect the public's
    health in the event of a biological or chemical terrorist attack. The
    initiative builds on the efforts begun at CDC in fiscal year 1999 that
    focused on building core capacity within CDC and in states to establish
    clinical laboratory surveillance, information technology and
    epidemiologic expertise for the highest probability agents. The ASM
    notes that funding for CDC bioterrorism preparedness activities
    decreases by $6.5 million to a level of $148.5 million in the
    Administration's budget request. Current funding levels permit only
    partial implementation of this program, leaving many states and cities
    with limited or no coverage in some key preparedness areas. Additional
    funding would allow more state and local health departments to build
    capacity in essential areas of biological and chemical preparedness
    including: planing, surveillance and epidemiology, biological and
    chemical laboratory services and electronic communication.
        A recent Institute of Medicine report on ``Chemical and Biological
    Terrorism: Research and Development to Improve Civilian Medical
    Response,'' stresses the need for long-term public health
    infrastructure improvements. Bioterrorism preparedness is also a part
    of CDC's larger effort to reinvest in the public health system to
    establish capability to respond to naturally occurring infectious
    disease threats. The ASM supports the requested $2 million for CDC
    deterrence efforts to monitor laboratory compliance with the
    Antiterrorism and Effective Death Penalty Act of 1996 and to ensure the
    safe handling of potential threat agents in diagnostic and research
    laboratories.
                       foodborne and waterborne diseases
        While often not as dramatic as a newly identified infection,
    foodborne and waterborne disease outbreaks in recent years have been
    sudden and deadly. The CDC rightly has not neglected this ever-present
    threat to the American public. In collaboration with the FDA and USDA,
    the CDC has revitalized measures against further outbreaks caused by
    contaminated food and water supplies. For example, the CDC PulseNet
    program, now in more than 30 states, enables local health departments
    to rapidly identify the microbial agents responsible for an outbreak,
    by utilizing modern molecular fingerprinting technologies. Rapid
    response is essential in such outbreaks, as spread of infection can
    occur if the food or water source is not quickly identified and
    removed. Foodborne diseases alone are estimated to cause 5,000 deaths
    and 76 million illnesses in the United States yearly. Therefore, the
    ASM recommends approval of the Administration's proposed increase of
    $10 million for foodborne diseases as part of the CDC budget for
    infectious diseases in fiscal year 2001.
                            cost effective strategy
        An investment today in the CDC is an investment in tomorrow's
    public health. Finding our way safely through the maze of public health
    problems often seems costly, but the collective price tag of infectious
    disease in death, illness, and dollars is alarming. For instance,
    hospital-acquired infections kill 88,000 people annually in United
    States and cost more than $4.5 billion each year. Public health
    officials estimate that foodborne illness costs this nation's economy
    several billion dollars annually. Just in this country, the influenza
    pandemics of 1957-1958 and 1968-1969 created combined economic losses
    of about $32 billion (1995 dollars).
        Monetary savings, of course, are not the only reward from a strong,
    innovative, and forward-looking public health system in the United
    States. More importantly, the American public rightly receives physical
    and emotional benefits from its long-standing support of medical and
    scientific research. Those benefits may be direct and obvious, such as
    identification of contaminated water supplies, or less obvious but
    equally important, as in the case of a strengthened infrastructure for
    public health to develop and share health-related technologies and
    information among health agencies. A reinvigorated public health system
    with effective programs will help protect the public against existing
    and emerging threats, such as antimicrobial resistance, chronic
    diseases with infectious origins and pandemic influenza.
        Thank you for the opportunity to provide a written statement for
    the hearing record on the CDC's fiscal year 2001 appropriations.
                                     ______

              Prepared Statement of The American Heart Association

        Chances are heart attack or stroke will be the death or disabler of
    you or a loved one. Heart attack, stroke and other cardiovascular
    diseases remain America's leading cause of death and a main cause of
    disability. Cardiovascular diseases account for nearly 1 of every 2
    deaths in the U.S.
        The American Heart Association is dedicated to reducing death and
    disability from heart attack, stroke and other cardiovascular diseases.
    We commend this Committee for making fiscal year 2000 funding for the
    National Institutes of Health and the Centers for Disease Control and
    Prevention a top priority. But, we are concerned that our government is
    still not devoting sufficient resources for research and prevention of
    America's No. 1 killer--heart disease--and to our country's No. 3
    killer and a leading disabler--stroke.
        Heart attack, stroke and other cardiovascular diseases have been
    America's No. 1 killer since 1919. Nearly 60 million Americans--1 in
    5--of all ages suffer from one or more of these diseases. Hundreds of
    millions of Americans have major risk factors for these diseases--about
    50 million have high blood pressure, 40 million have elevated blood
    cholesterol (240 mg/dL), 49 million smoke, 106 million adults are obese
    or overweight and 10 million have physician-diagnosed diabetes. As the
    baby boomers age, the number of Americans afflicted by these often
    disabling diseases will increase substantially. Cardiovascular diseases
    cost Americans more than any other disease. Americans will pay an
    estimated $327 billion for cardiovascular-related medical costs and
    lost productivity in 2000. These diseases constitute 4 of the top 5
    hospital costs for all payers, excluding childbirth and its
    complications, and 4 of the top 5 Medicare hospital costs. Heart
    disease is also the leading cause of premature, permanent disability of
    American workers, accounting for nearly 20 percent of Social Security
    disability payments.
                         how you can make a difference
        Now is the time to capitalize on a century of progress in
    understanding heart attack, stroke and other cardiovascular diseases.
    Promising, cost effective breakthroughs in treatment and prevention are
    on the horizon. We challenge our government to stay the course to
    double funding by year 2003 for NIH, for heart and stroke research and
    to translate research into effective clinical and community
    initiatives. This will cut health care costs and improve quality of
    life. For fiscal year 2001 we urge you to do the following.
      --Appropriate a 15 percent increase over fiscal year 2000 funding for
            the overall NIH--the third step toward the goal of doubling the
            budget by year 2003. This goal is echoed by groups such as
            Research!America and the Ad Hoc Group for Medical Research
            Funding.
        NIH research provides cutting-edge treatment and prevention
    strategies, cuts health care costs, creates jobs and maintains
    America's status as the world leader in biotechnology and
    pharmaceuticals industries.
      --Provide a 15 percent increase over fiscal year 2000 funding for NIH
            heart research and stroke research.
        Researchers are on the brink of advances that could pave the way to
    prevention and even a cure so you or a loved one will be spared pain
    and suffering from heart disease and stroke.
      --Allot a $25.2 million increase over fiscal year 2000 funding to
            expand CDC's Cardiovascular Health Program to 11 more states
            for a total of 29 states.
        We must make our science real and applicable through community
    interventions that encourage Americans to make healthful lifestyle
    choices to prevent heart disease and stroke.
                heart and stroke research benefits all americans
        Thanks to advances in addressing risk factors and in treating
    cardiovascular diseases, more Americans are surviving heart attack and
    stroke. Heart and stroke research and prevention breakthroughs are
    saving and improving lives. Several cutting-edge examples follow.
      --Emergency Cardiac Care.--Daily more than 700 Americans suffer
            sudden cardiac arrest--the unexpected, abrupt loss of heart
            function. A particular sequence of actions known as the ``chain
            of survival'' offers hope. Early use of both breathing and
            chest compression techniques of cardiopulmonary resuscitation
            and delivery of a powerful electrical shock to re-start the
            heart are critical to restore life. Each minute of delay in
            returning the heart to its normal rhythm decreases chance of
            survival by 10 percent. Our Operation Heartbeat Program, alone,
            estimates that 100,000 lives could be saved if automatic
            external defibrillators were more widely available.
      --Advanced Imaging Technology.--Research has revolutionized imaging
            technology to diagnose heart disease. You probably know someone
            who has had an angiogram. In this procedure, a catheter is
            inserted in an artery and navigated up to the heart. Then a dye
            is injected so x-rays can show artery narrowing that can
            trigger a heart attack or a stroke. About 1.2 million patients
            in 1997 were hospitalized for this procedure which causes
            discomfort and risk of infection and bleeding, and in rare
            cases, heart attack or stroke. Now angiograms are being
            replaced by two new imaging procedures that are easier, safer
            and cheaper. The high speed CT scan takes fast pictures,
            producing a measure of blockages in arteries to the heart, and
            help doctors better tailor treatments. Three-dimensional
            coronary magnetic resonance angiography (MRA), uses strong
            magnets to provide detailed images of the arteries to the
            heart. Taking less than an hour, MRA evaluates heart anatomy
            and other heart functions, providing a comprehensive,
            noninvasive, heart examination.
      --Surgery to Reduce Risk for Stroke.--In many cases surgeons can
            prevent stroke by removing the buildup of plaque from the main
            artery to the brain that is severely narrowed. Also, it helps
            stroke survivors reduce their risk of another stroke. About
            140,000 procedures are performed each year.
      --State-of-the-Art Life-extending drugs.--Research has produced new
            drugs to help prevent and treat heart attack and stroke.
            Cutting-edge drugs to control blood pressure and cholesterol
            are more effective than ever in saving lives and enhancing
            quality of life. When prevention fails, revolutionary
            ``clotbuster'' drugs can reduce disability from heart attack
            and stroke by dissolving blood clots causing the attack. Use of
            t-PA, within 3 hours of the onset of symptoms, can restore
            blood flow through the clot-obstructed artery and reduce
            chances of permanent disability by 33 percent, saving health
            care costs. T-PA offers hope for the estimated 1.1 million
            Americans who will suffer a heart attack and 450,000 at risk of
            a clot-caused stroke this year.
        So Americans can continue to benefit from these types of
    breakthroughs, we support a doubling of the overall NIH budget by year
    2003. We recommend an fiscal year 2001 appropriation of $20.5 billion
    for the NIH, the third step toward that goal. We have a special
    interest in individual NIH entities that relate directly to our
    mission. Our funding recommendations for these institutes and programs
    follow.
             heart research challenges and opportunities for nhlbi
        The above and other advances have been made possible by more than
    50 years of American Heart Association-sponsored research and more than
    a half-century of investment by Congress in the National Heart, Lung,
    and Blood Institute. Thanks to research, no longer does a heart attack
    or stroke necessarily mean immediate death. Now that more Americans are
    surviving, heart attack and stroke can mean permanent disability,
    requiring costly medical care and loss of productivity and quality of
    life.
        We urge this Committee to double the NHLBI budget, including heart
    research, by year 2003. As the next step toward reaching this goal, we
    advocate an fiscal year 2001 appropriation of $2.330 billion for the
    NHLBI, with $1.355 billion for heart and stroke-related research. A
    funding level of this amount will allow NHLBI to expand existing
    programs and invest in promising new initiatives. Several challenges
    and opportunities to advance the battle against heart disease are
    highlighted below.
      --Promoting Adherence to Medical and Behavioral Therapies.--Failure
            to follow medical recommendations causes tens of thousands of
            deaths a year, increased hospitalizations and delayed recovery,
            costing Americans $100 billion annually. An estimated 50
            percent of patients do not comply with prescribed treatments.
            Many life-extending drugs for heart attack survivors and heart
            failure patients are underused. Medical advances are
            continually improving chances of survival for Americans who
            suffer from or are at high risk of heart attack, stroke and
            other cardiovascular diseases. Not all patients or doctors take
            advantage of information we now know will reduce or treat
            Americans at risk of heart disease or stroke. Innovative
            theories about behavioral, cultural, social, psychological, and
            environmental methods to increase adherence to lifestyle and
            medical regimens must be tested. Research is needed on
            effective indicators to measure standard of delivery of care of
            health systems and to change physician behavior and practices.
            Increased funding in this area will lead to development of
            better methods for getting patients and healthcare providers to
            adhere to cost-effective, lifesaving therapies.
      --Immune System Research Programs for Heart Disease.--Basic knowledge
            about the body's disease fighting system is increasing rapidly,
            particularly in its involvement in the causes and development
            of heart disease and stroke. Innovative approaches are needed
            to use this knowledge to accelerate progress from basic
            knowledge to clinical applications. Promising areas that merit
            further research include, inflammatory response to blood vessel
            injury that occurs in atherosclerosis (the cause of most heart
            attacks and strokes); healing of damaged heart tissues after a
            heart attack; and chronic rejection following heart
            transplantation. Increased funding in this area would better
            identify those at risk and may lead to revolutionary treatments
            to prevent heart disease and stroke.
      --Maintaining Weight Loss.--An estimated 106 million Americans age 20
            and older are overweight or obese, a condition that increases
            risk of diseases such as heart attack, stroke, high blood
            pressure and diabetes. Clinical Guidelines on the
            Identification, Evaluation, and Treatment of Overweight and
            Obesity in Adults, supported by NHLBI and National Institute of
            Diabetes and Digestive and Kidney Diseases, reviews evidence
            that it is possible for overweight and obese Americans to lose
            a large amount of weight over six months, but only a few
            maintain it. Increased funding is needed to start studies to
            improve understanding of weight loss maintenance. Researchers
            must examine behaviors that influence obesity, weight loss and
            weight loss maintenance.
      --Heart attack, stroke and other cardiovascular diseases in women.--
            Cardiovascular diseases remain a main cause of disability and
            the No. 1 killer of American females, killing more than 500,000
            a year. Cardiovascular diseases kill more females than the next
            14 causes of death combined. They kill more females than males.
            About 1 in 5 females live with consequences of cardiovascular
            diseases. The clinical course of cardiovascular disease is
            different in women than in men and current diagnostic
            capabilities are less accurate in women than in men. Once a
            woman develops a cardiovascular disease, she is more likely
            than a man to have continuing health problems and is more
            likely to die from it. Despite the seriousness of these
            diseases, they are largely unrecognized by both women and their
            doctors. Additional funding is needed to allow NHLBI to expand
            research on cardiovascular diseases in women and to create more
            informational and educational programs for female patients and
            health care providers on cardiovascular diseases risk factors
            as authorized under Public Law 105-340, the Women's Health
            Research and Prevention Amendments of 1998.
             stroke research challenges and opportunities for ninds
        Stroke is a major cause of disability and America's No. 3 killer.
    America's 4.4 million stroke survivors often face debilitating physical
    and mental impairment, emotional distress and overwhelming medical
    costs. An estimated 600,000 Americans will suffer a stroke this year.
    Considered a disease that strikes our grandparents, stroke also
    afflicts newborns, children and young adults. More Americans are dying
    from stroke than ever before.
        We urge a doubling of the stroke research budget through the NINDS
    by year 2003. An fiscal year 2001 appropriation of $1.184 billion for
    NINDS, with $125 million for stroke research, the next step toward the
    goal, will allow the NINDS to expand studies and start new research to
    prevent stroke, protect the brain during stroke and enhance
    rehabilitation. Some challenges and opportunities follow.
      --Emerging Stroke Risk Factors.--Many Americans are controlling major
            stroke risk factors, such as high blood pressure and smoking,
            yet the number of people falling victim to stroke continues to
            rise. With the growing number of strokes, scientists are
            defining new stroke risk factors, re-examining existing ones
            and reconsidering a long-held belief that no difference exists
            in risk between young and older patients with similar risk
            factors. Researchers are studying heart valve disease coupled
            with an irregular heartbeat; elevated white blood cell count
            that signals an infection leading to inflammation and clogging
            of arteries; long-term effects of previous high blood pressure;
            and high levels of C-reactive protein in blood that signals
            inflammation of blood vessels. Increased funding to study these
            areas may lead to new ways to prevent stroke.
      --Therapeutic Strategies for Stroke.--Several major clinical trials
            investigating drugs and techniques have identified progressive
            methods for preventing and treating stroke in high risk
            populations. But, more drugs and procedures to prevent strokes
            need to be developed and evaluated. Funding for new clinical
            studies are crucial for advancing additional cutting-edge
            stroke treatment and prevention.
      --Public and Professional Education for Stroke.--T-PA is the first
            effective FDA-approved emergency treatment for clot-caused
            stroke. Yet, only 5 percent of those eligible for t-PA receive
            it. As a member of the Brain Attack Coalition, a group of
            national organizations committed to fighting stroke, we are
            working with NINDS to increase public awareness of stroke
            symptoms and appropriate emergency action. Together, we are
            sponsoring and distributing a televised PSA on this issue and
            striving to develop systems to make t-PA readily available to
            appropriate patients. When these systems are fully implemented,
            stroke treatment will change from supportive care to early
            brain-saving intervention. More funding is needed to educate
            the public about stroke symptoms and the need for prompt
            treatment and to assure appropriate community response systems
            are in place. More health professionals must be educated about
            t-PA and the need for rapid response.
      --Acute Stroke Treatment Centers.--Rapid, early treatment must be
            available to stroke victims who arrive in the emergency
            department within the three-hour window of opportunity for t-
            PA. Funding to develop acute stroke treatment centers is key to
            rapid early treatment. These centers would provide 24-hour
            emergency transportation, emergency department physician and
            nurse, a neurologist or stroke specialist, access to a
            diagnostic neuroradiologist or stroke professional with
            experiencing in reading and interpreting brain images and a
            neurosurgeron for treatment of bleeding stroke and serious
            complications. The centers would provide an opportunity for new
            stroke treatments to be evaluated early when they could have
            the most beneficial effect.
            research in other nih institutes benefit heart & stroke
        National Institute on Aging defines how the aging process
    contributes to cardiovascular diseases, a main disabler and No. 1
    killer of older Americans. An fiscal year 2001 appropriation of $62
    million for cardiovascular research will allow continuation of studies
    and expansion into promising areas.
        National Institute of Diabetes and Digestive and Kidney Diseases
    studies help in reducing cardiovascular disease death and disability.
    We advocate an fiscal year 2001 appropriation of $1.313 billion for the
    NIDDK to advance research to help diabetics, 2/3 of whom die from heart
    disease or stroke.
        National Institute of Nursing Research studies play a key role in
    promoting self-care and patient education. NINR research is critical to
    primary and secondary prevention of heart attack, stroke and other
    cardiovascular diseases. We advocate an fiscal year 2001 appropriation
    of $103 million for the NINR.
        Animal research is critical for heart and stroke research. We
    support an fiscal year 2001 appropriation of $776.3 million for the
    National Center for Research Resources to help institutions and
    researchers get animals and provide humane care. Increased resources
    will fortify animal research, help correct deficiencies in research
    animal resources and strengthen Clinical Research Area Centers and
    Biomedical Technology and Infrastructure Areas.
                   agency for healthcare research and quality
        AHRQ, the lead health care quality agency, acts as a ``science
    partner'' with public and private health care sectors in improving
    health care quality, reducing its costs and broadening access to
    essential services. AHRQ is an active participant in developing
    evidence-based information needed by consumers, providers, health plans
    and policymakers to improve health care decision making. We concur with
    the Friends of AHRQ's recommendation of an appropriation of $300
    million for the AHRQ to improve health care quality, reduce medical
    errors and expand availability of health outcomes information.
                   centers for disease control and prevention
        The best way to protect the health of Americans and lessen the
    enormous financial burden of disease is through prevention. Your
    commitment cannot stop at the laboratory door. You must fund the work
    that brings research into the places where heart disease and stroke
    live--the towns and neighborhoods that populate America.
        The CDC builds the bridge between what we learn in the lab and how
    we live in communities. CDC sets the pace on prevention. We recommend
    an fiscal year 2001 appropriation of $4.1 billion for CDC, with a
    doubling of the chronic disease prevention line for at total of $570
    million.
        As a result of the efforts of this Committee, since fiscal year
    1998, CDC's Cardiovascular Health Program will cover 18 states. This
    initiative allows states to design/and or implement programs to meet
    local needs to prevent and control heart attack, stroke and other
    cardiovascular diseases. In 1997, CDC released a report outlining what
    the nation's priorities should be in chronic disease prevention. The
    report, Unrealized Prevention Opportunities: Reducing the Health and
    Economic Burden of Chronic Disease, said ``strong chronic disease
    prevention programs should be in place in every state to target the
    leading causes of death and disability in our society --and their
    principal risk factors.'' Until the Appropriations Committee started a
    comprehensive Cardiovascular Health Program in fiscal year 1998, the
    CDC-administered Preventive Health and Health Services Block Grant was
    the only source of federal funding to states for targeting
    cardiovascular diseases, the No. 1 killer in every state.
        We laud this Committee's creation and expansion of a state-based
    cardiovascular health program that will be in 18 states in fiscal year
    2000. An fiscal year 2001 appropriation of $50 million for the
    Cardiovascular Health Program will allow CDC to expand it to 11 more
    states for a total of 29 states.
        The WISEWOMAN Program uses CDC's National Breast and Cervical
    Cancer Early Detection Program to also screen uninsured and low-income
    women age 50 and older for heart disease and stroke risk factors. We
    commend this Committee for providing funding to expand the program to
    seven states. An appropriation of $20 million will allow CDC to support
    20 states in WISEWOMAN.
        The Preventive Health and Health Services Block Grant is a vital
    resource for states in addressing heart disease and stroke. It is
    critical in helping states with their role in preventing chronic
    diseases. We recommend an fiscal year 2001 appropriation of $210
    million for the PHHSBG. We urge the Committee to address, as the
    Unrealized Prevention Opportunities document points out, the need to
    target risk factors. We support CDC's efforts to build:
      --a comprehensive nutrition and physical activity program with an
            appropriation of $30 million;
      --a national program to prevent tobacco use, including a public
            education campaign to reduce youth access to tobacco, through
            CDC's Office of Smoking and Health with an appropriation of
            $130 million; and
      --a comprehensive school health education program with an
            appropriation of $25 million.
        Coupled with a nationwide Cardiovascular Health Program, these
    initiatives will advance the fight against heart disease and stroke. We
    urge you to make cardiovascular health a national priority.
                                 action needed
        Significantly increasing resources for research and community
    intervention programs will allow this nation to continue making strides
    in the battle against heart attack, stroke and other cardiovascular
    diseases.
                                     ______

                         National Institutes of Health
                                Medical Research
    Prepared Statement of the Association of Women's Health, Obstetric and
                                Neonatal Nurses
        The Association of Women's Health, Obstetric and Neonatal Nurses
    (AWHONN) appreciates the opportunity to comment on the fiscal year 2001
    appropriations for nursing education, research, and workforce programs,
    as well as programs designed to improve maternal and child health.
    AWHONN is a membership organization of 22,000 nurses whose mission is
    to promote the health of women and newborns. AWHONN members are
    registered nurses, nurse practitioners, certified nurse midwives, and
    clinical nurse specialists who work in hospitals, physicians' offices,
    universities and community clinics across North America as well as in
    the Armed Forces around the world.
        AWHONN appreciates the support that this Subcommittee has provided
    for nursing education, research and workforce programs, as well as
    maternal and child health programs in the past. We realize that there
    are many competing priorities for the Subcommittee members, and we
    appreciate your consistent support.
                      national institutes of health (nih)
        AWHONN joins many others in supporting a 15 percent increase for
    the National Institutes of Health in fiscal year 2001. With the
    leadership provided by this Subcommittee, Congress is well on its way
    to doubling NIH funding by 2003. In addition to the overall support,
    there are two specific funding recommendations that AWHONN recommends
    within NIH.
    National Institute of Nursing Research
        AWHONN encourages this Subcommittee to support the professional
    judgement budget request of $110 million for the National Institute of
    Nursing Research (NINR).
        One of AWHONN's top priorities is a $20 million dollar increase in
    funding for the National Institute of Nursing Research (NINR). NINR
    engages in significant research affecting areas such as: research on
    health disparities in ethnic groups, training opportunities in genetic
    research and in health disparities, and studying telehealth
    interventions in rural/underserved populations. These research programs
    directly affect patients and families and contribute to decreased
    medical costs and increased quality of patient care.
        In addition, NINR research improves outcomes for women and
    children. A report by the U.S. Agency for Health Care states that the
    most common reason for hospital admission in the United States is
    childbirth. This accounts for 3.8 million annual hospital admissions.
    This is a joyous event in most women's lives, but complications of
    pregnancy such as pre-term birth and low birthweight infants are some
    of the more expensive reasons for hospitalization. Nurse research has
    helped redesign care delivery models that optimize pregnancy outcomes
    and shorten hospital stays for vulnerable low birthweight babies.
        For example, NINR-funded projects have contributed to breakthroughs
    in nursing that have improved infant health after hospital discharge
    for at-risk mothers and babies. One model utilized home follow-up
    assessment and care by an advanced practice nurse and showed decreased
    health system costs by shortening the length of stay of the infant and
    avoiding subsequent re-hospitalization.
        Because of the emphasis on biomedical research in this country,
    there are few sources of funds for high-quality behavioral research for
    nursing other than NINR. It is critical that we increase funding in
    this area in an effort to improve the consumer's experience with the
    health care system, optimize patient outcomes and decrease the need for
    extended hospitalization.
    National Institute of Child and Human Development (NICHD)
        AWHONN supports the professional judgment budget, which includes an
    increase of $294 million, bringing the appropriation for NICHD to just
    over $1 billion.
        NICHD seeks to ensure that every baby is born healthy, that women
    suffer no adverse consequences from pregnancy, and that all children
    have the opportunity to fulfill their potential for a healthy and
    productive life unhampered by disease or disability. With increased
    funding NICHD could expand its use of the NICHD Maternal-Fetal Medicine
    Network to study ways to reduce the incidence of low birth weight.
    Prematurity/low birthweight is the second leading cause of infant
    mortality in the United States and the leading cause of death among
    African American infants. AWHONN, like many organizations directly
    involved in initiates to improve the health of women and newborns,
    looks to NICHD to provide national initiatives, such as the Maternal-
    Fetal Medicine Network to assist with the care of pregnant women and
    babies.
        On specific example of the important research that evolves from
    NICHD is research that led to the remarkable reduction in the rate of
    HIV transmission from mother to infant during pregnancy and birth. In
    fact, this past year, grantees focused on treatment that reduces the
    viral load during pregnancy finding that the risk of HIV transmission
    from mother to infant can be further reduced. Additionally, NICHD, in
    collaboration with NIAID, is now conducting studies to evaluate whether
    nevirapine, administered during the time a mother is breastfeeding can
    reduce the rate of HIV transmission through breast milk. The results of
    these studies and many others will lead to significant advances in
    ensuring that babies are born healthy, while decreasing maternal
    morbidity.
                    department of health and human services
    Nurse Education Act (NEA)
        AWHONN is requesting an increase of 15 percent over fiscal year
    2000 to fund the NEA at approximately $78 million. Fiscal year 2000
    funding for the NEA was $67.8 million.
        The Nurse Education Act (Public Health Service Act Title VIII)
    helps schools of nursing and nursing students prepare to meet patient
    needs in a changing health care delivery system, favoring programs in
    institutions that train nurses for practice in medically underserved
    communities and Health Professional Shortage Areas. Reauthorized as the
    Nursing Workforce Development section in 1998, the new NEA gives the
    Department of Health and Human Services more discretion over the focus
    of federal spending, while keeping with previous goals. In addition,
    funds from the Nurse Education Act support projects that would increase
    educational opportunities for minority nurses who would then be able to
    provide culturally competent, linguistically appropriate health care
    services to underserved communities.
        AWHONN supports the continued designation of funds for education
    and training of critically needed primary care providers--advanced
    practice nurses. These nurses--clinical nurse specialists, nurse
    practitioners and certified nurse-midwives--have historically provided
    a pool of qualified providers for underserved communities. Advanced
    practice nurses are providing services in communities where physician
    services are sometimes not even available. Due to the current demand
    for these services, and expected increases in demand, it is critical
    that the Division of Nursing, through the Health Resources Services
    Administration, is provided the funding to address the education and
    training needs of this essential pool of providers.
        While many advance practice nurses are providing greatly needed
    services in critical areas, the nursing community is facing shortages
    in nurses with the competence, skills and experience to meet the
    demands for complex patient care. With greater frequency we are
    receiving calls from our members reporting gaps in staffing resulting
    from fewer and fewer available professional registered nurses. We
    understand that at this time the nursing shortage is regional in
    nature, but the entire nursing community is anticipating a significant
    professional nurse shortage to peak around 2010. With the increasing
    technical complexity of the health care system, it is critical that a
    pool of highly skilled and experienced professional nurses be available
    to safeguard the health of our nation. We anticipate that the aging
    baby boomer generation will require more health care resources in 2010
    at the time when there will be a historic low in nurse supply. While we
    wait for the results of the most recent nurse sample survey to confirm
    these concerns, AWHONN believes it is critical that Congress act to
    ensure the continued supply of professional nurses in our nation.
    Maternal and Child Health Block Grant
        Because of the increasing demands for the services provided through
    this block grant, AWHONN recommends a substantial increase for the
    Maternal Child Health Block Grant to $800 million for fiscal year 2001.
        This program provides comprehensive, preventive care for mothers
    and young children, as well as an array of coordinated services for
    children with special needs. MCH programs are facing increased demands
    for services due to continued growth in the Children's Health Insurance
    Program, which in turn identifies more children who are eligible for
    other MCH Services. Title V complements Medicaid and the State
    Children's Health Insurance Program by providing ``wrap-around''
    services and enhanced access to care in underserved areas.
        Additional funding would give states the resources they need to
    expand prenatal and infancy home visitation programs, an approach that
    has been shown to improve the prenatal health-related behavior of women
    and reduce rates of child abuse and neglect as well as maternal welfare
    dependence. Postpartum home visits can also increase the percentage of
    mothers who choose to breastfeed. Many new mothers can get frustrated
    and stop breastfeeding in the first few days; a visit from a qualified
    health care provider can greatly encourage women to continue
    breastfeeding. This can also positively impact the goals of the Healthy
    People 2010 initiative to raise the rate of initiation of breastfeeding
    to 75 percent and the six-month rate of breastfeeding to 50 percent.
        centers for disease control and prevention--folic acid awareness
        AWHONN recommends an increase to $20 million in the fiscal year
    2001 appropriation to enable CDC to effectively promote folic acid
    awareness.
        For over 30 years, the Centers for Disease Control and Prevention
    (CDC) has been deeply involved in the prevention of birth defects. The
    public health impact of birth defects is tremendous. Of the four
    million babies born each year in the United States, approximately
    150,000 are born with a serious birth defect. According to CDC, the
    lifetime costs of caring for infants born in 1992, with at least one
    birth defect \1\ or cerebral palsy was about $8 billion. The emotional
    and financial burden for the families with affected children is
    devastating.
    ---------------------------------------------------------------------------
        \1\ These birth defects include: Spina bifida, truncus arteriosus,
    single ventricle, transposition/double outlet right ventricle,
    Tetralogy of Fallot, tracheo-esophageal fistula, colorectal atresia,
    cleft lip or palate, atresia/stenosis of small intestine, renal
    agenesis, urinary obstruction, lower-limb reduction, upper-limb
    reduction, omphalocele, gastroschisis, Down syndrome, and diaphragmatic
    hernia.
    ---------------------------------------------------------------------------
        The first steps in preventing birth defects includes surveillance,
    to find out what types of birth defects are occurring, how often and
    where, and research into the causes of birth defects. The ultimate goal
    of surveillance and research is to develop and implement strategies to
    prevent birth defects. An example of such a prevention activity is the
    current folic acid education campaign to prevent neural tube defects
    (NTDs). Each year in the United States, an estimated 2,500 babies are
    born with NTDs, birth defects of the brain and spinal cord, such as
    anencephaly and spina bifida. These NTDs are among the most serious,
    costly and preventable birth defects. The lifetime cost of each case of
    spina bifida in 1992 was estimated to be nearly $300,000. Yet, up to 70
    percent of NTDs can be prevented if all women of childbearing age
    consume 400 micrograms of folic acid daily, beginning before pregnancy.
        In an effort to spread this information, AWHONN is working closely
    with the CDC, March of Dimes, and more than 40 public and private
    organizations, to coordinate a national educational campaign through
    the National Council on Folic Acid. Last year Congress increased
    funding for CDC's efforts in support of the folic acid campaign from
    $1.5 to $2 million. However, current funding is woefully inadequate. We
    respectfully request that you provide the CDC $20 million in funding to
    prevent these serious birth defects.
        Thank you for the opportunity to submit testimony on these critical
    areas of funding.
                                     ______

          Prepared Statement of the American Society for Microbiology

        The American Society for Microbiology (ASM), representing over
    42,000 researchers and clinicians, recognizes with appreciation
    Congress' historically strong support of medical research funded by the
    National Institutes of Health (NIH), which is critical to improving the
    health and well-being of all Americans. The ASM particularly commends
    the leadership of Senators Specter and Harkin and the members of the
    Senate Subcommittee on Labor, Health and Human Services, Education and
    Related Agencies for providing a $17.8 billion appropriation for NIH in
    fiscal year 2000. This investment in basic and clinical research will
    lead to further advances in disease diagnosis, treatment and
    prevention.
        As an organization knowledgeable about public health threats, the
    ASM recommends that Congress increase the proposed fiscal year 2001
    budget request for NIH to provide additional resources for basic and
    clinical research to address an increasingly complex set of scientific
    and medical challenges. The ASM endorses a $2.7 billion increase (15
    percent) which would bring the NIH budget to $20.5 billion in fiscal
    year 2001. During the past two years, Congress has increased the NIH
    budget by 15 percent each year, steps toward the goal of doubling the
    NIH budget by 2003 \1\.
    ---------------------------------------------------------------------------
        \1\ The ASM is a member of the Ad Hoc Group for Medical Research
    Funding and endorses the Ad Hoc Group's recommendation for NIH funding
    for fiscal year 2001.
    ---------------------------------------------------------------------------
        One of the NIH's highest priorities is the funding of medical
    research through research project grants, which generate new scientific
    knowledge and opportunities. Under the proposed fiscal year 2001
    budget, the NIH estimates that it would support 7,641 new and competing
    grants, a disturbing 1300 fewer grants than awarded in the current
    fiscal year. In addition, noncompeting and competing grants would be
    allowed only a 2 and 2.1 percent inflation increase, respectively, well
    below the 3 percent normally allowed and certainly well below general
    inflation rates.
                              public health needs
        There is no doubt that public health has benefited, not only in the
    United States but around the world, from bipartisan support for
    scientific research. The U.S. public expects and deserves, real
    advances in medicine and science. Through research funding, the NIH
    consistently contributes to our national health and to a real return on
    the public's financial investment. Advances from NIH supported research
    in the past year alone include the identification of a gene in
    salmonella bacteria linked to pathogenicity and present in many other
    disease-causing bacteria, suggesting innovative approaches to
    antibiotics and vaccines. NIH supported scientists also demonstrated
    that an inexpensive and simple treatment regimen with the
    antiretroviral drug nevirapine can reduce transmission of the HIV virus
    from mother to infant. These and other impressive successes must
    continue in the fight against infectious and chronic diseases and other
    threats to public health.
        Infectious diseases remain the third largest cause of death in the
    United States, and a number one killer worldwide. Globally, acute
    respiratory infection is the leading infectious killer, responsible for
    3.5 million deaths in 1998. Pneumonia and influenza are the leading
    infectious killers in the United States, ranked 5th in preliminary data
    for 1998. In an age of medical miracles, stubborn infectious diseases
    such as malaria persist, new infectious diseases such as hantavirus are
    emerging and old infectious diseases such as tuberculosis (TB) are
    reemerging. One-third of the world's population has latent TB and
    multi-drug resistant TB cases have been reported from 45 states over a
    5 year period. The disease is the 8th leading cause of death worldwide,
    and on the rise in this country. Another ``old'' disease, malaria, is
    undergoing a global resurgence, with 275 million cases annually
    resulting in an estimated 1.1 million deaths. In the United States, an
    estimated 271,000 people are living with HIV infection, while the
    hepatitis C virus (a cause of cirrhosis and liver cancer) has infected
    almost 4 million and kills about 9,000 annually. In the United States,
    the rate of new HIV/AIDS infections is 40,000 per year, and over
    420,000 people with AIDS have died as of June 20, 1999. The HIV/AIDS
    epidemic will soon become the worst epidemic of infectious diseases in
    recorded history, with over 16 million people estimated to have already
    died from AIDS at the end of 1999 and 33.6 million living with HIV/AIDS
    worldwide. Vaccines against both viruses are desperately needed.
        As a nation, global health should be a high priority, for
    humanitarian reasons and because of our own vulnerability. For example,
    over 60 cases of West Nile virus encephalitis were detected in New York
    last year, the first documented cases in the Western Hemisphere of a
    virus restricted to Africa, West Asia and the Middle East.
        Within the NIH, the National Institute of Allergy and Infectious
    Diseases (NIAID), has responded aggressively and effectively to
    microbial threats. The NIAID is the third largest component of the NIH
    due to the emergence of HIV/AIDS in the early 1980s and the realization
    that infectious diseases will continue to emerge unpredictably and at
    times explosively. It is clear that despite the defeat of diseases like
    smallpox, the dangers of infectious diseases are far from eliminated.
    One of the most significant threats to public health continues
    unabated, namely our inability to treat some infectious diseases
    because of antibiotic resistance. Antibiotic resistance is emerging for
    almost one-third of hospital acquired pathogens, as well as for many
    community acquired pathogens. Newly discovered pathogens, reemerging
    more virulent pathogens, with their sobering potential as bioterrorist
    weapons, mean that our struggle against infectious diseases is far from
    over and must be intensified.
        The ASM recommends that NIH funding be increased to expand support
    for research to unlock the basic mechanisms of disease, for
    antimicrobial resistance, vaccine research, the infectious etiology of
    chronic diseases, emerging infectious diseases, hepatitis C, Lyme
    disease, opportunistic infections including tuberculosis, AIDS-related
    research, and microbial gene sequencing research. This intimidating
    list of microbial targets represents some of the most serious threats
    to public health, but also offers exciting possibilities for scientific
    advancement.
                     scientific progress and opportunities
        As we enter the 21st century, scientific opportunities are greater
    than ever, thanks to historic advances in basic and clinical research
    over recent years. These opportunities promise future benefits through
    new knowledge, new treatments, and new prevention strategies. We have
    witnessed the power of basic research to enhance public health
    manifested, for example, as effective hepatitis B vaccines or the
    development of rapid diagnostic tests for specific pathogenic
    microorganisms. We enter the century with new research capabilities,
    with more sophisticated laboratory tools and with a scientific
    workforce that is increasingly interdisciplinary in its attitudes and
    abilities.
        Remarkable opportunities await researchers as a result of DNA and
    computer technologies developed in the latter part of the 20th century.
    ASM concurs with the NIAID's strategic plan statement that ``DNA
    technologies are profoundly altering the health research landscape . .
    . [and] revolutionizing approaches to understanding pathogenesis,
    microbial physiology, and epidemiology of infectious diseases;
    radically advancing the understanding of immune activation and
    regulation; uncovering the genetic bases of disease susceptibility; and
    accelerating the development of new diagnostic, treatment and
    intervention strategies.'' This suggests stunning returns on public
    investment in basic research through the NIH. Add to these
    possibilities those provided by computer modeling, robotics and x-ray
    crystallography, and our future defenses against infectious diseases
    will likely look quite different than those of the past century.
                 nature of and requirements of today's research
        New technologies will be a trademark of research in the 21st
    century, but they will not be the only agent of change reshaping our
    scientific approach to fighting both old and new diseases. The NIH will
    support the skilled personnel and the knowledge base necessary to adapt
    to these changes.
        Much of the research landscape has changed over the past century,
    and will continue to change. Undoubtedly, scientific research will
    become even more expensive. Our increasing dependence on highly
    sophisticated technologies, such as advanced computers, functional
    imaging, and gene chips, increases the cost of doing research. The
    growing use of genetically modified animals and more elaborate animal
    facilities adds significant cost, as does the obvious need for more
    clinical research and clinicians participating in multi-institution
    studies. Scientific advances are cumulative and research is a multi-
    year process that may not produce a satisfactory product for a long
    period of time. Long-term funding for research and its underpinning
    infrastructure remains a necessary part of assuring scientific and
    medical advances.
        Among the factors reshaping how we will do research is the absolute
    necessity for burgeoning data bases, innovative computer usage, and
    information sharing within highly complex research projects. The NIH is
    responding to this new world of information with informatics projects,
    input from the National Library of Medicine, and interdisciplinary
    efforts in the fields of biology, computer science, and mathematics. In
    fiscal year 2001, the NIH plans to provide the infrastructure to train
    the next generation of interdisciplinary scientists, to develop new
    means for storing, managing, and accessing vast data collections, and
    to enhance basic research in biomedical computing. To accomplish these
    new approaches to research, resources must be sufficient to train
    scientists in interdisciplinary fields and to encourage cooperative
    efforts among specialists.
        Research in the 21st century must also adapt to significant changes
    in patient populations. Since the beginning of 20th century, life
    expectancy at birth in the United States has increased from fewer than
    50 years to more than 76 years. As a result, future research will focus
    more than ever on enhancing the quality of human life. By the middle of
    this new century, the number of Americans over 65 will more than double
    and the number over age 85 will increase five-fold, making diseases of
    the aged a higher priority for researchers. An example is our growing
    awareness that microorganisms play more of a role in chronic disease
    than previously thought, an area now being investigated by the NIH. A
    virus has been found in spinal cords of victims of the neuromuscular
    disease known as Lou Gehrig's disease. Other chronic diseases with a
    possible microbial etiology include peptic ulcers, arthritis,
    cardiovascular disease, conditions affecting the lungs, and some types
    of cancer.
        Women and minorities in the United States and around the world also
    bear a disproportionate burden of many infectious diseases, including
    AIDS, sexually transmitted disease, auto immune diseases and end stage
    renal disease. The NIH supports research to improve the health status
    of patients affiliated with these diseases.
                               economic benefits
        Triumph over diseases that assault human health is not the only
    reward from research. The financial benefits of research are
    significant, through both economic stimulus and cost-savings.
    Approximately 82 percent of the funds appropriated to the NIH flows
    into research labs across the nation, supporting the work of more than
    50,000 researchers affiliated with some 2,000 hospitals, universities,
    and other research institutions. Federally supported research offers
    obvious benefits to the biotechnology and pharmaceutical industries,
    which utilize discoveries from basic research and in return receive
    increased revenues and a steady input of opportunities for new-product
    development. In 1999, more than 153,000 highly skilled workers were
    employed by U.S. biotech companies, generating an impressive $19
    billion in annual revenues.
        The American public, however, is the greatest recipient of
    scientific and medical advances. Surveys consistently show that
    citizens support increased funding for medical research, in recognition
    of the importance of public health and of research as the foundation
    underlying success against disease. Through efforts by the NIAID there
    are clear examples of direct benefits from basic research: the
    identification of infectious agents for several human diseases,
    including Lyme disease, bronchopneumonia, hemorrhagic fevers, and
    diarrheal illness; and the genomic sequencing of the cause of syphilis,
    Treponema palllidum, and of E. coli strain K 12 and Chlamydia
    trachomatis, of a chromosome of the malaria parasite Plasmodium
    falciparum, and of Mycobacterium tuberculosis. As a result of these
    laboratory discoveries, we will develop more specific and more
    effective diagnostic, treatment and prevention strategies. The
    dividends from public investment in a vigorous and well-funded research
    enterprise are not merely hypothetical, but very real improvements in
    public health and the national economy.
        The ASM appreciates the opportunity to submit written testimony to
    support increased funding for the NIH in fiscal year 2001
    appropriation.
                                     ______

       Prepared Statement of Texas Tech University Health Sciences Center

        Mr. Chairman, thank you for the opportunity to submit this
    testimony for the record on a subject of utmost importance to diabetic
    patients in Texas and the nation. Texas Tech University Health Sciences
    Center (TTUHSC), in response to the prevalence of diabetes among the
    Hispanic and elderly populations that it serves, is proposing to
    establish a Center for Diabetes Prevention and Control for which TTUHSC
    is seeking $6.3 million over three years. This center will engage in a
    wide array of diabetes prevention and control activities including:
      --Development and operation of easily accessible diabetes eye care
            outreach, assessment, and treatment centers;
      --Perform clinical investigations of the predisposition to infection
            among diabetics, especially diabetic Hispanics; and,
      --Conduct in-depth surveys that focus on Hispanics and the elderly
            residents of rural areas to identify persons with undiagnosed
            and untreated diabetes and to track the incidence, prevalence,
            and treatment of diabetes among the general populations;
      --Examine the use of telemedicine and other technologies as a means
            of delivering diabetes education, consultation, and care to
            patients in remote communities and rural areas.
        Mr. Chairman, diabetes is one of the most physically and
    financially debilitating preventable diseases facing our nation. The
    number of people diagnosed with diabetes continues to increase,
    especially among Hispanics and the elderly in regions like West Texas.
    It is for these reasons that the Texas Tech University Health Sciences
    Center (TTUHSC) seeks funding to support its diabetes efforts and to
    assist the Health Sciences Center in enhancing its diabetes expertise
    and facilities.
        Today, an estimated 865,347 adults in Texas have diagnosed diabetes
    and for every recognized diabetic there is at least one case where the
    disease has not been diagnosed. The situation may be starker still for
    West Texas because diabetes occurs more often in the elderly and among
    Hispanics--two groups prominent in the region's population. As in the
    nation, Hispanics in Texas are two to four times more likely to have
    diabetes than are members of the non-Hispanic Caucasian population. It
    is estimated that approximately 22 percent of elderly Hispanics suffer
    from the disease. Hispanics are already the second largest and are also
    the fastest growing minority group in the United States. In 1993 there
    were 27 million Hispanics in the United States, representing 10 percent
    of the population. By 2050 Hispanics will constitute 21 percent of the
    U.S. population. In light of this demographic trend, the following
    statistics on diabetes among Hispanics are indeed ominous. About 5
    percent of Hispanic Americans between the ages of 20 and 44 years, and
    20 percent of those between the ages of 45 and 74 years have diabetes.
    These data translate to 1.8 million Hispanic adults with diabetes.
    About half of those have been diagnosed, but the other half remains
    undiagnosed and untreated.
        The Texas Diabetes Council estimates that 35 percent of the
    diagnosed diabetics in Texas are Hispanic. Studies conducted in Texas,
    New Mexico and in Mexico show that the risk of having diabetes in adult
    Hispanic men and women is 13 to 25 percent, compared to 3 to 8 percent
    in Anglo adults.
        The problem of diabetes in the Hispanic population is aggravated by
    a variety of financial and non-financial barriers that limit access to
    modern health care and health information. When limited access delays
    diagnosis and treatment of diabetes, irreversible complications
    involving the visual, renal, cardiovascular, and nervous systems are
    more likely to develop. When education on ways to manage diabetes is
    unavailable, the disease is much more likely to progress and to result
    in needless, preventable exacerbation.
        The total economic impact of diabetes in 1997 was estimated to be
    $98 billion. That includes $44.1 billion in direct medical and
    treatment costs and $54 billion in indirect costs attributed to
    disability and mortality.
        The overall annual cost of diabetes in Texas is approximately $4
    billion, $1.6 billion in direct costs and $2.4 billion in indirect
    costs, largely from long-term disability. The shortage of health
    professionals in West Texas compounds the problem by limiting the
    number of people who can screen for the disease and provide proper
    care, appropriate nutrition education, and other self-management
    instruction.
        Additionally, diabetes is the leading cause of blindness, kidney
    failure, and amputations as well as a leading cause of heart disease,
    stroke, birth defects, premature death, and disability. The diabetics'
    risk of renal disease, ocular disorders, and gangrene is 17 to 50 times
    greater than that of the general population. Cardiovascular
    complications among diabetics occur twice as often as they do among
    non-diabetics. A higher incidence of complications from diabetes,
    including: nephropathy, retinopathy, and peripheral vascular disease,
    has been documented among Hispanics.
        Kidney failure is one of the most devastating consequence of
    diabetes--half of the nation's cases of End Stage Renal Disease (ESRD)
    are caused by diabetes. Annual Medicare costs from ESRD total $15
    billion. In West Texas, it is estimated that nearly 70 percent of all
    ESRD is caused by diabetes. The extraordinarily high prevalence of
    diabetes-related ESRD in TTUHSC's catchment area is due in part to its
    large Hispanic and Native American populations, groups having the
    highest rates of diabetes in the United States. Preventing diabetes-
    related ESRD has the potential for saving billions of dollars in
    Medicare costs annually.
        The risk of renal disease, ocular disorders, and gangrene in
    diabetics are, respectively, 17, 25, and 50 times that of the general
    population. The risk of cardiovascular complications is twice that seen
    in non-diabetic subjects. The overall annual cost of diabetes in Texas
    is approximately $4 billion, $1.6 billion in direct costs and $2.4
    billion in indirect costs, largely from long-term disability.
        The proposed TTUHSC Center for Diabetes Prevention and Control will
    include the following components:
    Diabetic Eye Care Assessment and Treatment Center
        Because diabetes is the leading cause of blindness, an Eye Care
    Assessment and Treatment Center can provide greatly needed evaluation
    and treatment for all types of diabetic retinopathy, particularly those
    that respond to laser surgery. Comprehensive eye examinations utilizing
    digital retina photography detect diabetic retinopathy, photography
    coupled with angiography quantifies disease severity, and state-of-the-
    art eye lasers provide sight-preserving treatment. Using public
    outreach to emphasize the need for regular screenings--even when visual
    loss is not apparent--centers in both El Paso and Lubbock will help
    fill the need for quality eye care among the West Texans most prone to
    diabetes--Hispanics and the elderly.
    Population-Based Diabetes Survey
        Although estimates can be derived from national surveys, hard data
    are not available on either the disease's prevalence or the quality of
    care provided to rural and Hispanic diabetics. Research by TTUHSC
    faculty suggests that Hispanics and rural elderly are much less likely
    to receive appropriate medical care than non-Hispanics. The proposed
    survey would provide precise estimates of the prevalence of diabetes in
    a region with substantial numbers of rural and Hispanic residents as
    well as information on ethnic differences in the continuity and quality
    of medical care afforded diabetics. To derive estimates of the
    prevalence, along with the additional needed information, a base sample
    of approximately 6,600 completed surveys will be obtained.
    Diabetes Clinical Research Center
        Cardiovascular disease (CVD) is the nation's leading cause of death
    and diabetics have a higher incidence of CVD than do non-diabetics.
    Because TTUHSC serves a region with particularly high rates of
    diabetes, CVD is very prevalent among its patients. By establishing a
    Diabetes Clinical Research Center, TTUHSC can better identify diabetics
    at increased risk for CVD. Center investigations can also help predict
    the specific form of CVD to which these patients are most prone--heart
    attack, heart failure, stroke, disease of blood vessels in the legs and
    arms, or kidney failure. Armed with this knowledge, physicians can
    customize their patients' disease management.
    Research Project: Diabetes Mellitus and Infections
        Diabetics are particularly prone to infection, perhaps because of
    the effects of high glucose levels and other diabetes-related changes
    on the white blood cells that defend the body against infection-causing
    organisms. However, definitive evidence on possible diabetes-linked
    changes in the function of these blood cells is lacking.
        This project will evaluate white blood cell activity in Hispanic
    diabetics. Cells will be examined for possible causes of any changes in
    their protective function. If compromised cellular function can be
    documented, then clinical trials of medications that inhibit white cell
    damage would follow. Prevention of infection and related complications
    of diabetes would represent a clinical ``cure'' of the disease.
    Diabetes Education Telemedicine Project
        A two-year demonstration project will evaluate the medical efficacy
    and economic feasibility of telemedicine as a means to deliver diabetes
    education to underserved diabetics, particularly Hispanic and elderly
    residents of remote, rural West Texas counties. Over a network linking
    rural health facilities with TTUHSC-El Paso, a bilingual Certified
    Diabetes Educator (CDE) will serve diabetics and their family members
    who cannot access effective education on diabetes management.
        The CDE will implement and manage the project in four rural
    communities. The project will be evaluated to determine the medical
    efficacy and economic feasibility of providing diabetes education and
    related services to rural communities via telemedicine technology.
        The funds requested for the proposed Center will allow TTUHSC to
    significantly enhance it faculty expertise and expand its diabetes
    prevention and control activities and facilities. TTUHSC has as its
    major objectives the provision of quality education and the development
    of academic, research, patient care, and community service programs to
    meet the health care needs West Texas. The 108 county region served by
    TTUHSC which comprise 50 percent of the state's land mass and 13.9
    percent of the population of the total state. This 131,000 square mile
    service area that is home to 2.55 million people has been and remains
    highly underserved by health professionals and accessible health care
    facilities.
        This initiative brings the clinical and scientific expertise of
    TTUHSC to bear on the provision of comprehensive, accessible and
    affordable diabetes outreach, education, prevention and care for the
    underserved and Hispanic and elderly populations of West Texas. The
    proposed Center will provide a national model of diabetes outreach,
    education, prevention and care. Because the region's Hispanic
    population tends not to be transient, the Center can track significant
    disease indicators and outcomes over a substantial period of time in a
    large Hispanic sample, data available nowhere else in the United
    States. Such data will be crucial for federal and state efforts to
    create prevention and care programs that reduce long-term health care
    costs and improve state and national health indicators. The Center's
    national relevance justifies TTUHSC's request for federal support.
        Mr. Chairman, we here at Texas Tech Health Sciences Center look
    forward to working with you to successfully implement this initiative
    over the coming three years. We are seeking $6.3 million over three
    years for the complete implementation of this initiative.
        Thank you for the opportunity to submit this testimony for the
    record.
                                     ______

                   Prepared Statement of Santa Marta Hospital

        Thank you Mr. Chairman for the opportunity to submit this testimony
    for the written record on a very important initiative underway at Santa
    Marta Hospital in Los Angeles California, The Diabetes Education and
    Management Program. This initiative has been implemented in response to
    one of the most critical and expensive medical crises threatening our
    patients. This program will provide a national model for diabetes
    education, outreach and disease for underserved and highly at-risk
    populations, specifically, Hispanic Americans.
        Santa Marta Hospital's three-year multi-site, Diabetes Education &
    Management Program will focus on the provision of diabetes education,
    outreach and health care services to an extremely at-risk, underserved
    and economically disadvantaged Hispanic population. Approximately 40
    percent of the target population for the Diabetes Education and
    Management Program are uninsured, and live at or below the federally
    defined poverty line.
        This initiative will address the urgent diabetic epidemic that is
    affecting the Hispanic population in Santa Marta's service area, the
    State of California and the nation. This innovative community-based
    program will use specially trained residents of the community to
    provide educational presentations, information and outreach to the
    residents of the hospital's service area. These ``Health Promoters''
    who will themselves be graduates of the Diabetes Education program,
    will be trained to provide screening, educational presentations,
    preventative services and outreach for primary medical care to
    residents of the neighborhood. The specific Objectives, Methods and
    Evaluation strategies that will be implemented as part of this
    initiative include:
    Objectives
        1. To train initially 20 (and ultimately 100 over the three year
    life of the demonstration) Community Health Promoters who will then
    provide diabetes education and medical services to at least 150 people
    in the East Los Angeles community annually, moving to 200 people in
    year three.
        2. To develop 70 courses annually that will include educational
    presentations addressing stages of diabetes, symptoms, nutrition and
    treatment options, both in Spanish and English.
        3. To provide low cost or no cost lab tests, medical care, and
    diabetes treatment to members of the East Los Angeles community.
        4. To expand the scope of community outreach to include a much
    broader range of diabetes medical, educational and psychosocial
    services provided to poor people in East Los Angeles.
    Methods/Strategies to be used to meet the program objectives
        1. The program will be composed of both diabetes education classes
    and preventative and primary care medical services. The education
    component will focus on diabetes presentations addressing symptoms,
    nutrition, and treatment. Approximately 10 or 12, 12-week courses will
    be offered serving approximately 30 people per class (at least 200
    people per year, by year three).
        2. Primary care programs will include: regular medical check-ups
    and lab work, screenings for diabetes, referrals to specialized
    physicians, and referrals to psychosocial services. Lab work and
    medical family history will be obtained at the beginning and end of the
    12-week program. Results will be compared and used as a performance
    evaluation tool for the Diabetes Education & Management Program.
        3. Diabetes education and management courses will be taught first
    by trained hospital staff. Eventually, 20 community Diabetes Education
    & Management Program participants, diagnosed diabetics themselves, will
    receive 50 hours of training to become diabetes educators in order to
    increase the number of people providing screenings in the community.
    This will improve program effectiveness because this community responds
    positively to community based programs.
        4. The community outreach program will continue to be supplemented
    by regular visits from Santa Marta's Mobile Health Care Delivery Van.
    This mobile clinic, staffed by doctors and nurses, will provide basic
    medical evaluations, testing, health education materials, and referrals
    to the Diabetes Education & Management Program.
    Evaluation Strategies
        1. Monthly, the project Clinical Director will review progress and
    present status reports to Santa Marta Hospital. The project Clinical
    Director's report will list the number of people benefiting from the
    education program, accomplishments, problems, corrective actions, and
    campaign status.
        2. At the end of each 12-week course, participants will fill out
    evaluation forms assessing course effectiveness. The results will be
    compiled by the project Clinical Director quarterly and presented to
    the Hospital.
        3. At the end of year one, the program will be thoroughly reviewed
    by the hospital President & CEO to determine program effectiveness,
    formulate recommendations, and make required changes to ensure its
    continued success. Their report will be shared with all interested
    parties, including donors and local health and social service agencies.
        The Diabetes Education & Management Program will provide education,
    medical and psychosocial services to people living in East Los Angeles.
    The program includes: free educational classes, two free lab work
    visits per participant (one at the beginning of the 12-week course and
    one at the end to test compliance and program effectiveness), and low
    or no cost medical services for related health effects of diabetes.
        Diabetes is known to be one of the most under identified causes of
    and contributions to death and that it disproportionately affects the
    Hispanic population. Additionally, it is widely recognized that the
    Hispanic population is three times more likely to have diabetes than
    other non-Hispanic populations. Today, there are approximately 15.7
    million people or 5.9 percent of the population who have diabetes.
    While an estimated 10.3 million have been diagnosed, 5.4 million go
    undiagnosed. Hispanics represent 12 percent to 14 percent of all
    diabetes cases nation-wide. Additionally, it is estimated that
    approximately 22 percent of elderly Hispanics suffer from the diabetes.
    Hispanics are the second largest and fastest growing minority group in
    the United States. In 1993, there were 27 million Hispanics in the
    United States, representing 10 percent of the population. By 2050
    Hispanics will constitute 21 percent of the U.S. population.
        Ninety-seven percent of the population surrounding Santa Marta
    Hospital is Hispanic.--The Hospital's census indicates that 66 percent
    of its patient population suffers from undiagnosed and diagnosed
    diabetes, and there are alarmingly high statistics for those who suffer
    from complications such as gangrene, kidney failure, heart disease and
    blindness. Of that number the Hospital estimates that it can target at
    least 2,440--2,840 with its Diabetes Education and Management Program.
        Located within an inner-city neighborhood plagued by poverty, gang
    violence and drugs, Santa Marta Hospital is a sanctuary of hope for the
    19,000 people who walk through its doors each year as well as the
    955,000 who reside in its service area. Ninety percent of Santa Marta's
    patients rely on Medicare and MediCal programs to access health care
    services. The remainder can pay only a small portion of their hospital
    expenses or rely on Santa Marta's charity care. Given the poverty of
    its patients, the hospital depends on the partnership of corporations,
    foundations and individual donors to fund the cost of new medical
    programs and necessary major capital expenditures.
        The per capita cost per diabetic admission to hospitals in
    California is $8,600. This does not include non-hospital-based dialysis
    and other medical supply costs; lost work time; or other societal
    effects. The cost of doing nothing is $4,472,000 (520 people
    $8,600), and these costs are generally supported by Medicare and
    MediCal (Medicaid) reimbursement. Santa Marta's proposed program will
    save Medicare/MediCal programs in California alone $2,400,000.
        Given the financial ability of the affected population and the high
    expense of diabetes, Santa Marta Hospital is seeking $2 million in
    fiscal year 2001 for the full implementation of this needed community
    based prevention, education and management initiative.
        Poverty, gang violence, drug dealing, alcohol abuse, rampant teen-
    age pregnancy and an exceptionally high school dropout rate are just
    some of the harsh realities impacting the seven-mile area surrounding
    Santa Marta Hospital. There are over 9,000 hardcore gang members and 58
    established gangs who shadow the community with a constant threat of
    violence. As the only Catholic Hospital in an overwhelmingly Catholic
    population, Santa Marta provides a sense of sanctuary where patients
    experience safety and care with dignity.
        Founded in 1924, Santa Marta Hospital was originally a ten-bed
    maternity hospital. Today the hospital's maternity department delivers
    over 1,500 newborns each year, and coordinates Comprehensive Perinatal
    Service Programs for the almost 1,000 poor pregnant women who walk
    through its doors annually. The hospital expanded in 1971, and grew
    into a 110-bed acute care facility offering medical services including:
    Radiology, Surgery, Labor and Delivery, Nuclear Medicine, Laboratory,
    Pharmacy, Cardiopulmonary, and Physical Therapy. In 1989, a 20,000
    square foot, 24-hour Emergency Room Intensive/Coronary Care Unit (ICU/
    CCU) transformed the hospital into a complete comprehensive medical
    facility.
        The hospital prides itself on offering several critical programs
    that impact the health of the larger community. Santa Marta is a place
    of hope and service in their community. They know that the hospital
    doors are open, and that no one is ever turned away or refused care on
    the basis of race, religion, gender, sexual orientation, age, national
    origin, disability, or ability to pay.
        Enhancing its broad range of hospital services, Santa Marta
    coordinates the structure for Pediatric, Family Care, and Obstetrical
    Clinics to assist overall outpatient health care. ``Health Fairs'' and
    ``Health Seminars for Seniors,'' reinforce the hospital's outreach to
    the medically indigent with an emphasis on preventative care.
    Additionally, the hospital coordinates a highly successful program for
    ``at-risk'' youth that has the collaboration of local area schools,
    social service agencies, juvenile authorities, and youth/adult
    employment programs. The program introduces teens to a professional
    environment where they can explore positive, future-oriented
    alternatives to the world of drugs and gang violence. Each year over
    250 at-risk residents of the community work more than 9,600 hours and
    are exposed to positive role models, while gaining the self-esteem
    resulting from helping others in need.
        In the fiscal year ending June 1999, Santa Marta Hospital treated
    over 19,000 patients and wrote off more than $11 million in fee
    reductions, and more than $2.1 million in charity care. The hospital
    also spent nearly $900,000 in community service programs. Nearly 90
    percent of Santa Marta's patients are government reimbursed cases (45
    percent Medicare and 45 percent Medi-Cal). And due to extreme hardship,
    the remainder are treated for a very low fee or at no charge.
        Santa Marta understands well that patient education is critical.
    People with diabetes can reduce their risk for complications if they
    are educated about their disease, learn and practice the skills
    necessary to better control their blood glucose levels, and receive
    regular checkups from their health care team. Santa Marta Hospital
    encourages its patients to work with them to set goals for better
    control of blood glucose levels, as close to the normal range as is
    possible for them. Health care education is vital.
        Because people with diabetes have a multi-system chronic disease,
    they are best monitored and managed by highly skilled health care
    professionals trained with the latest information on diabetes to help
    ensure early detection and appropriate treatment of the serious
    complications of the disease. Santa Marta Hospital is proposing its
    Diabetes Prevention and Management as a team approach to treating and
    monitoring this disease in an extremely at-risk population.
        Hospital statistics indicate that members of the East Los Angeles
    community are more likely than the national average to suffer, or be at
    risk of suffering from diabetes. In addition to genetic predisposition,
    many community members are obese, have poor nutrition, and do not
    practice strong preventative medicine. Consequences of untreated or
    unmanaged diabetes include blindness, amputations, kidney failure, high
    blood pressure and strained work, financial and family relations.
    Remember, there is no cure for diabetes.
        This initiative, at its core a twelve week program of diabetes
    screening, education, and management program, will be culturally and
    linguistically sensitive order to address diabetes from a prevention
    perspective, preserving the health and financial resources of our
    patients, our hospital, and governmental health care programs.
        Santa Marta estimates that the program cost to test, educate, and
    provide initial medical treatment to program participants will be
    between $1,000 and $1,500, depending upon the seriousness of pre-
    existing diabetes-related conditions. In 1997, the average cost of
    health care for people with diabetes nationally was $10,071, as opposed
    to $2,699 for individuals without the disease.
        By learning to manage their diabetes, participants of Santa Marta's
    Diabetes Education & Management Program can potentially eliminate days
    missed from work due to diabetes, costly hospitalizations, and
    permanent disability from blindness, amputation, or kidney-failure.
    Given program compliance, the cost of the educational program would be
    recouped in health care savings within three months. Using 1997 health
    care cost data, the initiative could demonstrate $200 million savings
    over a twenty-five year span.
        Thank you Mr. Chairman for the opportunity to submit this
    testimony. We look forward to working with you this year to secure $2
    million in fiscal year 2001 to implement this very needed community
    based diabetes education and management program.
                                     ______

                Prepared Statement of the University of Michigan

        Good afternoon. I am Gilbert Omenn, Executive Vice President for
    Medical Affairs of the University of Michigan and CEO of the University
    of Michigan Health System. I am an internist and a geneticist, as well
    as a former Associate Director of OSTP and of OMB.
        I am submitting this testimony on behalf of a coalition of over 20
    academic health centers across the nation to highlight several specific
    needs in the NIH budget. The recommendations which I will present have
    been endorsed in various parts by the Association of American Medical
    Colleges (AAMC) and the Federation of American Societies for
    Experimental Biology (FASEB).
        I want to thank all the Members of this Subcommittee for your
    outstanding support of the National Institutes of Health. The funding
    increases you have provided over the past several years have had--and
    will continue to have--a significant impact on our nation's biomedical
    and behavioral research enterprise. We are hopeful, even confident,
    that the NIH budget will continue on the trajectory to double by fiscal
    year 2003. The remarkable scientific advances from recent decades have
    positioned our nation to exploit very responsibly what is certain to be
    a ``golden era of biology'' for benefits in medicine, public health,
    and the broader economy and society.
        I seek your support for three specific items in the NIH budget that
    will enhance the extraordinary partnership between academic
    institutions and the federal government, representing the research
    community and the investing public:
      --Increase extramural construction funding so that academic
            investigators supported on a project basis by NIH can have a
            greater probability of access to state-of-the-art facilities to
            carry out their highly valued biomedical and behavioral
            research.
      --Adjust the salary cap to treat extramural researchers similarly to
            their colleagues in the intramural programs of NIH itself.
      --Establish a peer-reviewed, flexible grant program for shared
            resources to meet evolving and transitional research needs at
            the institutional level, aligning the efforts of the
            institutions and not just the faculty in the research agenda of
            the NIH.
        increase funding for facilities: construction, renovation, and
                                   equipment
        It is vitally important that we have the facilities and equipment
    to fully exploit research opportunities and utilize the increased
    project grant funding. Exciting developments in genomics, chemical
    biology, neurosciences, cancer, and many other fields require new kinds
    of equipment and facilities. Even the best minds cannot compensate for
    outdated equipment and facilities.
        We thank you and your Senate colleagues for including $75 million
    in competitive funds for extramural construction in the fiscal year
    2000 budget through the NIH National Center for Research Resources
    (NCRR).
        The National Science Foundation (NSF) completed a study in 1998 on
    the status of scientific research facilities at U.S. colleges and
    universities. This analysis generated an estimate of $3.6 billion in
    deferred biomedical research construction and repair or renovation
    projects. In a March 1998 report, the Association of American Medical
    College (AAMC) stated that ``The government should reestablish and fund
    an NIH construction authority, consistent with the general
    recommendations of the Wyngaarden Committee report of 1988, which
    projected at that time the need for a 10-year spending plan of $5
    billion for new facilities and renovation.'' In June 1998, the
    Federation of American Societies of Experimental Biology (FASEB)
    reported that ``Laboratories must be built and equipped for the science
    of the 21st Century. Infrastructure investments should include
    renovation of existing space as well as new construction, where
    appropriate.''
        Thus, there is a well-documented need for several billion dollars
    to rectify this situation as we ramp up the research project
    investments. Such funding must come from all possible sources, of which
    federal participation is a key element.
        We urge the Subcommittee to provide a funding level of $250 million
    for extramural construction in fiscal year 2001. The funds would be
    awarded on a peer-reviewed, competitive basis and would require
    institutional matching funds to leverage these NIH resources.
                 raise the salary cap on extramural scientists
        NIH and the academic community share a major concern about
    recruiting and retaining excellent clinician-investigators in
    biomedical and behavioral research. These physicians typically have
    considerable accumulated debt from their medical and post-graduate
    training, and they have an opportunity cost in choosing research
    careers. Medical schools increasingly expect them to earn their way
    through clinical service and by earning support for their research time
    by competing for federal grants. Both clinical practice and industrial
    research opportunities offer substantial higher incomes.
        As these faculty move up the ranks and develop successful careers,
    they or their academic departments are penalized by a salary rate cap
    imposed back in 1991. Unfortunately and, I believe, unintentionally,
    Congress omitted a salary adjustment to account for inflation. Thus,
    the maximum salary rate (on a 100 percent basis, prorated for the
    proportion of time spent in funded research) was locked at $125,000
    from 1991 through 1998. Of course, NIH pays only a portion of each
    faculty member's salary, so the rate is set at competitive levels at
    the institution and the vast majority are below the maximum.
        Meanwhile, the NIH intramural program--through the Senior
    Biomedical Research Service (SBRS)--can pay senior investigators
    salaries up to $157,000 a year. This amount is roughly equal to what
    the salary cap on academic researchers would be if it had been indexed
    for inflationary increases over the past decade.
        Congress has wisely moved, step-by-step, toward achieving
    equivalent maximal salary rates for the extramural program. Starting
    with fiscal year 1999, as you know, Congress established the principle
    of increasing the cap by linking the salaries to the Senior Executive
    Pay Scale of the Senior Biomedical Research Service, at Level III in
    fiscal year 1999 and level II ($141,300 per year) in fiscal year 2000.
    This process can be completed this year by setting the maximum for
    senior investigators at Level I.
        In sum, in order to retain the most talented academic researchers
    in biomedical and behavioral research, especially clinician-
    investigators, and in order to assure equity between intramural and
    extramural scientists, we seek your support in raising the current
    salary maximum for extramural academic researchers to Executive Level
    I, or $157,000 per year.
        establish a flexible institutional research fund to enhance the
                             efficiency of research
        Government, universities, and industry observers all have called
    for attention to various inefficiencies in the federal-academic
    partnership. The White House Office of Science and Technology Policy
    has held four hearings around the country, including the final hearing
    in New York City, at which I was a speaker, to draw attention to ways
    to strengthen the relationship between the federal government and
    universities for research.
        As you know, during the past decade, financial pressures on the
    clinical enterprise of academic medical centers have intensified,
    particularly so since the implementation of the Balanced Budget Act of
    1997, which was on a path to generate far deeper spending cuts than
    Congress intended in 1997 (partly redressed in 1999). It is
    increasingly difficult to generate institutional margins to underwrite
    research needs that are not covered well in the individual project
    grant mechanism.
        We want to enhance the impact of NIH funding by being flexible
    enough to change with the science, accommodate and align ourselves with
    new national priorities, and make the most of the NIH and institutional
    investments in individuals throughout their careers. Glitches in
    funding cycles, changes in NIH policies and priorities, needs for
    research resources, and opportunities to mobilize research in new
    directions could be addressed better with a modest fund in the hands of
    the institutional leaders, based on competitive funding. Collaborative,
    interdisciplinary research initiatives can be stimulated much more
    effectively and accountably through a modest amount of flexible
    resources at a level above the individual investigators.
        Thus, we propose that you provide funding for NIH to establish a
    ``Flexible Institutional Support for Health Research'' or ``FISHR''
    program. Program resources would provide institutional support for the
    following priorities: to fund interdisciplinary, shared research
    resources; to assist postdoctoral fellows and beginning investigators
    to establish independent research projects; and to rapidly infuse
    short-term resources into investigations which offer tremendous promise
    for research progress.
        We recommend that the NIH establish such a peer-reviewed, three-
    year grant program through the National Center for Research Resources.
    Grants could be in the range of $25,000 to $300,000 per year for Deans
    of medical, public health, nursing, dental, and pharmacy schools which
    qualify through having NIH project awards. Applications would provide
    general plans for needs anticipated to evolve. Awards would permit
    flexibility within the institution to determine spending priorities,
    within the categories approved (as proposed above). To assure
    accountability, we suggest two mechanisms: (1) a local internal review
    committee, comprised of NIH-supported investigators at the institution,
    to review specific proposed allocations, on a prospective basis; and
    (2) a retrospective review by NIH research program staff prior to
    approving eligibility to submit a competitive renewal application at
    the end of the grant award period.
        We urge you to include $60 million in the fiscal year 2001
    appropriation for NIH to initiate this Flexible Institutional Support
    for Health Research (FISHR) Program. Such annual funding would
    favorably modify the impact of the recent stresses experienced by
    research and academic institutions which threaten the efficiency of our
    national research enterprise.
                               concluding remarks
        Mr. Chairman, the extramural research community applauds the
    bipartisan actions and commitments to increase funding for biomedical
    and behavioral research through the NIH. Based on polls conducted by
    Research!America, including polls in my state of Michigan, we know that
    the American public strongly supports these investments and has high
    expectations for payoff in new knowledge and medical and public health
    innovations. We also applaud the investments in related federal
    agencies, such as the Centers for Disease Control and Prevention, the
    Agency for Healthcare Research and Quality, and the National Science
    Foundation.
        We are confident that the Congress and the NIH can enhance the
    impact of the project-based investments by taking the three additional
    steps we recommend: provide $250 million in fiscal year 2001 to upgrade
    extramural laboratory space and instrumentation; increase the maximal
    salary rate on NIH grants to Executive Level I so that extramural
    salaries can match the maximum for intramural scientists; and initiate
    a Program for Flexible Institutional Support for Health Research
    (FISHR). Each of these steps will increase the productivity and
    efficiency of the academic/government partnership in biomedical and
    behavioral research and research training.
        On behalf of academic health centers across the nation, I thank you
    for your attention to these needs and recommendations. Best wishes to
    each of you and to your families and staff members.
                                     ______

            Prepared Statement of the American Physiological Society

        The American Physiological Society is pleased to have this
    opportunity to submit its views on fiscal year 2001 funding for the
    National Institutes of Health. The APS appreciates this Subcommittee's
    strong support for biomedical research, its dedicated efforts for many
    years, and in particular, the extraordinary efforts that yielded 15
    percent funding increases over the past two years, placing the NIH on
    the path to a five-year doubling of its budget.
        The American Physiological Society (APS) is a nonprofit scientific
    society that seeks to integrate life sciences research and education
    from the molecule to the whole organism. The APS was founded in 1887
    and currently has more than 9,000 members. Our members conduct research
    and educate the next generation of physicians and scientists at
    colleges, universities, and medical schools throughout the U.S. Many of
    our members are also engaged in research activities in industry and
    government.
        The APS is grateful for the $17.8 billion that Congress has
    provided for the NIH for fiscal year 2000. This is a time of abundant
    scientific opportunity. One emerging area of particular interest to the
    APS is the new field of physiological genomics. Thanks to the
    revolution in information technology, scientists have been able to
    accomplish large-scale genome sequencing, and some are already working
    on the analysis of these huge collections of data. With our growing
    ability to analyze this data and zero in on key genes, we find
    ourselves poised before a promising and challenging new era. As the
    editors of the new on-line and print journal Physiological Genomics
    observed in an editorial published on-line July 15, 1999, ``[T]he
    enormous task of linking genes to function has now begun.'' The editors
    go on to explain that our current state of knowledge now permits us to
    trace biological processes from the first actions of genes within the
    nucleus of cells through cellular processes, the influence of specific
    genes upon the functions of tissues and organs and, ultimately, their
    impact on the workings of the whole organism. Conducting such studies
    on individual genes and gene combinations responsible for particular
    diseases will permit us to identify how the internal environment
    defined by our genetic makeup interacts with external influences to
    keep us healthy or make us sick. The promise of physiological genomics
    is that this knowledge will point the way to new therapies, diagnostic
    tools, and better overall health management.
        The APS offers this as an example of how NIH-funded research is
    leading us toward a treasure trove of medically useful knowledge. The
    APS joins with the Federation of American Societies for Experimental
    Biology and the Ad Hoc Group for Medical Research Funding in urging
    Congress to provide a $2.7 billion or 15 percent increase in fiscal
    year 2001 as the third step toward doubling the NIH budget by fiscal
    year 2003.
                                     ______

              Prepared Statement of the American Chemical Society

        The American Chemical Society (ACS) would like to thank Chairman
    Arlen Specter and Senator Tom Harkin for the opportunity to submit
    testimony for the record on the Departments of Labor, Health and Human
    Services, and Education Appropriations bill for fiscal year 2001.
        As you may know, ACS is a non-profit scientific and educational
    organization, chartered by Congress, representing 161,000 individual
    chemical scientists and engineers. The world's largest scientific
    society, ACS advances the chemical enterprise, increases public
    understanding of chemistry, and brings its expertise to bear on state
    and national matters. ACS firmly believes that no investment the
    government makes generates a higher rate of return for the economy than
    research and development (R&D). In fact, economic experts maintain that
    today's unprecedented economic growth would not have been realized but
    for the substantial research investments by the public and private
    sectors over the past few decades. Looking ahead, the American Chemical
    Society (ACS) is concerned that constant dollar declines in federal
    support for basic research over the past decade, particularly in the
    physical sciences, have weakened the roots of innovation in all fields
    and put future economic growth at risk. In order to sustain our
    technological leadership and living standards, increased funding for
    basic research should be a top priority for use of the non-Social
    Security budget surpluses. As a framework for increasing R&D funding,
    ACS supports doubling federal spending on research within a decade, as
    well as balanced funding among different areas of science.
              national institute of health budget recommendations
        ACS commends Congress and the administration for the 15-percent
    increase last year for the National Institutes of Health (NIH) and we
    support a comparable increase for fiscal year 2001. As the major
    supporter of biomedical research in the United States, NIH is the
    primary source of new biomedical discoveries that are leading to
    longer, healthier lives as well as reduced health-care costs due to
    prevention, early detection, and more cost-effective treatment of
    disease. An example of the enormous return on this investment is the
    recent decline in both the incidence of cancer and the mortality rate
    from it. In addition, NIH-supported research provides training for new
    scientists, stimulates technological advances in the pharmaceutical and
    biotechnology industries--both of which contribute positively to the
    balance of trade--and makes the United States a world leader in
    biomedical research.
                 national institute of general medical sciences
        As the largest source of federal funding for basic research, NIH
    should leverage its investments in biomedical research by maintaining
    strong support for all areas of basic research critical for sustained
    advances in public health and quality of life. Strong support for
    chemistry and the other physical sciences that underlie or complement
    biomedical research must be maintained if cutting-edge biomedical
    discoveries are to continue. For this reason, ACS believes it is
    essential that the National Institute of General Medical Sciences
    (NIGMS) receive increases proportional to the other NIH institutes.
    NIGMS supports quality, non-disease specific basic research and
    training that underpins advances in other institutes. NIGMS plays a
    central role in generating basic knowledge across science disciplines,
    strengthening the roots of innovation in the biomedical community, and
    fostering tomorrow's breakthrough discoveries.
                     national center for research resources
        The National Center for Research Resources (NCRR) supports the
    state-of-the-art research infrastructure necessary to provide high-
    quality biomedical and behavioral research, including the expansion,
    remodeling, and construction of extramural research facilities. The
    Center facilitates the development of new technologies and techniques
    by which scientific inquiry can be undertaken. In addition, NCRR
    provides grants such as the Shared Instrumentation Grants program,
    which provides a cost-effective mechanism for groups of NIH-supported
    investigators to obtain commercially available, technologically
    sophisticated equipment costing more than $100,000. Through these
    contributions, NCRR offers the potential for revolutionary approaches
    to health-related research.
        Strong and steady support for cutting-edge researchers that
    advances human health is absolutely essential to ensuring the large
    return investment made on NIH research over the past decade. Sustained
    growth in funding for NIH is needed to build upon past scientific
    achievements, address present medical needs, and anticipate future
    health challenges. Volatility and significant fluctuations in funding
    can be as harmful to the research enterprise as inadequate growth.
                                     ______

         Prepared Statement of the National Multiple Sclerosis Society

        Mr. Chairman and distinguished members of the subcommittee, we
    appreciate the opportunity to submit written testimony on behalf of the
    National Multiple Sclerosis Society. The Society is the world's largest
    private voluntary health agency devoted to the concerns of all those
    affected by MS. Throughout the Society's 53-year history, our number
    one priority has been research to understand MS and apply this
    knowledge to the development of new treatments and a cure.
    Cumulatively, the Society has expended over $260 million in research
    funds in the United States and abroad. Our current annual budget for
    research exceeds $20 million. This represents the largest privately
    funded program of basic, clinical, and applied research and training
    related to multiple sclerosis in the world.
                               multiple sclerosis
        MS is an often progressive, degenerative disease of the central
    nervous system, unpredictable in its course, and devastating in its
    effects. It can cause spasticity, tremor, abnormal fatigue, bladder and
    bowel dysfunction, visual problems and mobility impairment. The disease
    usually is diagnosed between the ages of 20 and 40--but is life long.
    Many people with MS live thirty years or more with constant
    unpredictability and increasing disability. MS affects more than twice
    as many women as men, can result in loss of employment and loss of a
    place in society and the community. Recent studies sponsored by the MS
    Society show that the annual cost to each affected individual as a
    result of MS averages $34,000, and the total cost can exceed $2 million
    over an individual's lifetime. For all people with MS in the United
    States--some third of a million individuals--the annual cost is nearly
    $9 billion. Ending the devastating medical, personal and financial
    effects of this unpredictable disease is completely dependent upon the
    discovery of safe and effective treatments that halt progression of the
    disease and reverse its symptoms.
                          recommendations for funding
        NIH plays the major role in maintaining our country's preeminence
    in biotechnology and provides worldwide leadership in health research
    and discovery. The National MS Society recognizes that new discoveries
    and breakthroughs could come from any area of biomedical research and
    could apply to the primary concern of our members: finding new
    treatments and eventually a cure for MS. Therefore we encourage
    Congress to focus on NIH as a whole and on agencies of particular
    relevance to our concern, knowing that a well-funded federal research
    enterprise will benefit all of us.
        The National Multiple Sclerosis Society believes that in order to
    take advantage of current opportunities in biomedical and
    rehabilitation research, Congress must continue the trend of the last
    two budget cycles. A further 15 percent increase in NIH funding for
    fiscal year 2001 would bring us closer to doubling the NIH budget over
    the five-year period 1999-2003. In order to pursue cutting edge
    research, the Society recommends that this translate into a parallel 15
    percent increase for the National Institute of Neurological Disorders
    and Stroke, the National Institute of Allergy and Infectious Diseases
    and the National Center for Medical and Rehabilitative Research, the
    primary institutes that conduct nearly all of the MS-related research
    undertaken by the Federal Government.
                              neuroscience center
        The NIH budget proposal for fiscal year 2001 includes $73 million
    over two years for construction of a new National Neuroscience Center
    at NIH. The Center will bring together in one facility, with necessary
    new lab space, both basic and clinical intramural scientists from the
    many institutes involved in neuroscience in order to encourage their
    interaction and the translation of basic research findings. The Center
    will emphasize important cross cutting themes such as
    neurodegeneration, regeneration and repair of neurons, neurogenetics
    and pain research. Federal funding for the Center would increase the
    pace of discovery in all areas of neuroscience and help translate
    laboratory discoveries into new and effective treatments for patients.
    The proposed funding is included in NIH's Building and Facilities
    budget, and it is our understanding that it will not affect funding for
    research. The National MS Society recommends fully funding the proposed
    National Neuroscience Center at NIH.
                       strategic analysis of ms research
        The National MS Society has commissioned the National Academy of
    Sciences/Institute of Medicine (NAS/IOM) to undertake a strategic
    analysis of basic and clinical research for multiple sclerosis. The
    NAS/IOM will review current knowledge about the cause and treatment of
    MS and recommend a strategic plan to guide future investment. The study
    will be broadly based, assessing current and future contributions from
    private and governmental organizations, both in the U.S. and aboard. An
    important goal of the study will be to identify areas of research that
    may not have been exploited in the past and to identify new fields of
    research. At the completion of the study, we anticipate a set of
    recommendations for future strategies that can be considered not only
    by the NMSS, but also other MS societies around the globe, governmental
    funding agencies, and by pharmaceutical and biotech companies involved
    in MS programs. The analysis was initiated in May 1999, and should be
    completed early in 2001. We look forward to the opportunity to report
    the results to the Subcommittee in our testimony next year.
                                    summary
        The National MS Society recognizes that new discoveries and
    breakthrough findings could come from almost any area of biomedical
    research and could apply to the primary concern of our members: finding
    a cure for MS. We thus encourage Congress to focus on NIH as a whole,
    and on agencies of particular relevance to our concern, knowing that a
    well-funded federal research enterprise will benefit all of us.
    Continuing the 15 percent annual increase in funding through 2003 is an
    extraordinarily good use of federal resources, and we encourage you to
    do whatever you can to make this a reality. In addition, in order to
    take advantage of potential discoveries in all areas of neuroscience
    and help translate these discoveries into new and effective treatments
    for patients, we recommend fully funding the proposed National
    Neuroscience Center at NIH.
                                     ______

              Prepared Statement of New York-Presbyterian Hospital

        I am Dr. Herb Pardes, President and CEO of New York-Presbyterian
    Hospital. For the last several years, I was Dean of the College of
    Physicians and Surgeons of Columbia University in New York. I submit
    this testimony on behalf of academic health centers across the nation
    that play a vital role in advancing the frontiers of medicine by
    conducting extramural NIH biomedical and behavioral research.
        We in the academic health community urge you to improve this
    academic/federal partnership by recognizing the following three
    concerns which limit the extramural biomedical and behavioral research
    community from operating at optimal capacity and efficiency:
      --the need for state-of-the-art facilities to carry out the
            increasing volume of federally-supported biomedical and
            behavioral research;
      --the need for competitive salaries for extramural researchers; and
      --the need for a peer-reviewed, flexible grant program for shared
            resources to meet evolving and transitional research needs at
            the institutional level.
      increase funding for facilities-construction, renovation, equipment
        Exciting developments in genomics, chemical biology, neurosciences,
    cancer, and many other fields require new kinds of equipment and
    facilities. Even the best minds cannot compensate for outdated
    equipment and facilities. It is vitally important that we have the
    facilities and equipment to fully exploit research opportunities and
    utilize the increased project grant funding.
        The National Science Foundation (NSF) completed a study in 1998 on
    the status of scientific research facilities at U.S. colleges and
    universities. This analysis generated an estimate of $3.6 billion in
    deferred biomedical research construction and repair or renovation
    projects. In a March 1998 report, the Association of American Medical
    College (AAMC) stated that ``The government should reestablish and fund
    an NIH construction authority, consistent with the general
    recommendations of the Wyngaarden Committee report of 1988, which
    projected at that time the need for a 10-year spending plan of $5
    billion for new facilities and renovation.'' In June 1998, the
    Federation of American Societies of Experimental Biology (FASEB)
    reported that ``Laboratories must be built and equipped for the science
    of the 21st Century. Infrastructure investments should include
    renovation of existing space as well as new construction, where
    appropriate.''
        My colleagues and I urge you to provide the NIH with $250 million
    for extramural facilities construction in the fiscal year 2001 Labor/
    HHS/Education funding bill. The funds would be awarded on a competitive
    basis, requiring institutional matching to leverage the NIH resources.
                 raise the salary cap on extramural scientists
        Another case of cost-shifting by the Federal Government is the cap
    on salaries for academic researchers. Since the cap was first imposed
    in the early 1990s, at roughly $125,000 a year, the Consumer Price
    Index has risen more than 20 percent. The result is two-fold. Academic
    medical centers and universities have been increasingly forced to bear
    more of the costs of investigators' salaries; and many promising
    researchers have been driven out of academic research altogether, drawn
    by more lucrative posts in the private sector.
        Physician investigators are critical to translating the substantial
    fundamental scientific advances to patients. Additional years of
    postgraduate training, after physicians receive their MD degree, are
    required for board eligibility, independent of research training and
    career development. Newly trained MDs are incurring insurmountable
    debts as a result. In 1997, nearly half of all medical school graduates
    held debts greater than $75,000. Mounting debts combined with the
    salary cap serve as disincentives for the youngest and brightest
    physicians from pursuing careers in academic research. The results are
    dramatic and disturbing: Between 1994 and 1997, the number of MDs
    submitting new grant applications to the National Institutes of Health
    dropped by more than 32 percent.
        At the same time, the National Institutes of Health has created new
    mechanisms such as the Senior Biomedical Research Service (SBRS) to
    keep its most talented intramural scientists on the NIH campus. Under
    the SBRS, the NIH can pay its senior investigators up to $157,000,
    (Executive Level I) roughly equal to what the salary cap on academic
    researchers would be if it were indexed for inflationary increases over
    the past decade.
        In fiscal year 1999, Congress tied the extramural salary cap to
    Level III of the Executive Pay Scale, which--at that time--was
    $125,900. Thus, the increase was not significantly above the previous
    cap of $125,000. In fiscal year 2000, Congress raised the salary cap
    from Executive Level III to Executive Level II (now $141,300). While
    this takes into account increases in the cost-of-living over the past
    decade, the extramural salary cap is still not on par with intramural
    NIH scientists who can receive a maximum salary of Executive Level I.
        I urge you to raise the current cap on academic researchers should
    to Executive Level I ($157,000/year) to match the cap currently imposed
    by the NIH on its own senior scientists under the Senior Biomedical
    Research Service.
        establish a flexible institutional research fund to enhance the
                             efficiency of research
        A third concern to our nation's academic medical institutions is
    inefficiency in the federal-academic partnership. As you know, during
    the past decade, financial pressures on the clinical enterprise of
    academic medical centers have intensified, particularly so since the
    implementation of the Balanced Budget Act of 1997 during the past year.
    It is increasingly difficult to generate institutional margins to
    underwrite research needs that are not covered well in the project
    grant mechanism.
        These funds would be used to enhance the impact of NIH funding by
    being flexible enough to change with the science, accommodate changing
    national priorities and make the most of the NIH and institutional
    investments in individuals throughout their careers. Glitches in
    funding cycles, changes in NIH policies and priorities, needs for
    research resources, and opportunities to mobilize research in new
    directions could be addressed better with a modest fund in the hands of
    the institutional leaders, based on competitive funding. Collaborative,
    interdisciplinary research initiatives can be stimulated through
    resources at a level above the individual investigators.
        Thus, I urge you to provide funding for NIH to establish a
    ``Flexible Institutional Support for Health Research'' or ``FISHR''
    program. Program resources would provide institutional support for the
    following priorities: to fund interdisciplinary, shared research
    resources; to assist postdoctoral fellows and beginning investigators
    to establish independent research projects; and to rapidly infuse
    short-term resources into investigations which offer tremendous promise
    for research progress.
        Academic health centers recommend that the NIH establish such a
    peer-reviewed, three-year grant program through the National Center for
    Research Resources. Grants could be in the range of $25,000 to $300,000
    per year for Deans of medical, public health, nursing, dental, and
    pharmacy schools which qualify through having NIH project awards.
    Applications would provide general plans for needs anticipated to
    evolve. Awards would permit flexibility within the institution to
    determine spending priorities, within the categories approved (as
    proposed above). To assure accountability, I would suggest two
    mechanisms: a local internal review committee, comprised of NIH-
    supported investigators at the institution, to review specific proposed
    allocations, on a prospective basis; then a retrospective review by NIH
    research program staff prior to approving eligibility to submit a
    competitive renewal application at the end of the grant award period.
        I urge you to include $60 million in the fiscal year 2001 NIH
    funding bill to initiate this Flexible Institutional Support for Health
    Research (FISHR) Program. Such annual funding would favorably modify
    the impact of the recent stresses experienced by research and academic
    institutions which threaten the efficiency of our national research
    enterprise.
                               concluding remarks
        The Congress and the NIH can enhance the impact of the project-
    based investments by taking three additional steps: increase to $250
    million the funding to upgrade extramural laboratory space and
    instrumentation; increase the maximal salary rate on NIH grants to
    match the maximum for intramural scientists; and initiate a Program for
    Flexible Institutional Support for Health Research (FISHR). Each of
    these steps will increase the productivity and efficiency of the
    academic/government partnership in biomedical and behavioral research
    and research training.
        On behalf of academic health centers across the nation, I thank you
    for your attention to these needs and recommendations. Best wishes to
    each of you.
                                     ______

       Prepared Statement of the American Society of Mechanical Engineers

        The Bioengineering Division of the Basic Engineering Group of the
    Council on Engineering, American Society of Mechanical Engineers (ASME
    International), is pleased to provide comments on the bioengineering-
    related programs in the NIH fiscal year 2001 budget request. The ASME
    Bioengineering Division is focused on the application of mechanical
    engineering knowledge, skills and principles from conception to the
    design, development, analysis and operation of biomechanical systems.
                        the importance of bioengineering
        Bioengineering is an interdisciplinary field that applies physical,
    chemical and mathematical sciences and engineering principles to the
    study of biology, medicine, behavior, and health. It advances knowledge
    from the molecular to the organ systems level, and develops new and
    novel biologics, materials processes, implants, devices, and
    informatics approaches for the prevention, diagnosis, and treatment of
    disease, for patient rehabilitation, and for improving health. From the
    perspective of mechanical engineering, bioengineering provided for the
    development of the artificial heart, prosthetic joints and numerous
    rehabilitation technologies, as just several examples.
              the need for increased investment in bioengineering
        The Bioengineering Division recommends that support for
    Bioengineering Research as a percentage of the total NIH research
    project grants (RPGs) budget be increased to meet the future explosion
    in Biomedical Engineering Research. In addition, it recommends that a
    separate, independently funded institute be established to provide
    adequate support for basic Bioengineering Research.
                                   background
        NIH is the world's largest and most eminent organization dedicated
    to improving health through medical science. During last 50 years, the
    NIH has played a preeminent role in the major breakthroughs that have
    increased average life expectancy by 15 to 20 years.
        The NIH is comprised of different Institutes and Centers that
    support a wide spectrum of research activities including basic
    research, disease and treatments related studies, and epidemiological
    analyses. The missions of individual Institutes and Centers may focus
    on a particular organ (e.g. heart, kidney, eye), on a given disease
    (e.g. cancer, infectious diseases, mental illness), or on a stage of
    development (e.g. childhood, old age), or, may encompass crosscutting
    needs (e.g. sequencing of the human genome).
        Investigator-initiated RPGs continue to be one of the NIH's highest
    funding priorities. In fiscal year 2001, RPGs represent 56.9 percent of
    the total NIH budget, and provides $10.3 B, a 6.1 percent increase over
    fiscal year 2000, to fund an estimated 31,524 research project grants.
    This represents an addition of 237 grants over the fiscal year 2000
    total. Total grants include non-competing grants and competing new
    grants. NIH estimates it will support 7,641 competing new RPGs in
    fiscal year 2001. This number is 1,309 below estimated fiscal year 2000
    levels.
               current investment in bioengineering is inadequate
        In fiscal year 1999, Bioengineering Research Support was at $0.645
    B or 7.6 percent of the total NIH RPGs budget. In fiscal year 2000,
    Bioengineering Research Support is estimated at $0.661 B or 6.8 percent
    of the total NIH RPGs budget. While the Bioengineering Division
    acknowledges that there is a small increase in the budgeted support for
    Biomedical Research, it also notes there is an actual decrease in the
    percentage of funding, a trend which could indicate a decrease in
    emphasis on Bioengineering within NIH.
        The focus of bioengineering issues at the NIH is the Bioengineering
    Consortium (BECON), which consists of intramural and extramural senior-
    level representatives from each of the NIH institutes, centers, and
    divisions plus representatives of other federal agencies with funding
    authority for bioengineering research. BECON itself does not have
    funding authority.
        Because BECON is not independently funded, the individual
    Institutes and Centers under the NIH umbrella must use their annual
    appropriations to support bioengineering research, a practice that may
    contribute to the under-funding of bioengineering research. For
    example, the National Institute of Dental and Craniofacial Research's
    (NIDCR) share of the total RPG NIH budget, excluding AIDS, is
    approximately 1.38 percent for fiscal year 2000. Yet, it is anticipated
    that NIDCR will allocate 41.28 percent of that budget, or $55.4
    million, to bioengineering research, an amount representing 8.38
    percent of the total RPG NIH budget for fiscal year 2000. ASME's
    Bioengineering Division believes that this is indicative of the under-
    investment being made in Bioengineering Research.
                                    concerns
        While ASME's Bioengineering Division supports NIH and the
    priorities identified in the fiscal year 2001 Budget Request, it is
    concerned about two issues: the reduction in the number of new
    projects; and, the lack of a direct support mechanism for
    bioengineering research.
        Reduction in the Number of New Projects.--NIH estimates it will
    support a total of 7,641 new and competing RPGs in fiscal year 2001.
    This number is 1,309 below estimated fiscal year 2000 levels, a
    reduction of 14.6 percent. This reduction appears to be inconsistent
    with the theme of recruiting and training new clinical investigators,
    especially in Bioengineering where the number of researchers is
    increasing rapidly in Bioengineering academic departments at
    universities across the nation. As an example, the number of applicants
    for CAREER Awards in Biomedical Engineering at the National Science
    Foundation increased from 38 in fiscal year 1999 to 55 in fiscal year
    2000, an increase of 45 percent. ASME's Bioengineering Division
    believes this is an early indication of the coming explosion in
    Biomedical Engineering Research.
        Lack of a Direct Support Mechanism for Bioengineering Research.--
    Funding for Bioengineering research remains a small portion of the
    total NIH research budget. BECON does not include resources for the
    collaborative support of extramural research. At this time, an
    intramural bioengineering research program does not exist for broad-
    based, multidisciplinary research. This situation places a burden on
    individual NIH Institutes, and appears to be inconsistent with the
    vision of the role of Biomedical Engineering in increasing biological
    knowledge, facilitating the development of novel devices and drugs, and
    providing the technological means to improve health care.
                                recommendations
        To address the concerns listed above, the ASME Bioengineering
    Division recommends that:
      --support for Bioengineering Research as a percentage of the total
            NIH RPGs budget be increased to meet the future explosion in
            Biomedical Engineering Research; and,
      --a separate bioengineering research institute be established to:
        provide an administrative structure to assist in the coordination,
                communication, and promotion of bioengineering research
                supported by the many institutes within NIH to increase the
                opportunities for new collaborations, dissemination of new
                technologies or research findings and the availability of
                funding opportunities, special seminars, conferences, and
                related activities;
        have the authority and funding to provide extramural grants
                specifically targeted to support activities that do not
                fall within the disease-related institutes of NIH (e.g.,
                proposals for the development or evaluation of generic
                technologies that cross many health disciplines; training
                grants for pre-doctoral and post-doctoral trainees in
                bioengineering; and, funding for specialized extramural
                centers which would enable universities to develop core
                support structures for enhancing the training, research
                endeavors and development of technology in all fields of
                bioengineering); and,
        support the development of a modest intramural program in
                Biomedical Engineering to focus primarily on new
                technologies that could evolve to become core resources for
                both intramural and extramural investigators.
      --as an interim measure prior to the establishment of a separate
            Bioengineering Institute, the NIH create an Office of
            Bioengineering Research modeled after the Office for Research
            on Minority Health (ORMH) to:
        serve as the coordination center within the Office of the Director
                for Bioengineering Research issues; and,
        have the legislative authority to award grants for priority
                bioengineering research that other Institutes or Centers
                are unable to fund.
                                   conclusion
        The ASME Bioengineering Division endorses the National Institutes
    of Health's fiscal year 2001 budget request for bioengineering. Triumph
    over disease and disability, and speeding the rate at which fundamental
    discoveries are translated into effective therapies, are essential for
    the vitality of this nation.
        The Division is concerned about details of the budget request. To
    address these concerns, the ASME Bioengineering Division recommends
    that:
      --support for Bioengineering Research Support as a percentage of the
            total NIH RPGs budget be increased to meet the future explosion
            in Biomedical Engineering Research;
      --a direct support mechanism for bioengineering research be
            established to provide adequate support for basic
            bioengineering research, a centralized focus for extramural
            bioengineering research at NIH, a strong intramural
            bioengineering program at NIH, and increased coordination of
            bioengineering research within the highest levels of NIH and
            among other federal agencies; and,
      --as an interim measure, the NIH establish an Office of
            Bioengineering Research based on the ORMH model.
        ASME International's Bioengineering Division appreciates the
    opportunity to present its views to the Subcommittee on Labor, Health
    and Human Services and Education.
                                     ______

        Prepared Statement of the National Coalition for Cancer Research

        On behalf of the 26 organizations which comprise the NCCR and
    consist of 80,000 cancer researchers, nurses, physicians, and health
    care workers; tens of thousands of cancer survivors and their families;
    40,000 children with cancer and their families; 90 cancer hospitals and
    cancer centers across the country; and more than 2 million volunteers.
    It is on their behalf that I submit this testimony in support of the
    National Institutes of Health (NIH), the National Cancer Institute
    (NCI), and the Centers for Disease Control and Prevention.
        Indeed, the harvest of the past investment of the American people
    and Congress in supporting biomedical research is now being realized as
    we are bringing on line powerful new tools that are delivering more
    precise and rapid information that is already enhancing our
    understanding and control of cancer. As just one example, I will focus
    here on diet and the prevention of cancer to illustrate one facet of
    this exciting advancement.
        We have all known that eating more fresh vegetables and fruits are
    good for us. For example, eating broccoli appears to be beneficial in
    lowering the risk of cancer. A few years ago, a group at Johns Hopkins
    isolated and identified the active sulfur compound from broccoli called
    sulforaphane that when administered to animals prevented cancer from
    developing when they were subjected to carcinogens. Most recently, Dr.
    James Brooks and Dr. Pat Brown at Stanford University have illuminated
    the mechanisms through which this compound might prevent cancer. When
    cells were administered this sulforaphane, they turn on a battery of
    genes that increase the cell's defense system that protects DNA from
    damage. Conversely, sulforaphane turns off a set of enzymes that tend
    to activate the carcinogens to a more DNA damaging form. This double
    barrel effect of sulforaphane of both enhancing the ``good guys,''
    while eliminating the ``bad guys'' in the carcinogenic mechanisms, is
    at the heart of how sulforaphane might protect us from cancer.
        This new DNA chip assay allows us to test many other similar
    compounds and select the ones that would be most beneficial. This study
    was made possible by another application of this new DNA chip
    technology of which Dr. Klausner spoke to you in his testimony on
    February 15. He reported how this technology was used to accurately
    identify two different forms of what appeared to be similar cancers
    that had responded differently to the same therapy. Therefore, the DNA
    chips are not only being used to identify specific types of cancers and
    how they might respond to different drugs, but are also being used to
    study how factors in our diet might lower the risk of cancer.
        For a long time, we have known that people living in China and
    Japan have one-tenth the rate of breast and prostate cancer in
    comparison to the United States. However, when the people from Asia
    migrate to this country, their breast and prostate cancer rates
    increase dramatically toward that which we experience here within the
    United States population. What is it in the diets and environments that
    brings this dramatic change about? Is the increased rate due to a loss
    of a protective factor or the addition of a detrimental factor such as
    a carcinogen? We have always suspected that there are many things in
    our diet that might alter our cancer risks, and through the use of
    these new molecular techniques, it will be possible to hunt these
    agents out in a more systematic and rapid form. This means that much of
    the initial testing can take place in cell systems using these DNA
    chips and then extending the information to a more definitive study in
    animals and then in clinical trials in humans. More is coming from the
    new DNA technology, and this is only the first steps in a major
    revolution in how we study cancer that resulted from your previous
    investments, and it is now applicable to many diseases.
        Another exciting area of research is on human pluripotent stem
    cells. A new, emerging theory is that cancer is a stem cell disease.
    The potential applications for stem cell research could have an
    incredible impact on improving cancer treatment and prevention. The
    research in this area is just emerging, and it would be a tragedy to
    restrict. The NCCR urges Congress to permit the National Institutes of
    Health (NIH) to fund and provide oversight for research on human
    pluripotent stem cells and strongly opposes any attempts to ban this
    very promising area of research. The NIH guidelines, which the NCCR
    supports, create a federal regulatory framework for appropriate
    applications and derivations of stem cells, require that stem cell
    research is accountable to federal oversight and federal reporting
    mechanisms, and ensure that stem cell research is pursued in an ethical
    and responsible manner under public scrutiny.
        There are dozens of other discoveries and exciting possibilities as
    delineated in the NCI Bypass Budget Report and elsewhere that need to
    be funded. We know that the control of cancer will only come through
    research. The bad news is that we are not taking advantage of these
    opportunities in an appropriate manner. The question that always comes
    up is, ``Are we paying for bad research.'' It is important to realize
    that when President Richard Nixon declared ``war on cancer'' we were
    funding at 40 percent of the approved grants, and today we have dropped
    down to 32 percent of the approved grants. There is little doubt that
    if we now extended this up to 50 percent of the approved grants that we
    would have a much better chance of finding discoveries at a more rapid
    rate. No one knows where the next major discovery will come from, and
    history has shown that many of the experts have often guessed wrong on
    this matter. It would seem apparent that funding more approved projects
    would increase the chances.
        This increase in funding is not a waste in comparison to the cost
    to the nation--over $107 million and half a million lives annually--and
    the need to stop the devastation and carnage of cancer as quickly as
    possible. I think we need to bet on more horses in the research race.
    We all might be surprised at which research will win, but one will win
    as it did for Lance Armstrong in his fight against cancer so he could
    finally reenter and win the grueling Tour De France bicycle race. I am
    confident that increasing our bets to funding the top 50 percent of the
    approved grants will prove to be a good bet for the American people. To
    do this, we would have to extend the budget to $4.1 billion for the
    National Cancer Institute, the level recommended in the fiscal year
    2001 Bypass Budget.
        More funding for young physician scientists is also of critical
    importance, because the goose that lays the golden eggs is now dying of
    malnutrition. The work to which I just referred, on diet studies, of
    Dr. James Brooks at Stanford as well as other important discoveries in
    this area by Dr. William G. Nelson at Johns Hopkins are the results of
    a young surgeon and a young medical oncologist having the opportunity
    to carry out laboratory based research on cancer while still practicing
    as leading physicians. They are some of the most valuable warriors in
    our fight against cancer. Unfortunately, there has been a dramatic drop
    in the number of these young physicians entering research, and this is
    witnessed by the M.D. postdoctoral training funded by the National
    Institutes of Health (51 percent decrease in six years) and in those
    trainees funded by the Howard Hughes Medical Institute (57 percent
    decrease in two years). These numbers are documented in a study
    appearing in Science (Vol. 283, Page 131, 1999) by Dr. Leon Rosenberg.
        These young physician scientist are under intense pressure as funds
    have moved away from our non-profit medical institutions and over to
    become the profits of the insurance companies. The insurance companies
    do not invest in the training of these young scientists and neither do
    they fund their research. At prior times, the non-profit medical
    schools used funds that they received for medical care to support these
    young physician scientist. All that has happened is that the funds have
    now shifted from one pocket to the other, and the support for the
    development of physician research has evaporated. The insurance
    companies may be the only major industry that does not return any
    appreciable percent of their profits to support research and
    development and to protect their customer, the patient, in the future.
        This shift in research funding is a tragedy that is choking the
    goose that lays the golden egg of research discovery for our people. It
    is urgent for Congress to act to support the National Cancer Institute
    and the NIH in these dire times and to help stop this hemorrhaging of
    our major medical training centers that is choking our young physician
    scientist who are forced away from the laboratories and research to
    desperately try to fill beds to compete for the decreasing care dollar
    distributed from the insurance companies.
        Insurance companies are also slowing the pace of research by
    denying payment for and, therefore, patient access to clinical trials.
    Investigational therapy administered under the aegis of a fully
    approved clinical trial is often the best therapy available to many
    patients. It is important that patients not be denied access to
    clinical trials. The knowledge gained through these studies is
    absolutely essential to achieve progress in cancer care. Both patients
    and research suffer when health insurers will not reimburse for routine
    patient care costs in clinical trials. This is compromising our
    capacity to translate research from the laboratory bench to the
    bedside. The NCCR supports legislative efforts to ensure third-party
    payer's coverage of patient-care costs in clinical trials.
        In my 40 years in research at Johns Hopkins, I have never seen such
    a dramatic change as that which has occurred in the past few years, and
    it certainly is not for the good of the patient nor for the future
    generations. America deserves better. I know these are difficult and
    sensitive issues, but I hope you can help lead us into an exciting
    future. Increasing NIH and NCI support would certainly make a
    tremendous difference, and it is most needed.
        I am also here to assure you that cancer researchers are committed
    to upholding the integrity of the clinical trial process, so that
    patient safety and confidentiality are of the utmost importance. There
    are inherent risks to being a cancer patient, as there are to receiving
    anesthesia or any drugs. The critical points are to ensure patient
    safety through close patient evaluation and informed decision-making,
    which are hallmarks of clinical research. Informed decision-making is
    enabled by explaining all potential risks and benefits to patients.
    This process is an essential component to clinical trials, so that
    patients are fully aware of complications that could occur and can
    weigh the risks and benefits in order to determine whether or not to
    participate.
        An oversight structure, comprised of federal guidelines and
    oversight as well as local oversight through institutional review
    boards (IRBs) and data safety monitoring boards (DSMBs), closely tracks
    research protocol activities to safeguard patient care in research.
    Further, investigators and protocol nurses carefully monitor the
    progress and safety of patients participating in clinical trials. In
    conclusion, clinical trials provide excellent care for patients, are a
    necessary and important step in research, are very closely monitored,
    and serve as the lynchpin between research and accepted medical
    practice for making advancements in the war against cancer.
        The NCCR thanks you for providing this year's 15 percent increase
    to NIH as the second installment to double the budget of the NIH over
    five years. In terms of funding for fiscal year 2001, we are requesting
    the third 15 percent increase for NIH, $4.1 billion for the NCI, and
    $622 million for cancer control efforts and the CDC. This third
    increase to NIH will bring us within 2 years of doubling the NIH
    budget.
        While amazing progress has been achieved in cancer treatment,
    cancer remains the second leading cause of death in America. Let me
    share with you a few facts which indicate the wide-reaching scope and
    magnitude of cancer. One in two males and one in three females will
    develop cancer of the course of a lifetime. Look to your left and look
    to your right. The odds are that one of these individuals will be
    diagnosed with cancer. One in four Americans will die form cancer. Now,
    look to your left, look to your right, and look at me. The odds are
    that one of us will die from cancer. Today alone, more than 3,000
    people will be diagnosed with cancer, and over 1,500 will die from
    cancer. Over the course of this year, over 1.2 million Americans will
    be diagnosed with cancer and over half a million will die from cancer.
    Too many people live with cancer, Mr. Chairman, and too many people die
    from cancer. We have a moral obligation to aggressively pursue cancer
    research and turn cancer from a too-often terminal disease into a
    treatable, preventable disease.
        It is important that we understand the magnitude of cancer
    statistics both now and in the future. While cancer rates--the number
    of people per thousand in the population who develop cancer in a given
    year--have dipped slightly by 2.6 percent between 1991 and 1995, cancer
    incidence, the new cases of cancer reported each year, is expected to
    increase hugely over the next decades. As the Baby Boom Generation
    ages, the number of Americans over age 65 will double to 69.4 million
    in 30 years, and the number of Americans over age 85 will quadruple.
    Currently, 64 percent of cancer occurs in patients over 65, the
    Medicare population. By 2010 cancer incidence is expected to increase
    29 percent and mortality 25 percent with annual costs exceeding $200
    billion. The Medicare program is already facing serious problems, but
    it will be utterly overwhelmed and crippled if cancer prevention and
    treatment options do not improve significantly over the next thirty
    years. It is imperative, thus, to mount an aggressive cancer research
    front immediately.
        Let me summarize for you what is needed to mount an aggressive and
    successful, federal campaign against cancer that can fully exploit the
    promising research opportunities that abound and then apply that
    knowledge to improve cancer prevention, detection, and treatment at a
    time when the incidence of cancer is projected to increase
    dramatically. We need a 15 percent increase in the NIH budget and $4.1
    billion for the National Cancer Institute. These increases will enable
    high-quality and innovative research, much needed support and training
    for young investigators, new equipment for researchers and
    institutions, and the necessary infrastructure to support cancer
    research in our increasingly technologically sophisticated age. We also
    need to fully support the important cancer related programs at the CDC,
    such as the cancer registries, breast and cervical cancer detection
    programs, and the Environmental Health lab among others. We recommend
    that the Committee provide $622 million for cancer control efforts at
    the CDC. The combined efforts of and adequate funding for NIH, NCI, and
    CDC are integral to understand, prevent, diagnose, treat, and
    ultimately eradicate cancer. I wish to thank you for allowing me to
    present this to you for your consideration.
                                     ______

             Prepared Statement of the Children's Heart Foundation

        Mr. Chairman and Distinguished Subcommittee Members: On behalf of
    The Children's Heart Foundation and all who are suffering from
    congenital heart defects we enter this testimony for consideration at
    the fiscal year 2001 budget hearings.
        According to the NIH Guide (Gene Nutrient Interactions in the
    pathogeneses of congenital heart defects), September 1994, 42 percent
    of all birth defects are caused by congenital heart defects. Eight
    percent of all deaths during the first year of life are caused by this
    condition, and of the 30,000 babies born each year with this anomaly,
    2,900 of them will die before their first birthday. Thirty six hundred
    children under the age of fifteen die annually from congenital
    cardiovascular malformations (CCVM) or congenital heart defects.
        In addition to the incredible impact on families, the social costs
    are great as well. Many children who survive infancy are forced into a
    life of dependency on medications, medical procedures, and repeated
    open-heart surgeries. In 1992 nearly $500 million was spent to pay for
    44,000 hospitalized children who were under fifteen years old.
        Because so few of these children live long enough to have children
    of their own, it has been difficult to carry out genetic studies of
    CCVM. However researchers have now come to the conclusion that most
    CCVM occurrences are caused by genetic defects. According to
    information provided by the NHL&BI, the direct cause for at least eight
    different structural heart defects may be genetic.
        While we at The Children's Heart Foundation appreciate the genetic
    studies that have been ongoing at the NIH, we also realize that
    clinical studies on procedures and methods of treatment are vital to
    the future of patients suffering with congenital heart defects. We wish
    to encourage the committee to support more clinical projects in
    congenital heart research. It is our understanding that at present the
    budget for congenital heart research at the NHL&BI is fifty million
    dollars.
        We ask that the members of this committee grant fifty million
    additional dollars to the NHL&BI with directives to increase clinical
    and molecular research concerning congenital heart defects. The
    increase will bring the budget to 100 million dollars, but in a budget
    of, what we understand to be 15 billion dollars this is a small
    increase to support research in America's number one birth defect.
        In the next few pages we will present the stories of some of the
    families who have lived with these life-threatening conditions. One of
    these families has lost the battle while others still live with the
    daily difficulties that accompany their illness. Please accept these
    testimonies and the requests to testify before this committee under the
    auspices of The Children's Heart Foundation.
        Individuals and grassroots efforts can only do so much. Congress
    must take on this effort and increase appropriations. So again, we
    implore this committee to grant an increase of fifty million dollars to
    the fiscal year 2001 budget earmarked to the NHL&BI for congenital
    heart defects research. We thank you for your attention to our
    requests.
                                     ______

                      prepared statement of jessica cowin
        Mr. Chairman, members of the committee and all who hear this
    testimony. My name is Jessica Cowin and I am 16 years old. I am
    requesting to be slotted to testify before the appropriations
    subcommittee.
        I have had five heart surgeries since I was 4 days old because I
    was born with a hypo plastic left heart. A hypo plastic left heart is a
    heart that has no left side, in other words I had no pump. At 4 days
    and 18 months the doctors performed closed heart surgeries on me. At 5
    years and 13 years, I had open-heart surgeries. All of these surgeries
    worked, for a while, but my heart began to fail in the last two years.
    The doctors and my parents agreed that I needed a heart transplant. It
    was very scary to think that the doctors were going to put someone
    else's heart inside of me, but if I wanted to live longer that's what I
    had to do.
        On September 25, 1999, my mother got a phone call from the
    Children's Memorial Hospital in Chicago (where I have had all of my
    surgeries), saying that they had a heart for me. It has been two months
    since my transplant and even though I am on a lot of medication I
    already feel better. Before the transplant I had no energy and got sick
    more often than other children. It also took me longer to get better. I
    have also missed a lot of school in the past three years and I missed
    my friends, too.
        This has been very stressful for my family because everyone worries
    a lot about me. I still have to go to a lot of doctors, physical
    therapy, counseling and cardiac rehabilitation. I know my mom worries a
    lot about the medical bills even though she tries not to show it.
        Without the research for congenital heart defects, I would not be
    here today. I was born in 1983 at Children's Memorial Hospital. At that
    time they were not even doing heart transplants there. They started
    doing transplants in 1988, when I was 5 years old. I have personally
    benefited from the research of all of my five surgeries.
        My mom tells me that there are still babies born with heart
    problems that do not live and that I am really lucky that I have such
    good doctors and that they knew what to do for me. I agree with her.
    Please provide more federal funding for congenital heart research to
    the National Institute of Health.
                                     ______

                      prepared statement of andrea piwowar
        My name is Andrea Piwowar. Twenty-three years ago, I was born with
    several congenital heart defects. I was diagnosed with tricuspid
    atresia with transposition of the great arteries and a large
    ventricular septal defect associated with pulmonary hypertension and an
    absent pulmonary valve.
        When I was three months old, I had a banding of the pulmonary
    artery. In January of 1982, I had a modified Fontan, a surgical
    procedure which makes it possible for blood to enter the lungs without
    being pumped in by the right ventricle. This is achieved by connecting
    the pulmonary artery directly to the right atrium. In my situation,
    since I had transposition of the great arteries and a ventricular
    septal defect along with tricuspid atresia, the underlying need for the
    Fontan procedure, the surgeon corrected the transposition and closed
    the hole between the two atria.
        Seven months following the modified Fontan, I had a stroke. In
    December of the same year, I had yet another stroke. It is my
    understanding that it was thought that clots were forming in the
    pulmonary stump; therefore, after the second stroke, I was operated on
    again and the pulmonary stump was removed. The doctors could not find
    where the clots came from. Even to this day, there is no explanation of
    the strokes. After that operation, I was put on Coumadin and Lanoxin.
        As a result of the strokes, which occurred after my corrective
    heart operations, I have both orthopedic and speech impairments and
    require the use of an electric wheelchair for mobility purposes.
    Throughout my childhood, my parents fought for the appropriate
    accommodations to be made in the school systems and for my right to be
    in classes with able-bodied children. I felt like it was necessary for
    me to work harder on class assignments just so I could keep up with the
    class. I also felt that I had to prove myself to my teachers.
        I am now an Indiana University graduate and am currently looking
    for a job. I have had a couple of interviews and have spoken with
    employers and recruiters over the telephone. At times, I feel as if my
    impairments make it difficult for me to make a good first impression
    with potential employers. I have been hung up on while speaking with
    recruiters and employers have postponed and cancelled interviews with
    me.
        Like other patients who have had the Fontan operation, I am
    beginning to see some of its side effects. Within two years, I have had
    atrial fibrillation three times, each time requiring a cardio version
    to get back into normal rhythm. I also have an enlarged atrium which is
    causing my blood return to become sluggish.
        My first bout with atrial fibrillation occurred during the week of
    college midterms. I thought it might have been something that I had
    brought on myself, because I had been working on several projects at
    one time and staying up late to study, but I hadn't done anything
    differently than I did during the previous semester. It wasn't until I
    was in the hospital that I found out that atrial fibrillation was a
    side effect from the Fontan procedure.
        No one had informed me of any possible side effects of the Fontan.
    Only by speaking with my cardiologist and reading personal experiences
    of other Fontan patients I am beginning to understand more about the
    side effects; however, I have yet to understand why some people with
    congenital heart defects have strokes while others do not. As I
    mentioned earlier, no one can explain why I had two strokes after the
    Modified Fontan operation.
        Several years ago, I wrote a letter to Dr. Thilenius, the
    cardiologist who saw me before and after the modified Fontan procedure
    was performed, inquiring about Hypo plastic Left Heart Syndrome. I
    received a response that explained what Hypo plastic Left Heart
    Syndrome was and the surgical procedures that could be performed,
    depending on the severity of this disease. I was also given an
    explanation of my congenital heart defects and the surgical procedure
    that were performed to correct them. I was informed that strokes rarely
    occur after a Fontan procedure, so rarely in fact, that it is not even
    mentioned as a complication, but yet they still occur and no one seems
    to know why.
        So, I ask you, the distinguished members of the subcommittee, to
    increase appropriations to the National Heart Lung and Blood Institute
    to support clinical studies in the area of congenital heart research.
    As more congenital heart research is performed, researchers may
    discover why some people with congenital heart disease are more prone
    to having a stroke than others and find a way to prevent them from
    occurring.
        I would like to submit my request to be given the opportunity to
    testify before you, the distinguished members of the subcommittee, on
    the issue of allocating increased funds to the National Institute of
    Health for congenital heart research.
        Thank you for your time.
                                     ______

                      prepared statement of megan van pelt
        My name is Megan Van Pelt and I am the mother of a child born with
    a congenital heart defect. Congenital heart defects have been a part of
    my life since I was a child. My Cousin was born with a very severe
    congenital heart defect and underwent many open-heart surgeries. Being
    a child I could have never understood the magnitude or impact on the
    family during this time. Doctors told my aunt that he would not live
    past the age of nine. By the grace of god and congenital heart research
    twenty-nine years later my cousin is still alive and functioning as a
    normal healthy adult. Who could know that twenty-seven years later, I
    myself would deal with the issue of congenital heart defects. In the
    summer of 1997 my husband and I were anxiously awaiting the arrival of
    our first child. During my routine twenty-four week check up I was
    excited to finally see our baby in an ultrasound. As the ultrasound
    progressed the technician informed me that she needed to get the
    obstetrician to come in and look at the baby's heart. After the doctor
    reviewed the tape, he informed me that our unborn child had a complex
    congenital heart defect. For my husband and me the next three months
    were a blur of cardiology visits and Internet research. On October 10,
    1997 my amazing son, John ``Jack'' Ryan Van Pelt, came into our lives,
    changing us forever. Nothing could have prepared me for the next four
    months. Jack was born a navy blue color which according to the doctors
    was normal because of the lack of oxygen his body was getting. Jack
    weighed 4.5 pounds at birth. He was immediately transported to
    Children's Hospital in Chicago. I have never felt so helpless.
        A heart catheterization which was done shortly after Jack arrived
    at Children's Hospital, confirmed the initial diagnosis of
    transposition of the great vessels as well as three holes in his heart.
    This meant that Jack's heart had developed backwards and all his blood
    was flowing in the wrong direction. Because of Jack's size the Cardio-
    Thorasic team did not feel that he was strong enough or big enough to
    survive the complicated surgery that he needed. We spent the next two
    months in the Neonatal Intensive Care unit, waiting. Because of his
    heart Jack experienced liver and kidney failure. Everyday was a hurdle
    for Jack and many days were touch and go. I thanked God for everyday I
    had with him.
        Finally on December 4th the surgeons felt Jack's condition was
    deteriorating and the surgery could no longer wait. The surgeons
    explained at length the surgery that Jack would undergo. The procedure
    was relatively new and if successful Jack would not need to undergo
    future surgeries. I will never be able to verbalize how it felt to sign
    my son's life over to this team of doctors. The actual surgery took ten
    hours. When Jack came out of surgery everyone warned us he would look
    horrible, I am happy to say, they were all wrong. My husband and I
    could not believe how pink he now looked. His body was finally
    receiving oxygen. The doctors warned us that the next 48 hours would be
    the most critical. Jack came through with flying colors. He had fought
    for his life and won. My son was a survivor.
        Through those three months I could not believe the amount of people
    I became close to who had children surviving with congenital hearts
    defects and dying from congenital heart defects. This is the number one
    birth defect that children are born with, why don't most parents know
    this? Why isn't there better education? But most importantly why isn't
    there more research? There are children that I met who will undergo
    open-heart surgery every three years as their hearts grow.
    Unfortunately the funding for projects is not there to help researchers
    find ways to fix defects the first time so it will be the only time
    these children are forced to undergo additional lifesaving procedures.
        I am happy to say that Jack is doing very well at the age of two.
    We visit the cardiologist once a year. With every visit I hold my
    breath afraid that he will need another surgery. Should that day come
    we will take it in stride. The most terrifying part of having one child
    with a congenital heart defect becomes the fact that every child you
    have following has an even higher chance of being born with a
    congenital heart defect. One out of every 115 babies is born with a
    congenital heart defect in the U.S. each year. There are many worthy
    causes and issues today, but there needs to be a greater awareness of
    this, our number one birth defect. Because of our experience it has
    been extremely important to my husband and I to give back. We have
    become involved with the Children's Heart Foundation, which raises
    money for research in congenital heart defects. Many of our recipients
    have gone on to receive funding from the NIH for pediatric congenital
    heart research. When it comes right down to it, the funding that is
    needed isn't there. The American Heart Association gives less than 1
    percent of their funding to research of congenital heart defects.
        I ask you to take the time to visit a cardiac wing in a pediatric
    hospital. There is a great chance that your family, friends, or
    associates have been or will be affected by a congenital heart defect.
    My family is reminded of it daily my cousin whom I spoke of earlier and
    his wife are seven months pregnant. Sadly they have just found out
    through ultrasound that their child will need to have open-heart
    surgery. I ask you to sincerely consider dedicating more money for the
    research of pediatric congenital heart research. Help us to educate the
    public and find the answers to the number one birth defect. Thank you
    for your time and consideration. We have an opportunity as the leading
    healthcare nation in the world to find cures and new surgical
    procedures to help these brave young fighters and I encourage you to
    support us in the fight.
        Thank you for your attention.
                                     ______

                      prepared statement of teresa taylor
        Mr. Chairman; and Members of the Committee. I am requesting to be
    slotted to testify before the appropriation sub-committee and I am
    honored to give my personal testimony.
        My name is Teresa Taylor from Skokie, Illinois in the county of
    Cook, the 21st Congressional District of Illinois in the United States
    of America. I would like to address this committee on behalf of all the
    children born with congenital heart disease, those surviving, and in
    honor of those that have lost their lives including my son, Sam. It is
    with a personal story and a family history that I testify.
        I want to go down on record that my son Sam and countless others
    that have died prematurely not forgotten but remembered. And to be a
    constant reminder for the need for additional federal funding for
    research on congenital heart defects.
        My son Sam, was born in Chicago, Illinois April 1993. He was born
    with hypo plastic left heart syndrome. In other words, his left side of
    his heart was underdeveloped. The left side of the heart is the main
    pumping chamber of the heart and pumps blood to the rest of the body.
        The devastation over our son's condition has caused us great sorrow
    and pain. We knew very little in 1993 of his disease. There was little
    that we could do except listen to the Doctors' prognosis and go along
    with the treatment they suggested. In 1993, the options for Sam were
    immediate open-heart surgery, or wait for a heart transplant. We opted
    to place Sam on a heart transplant list originally called the UNOS
    (united network of organ sharing). We were told that Sam would probably
    get a heart within the next 6-9 weeks. We did not receive a heart when
    we had thought. The heart for Sam came when he was 5 months old. He
    lived in the hospital his whole life on a ventilator. I would not call
    this life support but assistance so that his heart and lungs would not
    flood up with blood while he waited for a heart. Sam died 2 weeks after
    transplantation. He died due to lung and hospital related infections.
    Because Sam waited only two days short of the longest wait for an
    infant heart doctors did not know what to expect of his out come. Today
    doctors know that an infant and most likely any patient waiting for a
    heart transplant cannot survive as long as Sam did on a ventilator.
    Because of Sam, doctors know that it is critical to find better ways to
    manage a patient waiting for a heart transplant and open-heart surgery.
    Today at Children's Memorial Hospital in Chicago, doctors have
    perfected open-heart surgery that would have been used on Sam instead
    of transplantation (the procedure is called Norwood). Research helped
    in this matter and patients like Sam helped them in their research. Sam
    and other children paid with their lives to help doctors understand
    congenital heart defects and find ways to better manage and treat their
    condition.
        I make a plea to this committee, let this show that research is
    direly needed to prevent cases where the doctors only learned after the
    child's death of appropriate treatment for a child with a congenital
    heart defect.
        My story does not end here. I had a brother who died from a
    congenital heart defect called tetralogy of Fallot. Today, many are
    living many more years thanks to research. These dedicated Doctors to
    find ways to manage and treat children with congenital heart defect
    such as tetralogy of Fallot. My family history of congenital heart
    defects goes back at least three generations. All of those in my family
    who died were boys. I would like my daughters to one day have children
    of their own. I would hope that they will feel safe that if they have a
    boy and he is born with congenital heart disease that they will not
    have to grieve for the loss of their son but embrace his survival. It
    is my personal dream to see my son in the face of my daughter's
    children, happy and healthy.
        I want this story to someday have a happy ending to parents across
    the country because federal dollars were spent in providing research in
    this area, we need as parents to take a stand and ask questions. Why
    did this happen to my child, is there research being done in this area,
    what is the treatment for these children, what is their long term
    prognosis, will we learn something from this and can our children have
    the future that they deserve so much?
        I have heard countless stories subsequent to our son Sam's death.
    Stories of survivors with the same condition Sam was born with. These
    children are living today because of research in congenital heart
    defects. I only wish today that my son had this chance for a life. I
    can only wish to carry on a legacy in his name, to help other children
    have a chance to live and enjoy life like other children. The more
    money that can be generated toward research, the more children in the
    future will live with a heart defect not die of it. I plead to this
    committee to pleases allocate more federal dollars to the to the Heart,
    Lung and Blood Institute, and to direct research funds on congenital
    heart disease.
        Thank you for your attention in this matter.
                                     ______

               Prepared Statement of the Doris Day Animal League

        The Doris Day Animal League is a non-profit, member supported
    national animal advocacy organization located in Washington, D.C. On
    behalf of our 295,000 members and supporters, we respectfully present
    to the subcommittee our concerns relating to The Coulston Foundation of
    New Mexico and continued federal funding of that facility.
        The Coulston Foundation is a private animal research laboratory
    based in Alamogordo, New Mexico. It reportedly owns more than 600
    chimpanzees, 300 other primates, and an unknown number of other animals
    who are kept at two facilities, one on civilian ground, the other on
    Holloman Air Force Base.
        The Coulston Foundation has the worst animal care record of any
    research facility in the history of the Animal Welfare Act, and has
    long been of concern to the animal protection community and many
    Members of Congress. The laboratory has been investigated seven times
    by the U.S. Department of Agriculture (USDA) for serious violations of
    the Animal Welfare Act. While the seventh investigation is ongoing, the
    previous six have led to formal charges against the lab.
        In August 1999, The Coulston Foundation and USDA signed an
    unprecedented settlement agreement pertaining to the most recent set of
    charges. Under the settlement, The Coulston Foundation agreed to divest
    300 of its chimpanzees by January 2002, allow external financial and
    animal welfare monitors to inspect the facilities, and to ``cease and
    desist'' from further violating the Animal Welfare Act. Yet at least
    five chimpanzees have died at The Coulston Foundation since the
    agreement was signed.
        The case of Donna, a 36 year old chimpanzee is perhaps the most
    shocking of these recent deaths. She died last November from severe
    infection to the uterus, bowels and peritoneal cavity after carrying a
    dead fetus in her womb for at least two weeks. Records indicate that
    veterinary staff at The Coulston Foundation were aware of Donna's
    condition, but failed to provide adequate care in a timely fashion.
        In total, at least 14 chimpanzees and 4 other primates have died
    negligent deaths at The Coulston Foundation since 1993. Three
    chimpanzees died at the lab that year when the temperature in their
    cage soared to 150 degrees. In 1994, four monkeys died at the
    laboratory from water deprivation and resultant dehydration. In 1997, a
    healthy 11 year old chimpanzee named Jello died after being improperly
    anesthetized. In March of that year, another chimpanzee, Echo, died
    when veterinary staff failed to stabilize her for shock before surgery.
    In early 1998 a chimpanzee named Holly died during a drug testing
    protocol. In June 1998, two more chimpanzees died during a protocol
    involving the same drug tested on Holly. In May 1999, a chimpanzee who
    was being used in an invasive spinal study died from negligent care.
    Five others, including Donna, died at The Coulston Foundation in the
    second half of 1999.
        The USDA is not the only federal agency concerned with the
    deteriorating situation at The Coulston Foundation. In fact, in
    December 1999, the Food and Drug Administration placed a restriction on
    The Coulston Foundation for 270 violations of Good Laboratory Practice
    standards, and warned the lab that no protocols or data would be
    accepted by the agency until the violations are corrected.
        As a major funder of The Coulston Foundation, the National
    Institutes of Health (NIH) has also shown concern over the laboratory's
    record, and in February, 1999, it placed a restriction on funding to
    the lab. According to the restriction, future funding would depend on
    The Coulston Foundation's hiring of seven ``fully qualified''
    veterinarians. However, it is our understanding that the laboratory has
    only two full-time veterinarians to date.
        The situation at The Coulston Foundation is quickly deteriorating.
    Documents obtained from NIH under the Freedom of Information Act state
    that ``Based on current cash flow of [The Coulston Foundation], it
    appears unlikely that it can continue operating for much more than two
    or three months longer''.
        That document was dated April 29, 1999. Since that time, NIH has
    granted at least $1.1 million in ``supplemental awards'' to the
    laboratory. This continued funding appears to be in direct
    contravention of NIH's own restriction and the Health Research
    Extension Act of 1985, under which the Director of NIH must ``suspend
    or revoke Public Health Service funds'' to any facility which has
    failed to correct violations of the Animal Welfare Act.
        It is time for a candid reassessment of the Federal Government's
    involvement with The Coulston Foundation. The prospect of the
    laboratory going bankrupt is very real, and the short- and long-term
    ramifications for the welfare of hundreds of animals there are serious.
    While my organization understands that NIH is not ultimately
    responsible for the welfare of the animals at The Coulston Foundation,
    it does bear some moral responsibility for the animals there, many of
    which were bred for and used in NIH-funded research.
        There is immense public concern for the welfare of the animals at
    The Coulston Foundation, many of whom were previously owned by the Air
    Force and are the survivors and descendants of America's space program.
    There is also frustration over the financial aspect of the situation.
    While The Coulston Foundation is seemingly incapable of complying with
    the law, it has been the recipient of millions of federal dollars (at
    least $27 million since 1993), and continues to receive taxpayers'
    money through NIH.
        The government must address the situation at The Coulston
    Foundation and work to avert what could be a potentially disastrous
    scenario. We, therefore, respectfully ask the government to take
    emergency action and appropriate $5 million via fiscal year 2001
    Appropriations for Labor, Health and Human Services, Education and
    Related Agencies for the care of the 300 chimpanzees which The Coulston
    Foundation is under federal order to divest. While the ownership and
    care of the animals certainly ought to be transferred to another party,
    the chimpanzees could feasibly remain on Holloman Air Force Base for
    the time being.
        As a long-term solution to the problems at The Coulston Foundation,
    we urge Congress to pass the Chimpanzee Health Improvement, Maintenance
    and Protection Act (H.R. 3514), which would create a network of
    federally supported private sanctuaries to which chimpanzees no longer
    needed in research could be retired.
        The chimpanzees and other animals at The Coulston Foundation are
    unable to advocate for themselves, and the laws which are supposed to
    protect them are failing to do so. While it is The Coulston
    Foundation's ultimate responsibility to provide for the animals in its
    care, it seems incapable of doing so. The government has enabled the
    situation to escalate by continuing to fund the breeding and use of
    animals at the laboratory.
        A new direction is desperately needed. We respectfully ask this
    Congress to ensure that our own government does not perpetuate a
    situation which is ultimately harmful to the very animals it is charged
    with protecting, and instead takes action to remedy the deteriorating
    situation at The Coulston Foundation. Thank you for your consideration.
                                     ______

        Prepared Statement of the Federation of American Societies for
                              Experimental Biology

        Mr. Chairman, Mr. Harkin, Members of the Subcommittee: The
    Federation of American Societies for Experimental Biology, FASEB, is
    the largest organization of life scientists in the United States.
    Founded in 1912, FASEB is comprised of 20 societies with a combined
    membership of more than 60,000 scientists. Each year, FASEB brings
    together representatives of our member societies to review the
    biomedical research programs at NIH and other federal agencies. After
    considerable deliberation and debate, these scientists produced funding
    recommendations for each agency examined. This year's proposals are
    contained in a report released for this budget cycle.\1\
    ---------------------------------------------------------------------------
        \1\ Federation of American Societies for Experimental Biology.
    2000. Federal Funding for Biomedical and Related Life Science Research
    fiscal year 2001. http://www.faseb.org.
    ---------------------------------------------------------------------------
        First, we would like to thank both the chairman and ranking member
    for their ardent support for the research programs at the National
    Institutes of Health (NIH) and for their efforts over the past two
    years toward doubling the NIH budget within five years. We also would
    like to ask that both Mr. Specter and Mr. Harkin continue to work with
    their colleagues to press forward with this vital national investment.
    We urge them to provide NIH with a 15 percent increase for fiscal year
    2001, making the third installment toward the bipartisan goal to double
    the NIH budget. This additional funding is needed to sustain and
    further increase the momentum within NIH programs that has been begun
    through your hard work.
        While FASEB believes there are many issues important to the
    continued long-term success of the NIH and health research in this
    nation, our statement will focus on our two highest priorities. First,
    we need to fund more research projects, especially investigator-
    initiated research projects, and second, we need to ensure a continued
    supply of highly-talented science personnel to carry out that research.
        Research that is conceived and initiated by individual scientists,
    investigator-initiated research, has been the key to the nation's
    extraordinary progress in science. The magic that NIH has produced over
    its history has occurred by supporting creative scientists to do
    excellent research in laboratories around the nation. We have required
    them to compete for support, under scrutiny of their peers and
    competitors, in the marketplace of ideas. The resulting scientific
    innovation and progress produced by this mechanism is attested to by
    the fact that since 1945, 57 of the 76 U.S. winners of the Nobel Prize
    in Physiology or Medicine were supported by NIH before they won their
    award, including the 1999 award-recipient, Dr. Gunter Blobel. The
    competitive, peer-reviewed system has excellence at its core and should
    remain the principal mechanism used by NIH to distribute research
    support. NIH should support the work of more scientists in their
    laboratories; this will be the key to increasing research productivity
    of the system as a whole. This competitive system is, we truly believe,
    the most efficient, cost-effective and productive way to carry out
    biomedical research and to maximize the return we get from it.
        Budget increases, therefore, should be used largely to support more
    research grants and to fund them at the lengths and levels approved by
    the peer-review process. In some study sections, where grant
    applications are reviewed, my colleagues report that projects rated
    among the top twenty to twenty five percent come back for re-review
    when the NIH is unable to fund them. We need more resources to
    eliminate the redundant and discouraging cycle of re-submission and re-
    review. We need scientists doing research, not ``in the system'' of
    review. There is no shortage of good ideas. Therefore:
      --the central principle guiding dispersal of research funds by NIH
            is--and should remain--competitive merit review by their peers;
            and
      --the first priority in allocating NIH budget increases should be to
            support more grants for research initiated by individual
            scientists and to fund proposals at the durations and levels
            recommended by peer-review.
        With a 5.6 percent increase in funding for fiscal year 2001, NIH
    predicts that it will be able to fund 31,524 research project grants,
    an increase of only 237 grants over the fiscal year 2000 estimate. We
    recognize that several mitigating issues contribute to this situation.
    One appears to be the prudent concern about making too many long-term
    commitments without the assurance of continuity of growth in NIH
    funding. That is, if too many grants are funded one year then many
    fewer grants might be renewed the next year if growth does not
    continue. There was also significant need to re-build base programs
    that were unable to be fully developed by NIH in the past due to
    financial restraints. Furthermore, an increasing number of scientific
    questions today require interdisciplinary strategies. These strategies
    tend to involve powerful new areas of science and involve complex new
    technologies and, consequently, they are typically very expensive.
        However, the inability to fund more grants illustrates the
    limitations of the proposed 5.6 percent increase. The total number of
    funded projects will rise only less than one percent, and the number of
    new grants awarded will actually decrease. With the continued increase
    in the NIH budget that we advocate here, it is now time to turn our
    attention toward investigator-initiated projects and substantially
    increase their numbers.
        In summary, the best way to sustain the phenomenal productivity
    flowing from laboratories across the country is through competitively
    reviewed, investigator-initiated research projects. Further increasing
    the number of investigator-initiated projects will accelerate our
    efforts to prevent, treat and cure diseases affecting millions of
    Americans and their families.
        Hand in hand with the need for more research projects is the need
    to invest in the training of more scientists. We need to inspire young
    people to pursue careers in science. To attract a new generation of
    highly talented individuals, we must present them with a vision of
    opportunity to make a career in academic biomedical research with a
    realistic chance for success. Funding new investigators brings new and
    creative ideas into science and sets the stage for future progress. A
    decrease in new grants sends a devastatingly negative message to the
    young people of this nation.
        The absolute number of proposals from first-time applicants has
    declined as a percentage of total grant applications during the 1980s
    and 1990s. This is an unfortunate loss to the science community, as
    young investigators have frequently been the source of the novel
    insights that have led to major scientific breakthroughs. We are
    successful at ensuring that our young scientists have the appropriate
    skills to succeed, but we must also make sure that they do not lose the
    desire or lack the means to establish their own laboratories and
    initiatives. Therefore we encourage NIH to continue developing and
    implementing competitive funding mechanisms that provide salary support
    and start-up funding to facilitate the transition of outstanding young
    investigators from their post-doctoral training to independent
    positions.
        One indispensable group of researchers, physician-scientists, is
    already facing a critical shortfall. Physician-scientists bring a
    unique perspective to medical research and education. This group plays
    an essential role in the cross-fertilization between medical research
    and medical practice. Their contributions in laboratory and clinical
    settings are central to the progress in the battle against disease. In
    addition, they play an essential role in training tomorrow's physicians
    in the practice of scientific medicine. To ensure the rapid and
    effective translation of research knowledge into health care practice,
    and to ensure that insights from medical practice reach the
    laboratories, we need to have a strong cadre of physician-scientists
    working in medical schools and teaching hospitals across the nation.
        Concern over the relative decline in the numbers of physician-
    scientists led FASEB to initiate a major review of issues related to
    the education and career development of this important research
    resource. Our study concluded that there is a real threat to the future
    supply of physician-scientists. There has been a decline in the number
    of new physicians choosing to pursue research careers. Concomitantly,
    the current pool of physician-scientists is aging. We found that the
    proportion under the age of 45 was at an all-time low. These findings
    suggest that we may have lost our ability to recruit young, talented
    physicians to careers involving research.
        One plausible cause for this trend is that increasing medical
    school debt compels newly trained physicians to enter clinical practice
    in order to pay off their sizable loans. Other possible factors include
    a dearth of physician-scientist role models in medical schools and
    residency training programs, a decrease of emphasis on research and the
    science underlying medicine in medical school curricula, as well as
    perceptions that the research career is too daunting or prone to
    failure. Furthermore, declining revenues in academic medical centers
    (brought on by managed care and other external forces) have tended to
    increase the clinical burdens placed on physician-scientists and have
    adversely affected the attractiveness or feasibility of this career
    path.
        Combined M.D./Ph.D. programs such as the Medical Scientist Training
    Program (MSTP) have been quite successful in producing physician-
    scientists; however, these programs do not support many or most M.D./
    Ph.D. candidates because funding for positions in these programs is so
    limited. FASEB therefore recommends that you enhance the contribution
    of this successful program by doubling its budget, thereby increasing
    its capacity to recruit and train bright, young physician-scientists.
        MSTP and other M.D./Ph.D. programs are designed for first-year
    medical students who know they seek a career in medical research;
    however, there are also insufficient training opportunities for medical
    students and medical graduates who become interested in pursuing this
    career path after their medical training begins. FASEB has proposed a
    series of recommendations to correct this situation:
      --a national program for debt forgiveness for physicians who receive
            rigorous research training and pursue research careers;
      --support for the training and mentoring of early career physician-
            scientists through expansion of research training programs for
            medical students, residents and physicians who have already
            completed specialty training; and,
      --elimination of the statutory salary caps on NIH awards to
            extramural investigators so as to remove disincentives to
            research careers in medical centers.
        Our principal reason for submitting our perspective to the
    subcommittee is to ask their continued support for doubling NIH funding
    by fiscal year 2003. We need to fund more research projects and support
    more researchers. Quantifiable results will take time to see from this
    new investment. But as evidenced by the spectacular achievements
    resulting from our past investment that are being realized in doctor's
    offices and biotechnology companies today, the funds that we invest now
    will yield amazing future results that will further revolutionize
    medicine.
        For instance, a recent NIH-sponsored breast cancer prevention trial
    offers to make an enormous impact on public health, and the lives of
    countless American women, by providing the first proven measure to
    reduce the risk of breast cancer. In this trial, the drug tamoxifen,
    was shown to reduce the incidence of breast cancer in women at high
    risk for the disease. The underlying evidence that led the NIH
    investigators to pose this particular question was grounded in studies
    initiated decades ago. Specifically, tamoxifen was first developed more
    than 20 years ago as a treatment for breast cancer, and the genetic
    mapping efforts that culminated in the identification of two breast
    cancer related genes, BRCA 1 and 2, were also initiated in the 1980s.
    Today, scientists are continuing to look for other drugs that might
    similarly reduce the risk of cancer and also reduce the side effects
    associated with use of this drug in some women. Thus, the cycle
    continues and the gains to be had are amplified. But such benefits take
    time to accomplish.
        Another example is the discovery that mutations of the RET proto-
    oncogene cause medullary thyroid carcinoma; a cancer that is often
    hereditary and is difficult to treat once it develops. This discovery
    made it possible to identify the carriers of this mutated gene within
    high-risk families with 100 percent certainty. The thyroid gland of
    carriers of the mutated gene could then be removed in early childhood
    before any tumors developed and metastasized. NIH-funded research
    supported investigators at each stage of this work from the discovery
    of this gene to the mapping of the genetic locus and the identification
    of mutations. Nearly 15 years elapsed from the initiation of the
    mapping to the identification of the causative gene. Today, the
    discovery process stemming from this research continues with the
    identification of other components in the RET system and the unexpected
    recent recognition that mutations in some of these other components
    cause Hirschsprung disease, which is the most common cause of
    intestinal obstruction in childhood.
        In conclusion, Mr. Chairman (and members of the subcommittee), the
    public has expressed its support for increased funding for medical
    research and leaders both in Congress and in the Administration have
    supported the goal of doubling the NIH budget within five years.
    Funding increases in the last two years have enabled NIH to sow the
    seeds of discoveries that we will reap three to five years from now.
    With increased support for young investigators and physician-
    scientists, we will inspire and encourage researchers who will continue
    to make these discoveries a decade from now.
                                     ______

         Prepared Statement of the American College of Chest Physicians

        I am Susan Pingleton, M.D., FCCP, President of the American College
    of Chest Physicians, Professor of Medicine at the University of Kansas
    Medical Center, Director of the Pulmonary and Critical Care Division at
    the University of Kansas Medical Center, Medical Director of the
    Medical ICU, Chair of the ICU Committee, and a member of the KU
    Internal Medicine Foundation Board Trustees and the Graduate Medical
    Education Committee.
        Thank you for affording me the opportunity to submit this testimony
    for the record on behalf of the American College of Chest Physicians
    (``ACCP''). The ACCP is a professional medical specialty society of
    more than 14,500 physicians, scientists, allied health professionals
    and educators who specialize in diseases of the heart, lungs, and
    circulatory system. Since it was established in 1935, the College has
    been a leader in cardiopulmonary medicine. Its members are specialists
    in pulmonology, cardiology, cardiovascular and cardiothoracic surgery
    and critical care medicine. The College provides a unique opportunity
    for these specialists to further their professional education and to
    combine expertise from several disciplines in the study of heart and
    lung disease.
        The ACCP appreciates the opportunity to offer its views to this
    important Committee on fiscal year 2001 appropriations for the National
    Institutes of Health (``NIH'') and the Centers for Disease Control and
    Prevention (``CDC''). The ACCP is proud of its historic role in working
    with and supporting various institutes at NIH who in turn support and
    encourage biomedical research of great importance to our patients and
    the entire country.
        The President's budget request for NIH of approximately $18.8
    billion, while laudable, does not go far enough to prevent and combat
    all of the health problems over which the NIH has responsibility. We
    applaud this Committee's efforts to make fiscal year 2000 funding for
    the National Institutes of Health a top priority, but we still need to
    commit substantial resources to research and prevention of pulmonary
    and cardiovascular disease. Therefore, the College urges you to
    appropriate a 15 percent increase over fiscal year 2000 funding for the
    overall NIH. We agree with such groups as the Ad Hoc Group for Medical
    Research Funding and the American Heart Association that an increase of
    this level is necessary to sustain the high standard of scientific
    achievement embodied by the institutes. Thus, we recommend a fiscal
    year 2001 appropriation of $20.6 billion for the NIH. We also support a
    15 percent increase over fiscal year 2000 funding for NIH heart and
    lung research specifically.
        The College supports significant increases to the budgets of the
    National Heart, Lung and Blood Institute (``NHLBI'') and the National
    Institute of Allergy and Infectious Disease (``NIAID'') to levels that
    will enable these fine institutes to continue their wide spectrum of
    research, both basic and applied, for the prevention and treatment of
    cardiovascular and lung disease. With respect to the NHLBI, the ACCP
    recommends a fiscal year 2001 appropriation of $2.330 billion. This
    level of funding will allow the NHLBI to expand many of its existing
    programs and fund exciting new initiatives. The NHLBI is committed to
    maximizing the use of new technologies that are quickly becoming
    available and ensuring that standard health practices throughout the
    country reflect a thorough utilization of the knowledge that
    researchers and health professionals have acquired. This increase in
    funding will allow the NHLBI to expand its programs for genomic
    analysis in cardiovascular, lung, and blood diseases, in an effort to
    more precisely identify the causes and appropriate treatments of
    disease. NHLBI will be able to continue and advance a pilot program
    that is testing new uses of MRI technology to diagnose heart attack
    patients who may be candidates for thrombolytic therapy, a clot-
    dissolving treatment that may be able to significantly limit damage
    from heart attacks. This increase in funding will also enable NHLBI to
    establish innovative new clinical research networks, and study the
    underlying reasons for health disparities among various segments of the
    population in order to reduce these disparities.
        Combating asthma is a high priority for the College. We know it is
    a priority for both the NHLBI and NIAID. The ACCP supports a fiscal
    year 2001 appropriation of $935 million for NIAID, not including the
    estimated allocation for AIDS. More than 50 million Americans suffer
    from allergies and/or asthma, and these diseases are major causes of
    illness and disability. The economic costs associated with asthma are
    enormous. Asthma costs the U.S. about $7.5 billion annually. Between
    the years 1980 and 1994, the prevalence of asthma in the U.S. rose 75
    percent. The prevalence of pediatric asthma rose 160 percent during
    these years. In addition, asthma morbidity and mortality rates have
    been increasing in the United States over the last decade, with over
    5,500 people dying in 1996 as a result of an asthma attack. These
    increases have been concentrated disproportionately in children and
    minorities. These increases are alarming to the ACCP. We therefore
    strongly support the efforts of the NHLBI and NIAID in working to
    establish control over this disease.
        The need for continued funding of tuberculosis (``TB'') prevention
    and treatment is painfully clear. TB is the eighth leading cause of
    death worldwide. Two million people will die from TB this year. One out
    of every three people in the world has latent TB, thus creating a huge
    potential for transmission of the disease and development of active TB.
    Multi-drug resistant TB, which is caused by incorrect or incomplete
    treatment, is an increasing problem in this country and throughout the
    world, with as many as 50 million individuals infected. Multi-drug
    resistant TB kills more than half of those infected in the United
    States and is usually fatal in the developing world. These statistics
    underscore the necessity of continued funding for TB prevention and
    treatment activities.
        Given the ease with which TB is transmitted, however, the
    statistics of reported cases do not reveal the whole story. Consider
    these statistics: an infected person with a normal immune system has
    approximately a 10 percent lifetime risk of developing active TB. If a
    person is HIV co-infected, he or she has an 8 percent annual risk of
    developing active TB. Therefore, if a person is infected with HIV and
    TB, and lives five years from the time of the TB infection, there is a
    40 percent chance that person will develop active TB with the risk it
    will be spread to others. If that same person lives 12 years, it is a
    virtual certainty that he or she will develop active TB. With the lives
    of our children at stake, our Nation's future, now is not the time to
    reduce funding for TB. A decrease in federal funding is likely to lead
    to a surge in active TB cases, including deadly multi-drug resistant TB
    cases. Tuberculosis is an immense economic drain on families and on
    nations and is a significant cause of poverty. The ACCP, therefore,
    urges this Committee to increase funding for TB prevention and
    treatment activities. Through its federally-funded research, NIAID has
    already determined the complete genomic sequence of two strains of the
    TB bacterium. These exciting breakthroughs are crucial to NIAID's plans
    to develop a TB vaccine, but these efforts cannot advance without
    Congress's substantial financial support.
        We urge the Congress to support basic and applied research to the
    fullest capabilities. Without it, many of the crucial health benefits
    produced by the NIH would not be possible. With respect to the NHLBI,
    we continue to be impressed with the quality of leadership of its
    Director, Dr. Claude Lenfant. Research sponsored by the NHLBI has led
    to tremendous strides in combating cardiovascular and pulmonary
    diseases as well as hematological disorders. We recognize the strains
    that have been placed upon the federal budget in recent years.
    Nonetheless, diseases of the heart and lungs continue to pose the most
    serious threat to our Nation's health. The desirability of exercising
    fiscal austerity should not cause us to lose sight of the significant
    health and financial benefits of funding medical research. The recent
    scientific achievements of the NIH, and in particular NHLBI, have
    created promising opportunities for understanding disease and improving
    medical care. In order to benefit from these efforts and create new
    opportunities for advancement, Congress must increase its funding of
    both existing and proposed research projects.
        These scientific achievements hold a personal interest for me. I
    was born with a serious heart defect that had to be corrected through
    primitive cardiac surgery when I was a child. I had to be packed in ice
    to slow down my heart rate. Today, bypass machines do this work,
    leaving surgeons to concentrate on the heart itself. My heart stopped
    during the operation, and the resulting nerve and muscle damage to my
    legs required me to learn how to walk again. I was given a low
    probability of surviving past my teenage years, yet here I am today,
    partially due to scientific achievements.
        These experiences led me to enter into the medical profession. They
    also lead me now to support substantially increased funding for
    clinical research. Indeed, we believe that NIH in general and NHLBI in
    particular ought to devote greater resources to clinical research, the
    primary focus of many of our members.
        I am compelled to share with the Committee some very telling NIH
    statistics about the prevalence of heart and lung disease.
    Cardiovascular diseases afflict more than 60 million people.
    Cardiovascular diseases account for nearly 1 out of every 2 deaths in
    the U.S., and lung disease accounts for 1 out of every 7 deaths in the
    U.S. In addition to the untold costs of human suffering, the economic
    costs associated with diseases of the heart, blood vessels, lungs and
    blood represent 25 percent of the total economic costs due to illness,
    injury, and death in 1999. More than 30 million Americans suffer from a
    chronic lung disease. Lung diseases alone cost the U.S. economy an
    estimated $85 billion annually in direct medical expenditures. The most
    telling statistic, however, is that heart disease continues to be the
    number one cause of death in this country. Cerebrovascular disease
    ranks third, and chronic obstructive pulmonary disease (COPD),
    including asthma, ranks fourth. Thus, three of the top four leading
    causes of death are diseases that NHLBI is charged with combating.
        These numbers point to NIH's need for continued federal support for
    its vital programs. The ACCP continues to do its part to support
    research. Through our CHEST Foundation, many ACCP members voluntarily
    donate their own funds every year to support young investigators. This
    year, the CHEST Foundation will award more than 20 clinical research
    grants to young investigators. We believe this is unique compared to
    other medical societies. We are committed to improving the quality of
    the lives of the most important people we represent--our patients. But
    we cannot do it alone. NIH appropriation levels must be increased to
    ensure that our progress toward that goal is not thwarted. The Federal
    Government must not waiver in its strong commitment to biomedical
    advances of the future that would yield tens of billions of dollars in
    health care savings. Therefore, funding levels consistent with the
    important goals and essential mandate of NIH must be achieved.
        As first hand observers of hundreds of thousands of deaths each
    year caused by tobacco usage, the members of the ACCP urge this
    Committee to fully fund the tobacco control efforts of the NIH and
    Centers for Disease Control and Prevention (``CDC''). Smoking is the
    primary cause of preventable death and disability in America, causing
    more than 400,000 deaths, and costing approximately $89 billion
    annually in medical expenses alone. An estimated 48 million Americans
    smoke cigarettes, and over time, about half will suffer death or
    disability as a result of their addiction. Smoking diseases, such as
    lung cancer, emphysema, and coronary artery disease, and other
    cardiopulmonary diseases have become a major socioeconomic problem of
    transcending importance. Treatment of these diseases will continue to
    drain over $800 billion from the Medicare Trust Fund. There are over 40
    diseases/conditions that are caused by or aggravated by the use of
    tobacco. Lung cancer is the leading cause of cancer-related death in
    our population. Yet, the numbers of cancer diagnoses could be
    drastically reduced if we could make serious inroads by curtailing the
    use of tobacco--the number one cause of lung cancer. The NHLBI has made
    important strides in identifying the deleterious health effects of
    smoking, especially with respect to women. The ACCP, which has its own
    Task Force on Women, Smoking, and Lung Cancer, supports the Institute's
    continued efforts in this important area.
        Increasing social, political, and legal pressure nationwide against
    smoking has, overall, made a modest dent in reducing the prevalence in
    smoking. As physicians, we confront on a daily basis debilitating
    disease and death that result from inhalation of tobacco smoke. While
    the ACCP has been active for more than 30 years in educating the public
    about the harms of smoking, even our best efforts cannot match the
    power of Congress to direct funds to combat lung cancer and other
    deadly diseases that result from tobacco use.
        As part of our commitment to improving the health of our patients,
    the ACCP supports the work of the CDC in reducing death and chronic
    morbidity caused by tobacco use. Adequate funding of the tobacco-
    related research and state initiatives of the CDC are critical. We urge
    Congress to increase funding for this tobacco prevention work at the
    CDC to $130 million. CDC plays a leadership role in implementing and
    coordinating state-based efforts and is focused on preventing
    initiation among youth and promoting cessation. States that are
    planning to commit tobacco settlement funds to tobacco prevention have
    requested considerable technical assistance from CDC as they seek to
    develop comprehensive and effective state programs. States such as
    Florida, Massachusetts and Mississippi that already have comprehensive
    programs in place relied considerably on CDC's expertise. Funds for
    tobacco prevention at CDC are also used to maintain a comprehensive
    database of smoking and health information and conduct laboratory work
    regarding the dangers of nicotine and other toxic compounds in tobacco.
    An appropriation of $130 million will significantly expand the capacity
    of health and education departments to build and evaluate comprehensive
    tobacco control programs, develop and promote health communication
    campaigns for target audiences, and expand school health programs that
    equip young people with the skills and knowledge to avoid tobacco
    addiction.
        Medical science has made giant strides in eliminating some diseases
    that have afflicted populations in the United States and throughout the
    world. The ACCP continues to seek new and improved treatments and
    procedures to ameliorate the effects of diseases resulting from the
    direct and indirect inhalation of tobacco smoke. We urge this Committee
    to take action to curtail the national epidemic of tobacco-related
    death and disease and to protect our Nation's children from tobacco
    addiction and disease.
        On behalf of the American College of Chest Physicians and our
    millions of patients, I would like to thank you for affording us this
    opportunity to submit our views for your consideration. The ACCP would
    be happy to answer any questions you may have in the future.
                                     ______

       Prepared Statement of the American Gastroenterological Association
                           summary of recommendations
        The American Gastroenterological Association (``AGA'') urges
    Congress to increase funding for medical research on digestive diseases
    and disorders over fiscal year 2000 by 15 percent for the National
    Institutes of Health (``NIH''), by 41 percent for the Centers for
    Disease Control and Prevention (``CDC''), and by 47 percent for the
    Agency for Healthcare Research and Quality (``AHRQ''). Within NIH, AGA
    recommends at least a 15 percent increase for the National Institute of
    Diabetes and Digestive and Kidney Diseases (``NIDDK''), the National
    Cancer Institute (``NCI''), and the National Institute of Allergy and
    Infectious Diseases (``NIAID'').
                        medical research recommendations
        AGA appreciates the opportunity to present its views regarding
    fiscal year 2001 appropriations for NIH, CDC, and AHRQ. AGA is the
    nation's oldest, not-for-profit specialty medical society, consisting
    of over 10,000 gastroenterologic physicians and scientists who are
    involved in research, clinical practice, and education on disorders of
    the digestive system. As the nation's largest and leading voice of the
    gastrointestinal research community, AGA is uniquely qualified to
    advise Congress on the current status of federally-supported digestive
    disease research programs and the areas in need of further research.
        Each year more than 62 million Americans are diagnosed with
    digestive disorders.--Among the more common gastrointestinal disorders
    are inflammatory bowel disease, irritable bowel disorders,
    gastrointestinal cancers, and foodborne illness. In some of these
    areas, medical research has brought us close to developing lifesaving
    treatments and cures. Yet, in others, we still lack even a basic
    understanding of the cause and transmission of the disease. This
    testimony focuses on these serious health problems and makes
    recommendations on how Congress should allocate this country's precious
    medical research dollars. Specifically, AGA recommends that Congress
    urge NIH to issue research grants in the following areas:
      --Intestinal diseases caused by combinations of luminal (including
            nutritional and bacterial), environmental, and genetic factors
            with an emphasis on inflammatory bowel diseases and GI cancers;
      --Modulation and understanding of epithelial injury and repair to
            include: understanding of epithelial cell cycle regulation in
            the GI tract; the effect of aging; and studies of epithelial
            stem cells and their use for developing new approaches to
            organogenesis;
      --Cellular and molecular regulation of intestinal nutrient and
            electrolyte transporters--to include effects of nutritional
            factors, genetic abnormalities, aging, and disruption of
            transport function to understand physiology and pathobiology;
            and
      --Development of physiologic tests to characterize the phenotypic
            subgroups of functional gastrointestinal disorders, including
            non-ulcer (functional) dyspepsia, functional constipation and
            irritable bowel syndrome (motility).
        The following discussion supports the need for research in the
    aforementioned areas.
    Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease)
        It is estimated that one million Americans have inflammatory bowel
    disease (``IBD'').--The two forms of IBD are Crohn's Disease and
    Ulcerative Colitis. Crohn's Disease usually causes intermittent
    inflammation deep within the intestinal wall of the small intestine
    whereas Ulcerative Colitis causes continuous inflammation and sores in
    the top layers of the lining of the large intestine. Although older and
    younger people may also develop this disease, IBD usually begins
    between the ages of 15 and 40 and persists throughout life with
    remissions. IBD affects people in the prime and most productive years
    of their lives and results in substantial morbidity and economic loss
    to them and society. It is especially brutal in children who may suffer
    developmental delays or stunted growth. People with IBD experience
    abdominal pain, fever, bowel sores, intestinal bleeding, anorexia,
    weight loss, fullness, diarrhea, constipation, and vomiting. In severe
    cases, IBD can cause death. In addition to potentially disabling
    gastrointestinal problems, people with this disease may also suffer
    from arthritis, skin problems, inflammation of the eyes or mouth,
    kidney stones, gallstones, or other diseases of the liver and biliary
    system. Further, approximately five percent of people with ulcerative
    colitis will develop colon cancer with the risk increasing based on the
    duration and extent of involvement of the colon.
        Studies on the cause of IBD are desperately needed in order to have
    a better understanding of the disease and work towards more effective
    management and treatment. Specifically, AGA recommends that NIDDK
    support genomic research aimed at identifying abnormal genes in persons
    with IBD and finding the causes of IBD.
    Motility Disorders
        It is estimated that up to thirty percent of all Americans may be
    affected at some time during their lives by motility disorders.--
    Irritable bowel syndrome (``IBS''), the most common motility disorder,
    is especially troubling because a patient does not present with any
    pathognomonic symptoms or laboratory findings of the disease, making
    diagnosis and treatment extremely difficult. Instead, patients present
    with abdominal pain, bloating, gas, diarrhea, and constipation. It is
    believed to be caused by overly sensitive intestines that have muscle
    spasms.
        Further research is needed in this area due to the high prevalence
    and the lack of a basic understanding of IBS, a factor which has made
    drug manufacturers reluctant to fund research. If more federally funded
    research was focused on IBS, it would stimulate more private-public
    partnerships, and lead to advances in medical knowledge. As such, AGA
    urges Congress to direct the NIDDK to focus additional resources on IBS
    and to encourage the Office of Research on Women's Health to devote
    more of its attention to these areas of research in light of the high
    incidence of IBS among women. Specifically, AGA recommends that NIDDK
    support research into the development of physiologic tests to
    characterize the phenotypic subgroups of functional gastrointestinal
    disorders, including non-ulcer (functional) dyspepsia, functional
    constipation, and irritable bowel syndrome (motility).
    Gastrointestinal Cancers
        Approximately 226,600 new cases of gastrointestinal cancers will be
    diagnosed this year.--Sadly, 129,800 Americans will die from these
    cancers. The most common cancers involve the colon/rectum, stomach/
    esophagus, and pancreas.
      --Colorectal cancer is the second leading cause of cancer-related
            deaths in the United States and ranks fourth as the most common
            cancer.--Although risk factors, such as race (increased
            prevalence and mortality for African Americans), influence the
            development of this cancer, 70 percent to 80 percent of
            colorectal cancer cases involve average-risk individuals. If
            diagnosed early, this cancer is highly curable. However, many
            people with colorectal cancer are asymptomatic until the later
            stages of the disease and wait to seek professional advise
            until this time. As such, research and early detection through
            screening remains the key to preventing, treating, and curing
            this disease. We applaud Congress for its major step forward in
            preventing and curing this disease by providing Medicare
            coverage for screening and declaring March ``National
            Colorectal Cancer Awareness Month''. We encourage Congress to
            continue this work and require coverage for screening for all
            Americans. Further, we urge Congress to support additional
            research on colorectal cancer. Finally, we commend NCI for its
            work on the Progress Review Group (``PRG'') for colorectal
            cancer.
      --Pancreatic cancer will be diagnosed in 28,300 Americans in 2000
            with 28,200 people projected to die from this disease.--It is a
            highly lethal form of cancer with the lowest survival rate
            among all major malignancies. Like other digestive cancers,
            this cancer is frequently asymptomatic. African Americans have
            a 50 percent higher incidence and mortality rate than
            Caucasians. Further, age may increase the risk for this disease
            because the average age at diagnosis is 70 and it rarely occurs
            before 40. Diabetes mellitus has also been linked to the
            development of this cancer. We appreciate NCI's recognition of
            this growing problem and the need for research in this area
            through its establishment of pancreatic cancer PRG.
      --Of increased concern to AGA are esophageal and stomach cancers.
            Lower esophageal and upper stomach cancers are the second most
            common gastrointestinal cancers.--It is projected that 33,800
            Americans will be diagnosed and 25,100 will die in 2000 from
            these cancers. These cancers also often remain undetected
            because they are asymptomatic or present with vague symptoms.
            In fact, only 10 percent to 20 percent of patients with stomach
            cancer are diagnosed at an early stage. Both are more common in
            African Americans with stomach cancer also occurring more
            frequently in Hispanics and Asian Americans. Of heightened
            concern to AGA is Barrett's esophagus, a precursor to
            esophageal cancer, and the relationship between Barrett's and
            chronic gastroesophageal reflux disease (``GERD''). Five to ten
            percent of people with Barrett's esophagus develop cancer of
            the esophagus. We urge Congress to direct the NCI to fund a
            Progress Review Group (``PRG'') on esophageal and stomach
            cancers to further study these deadly diseases. AGA encourages
            the NIDDK to support research into the modulation and
            understanding of epithelial injury and repair to include the
            understanding of epithelial cell cycle regulation in the
            gastrointestinal tract and studies of epithelial stem cells and
            their use for developing new approaches to organogenesis and
            transplantation.
    Foodborne Illness
        Foodborne illness is estimated to cost annually $5 to $6 billion
    dollars in direct medical costs and productivity losses.--Most
    foodborne illnesses attack the gut causing gastrointestinal problems
    which may lead to dehydration and shock, and if not treated, death from
    vascular collapse and renal failure. Those populations at-risk for
    severe repercussions from foodborne illness include those with
    decreased immune systems, pregnant women and fetuses, young children,
    elderly, and those with inadequate access to health care. We appreciate
    NIDDK's efforts to further our understanding of this illness through
    its RFA on foodborne illness research which was co-sponsored by AGA
    through the American Digestive Health Foundation (``ADHF'') and the
    National Cattlemen's Beef Association. AGA recommends that Congress
    encourage the NIH, including NIDDK and NIAID, and others conducting
    foodborne illness research like the United States Department of
    Agriculture and the CDC to concentrate more intensively on research
    into treatments for foodborne illness. AGA urges NIDDK and NIAID to
    support research on (1) intestinal diseases caused by combination of
    luminal (including bacterial), environmental, and genetic factors with
    an emphasis on inflammatory bowel diseases, and (2) the reaction of the
    gut to foodborne pathogens, including research on the pathogenesis of
    the disease, the reasons for antibiotic resistance, the reaction of the
    gut to infections, the development of animal models to test therapies,
    and the invention of vaccines or substances that bind with the toxins
    to prevent the illness.
    Training of Physician-Scientists
        While research has expanded our medical knowledge and enabled
    providers to better prevent diseases, diagnose disorders, and treat
    people, there is growing concern that the number of physician-
    scientists (e.g., investigators who have medical degrees) is declining
    and that this decline will negatively impact many key future research
    endeavors. A recent study documenting this decline points to the
    tremendous debt incurred by medical school graduates who have more
    lucrative options outside of research as a primary cause. See Tamara R.
    Zemlo et al., The Physician-Scientist: Career Issues and Challenges at
    the Year 2000, 14 The FASEB Journal 221-230 (2000). Also influencing
    this trend is a decline in mentorship due to a decrease in the number
    of physician-scientist faculty in basic science departments and the
    increased clinical responsibility currently assumed by such faculty
    members. AGA views this problem as an immediate and serious threat to
    the future of biomedical research generally, and gastrointestinal
    research in particular. As such, AGA urges Congress to take the
    following steps:
      --Increase pre- and post-doctoral research training stipends;
      --Raise the salary cap for individual grant recipients to the maximum
            amount allowable under the Senior Biomedical Research Service;
            and
      --Enact the ``Clinical Research Enhancement Act of 1999'' (H.R. 1798,
            S. 1813).
                                     ______

      Prepared Statement of the National Depressive and Manic-Depressive
                                  Association

        The National Depressive and Manic-Depressive Association is pleased
    to have this opportunity to submit written testimony in support of
    fiscal year 2001 funding for mental health research supported by the
    National Institutes of Health and the National Institute of Mental
    Health.
        With nearly 300 affiliated groups in nearly every major
    metropolitan area, National DMDA is the nation's largest patient-
    directed, illness-specific organization committed to advocating for
    research toward the elimination of mood disorders; educating patients,
    professionals and the public about the nature of depression and manic-
    depression as treatable medical diseases; fostering self-help;
    eliminating discrimination and stigma; and improving access to care.
    National DMDA was founded in 1986 and is headquartered in Chicago,
    Illinois. A distinguished Scientific Advisory Board of nearly 65
    members reviews all materials published by National DMDA for medical
    and scientific accuracy and provides critical and timely advice on
    important research opportunities and treatment breakthroughs. This
    Board includes the leading researchers and clinicians in the field of
    mood disorders.
                          the impact of mood disorders
        More than 20 million American adults suffer from unipolar or major
    depression every year. An additional 2.3 million people suffer from
    manic-depression or bipolar disorder. Women are more than twice as
    likely as men to experience major depression. Two out of three people
    with mood disorders do not get proper treatment because their symptoms
    are not recognized, are misdiagnosed or, due to the stigma associated
    with mental illness, their symptoms are blamed on personal weakness.
    Depression is the leading cause of suicide in the United States. In
    fact, the suicide rate is 50 percent higher than the homicide rate in
    the United States.
        According to a recent study by the World Health Organization (WHO),
    the World Bank, and the Harvard School of Public Health, unipolar major
    depression is the leading cause of disability in the world today and
    bipolar disorder is the seventh-ranked cause of disability. The
    economic cost of mood disorders in the United States was estimated in
    1996 to be almost $44 billion per year in direct and indirect costs
    including absenteesim, mortality and lost productivity. The fact that
    mood disorders carry a higher burden of disease in our society than
    cancer illustrates the need for more adequate funding in this area for
    research. We can no longer continue to ignore the burden of mood
    disorders for our society and must focus our research resources on
    better understanding these illnesses, significantly improving
    treatments, and seeking a cure.
                progress in diagnosis, prevention and treatment
        Depression and manic-depression are highly treatable medical
    illnesses, if diagnosed and treated correctly. In fact, their treatment
    success rates are higher than for other chronic illnesses. However, one
    of the biggest obstacles to expanding access to services is the
    historical stigma surrounding mental health treatment, exemplified by
    arbitrary and unfair limits placed on access to mental health services
    by private health insurance plans. Access to treatment due to financial
    limitations is, for many patients, a huge barrier.
        Increased public awareness and understanding of mood disorders
    would contribute significantly to improved diagnoses and treatment
    rates for these potentially fatal illnesses. Tragically, individuals
    untreated or undertreated for major depression have a suicide rate in
    excess of 15 percent. The rate for those with untreated or undertreated
    bipolar disorder is over 20 percent.
        National DMDA is encouraged by the heightened attention being paid
    to mental illness as evidenced by last year's White House Conference on
    Mental Illness and the recent Surgeon General's Report on Mental
    Health. Getting people to talk openly and publicly about mental illness
    is an important first step toward reducing the stigma. But there is
    much left to be done.
        As the Surgeon General's report notes, there is a link between
    research yielding explanations of and effective treatments for mental
    illnesses and reduction of this stigma. We know that science
    destigmatizes. As more and more people come to understand that mood
    disorders are medical illnesses, not character flaws, and that they are
    treatable, we can make significant reductions in both the human and
    economic costs of these illnesses.
        Research supported by NIMH has already led to many discoveries
    resulting in improved diagnostics, prevention, and treatments, which
    has saved lives and billions of tax dollars. For example, more than
    $145 billion has been saved since 1970 as a result of the development
    of lithium treatment for bipolar illness--almost $6 billion per year. A
    study supported by NIMH showed that intervention to prevent depression
    in the workplace resulted in $1,314 per person in increased federal and
    state taxes generated over a two and a half year period, with a cost of
    only $286 per person. Finally, it has been shown that every $1 spent on
    treatment of mood disorders yields between $3 and $9 in net economic
    return on employment earnings.
        NIMH-supported research has led to new and more effective
    medications for both depression and manic-depression. We also have a
    better understanding of mood disorders and are learning more about
    their impact on cardiovascular disease, stroke and diabetes. The co-
    morbidity of depression and alcohol and tobacco use is also becoming
    clearer. Research indicates that treating addiction but not depression
    leads to failure and relapse and vice versa.
                                    genetics
        Current research indicates that there is a genetic predisposition
    to manic-depressive illness and major depression, involving multiple
    genes. Understanding the genetic basis of mood disorders will lead to
    vastly superior methods of prediction, diagnosis, treatment and
    prevention. We support a continued investment in NIH to achieve the
    completion of the human genome sequencing project and applaud the
    accelerated timetable for completion. Mapping of the human genome will
    be critical to uncovering the genetic factors involved in mental
    illness and clarifying the phenotypes of major mental disorders. We are
    pleased that NIMH has compiled a database of families with mental
    illness for genetic analysis as the science and technology becomes
    available in the near future. A high priority should also be the
    epidemiology and clinical evaluation of individuals with manic-
    depression and their family members. Of utmost importance as these
    projects move forward is respect of the privacy of those individuals
    involved, especially given the continued struggle to fight the stigma
    of mental illness. Confidentiality is of critical importance in the
    management of all medical records.
                               clinical research
        National DMDA believes that the translation of research from the
    laboratory to the bench in a rapid and efficient manner is of paramount
    importance and is pleased to see the Surgeon General's report and NIH
    leadership acknowledge the need for increased clinical research. The
    expansion of NIMH's Translational Centers program, dedicated to rapidly
    moving basic science from the lab into the clinical setting, is another
    strong step toward getting new and improved treatments to patients more
    quickly. Requiring third-party payors to support important patient care
    costs associated with promising experimental therapeutics would further
    facilitate completion of clinical evaluation at the earliest possible
    moment.
        National DMDA plays an important role in several large NIMH-
    sponsored clinical trials. Our representatives are members of oversight
    committees for trials studying the effectiveness of treatments for
    bipolar disorder (STEP-BP), the study of treatments for adolescents
    with depression (TADS), and the study treatment of individuals with
    depression who do not benefit from standard initial treatments
    (STAR*D). We are also on the advisory board of the trial studying the
    efficacy of Hypericum perforatum (St. John's wort), a compound millions
    of Americans take with very little scientific data available to show
    efficacy or safety. National DMDA participates in the oversight of
    these trials because of its belief that the priority of all clinical
    trials must always be the safety of the patient.
        We fully support NIMH plans to further expand clinical trials of
    treatments for mental illnesses, including exploration of depression in
    young children. We urge a significant increase in research of mood
    disorders in child and adolescents with special emphasis on the
    efficacy and safety of current treatments, the epidimology of these
    illnesses and improved diagnostic tools.
                   mood disorders in children and adolescents
        The issue of mood disorders in children and adolescents is of
    particular concern to National DMDA. Up to 2.5 percent of children and
    up to 8.3 percent of adolescents suffer from clinical depression, which
    if left untreated is the predominant cause of suicide, the third
    leading cause of death in males ages 15 to 24.
        While mood disorders in children and adolescents is a critical area
    of concern, virtually no research about this population exists. As the
    Surgeon General's report points out, to be effective, diagnosis and
    treatment of mental illness must take into consideration a variety of
    characteristics including age. Further, identifying depression in
    children as well as understanding its causes and how best to intervene
    during childhood offers the best hope for preventing many cases of
    adult mental illness.
        National DMDA supports the aggressive research agenda NIMH is
    pursuing in this area, including a study to examine the course and
    outcome of bipolar disorder with onset in childhood and early
    adolescence, and research examining underlying bioregulatory processes,
    neurobehavioral system, adolescent pubertal development and their links
    to major depressive disorder. We are particularly encouraged by NIMH
    efforts to strengthen the field of children's mental health research by
    creating new incentives for experienced investigators to move into
    studies of mental illness in children.
        We are pleased that NIMH will play a lead role in the Surgeon
    General's upcoming report on youth violence and support the continued
    coordination between NIMH and Centers for Disease Control (CDC) and
    other agencies to research the relationship between mental illnesses--
    including mood disorders--and suicide and other forms of violence.
                      bipolar disorder (manic depression)
        The World Health Organization has identified bipolar disorder as
    the seventh-ranked cause of disability in the world today. Nearly one
    in 100 Americans suffers from manic depression yet research in this
    area has been seriously underfunded. In fact, In 1998, NIMH spent only
    $39 million on bipolar research and it is expected to spend just $46
    million in fiscal year 1999. Congress must continue to increase its
    investment in this important area of mental health research.
                             research opportunities
        National DMDA urges NIMH to pursue genetic research aggressively in
    collaboration with other NIH Institutes, academia, the private sector
    and by continuing studies of individuals with manic depression and
    their family members. Other factors to examine in relation to genetics
    include building and refining knowledge of risk factors for mood
    disorders, developing better predictors of risk, designing and piloting
    new screening measures, advancing early-intervention strategies for
    these risk factors, and studying the role stress and the environment
    play.
        Neuroscience advances bring us to the brink of tremendous
    opportunities to understand underlying deficits in major mental
    disorders. We know more about neurobiology today than ever before and
    we must support, as a national priority, continued efforts to enable us
    to more fully exploit our recent advances. Flexibility of connections
    in the nervous system underlies many of the adaptive responses of the
    individual to the environment--including response to psychological and
    physical trauma and the more general processes underlying learning and
    memory--and such changes in the neural function are central to most
    mental disorders. The field is now poised to make deep inroads into the
    understanding of these critical processes.
        Other important opportunities include research to better
    characterize subtypes of depression; to find treatments with fewer side
    effects and understand the psychopharmacology of current
    antidepressants; and studies to close the gap between what is known
    about treating mood disorders and what is practiced, particularly in
    managed care settings. These are just a few of the research areas where
    great opportunities exist.
                                funding request
        An aggressive research agenda requires sustained funding. While we
    recognize the Subcommittee's budgetary constraints, National DMDA
    supports the effort initiated in fiscal year 1999 to double the budget
    for NIH and NIMH by fiscal year 2003. This will allow us to take full
    advantage of the many exciting mental health research opportunities
    that exist today. To continue the successes toward achieving this
    important goal, we strongly support the fiscal year 2001 funding
    recommendation of the Ad Hoc Group for Medical Research Funding of
    $20.5 billion for NIH. National DMDA supports a corresponding increase
    for NIMH.
        Sustained, stable growth in funding for NIH is needed to build upon
    past scientific achievements, address present medical needs, and
    anticipate future health challenges. Dramatic fluctuations can be as
    harmful to the research enterprise as inadequate growth.
        We appreciate your past support and look forward to working with
    you in the future to ensure a sustained commitment to mental health
    research. Together we can provide the gateway to new discoveries that
    will improve access to care and eliminate discrimination and the stigma
    associated with depression and manic-depression.
                                     ______

     Prepared Statement of the American Association of Colleges of Nursing

        The American Association of Colleges of Nursing (AACN) appreciates
    the opportunity to present this statement on funding recommendations
    for nursing research and education programs within the jurisdiction of
    the Subcommittee. AACN represents over 540 baccalaureate and graduate
    nursing education programs in senior colleges and universities across
    the United States.
        We thank the Subcommittee members for providing fiscal year 2000
    funding to the National Institute of Nursing Research (NINR) at its
    full Professional Judgment Budget level. AACN also appreciates the
    leadership of Chairman Specter and the Subcommittee over the years in
    funding nursing and health professions education programs to benefit
    the health and well being of the Nation. Our appreciation extends to
    the Subcommittee's leadership regarding the Health Resources and
    Services Administration's (HRSA) Health Profession Programs,
    particularly the Nurse Education Act (NEA) (Public Health Service Act
    Title VIII) and Scholarships for Disadvantaged Students (SDS) programs
    (in PHSA Title VII).
                     national institute of nursing research
        Mr. Chairman, we thank you and the Subcommittee for NINR's
    significant funding increase for fiscal year 2000 at an adjusted level
    of $89.522 million, an increase of $19.734 million or 28 percent more
    than the fiscal year 1999 level. The entire nursing community is
    grateful for this funding level, which brought the estimated success
    rate for NINR research project grants for fiscal year 2000 to 24
    percent, compared to the projected average of 31 percent for NIH
    overall. This is an enormous improvement over fiscal year 1999 when
    NINR's success rate was only 14 percent.
        Unfortunately the excellent progress made by the Subcommittee last
    year is threatened by the Administration's fiscal year 2001 request of
    $92.524 million, an increase of only $3 million or 3.3 percent for
    NINR. This is the lowest proposed increase of all NIH Institutes and
    Centers. The fiscal year 2001 request would continue NINR's
    disproportionately slow growth rate compared to NIH in general. Since
    1986, NINR has received only $75.5 million, or 0.6 percent of the total
    NIH growth of $12.3 billion. In fact, the entire fiscal year 2000 total
    for NINR is less than the increase provided by the Subcommittee in
    fiscal year 2000 for 10 NIH Institutes and Centers. Finally, the
    Administration's proposed NINR funding level would plunge NINR's
    projected research project grant success rate for fiscal year 2001 to
    14 percent compared to the 26 percent success rate projected for NIH
    overall. Clearly this would result in missing a significant amount of
    important scientific opportunities.
        AACN, supported by the Tri Council for Nursing and the 33 members
    of the Coalition for Nursing Research Funding, urges funding the NINR
    at $110 million, $17.476 million above the Administration's request. At
    this funding level, NINR could conduct significant new research
    recommended by its Professional Judgment Budget such as: research on
    health disparities in ethnic groups, self management of chronic
    illness, expanding end of life research to address pain, nausea, weight
    loss and caregiver issues, and studying telehealth interventions in
    rural/underserved populations.
        NINR is the lead institute at NIH to coordinate research on end-of-
    life care that is critically important to our aging population. End-of-
    life care utilizes many of the skills of nursing such as management of
    pain, handling of chronic conditions, and family counseling. As the
    American population continues to age, the importance of this research
    both to reduce morbidity and health system costs continues to grow.
    While 13 percent of the current U.S. population is 65 years of age or
    older, by the year 2030 this proportion is projected to be 20 percent.
        The Subcommittee investment in NINR is well justified as nursing
    research contributes extensively to wellness and health outcomes. The
    NINR performs a wide span of clinical research, developing and testing
    interventions to improve patient care, treat disease, manage chronic
    conditions and address other concerns. There is growing evidence of
    advances made possible through NINR research, but we will highlight
    just five recent success stories. AACN believes that based on these and
    numerous other examples, there is broad agreement that nursing research
    is making a difference in health outcomes. For example, NINR research
    has made a difference by identifying interventions to:
      --Facilitate early hospital discharges of high risk elderly patients,
            reducing the length of stays, the hospital re-admission rate
            and Medicare costs;
      --Reduce the rate of low birth weight babies among high risk women,
            as well a reducing the rate of subsequent emergency room
            admissions of the mothers and their babies;
      --Estimate the (often fatal) improper insertion of feeding tubes with
            the use of a low cost bedside chemical test;
      --Reduce high blood pressure in young urban African-American men at
            high risk for cardiovascular disease and reduce cholesterol
            levels in minority children; and
      --Avoid the need for nursing home care of elderly women by
            controlling urinary incontinence.
                            the nurse education act
        The Nurse Education Act (Public Health Service Act Title VIII)
    helps schools of nursing and nursing students prepare for a changing
    health care delivery system. Reauthorized in 1998, the NEA offers
    flexibility through expanding specific program initiatives, including
    Advanced Education Nurse Grants, Work Force Diversity Grants, Basic
    Nurse Education and Practice Grants, and an education loan repayment
    program to attract nurses to practice in shortage areas.
        Advanced Education Nurse Grants to schools help educate advanced
    practice primary care nurse practitioners and nurse midwives. The
    program also provides grants to educate master's and doctoral students
    as clinical nurse specialists, public health nurses, nurse
    administrators, faculty (a major shortage exists), nurse anesthetists,
    and non-primary care nurse practitioners and includes traineeships for
    master's and doctoral students with a limit of 10 percent of
    appropriations for doctoral traineeships. The growing number of
    elderly, increasing number of individuals with chronic diseases, high
    infant mortality rates, and rising number of uninsured and underserved
    individuals all drive the demand for affordable, cost-effective health
    care. This need is successfully met by nurses with advanced nursing
    education.
        The Work Diversity Grants program provides funds to increase
    opportunities for nursing education for disadvantaged students
    including underrepresented minorities by providing scholarships,
    stipends, pre-entry preparation, and retention activities. In addition
    to contributing to the preparation of a racially and ethnically diverse
    nursing workforce, this program contributes to the basic preparation of
    disadvantaged and minority nurses for leadership positions within
    nursing and the health care community. The minority enrollment in
    schools of nursing supported by this program is 46 percent compared to
    the national average of 19 percent.
        The Basic Nurse Education and Practice Grants can support nursing
    centers as training and care delivery sites, increase undergraduate
    enrollments (a nursing shortage looms), provide entry level training
    for practice within underserved populations, managed care facilities,
    to develop cultural competence and for other purposes. AACN recommends
    $78 million for Title VIII Nurse Education Act programs in fiscal year
    2001, $10.2 million or 15 percent more than requested by the
    Administration.
                 scholarships for disadvantaged students (sds)
        Scholarships for Disadvantaged Students (SDS) is a PHSA Title VII
    program that provides funds to disadvantaged and minority health
    professions students. Federal law directs 16 percent of the funds
    appropriated to nursing students in the program-making this the major
    federal scholarship source for undergraduate nursing students.
        The goals of the SDS Program are to increase diversity in the
    health professions and nursing workforce and improve access to health
    care. The program provides scholarships to financially needy students
    from disadvantaged backgrounds who are enrolled in schools of nursing,
    and in programs of allopathic medicine, osteopathic medicine,
    dentistry, veterinary medicine, optometry, podiatry, pharmacy,
    chiropractic, behavioral and mental health, public health, allied
    health, and physician assistants. The SDS program allows eligible
    students the opportunity to pursue health professions or nursing
    education by eliminating or reducing financial barriers that might
    otherwise prevent these students from enrolling.
        AACN recommends funding the SDS program at $43.7 million for fiscal
    year 2001, a $5.61 million or 14.7 percent above the fiscal year 2000
    level. AACN is a member of and supports the Health Professions and
    Nursing Education Coalition's recommendation of $335 million for Public
    Health Service Act Titles VII and VIII, which support health
    professions and nursing education programs.
               agency for healthcare research and quality (ahrq)
        The mission of the Agency for Healthcare Research and Quality
    (AHRQ) is to support, conduct, and disseminate research that improves
    the outcomes, quality, access to, and cost and use of health care
    services. This mission, which focuses on the effectiveness and value of
    health care in daily practice, is unique and complements the biomedical
    and behavioral research responsibilities of the NIH. The products of
    the Agency include knowledge that supports decision making to improve
    health care, and tools that help improve quality and reduce costs. In
    view of the AHRQ's significant contributions to health outcomes, the
    AACN recommends appropriate increases for the AHRQ budget in fiscal
    year 2001.
                         national institutes of health
        AACN applauds the leadership of Chairman Specter and the
    Subcommittee in the continuing campaign to double the NIH budget in 5
    years. The investment in biomedical and behavioral research has
    propelled a remarkable transformation in our understanding of the life
    sciences and has given us a bounty of new ways to prevent, treat, and
    cure disease. Major threats to public health have been reduced, quality
    of life has improved, and life expectancy has continued to rise. A
    child born in the United States today can be expected to live 76.5
    years, 3.9 years longer than a child born in 1975. AACN joins the Ad
    Hoc Group for Medical Research Funding in recommending a fiscal year
    2001 funding level of $20.47 billion for the NIH, a 15 percent increase
    over the fiscal year 2000 level.
                             indian health service
        Mr. Chairman, the Indian Health Services (IHS) provides vital
    health services to our Native American populations and nursing
    professionals have been a central component of the IHS health delivery
    system since the agency's inception. The IHS provides direct health
    care services in 37 hospitals, 61 health centers, 4 school health
    centers, and 48 health stations. Tribes and tribal groups, through
    contracts with the IHS, operate 12 hospitals, 134 health centers, 4
    school health centers, and 241 health stations (including 168 Alaska
    village clinics.) The IHS, tribes and tribal groups also operate 7
    regional youth substance abuse treatment centers. AACN recommends
    increases for the Indian Health Service for fiscal year 2001.
    higher education act programs--student financial and general assistance
        There are several student financial and general assistance programs
    that are particularly important to the nursing community. The Pell
    Grant Program helps ensure access to post secondary education for low
    and middle income undergraduate students by providing grants that, in
    combination with other sources of student aid, help meet post secondary
    education costs. The Federal Work Study Program ensures access by
    assisting needy undergraduates and graduate students in financing post
    secondary education costs through part time employment. The TRIO
    Programs fund post secondary education outreach and student support
    services designed to encourage individuals from disadvantaged
    backgrounds to enter and complete college. AACN recommends increases
    for each of these programs over the levels provided in fiscal year
    2000.

            SUMMARY OF AACN HIGHEST PRIORITY FISCAL YEAR 2001 FUNDING
                                 RECOMMENDATIONS
                            [In millions of dollars]
    ------------------------------------------------------------------------
                                         Fiscal year        Fiscal year 2001
        Highest AACN priority     -------------------------       AACN
            recommendation            2000         2001      recommendation
    ------------------------------------------------------------------------
    National Institute of Nursing       89.5        92.524             110
     Research....................
    Nurse Education Act..........       67.8        65.576              78
    Scholarships for                    38.09       38.09               43.7
     Disadvantaged Students......
    ------------------------------------------------------------------------

                                     ______

                    Prepared Statement of The Humane Society

        We appreciate the opportunity to provide testimony to the Labor,
    Health and Human Services, and Education Subcommittee on two funding
    items of great importance to The Humane Society of the United States
    (HSUS) and its 7.3 million supporters nationwide. As the largest animal
    protection organization in the country, The HSUS urges the Committee to
    address these priority issues in the fiscal year 2001 budget.
                      class b random source animal dealers
        The HSUS is grateful for the leadership of Chairman Specter,
    Ranking Democrat Harkin, and this Committee in raising concerns last
    year about the problem of Class B dealers, who acquire the animals they
    sell to biomedical research facilities from a variety of sources,
    including ``free to good home'' ads, animal shelters, and outright
    theft of family pets. Squalid conditions, abusive handling, sickly and
    under-cared for animals, and sloppy record-keeping are the hallmarks of
    Class B dealers. As Robert A. Whitney, D.V.M. and former Director of
    both the National Center for Research Resources and the Office of
    Animal Care and Use at NIH, testified in July 1997, ``The continued
    existence of these virtually unregulatable Class B dealers erodes the
    public confidence in our commitment to appropriate procurement, care,
    and use of animals in the important research to better the health of
    both humans and animals.''
        Committee Report language accompanying the fiscal year 2000
    appropriations encouraged NIH to consider extending its intramural
    research practice of using only purpose-bred animals (not those
    obtained from Class B dealers) to the extramural research funded by NIH
    as well. Unfortunately, NIH has taken no clear steps since last year's
    legislation to ensure that taxpayer dollars will not be used in the
    future to support research on animals obtained through Class B dealers.
    Consequently, we urge the Committee this year to direct NIH, in bill
    language, not to award grants for research projects that utilize random
    source dogs or cats supplied by Class B dealers. We commend NIH for its
    internal research practice, but feel strongly that NIH should exercise
    the same caution and concern with respect to its grant recipients. The
    public deserves to know that animals used in government-funded research
    have not been stolen from their families or obtained through other
    disreputable means commonly employed by Class B dealers.
                             chimpanzee sanctuaries
        We also consider it a high priority for the 106th Congress to enact
    H.R. 3514, legislation to establish a federal chimpanzee sanctuary
    system for the permanent retirement of chimpanzees no longer needed in
    medical research. This cost-effective and humane approach to dealing
    with the problem of ``surplus chimpanzees,'' who were overbred and
    languish in laboratories across the country, deserves to be enacted by
    this Congress. It will save taxpayers considerable money in the long
    run, and significantly improve the quality of life for these animals
    who have served humanity but are now simply being warehoused in costly
    research facilities.
        Along with the united support of the animal protection community,
    H.R. 3514 has been endorsed by more than 100 members of the scientific
    and academic community who have particular expertise involving
    chimpanzees, as follows:
        Jonathan S. Allan, D.V.M., Scientist--Department of Virology and
    Immunology, Southwest Foundation for Biomedical Research (San Antonio,
    TX)
        American Zoo and Aquarium Association (Silver Spring, MD)
        James Anderson, Ph.D., Senior Lecturer in Psychology--University of
    Stirling (Stirling, Scotland)
        Kate Baker, Ph.D., Research Associate--Yerkes Regional Primate
    Research Center, Emory University (Atlanta, GA)
        Marc Bekoff, Ph.D., Professor of Environmental, Population and
    Organismic Biology--University of Colorado (Boulder, CO)
        Carol Berman, Ph.D., Professor of Anthropology--University of
    Buffalo (Buffalo, NY)
        Tammie Bettinger, Ph.D., Curator of Conservation and Science--
    Cleveland Metroparks Zoo (Cleveland, OH)
        Joseph T. Bielitzki, MS, DVM, Chief Veterinary Officer--NASA
    (Mountain View, CA)
        Mollie Bloomsmith, Ph.D., Director of Research and Director of
    TECHlab Zoo Atlanta; Affiliate Scientist--Yerkes Regional Primate
    Research Center, Emory University (Atlanta, GA)
        Carolyn Bocian, Ph.D.
        Sarah Boysen, Ph.D., Director of Primate Cognition Project and
    Associate Professor of Comparative Psychology--Ohio State University
    (Columbus, OH)
        Hilary O. Box, Ph.D., Senior Lecturer in Psychology--University of
    Reading; Vice President for Captive Care, Primate Society of Great
    Britain and the International Primatological Society (Reading, UK)
        Linda Brent, Ph.D., President Chimp Haven, Inc. (San Antonio, TX)
        Betsy Brotman, Director--Vilab II (Robertsfield, Liberia) and the
    New York Blood Center (New York, NY)
        Hannah Buchanan-Smith, Ph.D., Lecturer in Psychology--University of
    Stirling, (Stirling, Scotland)
        Thomas Butler, D.V.M.
        Richard W. Byrne, Ph.D., Professor of Evolutionary Psychology--The
    University of St Andrews; Vice President for Membership, International
    Primatological Society (St Andrews, Scotland)
        Nancy Caine, Ph.D., Professor of Psychology--California State
    University San Marcos (San Marcos, CA)
        John Capitanio, Ph.D., Associate Professor of Psychology--
    University of California at Davis; Staff Scientist--California Regional
    Primate Research Center
        Gary Comstock, Ph.D., Associate Professor of Philosophy and
    Religious Studies & Coordinator Bioethics Program--Iowa State
    University (Ames, IA)
        Robert Cooper, D.V.M.
        Colleen Crangle, Ph.D., Computer Science (Palo Alto, CA)
        Steve Davis, D.V.M., Professor of Animal Sciences--Oregon State
    University (Corvallis, OR)
        David DeGrazia, Ph.D., Associate Professor of Philosophy--George
    Washington University; Senior Research Fellow--Kennedy Institute of
    Ethics, Georgetown University (Washington, DC)
        Frans de Waal, Ph.D., Chandler Professor of Primate Behavior
    Psychology Department, and Director of LIVING LINKS CENTER--Yerkes
    Regional Primate Research Center, Emory University (Atlanta, GA)
        Wendy Dirks, Ph.D., Assistant Professor of Anthropology--New York
    University (New York, NY)
        Merelyn T. Dolins, Ph.D., Director of Physical Therapy--Department
    of Child Development and Rehabilitation, Valley Hospital (Paramus, NJ)
        Francine L. Dolins, Ph.D., Program Scientist for Research,
    Behavioral Primatologist Animal Research Issues--The Humane Society of
    the United States (Washington, DC)
        Alessandro Duranti, Editor, Journal of Linguistic Anthropology,
    Department of Anthropology--University of California at Los Angeles
    (Los Angeles, CA)
        Stephen Easley, Ph.D., Director--Easley and Associates,
    Professional Consultants (Alamorgordo, NM)
        Sian Evans, Ph.D., The DuMond Conservancy (Miami, FL)
        Brian Fay, Ph.D., Professor of Philosophy--Wesleyan University
    (Middletown, CT)
        Jo Fritz, Director--Primate Foundation of Arizona (Mesa, AZ);
    Member, National Research Council Committee that produced 1997 Report,
    Chimpanzees in Research: Strategies for Their Ethical Care, Management,
    and Use
        Randy Fulk, Ph.D., Curator of Research--North Carolina Zoological
    Park (Asheboro, NC)
        Paul A. Garber, Ph.D., Professor of Anthropology--University of
    Illinois (Urbana, IL)
        Michele L. Goldsmith, M.S., Ph.D., Assistant Professor of
    Environmental and Population Health Center for Animals and Public
    Policy--Tufts University School of Veterinary Medicine (North Grafton,
    MA)
        Jane Goodall, Ph.D.--The Jane Goodall Institute (Silver Spring, MD)
        Thomas Gordon, Ph.D., Director--Yerkes Regional Primate Research
    Center, Emory University (Atlanta, GA)
        Lisa Gould, Ph.D., Assistant Professor of Anthropology--University
    of Victoria (Victoria, Canada)
        Victoria Hampshire, D.V.M., Director--Advanced Veterinary
    Applications (Bethesda, MD)
        Beatrice H. Hahn, M.D., Professor of Medicine and Microbiology--
    University of Alabama (Birmingham, AL)
        Lynette Hart, Ph.D.
        Ned Hettinger, Ph.D., Professor of Philosophy--College of
    Charleston (Charleston, SC)
        Robert A Hinde, Ph.D., Professor Emeritus--Cambridge University;
    Fellow of the Royal Society; Honorary Foreign Associate of the National
    Academy of Sciences (Cambridge, UK)
        William D. Hopkins, Ph.D., Professor of Psychology--Berry College
    (Rome, GA); Research Associate--Yerkes Regional Primate Research
    Center, Emory University (Atlanta, GA)
        Sue Howell, Ph.D., Research Director--Primate Foundation of Arizona
    (Mesa, AZ)
        Robert Hubrecht, Ph.D.--University Federation for Animal Welfare,
    United Kingdom
        Ellen Ingmanson, Ph.D. Assistant Professor of Anthropology--
    Dickinson College (Carlisle, PA )
        Thomas Insel, M.D. , Director--The Center for Behavioral
    Neuroscience, Emory University (Atlanta, GA)
        Joseph Jacquot, Ph.D., Professor of Biology--Grand Valley State
    University (Allendale, MI)
        Alicia Karas, D.V.M., Dipl. ACVA, Assistant Professor of
    Anesthesiology--Tufts University School of Veterinary Medicine, Foster
    Hospital for Small Animals (North Grafton, MA)
        Michael Kastello, D.V.M, Executive Director, Research Resources--
    Merck & Co., Inc. (Rahway, NJ)
        James King, Ph.D., Professor of Psychology--University of Arizona
    (Tucson, AZ)
        Bette Korber, Ph.D., Research Scientist--Santa Fe Institute (Santa
    Fe, NM)
        A. Lanny Kraus, D.V.M., Dipl. ACLAM, Professor Emeritus--Division
    of Laboratory Animal Medicine, University of Rochester School of
    Medicine & Dentistry, (Rochester, NY)
        Susan P. Lambeth, Environmental Enrichment Director--M.D. Anderson
    Cancer Center (Bastrop, TX)
        Louise Lamphere, Ph.D,, Professor of Anthropology--University New
    Mexico (NM)
        Virginia Landau, Ph.D., Staff Primatologist--The Jane Goodall
    Institute (Silver Spring, MD); Director--ChimpanZoo (Tucson, AZ)
        Clark Larsen, Ph.D., Amos Hawley Professor of Anthropology--
    University of North Carolina (Chapel Hill, NC)
        Alecia Lilly, Ph.D., Research Fellow--Department of Anthropology,
    State University of New York (Stony Brook, NY)
        Orla Mahoney, D.V.M.--Tufts University, School of Veterinary
    Medicine (North Grafton, MA)
        Terry Maple, Ph.D., President and CEO--Zoo Atlanta (Atlanta, GA)
        Linda Marchant, Ph.D., Professor of Anthropology--Miami University
    (Oxford, OH)
        Preston A. Marx, Ph.D., Senior Scientist and Professor of Tropical
    Medicine--Tulane University Medical Center (Covington, LA) and Aaron
    Diamond AIDS Research Center (New York, NY)
        William C. McGrew, Ph.D., Professor of Zoology--Miami University
    (Oxford, OH)
        Patrick Mehlman, Ph.D., Director of Mondika Primate Research
    Center--Department of Anthropology, State University of New York (Stony
    Brook, NY)
        Robert Mitchell, Ph.D., Associate Professor of Psychology--Eastern
    Kentucky University (Richmond, KY)
        John Moore, Ph.D., Scientist--Aaron Diamond AIDS Research Center,
    The Rockefeller University (New York, NY)
        Toshisada Nishida, Ph.D., Professor of Anthropology, President of
    the International Primatological Society--Kyoto University (Kyoto,
    Japan)
        April Nowell, Ph.D., Professor of Anthropology--University of
    Victoria (Victoria, Canada)
        John Oates, Ph.D., Professor of Anthropology--Hunter College, City
    University of New York (New York, NY)
        Barbara Orlans, Ph.D., Senior Research Fellow--Kennedy Institute of
    Ethics, Georgetown University (Washington, D.C.)
        Sue Taylor Parker, Ph.D., Professor of Anthropology--Sonoma State
    University (Rohnert Park, CA)
        Gary J. Patronek, VMD, PhD, Director--Tufts Center for Animals and
    Public Policy (North Grafton, MA)
        Andrew Petto, Ph.D., Editor and Assistant Professor--National
    Center for Science Education, University of the Arts (Philadelphia, PA)
        Evelyn Pluhar, Ph.D., Professor of Philosophy--Penn State
    University (University Park, PA)
        Trevor Poole, Ph.D.--University Federation for Animal Welfare
    (England)
        Alfred M. Prince, M.D.--The New York Blood Center (New York, NY)
        Jill Pruetz, Ph.D. Postdoctoral Fellow--Department of Anthropology,
    Miami University (Oxford, OH)
        Anne E. Pusey, Ph.D., Distinguished McKnight Professor of Ecology,
    Evolution & Behavior--University of Minnesota (St Paul, MN)
        Ed Ramsey, D.V.M., University of Tennessee
        Viktor Reinhardt, Ph.D., Laboratory Animal Specialist--Animal
    Welfare Institute (Washington, DC)
        Vernon Reynolds, Ph.D. Professor of Biological Anthropology--
    Institute of Biological Anthropology, Oxford University (Oxford, UK)
        Anthony Rose, Ph.D., Director--The Biosynergy Institute (Hermosa
    Beach, CA)
        William E. Roudebush, Ph.D., Associate Professor of Obstetrics &
    Gynecology and Molecular Cell Biology & Pathobiology; Treasurer,
    International Primatological Society--Medical University of South
    Carolina (Charleston, SC)
        Andrew N. Rowan, D. Phil., Senior Vice President of Research,
    Education & International Affairs--The Humane Society of the United
    States (Washington, DC)
        Thomas Jefferson Rowell, D.V.M., Director--University of
    Southwestern Louisiana, Lafayette-NIRC (New Iberia, LA)
        Duane Rumbaugh, Ph.D., Director--Language Research Center, Georgia
    State University (Atlanta, GA)
        Lilly-Marlene Russow, Ph.D., Professor of Philosophy--Purdue
    University (West Lafayette, IN); Member, National Research Council
    Committee that produced 1997 Report, Chimpanzees in Research:
    Strategies for Their Ethical Care, Management, and Use
        Anthony Rylands, Ph.D.--Conservation International and IUCN/SSC,
    Primate Specialist Group
        Dale Schwindaman, D.V.M.
        Jack F. Sharp, President--Biomedical Research Foundation of
    Northwest Louisiana (Shreveport, LA)
        James Serpell, Ph.D., Associate Professor of Humane Ethics & Animal
    Welfare, and Director--Center for the Interaction of Animals & Society,
    Department of Clinical Studies, School of Veterinary Medicine,
    University of Pennsylvania (Philadelphia, PA)
        Yukimaru Sugiyama, Ph.D., Professor Emeritus of Kyoto University
    and Dean of Faculty of Humanities--Tokai-gakuen University; President
    of Primate Society of Japan
        Erna Toback, Ph.D., Assistant Professor of Psychology--Santa Monica
    College (Santa Monica, CA) and University of Stirling (Stirling,
    Scotland)
        Joel Trupin, Ph.D. Professor of Biochemistry--Meharry Medical
    School (Nashville, TN)
        Caroline Tutin, Ph.D., Senior Research Fellow--Centre International
    de Recherches Medicales, (Franceville, Gabon); Department of Biological
    and Molecular Sciences--University of Stirling (Stirling, Scotland)
        Augusto Vitale, Ph.D., Research Fellow in Animal Behaviour Section
    of Comparative Psychology--Laboratorio di Fisiopatologia di Organo e di
    Sistema, Istituto Superiore di Sanita' (Rome, Italy)
        Janette Wallis, Ph.D., Associate Professor of Research--Department
    of Psychiatry & Behavioral Sciences, University of Oklahoma Health
    Sciences Center (OK)
        Lyna Watson, Ph.D. Affiliated Scientist--Zoo New England (Boston,
    MA)
        Francoise Wemelsfelder, Ph.D., Research Fellow in Animal Welfare,
    Animal Biology Division--Scottish Agricultural College (Edinburgh,
    Scotland)
        Brent C. White, Ph.D., Matton Professor of Psychology--Centre
    College (Danville, KY)
        Roger D. White, M.D., Anesthesiology (Rochester, MN)
        Thomas Wolfle, D.V.M., Retired Director--Institute of Laboratory
    Animal Research, National Research Council; Program Director, National
    Research Council Committee that produced 1997 Report, Chimpanzees in
    Research: Strategies for Their Ethical Care, Management, and Use
        Richard Wrangham, Ph.D., Professor of Anthropology--Department of
    Anthropology, Harvard University (Cambridge, MA)
        Stephen L. Zawistowski, Ph.D., Certified Applied Animal
    Behaviorist, Senior Vice President and Science Advisor--The American
    Society for the Prevention of Cruelty to Animals; Co-Editor, Journal of
    Applied Animal Welfare Science (New York, NY)
        The HSUS was very pleased to learn of the possibility, raised by
    House Subcommittee Chairman John Porter at a recent hearing, that H.R.
    3514 may be incorporated into the fiscal year 2001 Labor-HHS
    Appropriations bill. We would strongly support that as a way to ensure
    enactment of this vital legislation in the 106th Congress. We also
    strongly support efforts in this appropriations bill to address the
    crisis facing hundreds of chimpanzees at The Coulston Foundation in
    Alamogordo, New Mexico, where recurrent mismanagement and inappropriate
    veterinary care have caused several painful and needless chimpanzee
    deaths.
        Again, we appreciate the opportunity to share our views and
    priorities for the Labor, Health and Human Services, and Education
    Appropriation Act of fiscal year 2001. We hope the Committee will be
    able to accommodate these requests to alleviate some very pressing
    problems affecting animals across the United States. Thank you for your
    consideration.
                                     ______

              Prepared Statement of the National Sleep Foundation

        Mr. Chairman, distinguished Members of this Subcommittee, thank you
    for allowing us to present testimony on fiscal year 2001 Appropriations
    for the Centers for Disease Control and Prevention.
        The National Sleep Foundation (NSF) is a science-based, non-profit
    voluntary health organization dedicated to promoting awareness about
    the importance of good sleep, sleep disorders, and the consequences of
    sleep deprivation.
        The National Institutes of Health estimates that 40 million
    Americans suffer from chronic sleep disorders the vast majority of
    which remain undiagnosed and untreated and another 20 to 30 million
    suffer intermittent sleep-related problems. An NSF survey found that
    fifty-eight million Americans report suffering excessive daytime
    sleepiness at levels that interfere with their day-to-day activities.
    Evidence tells us that Americans sleep debt is on the rise, yet
    numerous studies have concluded that the general public and primary
    care physicians lack the basic sleep knowledge to address these
    problems. As a result, the toll on human health, safety and
    productivity is enormous. NSF and sleep experts like myself take this
    chronic sleep deprivation very seriously. Lack of adequate amounts of
    sleep has been associated with significant physical and mental
    problems. For example, cardiovascular disease, gastrointestinal
    disorders, mood disorders and drug abuse are more prevalent among shift
    workers. This problem is more than simply getting a good nights rest.
    It encompasses medical problems, lack of education, and the tools
    required to address this public health crisis.
        Sleepiness, whether the result of untreated sleep disorders or
    volitional sleep deprivation has been identified as a causal factor in
    a growing number of on-the-job injuries. This corresponds directly in
    lost productivity, personal injuries, medical expenses, property and
    environmental damage due to fatigue, sleep disorders and sleep
    deprivation and is estimated to exceed $100 billion each year. It is,
    however, the personal injuries that are the most tragic part of this
    equation. In my daily practice, I routinely hear stories of drivers who
    fall asleep at the wheel and kill themselves, a family member, or an
    innocent bystander.
        In the first-ever case-controlled epidemiological study of drowsy
    driving crashes recently completed by one of our partners, the AAA
    Foundation for Traffic Safety, work and sleep schedules were strongly
    associated with involvement in a sleep-related crash. Compared to
    drivers in non-sleep crashes, drivers in sleep crashes were nearly
    twice as likely to work at more than one job and their primary job was
    more likely to involve an atypical schedule. This characterizes many
    Americans and yet, represents a crisis in our country that remains to
    be largely unaddressed except by organizations like the National Sleep
    Foundation and AAA.
        The National Sleep Foundation has taken some small steps to work on
    lowering the number of injuries associated with sleepiness. NSF, in
    cooperation with many partners, has successfully mounted state programs
    in New York, Arkansas, California, Washington, Oregon and Idaho that
    target fatigue-related injuries. In New York, NSF worked with state and
    federal agencies and other partners to launch the nations first
    statewide public information and injury prevention program related to
    the dangers of sleep deprivation. Unfortunately, NSF alone does not
    have the resources to continue to mount these state-by-state campaigns.
    Information gathered by our sleep polls and work in the states also
    suggests that the percentage of population adversely affected by
    sleepiness is higher than current statistical information provides.
        Let us provide one example that illustrates the problem. The AAA
    study points out that countermeasures or strategies that drivers
    typically employ, rolling down the car windows, turning up the radio,
    or stopping to stretch are largely unsupported by the scientific
    literature. Yet these strategies were often cited by our drivers and
    are believed by them to be anywhere from somewhat, to very effective in
    countering drowsy driving. Let us be clear almost all experts agree
    that the only truly effective strategy drowsy drivers can take to
    prevent a crash is to immediately stop driving and get some sleep. If
    this is not possible, drivers should be encouraged to stop, drink some
    caffeine (the equivalent of two cups of coffee), and take a brief nap
    before getting back behind the wheel.
        Traffic safety data is incomplete due to the difficulty in
    measuring the role sleepiness played in an accident investigation. This
    is in part due to the fact that sleepiness is often overlooked when
    investigating work or traffic related injuries. This problem exists in
    every area that sleepiness is a problem. Yet we believe, through work
    at the National Center for Injury Prevention and Control at the Centers
    for Disease Control and Prevention (CDC), we can begin to adequately
    address this crisis, particularly in the area of physician education.
        In our discussions with CDC it is clear that sleepiness crosscuts
    many centers. This is not only an issue for the National Center for
    Injury Prevention and Control but also the National Institute for
    Occupational Safety and Health and the National Center for Chronic
    Disease Prevention and Health Promotion at the very least. The common
    question of all these Centers revolves around data collection. It is
    this first step we would propose that the Subcommittee consider
    providing funding for.
        The NSF has the network of experts in the sleep field. The CDC has
    links to other health divisions who address at risk patient populations
    including shift workers and adolescents. We seek support for the
    development of evaluative research, including data collection, through
    the National Center for Injury Prevention and Control at CDC. This
    would likely include an attempt to validate or improve existing surveys
    and survey methodologies. It would also evaluate new ways to capture
    data and validate program effectiveness. The data from this research
    will allow us to develop accurate and informative material and model
    programs to provide to states as they address these important issues.
        NSF experts are willing to work with CDC to reach out to
    corporations and other partners to develop accurate data collection
    methods to identify the scope of the problem. One area where more data
    would be helpful is with the accurate medical diagnosis of sleep
    disorders. A recent study in Walla Walla, Washington concluded that
    sleep apnea is significantly under recognized by primary care
    physicians. The study was done through the utilization of primary care
    physicians who were trained to recognize the warning symptoms of
    certain sleep disorders. With this training, physicians were able to
    diagnose and ultimately recommend treatment to hundreds of people for
    sleep apnea and restless legs syndrome. These disorders are not unique
    to Walla Walla, but are believed to affect millions of Americans.
    Patients are receiving no diagnosis or treatment due to a general lack
    of training within the physician community. In this instance, a
    significant public health problem is identified and a solution
    established. Accurate data from the health care community along with
    additional training would show the extent of the problem and allow us
    to target physicians who are on the front lines of our health care
    system.
        Current CDC resources within the National Center for Injury
    Prevention and Control are allocated for other projects that are of
    equal importance to the country. It is with this recognition that we
    ask the subcommittee to increase the overall budget for this center by
    $1.2 million to allow the Center to act as the coordinating body for
    the gathering and evaluation of the types of data discussed above.
        This data will allow the NSF, CDC, and other federal agencies to
    develop and distribute accurate medically sound information. This
    information coupled with training for those involved with public health
    and safety at the state level will begin to turn the tide of injuries
    and costs associated with sleepiness and sleep disorders.
        Thank you for consideration of this request.
                                     ______

      Prepared Statement of the National Center for Learning Disabilities

        Mr. Chairman, my name is Anne Ford and I am the volunteer Chairman
    of the Board of Directors for the National Center for Learning
    Disabilities (NCLD). NCLD is a not-for-profit organization founded in
    1977, which seeks to ensure that all individuals with learning
    disabilities (LD) gain access to research-based knowledge and
    opportunities to fully achieve their potential. NCLD protects the
    rights of individuals with LD and promotes the widespread
    implementation of effective research-based instructional methods. As
    Chairman of NCLD for the past ten years, and as a parent of a child
    with learning disabilities, I am keenly aware of the need for greater
    access to services and increased awareness among parents, early child
    care providers, teachers and other professionals about how early
    recognition and intervention can lead to greater success for children
    in school and beyond.
        I am pleased to submit this testimony to encourage the committee's
    endorsement of a Literacy Early Screening Initiative supported by the
    National Institute of Child Health and Human Development (NICHD), in
    partnership with NCLD. The focus of the initiative is to assure that
    parents, early child care providers, teachers and other professionals
    have a research-based, easy-to-use tool to screen preschool-age
    children for behaviors that place them at risk for reading failure, and
    the information, training and support to implement screening on a
    nationwide basis.
                                   background
        The impetus for this early reading screening initiative comes from
    the convergence of data from a number of sources. Studies of early
    learning (Ramey, et al, 1985), patterns of early care in families
    (Hofferth, 1996), the efficacy of early instruction and intervention
    (Snow, et al, 1998), the benefits of quality child care (Phillips, et
    al, 1987), early brain development (Huttenlocher, 1995), and the
    benefits of early identification of risk factors in young children
    (Fletcher et al, 1994) all support the initiative's premise that
    learning difficulties identified early in a child's life can circumvent
    the longer-term consequences of school failure.
        Due in great part to longitudinal studies conducted by NICHD, there
    is already a considerable body of evidence regarding the specific
    aspects of young children's physical, cognitive, and social behaviors
    that are most predictive of later learning difficulty, particularly in
    the area of early reading and related literacy skills (National Reading
    Panel, 2000). Studies have shown that learning to read is a process
    that begins very early in development, well before children enter
    formal schooling. There is a strong and critical relationship between
    the amount and quality of early language, literacy interactions and
    experiences, and the acquisition of linguistic skills necessary for
    reading (Lyon, 1999).
                       need for research-based screening
        A number of complementary efforts are underway to ensure that the
    United States becomes a nation of readers. The America Reads Challenge,
    the Reading Excellence Program and the creation of the National
    Institute for Literacy are a few examples of major efforts through
    which commitments have been made by the federal government. These
    programs are working to enable all citizens, both young and old, with
    and without special educational needs, to develop strong reading and
    other literacy skills. These and other successful programs show how
    government and private organizations are working to assure universal
    school readiness to all our nation's youth.
        There is a shared vision among parents, early care providers,
    educators, and policy officials to develop strong reading and other
    literacy skills in our nation's children. However, there has been no
    coordinated effort to date that addresses the need of parents and early
    care providers to identify children who show signs of early literacy
    difficulties and, in particular, to provide research-based information
    and support. This initiative will provide parents and early care
    providers with an understanding of these findings, an ability to screen
    children for behaviors that place them at risk for reading failure, and
    the information needed to take effective steps toward assuring all
    children early success in learning to read.
                                 the initiative
        Through the Literacy Early Screening Initiative, NCLD, under the
    direction of NICHD, will direct the development of a research-based
    screening tool. This tool will reflect the most current knowledge on
    reliable early predictors of reading success and early identification
    of literacy problems in the preschool and early elementary grades. The
    initiative will create and support a development team of national
    experts to design the screening tool. An advisory committee will also
    inform the ongoing collaborative relationships upon which the
    implementation of the initiative will be based.
        As a leading not-for-profit organization committed to the well
    being of all children, including those with learning disabilities, NCLD
    is ideally suited to work with NICHD and launch a collaborative
    initiative of this nature. In May 1999, NCLD hosted a national summit
    on research in learning disabilities in partnership with the U.S.
    Department of Education, Office of Special Education Programs (OSEP)
    and the National Institutes of Health, NICHD. With our partners, NCLD
    released syntheses of 20 years of study and convened over 400 national
    leaders to propose ways to shorten the distance between research and
    classroom practice.
        In the first phase of the project, NCLD will take the following
    steps to launch the initiative in Kentucky and Mississippi:
      --Establish a nationally recognized Development Team to assess the
            research evidence and select key predictors for the core of the
            tool.
      --Establish an Advisory Committee of nationally recognized experts to
            provide ongoing expertise and guidance.
      --Engage a Project Director to manage the work.
      --Identify successful strategies to reach target audiences.
      --Design and pilot test the screening tool.
      --Confirm partnerships in key states for roll out.
      --Develop content and infrastructure on NCLD's Web site and other
            information sources.
      --Conduct outcome evaluation activities.
      --Develop a plan for national roll out.
                                 implementation
        Once the screening tool is developed, training, dissemination, and
    marketing activities will be carried out in Kentucky and Mississippi in
    partnership with early childhood education, child care, and family
    support organizations as well as with professional organizations whose
    activities focus on the well-being of young children and their
    families. Local and national partners may include:
      --American Library Association
      --National Association for the Education of Young Children
      --National Association for Family Childcare
      --National Center for Family Literacy
      --National Head Start Association
      --National Institute for Literacy
      --National Parent Teachers Association
      --Reach Out and Read
      --WGBH/Between the Lions
      --Yale University Bush Center/21st Century Schools
      --University of Louisville
      --University of Southern Mississippi/Center for Literacy and
            Assessment
        Working in partnership, we will use select media conduits and other
    methods known to be effective in reaching specific groups of
    individuals such as parents of preschool-age children, early childhood
    educators, health care professionals, and other information and service
    providers.
        Based on its own research and marketing strategies, the project
    will ensure extensive use of the tool by promoting its `user
    friendliness' and utility for non-expert users through its own and
    other organizations' Web sites. Opportunities for volunteer marketing
    through food, toy and clothing manufacturers will also be explored, as
    will ways to incorporate information about the screening tool in
    corporate employee assistance programs and human resource services. Of
    special interest will be opportunities to promote the use of this early
    screening tool through relationships with major PBS outlets.
        Mr. Chairman, by supporting this project, you have the chance to
    bring our collective investment in research to the next level. It's an
    exciting challenge and opportunity. Together, we can help parents and
    others vested in our children's success have direct access to an easy-
    to-use tool that can determine whether to seek early intervention and
    professional assessment to prevent reading failure. By spending a
    limited amount of time and money early in a child's life, we can help
    prevent spending hundreds of thousands later. Perhaps we can stop the
    heartache and frustration that comes from wondering what could have
    been done if we had only known. Let's take action with the reliable
    science available to us and give young children an early chance at
    success in school and in their lives. Thank you for your consideration
    and support.
                                     ______

            Prepared Statement of the Council for Chemical Research

        Issue.--The National Institutes of Health (NIH), through the
    National Institute of General Medical Sciences (NIGMS), is one of the
    largest funders of synthetic chemistry--the heart of advances in
    medicinal chemistry. While the Administration's requested fiscal year
    2001 budget for NIH contains a 5.6 percent increase, it fails to meet
    the 7 percent needed to reach the congressional goal of doubling
    federal spending on research in ten years.
                                    position
        The Council for Chemical Research (CCR) endorses the congressional
    goal of doubling the total federal spending on research within a
    decade. To achieve this end requires an average increase for NIGMS of 7
    percent each year for ten years. For this reason, the CCR applauds the
    commitment Congress made to NIH with the approval of a 14.2 percent
    increase for fiscal year 2000. The Council believes that in the
    present, strong economy it would not be prudent for the NIH-NIGMS
    budget to increase at a rate less than the 7 percent average needed to
    reach our mutual goal. Therefore, the CCR strongly supports increasing
    the federal investment in NIH beyond the Administration request to
    further strengthen the national investment in basic research, since
    discoveries in biomedical research are very highly dependent progress
    in chemistry and chemistry related sciences. Moreover, increasing our
    investment in research will lay the basis for the future continuation
    of our strong economy.
                                   rationale
        NIGMS provides the enabling research and training for the
    biomedical community that underpins the advances and discoveries of
    other NIH institutes. This Institute is responsible for generating
    basic knowledge and new technologies which is the spring from which
    discovery in the biomedical field pours. NIGMS supports three crucial
    aspects of chemical research:
      --Basic research in chemistry provides the foundation of many
            biomedical advances. It has led to combinatorial chemistry
            methods and rational drug design, which allow for the more
            efficient development of pharmaceuticals having greater
            potency, higher selectively, and fewer side effects.
      --The single most important element of any research program is the
            presence of well-trained, talented, and dedicated
            investigators. Training programs at NIGMS develop the multi-
            disciplinary skills demanded by modern biomedical and
            pharmaceutical research. Well-trained researchers not only
            increase productivity for the rapidly expanding biotechnology,
            pharmaceutical, and diagnostic industries, but also help
            maintain the world leadership of these industries in extremely
            competitive markets. Moreover, to maintain this strong pool of
            researchers the first priority in allocating NIH budget
            increases should be to support more investigator-initiated
            research grants and to fund this increased number of proposals
            at the appropriate levels needed for their successful
            execution.
      --Basic research requires access to modern instrumentation ranging
            from computers to high-field nuclear magnetic resonance (NMR)
            spectrometers, laser systems, x-ray light sources, and mass
            spectrometers. Emphasis on high performance computing
            applications in basic biomedical studies is a particularly
            timely use of resources. These instruments enable researchers
            to directly observe the fundamental chemical and biomedical
            processes involved in life and to gain much-needed insight into
            the workings of the chemistry of living organisms. Through
            continued modification and refinement, research instruments
            often develop into clinically important tools. Thus,
            instrumentation supported by the National Center for Research
            Resources (NCRR) plays a crucial role in providing the
            underpinning for biomedical research.
        Research in chemistry supported by NIGMS and NCRR provides the
    strong foundation necessary to ensure progress in the quest for
    improvements in health and the quality of life. The CCR supports
    strengthening NIH since it provides training for new scientists,
    stimulates the pharmaceutical and biotechnology industries--both of
    which contribute positively to the balance of trade--leads to reduced
    healthcare costs, healthier lives, and, ultimately, makes the United
    States a world leader in biomedical research.
                                     ______

                Prepared Statement of the Joslin Diabetes Center

                                  introduction
        Mr. Chairman, I am Dr. Gordon Weir, Chief of Section on Islet
    Transplantation and Cell Biology and former Medical Director of the
    Joslin Diabetes Center in Boston, Massachusetts. I am here today to
    request for full funding of the first year recommendations of the
    report issued by the Congressionally mandated Diabetes Research Working
    Group.
                                   background
        Diabetes Research Working Group.--The Diabetes Research Working
    Group was established by this Subcommittee and its Senate counterpart
    through the fiscal year 1999 Conference Agreement, House Report 105-
    635.
        The charge to the Diabetes Research Working Group called for the
    development of a comprehensive plan for all NIH-funded diabetes
    research efforts, including the recommendations of future diabetes
    research initiatives and directives. The Conference Agreement language
    specifically instructed the DRWG to include overall cost estimates to
    accomplish its recommendations in the final research plan. The final
    report was provided to the Appropriations Committees in mid 1999.
    Fiscal year 2001 will be the first year the Congress can act on the
    funding recommendations contained within the DRWG Report.
        The Chairman of the Diabetes Research Working Group, C. Ronald
    Kahn, M.D., a distinguished researcher, is the former Executive Vice
    President and Research Director and now President of Joslin Diabetes
    Center in Boston.
        Fiscal year 1999 base funding for the categories addressed in the
    DRWG report totaled $442.8 million. The DRWG recommended increment for
    the first of five years over the fiscal year 1999 base was $384.5
    million, for a total recommended funding level of $827.3 million.
        H. Res. 325.--On November 16, 1999, in the closing days of the
    First Session of the 106th Congress, H. Res. 325 was considered and
    approved by the House 414-0. Every Member of this Subcommittee, and
    every Member of the Full Appropriations Committee, voted YEA on the
    passage of H. Res. 325. A similar resolution passed the Senate 93-0.
        In voting for H. Res. 325, you individually and collectively
    approved the principles underlying the recommendations for funding that
    were contained in the report submitted by the Diabetes Research Working
    Group.
        The first component of H. Res. 325 expresses ``the sense of the
    House of Representatives that:
      --the Federal Government has a responsibility
        --to continue to increase research funding, as recommended by the
            Diabetes Research Working Group, so that the causes of, and
            improved treatment and cure for, diabetes may be discovered . .
            .''
        Fiscal year 2000 funding resulted in an increase for diabetes
    research of approximately 15 percent above the fiscal year 1999 funding
    level.
                            fiscal year 2001 funding
        The fiscal year 2001 Budget for NIH, and specifically NIDDK,
    requests increased funds for NIH research, though not at the level
    recommended by the Diabetes Research Working Group. We realize that
    funding constraints represent a significant obstacle to reaching the
    diabetes research levels the DRWG recommends for fiscal year 2001. If
    the Committee is unable to increase the diabetes research
    recommendations with the DRWG of an increase of approximately $350
    million, there are immediate priorities that we would urge you include
    within funding for fiscal year 2001 appropriations.
        Dr. Kahn, Chairman of the DRWG, has indicated that, absent full
    funding at $827.3 million for diabetes research in fiscal year 2001,
    the following categories represent the highest priority among the DRWG
    recommendations. While we still request the full increase recommended
    by the DRWG, the following four categories represent the most urgently
    requested activities, which total $79 million, in increases above the
    fiscal year 2001 President's Budget:
      --Create new Comprehensive Diabetes Research Centers to provide
            enhanced infrastructure support, and enhance the effectiveness
            of existing Diabetes Centers (DERCs and DRTCs) by significantly
            increasing their funding levels and expanding their mission ($6
            million);
      --Create new regional centers with advanced technologies required for
            metabolic and functional imaging studies, such as nuclear
            magnetic resonance (NMC), positron emission tomography (PET),
            and related technologies, which are required for contemporary
            diabetes research, and provide ongoing support ($5 million);
      --With regard to Autoimmunity and the Beta Cell ($30 million):
        Define the immunological basis of type 1 diabetes and develop
                methods for prevention of the disease;
        Advance research on islet cell transplantation for treatment of
                diabetes; and
        Develop methods to stimulate beta cell growth and regeneration; and
      --With regard to Cell Signaling and Cell Regulation ($38 million):
        Complete the dissection of hormone signaling pathways, particularly
                the pathways of insulin action, and define their
                alterations in diabetes, including insulin resistance;
        Define mechanisms regulating beta cell function and their
                alterations in type 2 diabetes; and
        Allow metabolic staging of diabetes and identify the mechanisms of
                complications.
        Thank you, Mr. Chairman, for this opportunity to present the views
    and recommendations of Joslin Diabetes Center for diabetes research
    funding through NIH in fiscal year 2001.
                                     ______

       Prepared Statement of the Lovelace Respiratory Research Institute

        Mr. Chairman and Members of the Subcommittee: I appreciate the
    opportunity on behalf of the Lovelace Respiratory Research Institute
    (LRRI) to endorse and elaborate upon the written testimony of Dr. Clyde
    B. McCoy from the University of Miami School of Medicine (UMSM), with
    whom we are collaborating for our proposed Minority Health Tobacco
    Research Center (MHTRC).
                               impact of smoking
        Nicotine is a drug. It is a highly addictive drug that is
    unregulated. It is also a drug that appears to have profound inhibitory
    effects on the mammalian immune system. The delivery system of choice
    for this drug is the cigarette. There is no doubt that the use of
    tobacco products causes untold human injury and suffering.
        What is less well studied is the effect of secondary smoke (and by
    inference the delivery of nicotine to non-smokers) on the health of
    family members and co-workers of addicted users of these products. We
    propose the creation of a Center designed to study the physiology and
    behavioral medicine of secondary smoke combining the unique
    capabilities of two leading complementary research institutions: the
    University of Miami School of Medicine and its Drug Abuse Research
    Center and the Lovelace Respiratory Research Institute in New Mexico.
        Extensive experience in health research at UMSM in minority
    substance abuse and minority health will be linked to the world class
    physiology, cell and molecular biology and toxicology expertise present
    at LRRI to model the role of secondary smoke on the biology of the
    individual using cellular and rodent models followed by studies of
    family members of smokers. Medical and behavioral interventions will
    then be developed based on the resulting data.
                  the need to focus on the minority population
        Surgeon General David Satcher reported in a March 23, 2000 news
    release that there is an increase in tobacco use, especially among
    teens from African American, American Indian and Alaska Natives, Asian
    Americans, Pacific Islanders, and Hispanic communities. This increase
    in use will lead to an increase in cancer, heart disease, emphysema,
    stroke and other diseases among minorities. In addressing this
    increase, the Surgeon General noted, ``Unless they are reversed, these
    increases in tobacco use are a time-bomb for the health of our minority
    populations . . . If tobacco use continues to increase among minority
    adolescents, we can expect severe health consequences to begin to be
    felt in the early part of the next century.''
        ``This new report clearly shows tobacco's increasing grip on racial
    and ethnic minorities--the fastest growing segments of the American
    population,'' said HHS Secretary Donna E. Shalala. ``This new report
    underscores the need for Congress to pass comprehensive tobacco
    legislation this year based on the President's five key principles that
    include a significant price increase and plans to dramatically reduce
    youth tobacco use.''
        Of particular relevance to this proposal to fund the MHTRC, were
    the following major conclusions:
      --``Cigarette smoking is a major cause of disease and death in each
            of the four population groups studied in this report . . .
            Differences in the magnitude of disease risk are directly
            related to difference in patterns of smoking . . .
      --No single factor determines patterns of tobacco use among racial/
            ethnic minority groups . . . These patterns are the result of
            complex interactions of multiple factors, such as socio-
            economic status, culture characteristics, acculturation,
            stress, biologic elements, targeted advertising, price of
            tobacco products, and varying capacities of communities to
            mount effective tobacco control initiatives.
      --Rigorous surveillance and prevention research are needed on the
            changing cultural, psychosocial, and environmental factors that
            influence tobacco use to improve our understanding of racial/
            ethnic smoking patters and identify strategic tobacco control
            opportunities. The capacity of tobacco control efforts to keep
            pace with patterns of tobacco use and cessation depends on
            timely development of appropriate community-based programs to
            address the factors involved.'' (emphasis added)
        Please note that the report went on to call for more research into
    the effects of tobacco use among the groups, and called for studies to
    determine the health effects of exposure to secondhand smoke.
        Given the concentration of the Native American population in New
    Mexico, the focus of the MHTRC will also include American Indians. The
    Surgeon General found that ``Nearly 40 percent of American Indian and
    Alaska Native adults smoke cigarettes, compared with 25 percent of
    adults in the overall U.S. population. They are more likely than any
    other racial/ethnic minority group to smoke tobacco or use smokeless
    tobacco . . . American Indians . . . were only one of the four major
    U.S. racial/ethnic groups to experience an increase in respiratory
    cancer death rates in 1990-1995.'' (www.cdc.gov/tobacco)
        The bad news continues. The need to focus on the minority
    population is even more significant given the underutilization of the
    health system by the population. This disturbing fact is documented in
    a recent study produced by the Commonwealth Fund and published on
    February 18, 2000. The report discovered that Hispanics account for an
    alarming one-quarter of the nation's 44 million uninsured people.
    According to the report, ``Nearly 40 percent of Hispanics under the age
    of 65 do not have insurance. Despite their increasingly vital
    contribution to the nation's economy.'' Hispanics are twice as likely
    as the general population to go without coverage. ``Overall, 18 percent
    of the population under age 65 has no health insurance . . . Among
    whites, one of seven lacks insurance; among blacks, one of four lacks
    insurance; and among Hispanics, nearly two of five is uninsured. . .
    .'' (bkb@cmwf.org)
      lrri and umsm are uniquely qualified to address tobacco and harmful
                 substance addition in the minority population
        As Dr. McCoy points out, the University of Miami School of Medicine
    researchers have significant expertise and experience in the treatment
    of tobacco-related disease including the evaluation of Florida's
    Tobacco Pilot Program. LRRI has also gained a national reputation for
    its research work in the areas of prevention and cure of respiratory
    disease.
        Because of LRRI's unique capabilities to perform basic science
    research, LRRI and UMSM bring their strengths to the formation of the
    MHTRC. LRRI has undertaken some of the leading studies of animal models
    of smoking and the role of nicotine in immune function. It is one of
    the few research organizations capable of undertaking complex
    inhalation exposure protocols with appropriate animal models that
    predict human physiological responses.
                                  bottom line
        LRRI will undertake experimental protocols investigating the role
    of second hand smoke on neonates, children and adults. These models
    determine the precise immunological defects that result from these
    exposures. This data will then be compared to the cellular immune
    function of newborns, older children, and family members of minority
    subjects.
        UMSM will use its experience with understanding the unique cultural
    and social systems found in these minority populations, and as
    preserved in their unique database, to tailor medical and behavioral
    interventions to treat and prevent this terrible disease, not only on
    those who choose to smoke, but more importantly, on those who are
    exposed, yet have no choice.
                                     ______

        Prepared Statement of the American Society of Clinical Oncology

        The American Society of Clinical Oncology (ASCO) represents more
    than 14,000 physicians involved in cancer research and treatment. ASCO
    is the leading voice among medical professional societies concerning
    issues of cancer clinical research. The Society is pleased to have the
    opportunity to comment on fiscal year 2001 appropriations for the
    National Institutes of Health (NIH) and other issues related to the
    mission of NIH. These matters are of great importance to clinical
    researchers and their patients.
                fiscal year 2001 appropriations for nih and nci
        ASCO applauds the commitment of this Subcommittee to doubling the
    budget for NIH between 1999 and 2003. This panel's leadership has been
    essential to ensure predictability and stability in the NIH
    appropriation and allow scientists to pursue exciting new research
    endeavors. We believe the biomedical research effort of this country is
    as strong as it has ever been, in no small part because of the
    unwavering support of Congress.
        In order to sustain progress toward the goal of doubling the NIH
    budget by 2003, a funding boost of 15 percent is necessary in 2001. We
    strongly support a 15 percent increase for NIH. In addition, we
    recommend that funding for the National Cancer Institute (NCI) be
    enhanced in accordance with the Bypass Budget. Funding NCI at a level
    of $4.1 billion will allow the Institute to fund promising and
    innovative investigator-initiated research proposals and facilitate
    research that capitalizes on important advances in molecular biology.
    ASCO believes the Bypass Budget includes a persuasive rationale for
    boosting the NCI budget to $4.1 billion, and we urge the Subcommittee
    to begin the new millennium by implementing the Bypass Budget
    recommendation.
                        clinical research study section
        If promising basic research advances are to have meaning for
    Americans, they must be translated into medical practice. This
    translation process can only be accomplished through clinical research.
    Unfortunately, investigator-initiated clinical research proposals have
    historically not fared well at NIH because they have been reviewed by
    basic researchers who are not well versed in clinical research. ASCO
    has maintained that allowing basic researchers to dominate the review
    of cancer clinical research proposals is inequitable, a position
    endorsed by several blue ribbon panels charged with oversight of the
    NIH peer review process. Furthermore, according to recent reports,
    physician scientists' success in obtaining NIH funding for
    investigator-initiated research has a significant impact on their
    willingness to remain in the field. Therefore, the research review
    process has a significant impact on today's research and on the future
    of clinical research.
        ASCO has previously brought the issue of peer review of cancer
    clinical research to the attention of this Subcommittee, and the panel
    has supported efforts to improve the grants evaluation process. As a
    result of Subcommittee directives to the NIH, the Center for Scientific
    Review (CSR) appointed a special emphasis panel to review clinical
    oncology research proposals. The special emphasis panel is composed of
    clinical researchers who have the expertise and experience to evaluate
    cancer clinical research proposals. The early reports from the special
    emphasis panel have been positive. ASCO believes this model for review
    has been successful and should be made a permanent study section. We
    believe this would result in a system of fair and informed review of
    clinical oncology research.
        We are concerned, however, that CSR has announced plans to
    reinstate a system in which clinical oncology research proposals will
    be evaluated by panels in which as few as one-third of the members will
    have clinical research expertise. This situation--where basic
    researchers dominate the review of clinical research proposals--is one
    that external NIH advisors recommended be avoided. ASCO urges the
    Subcommittee to renew its directive to NIH officials to maintain a peer
    review system that has clinical researchers reviewing cancer clinical
    research proposals. ASCO believes that a rigorous and fair peer review
    system is fundamental to a strong clinical research effort and urges
    the Subcommittee to ensure that clinical researchers will review
    clinical research proposals.
                            clinical trials coverage
        ASCO has worked for several years for enactment of the Medicare
    Cancer Clinical Trials Coverage Act, which would require Medicare to
    reimburse the routine patient care costs for those enrolled in cancer
    clinical trials. More recently, we have been actively involved in
    efforts to ensure clinical trials coverage provisions in the Patients'
    Bill of Rights. Although coverage for routine patient care costs is not
    technically a matter for this Subcommittee, assurance of such coverage
    is critical to the efficiency of the research enterprise and is
    therefore surely a concern for this panel. Only if treatments can be
    tested in clinical trials can clinical researchers determine their
    effectiveness. If reimbursement denials or the fear of such denials
    slow accrual to clinical trials, this will adversely affect the ability
    of researchers to answer questions about new treatments. ASCO believes
    it is absolutely necessary that barriers to enrollment in clinical
    trials, including possible reimbursement uncertainties or denials, be
    eliminated.
        ASCO appreciates the opportunity to submit its views on NIH funding
    and clinical research. On behalf of oncologists and their patients, we
    urge Congress to continue its strong support of NIH. We also recommend
    that special attention be paid to the clinical research enterprise to
    ensure that basic research findings are promptly brought to the patient
    bedside.
                                     ______

          Prepared Statement of the National Prostate Cancer Coalition

        Mr. Chairman and members of the Subcommittee on Labor, Health &
    Human Services and Education Appropriations, the National Prostate
    Cancer Coalition (NPCC) is a vital organization that includes, on its
    board of directors, representatives from the American Foundation for
    Urologic Disease, the Cancer Research Institute, CaP CURE, the Huntsman
    Cancer Center and Us TOO! International. Other coalition partners
    include the American Urological Association, B'nai B'rith International
    and Men's Health Network. NPCC supporters are also thousands of
    survivors and their families, researchers and health professionals.
        Mr. Chairman, the NPCC strongly urges you and your colleagues to
    make appropriations to the National Institutes of Health (NIH) and the
    National Cancer Institute (NCI) such that $324.4 million will be
    available to carry out the fiscal year 2001 commitment to the NIH five-
    year investment strategy for prostate cancer research. This funding
    will give hope to the nearly 200,000 men who learned they have prostate
    cancer in 1999. And it will bring closer the day when the coalition no
    longer has to cite the chilling fact that nearly 40,000 American men
    lost their lives to prostate cancer last year.
        The amount required for NIH is an increase of 15 percent over the
    fiscal year 2000 appropriation. We also request full funding of the NCI
    director's professional judgment, or ``bypass,'' budget at $4.1
    billion.
        As you know, the bypass budget goes directly to support badly
    needed investigations that will hasten new treatments and cures for
    cancer. The 15 percent increase to NIH is necessary to fulfill
    Congress's 1998 bipartisan commitment to double the NIH budget within
    five years. Reaching that funding target will allow NIH to pursue
    research opportunities that will make a difference in the lives of
    every family fighting a dread disease, including those facing cancer.
        Mr. Chairman, in addition to asking for your support of prostate
    cancer research, the men and their families of the NPCC also
    congratulate you and the members of this committee. You took a dramatic
    step to improve the nation's biomedical research capabilities when you
    committed to double the NIH budget between fiscal year 1999 and fiscal
    year 2003. Last year, you showed how serious you were when you provided
    NIH with about $2.0 billion more than it received in fiscal year 1999.
        And you also took specific action on behalf of prostate cancer
    research. Your hearing, in June 1999, brought together oncologist
    Christopher Logothetis, M.D., Senator Bob Dole, Michael Milken and
    Yankees' great Joe Torre to discuss the near-term promises for prostate
    cancer research. As a product of that hearing, NIH presented its five
    year investment strategy for prostate cancer research, recognizing that
    funding in this important area has fallen far short of meeting the
    disease's challenges.
        Prostate cancer has been the number one diagnosed non-skin cancer
    in the country. It has accounted, on average, for 15 percent of all
    cancer cases and 15 percent of cancer deaths among men. Yet, until you
    and your colleagues acted, an average of only 5 cents of every federal
    cancer research dollar had been allocated to find a cure for this
    disease.
        While recent increases in prostate cancer research funding are
    vital, Mr. Chairman, the unfortunate truth is that they still fall far
    short of the need--and they alone are not sufficient to fund all of the
    most promising paths to treatment and cure. The NPCC's Medical and
    Scientific Advisory Committee--which includes some of the nation's
    leading prostate cancer researchers and clinicians--has already
    identified more than $500 million in promising research that has not
    received funding. Missed opportunities cost lives. The NPCC believes we
    must accelerate treatment opportunities by providing the resources to
    fund all promising research on the horizon.
        We have a strong working relationship with NIH and NCI and applaud
    the agencies' leadership and their intramural and extramural
    researchers for the tremendous work they have done to help prostate
    cancer patients and their families. We've worked hard for NIH's five-
    year prostate cancer research strategy. But, because we must remain
    attuned to opportunities, we must revisit that strategy next year. The
    program's budget was based on conservative projections. We believe that
    new treatments could be available soon, but they call for rapid
    acceleration of commitments to translational and clinical research. We
    must end the bottlenecks in drug development to allow agents to move
    quickly from the laboratory bench to the patient's bedside and medical
    clinics, where they can end the toll that prostate cancer takes on
    America's families.
        We support NCI's existing innovative programs in translational and
    clinical prostate cancer research, particularly its RAID and
    QuickTrials projects. We would like to see these expanded--and married
    to innovative collaborations among public and private funders and
    providers of prostate cancer research. We also appreciate NCI's
    commitment to increase the number of prostate cancer Special Programs
    of Research Excellence (SPOREs) and other opportunities that mobilize
    interdisciplinary research talent and accelerate institutional
    collaborations.
        Mr. Chairman, I want to conclude by stressing to the committee that
    an investment in cancer research really is an investment, one that will
    yield dividends both in lives saved and in dollars and cents.
        It may seem shocking to think that, in the past five years, more
    than one million men in the United States learned they had prostate
    cancer. But the real shock is that we've seen just the tip of the
    iceberg.
        The American population is aging. Between 1996 and 2014, the 76
    million members of the baby boom generation--31 percent of our American
    population--turn fifty years old. Those born before 1957 are turning
    fifty at the rate of one every seven seconds. Because the risk of
    cancer increases after this milestone, more and more Americans will
    battle cancer--including prostate cancer--in the coming years.
        Cancer care already costs this country more than $100 billion
    annually. With the graying of the baby boomers, THE MARCH Research Task
    Force had estimated, in 1998, that, if unchecked, the cost of cancer
    will jump to more than $200 billion within a decade. Even if Congress's
    commitment to cancer research continues to grow at its current rate, we
    will still be spending 20 times more on care than cure.
        In 2000, one American man in every six is at risk of prostate
    cancer; one cancer diagnosis in every seven will be prostate cancer;
    and one male cancer death in every eight will be prostate cancer. Some
    clinicians note that the number of men in their forties and fifties who
    are battling prostate cancer is increasing, and they report seeing more
    aggressive forms of the disease in younger men.
        Mr. Chairman, in the face of these daunting facts and as you
    consider the future investments in NIH and NCI research, NPCC asks you
    and your colleagues to be mindful of the impact of prostate cancer on
    the country as a whole.
        While advancing research in these important programs costs federal
    dollars, we ask you to remember the greater costs involved in any
    further delay to the cure of prostate cancer.
        General Norman Schwarzkopf, a very wise military leader and himself
    a prostate cancer survivor, recently discussed cancer research in the
    context of military strategy. He put the issue this way: ``There always
    comes a time when you must get on with the battle. You cannot sit back
    and do nothing, because you'll never have perfect intelligence on the
    enemy. Base your battle plan on the best information you have and be
    ready to modify your strategy and line of attack. The important thing
    is just to get on with it.''
        Thank you for your consideration.
                                     ______

              Prepared Statement of the Cancer Leadership Council

        The Cancer Leadership Council (CLC) is a forum of national advocacy
    organizations addressing public policy issues in cancer. CLC
    participants include organizations representing patients and their
    caregivers. We are pleased to have this opportunity to submit comments
    to the Subcommittee regarding funding for the National Institutes of
    Health (NIH), including the National Cancer Institute (NCI). We are
    particularly concerned about clinical cancer research and have
    recommended special actions that must be taken to protect clinical
    research and ensure that basic research findings are rapidly translated
    into improved therapies.
                          fiscal year 2001 nih funding
        The CLC commends the Subcommittee for its leadership in securing
    substantial increases in funding for NIH in fiscal year 1999 and fiscal
    year 2000 and ensuring steady progress toward a goal of doubling the
    NIH budget between 1999 and 2003. Because of the commitment of the
    Subcommittee to biomedical research, NIH has experienced a period of
    predictability and stability in its funding, and the research
    enterprise has benefitted greatly.
        The CLC wholeheartedly supports increasing NIH funding by 15
    percent in fiscal year 2001, a boost that is necessary to ensure
    movement toward the year 2003 funding goal. We also urge that Congress
    fund the NCI according to the Bypass Budget, or at a level of $4.1
    billion. The Bypass Budget outlines promising research opportunities
    that could be funded if NCI receives that level of funding. CLC
    believes that important cancer research projects are being abandoned
    because of funding constraints, and Congress could ensure that good
    science is funded if it meets the Bypass Budget funding recommendation.
                          coverage for clinical trials
        In order to move basic research findings to the patient bedside,
    they must be tested in clinical trials. The optimal clinical trials
    system is one that enrolls patients promptly and tests therapies
    rapidly to answer questions about the best possible treatments.
    Unfortunately, there are a number of barriers that prevent individuals
    from enrolling in trials and therefore slow the clinical trials
    process.
        CLC and others in the cancer community have worked diligently to
    remove barriers to patient enrollment in clinical trials, and our
    efforts have focused on guaranteeing that third-party payers reimburse
    the routine patient care costs of those enrolled in cancer clinical
    trials. In this Congress, we are seeking passage of the Medicare Cancer
    Clinical Trials Coverage Act and inclusion of a clinical trials
    coverage provision in the Patients' Bill of Rights.
        Although Medicare and other third-party payer policies are not in
    the jurisdiction of the Subcommittee, they are vitally important to the
    health of the clinical research effort. If researchers face obstacles
    to enrolling patients in clinical trials due to real or perceived
    difficulties in reimbursement, the speed and efficiency of clinical
    trials will be adversely affected and the translation of basic research
    findings into new therapies will be slowed.
        The CLC urges your support for efforts to guarantee third-party
    reimbursement for those enrolling in cancer clinical trials. This
    coverage is a necessary component of the biomedical research enterprise
    and is of utmost concern to cancer patients and their caregivers.
                        clinical research study section
        In the past, CLC has asked the Subcommittee to direct NIH to revise
    the peer review process to ensure that cancer clinical research
    proposals receive a fair evaluation. Cancer clinical research proposals
    have historically been reviewed by basic researchers, and several
    advisory groups to the NIH have concluded that this results in
    inequitable review of clinical research because basic researchers are
    not well versed in clinical research and the challenges associated with
    it.
        This Subcommittee previously directed NIH to alter its peer review
    process, and the NIH finally responded by establishing a Clinical
    Oncology Research Special Emphasis Panel. This panel represented a
    significant advance because it provided for the review of clinical
    cancer research proposals by clinical researchers. Regrettably, the
    Center for Scientific Review (CSR) has indicated that it will
    reinstitute a system in which basic researchers will review clinical
    research. We urge you to direct the NIH to retain the Special Emphasis
    Panel and abandon plans for a system in which cancer clinical research
    will again be reviewed by basic researchers.
        The CLC is pleased to have the opportunity to submit comments to
    the Subcommittee. This panel's steadfast advocacy for biomedical
    research is very important to the CLC, and we lend our enthusiastic
    support to your efforts to enhance NIH funding. We request your special
    consideration of our proposals to protect and foster clinical cancer
    research.
    Cancer Leadership Council
        Alliance for Lung Cancer Advocacy, Support, and Education, American
    Cancer Society, American Society of Clinical Oncology, Cancer Care,
    Inc., Cancer Research Foundation of America, The Children's Cause,
    Inc., Cure For Lymphoma Foundation, Coalition of National Cancer
    Cooperative Groups, Inc., Colorectal Cancer Network Kidney Cancer
    Association, The Leukemia & Lymphoma Society, Multiple Myeloma Research
    Foundation, National Coalition for Cancer Survivorship, National
    Patient Advocate Foundation, National Prostate Cancer Coalition, North
    American Brain Tumor Coalition, Oncology Nursing Society, Ovarian
    Cancer National Alliance, The Susan G. Komen Breast Cancer Foundation,
    US-TOO International, Inc., and Y-ME National Breast Cancer
    Organization.
                                     ______

             Prepared Statement of the Lymphoma Research Foundation

        Chairman Specter and Members of the Subcommittee: My name is Neil
    Ruzic and I have lymphoma, cancer of the lymph system. So do 600,000
    other Americans. This country is suffering a lymphoma epidemic. The
    incidence of lymphoma is increasing the second fastest of all cancers,
    the fastest of cancers that cannot be prevented. That is, unlike
    melanoma (the fastest growing) and unlike lung cancer, you can't
    prevent lymphoma by staying out of the sun or stopping smoking. The
    cause is unknown.
        Another 87,000 or more Americans will contract lymphoma this year.
    Our children are getting it--60 percent of childhood cancers are
    lymphoma or the related disease of leukemia. Our men are dying from
    it--lymphoma is the fourth leading cause of death by cancer. Our women
    are dying from it at almost the same rate.
        The Lymphoma Research Foundation of America does what it can to
    help these people. It funds research projects mostly of young PhD or MD
    scientists. It is the nation's primary organization dedicated to
    providing information and support to lymphoma patients and their
    families. On behalf of the Lymphoma Research Foundation, I want to
    thank Chairman Specter, Ranking Member Harkin and the Subcommittee for
    being instrumental in the NCI's convening a Progress Review Group on
    lymphoma later this year. Panels of prominent scientists will review
    NCI's lymphoma research portfolio and recommend a plan of action that
    will speed progress, helping ensure that limited resources are used
    optimally. These are important steps . . . but there could be more.
        A year and a half ago, following surgery to remove my spleen that
    had grown four times too large, I was diagnosed with mantle cell
    lymphoma. This is the deadliest of the lymphomas, whose victims have an
    average time from diagnosis to death of three years. Despite the lack
    of a cure, oncologists at five leading institutions advised me to take
    aggressive chemotherapy. Nothing else, they said at the end of 1998,
    was proved and ``probably would not work.'' They admitted that chemo
    would only ``buy time,'' and in the long-run--if there was one--would
    work for shorter and shorter times until it destroyed my immune system.
        Instead of taking chemotherapy, I immediately stopped the book I
    was working on and devoted my time to learning about lymphoma by
    reading scientific papers and visiting the nation's medical research
    centers. After 18 months of looking, I can tell you that the cures are
    there, in the brains and experiments of the medical researchers. These
    discoveries are in their infancies and require much more research and
    testing, but they are there--right now--in the laboratories of the
    United States.
        I am one of the lucky ones, at least so far. Without treatment of
    any kind, my lymphoma for unknown reasons not only remains indolent but
    seems to be subsiding. That is, the lymph nodes or glands in my
    abdomen, once the size of golf balls, now are the size of grapes, and
    some have shrunk to normal size (the size of a pea.) I am not sick. I
    have no symptoms. Why?
        I approached a team of creative gene researchers at UCLA, and
    together with the Lymphoma Research Foundation and the Mantle Cell
    Group (an e-mail information assembly of patients), sponsored a project
    to try to answer that question. The idea was that if we could render
    lymphoma quiescent, or indolent, it would be almost as good as finding
    a cure. The project, now underway, is a small part of the sudden
    revolution in genetics and molecular biology. New therapies are being
    tested every day, even faster than the completion of the human genome
    project, which already is of enormous benefit to cancer research.
        There are good scientific reasons why funding should be increased
    immensely for lymphoma research. Lymphoma is to the lymph system what
    leukemia is to the blood system. The liquid lymph contains white blood
    cells that produce antibodies which, in turn, fight infection and
    filter out pathogens. Because lymph cells move freely between the lymph
    and blood systems, an actual and comprehensive cure for lymphoma must
    begin with a basic understanding not only of the interplay between
    these systems but also of how the immune system works, how the
    chromosomes and genes function, how the very molecules of the cells
    work together. Because of this systemic nature of lymphoma, any actual
    cure would be applicable to lung, colon, breast, prostate, and other
    kinds of cancer.
        As important as is the study of lymphoma to curing all cancers,
    lymphoma research constitutes a mere 2.2 percent of the budget of the
    National Cancer Institute! And the NCI's budget for all cancer
    research, even now that it has been increased, is only $3.3 billion.
        That satisfaction with the status quo is wrong when human lives are
    at stake. For the first time in history, lymphoma and other hopeless
    diseases are suddenly and uniquely vulnerable to a massive, coordinated
    attack by government and university laboratories. There has never been
    a better time than right now.
        Significant breakthroughs in previously unrelated fields of
    engineering, chemistry, biology, and physics have been quietly
    maturing--remarkably at the same time--and everything at last is
    finally coming together. Computer technology, for instance, finally has
    merged with gene engineering so that we actually can put DNA on a
    microchip and isolate genes that are broken, or determine the pathways
    of genes responsible for specific diseases.
        Common wisdom says that cancer is not just one, but hundreds of
    diseases--lymphoma, leukemia, lung, breast, prostate and other organ
    cancers, and so on--leading you to believe that curing cancer requires
    an equal number of hundreds of different approaches. That assumption is
    no longer true. All cancers have in common uncontrolled cell growth,
    and for that to occur a series of mutations in the genes which control
    cell growth and behavior must take place. Tremendous progress in the
    understanding and manipulation of genes has been made in just the past
    year or so.
        Yet genetics researchers such as Dr. Jonathan Braun, Dr. Phillip
    Koeffler, and their teams at UCLA, who are at the front lines in this
    battle, lack funds for a truly large expansion of their programs and
    can test only a small number of their ideas. Typically these labs
    employ 10 to 20 scientists and technicians. They could expand to 100 or
    200 workers, effectively, without wasted effort, and thereby hasten the
    research payoff .
        A novel approach pioneered by Dr. Judah Folkman at Children's
    Hospital in Boston that stops angiogenesis or ``blood growth'' that
    feeds tumors has caused scores of new compounds to be tried. Dr.
    Parkash Gill and his group at the University of Southern California,
    for instance, have found ways to alter the genes to cut off tumor blood
    supply. These researchers and others at Northwestern University have
    wiped out cancer in near-death patients who have had metastasized
    cancers all over their bodies. But Dr. Gill, chronically underfunded,
    lacks the means to pursue all but a few animal studies. Like others in
    small labs, he must take valuable research time to seek the funding he
    needs. (The average project leader in this field spends a third of his
    research time writing proposals or otherwise seeking grants.)
        As new therapies begin to replace outmoded, often-harmful
    chemotherapies, we must speed up testing and clinical trials of other
    techniques, even as the more fundamental, ultimate, solutions such as
    gene therapy are being refined. For instance, antibodies made from
    human cells and cloned to produce large numbers of them now are
    targeted to kill cancer cells specifically, instead of killing all
    cells that grow, normal or diseased (as does chemotherapy.) These
    monoclonal antibodies also are being combined with radioisotopes to be
    even more effective.
        Another new technique applicable to all cancers is the stimulation
    of the body's own ``T cells,'' our immune system's most effective
    killers of viruses, bacteria, and parasites. The problem is that cancer
    cells have evolved mechanisms to hide themselves from T cells. It's
    like having an Air Force armed with one-ton bombs ready to destroy an
    army of invaders but not bombing the enemy troops because you can't
    find them. Dr. Carl June and co-workers at the University of
    Pennsylvania have discovered that by stimulating two different
    receptors they can get the T cells to launch an immune response. In
    fact, the T cells are so sensitive to co-stimulation they also secrete
    chemical messengers that work to make even more T cells. Now not only
    can we use those one-ton bombs, but they are multiplied! This project
    has received private funding from many sources, including the author's.
    But with the massive governmental spending increase envisioned here,
    other labs could replicate the results and help push it to the hilt.
        Vaccines--not to prevent but to cure--are being grown from
    patients' tumors and customized to kill lymphomas in those lucky enough
    to get into the right protocol. Human trials run by such pioneers as
    Dr. Ronald Levy at Stanford and Drs. Larry Kwak and Wyndham Wilson at
    the NCI include only hundreds instead of hundreds of thousands of
    cancer patients.
        Most of these and other potential new cures began with research
    into lymphoma, but they are applicable to all cancers!
        In addition there are the important basic research projects of
    hundreds of bright, mostly young medical scientists which have had to
    shut down before hardly getting started for lack of funding.
    Individuals and foundations contribute at least as much as the
    government, but most of those funds go for education and prevention.
    Pharmaceutical companies add another $4.8 billion annually for
    research--almost double that of the government--but little of this sum
    is spent on untargeted basic research
        The 10,000 universities in this country are among America's
    greatest assets. Let's use them to the hilt. These institutions not
    only educate the brightest of our young men and women but also attract
    the best foreign students who earn advanced degrees and often stay to
    work in the U.S. All graduate students in science do basic research. It
    is this constant probing into fundamental knowledge in molecular and
    even atomic biology, immunology, genetics, and into even seemingly
    unrelated research in bioengineering, chemistry, and computer
    technology that will cure cancer. The research freedom at the
    universities and peer reviews to decide on worthy ideas are good
    practices that should not be changed. Instead, the government should
    seek opportunities to expand the existing system and infrastructure
    massively.
        The key question is whether the new money could be spent profitably
    so that real cancer cures will be in use in ten years. Here are five
    spending steps that occur to me, which I am sure can be improved upon
    by university and NCI scientists:
        Massively increase funding for non-targeted basic research, using
    the majority of the funds.--Here are two examples of how basic
    research, which when undertaken was not directed toward curing any
    specific disease, but now is leading to specific cancer-fighting
    studies: The 1953 discovery that earned the Nobel Prize for Watson and
    Crick, showing that the double helix shape of DNA contained subunits of
    nucleotides, led directly to the current sequencing of more than
    100,000 genes on our 23 pairs of chromosomes. Dr. Gunter Blobel of New
    York's Rockefeller University recently was awarded a Nobel Prize for
    his discoveries into how proteins locate themselves in cells and how
    environmental mutations in the process lead to disease.
        Ask every university cancer project leader which of them could gear
    up to handle-effectively and efficiently--10 or 20 times their present
    funding.--If their answers make sense, fund them. That may not be the
    most cost-effective method of funding in the short run, but any money
    wasted on the way to the greater goal will pale in comparison to the
    overwhelming financial benefit of a cancer-free economy. We can not
    afford to let research funding remain a zero-sum game where spending
    additional money on, for instance, breast cancer, detracts from, say,
    lymphoma research.
        Proselytize young people into following scientific careers in
    medicine, medical engineering, immunology, genetics, and related
    fields, both at the professional and technical-support level.--Yes,
    education takes time. But these new people will be needed in the
    massive fight against cancer, and the sooner they start the sooner they
    will contribute. We should offer full economic assistance for students
    to enter such careers, and for graduate students to earn combined MD
    and PhD degrees. Such funding will relieve professors from having to
    pay their graduate students out of their research grants, thereby also
    making them more productive. Such a program should be publicized widely
    to attract the most creative people from throughout the world.
        Create a dozen more big cancer centers of excellence throughout the
    country, letting the universities compete for the new sites.--Encourage
    competition by funding post-doctoral researchers and by endowing chairs
    in medical research laboratories. It is through competition, the engine
    of progress, that enormous goals are realized. Biotechnology is the
    ``dot com'' of the new decade. The U.S. has benefited profoundly from
    the internet change relative to other countries because of the
    technological infrastructure already in place. Intensifying the
    infrastructure and career development in bioscience for cancer
    breakthroughs is a role that government plays well, and industry does
    not.
        Coordinate the research results of the NCI, universities, and
    others by instituting a worldwide central data base and ultrafast
    communications system.--The recent inauguration of PubMed Central and
    the database of the National Library of Medicine are welcome steps, but
    the effort is still terribly underfunded. Researchers need to be
    informed instantly of discoveries elsewhere that may bear upon their
    work. One can picture a thousand information experts at their computers
    alerting university researchers to meaningful experiments. It is
    important that the government avoid playing the role of director of
    this War on Cancer; the government should be the coordinator.
        If, in providing for such an expansion, the Congress voted for a
    dramatic and immediate increase for the NCI of some $30 billion--with
    the majority of the money going for basic research--the returns would
    begin to pour in almost right away. They would build to a flood in a
    few years. They would race to a crescendo by the end of the decade.
        Is it worth the money?
        Yes, in terms of misery and death avoided. Yes again, in economic
    terms. The annual cost of cancer to the U.S. alone currently is $107
    billion, including direct and indirect costs. According to economists
    Kevin Murphy and Robert Topel at the University of Chicago, if all
    forms of cancer were eliminated the economic value to the United States
    would be $46.5 trillion, which is more than all U.S. assets! The
    economic and humanitarian benefit to other nations also would be
    overwhelming. What a fantastic tool of foreign policy, the exportation
    to other countries of the cure for cancer!
        Elimination of death by cancer would usher in a new era of
    worldwide health and prosperity, removing misery, and rendering human
    life more productive and happier. Progress in the various sciences is
    rushing steadily toward the cure of cancer. From the viewpoint of
    government appropriations, whether that cure arrives in ten years or in
    fifty years, or somewhere in-between, is only a matter of money.
                                     ______

        Prepared Statement of the National Nutritional Foods Association

        Mr. Chairman and Members of the Subcommittee: Thank you for the
    opportunity to present public witness testimony on behalf of the
    National Nutritional Foods Association (NNFA). My name is Patrick
    Toomey. I am President of NNFA, a trade association representing 3,000
    independent health food stores and 1,000 manufacturers, distributors
    and suppliers of natural health products, including organic and natural
    foods, natural ingredient cosmetics and dietary supplements.
        In addition to being the President of NNFA, I also own a small
    natural foods store, Toomey's Natural Foods in Milford, Ohio. I have
    been an industry retailer for 25 years and for the past ten years I
    have served on both national and regional boards of the NNFA.
                  congressional mandate mirrors citizen demand
        National interest in access to reliable information on safe and
    effective vitamins, minerals, herbs, amino acids and other dietary
    supplements has grown steadily since the Dietary Supplement Health and
    Education Act (DSHEA) unanimously passed the House and Senate to become
    the law of the land in 1994.
        Approximately 158,000,000 Americans are taking dietary supplements,
    spending, by some estimates, as much as $14.5 billion a year in health
    food stores alone. Americans are looking to safe, natural alternatives
    to prescription drugs to treat and prevent disease, and to maintain
    good health by supplementing inadequate diets with vitamins and
    minerals.
                     nutrients can prevent chronic disease
        We are entering a new era of recognition of the value of natural
    pathways to good health. For example, the Food and Nutrition Board of
    the National Academy of Sciences, which devises Recommended Daily
    Allowances (RDAs) for nutrients for the Food and Drug Administration,
    has issued the first of a series of reports presenting revised nutrient
    intake guidelines. Originally introduced in 1941, RDAs were intended to
    prevent classical nutrient deficiency diseases nearly extinct in the
    U.S. today, such as scurvy, beriberi and rickets. Now, these reports
    are revising and expanding RDAs to reflect compelling evidence, which
    supports the use of nutrients to help prevent chronic disease, such as
    osteoporosis. We agree with the Chairman of the Food and Nutrition
    Board, who characterized this approach as ``. . . a major leap forward
    in nutrition science.''
        Similarly, the report of the President's Commission on Dietary
    Supplement Labels endorsed continued research on the benefits of
    dietary supplements in health promotion and disease prevention. The
    Commission hailed the increasing research-based documentation of the
    benefits of dietary supplements in maintaining health and preventing
    chronic disease and other health-related conditions, and called for
    continuation of this welcome trend. NNFA continues to endorse the
    Commission's recommendation that, ``. . . the public interest would be
    served by more research that assesses the relationships between dietary
    supplements and maintenance of health and/or prevention of disease.''
             herbs and botanicals are beneficial and cost-effective
        In addition to supporting these kinds of exciting new findings on
    the health benefits of nutrients, NNFA urges the Committee to continue
    to support research on medicinal herbs and botanicals, also classified
    as dietary supplements under the DSHEA. The results of a study on
    ginkgo biloba, published recently in the October 22, 1997 Journal of
    the American Medical Association, indicates that administration of this
    herbal extract, recognized for centuries in Chinese medicine for its
    ability to stimulate and improve blood circulation in the brain, could
    delay the onset of Alzheimer's Disease for up to six months. This could
    represent tremendous savings of lives and dollars from a disease, which
    costs society approximately $90 billion a year. Other studies show saw
    palmetto more effective than prescription medicine at reducing benign
    prostate enlargement, with far less expense and no reportable side
    effects. In 1998, Harvard University completed a 14-year study of
    80,000 nurses, concluding that large amounts of vitamin B6 and folic
    acid could prevent heart attacks by an astounding 51 percent.
        Millions of Americans are turning daily to herbal remedies and
    seeking primary health care from the alternative, holistic providers
    who prescribe them. There is an urgent need for a dramatic increase in
    support for research on herbs and botanicals, justified by consumer
    demand and the Congressional intent expressed in DSHEA. The Dietary
    Supplement Commission report recommends that, ``. . . Federal agencies
    continue to support off research on the health benefits and safety of
    dietary supplements. Research should be expanded beyond the
    traditionally supported areas associated with vitamin and mineral
    supplements and include research on some of the more promising
    botanical products used as dietary supplements.'' NNFA whole-heartedly
    agrees.
        Ours is one of the few cultures in the world for whom the
    prevention and treatment of disease with non-prescription herbal
    medicines is the exception rather than the rule. This is largely due to
    the fact that foreign research oftentimes is deemed unacceptable by the
    Food and Drug Administration for use in justifying health claims for
    herbs and botanicals. We urge the Committee to provide the adequate
    funding for research on the safety and benefits of medicinal herbs.
                      nih's office of dietary supplements
        The Office of Dietary Supplements (ODS) was established at the
    National Institutes of Health by DSHEA, to stimulate, coordinate and
    disseminate the results of research on the benefits and safety of
    dietary supplements in the treatment and prevention of chronic disease.
    It is my understanding that ODS will receive its authorized level of $5
    million for fiscal 2000. NNFA requests a further increase for this
    office in fiscal 2001.
        NNFA agrees with the President's Commission on Dietary Supplement
    Labels that if fully-funded, `` . . . ODS could play a valuable role in
    providing consumers with information about dietary supplements . . .
    including [the] promotion of scientific studies on potential roles of
    dietary supplements in health promotion and disease prevention.
    Appropriations as authorized by DSHEA are essential if ODS is to meet
    [the] mandates of the Act.'' ODS now has the capacity to provide useful
    information to consumers whereby meeting the Congressional mandate of
    the Office.
        We also urge continued funding for the botanical research
    initiative which began in fiscal 1999 at the ODS. ODS has recently
    funded two botanical research centers located at the University of
    California at Los Angeles (UCLA) and the University of Illinois at
    Chicago (UIC). ODS expanded the botanical research center initiative by
    releasing an additional request for application for a botanical
    research center at the end of 1999. ODS' long-term goal is to expand
    the initiative and obtain botanical research centers throughout the
    country. NNFA supports this goal.
           national center for complimentary and alternative medicine
        In 1992 Congress directed the National Institutes of Health to
    establish the Office of Alternative Medicine with the expressed task of
    assuring objective, rigorous review of alternative therapies to provide
    consumers reliable information. In fiscal 1999 the Office of
    Alternative Medicine was elevated to a Center with its own grant making
    capabilities. Funding for the Center has grown along with its increased
    authority from $2 million in fiscal 1992 to $50 million in fiscal 1999
    to $68.8 million in fiscal 2000. I thank the Committee for its support
    of NCCAM. NNFA supports increased funding for this important Center in
    fiscal 2001. This has given alternative research a well-deserved boost
    and is more in line with the health choices of most Americans.
        A 1998 Newsweek study states that some 83 millions Americans, about
    40 percent of the adult population, are seeking alternative medical
    treatment. Also, findings from the ``National Survey of Alternative
    Medicine Use,'' published in the January, 1993 New England Journal of
    Medicine, reveal that Americans made an estimated 425 million visits to
    alternative medical therapy providers in 1990, exceeding the 338
    million visits made to all U.S. primary care providers that year. The
    survey also showed that out-of-pocket expenditures associated with
    alternative therapies totaled $10.3 billion in 1990, approaching the
    $12.8 billion in out-of-pocket expenses incurred for all U.S.
    hospitalizations during the same period. It is crucial for the health
    and security of all Americans that objective, scientific research is
    done to determine the effectiveness of complementary and alternative
    therapies.
                    demonstration projects at ahrq and hfca
        The Agency for Healthcare Research and Quality (AHRQ) is often
    directed by the Committee to pursue projects designed to research the
    cost-effectiveness attendant to novel approaches to the treatment and/
    or prevention of illness. The time is right for investigation of the
    worthiness of certain dietary supplements, based on well-designed,
    cost-effectiveness research.
        Every year, treatment of chronic conditions and illnesses--from
    flus and colds to hypertension to dementia and Alzheimer's disease--
    generates enormous publicly and privately funded health care
    expenditures. There exists an opportunity to trim such burgeoning costs
    through prevention and/or treatment of these chronic ailments--or delay
    of their onset--with safe, effective, low cost dietary supplements.
    NNFA is confident that basic research at NIH can lead to appropriately
    structured, cost/outcome research at AHRQ which would demonstrate the
    value of dietary supplements in comparison to contemporary medical
    intervention. This evidence can, in turn, lead to Health Care Financing
    Administration (HCFA) projects to determine if a policy of
    reimbursement could be established.
        Despite the growing popularity and demand for herbs and nutritional
    supplements, and their widespread use for prevention and intervention
    of chronic illness, precious few large-scale outcome studies on
    American populations are available to give health professionals the
    information they need to make decisions on alternatives to contemporary
    medical approaches. Echinacea has been shown to be effective in
    preventing and treating colds and flus; folic acid has been shown
    effective for neural tube defects and also homocysteine levels in
    cardiovascular disease; herbal/nutritional combinations have been shown
    to provide control for hypertension without the side effects which
    cause many patients to stop using their prescription medicine; and the
    use of glucosamine sulfate for joint function. NNFA believes that a
    sufficient body of botanical and nutrient research may exist in certain
    instances, to whet AHRQ's appetite and to warrant Congressional
    consideration of cost-effectiveness studies in this area.
        NNFA urges the Committee to consider directing AHRQ to work with
    the Office of Dietary Supplements and the National Center of
    Complimentary and Alternative Medicine to review the existing outcome
    research on dietary supplements. The AHRQ could then investigate the
    feasibility, under appropriate protocols, of developing cost-
    effectiveness projects designed to compare the value of herbs and other
    dietary supplements in the treatment and prevention of chronic illness
    to typical medical approaches. The areas I have mentioned are but a few
    of the many possibilities which urgently present themselves for
    research and evaluation. Once the necessary biomedical and cost-
    effectiveness research have been completed, NNFA urges the Committee to
    direct HCFA to investigate the potential reimbursement for promising
    alternative therapies and treatments involving nutritional supplements
    and herbs.
        a sound investment in the health and well-being of all americans
        Science and experience ably demonstrate a wealth of benefits
    attendant to the regular use of vitamins, minerals, amino acids,
    enzymes, herbs and botanicals--all classified by DSHEA as dietary
    supplements. Dietary supplements are allowing millions of American
    consumers to take charge of their own good health by safely and
    effectively preventing and treating a host of illnesses and conditions.
    The body of research supporting use of these products is impressive,
    but sorely requires immediate and dramatic expansion. NNFA urges the
    Committee to endure the Congressional mandate expressed in DSHEA by
    investing in the scientific research which holds the key to our
    knowledge of the remarkable importance and value of dietary
    supplements.
        Thank you.
                                     ______

                Prepared Statement of the NYU School of Medicine

        I want to begin by thanking you, Mr. Chairman, and members of this
    Subcommittee for your continued support of the National Institutes of
    Health (NIH). You clearly recognize the importance of a strong Federal
    investment in medical research and that today's investments may
    represent tomorrow's treatment and cures for many disorders and
    diseases. This Subcommittee has been a leader in ensuring that our
    nation remains a leader in the field of medical research, and on behalf
    of the NYU School of Medicine, I thank you.
        The NYU School of Medicine takes pride in a history that goes back
    to 1837 and includes the initiation of and the participation in many of
    the major events in American medicine through two centuries. The School
    annually graduates 150 physicians, and it employs 3,000 individuals
    including more than 800 faculty members. For 150 years the School has
    provided high quality patient medical services and medical supervision
    to Bellevue Hospital Center, New York City's premiere municipal
    hospital. The mission of the School is threefold: the training of
    physicians, the search for new knowledge, and the care of the sick.
    These three missions must be carried out simultaneously for they are
    wholly dependent upon each other, not only for inspiration, but for
    their very means of success. At the School of Medicine, we recognize
    that in order to excel in these three missions, we must be responsive
    to the major events and trends that are shaping medicine in our time.
    These include: the revolution in molecular biology and medical
    technology; the societal imperatives imposed by rising health care
    expectations and the finite limits on resources; the explosive growth
    in biomedical information; and the increasing role of the patient in
    the decision-making process.
        In my opinion, there has never been a more exciting time to enter
    medicine. Enormous breakthroughs have allowed great advances in our
    understanding of disease and our ability to devise new therapies. We
    know with certainty that this explosion of knowledge will continue.
    With continued federal support for basic, cutting edge research
    supported through the NIH, we will continue to move closer to our goal
    of translating the promise of scientific discovery into an improved
    quality of life for all Americans. As we enter this century, we must
    continue to provide the resources and investments necessary to seize
    upon these tremendous opportunities. The NYU School of Medicine
    supports the recommendation of the Ad Hoc Group for Medical Research
    Funding, a coalition of nearly 200 patient and voluntary health groups,
    medical and scientific societies, academic and research organizations,
    and industry, of $20.5 billion for NIH in fiscal year 2001. This $2.7
    billion (15 percent) increase represents the third step toward
    fulfilling the bipartisan goal of doubling the NIH budget by fiscal
    year 2003.
        As the volume of NIH research increases, we must address the need
    for upgraded, state-of-the-art facilities to carry out this federally-
    supported biomedical and behavioral research. A 1998 National Science
    Foundation (NSF) study on the status of scientific research facilities
    at U.S. colleges and universities identified an estimated $11.4 billion
    in deferred research construction and repair/renovation projects, as
    well as a decrease in new construction of health research facilities
    across an array of institutions. Adequate laboratory space and research
    instrumentation are necessary to obtain the best data from NIH research
    dollars. For this reason, I urge you to provide $250 million for
    extramural facilities construction at the National Institutes of Health
    (NIH) in your fiscal year 2001 bill.
        In addition to providing significant funding increases for NIH--
    including increased funds for extramural research infrastructure--I
    thank you for raising the salary cap imposed on extramural researchers
    from Executive Level III to Executive Level II ($141,000) in last
    year's bill. The higher salary level will allow many institutions, such
    as the NYU School of Medicine, to attract and retain the best
    investigators in their respective academic research programs. However,
    under the Senior Biomedical Research Service (SBRS) program on the NIH
    campus, the NIH can pay its senior investigators up to $151,000--
    roughly equal to what the salary cap on academic researchers would be
    if it were indexed for inflationary increases over the past decade. To
    seek a level playing field with intramural NIH researchers, we seek
    your support in raising the current salary cap to Executive Level I in
    the fiscal year 2001 bill.
        Over the past decade, several trends in the health care marketplace
    and fiscal stewardship of the public-private partnership have
    destabilized research institutions and the pool of specially trained
    personnel necessary to continue to push the frontiers of medical
    research. For this reason, the medical center supports the proposal
    that the NIH establish a Flexible Institutional Support for Health
    Research (FISHR) program. This peer-reviewed, three-year grant program
    will provide institutional resources to meet evolving needs in research
    in the range of $25,000 to $300,000 a year for deans of medical, public
    health, nursing and dental schools. We suggest a funding level of $60
    million in fiscal year 2001 for this competitive, renewable pool of
    accountable resources which will help modify the impact of the recent
    stresses experienced by research and academic institutions and will
    serve to maintain the integrity of our national research enterprise.
        I would like to highlight an exciting initiative at the School of
    Medicine. The School of Medicine is developing a comprehensive Program
    in Women's Cancer (PWC). This program will be an integral component of
    the Comprehensive Cancer Center (CCC). The PWC will encompass the full
    spectrum of clinical services, advanced training, fundamental and
    translational research into those cancers that exclusively or primarily
    affect the female reproductive tract. The components of this program
    include: etiology and biology; risk identification and prevention;
    screening; diagnosis and treatment; palliation and rehabilitation; and
    psycho-social support.
        The PWC will function as a multi-departmental entity with on-site
    clinical services provided by the Departments of Medicine, Obstetrics
    and Gynecology (Ob/Gyn), Pathology, Radiation Oncology, Radiology, and
    Surgery. The physicians from these departments will be supported by a
    team of social workers, physical and occupational therapists to ensure
    continuity between in-patient and out-patient care.
        The School is seeking the Subcommittee's support to expand its PWC.
    The School is requesting $5 million in support through the Health
    Resources and Services Administration's Health Facilities Construction
    account in your fiscal year 2001 bill.
        Thank you again, Chairman Specter, for your attention to these
    important issues.
                                     ______

          Prepared Statement of the Texas Neurofibromatosis Foundation

        The Texas Neurofibromatosis Foundation is pleased to submit
    testimony in support of funding for the National Institutes of Health
    and for neurofibromatosis in your fiscal year 2001 bill.
        The Texas Neurofibromatosis Foundation was established in 1981 and
    is committed to meeting the needs of people challenged with NF by
    providing care, comfort, support, information, education, funding, and
    other resources for the treatment, prevention, and eventual cure of
    this disease. With offices in Dallas and Houston, the Foundation
    coordinates support groups, organizes fundraising events and
    educational symposiums, and assists with NF clinics across the state
    that serve the more than 5,000 individuals with NF in Texas. Dedicated
    volunteers form the heart of the organization, giving their time and
    talents to increase public awareness and raise the money necessary to
    support patient programs and research projects. Advocates from around
    the country look to the Texas NF Foundation as a model when
    establishing new a NF organization in a state. Texas is also home to
    some of the most exciting NF research described below.
        NF, incorrectly but commonly known as elephant man disease,
    involves the uncontrolled growth of tumors along the nervous system
    which can result in terrible disfigurement, deformity, deafness,
    blindness, brain tumors, cancer and/or death. It is the most common
    neurological disorder caused by a single gene. While not all NF
    patients, like myself, suffer from the most severe symptoms, all of us
    live our lives with the uncertainty of not knowing whether we too will
    be severely affected because NF is a highly variable and progressive
    disease. Approximately 100,000 Americans have NF, and it appears in
    approximately one in every 3,500 births. It strikes worldwide, without
    regard to gender, race or ethnicity. There are two types of NF; type 1,
    which is the more common of the two and NF2 which primarily involves
    acoustic neuromas causing deafness and balance problems as well as
    other types of tumors such as schwannomas and meningiomas.
        With your continued support and a relatively small Federal
    investment, NF has become one of the great success stories in the
    current revolution in molecular genetics. Because of the enormous
    advances that have been made, one leading NF researcher has stated that
    more is known about NF genetically than any other disease. Accordingly,
    many NF researchers believe that NF should serve as a model to study
    all diseases. The future promise of NF research is based upon these
    successes. Let me highlight for you some of the advances in NF research
    that have occurred since 1990:
      --The discovery of the NF1 and NF2 genes and gene products;
      --Determination of the close connection between NF and cancer, brain
            tumors, learning disabilities, heart disease, and other
            neurological disorders;
      --Determination and understanding of the functions of the NF1 and NF2
            genes and gene products including the discovery of new pathways
            impacted by the NF genes and gene products;
      --Development of advanced animal models;
      --Development of drug and gene therapies;
      --Commencement of clinical trials at NCI;
      --Establishment of an international consortium of NF researchers and
            patients;
      --Rescuing learning deficits in animal models with NF1;
      --Substantial increase in the number of NF researchers
        The enormous promise of NF research--and its potential to benefit
    tens of millions of Americans in this generation alone--has gained
    increased recognition from Congress and the NIH. This is evidenced by
    the fact that five Institutes at NIH are currently supporting NF
    research (NCI, NINDS, NIDCD, NICHD, and NHLBI) and NIH's total NF
    research portfolio has increased from $11 million in 1995 to
    approximately $18 million in 2000. The National Institute on Disability
    Research and Rehabilitation (NIDRR) within the Department of Education
    has also expressed an interest in pursuing NF research in the learning
    disability area since 35-60 percent of children with NF suffer from
    learning disabilities. For fiscal year 2001, the Subcommittee's
    continued support will be critical to build upon the basic and clinical
    research described below which is essential to moving us closer to a
    treatment and cure for this disease.
        Since the discovery of the NF gene, researchers have established
    the connection between NF and the following diseases and disorders:
        Cancer.--Dr. Samuel Broder, former Director of the National Cancer
    Institute, stated that NF was at the ``cutting edge'' of cancer
    research. Studies have investigated the connection between the ras
    oncogene, which is critical to control growth and development in
    healthy cells (and when mutated contributes to the formation of
    tumors), and the NF1 gene which is a tumor suppressor. The studies
    showed that ras activity can be inhibited by the NF1 protein
    neurofibromin. Since elevated ras activity is involved in 30 percent of
    all cancers, the inhibition of ras by neurofibromin may result in a
    cure, not only for NF, but also for many of the most common forms of
    cancer.
        Learning disabilities.--In addition to NF's connection to cancer,
    NF also provides a unique opportunity to begin to uncover a molecular
    basis for cognitive impairment, and it holds the prospect of possessing
    a radiologic marker for brain dysfunction. Specific learning
    disabilities are the most common neurological complication in children
    with NF1. The reported frequency of learning disabilities in children
    with NF ranges between 30-65 percent. Uncovering the molecular and
    cellular causes for the learning deficits caused by NF should also
    reveal important clues on what causes and how to cure tumors in NF1
    patients, because the same molecular mechanisms underlie both tumor
    formation and learning disabilities. For example, recent research on
    mice with the same mutation that causes NF1 in humans (NF1 mice) has
    shown that treating the mice with a drug (farnesyl transferase
    inhibitor) that decreases ras function (the same ras that causes cancer
    and tumors) CURES their learning disabilities. Studies on fruit flies
    have also demonstrated that the protein made by the NF1 gene is part of
    the c-AMP pathway, the pathway which is known to control learning and
    memory.
        Deafness.--Leading NF researchers believe that the science has
    progressed to the point when a gene therapy for NF2 can be developed
    and tested. Unlike other genetic forms of deafness, in which mutation
    leads to a development or structural abnormality in the ear for which
    it would be difficult to envisage a treatment in the adult, NF2-
    associated deafness is potentially preventable or curable if tumor
    growth is halted before damage has been done to the adjacent nerve. NF2
    accounts for approximately 5 percent of genetic forms of deafness. It
    is also related to other types of tumors including schwannomas and
    meningiomas, as well as being a major cause of balance problems.
        Heart disease.--Recently published research has also demonstrated
    the relationship between NF and heart disease. Researchers have
    demonstrated that mice completely lacking in NF1 have congenital heart
    disease that involves the endocardial cushions which form in the valves
    of the heart. This is because the same ras which causes cancer and
    learning disabilities also causes heart valves to close and
    neurofibromin suppresses ras, thus opening up the heart valve. Errors
    in valve formation account for a large percentage of congenital heart
    disease in humans, and congenital heart disease is the most common type
    of congenital defect. Researchers believe that further understanding
    how an NF1 deficiency leads to heart disease may help to unravel
    molecular pathways affected in genetic and environmental causes of
    heart disease. This finding opens up a new area for future research in
    congenital heart disease. In addition, the role of NF1 in neural tube
    closure suggests that NF1 research may bear on the understanding of
    causes of Spina Bifida, a common birth defect.
        NF research is on the precipice of many major discoveries that will
    have broad and significant implications for Americans suffering from
    many disorders and diseases. For example, NCI is currently conducting
    clinical trials on NF patients involving the use of farnesyl
    transferase inhibitors in pediatric patients with refractory solid
    tumors. Other areas of research opportunity include:
      --Further clinical trials;
      --Expansion of drug and genetic therapies for NF and related
            disorders;
      --Further development of NF animal models;
      --Maintenance and expansion of consortium of NF clinical researchers
            and patients;
      --Further determination of the connection between NF and cancer,
            tumors, heart disease, learning disabilities, deafness, bone
            and other disorders;
      --Further determine function of the NF genes and gene products;
      --Expansion of pool of NF researchers
        This Subcommittee recognizes that our goal should be to translate
    the promise of scientific discovery into an improved quality of life
    for all Americans. To accomplish this goal, we must, as a nation,
    continue to invest in medical research at the NIH. Sustained, stable
    growth in funding for the NIH is needed to build upon past scientific
    achievements, address present medical needs, and anticipate future
    health challenges. Volatility and dramatic fluctuations in funding can
    be as harmful to the research enterprise as inadequate growth. Towards
    this end, I encourage the Subcommittee to support the recommendation of
    the Ad Hoc Group for Medical Research Funding, a coalition of over 200
    patient and voluntary health groups, medical and scientific societies,
    academic and research organizations, and industry, which calls for a
    fiscal year 2001 appropriation of $20.5 billion for the National
    Institutes of Health (NIH). In addition to providing increased funding
    for the NIH as a whole, this Subcommittee has recognized the promise of
    NF research and has included language in your fiscal year 2000 Report
    encouraging NCI, NINDS, NICHD, NIDCD, NHLBI, and NIDRR at the
    Department of Education to increase their NF research portfolios
    through the use of: Requests for Applications, Program Announcements,
    the National Cooperative Drug Discovery Group Program, and Small
    Business Innovation Research Grants, as appropriate. I urge the
    Subcommittee to continue to encourage these Institutes to continue this
    trend.
        In closing, I will end with a statement that appeared in an edition
    of Cold Spring Harbor Laboratory's newsletter which focused on major
    breakthroughs in NF research: ``the hope is that the day may come when
    doctors can flip critical switches to repair the broken circuits in
    each of these disorders and diseases. Such life-changing therapies will
    be the reward for years of enthusiastic basic research.'' I believe,
    Mr. Chairman and members of the Subcommittee, that with your continued
    support, that day will soon be here.
                                     ______

    Prepared Statement of the Wake Forest University Baptist Medical Center

        I would like to begin by thanking the members of this Subcommittee
    for their continuous support of and tireless efforts to increase
    funding at the National Institutes of Health. You have all been leaders
    in helping to advance science to ensure that today's discoveries
    translate into tomorrow's treatments and cures for millions of
    Americans. Your leadership has also helped to ensure that America
    remains a leader in the field of medical research. The Wake Forest
    University Baptist Medical Center stands behind your goal of doubling
    the budget of the National Institutes of Health (NIH) by the year 2003.
    As you have stated so eloquently many times, Chairman Porter, there are
    more opportunities in basic and clinical research than ever before. And
    as we enter this century, we must provide the resources and investments
    necessary to seize upon these opportunities. The medical center
    supports the Ad Hoc Group for Medical Research Funding's fiscal year
    2001 request of $20.5 billion for NIH. This $2.7 (15 percent) increase
    represents the third step toward fulfilling the bipartisan goal of
    doubling the NIH budget by fiscal year 2003.
        As the volume of NIH research increases, we must also recognize the
    need for upgraded, state-of-the-art facilities to carry out this
    federally-supported biomedical and behavioral research. A 1998 National
    Science Foundation (NSF) study on the status of scientific research
    facilities at U.S. colleges and universities identified an estimated
    $11.4 billion in deferred research construction and repair/renovation
    projects, as well as a decrease in new construction of health research
    facilities across an array of institutions. Adequate laboratory space
    and research instrumentation are necessary to obtain the best data from
    NIH research dollars. For this reason, I urge you to provide $250
    million for extramural facilities construction at the National
    Institutes of Health (NIH) in your fiscal year 2001 bill.
        In addition to providing significant funding increases for NIH--
    including increased funds for extramural research infrastructure--I
    thank you for raising the salary cap imposed on extramural researchers
    from Executive Level III to Executive Level II ($141,000) in last
    year's bill. The higher salary level will allow many institutions to
    attract and retain the best investigators in their respective academic
    research programs. However, under the Senior Biomedical Research
    Service (SBRS) program on the NIH campus, the NIH can pay its senior
    investigators up to $151,000--roughly equal to what the salary cap on
    academic researchers would be if it were indexed for inflationary
    increases over the past decade. To seek a level playing field with
    intramural NIH researchers, I am seeking your support in raising the
    current salary cap to Executive Level I in the fiscal year 2001 bill.
        Over the past decade, several trends in the health care marketplace
    and fiscal stewardship of the public-private partnership have
    destabilized research institutions and the pool of specially trained
    personnel necessary to continue to push the frontiers of medical
    research. For this reason, the medical center supports the proposal
    that the NIH establish a Flexible Institutional Support for Health
    Research (FISHR) program. This peer-reviewed, three-year grant program
    will provide institutional resources to meet evolving needs in research
    in the range of $25,000 to $300,000 a year for deans of medical, public
    health, nursing and dental schools. We suggest a funding level of $60
    million in fiscal year 2001 for this competitive, renewable pool of
    accountable resources which will help modify the impact of the recent
    stresses experienced by research and academic institutions and will
    serve to maintain the integrity of our national research enterprise.
        There are many exciting initiatives under development and underway
    at the medical center. This year, we are seeking support from this
    Subcommittee to complete two floors in the Center for Research on Human
    Nutrition and Chronic Disease Prevention facility to expand research in
    the area of prostate cancer and women's health. Specifically, we are
    seeking $5 million in the Subcommittee's fiscal year 2001 bill through
    the Health Resources and Services Administration's Health Facilities
    Construction Program for this important project.
        Prostate cancer is the most common cancer in men and the second
    most common cause of cancer deaths among men. Nationally, one in nine
    men will, during their lifetime, be affected with prostate cancer.
    Given the high incidence (28 percent), high prevalence (41 percent),
    and low mortality (7 percent) of prostate cancer, the need for better
    diagnosis, prevention, treatment and supportive care is compelling.
    North Carolina and the Southeast have pockets of the highest incidence
    and mortality of prostate cancer in the country. Areas of South
    Carolina and eastern North Carolina have an exceedingly high incidence
    of the disease. One North Carolinian will die from prostate cancer
    every 7.3 hours. Explanations of this high incidence have included the
    typically Southern high fat diet as well as exposure to agricultural
    pesticides. These epidemiologic associations, however, are still
    inconclusive and more research is needed. Further, strategies to
    prevent prostate cancer by altering dietary habits or environmental
    exposures have been incompletely developed. African American men are
    particularly prone to prostate cancer for a number of reasons.
    Incidence of prostate cancer is higher in African Americans than in
    Caucasians and African Americans are diagnosed at later stages of the
    disease. The Comprehensive Cancer Center at Wake Forest University
    Baptist Medical Center has a long history of achievement in the area of
    minority population research as it relates to cancer, and this program
    will build on this strength. This program initiative will integrate
    basic, clinical and population science research.
        In this decade, most women can expect to live 30 years or more
    beyond menopause. Several critical health issues and chronic conditions
    begin to emerge during this stage in a woman's life, yet we are just
    beginning to examine and understand these conditions. This program will
    build upon the nationally-recognized work of investigators at the
    Medical Center in the area of postmenopausal women. The Medical Center
    is already recognized as a world leader in research concerning the role
    of hormone therapy in the prevention of cardiovascular and other
    chronic diseases. The goal of this program is to establish a well-
    integrated primary clinical care program for women in their post-
    menopause years as well as expand the research in this area. Developing
    and testing multiple models to understand the complex relationship
    between estrogen and other estrogen-related products and various
    systems in women will be a major focus of this program.
        Thank you, Chairman Specter for considering these important issues.
                                     ______

                   Prepared Statement of the FDA-NIH Council

                                  introduction
        The FDA-NIH Council appreciates the opportunity to submit testimony
    concerning the National Institutes of Health (NIH) as the world's
    largest and most distinguished organization dedicated to maintaining
    and improving health through medical science, and we consider
    investment in medical research to be our greatest hope for a healthy
    future. To that end, the FDA-NIH Council joins the medical research
    advocacy community, the Ad Hoc Group for Medical Research, in
    supporting an appropriation of $20.47 billion for the NIH in fiscal
    year 2001, with the goal of doubling the Agency's budget within five
    years. We believe that it is an important priority for the Congress to
    continue its commitment to double the budget of the NIH, and the
    Council is indebted to the Committee for keeping the NIH a priority
    within the Congress.
        The FDA-NIH Council is a broad based coalition comprised of patient
    advocates, academic scientists, health professionals, and medical
    research-based corporations. These partners in the process of medical
    discovery and innovation have come together to seek common ground in
    addressing the complex challenges and enhancing the noble missions of
    the Food and Drug Administration (FDA) and the NIH.
        Medical research and innovation aim to improve health and the
    quality of life by finding better ways of diagnosing and treating, and
    preventing and curing disease. Breakthroughs come from a process of
    innovation, each advance building upon the one that preceded it. From
    research in academic, government and industry laboratories, and from
    the accumulation of clinical experience in managing disease, our
    information about the mechanisms of disease and innovation in medicine
    are continually developed. We welcome the opportunity to address the
    unique contributions of the government in this regard as it is the
    national commitment to the NIH which lays the foundation for our
    ability to bring research discoveries from the laboratory to the
    patient.
        Together with its partners in medical discovery and innovation--
    academia, biomedical research industries, voluntary health foundations,
    health professionals and consumers--the work funded by the NIH and
    subsequent product development with its partners has jettisoned the
    United States into international preeminence in this area. All of the
    partners in the process of medical discovery are interdependent, each
    contributes a critical piece to the puzzle. The success of our national
    enterprise is not possible without each piece remaining vibrant and
    strong. A healthy partnership between government, industry, academia
    and non-profit foundations is critical to maintain the U.S. position as
    the world leader in medical research and innovation. Most importantly,
    the millions of Americans afflicted with catastrophic, acute and
    chronic diseases are the REAL beneficiaries of this partnership.
    Breakthroughs such as the development of antibiotics and organ
    transplantation, life-extending and life-saving cancer therapies, the
    identification of the AIDS virus and the drugs to treat AIDS, have
    given the American public a glimpse into the potential offered through
    the rapid advances in medical science. But, we must take these ``half-
    way'' technologies all the way to the finish line by continuing our
    strong funding commitments to research breakthroughs.
        The FDA-NIH Council supports the research themes advanced by the
    NIH, including:
        To Exploit Genomics by accelerating the human genome project;
    expanding work on model animal systems; learning to gather and use
    complex biological information; and building bioinformatics.
        To Reinvigorate Clinical Research by recruiting, training, and
    retaining clinical investigators; strengthening clinical research
    centers; supporting clinical trials, networks, and databases; and
    developing partnerships with managed care organizations, foundations,
    industries, and other Federal agencies.
        To Harness the Expertise of Allied Disciplines, such as chemistry,
    engineering, computer science, mathematics, optics, and physics in
    order to work with medical scientists in, for example, designing new
    drugs; imaging molecules, chromosomes, cells, and organs; developing
    biomaterials; and analyzing bioinformatics and clinical data.
        To Reduce Health Disparities at Home and Abroad through research
    and training, testing interventions, and building international
    research capacity.
        We are now on the threshold of the next great revolution in modern
    medicine, gene therapy. With the identification of the genes
    responsible for a large number of our normal functions and the genetic
    abnormalities that cause many diseases, we gain greater understanding
    into disease and keys to unlock the future of medicinal research. Each
    time researchers discover a gene, they open the door to a new therapy
    or cure. Today, when we talk about our medical research enterprise, we
    speak from the standpoint of great success and even greater
    opportunities.
        The health of our nation is dependent upon a strong national
    commitment to medical research. As we enter the new millennium, we have
    attracted some of the best scientific minds to our national enterprise,
    and initiated ground-breaking programs that have already yielded
    critical knowledge, and improved patient care and quality of life.
    However, we are confronted with the extraordinary challenge of how to
    maintain the integrity of our research efforts, and rapidly and cost-
    effectively translate that research and development into use by health
    professionals and consumers, in both the public and private sectors.
        The FDA-NIH Council would like to draw your attention to the
    growing capacity of our national research enterprise and the need to
    sustain its long term health as it undergoes the transformation
    required to meet the challenges of this century.
      --Investigator-initiated Research.--The support of basic medical
            research through competitive, peer-reviewed, and investigator-
            initiated research project grants continues to be among the
            highest of funding priorities. As new knowledge is discovered,
            it is vitally important for the NIH to support early patient-
            oriented research to determine the application of laboratory
            advances to persons with disease. Further, training and
            educational programs require adequate resources to ensure that
            the next generation of clinical scientists is in place to
            continue the rapid translation of research from the bench to
            the bedside.
      --Eliminating Health Disparities.--A key component to eliminate
            health disparities among populations in the United States is
            medical research and research training. We need to ensure that
            multidisciplinary collaborations take place to understand the
            causes of health disparities; develop new and improved
            prevention strategies, diagnostics, and treatments to reduce
            health disparities; and enhance communication of research
            results to scientists, health professional, affected
            communities, and the public.
      --Clinical Research.--To take full advantage of rapid research
            advances, the NIH is planning to initiate new pilot and early-
            phase clinical trials, thereby speeding the testing of new
            therapies. Further, the NIH has expanded the national clinical
            trials database, and made it more accessible to the public
            through the Internet (ClinicalTrials.gov). The early research
            conducted through the NIH is imperative prior to the maturation
            and full exploitation of advances in the marketplace.
      --Research Facilities.--The sophistication of the research
            initiatives requires an ever-increasing sophistication in the
            physical plants and research laboratories. Research facilities,
            equipment and instrumentation, and animal facilities must be
            state-of-the-art in order to fully exploit our research
            potential.
        The FDA-NIH Council recognizes the inherent difficulties in terms
    of weighing the available resources and supporting numerous worthy
    federal programs. We recognize and are extremely grateful for the
    support that this Committee has provided to the NIH in the past.
    However, we also believe that the functions of the NIH are vital to our
    economy as well as the health and welfare of our citizens and urge your
    support for continued strong funding.
        The FDA-NIH Council thanks the Committee for the opportunity to
    submit testimony. We appreciate the support of this Committee.
        The members of the FDA-NIH Council are: the A-T's Children Project;
    Candlelighters Childhood Cancer Foundation; Allergy and Asthma
    Network--Mothers of Asthmatics, Inc.; Alliance for Aging Research;
    Schering-Plough Corporation; Albert B. Sabin Vaccine Foundation; Merck
    & Co., Inc; Pfizer, Inc.; American Veterinary Medical Association;
    Joint Council of Allergy, Asthma and Immunology; American Society of
    Tropical Medicine and Hygiene; American Academy of Pediatrics; National
    Multiple Sclerosis Society; Glaxo Wellcome, Inc.; Cystic Fibrosis
    Foundation; Bristol-Myers Squibb Company; Society of Toxicology;
    Research Society on Alcoholism; Theracom; Parkinson's Action Network;
    Academic Contract Research Organization; American Academy of Allergy,
    Asthma and Immunology; Bermuda Biological Station for Research; and the
    Cancer Research Foundation of America.
                                     ______

    Prepared Statement of the National Alliance for Eye and Vision Research

        My name is Mike Veeck. I am the owner and operator of five
    professional baseball franchises. My daughter, Rebecca, has a blinding
    retinal degenerative disease called cone-rod dystrophy. I appreciate
    the opportunity to present this written testimony on behalf of the
    National Alliance for Eye and Vision Research (NAEVR), an umbrella
    organization of thirty professional, lay advocacy and industry
    organizations dedicated to expanding our national capacity to address
    eye and vision research opportunities. I am an active member of the
    Foundation Fighting Blindness, which is an active participant in the
    National Alliance for Eye and Vision Research.
        I would like to begin by thanking you, Chairman Specter, and
    members of this Subcommittee for your continuing commitment to medical
    research supported by the National Institutes of Health (NIH) and the
    National Eye Institute (NEI). Mr. Chairman, you and your colleagues
    have been tremendously supportive of pushing the frontiers through
    unprecedented support of the NIH. We know that you have many difficult
    decisions with regard to funding priorities in your Appropriations Bill
    and we appreciate the strong support that you have provided NIH.
    Without this support we would not be on the verge of many new treatment
    breakthroughs for blinding eye diseases. Due to the amazing advances in
    basic and clinical science, we are beginning to reap the benefits of
    our research investment. However, more and more we are forced to
    prioritize what areas of research to support because we do not have the
    funding available to support all of the opportunities that exist. This
    is true in all areas of vision research, and in the public and private
    sectors.
        The written testimony that follows focuses on three specific
    issues:
      --Fiscal year 2001 funding request for the NIH and NEI
      --Scientific opportunities in eye and vision research
      --Why eye and vision research is so important to me personally
                        fiscal year 2001 funding request
        The National Alliance for Eye and Vision Research urges your
    continued commitment to the campaign to double the budget for NIH by
    fiscal year 2003, referred to as the NIHx2 campaign. We strongly
    support the recommendation of the Ad Hoc Group for Biomedical Research
    Funding calling for a $2.7 billion, or 15 percent, increase for NIH in
    fiscal year 2001, which is the level necessary to pursue a doubling of
    the NIH budget.
        Within the context of the NIH budget, the National Alliance for Eye
    and Vision Research seeks your strong support for the NEI professional
    judgement budget calling for a 20 percent increase in fiscal year 2001.
    The priorities identified in this budget were a part of long range
    strategic plan, Vision Research--A National Plan: 1999-2003, in which
    the entire extramural research community participated. This funding
    level would provide $90.5 million above current year levels resulting
    in an NEI budget of $543 million in fiscal year 2001. This level of
    increase for eye and vision research is called for as a result of
    previous disparities which have disadvantaged NEI in the NIH priority
    setting and funding allocation process. Historically, the NEI ranks
    among the lowest Institutes relative to the percentage increase in
    funding provided by the Congress.
        As you know Mr. Chairman, the professional judgement budget
    reflects the funding necessary to continue ongoing research initiatives
    and pursue new scientific opportunities that have resulted from the
    nation's investment in eye and vision research. I would like to discuss
    some of the exciting research opportunities that will be pursued with
    this level of investment to assure you that an investment in eye and
    vision research will be a wise and cost-effective investment.
              scientific opportunities in eye and vision research
        Neurodegeneration Research.--Research on neurodegeneration and the
    rescue and regeneration of neural cells is an area of tremendous
    opportunity with application to many neurological diseases and
    conditions, and to cases of traumatic injury, including:
      --Rescue of Photoreceptor Cells in Retinal Degenerative Diseases.--
            Retinal degenerative diseases such as macular degeneration,
            retinitis pigmentosa and Usher syndrome affect more than six
            million Americans of every age and race. NEI funded scientists
            have already developed several promising experimental
            treatments for preventing or dramatically slowing vision loss
            from these blinding diseases. Pharmaceutical and neurotrophic
            agents, retinal cell transplantation, and molecular and genetic
            technologies have shown therapeutic value in laboratory
            animals. Further laboratory research is needed to advance these
            promising therapies to clinical trials.
      --Survival of Retinal Ganglion Cells in Glaucoma.--Retinal ganglion
            cells (RGCs) can be studied in culture conditions, providing a
            special opportunity for investigating signaling mechanisms that
            normally promote survival and how these mechanisms are altered
            by injury.
        Protection of Nerve Cells in Glaucoma.--Researchers have found
    elevated levels of nitric oxide synthase in the optic nerve heads from
    human eyes with glaucoma and animal models of glaucoma. By
    pharmacologically inhibiting the production of nitric oxide in these
    animals, scientists found that axons of the optic nerve were protected
    from neurodegeneration.
        Resources for Research on the Visual System.--In order to better
    understand the molecular and genetic basis for inherited diseases of
    the eye, it is essential that research be conducted to identify and
    sequence genes that are expressed in the visual system and to identify
    disease-causing genetic mutations. There are a number of research
    projects, which could be pursued more aggressively with additional NEI
    funding. This genetic information will be collected from ocular tissues
    that are qualitatively and quantitatively representative of the genes
    expressed in the visual system and optimized to detect rare or unique
    sequences. It is anticipated that this catalogue of genes expressed in
    the visual system will be publicly available in an easily accessible
    and retrievable format to facilitate research on eye diseases with the
    goal of improving treatment or preventing their occurrence.
        Control of Angiogenesis.--Diseases that affect retinal blood
    vessels are among the major causes of visual disability and blindness
    in this country. These include diabetic retinopathy, retinopathy of
    prematurity, neovascular glaucoma, and age-related macular degeneration
    in which the proliferation of abnormal new blood vessels can result in
    the rapid and irreversible loss of vision. Scientists have discovered
    that inhibitors of certain growth factors and enzymes are ideal
    candidates for the treatment of these diseases.
        Bioengineering and Advanced Instrumentation.--NEI is pursuing the
    development of advanced assistive devices for the visually impaired,
    adaptive optics and other imaging techniques to improve non-invasive
    examination of ocular tissues for both research and disease diagnosis,
    instruments to analyze the biomechanics of the eye, and instruments to
    analyze visual performance. NEI is continuing research on the further
    development of laser-targeted dye delivery systems which could
    revolutionize the visualization of blood vessels in the retina and the
    treatment of eye disorders; and optical coherence tomography and
    confocal scanning laser polarimetry for quantitative measurements of
    the retinal nerve fiber layer.
        Clinical Research and Health Disparities.--Research in this area
    will enhance our understanding of glaucoma, diabetic retinopathy, and
    myopia incorporating studies of comorbidity, natural history, and
    genetics with special emphasis on populations at increased risk. For
    example, rates of blindness from glaucoma are six times higher in
    African-Americans than in Caucasians, however age-related macular
    degeneration is rare for African-Americans as compared to Caucasians.
        Low Vision.--A related area of concern is low vision, or vision
    impairment which is not correctable by glasses or contact lenses. As
    many as 12 million Americans suffer from visual impairments which
    affect their ability to read, drive, work, and perform many everyday
    activities we all take for granted. The most common eye diseases that
    cause visual impairment in adults are AMD, cataract, glaucoma, diabetic
    retinopathy, and optic nerve atrophy. Even more serious are eye
    diseases that cause visual impairment in children. These include
    certain forms of retinitis pigmentosa, Stargardt and Best disease,
    retinopathy of prematurity, cortical visual impairment, and coloboma.
    Low vision in children often affects their development and results in
    the need for special education, vocational training, and social
    services throughout their lives. The cost of these impairments is more
    than $22 billion each year.
        Under the auspices of the National Eye Health Education Program
    (NEHEP), NEI has developed and is initiating a program directed at low
    vision in order to increase public awareness about visual impairment
    and the impact it has on everyday life. The Low Vision Traveling
    Exhibit will be displayed in shopping malls around the country during
    the next five years and was recently launched in Birmingham, Alabama.
    The program provides information about low vision services and the
    devices, which are currently available to assist those with visual
    impairments. This effort is directed at those suffering from visual
    impairments and also to medical professionals, eye care specialists,
    managed care organizations, and family members. NAEVR supports this
    public education partnership and urges the Committee to support it as
    well.
                my personal interest in eye and vision research
        Mr. Chairman, I am in a race against time. Each day, my eight-year
    old daughter, Rebecca, loses more of her vision to a blinding retinal
    degenerative disease called cone-rod dystrophy. Retinal degenerative
    diseases are slowly robbing the vision of more than six million
    Americans of every age and race. Vision researchers working in NEI
    funded laboratories across the country have already developed several
    promising therapies that dramatically slow vision loss in animal
    models. Although my wife, Libby, and I are excited about this progress,
    we also live in fear that sight-saving treatments won't happen fast
    enough. With increased support for the NIH and NEI, we can speed these
    experimental treatments to clinical trials while my Rebecca can still
    see.
        Conclusion.--Mr. Chairman, the members of the National Alliance for
    Eye and Vision Research are supportive of an increased research focus
    on eye and vision disorders, such as those outlined above, and hope
    that the Committee will allocate a 20 percent budget increase to the
    NEI to allow these critically important research efforts to continue
    and expand. As we enter the 21st Century, we must ensure that we are
    doing our best to find ways to prevent and treat eye and vision
    disorders, and are providing quality eye care services and devices for
    those who are already suffering from visual impairment.
        Thank you.
                                     ______

      Prepared Statement of the American Society of Tropical Medicine and
                                    Hygiene

        Mr. Chairman and members of the Subcommittee, the American Society
    of Tropical Medicine and Hygiene (ASTMH) is pleased to have the
    opportunity to present its views on fiscal year 2001 funding priorities
    to the Subcommittee. The ASTMH, founded in 1903, is a professional
    society of approximately 3,500 researchers and practitioners who are
    dedicated to addressing the growing global threat of tropical
    infectious diseases. The collective expertise of our members is in the
    areas of basic molecular science, medicine, vector control,
    epidemiology, and public health. ASTMH is the principal voice for
    tropical medicine research within this country.
        The staggering burden of tropical and infectious diseases and the
    impact on global health confronts us on a daily basis. Poor health and
    the spread of infectious disease across borders has profound impacts on
    the social and economic development and stability of nations around the
    globe. With the enormous volume of travel and trade today, and with the
    expanded deployment of American troops, infectious diseases can impact
    populations around the globe within 24 hours. The globalization of
    infectious disease has brought an increased realization that infectious
    diseases represent not only a humanitarian concern but also a bona fide
    threat to the health and national security of the United States.
        In June 1996, President Clinton issued a Presidential Decision
    Directive calling for a more focused U.S. policy on infectious disease.
    The State Department's Strategic Plan for International Affairs lists
    protecting human health and reducing the spread of infectious diseases
    as U.S. strategic goals, and Secretary Albright in December 1999
    announced the second of two major U.S. initiatives to combat HIV/AIDS.
    The unprecedented UN Security Council session devoted exclusively to
    the threat to Africa from HIV/AIDS in January 2000 is a measure of the
    international community's concern about the infectious disease threat.
        Furthermore, the CIA's National Intelligence Council issued a hard-
    hitting report this past January entitled ``The Global Infectious
    Disease Threat and Its Implications for the United States.'' The report
    concludes that infectious diseases are likely to account for more
    military hospital admissions than battlefield injuries. The report
    assesses the global threat of infectious disease, stating ``New and
    reemerging infectious diseases will pose a rising global health threat
    and will complicate U.S. and global security over the next 20 years.
    These diseases will endanger U.S. citizens at home and abroad, threaten
    U.S. armed forces deployed overseas, and exacerbate social and
    political instability in key countries and regions in which the United
    States has significant interests.''
        Now more than ever, we must continue to be vigilant in our efforts
    to control and eradicate infectious diseases through prevention,
    treatment, and continued surveillance. As we enter the 21st century, we
    must marshal the efforts of government, industry, international
    organizations and private foundations if we are to protect our national
    security against biological and chemical attacks and protect Americans
    against infectious disease and antimicrobial resistance.
                         national institutes of health
        Mr. Chairman, the Society thanks you and members of the
    Subcommittee for your strong leadership in the area of biomedical
    research and for pursuing budget increases that will effectively double
    the NIH budget by fiscal year 2003. As a result of the 15 percent
    increase provided to the NIH in fiscal year 2000, new scientific and
    research opportunities are being pursued that hold the potential to
    prevent and control tropical and infectious diseases around the world.
    Your actions reflect the extraordinary importance of biomedical
    research to our national interest and are also helping to attract
    growing numbers of young scientists to the fields of academia and basic
    and clinical research.
        The American Society of Tropical Medicine and Hygiene requests your
    continued support for the NIHx2 campaign by providing a $2.7 billion,
    or 15 percent, increase for NIH in fiscal year 2001 as advocated by the
    Ad Hoc Group for Biomedical Research Funding. An appropriation of $20.5
    billion for NIH in fiscal year 2001 will allow promising research
    avenues to be pursued, including the development of new vaccines and
    treatments for diseases such as malaria, dengue fever, cholera,
    diarrheal diseases, HIV/AIDS, and a myriad of other viral bacterial,
    fungal and parasitic disease agents.
             national institute of allergy and infectious diseases
        The NIH's tropical disease research program is funded primarily by
    the National Institute of Allergy and Infectious Diseases (NIAID) and
    there are several important on-going issues relating to NIAID's
    research efforts that we would like to highlight.
        Malaria.--Globally, infectious diseases are the leading cause of
    morbidity and mortality, accounting for 1-3 times the mortality and
    morbidity resulting from heart disease, cancer and stroke combined. Of
    these infectious diseases, malaria continues to be the most devastating
    with a World Health Organization estimate of nearly 500 million
    clinical cases and up to 2.7 million deaths annually. Every 30 seconds
    a child somewhere dies of malaria. Even in the U.S., over 1,000 cases
    of malaria are reported every year, with local transmission being
    documented by the Center for Disease Control and Prevention (CDC).
        The Society commends the NIH and NIAID for their continued
    leadership and focus on malaria. We strongly support the NIAID research
    agenda which has made malaria vaccine development a high priority and
    has involved collaborative research efforts with private sector
    partners, including the Malaria Vaccine Initiative. We urge the
    Subcommittee to strongly support these efforts. Malaria is a complex
    disease and its control will require a significant research effort in
    therapeutics as well as in vaccine development for improved disease
    treatment. We encourage an equally vigorous effort in development of
    new antimalarial drugs.
        Tropical Medicine Research Centers.--The three centers overseas are
    most important in facilitating the NIAID's international tropical
    infectious disease research collaborations in areas endemic for these
    diseases. The research in the center is carried out in the endemic area
    by U.S. and local scientists. These centers are critical for the
    advancement of our scientific understanding and preparedness for
    emerging, re-emerging and other tropical infectious disease threats.
    The awarding of these centers is highly competitive. The Society
    strongly urges that the Subcommittee express its continued support for
    these unique research opportunities.
        Challenge Grants.--The Society of Tropical Medicine and Hygiene
    would like to thank the Subcommittee for its support of the new NIH
    Challenge Grants that were funded through the Public Health and Social
    Services Emergency Fund in fiscal year 2000. This initiative was
    created to promote collaborative research and development efforts
    between NIH, biotechnology, pharmaceutical and medical device
    industries to reduce the impact of infectious disease both nationally
    and worldwide. This unique investment in research and development will
    facilitate greater industry participation in the global effort to
    combat tropical and infectious diseases while at the same time
    leveraging private sector resources through the program's dollar for
    dollar matching requirement. The Society is pleased to note that NIAID
    has identified priority areas where the agency believes successful
    product research and development efforts could make a significant
    impact. The areas identified are malaria, tuberculosis, influenza, and
    emerging and resistant infections. The Society strongly urges the
    Subcommittee to provide continued support for the NIH Challenge Grant
    program in fiscal year 2001.
        The Society commends Congress for its leadership in combating
    infectious disease and encourages this Subcommittee to work with your
    colleagues and the Administration to create additional incentives that
    encourage public-private partnerships in the battle against tropical
    infectious diseases. We strongly endorse efforts such as the
    President's Millennium Vaccine Initiative and legislation pending in
    the House and Senate that provide a catalyst for research, development
    and production of vaccines and drugs, and make these products
    accessible in developing countries hardest-hit by infectious disease.
    If we hope to win the war against new and re-emerging tropical and
    infectious disease we must engage the collective resources of the
    private and public sector--both at home and abroad--in order get
    infectious disease under control until we can effectively conquer and
    prevent it.
                          fogarty international center
        The Fogarty International Center (FIC) is a unique component of NIH
    with a mandate to support training in biomedical research on behalf of
    the developing nations of the world. The ASTMH wishes to acknowledge
    the significant contributions of the FIC in overall support of tropical
    disease research of direct vital importance to American travelers,
    servicemen, missionaries, Peace Corps volunteers, and foreign service
    officers, among others. Less obvious are the indirect benefits of
    training in tropical disease research for our foreign biomedical
    counterparts.
        The Society supports the continued focus by the FIC to establish
    appropriate ethical standards relevant to internationally-based
    research. A delicate balance must be achieved between the need to
    facilitate vaccine and drug development and the testing of new products
    on human subjects in developing countries. The Society is pleased that
    the FIC has identified ethical principles and practice in patient-
    oriented research as one of four priorities it pursues in establishing
    research capabilities in developing nations. The Society encourages the
    Subcommittee to be supportive of FIC collaborations with its
    counterparts abroad and with international organizations in the pursuit
    of a broad ethic to be applied to internationally-based research
    initiatives.
                centers for disease control and prevention (cdc)
        The ASTMH appreciates the Subcommittee's past support for the CDC's
    infectious diseases program and requests your support for at least the
    President's fiscal year 2001 request of $202 million for these
    critically important public health initiatives Increased funding will
    help support the development of a national electronic disease
    surveillance network that will enable State and local health
    departments to respond to infectious disease outbreaks and share
    information about infectious disease emergencies and trends. The
    President's funding request will also increase the investment in the
    CDC's Food Safety Initiative, expanding the ability to more rapidly
    identify and track disease-causing bacteria including E. coli and
    Salmonella, and Shigella Sonnei, and provide for the implementation of
    a national prevention and control plan for hepatitis C.
                                   conclusion
        As we enter the 21st Century, we must aggressively pursue the
    battle against tropical and infectious diseases, that undoubtedly will
    intensify in the years ahead. We must have adequate surveillance
    systems and modern infrastructure, coupled with scientific expertise in
    both basic and clinical research, if we are to develop the tools
    necessary to rapidly respond to, and control, the threats posed by
    tropical infectious diseases.
        The Society greatly appreciates your support for our nation's
    investment in infectious disease research, control, and prevention
    activities. We urge you to continue your efforts to double the NIH
    budget over the next five years and towards this end we request a 15
    percent increase for the NIH budget in fiscal year 2001. We also
    request that the Subcommittee support the Administration's proposed
    increase of $26 million for the CDC's infectious disease activities.
        The Society of Tropical Medicine and Hygiene appreciates the
    opportunity to express our views and for your consideration of these
    requests.
                                     ______

                Prepared Statement of the Society of Toxicology

        The Society of Toxicology is pleased to have this opportunity to
    present its views concerning research in toxicological sciences and its
    strong support for the National Institutes of Health (NIH), and
    specifically for the National Institute of Environmental Health
    Sciences (NIEHS).
        The Society of Toxicology is a professional organization that
    brings together over 5,000 toxicologists in academia, industry, and
    government. The Society of Toxicology is dedicated to supporting
    research in toxicological sciences that leads to sound scientific
    information that can be employed to reduce uncertainties in assessing
    risks to human health and the environment. Enhancing science-based risk
    assessment benefits everyone through improved decision-making that
    protects the health of people and their environment while at the same
    time providing for a more rational use of our limited financial
    resources, i.e., a win-win situation.
                                funding request
        First, the Society of Toxicology would like to thank you, Chairman
    Specter, and thank your colleagues on this Subcommittee for
    demonstrating tremendous leadership in the area of biomedical research
    by providing a 15 percent increase to the National Institutes of Health
    (NIH) in both fiscal years 1999 and 2000. Your commitment to the
    campaign to double the budget for NIH by fiscal year 2003 provides
    great hope to Americans afflicted with disease and disabling conditions
    and ensures that we will continue to unlock the mystery of disease,
    including diseases that may be attributable to causal agents in the
    environment.
        Mr. Chairman, the Society of Toxicology strongly supports you in
    this goal and urges that you continue the NIHx2 campaign in fiscal year
    2001. We urge the Subcommittee to support the recommendation of the Ad
    Hoc Group for Biomedical Research Funding calling for a $2.7 billion,
    or 15 percent, increase for NIH in fiscal year 2001. We also urge the
    Subcommittee to support the professional judgement budget recommended
    by the NIEHS calling for a 19 percent increase in fiscal year 2001,
    given its important role in increasing our understanding of how the
    environment potentially affects our health. Whether it is exploring
    asthma incidence in children, testing for the toxic potential of
    chemicals, or better understanding the genetics underlying
    environmental risk factors, NIEHS supported research is leading the way
    in bridging the gap between public policy and environmental health
    science.
                             research opportunities
        Basic research focused on discerning the mechanism or mode of
    action of a particular agent of interest is of fundamental importance
    to society. It provides the basis on which we make reasonable estimates
    as to whether or not harm might occur to people or the environment
    under realistic conditions of exposure. Furthermore, as we explore
    mechanisms by which chemical and physical agents may produce toxicity
    we learn more about basic biology; thus, toxicology is one of the basic
    biomedical sciences.
        The quality of life in our Country has improved markedly over the
    past century. For example, life span was approximately 45 in 1900 and
    today it is 75+ years. Indeed, much of the good life that many of us
    enjoy is attributable directly to the proper use of chemicals,
    including medicines, to benefit people. Research in toxicology,
    including the use of animals, has and continues to play a key role by
    defining the conditions of use under which we may employ chemicals for
    good causes that benefit society. Yes, there have been some problems/
    mistakes made; however, importantly, we are striving to improve and
    research focused upon the key aspects of risk assessment (outlined
    below) will permit us to continue to make progress.
        The scientific basis of risk assessment can be enhanced by the
    development of improved test systems and improved means for
    interpretation of results. Key aspects of any risk assessment include
    an emphasis on: (1) selection of doses used for testing and
    extrapolation, e.g., there should not be an emphasis on the use of
    excessive doses; (2) dose-response relationships, including
    extrapolation from high to low doses, e.g., effects that occur at high
    doses do not necessarily occur at low doses; (3) species-to-species
    extrapolation; and (4) exposure assessment, e.g., we need to take into
    consideration the relationship between doses used in testing as
    compared to the amounts that people might actually encounter. It is
    important to define conditions under which chemicals may be used,
    beneficially with a high degree of safety, and to identify those
    situations when a chemical's use should either be restricted severely
    or it should be banned. This entails hypothesis-driven research and it
    is consistent with the notion that it is the dose which makes the
    poison. Members of the Society of Toxicology believe strongly that our
    investment in biomedical research must be increased and sustained over
    the long-term if we are going to take advantage of the many exciting
    research opportunities that exist in environmental health sciences. We
    support the research agenda and priorities identified by NIEHS Director
    Dr. Kenneth Olden. These can further the development of the science
    that is necessary to provide a basis for sound decisions leading to
    both improved protection of human health and the environment.
        NIEHS research on the Environmental Genome Project will help us to
    better understand why some people might be more susceptible to
    environmental exposures leading to disease development than others.
    This area of risk assessment is one which we know the least about. In
    this context, it is important to understand that exposure assessment,
    as noted above, is a key aspect of risk assessment. In order to be
    credible, a risk assessment must be based upon realistic data
    concerning exposure. The Society of Toxicology commends NIEHS for its
    planned interagency collaboration with the Centers For Disease Control
    and Prevention (CDC) and the Environmental Protection Agency (EPA) to
    improve the technological sophistication of exposure assessment and the
    use of exposure assessment in developing disease prevention strategies.
        The Society of Toxicology supports the partnership between the
    NIEHS and the Environmental Protection Agency to establish a national
    network of Children's Environmental Health and Disease Prevention
    Research Programs to study children's health issues that might be
    linked to the environment, such as pediatric asthma and other
    respiratory diseases. These illnesses have lifelong adverse health
    implications for children and consume substantial health care dollars.
    Furthermore, basic research is required in order to learn whether or
    not there is a difference in the susceptibility of children as compared
    to adults with regard to the toxic potential of particular chemicals.
        A strong investment in NIEHS will continue the study of the
    potential adverse effects of chemicals that might be able to
    disregulate endocrine activity. It is important to ascertain whether or
    not these compounds, often referred to as endocrine disrupters,
    actually contribute to human disease at the levels they are found in
    the environment. The Society is especially pleased that NIEHS is moving
    forward with a number of studies to examine the possible linkage
    between exposure to alleged endocrine disregulating chemicals and
    disorders affecting both male and female reproductive health.
        We applaud the NIEHS for spearheading the NIH research effort in
    collaboration with the FDA and industry and academia, to develop
    biomarkers for the efficacy and safety of new drugs. It is imperative
    that promising therapeutics move from the laboratory to the patient in
    a more timely manner with a high level of assurance concerning their
    efficacy and safety. You can be sure that the Society of Toxicology
    will continue to promote this important research collaboration. Under
    Dr. Olden's direction, NIEHS has taken a leadership role with regard to
    encouraging partnerships involving government, academia and industry to
    work on environmental health-related issues.
        NIEHS continues to play an important role in the multi-agency
    effort to identify the research needs on the safety and efficacy of
    herbal medicines. Of the approximate 2,000 herbal products in use, only
    a few have been adequately tested for efficacy and toxic potential. As
    the use of these alternative therapies becomes more widespread, there
    is the need for scientifically valid information about both the
    benefits and risks of their use.
             superfund hazardous substances basic research program
        The Society of Toxicology also wants to express its strong support
    for the Superfund Hazardous Substances Basic Research Program. This
    program is administered by NIEHS although it is funded through a pass
    through from the EPA to NIEHS. The Superfund Hazardous Substances Basic
    Research Program is the only scientific research program focused on
    health and cleanup issues for Superfund hazardous waste sites. It
    represents an important collaboration between EPA and NIEHS, and it
    should ensure that environmental cleanup decisions are based on sound
    environmental health science.
        The Superfund Hazardous Substances Basic Research Program supports
    university and medical school research to understand the public health
    consequences of local hazardous waste sites, as well as to develop
    better methods for remediation. It is important to note that this is
    the only university-based research program that brings together
    biomedical and engineering scientists to provide the science and
    technology base needed for making accurate assessments of human health
    risks and developing cost-effective cleanup technologies.
        The primary purpose of Superfund Hazardous Substances Basic
    Research Program is to provide the scientific basis needed to make
    accurate assessments of the human health risks at hazardous waste
    sites. In addition, research data is used to determine which
    contaminated sites must be cleaned up first, to what extent clean up is
    needed, and how best to clean up contaminated sites in the most cost-
    effective manner. The Society of Toxicology is disappointed that the
    President's budget request reduces funding for this important program
    by $11.5 million. We hope Congress will consider restoring funding for
    this program to its fiscal year 2000 level of $60 million. We
    understand that this funding matter is not under the jurisdiction of
    this Subcommittee. With that said, we urge the Members of the
    Subcommittee to engage in the necessary discussions with the VA-HUD and
    Independent Agencies Appropriations Subcommittee to ensure that these
    resources are continued.
                                   conclusion
        Once again, thank you for continued leadership in the area of
    biomedical research and for considering the funding priorities outlined
    above. The Society of Toxicology looks forward to working with you to
    continue the campaign Congress initiated two years ago to double the
    NIH budget by 2003, and to continue the pursuit of the many promising
    research opportunities at hand as a result of the nation's investment
    in biomedical research. Under Dr. Olden's leadership, the NIEHS is
    taking a leadership role with regard to enhancing the scientific basis
    that is necessary in order to make better decisions concerning our
    environment.
        Thank you.
                                     ______

             Prepared Statement of Former Congressman Louis Stokes

        Mr. Chairman and Members of the Subcommittee, I respectfully submit
    the following testimony on my own behalf. As a former member of the
    House Subcommittee for Labor-HHS, I am so very proud of the work this
    Subcommittee and its House counterpart has accomplished in providing
    the vision and the leadership that has led to tremendous strides in the
    prevention, diagnosis, and treatment of disease and disabling
    conditions and has greatly enhanced the quality of education and
    training opportunities for all Americans. As you know, while serving in
    the House I shared your interest in developing programs and strategies
    to protect those most vulnerable in our society. I am continuing to
    pursue this interest by serving as a member of The Pew Environmental
    Health Commission. This Commission is an independent panel of
    representatives from the health field, industry, government, academia
    and the nonprofit community. Launched in May 1999, and chaired by my
    colleague, former three-term senator and governor of Connecticut,
    Lowell Weicker, Jr., the Commission's charge is to provide leadership,
    vision, and visibility for strengthening the country's defenses against
    environmental threats.
        My interest and passion for these issues brings me here today to
    discuss opportunities for this Subcommittee to once again exercise
    leadership by strengthening the federal investment in our public health
    infrastructure. I submit to you that if our nation's best and brightest
    researchers and public health officials had the tools necessary to
    develop meaningful disease prevention strategies, we would witness
    extraordinary achievements in health outcomes and in reducing the
    nation's health care costs.
        For more than a quarter century, we have made enormous strides in
    protecting our air and water quality and preserving areas of natural
    beauty and biological diversity essential to a healthy environment.
    Last month, Governor Ryan from the state of Illinois awarded over
    $950,000 to plug 148 abandoned oil and gas wells in Clinton and
    Lawrence counties and to clean up and restore a waste crude oil site in
    Saline County. The state of New York is successfully restoring the
    Hudson River, and California is doing a tremendous job of revitalizing
    its brownfields. Despite the progress made in cleaning up and
    preserving the environment around the country, we have lost our focus
    on protecting our children from health hazards arising from exposure to
    environmental contaminants.
        The Pew Environmental Health Commission is issuing a series of
    reports on children's health, including a report on birth defects which
    was released this past November and a report on childhood asthma which
    will be released later this Spring. As part of the birth defects
    report, entitled Healthy from the Start: Why America Needs a Better
    System to Track and Understand Birth Defects and the Environment, the
    Commission has called for a national approach for monitoring exposures
    linked to the environment and building the capacities and strategies
    for monitoring and evaluating chronic disease.
        Birth defects are the nation's leading cause of infant death in the
    United States, resulting in approximately 6,500 deaths annually.
    However, a major analysis of national data on birth defects and the
    environment has found unexplained increases in certain birth defects
    and related conditions that point to the need for strengthening the
    public health system. Even though birth defects are the nation's
    leading cause of infant death, one-third of the states, the District of
    Columbia and Puerto Rico--with a total population of nearly 59
    million--fail to track birth defects, and 25 more states have systems
    that need improvement. Without this data, public health officials are
    literally working in the dark. This makes it much more difficult to
    identify emerging disease clusters and tackle environmental threats
    that may cause sickness and death in our children.
        As many of you know, I took an active role in mitigating the
    effects of lead and protecting the health of Americans from lead
    exposure during my service in Congress. Congressional intervention,
    coupled with the efforts of CDC, EPA, and other private and public
    partners, has resulted in the reduction of the percentage of children
    in the U.S. with elevated blood lead levels from 88.2 percent in the
    late 1970's to 4.4 percent in the early 1990's. This is a prime example
    of how having good public health data can significantly improve our
    environmental decision-making process.
        When the EPA decided to phase out lead in gasoline in 1973,
    Congress received considerable pressure to reverse the regulation.
    While lead was a well-known neurotoxin, with children being most
    vulnerable to permanent neurological damage, it had been widely used in
    gasoline to prevent engine ``knocking.'' EPA's theoretical models
    suggested that a ban on lead would result in only minimal changes in
    human lead levels, but health data from the CDC saved the day by
    showing dramatic decreases in human lead levels, persuading Congress
    that EPA's restrictions on leaded gas were appropriate. Unfortunately,
    CDC does not routinely monitor the level of dangerous pollutants in the
    American population despite important past lessons during the great
    debate over leaded gasoline. If there is no significant change in our
    data collection system, we will be apt to make many costly mistakes.
        We have just been reminded of such a mistake with another fuel
    additive, Methyl Tertiary Butyl Ether, or commonly referred to as
    ``MTBE.'' The federal Clean Air Act Amendment requires MTBE to be used
    for reformulated gasoline in an effort to reduce air pollution.
        Shortly after the beginning of its widespread use in the gasoline
    supply, communities around the country began complaining about health
    problems--including headaches, eye, nose, and throat irritation,
    nausea, and disorientation--linked to MTBE. Yet before its widespread
    use we never investigated nor gave the money to CDC to track Americans'
    exposure to this chemical--despite having the technology. Since then,
    CDC has been given limited funding to study levels of MTBE in humans,
    but at this point--despite the numerous complaints and public outcry--
    population exposure to this compound cannot be evaluated. We have not
    paid appropriate attention to the health problems. Instead, we waited
    until leaks in storage tanks led to contaminated water supplies. If we
    had focused on health, we could be saving ourselves millions of dollars
    in clean up. This was a lesson learned from lead.
        This is why we need a modern public health system that readily
    tracks the health of Americans. In order to develop ways of testing
    whether people have been exposed to hundreds of carcinogens and toxic
    substances, we need an increase in environmental health funds. The
    President's budget request for the CDC's National Center for
    Environmental Health would more than double the $10 million given to
    the Federal Government in fiscal year 2000, and would enable the CDC to
    move toward monitoring human exposures to more than 100 potentially
    toxic substances, up from the current 25. This is a positive first
    step, but it is just a start.
        The Pew Environmental Health Commission recommends a broader
    national approach to biomonitoring that will encompass tracking all
    environmental health hazards that science suggests have a linkage to
    chronic and infectious diseases. It is estimated that the cost, about
    $275 million, or $1 for every man, woman, and child in America, would
    develop the monitoring capacity to identify and protect against agents
    in the environment that pose great risk to the public's health. This is
    a modest price to pay to prevent the many chronic and infectious
    disease killers which science suggests are linked to environmental
    causes and extract billions of dollars in health care costs each year.
    A $275 million investment in the CDC's National Center for
    Environmental Health will put real teeth into our nation's effort to
    protect the public from environmental hazards and preventable disease.
        Mr. Chairman and members of the Subcommittee, I know you realize
    the time has come to renew our investment in a public health system
    that will prevent the chronic diseases and disabilities that afflict
    millions of Americans. While medical science has advanced to conquer
    many infectious and chronic diseases, preventing chronic illness
    through public health programs has failed to keep pace.
        As you know, the President has also proposed to provide a $20
    million increase to the CDC's emerging infectious disease program to
    develop a national electronic disease surveillance network to assist
    local and state public health officials in responding to disease
    outbreaks. Again this is a start, however it too represents a piecemeal
    approach. The President's plan does not seize on the opportunity to
    provide a comprehensive, integrated strategy to the public health
    burden of chronic and infectious disease.
        While infectious disease remains important, chronic disease is now
    the no. 1 killer, responsible for three of every four deaths in the
    U.S. annually--about 1.8 million Americans--and a yearly economic cost
    of $325 billion. And the numbers are rising! I am, by no means,
    suggesting that infectious disease is not important. But while it is
    important to remain vigilant in protecting against infectious disease,
    we should also focus on causes and prevention of chronic disease and
    disability. These health problems might be preventable if only we knew
    more about the complex interactions among the social, biological and
    environmental factors that affect us.
        In 1995, health studies estimated that of the 30 years added to
    Americans' life expectancy since 1900, only five years on average are
    due to improvements in clinical medicine. The majority, 25 years, are
    attributable to public health programs. The steepest decline in
    mortality resulted from improvements to environmental conditions that
    prevented the spread of infectious disease, such as treatment of
    drinking water and removal of wastes, and better nutrition and food
    handling practices.
        When it comes to resources, our nation rightly spends billions of
    dollars to monitor the impact of the environment on plants and animals.
    However, as a nation, we do little to monitor the impact of the
    environment on our public health.
        At the turn of the 20th century, our nation faced the tremendous
    challenge of infectious disease by marshaling the resolve and the
    resources to conquer these killers. Now at the turn of the 21st
    century, it is chronic diseases--such as birth defects, asthma, and
    cancer--that are taking an immense toll on our public health. Our
    country needs to have a strong public health system. I am asking you to
    join me in supporting the following:
      --An investment of $275 million for a comprehensive national
            biomonitoring program that will alert us to hazards in our
            communities that pose serious, but preventable, health risks.
      --A renewed commitment to the public health infrastructure that
            mirrors the strength of our national commitment to biomedical
            research.
        It is time for CDC to step up as a leader in disease prevention. It
    is with your help that we can make the investment to get them there. We
    must rise to this challenge by utilizing the best research, treatment,
    and tracking tools to win the war against health threats and disease
    that cause enormous human pain and suffering.
        Thank you.
                                     ______

              Prepared Statement of the Kennedy Krieger Institute

        Mr. Chairman, Members of the Committee, thank you for the
    opportunity to submit testimony for your consideration in the fiscal
    year 2001 budget for programs under your committee jurisdiction.
                         the kennedy krieger institute
        The Kennedy Krieger Institute is an independent research
    institution located adjacent to Johns Hopkins University. The mission
    of the Institute is to focus solely on disorders related to the brain
    and central nervous system. Brain related disorders effect one in four
    adults and one in ten children at a cost to society of $400 billion per
    year. The overall goal of research at the Kennedy Krieger Institute is
    to understand the developing central nervous system through the study
    of relationships between genes, the brain and human behavior. While the
    Institute has special expertise with regard to children, the research
    scope includes studies of changes in the brain and the CNS across the
    lifespan. Our Institute integrates cutting edge neurobiological
    research efforts into a comprehensive program which includes inpatient
    and day treatment services; outpatient services; home and community
    services; and school programs for children with disorders of the brain.
    The Institute is well-known for its strong interdisciplinary research
    and care in many fields including medicine, psychology, education,
    physical and occupational therapy, audiology, speech and language
    therapy, social work, child development, nutrition and nursing. In our
    statement to the Committee, we will highlight the efforts of three
    federal agencies under your jurisdiction and the important work that
    they do to strengthen the capacity of Institute's, such as ours, to
    make progress in this important area.
                          basic and clinical research
        We are currently experiencing an unprecedented appreciation of the
    benefits to health and life quality that can result from biomedical and
    behavioral research. Of particular note is the most welcome present and
    predicted increase in public sector funding for basic research and the
    dramatic, if not explosive, private sector investment in biology. With
    such appreciation and tangible support comes the responsibility to
    organize the scientific enterprise so as to produce effective
    interventions. And, our challenges are many.
        Many children with developmental disabilities and neurological
    diseases display severe behavior problems. The mission of our basic and
    clinical research, clinical care and educational programs is to improve
    the quality of life for these children and their families through a
    variety of mechanisms including: providing advanced and comprehensive
    treatment services; promoting the widespread dissemination of effective
    interventions; and improving treatment technologies through basic and
    clinical research. With that said, we support treatment and research
    initiatives including but not limited to behavior programs, pediatric
    feeding disorders, neuroimaging, basic and clinical research efforts
    and training.
        The National Institute of Child Health and Human Development
    (NICHD) and the National Institute of Neurological Diseases and Stroke
    support a number of important initiatives with regard to brain biology;
    neurobehavioral assessment and protocol development; translation
    studies related to cognition pathways of learning disorders from a
    developmental perspective; molecular sciences to further understand the
    molecular basis of many developmental disabilities; brain mapping; and
    other basic and clinical programs which are at the core of the programs
    conducted at the Kennedy Krieger Institute. Further, the National
    Center for Research Resources (NCRR) supports important neuroimaging
    studies for neuroscience, metabolic and other research. We have support
    from the NCRR for our General Clinical Research Center (GCRC) in which
    we are conducting studies related to functional imaging. We believe it
    is important for the Committee to consider an NIH National Imaging
    Network for Clinical Research which will enable NCRR to provide the
    resources to create links between the GCRC to the imaging center. This
    sort of infrastructure would be vitally important to facilitate and
    integrate research networks.
        We are very excited regarding planning underway at the NICHD with
    regard to pediatric trauma. While injuries and violence are,
    respectively, the first and third most frequent causes of death in
    children 5 to 18, many clinical treatments are tailored to the adult
    population. NICHD is planning a multi-disciplinary, collaborative
    programs under the egis of its National Center for Medical
    Rehabilitation Research. This program will enable the development and
    assessment of therapies specifically targeted to the physical,
    emotional and social needs of children through a series of basic and
    clinical research initiatives. Mr. Chairman, this initiative marks the
    first such federally-funded program of its kind. The NICHD should be
    applauded for its efforts in this regard.
        We urge the Committee to continue its efforts in support of the
    NIH. The Kennedy Krieger Institute endorses the recommendation of the
    Ad Hoc Group for Medical Research Funding for fiscal year 2001 which
    recommends a 15 percent increase to double the budget of the NIH by
    2003.
                                   education
        Our approach to severe behavioral problems in many children with
    developmental disabilities and severe behavior problems is multi-
    focused. The Severe Behavior Program provides comprehensive diagnostic
    evaluations, parent training and school consultative services. The
    linkage to the child's school and school district is imperative to
    develop and effectively implement effective strategies to deal with the
    behavioral problems many of our patients present with. This initiative
    is complemented by inpatient and outpatient behavioral management
    services for children who display severe destruction behavior.
        The Institute's Lower and Middle Schools, recipients of the U.S.
    Department of Education's National Blue Ribbon Awards in 1996 and 1997,
    respectively, are recognized models in special education. Their track
    record includes: innovative models of education based upon current
    scientific understanding of brain functioning; creative integration of
    technology in the classroom; comprehensive curriculum tailored to
    unique needs of the student; and training in the field of special
    education. We are in the process of opening a high school which will
    serve as a national model of a comprehensive approach to school-to-work
    transition for youth with serious learning, emotional, neurological,
    and developmental disabilities. Our high school has a school-to-work
    curriculum. The Career and Technology High School is unique in that it
    will be the only program in the area to make career training the
    foundation of, and not merely a supplement to, the school's core
    curriculum. Drawing on the most current educational, work-readiness,
    and industry standards, the high school staff develop partnerships with
    business and community groups to develop a state-of-the-art model that
    will result in economically and personally rewarding employment for
    youth with disabilities. The Career and Technology High School will
    take students challenged by severe learning, emotional, traumatic brain
    injury, and developmental disabilities and provide a school-to-work
    instructional model that addresses the needs of students with serious
    disabilities with the skills to undertake meaningful employment.
    Students will leave the school with the knowledge and work and social
    experience they will need for successful post-secondary employment in a
    specific career clusters including: Information Technologies;
    Hospitality; Tourism Construction and Manufacturing; Business and
    Finance; Arts and Graphics; and Communications. Programs supported by
    the Department of Educations, including the Star Schools Program and
    the Technology Innovation Challenge Grant program are critical to
    enable cutting edge programs such as our to fully develop our capacity
    to create model systems which can be applied nationwide. The strong
    support that this Committee has provided to these programs in the past
    have been a worthwhile investment and we urge your continued support.
         national center for behavioral research in children and youth
        We, at the Kennedy Krieger Institute, believe that the time is
    right to build on our leadership in behavioral research and are
    establishing a National Behavior Center to address such problems as
    teenage smoking, substance use and abuse, school failure, violence,
    teen pregnancy and other behavioral problems of children and use which
    have similar causes and solutions. The National Behavior Center will:
    (1) study the causes of these behavior problems from multiple
    perspectives (e.g. family, society, environmental toxins, neuro-
    developmental, etc.); (2) design, evaluate and implement prevention and
    intervention programs for these problems; (3) train other professionals
    to significantly impact these important child and adolescent behaviors;
    and (4) serve as a national resource for other institutions of higher
    learning and government agencies.
        The National Behavior Center will expand the Institute's efforts
    from a primary focus on brain related disorders to the broad spectrum
    of child and youth behavior. We expect that it will have a national
    impact in terms of understanding children's behavior and how to
    identify and prevent the dramatic problems we see on the news every
    evening that every parent fears.
        As adults in society we have become all too painfully aware of
    behavior and health problems that our children are facing. Data
    demonstrates that serious attention must be paid to behavior problems
    of children and youth to address many societal challenges. School
    students are being directly exposed to unprecedented levels of
    violence: 80 percent of the children surveyed report witnessing threats
    and actual assaults, and 50 percent of students believe that violence
    like we saw in Litteton, Colorado could happen in their school.
    Tragically 50 percent of students in large city and rural schools know
    someone their age who has committed suicide.
        But our concerns for our children should not stop with issues
    related to violence. Only 58 percent of high school dropouts are
    employed, and one-third of major U.S. corporations spend $250 billion
    annually to provide basic academic skills training for employees, such
    as reading and math. Drug use has a strong link to the use of tobacco
    as a ``gateway'' drug. One million youth start smoking each year, 3,000
    every day. One million also begin to use smokeless tobacco. As few as
    3-5 cigarettes a day can increase the risk of mental retardation of an
    unborn child by 25-30 percent.
        The use of alcohol by children and youth causes automobile,
    pedestrian, and cyclist accidents, interpersonal violence, drowning and
    burns, suicides, fetal alcohol syndrome, alcohol poisoning, and alcohol
    dependence and abuse. In terms of interpersonal violence alone, alcohol
    contributes to 16 percent of all child abuse as well as to over a third
    of all robberies, assaults, rapes and murders. The estimated cost to
    society is $60 billion annually.
        One out of every ten women become pregnant at least once before
    they reach the age of 20. One million teenagers each year have an
    unwanted pregnancy with a yearly cost to society for medical care,
    foster care, decreased work productivity, welfare, and the like of some
    $7 billion. Further, an unwanted pregnancy often initiates a cascade of
    problems. Children of teenage mothers have lower birth weights, are
    more likely to perform poorly in school, and are at greater risk for
    abuse and neglect. Sons of teenage mothers are more likely to end up in
    prison and daughters are more likely to become teenage mothers
    themselves. Most unmarried teenage mothers end up on welfare.
        Mr. Chairman, a research and public education collaboration between
    the federal agencies you have identified is necessary if we are to get
    handle on the best approaches to the rapidly escalating problem of
    destructive behavior in youth in our society. It is of paramount
    importance to establish a comprehensive and multidisciplinary
    initiative that will enhance our understanding of why children become
    aggressive, why they commit violent acts, why they are unable to
    control their behavior, or why children choose to engage in risky
    behaviors. Efforts need to focus on identifying the varied roots of
    child and adolescent behavior and violence by addressing an array of
    potential influences, including social and cultural variable, family
    relationships and family violence, peer influences, child temperament
    and health, genetic influences, neurological processes and biological
    risk factors. We need to begin to apply what we have learned in the
    field of neurobiology, brain mapping, and behavior analysis in the
    developmentally impaired individual to the broader population of
    children and youth demonstrating behavioral problems.
        A coordinated national science agenda addressing the problems of
    behavior in children must include these components: enhance research,
    ranging from basic and to clinical, from genes to behavior, related to
    the behavior of children and youth; employ 21st Century technology for
    reliable behavior change; and establish a network to coordinate
    disciplines and delivery systems. Mr. Chairman, Members of the
    Committee, we applaud your efforts in this regard and look forwarding
    to working with the agencies involved in this important initiative.
        Thank you for the opportunity to present our views.
                                     ______

      Prepared Statement of the Society for Animal Protective Legislation

             the coulston foundation and the chimp act (h.r. 3514)
        The Society for Animal Protective Legislation (SAPL) urges the
    Subcommittee to support the efforts of the House Appropriations Labor,
    Health and Human Services and Education Subcommittee, led by Chairman
    John Porter, to find short and long-term solutions to ensuring the
    humane treatment of chimpanzees at The Coulston Foundation.
        The Coulston Foundation, a private biomedical research facility
    located in Alamogordo, NM, currently houses the largest chimpanzee
    colony in the world with over 650 chimpanzees and hundreds of other
    animals at the facility. The Coulston Foundation is the only research
    facility to be officially cited three times by the U.S. Department of
    Agriculture for violations of the Animal Welfare Act (AWA). The AWA
    violations are based on numerous negligent deaths of chimpanzees and
    monkeys over the past seven years. In fact, the USDA has completed six
    formal investigations of the Coulston Foundation and is currently in
    the middle of its seventh investigation in as many years. The sixth
    investigation ended with an unprecedented agreement between The
    Coulston Foundation and the USDA where The Coulston Foundation agreed
    to divest itself of 300 chimpanzees by 2002. Sadly, another six
    chimpanzees have died since the August 1999 USDA settlement. We have
    included six of the deaths reported at The Coulston Foundation: (1)
    Terrance, Muffin and Holly died from the well-known side effects of a
    drug that was later tested in children; (2) Donna, a former Air Force
    chimpanzee, died on November 9, 1999 due to carrying a large, dead
    fetus inside her womb for up to two months. TCF veterinarians removed
    one liter of pus from her abdomen during a belated C-section and
    reported seeing the skull of her decomposed fetus through the ruptured
    wall of her necrotic uterus; (3) Another chimpanzee died during a drug
    study after losing 29 per cent of his body weight in just 2-4 weeks
    (three other chimpanzees lost similar life-threatening amounts of
    weight). Responding to the FDA's citation of these violations, TCF
    actually told the agency that the lab had ``anticipated'' this fatal
    weight loss.
        In August 1999, Food and Drug Administration (FDA) investigators
    documented more than 270 violations of Good Laboratory Practice (GLP)
    regulations at The Coulston Foundation on just three studies reviewed.
    According to the FDA, GLP regulations exist to ensure data integrity
    and human safety. The FDA confirmed many of the USDA's findings, and
    identified new violations of animal welfare laws. On 12/22/99, the FDA
    issued a rare Warning Letter, finding the conditions at TCF to be
    ``serious violations'' with ``wide spread consequences'' for data
    integrity and human safety, and stating ``that there will be no further
    studies conducted that are subject to the FDA GLP regulations until
    corrections are made and verified.''
        We understand that the National Institutes of Health may be working
    on its own solution to the problem at The Coulston Foundation, yet no
    such plan has been presented, and the situation at The Coulston
    Foundation has continued to worsen. The problems at The Coulston
    Foundation are not new. In fact, circumstances at the laboratory have
    been deteriorating for several years. Meanwhile, NIH has done little to
    alleviate the situation but provide continued financial support to this
    non-compliant laboratory while the USDA and the FDA have filed several
    charges against the laboratory for hundreds of violations of federal
    law relating to human safety and animal welfare. Now is time for
    Congress to step in and put an end to the abuse and financial waste at
    this laboratory. NIH has spent over $30 million on The Coulston
    Foundation over the past 7 years while nothing has been done to ensure
    animal care or data integrity on the research.
        The only long-term solution to ensure the well being of the
    Coulston chimpanzees and all chimpanzees used in federal research is
    the passage of legislation creating a national chimpanzee retirement
    sanctuary. Legislation has already been introduced in the House that
    would create such a system (Chimpanzee Health Improvement, Maintenance
    and Protection Act--H.R. 3514). The Act will create a network of
    federal/private-supported sanctuaries to which chimpanzees formerly
    used in research will be retired. This approach is not only morally and
    ethically responsible, but will save the taxpayers several million
    dollars a year.
        A critical component of a chimpanzee retirement sanctuary, which we
    would like to address, is that of permanent retirement, the cornerstone
    of a chimpanzee sanctuary. Unfortunately, NIH has expressed concerns
    with this component, reportedly fearing that there might not be a
    sufficient number of chimpanzees to use in research, should an
    emergency arise which might warrant wide use of the species for
    research purposes. To address this concern, we wish to present the
    following details designed following the recommendations presented in
    the 1997 NIH requested and funded National Research Council (NRC)
    Report, Chimpanzees in Research: Strategies for Their Ethical Care,
    Management and Use. The NRC report specifically recommends that NIH
    maintain a core population of chimpanzees in case of just such
    emergencies. However, the report further states that the current
    chimpanzee population is above and beyond the number necessary both for
    current research needs and anticipated emergency use. It therefore
    concludes that several hundred ``excess'' chimpanzees should be retired
    to sanctuary facilities. The report suggests that to do so makes
    financial and moral sense. The sanctuary system would only apply to
    chimpanzees clearly no longer needed for research. It would not prevent
    the use of chimpanzees in research, nor would it prevent NIH from
    maintaining a ``reserve'' of chimpanzees in case of an unforeseen
    public health emergency. In addition, once a chimpanzee is no longer
    needed for research, the respective research facility has the sole
    authority to retire the chimpanzees, not the animal welfare community.
    This is especially important because there are currently several
    research facilities ready and willing to retire chimpanzees. The
    creation of a permanent retirement sanctuary system has the broad
    support of primate specialists including Dr. Jane Goodall, Dr. Frans de
    Waal, Thomas Insel, M.D., Thomas Gordon, Ph.D. and Michael Kastello,
    D.V.M., Executive Director, Research Resources, Merck & Co., Inc. to
    mention a few. We hope this information will satisfy any concerns NIH
    may have regarding permanent retirement of chimpanzees.
        Former National Academy of Science official and supporter of
    national sanctuary system Thomas Wolfle, was correct when he said that
    the NIH is ``morally responsible'' for caring for the chimpanzees it
    paid to breed and infect. It is time to live up to our moral
    obligations, first by providing alternative care for the chimpanzees at
    The Coulston Foundation, and then by creating a sanctuary system to
    provide permanent retirement to the Coulston chimpanzees and the
    hundreds of other chimpanzees who remain warehoused in laboratories.
    stolen and fraudulently obtained family pets are being used in taxpayer
                               funded experiments
        Approximately 100,000 dogs and cats are used for research purposes
    in the United States each year. The majority of these animals are
    obtained from breeders who raise the animals under controlled
    conditions and have extensive information on the health status and
    genetic background of the animals. Other dogs and cats are obtained
    directly from municipal pounds or the animals may come from breeding
    stock within the research facility.
        Unfortunately, despite extensive documentation strongly
    discouraging the practice, some research facilities are still
    purchasing dogs and cats from random source dealers. These dealers,
    with a Class B license designation by USDA, are notorious for selling
    animals to laboratories that have been acquired through theft or fraud
    and for their widespread failure to comply with the minimum
    requirements under the Animal Welfare Act.
        Recognizing the severity of the problem, the U.S. Department of
    Agriculture increased its enforcement efforts at the premises of Class
    B dealers approximately three years ago. Stronger enforcement drove
    some of the random source dealers out of business, but it has not
    solved the problem. These dealers continue to fail to maintain the
    legally mandated records identifying where they are getting the dogs
    and cats they sell to laboratories for hundreds of dollars each.
        The records are not completed (and traceable to a legitimate
    source) because these animals are being purchased from illegal sources
    (people who have not bred and raised the animals and/or did not
    willingly give them up for research purposes). For example, the
    inspection report from a USDA-licensed dealer in Iowa cited the
    following apparent violation, ``Records indicate that 290 dogs were
    sold to research, but only 83 animals exhibit required acquisition
    paperwork by this licensee. Fully 207 adult dogs are not accounted for
    via the release forms paperwork. Also, the dealer is listing himself as
    the source of animal acquisition, when this dealer is actually
    acquiring animals from a variety of individuals. . . .''
        This dealer has allegedly supplied more than one thousand dogs for
    experimentation that he acquired through fraud. Further, it is alleged
    that the individuals who bred and raised the animals were deceived by
    the dealer into believing that their dogs, former racing greyhounds,
    were being adopted to good homes. This situation became public this
    month, since then the dealer has disconnected his home and business
    telephone service. Now he is under investigation by USDA and the
    Wisconsin State Division of Gaming. As is usually the case, it is too
    late to rescue any dogs since all of the animals the dealer sold to
    laboratories have been euthanized following their use in
    experimentation.
        Meantime, the National Institutes of Health continues assuring
    Congress and the public that they are ``committed to ensuring the
    appropriate care and use of animals in research.'' NIH has left the
    decision of whether or not to use dogs and cats from Class B dealers
    ``to the local level on the basis of scientific need.'' NIH
    acknowledges ``Class B dealers provide biomedical researchers with
    animals that may not be available from other sources, such as
    genetically diverse, older, or larger animals.'' In fact, the animals
    needed are available from other sources; genetically diverse, older or
    larger animals could be acquired directly from those pounds that choose
    to supply animals for experimentation.
        The distinction between non-purpose-bred animals from pounds versus
    Class B dealers needs to be made and emphasized. By using Class B
    dealers instead of pounds, researchers are contributing to the problem.
    In their search to fill researchers demands for ``genetically diverse,
    older, or larger animals,'' random source dealers are stealing pets
    from backyards and farms or they are acquiring animals through fraud by
    collecting animals offered ``free to a good home.''
        Following is a statement recently circulated on the web from a
    gentleman in Jonesboro, Arkansas: ``I am no animal rights activist--I
    am a neurosurgeon, an avid hunter, conservationist, dog lover, horseman
    and all-'round country boy. I was brought up to believe in caring for
    the animals that we own and I love my 4 year old black Lab, Rebel,
    second only to my kids. He was stolen from my home on Dec. 18, 1999. I
    have solid information that he was taken by (or for) a nearby `buncher'
    who sells dogs to research facilities. . . . As a neurosurgeon, I
    support animal research for worthwhile purposes when the data cannot be
    acquired any other way and when the animals are properly procured and
    properly cared for--but not when they are our pets that have been
    stolen.''
        Each year as NIH and the researchers it funds fail to take action,
    more companion animals are stolen and the numbers of distraught and
    outraged pet owners continues to grow. This taxpayer financed supply,
    which has continued for decades, desperately needs to stop.
        Last year the Subcommittees in both Houses of Congress provided
    report language reflecting their regarding Class B dealers. We greatly
    appreciate the interest of this Subcommittee in this issue.
    Unfortunately, we must report that the problems continue and no action
    has been taken. We therefore respectfully request the Subcommittee
    include the following language in the appropriations bill: ``None of
    these funds shall be used for research which utilizes dogs and/or cats
    obtained from random source Class B dealers.''
        Implementation of this policy will allow research utilizing dogs
    and cats to continue--unhindered by the dark shadow currently cast by
    Class B dealers and their illegal practices.
      nih needs to redo the animal care and use section of its regulatory
                                 burden report
        In the fiscal year 1998 budget, the House Committee on
    Appropriations requested an effort by NIH to streamline and rationalize
    duplicative and unnecessary federal regulations that govern extramural
    scientific research. The report drafted by NIH failed to focus on the
    internal regulatory burden that NIH has the power to address. Instead,
    the report is being used as a vehicle to assault the federal Animal
    Welfare Act by those who wish to dismantle it.
        The use of animals in research includes a weighty responsibility to
    ensure the best possible care and treatment for these animals whose
    lives will be sacrificed following experimentation. Animals who are
    treated well will produce more sound research results with a lower
    variance. The Animal Welfare Act is the chief federal law ensuring
    proper treatment of laboratory animals and due consideration of
    alternatives.
        The Improved Standards for Laboratory Animals amendments to the
    Animal Welfare Act were adopted in 1985 following widespread public
    concern and extensive documentation of the need for legislation and of
    the failure of institutions to self-regulate, hearings in both the
    House of Representatives and the Senate, and careful consideration and
    negotiation. Many researchers and the lobbyists who represented them
    fought against this law, as those before them fought against the
    Laboratory Animal Welfare Act of 1966 (later renamed the Animal Welfare
    Act). Having lost that battle, opponents fought against regulations for
    enforcement of the law until weakened regulations were finally adopted
    nearly six years later. Now, we are faced with an effort to dismantle
    the remains.
        NIH should take an introspective look at ways in which it can
    reduce the regulatory burden to researchers and better streamline the
    process. For example, following is a review of site visits:
        There is great usefulness in the current system that mandates, at
    minimum, bi-annual inspections by the IACUC (self-regulation), but
    augmenting this with the unannounced inspections by USDA veterinary
    inspectors. Law mandates annual inspections by USDA. Review of USDA
    inspection report forms provides powerful evidence of the utility and
    great need for these compliance inspections. USDA has reported that it
    finds noncompliance with the minimum requirements under the Animal
    Welfare Act at 45 percent of the facilities it inspects.
        Perhaps NIH can do away with their site visits since this is not an
    activity that they undertake with regularity. In those instances where
    a registered research facility receiving NIH funds is not in compliance
    with the law, perhaps it is a USDA inspector, already familiar with
    inspection of the facility, who should be sent in to conduct an
    unannounced inspection, rather than a team of individuals organized by
    NIH who make a scheduled visit.
        This is but one example of the usefulness and practicality of the
    Animal Welfare Act. And an example of the need for NIH to pay
    particular attention to ways it may be able to improve the process
    internally.
        Thank you very much for your consideration.
                                     ______

          Prepared Statement of the Facioscapulohumeral Society, Inc.

        Mr. Chairman, it is a great pleasure to submit this testimony to
    you today.
        My name is Daniel Paul Perez, of Lexington, Massachusetts, and I am
    testifying today as President & Chief Executive Officer of the
    Facioscapulohumeral Society (FSH Society, Inc.) and as an individual
    who has this devastating disorder.
        As a chief patient activist for the tens of thousands of
    individuals living with Facioscapulohumeral Disease (FSHD) in the
    United States, I will continue to argue the case of wanting to live
    life free from disease.
        My testimony is about the profound and devastating effects of a
    disease known as Facioscapulohumeral Disease which is also known as FSH
    Muscular Dystrophy or FSHD and the urgent and immediate need for NIH
    funding for research on this disorder. In past years (1994, 1995, 1997,
    1998, 1999) and again this year we will submit testimony before both
    House and Senate Committees which states that the National Institutes
    of Health (NIH) and Congress could help bring about a significant
    research and scientific discovery program which, with modest
    investments, would benefit hundreds of thousands of people worldwide.
        The FSH Society has previously informed the members of this
    Committee of the United States Congress on the need and rationale for
    research on FSHD. We have updated you on the most recent developments
    in clinical medicine with respect to FSHD, kept you abreast of the
    latest breakthroughs in the molecular genetics of the disease and given
    you insight into the difficulty of living a lifetime with this disease.
        Thanks largely to your efforts, Mr. Specter, NIH research funding
    continues to grow to its current level of $17.793 billion annually up
    two billion from 1999. Our gratitude fuels our hope for promising
    research solutions for FSHD. Ironically, I must in all candor express
    our frustration that promising FSHD research support and programs have
    yet to appear from the NIH, even in light of Congressional mandates and
    report language for such. While NIH has seen a tremendous increase in
    funding in the past decade, FSHD research through the NIH has not
    benefited at all. In fact, research funding has gone significantly
    down, not up. Since the FSH Society first testified before Congress in
    1994, FSHD research has decreased from between $300-500,000 to between
    $100-250,000. During this time, Congressional directives to NIH
    regarding the state of FSHD research have been either ignored or
    responded to in an untimely manner. We have met with NIH officials,
    testified before the Institute of Medicine (IOM) Committee and taken
    the path indicated to put forth our goals and the situation has only
    gotten worse.
                             the fsh society, inc.
        The FacioScapuloHumeral (FSH) Society, incorporated in 1991, solely
    addresses specific issues and needs regarding facioscapulohumeral
    muscular dystrophy (FSHD). The Board of Directors and Scientific
    Advisory Board (SAB) of the Society are comprised of the top medical
    and research experts in neuromuscular and muscle disease several of
    whom are past and current NIH grant recipients, employees of the Howard
    Hughes Medical Institute and serve on the prestigious Institute of
    Medicine (IOM) at the National Academy of Sciences (NAS). We provide
    public awareness of FSHD by providing information, referral, education,
    and advocacy on FSHD. Additionally, the FSH Society offers assistance
    and support to patients, families, physicians, and other professionals.
    The Society publishes a newsletter with information about advances in
    research, political action effecting FSHD research and profiles of
    people with FSHD. We have awarded $500,000 in grants toward the
    prevention, cause and treatment of FSHD for research projects, post-
    doctoral and research fellowships and provided training support to
    institutions and fellowships to individuals in the field of FSHD
    research worldwide. The FSH Society promotes collaborative research and
    collects and disseminates research information. The Society organizes
    and sponsors annual international and national Scientific meetings on
    FSHD as well as annual international and national patient network day
    meetings.
     the clinical picture of facioscapulohumeral muscular dystrophy (fshd)
        FSHD is a neuromuscular disorder that is inherited genetically and
    has an estimated frequency of one in twenty thousand (1/20,000). FSHD
    affects 12,500-37,500 persons in the United States. The major
    consequence of inheriting this disease is that of a clinically
    unpredictable and progressive and severe loss of skeletal muscle, with
    the usual pattern of initial noticeable weakness of facial, scapular
    and upper arm muscles and subsequent developing weaknesses of other
    skeletal muscles. Retinal and cochlear disease can often be associated
    with FSHD although the pathogenesis and causative relationship to FSHD
    remains completely unknown. FSHD wastes the skeletal muscles and
    gradually but surely brings weakness and reduced mobility. Many with
    FSHD are severely physically disabled and spend the last 30 years of
    their lives in a wheelchair. The toll and cost of FSHD physically,
    emotionally and financially is enormous. FSHD is a life long disease
    that has an enormous cost-of-disease burden and is a life sentence for
    the innocent patient and involved persons. Clinically FSHD is quite
    variable. It can be very extreme causing devastating incapacity at an
    early age or it can be barely detectable in very old age. Often, the
    patient lives with the certainty and anxiety that the course of their
    disease will be reliably unpredictable and totally uncontrollable. FSHD
    can happen to anyone of us.
       new frontiers discovered in human genetics through fshd research.
        The FSHD gene was linked to the distal end of chromosome 4, a
    location known as 4q35, in 1990 by scientists in the Netherlands. At
    that time it was assumed that genetic testing would be imminently
    achievable and that the identification of the abnormal gene product(s)
    would soon follow. Genetic testing is now available though with
    reservation for certain patients with complicated novel genetic
    presentations. A decade of progress has led to the discovery of a novel
    genetic phenomena of crossover of subtelomeric DNA between chromosomes
    (4 and 10) in both normal individuals and diseased individuals and to
    the discovery that facioscapulohumeral muscular dystrophy may be the
    only human disease caused by a deletion-mutation causing a position
    effect variegation (PEV). PEV causes DNA in one part of the genome to
    affect DNA in other parts of the genome. In FSHD, DNA at the very end
    of the chromosome (telomere) interferes with DNA upstream towards the
    center (proximal) of the chromosome. Despite remarkable genetic insight
    and immense progress by a small team of scientists worldwide, the
    nature of the gene product(s) remain enigmatic and the biochemical
    mechanism and cause of this common muscle disease remains absolutely
    unknown and elusive.
        In the meantime, during the past decade, the genes and gene
    products for a significant number of other myopathies, most of which
    are rarer than FSHD, have been identified and classified. Although
    great progress has been made in these other myopathies and muscle
    diseases, our ability to intervene, treat and cure these diseases is
    rare. Ironically, FSHD research has not led to the identification of
    the gene(s) and the corresponding protein(s) encoded by the FSHD
    deletion-mutation causing FSHD. Instead, it has led the scientific
    community to discover a novel human genetic phenomenon that challenges
    the entire view and understanding of Mendelian genetics. In essence,
    FSHD has produced the anomaly that forces the scientific community to
    question the paradigm of Mendelian genetics. This finding will begin a
    whole scientific revolution in human genetics that will have far
    greater implications for medical genetics that will extend far beyond
    the study of FSHD.
        research dollars allocated directly to fshd as well as muscular
                             dystrophy are minimal.
        The Subcommittee members need consider and rationalize the
    following numbers. Neuromuscular and muscle disease has one of the
    highest cost-of-disease burdens in the U.S. economy. Yet, of $17.793
    billion annually given to NIH, $16.5 million is spent on Muscular
    Dystrophy and, of that amount, conservatively $250,000 is spent on the
    third most prevalent and third largest dystrophy FSHD. That makes nine
    hundred twenty one-thousandths (920/1000) of one percent (1/100) of the
    total NIH budget for Muscular Dystrophy and fourteen one-thousandths
    (14/1000) of one percent (1/100) of the total NIH budget for FSHD.
    Clearly, the Muscular Dystrophies as a class of disease are more than
    significantly under-funded by NIH. Secondly, FSHD research funding by
    NIH is woefully disproportionate given its ranking and severity.
    Thirdly, at best, $16.00 and at worst, $5.33 is spent on each person
    living with FSHD. The numbers on FSHD and Muscular Dystrophy research
    are appallingly and inexplicably low.
        Furthermore, muscular dystrophy is frequently overlooked and of no
    interest to the pharmaceutical industry, biotechnology industry and
    Wall Street. No privately or publicly owned company is currently
    pursuing FSHD research. FSHD is not Alzheimer's, Parkinson's disease or
    breast cancer with hundreds of millions of research dollars from the
    NIH supplemented by the enormous investments of hundreds of millions of
    dollars from the pharmaceutical and biotechnology sector. We have
    nowhere to go in the private sector and cannot even possibly go lower
    at the NIH. We are ostensibly at zero funding. The NIH has failed and
    is failing in its public responsibility to the muscular dystrophy and
    FSHD citizen by not carrying through on its public health
    responsibility.
     congressional directive has been and is repeatedly ignored by the nih.
        It should be noted that the FSH Society has given twelve (12)
    Congressional testimonies in seven years and has succeeded in three
    successive years in incorporating report language on
    Facioscapulohumeral Disease (FSHD) in both U.S. House and U.S. Senate
    Appropriations Committee Reports accompanying the budget. We have had
    over one hundred and fifty meetings and interactions with the three NIH
    Institutes primarily responsible for FSHD: The National Institute of
    Neurological Disorders and Stroke (NINDS/NIH), The National Institute
    of Arthritis, Musculoskeletal and Skin Diseases (NIAMS/NIH) and the
    Office of Rare Disease (ORD/NIH). We have the distinct honor of working
    with the prestigious and talented Directors and Staffs of all three of
    these Institutes since 1992.
        NIH is seriously out of compliance with previous Congressional
    Directives. NIH has not responded and is responding very slowly to the
    past three years of Report Language. Four (4) calendar years have
    passed and the NIH has still not convened a research planning
    conference. NIH is just now convening a research planning conference on
    Tuesday, May 9, 2000 responding to your directive three years too late.
    We await the results and plan that comes from that meeting. We request
    that your Committee ask for and receive the results of that planning
    conference in an immediate and timely manner.
        The Report Language for 2000 has been responded to in an untimely
    manner and mainly ignored. The status of action on Report Language for
    fiscal year 2000 will be ``current year items not done''. The 2000
    Report Language is as follows: ``The Committee is concerned that NIH
    has not responded to a previous request to develop a plan for enhancing
    NIH research into Facioscapulohumeral (FSH) disease. The Committee
    urges NIH to promptly convene a research planning conference and to
    establish a comprehensive portfolio into the causes, prevention, and
    treatment of FSH disease through all available mechanisms, as
    appropriate. The Director is requested to be prepared to testify on the
    status of this initiative at the fiscal year 2001 appropriations
    hearing.'' (House Report 3037, p. 81 for NINDS, p. 97 for NIAMS.)
        The status of fiscal year 2000 Report Language is as follows: Not
    done in the majority. Plan not created and no comprehensive research
    portfolio exists. NIAMS has no R01 or P01 grants on FSHD. NINDS has one
    R01 grant on FSHD. Intramural research on FSHD is non-existent at NIH.
        The Report Language for 1999 has been ignored and the status of the
    Report language for fiscal year 1999 is not done. The 1999 Report
    Language is as follows: ``The Committee encourages the Institute to
    continue and expand research efforts focused on aiding in the diagnosis
    and treatment of FSHD.'' (House Report, NINDS Section, p. 103.), and,
    ``The Committee was pleased with the Institute's response to last
    year's request which encouraged NIH to stimulate research in the area
    of facioscapulohumeral disease (FSHD). However, the Committee notes
    that NIAMS has not responded in developing a plan for enhancing FSHD
    research, and has not addressed the question of whether an intramural
    program in this area would be beneficial. Therefore, the Committee
    urges NIH to conduct a research planning conference in the near future
    in order to explore scientific opportunities in FSHD research, both
    intramurally and extramurally.'' (House Report, NIAMS Section, p.120-
    121.)
        The status of 1999 Report Language is as follows: Not done. Plan
    not created and research portfolio is not expanding. NIAMS has no R01
    or P01 grants on FSHD. NINDS has one R01. Intramural research on FSHD
    is non-existent at NIH.
        The Report Language for 1998 has been ignored and the status of
    Report language for fiscal year 1998 is not done. The 1998 Report
    Language is as follows: ``The Committee has heard compelling testimony
    about facioscapulohumeral (FSH) disease, which causes progressive and
    severe loss of skeletal muscle. FSHD research includes aspects such as
    molecular genetics, neurological function and muscular dystrophy
    involving multiple NIH Institutes. The Committee encourages NIH to take
    steps to stimulate research in this area and requests NIH to develop a
    plan for enhancing NIH research into FSH disease (FSHD), including an
    assessment of whether an intramural research program in this area would
    be beneficial.'' (House Report, p. 101.)
        The status of 1998 Report Language is as follows: Not done. Plan
    not created and no FSHD specific initiatives are undertaken to
    stimulate research. NIAMS has no R01 or P01 grants on FSHD. NINDS has
    one R01 grant for the majority of the year. Intramural research on FSHD
    is non-existent at NIH.
             nih still lacks presence in the area of fshd research.
        NIH has not funded any new grants to ``establish a comprehensive
    portfolio into the causes, prevention, and treatment of FSH disease''
    even though the previous two years of report language request that this
    happen. The Committee has asked NIH several times ``to establish a
    comprehensive portfolio into the causes, prevention, and treatment of
    FSH disease through all available mechanisms, as appropriate.'' And
    still, at the time of this testimony not one new P01 or R01 grant will
    have been issued on FSHD in the entire past year.
        NIH has not implemented or announced any new mechanisms to enhance
    funding on FSHD research in the last year despite the fact that last
    year's language requests that NIH do this ``through all available
    mechanisms, as appropriate.''
        NIH continues to inexplicably reject grant applications on FSHD. On
    March 8, 2000 a second submission within this year of a major grant
    application from a world renowned researcher was left unscored by the
    Center for Scientific Review (CSR) study section Brain Development and
    Child Neurology 3 (BDCN 3). Additionally, other grants in FSHD have not
    been funded within the last year.
     review of the nih track record on fshd and congressional directive on
                                      fshd
        NIH has ignored and is responding slowly to three (3) and now four
    (4) years of Congressional Directives.
        NIH has been slow and unorganized in convening the research
    planning conference and in developing the research plan on FSHD called
    for in the last three (3) years Report Language.
        NIH has not even begun to establish a portfolio in the causes and
    treatment of FSHD as called for in the past two years of House and
    Senate Report Language. A comprehensive portfolio has not even been
    initiated.
        NIH has not established ``a comprehensive portfolio through all
    available mechanisms, as appropriate'' as called for in last years
    Language. No new funding mechanisms have been announced.
        NIH has not funded any new R01 or P01 projects in FSHD.
        There is a complete disconnect between the fact that Institute
    Directors state that FSHD is a priority in long range planning papers,
    Congressional testimonies before the Committee, in their responses to
    questions raised by the Committee and in personal communications and
    yet NIH continues to inexplicably reject grant applications on FSHD.
        NIH has not yet responded to Congressional questions asked of the
    Director of NIH, Dr. Ruth Kirchstein, on February 15, 2000 and of the
    Director of the NINDS, Dr. Gerald Fischbach, on February 29, 2000 by
    the U.S. House Appropriations Committee, Subcommittee on Labor, HHS,
    Education (Hon. Randy ``Duke'' Cunningham).
        NIH is far from the $5-10 million needed to accelerate efforts in
    the area of FSHD.
        In 2000 to date, NINDS has only one issued grant in its portfolio
    that is for FSHD. In 2000, to date, NIAMS has no grants presently
    issued with FSHD in their title. That is correct, in 2000 NIAMS
    currently has funded $0 (zero) on FSHD research projects. NIAMS and
    NINDS state that they are beginning the process of organizing the
    research planning conference for May 9, 2000 and, less than four weeks
    before the conference, we still do not have a final roster for planning
    panel participants. NIH must understand that FSHD requires their
    attention.
        Although FSHD research may have benefited indirectly from NIH
    funding of the Human Genome Project, direct funding of FSHD research by
    the NINDS and the NIAMS at NIH has been minimal. The total NIH funding
    for directly titled FSHD research currently for the fiscal year 2000
    (fiscal year 2000) to date is approximately two hundred-fifty thousand
    dollars.
        FSHD researchers express incredulity with the lack of funds and
    rejection of grants submitted by the top laboratories in the world.
                  we implore the committee to act immediately
        Mr. Chairman, we know that the Committee is overwhelmed in hearing
    from patient groups such as ours. We know that you trusted that the
    Institute of Medicine (IOM), the Center for Scientific Review (CSR) and
    the NIH would set their priorities correctly. The truth is that we have
    come before Congress to testify year after year, given testimony in a
    wheelchair from the back of the room at the IOM as it was not
    wheelchair accessible, worked hard to have NIH take a more active,
    deliberate and responsible role and yet the NIH is not listening to the
    Congress, the scientific community and the patients on this issue.
        Mr. Chairman, this is a clear and disturbing trend regarding NIH's
    disregard for Congressional Report Language and for the scientific and
    medical opportunities present in FSHD research.
        There presently is very little funding of FSHD from NIH--perhaps
    two hundred-fifty thousand dollars. I re-iterate, this is clearly
    inadequate given the recent advances and the high likelihood of making
    significant progress in the very near future. With a budget of $17.793
    billion dollars, NIH is spending a miniscule amount on FSHD research.
    This tiny amount is utterly unconscionable and defies logic and reason
    given the prevalence of FSHD and the cost of doing molecular genetics
    research in 2000.
        Mr. Chairman, we ask the Subcommittee to earmark a dollar amount to
    FSHD research. We request that an amount of not less than five (5)
    million and not more than ten (10) million dollars be earmarked for
    FSHD research. We know that this Committee does not approve of
    earmarking. However, the record of six years indicates that NIH ignores
    Congressional direction as well as scientific opportunities. Earmarking
    appears to be the only way to get NIH attention.
        The FSHD community demands that the Congress of the United States
    of America take action on funding research on FSHD. We are asking today
    for a promise to people living with FSHD which commits to funding FSHD
    research in the following areas:
      --Cloning the gene, characterizing the nature of mutations in the
            gene,
      --Launching a major effort to understand the normal function of the
            FSHD gene and how its alteration causes the disease,
      --Conducting natural history studies to provide a baseline for future
            therapeutic techniques, and
      --Developing therapies based on information in 1, 2, and 3 above.
        Additionally, the FSHD community is requesting that Congress ask
    NIH to research and make recommendations on the following:
      --Creating a Center of Research Excellence (CORE) for FSHD research,
      --Enacting intramural NIH programs for FSHD research immediately,
      --Extramural contract programs for FSHD, and
      --Programs to attract and expedite extramural grant applications.
        The men, women and children who live with the daily consequences of
    this devastating disease are your friends, neighbors, fellow taxpayers
    and contributors to the American way of life. With an historic 88
    percent employment rate and an average educational achievement level of
    14 years, we personally bear our burden of the health care costs and
    training expenses to prepare for and maintain financial and personal
    independence. We appeal to you today to take our hard earned tax
    dollars commensurate with our numbers and valuable contributions to
    American Society. We urge the United States Government to allocate a
    proportion of our tax burden toward research on FSHD.
        This is the United States of America, and in a country as great as
    ours with all of its technical means and ability it should be
    absolutely clear that the number one priority for individuals with FSHD
    and the one absolutely commanding imperative for the Federal Government
    is to initiate and accelerate in any way possible, research on FSHD.
    With modest funding and a clear direction from Congress to the NIH to
    support research on FSHD significant progress can be made in conquering
    and eliminating this and other devastating diseases.
        Mr. Chairman and members of this Committee, let us remember that as
    the Constitutional Convention at Philadelphia drew to a close in 1787,
    James Madison noted some concluding remarks by the elder statesman,
    Benjamin Franklin. Franklin's observations had to do with a sun painted
    on the back of the chair of the presiding officer. He said, ``often and
    often in the course of the Session, and the vicissitudes of my hopes
    and fears as to its issue, I looked at that behind the President
    without being able to tell whether it was rising or setting. But now at
    length I have the happiness to know that it is a rising and not a
    setting sun.''
        Our founding forefathers toiled, fought and worked for Liberty and
    Freedom from oppression. They fully recognized that if their partial
    liberty gave way to full fledged oppression, the opportunity for
    freedom would be lost for a long time and that liberty threatened can
    be recovered. Living with a lifelong progressive and chronic
    neuromuscular disease imposes the same thoughtful consideration.
        In the same way as our forefathers, before the founding of this
    great country, I too, lose my physical Liberty every day as naturally
    and eventually as the sun rises and sets. My liberty is in constant
    decline and my happiness and courage sometimes is setting as the sun to
    the West. Everyday I choose to fight on, I am curious to know about
    what the next day will bring, simply curious. Despite the full fledged
    constant decline of my liberty, I live for the rising sun and have the
    faith that this country is great enough and powerful enough to enact
    change where it is needed. My liberty will surely be lost in my life
    time if I do not find it within me to fight for the recovery of my
    liberty and freedom from my natural born oppression. It is my duty and
    my obligation, as a citizen of this country, to act as my ancestors and
    their fathers did to ensure that the government acts responsibly
    carrying out its duty to uphold the public trust.
        Mr. Chairman, we trust your judgement on the matter before us.
    Please remember, we need your help to ensure that the sun is rising on
    FSHD.
        Mr. Chairman, again, thank you for providing this opportunity to
    testify before your Subcommittee.
                                     ______

           Prepared Statement of the Scleroderma Research Foundation

        The Scleroderma Research Foundation appreciates the opportunity to
    submit this written statement urging Congress to become our partner in
    pursuit of a cure for scleroderma.
        As we have in past years, the Scleroderma Research Foundation asks
    for a partnership that combines the strengths of the private, academic
    and public sectors in seeking a cure for this debilitating, often fatal
    disease, which strikes half a million Americans.
        Scleroderma is a chronic, degenerative disorder that leads to the
    overproduction of collagen in the body's connective tissue. The
    overabundance of collagen hardens the connective tissue (scleroderma
    means ``hard skin'') and damages the organs involved. About eighty
    percent of scleroderma patients are women. In approximately half the
    cases, the primary organ involved is the skin, which hardens and scars,
    often causing severe pain and disfigurement. The other half of patients
    suffer from systemic sclerosis which hardens internal organs, such as
    the heart, kidneys and lungs. Almost seventy percent of patients with
    systemic sclerosis die within seven years of initial diagnosis.
        The Scleroderma Research Foundation was established to fill a
    virtual void in research on this awful disease. From scratch, the
    Foundation has built an effective, respected, progressive research
    program dedicated to finding a cure for scleroderma. We have made
    astounding progress, to the point that our team of advisors and
    scientists agree that scleroderma is now a solvable problem. The
    researchers at our two centers--t University of California San
    Francisco and at Johns Hopkins University--ave made great advancements
    in understanding the key processes in the fibrosis and vascular
    problems of scleroderma. In other groundbreaking investigations,
    researchers have found several key antibodies that are unique to
    scleroderma. This work clearly points the way to identifying the
    environmental factors which lead to disease development, as well as
    helping isolate genes involved in its predisposition. Remarkably, these
    breakthroughs have been accomplished almost exclusively through funding
    from private donations. The lion's share of donations are contributed
    by individuals, many who are scleroderma patients, their family and
    friends, and many who have lost loved ones to this disease.
        At a time when we have renewed hope for a cure, we need help to
    reach our goal. The breakthroughs we have achieved have advanced our
    understanding of scleroderma and brought us closer to a cure. There is
    a surge of interest from scientists in related fields in opportunities
    to collaborate on this research. The right people and technology now
    exist to cure this disease. It is only a question of providing the
    resources necessary to get the job done. What is needed is your timely
    support in bringing the vast resources in science and technology to our
    mission. Clearly, there is a life saving opportunity here. Your
    partnership is vital if we are to continue to progress.
                            proposal for partnership
        Specifically, the partnership we are seeking is a collaboration
    with our research centers at University of California San Francisco and
    at Johns Hopkins University. Our request is not for a gift; we are
    requesting a match. We ask Congress to allocate funds to match what we,
    private individuals across the country, have given to fund our research
    centers. Since 1987, the Foundation has invested $4.874 million in
    research projects. With this match, we can strengthen our highly
    regarded ``cure advocacy'' approach to research, maximizing the
    efficiency and progress of our programs.
        Cure advocacy brings together scleroderma experts and top
    scientists from all basic scientific disciplines to analyze where we
    stand in the science of scleroderma and to identify the most promising
    research opportunities. Our team comprises scientists from Johns
    Hopkins University Medical Center, the National Institutes of Health,
    Stanford Medical Center, the University of California San Francisco,
    the University of Maryland, and Ohio State University. They participate
    in a truly interdisciplinary, multi-institutional environment, working
    together, sharing resources and ongoing research information with one
    common goal--to find a cure for scleroderma.
        Through cure advocacy the Scleroderma Research Foundation, in
    partnership with the private and academic sectors, is able to direct
    and manage the science on behalf of the patients. The Foundation is, in
    other words, driving the science in the direction of a cure. Now, we
    ask you to join this partnership in support of well-focused, results-
    oriented, disease-driven research, and in support of the hundreds of
    thousands of scleroderma patients awaiting a cure.
        We are also requesting your partnership in launching a new and
    innovative post doctorate program that will bring the efforts of the
    best and brightest new scientists to bear on finding a cure for
    scleroderma. Our goal is to create a program that focuses scientists in
    the field of scleroderma research at the beginning of their career,
    when they can devote their work early and exclusively to saving lives.
    Here again, the Scleroderma Research Foundation is working to raise
    funds for the post doctorate program from private donations. Our
    request is for a match of our funding at $1 million (five scientists
    located at five laboratories for a three-year period each).
                                   conclusion
        As a private medical research foundation, we have attempted,
    repeatedly, to create a public/private partnership. Year after year,
    there has been no response. What more can we, as an organization
    dedicated to an important and singular mission, do in terms of
    educating Capitol Hill and raising awareness of the urgency of finding
    a cure for scleroderma. There is still, after all, no known cause or
    cure for the disease. There are still no FDA-approved therapies. There
    are still hundreds of thousands of Americans, mostly women, suffering--
    nd dying--rom scleroderma. We cannot do this alone.
        From its beginnings, the Scleroderma Research Foundation has
    maintained a sharply focused program to insure no time is wasted in
    reaching our goal of saving lives. We have accepted this challenge, and
    extend the challenge to Congress, to the National Institutes of Health,
    and to the medical research community in this country: To channel
    today's incredible technologies into helping people and advancing
    science that is driven by saving lives. We ask Congress to participate
    in our mission by matching our efforts and speeding our progress to a
    cure.
        Thank you for providing us the opportunity to present this
    statement. The Scleroderma Foundation welcomes any questions Members of
    the Committee may have.
                                     ______

         Prepared Statement of the Association of American Universities

        Mr. Chairman and distinguished Members of the subcommittee, I am
    Dr. Virginia Hinshaw, Dean of the Graduate School and Senior Research
    Officer at the University of Wisconsin-Madison. I write today to
    provide several perspectives on research, because I've been fortunate
    to serve in different capacities during my own research career.
        For 25 years, I worked as a scientist and my research, specifically
    on influenza viruses, was made possible by the funding I received from
    the National Institutes of Health. So I certainly recognize the value,
    as well as the highly competitive nature, of obtaining such funding.
        Currently, I serve as a university administrator with the goal of
    facilitating research efforts of others. I certainly recognize the fact
    that the University of Wisconsin-Madison, as a major research
    institution, is highly dependent on NIH funding in that over 50 percent
    of our federal funding comes from NIH.
        Also, I am pleased to represent the Association of American
    Universities (AAU), an organization of 61 public and private research
    universities across the U.S. and Canada. I currently serve as president
    of the Association of Graduate Schools, a group within AAU. Many of you
    have AAU institutions within your States. We are joined in this
    statement by the American Council on Education, the Council of Graduate
    Schools, and the National Association of State Universities and Land-
    Grant Colleges.
        You have heard over the past several weeks from many organizations
    and individuals advocating increases in NIH funding--patient groups,
    scientific societies, and research institutions. I speak on behalf of
    research institutions, whose faculty translate NIH research grants into
    findings that improve human health and well-being. This is a great time
    to be in research--there is so much we can do and so much that needs to
    be done. A number of exciting, new areas being investigated by faculty
    at UW-Madison include genomics, chemical biology, nanotechnology,
    biomedical engineering, bioinformatics and many more. These are just a
    few examples of the kind of cutting-edge science that is going on all
    over the United States, due to this nation's wise investments in
    biomedical research at NIH. This investment is improving our lives and
    the lives of future generations.
        I also know that many of these advances depend on efforts in many
    other fields of science, including physics, chemistry, mathematics,
    computer science, and engineering. For example, lasers evolved from
    mathematicians and physicists studying light waves, and, because of
    those efforts, lasers are now common tools in medicine. A decade ago,
    cataract removal represented major surgery with substantial
    recuperation time; today, this is done with lasers as outpatient
    surgery with rapid recovery--that is progress through research by both
    physical and biological scientists. We hope that NIH, as well as the
    other science agencies, will be provided with the resources needed to
    support these other scientific fields that I can attest are critical to
    the success of biomedical research.
        Past investments in biomedical research have paid off for human
    health and for the American economy. For example, recombinant DNA
    research at our universities in the 1970's opened the door for today's
    multi-billion dollar biotechnology industry. It also allowed us to
    begin the human genome project, which is now nearly complete, again
    through a partnership between the Federal Government and research
    universities. This achievement is the next step in the genetic
    revolution which could profoundly alter our approaches to preventing,
    treating, and curing disease. Other examples include the tremendous
    progress NIH-supported researchers have made in discovering ways to
    reduce the tragedy of mother-to-infant transmission of HIV. As NIH has
    reported, a 1994 study indicated that zidovudine (AZT) could reduce the
    rate of transmission by two-thirds, and once these findings were widely
    disseminated, the number of AIDS cases from mother-to-infant
    transmission in the U.S. decreased dramatically--by 43 percent between
    1992 and 1996.
        Advances in cancer treatments enable many of us to be here today,
    including myself. I'm a breast cancer survivor and thriver. My father
    has had prostate cancer and is still active and vital at 83. So I have
    a strong personal, as well as professional interest, in seeing advances
    in our understanding of cancer which leads to improved treatments and
    hopefully prevention. Along with the subcommittee, I want our
    granddaughters and grandsons to be free of those threats to their
    health. That will only happen through research.
        Even with the great successes in research, I think it is important
    to remind ourselves that research is not an investment with guaranteed
    outcomes. We are seeking answers to questions with unknown answers.
    That means there are wrong turns and dead-ends as we search for those
    answers. I always tell students to remember the ``re'' in research
    which means that we search and then we search again and again to
    determine if our direction is the correct one. I surely believe that
    research is a wonderful adventure into the unknown, but that adventure
    also involves hard, repetitive, exhaustive work and requires patience
    in getting to the long term benefits. We need your steadfast support to
    make that adventure productive in the long term for the whole of
    society.
        This subcommittee has charted us on a bipartisan course to double
    NIH funding, which will enable us to continue making progress like this
    into the future. The associations I represent here, as well as my
    faculty colleagues, are tremendously grateful to Senator Specter and
    Speaker Harkin, and all the members of the Subcommittee, for having
    provided 15 percent increases in each of the last two fiscal years. We
    hope that the subcommittee will be able to repeat that success in the
    fiscal year 2001 bill as the third step on the path to double NIH
    funding by 2003. As you know, NIH makes grants for multiple years, and
    therefore needs stable support. As an investigator myself, I know the
    challenge and the stress of maintaining support for an active
    laboratory group--that responsibility keeps most of us awake at night,
    busy writing more grants to ensure continuity of our research personnel
    and programs.
        The President's Budget for fiscal year 2001 is a good start, but
    its 5.6 percent increase after two years of 15 percent increases would
    not even allow NIH to fund the same number of new grants in fiscal year
    2001 as the year before, sending a terrible message back through the
    biomedical research enterprise. The effects of the extraordinary
    funding increases this subcommittee has been able to provide are
    already producing positive results in the research community, where
    researchers are more likely to be able to get their innovative ideas
    funded and graduate students can again see biomedical research as a
    promising career choice. I want to underscore the fact that research
    universities are the educational homes for graduate students who are
    our nation's future researchers--we must keep that future strong. To
    accomplish that, we need to keep the momentum going, instead of
    reverting to the old boom-and-bust cycles that characterized NIH
    funding in the past.
        Some have asked whether there are enough good research ideas to be
    able to wisely spend a 15 percent increase. The simple answer is yes;
    there are truly a wealth of great research ideas yet to be pursued. The
    current state of research in so many fields abounds with promise.
    Advances in basic research in genetics, cell biology, and biochemistry,
    as well as in clinical applications for cancer, infectious disease, and
    aging, put us on the brink of discovery in a wider array of disciplines
    than ever before. Staying the course by providing another 15 percent
    increase will enable further research advances in these areas to the
    benefit of all Americans in the future. We recognize that the
    Subcommittee is faced with enormous challenges in finding sufficient
    funds to keep NIH on the path toward doubling, while adequately funding
    other important programs in the bill, given the constraints on
    discretionary spending. We hope that an agreement will be reached again
    this year to continue investing in basic research to support
    investments that are vital to the long-range health of the nation.
        Within biomedical research, several areas are particularly
    important to note. Support for clinical research remains vital if
    laboratory advances are to be translated to the bedside. Likewise,
    support for research infrastructure is critical for continued advances.
    As research funding increases, additional resources must be invested in
    renovating outdated facilities, financing state-of-the-art
    instrumentation, and providing new informational and computer
    technologies--all are critical and connected priorities. Great research
    ideas are constantly being generated by our faculty, staff and students
    but pursuing those ideas requires modern facilities and equipment,
    along with the analytical and communication tools rapidly emerging
    through computer technology.
        Let me conclude with a few words about federal student aid
    programs. The associations I represent encourage increased support for
    student financial aid programs funded by this subcommittee. My efforts
    are primarily directed at graduate students, but I know that many of
    them could never pursue graduate degrees without the support of student
    aid at the undergraduate level. An increase in the maximum Pell grant
    of $400, and additional support for the Supplemental Educational
    Opportunity Grants (SEOG), the Perkins loan program, Federal Work
    Study, the Leveraging Educational Assistance Partnerships (LEAP) and
    TRIO programs are essential to assist needy students in accessing
    higher education without the accumulation of excessive debt. It is
    important to note that high debt loads are a substantial deterrent to
    our minority and low income student populations in pursuing graduate
    degrees. To have full participation of all students in the educational
    process, we must work to reduce that financial barrier.
        In addition, I encourage, on behalf of these organizations,
    continued and increased support of the graduate education programs
    authorized under Title VII of the Higher Education Act. The Graduate
    Assistance in Areas of National Need and Jacob Javits Programs support
    graduate students with financial need in the sciences, arts, humanities
    and social sciences. These programs reduce loan dependency, shorten the
    time to degree and create incentives to enter essential but not
    particularly lucrative careers, such as teaching and research. And
    finally, I encourage support for the Title VI International Education
    Programs which are so important to the participation of students and
    faculty in today's global community.
        Today, as I ask for your support, I also want to assure you that
    research institutions recognize their responsibilities in receiving
    such support by being accountable and responsible in the use of these
    funds. We take that responsibility very seriously and we know that this
    government-university partnership demands that we meet those
    responsibilities.
        Thank you for this opportunity to express our views about funding
    for biomedical research and federal student aid programs, and I hope
    that the subcommittee colleagues will be as successful in supporting
    these areas as it has been in recent years.
                                     ______

      Prepared Statement of the Population Association of America and the
                       Association of Population Centers

        Thank you, Mr. Chairman for this opportunity to present the
    position of the Population Association of America (PAA) and the
    Association of Population Centers (APC) to the Subcommittee on Labor,
    Health and Human Services and Education on fiscal year 2001 funding for
    the National Institutes of Health (NIH), specifically the National
    Institute on Aging (NIA), and the National Institute of Child Health
    and Human Development (NICHD). You are a long-standing friend of both
    organizations and we want to emphasize how grateful we are for your
    appreciation and support of demographic research.
        As you know, PAA is a scientific and educational society of
    professionals working in demographic research. APC is a consortium of
    27 leading American population research centers. In addition to their
    academic roles, members of both organizations provide federal, state
    and local government agencies, as well as private sector institutions,
    with data and research to guide decision-making.
        Demographic research covers many issues important to our nation,
    such as retirement, minority health, disability and long term care,
    child care, immigration, labor force participation, worker retraining,
    family formation and dissolution, and population forecasting. The
    United States is undergoing far-reaching shifts in its demographic
    composition and distribution. Such changes often are not recognized or
    understood until they confront society with new and immediate needs--
    often requiring federal and state expenditures. Incorporating
    demographic, social and behavioral research into long term policy
    discussions allow such changes to be tracked and anticipated in a
    manner that promotes more coherent and efficient planning and policy
    implementation.
        The National Institute of Child Health and Human Development
    (NICHD) and the National Institute on Aging (NIA) provide primary
    support for demographic research. We would like to take this
    opportunity to share with you information concerning aging, the effects
    of welfare reform on children and families, profiles of legal
    immigrants, and changes in fatherhood.
      the national institute of child health and human development (nichd)
        NICHD has a well-established, successful population research
    program. NICHD is currently funded at $859.3 million with approximately
    $58.6 million of that budget dedicated to research funded through the
    Demographic and Behavioral Sciences Branch in fiscal year 1999. Among
    the many areas of demographic research supported by NICHD are families
    and household composition; marriage and family change; fertility and
    family planning; teen pregnancy; mortality; HIV prevention; and
    population movement, distribution and composition. NICHD also funds a
    highly regarded population research centers program. Population
    research centers provide a critical core of professionals who conduct
    research in a cost-effective manner. Further, the centers' training
    programs are an essential source of population scientists who bring
    fresh perspectives, ideas and improved methodologies to demographic
    research.
        NICHD-supported demographic research provides important, ongoing
    information critical to policymakers. We are pleased to provide
    information in this testimony that focuses on the Fatherhood
    Initiative, the effects of welfare reform on children and families,
    profiles of legal immigrants, and the Family and Child Well-Being
    Research Network.
    Fatherhood
        The decline of the incidence of marriage weakens the ties of men to
    women and children, with a resulting burden to the welfare system and
    to women and children themselves. Thus, it is important to understand
    the conditions which help to sustain men's participation in their
    family's lives. NICHD, in conjunction with the Federal interagency
    Forum on Child and Family Statistics and the National Center on Fathers
    and Families, launched a Fatherhood Initiative to review the capacity
    of the federal statistical system to conceptualize, measure and gather
    information from men about how they became fathers and how they provide
    economic and emotional support to their children.
        Among the results of this effort are the inclusion of men in the
    National Survey of Family Growth and the development of a father's
    component in the Early Childhood Longitudinal Survey and the inclusion
    of basic research on fathers in the Early Head Start Research and
    Evaluation Project. NICHD is also supporting research to understand
    factors leading to stable unions among unmarried fathers and mothers.
        The roles fathers play in the lives of their children are strongly
    affected by the father's relationship to the mother: the access of
    fathers to their children is highest when parents are living together.
    In cases of divorce, a NICHD grantee has shown that many fathers have
    enormous desire to maintain contact with their children, and with
    intervention can continue to be major influences in the lives of their
    children even after the divorce.
    Welfare Reform Effects on Children and Families
        The 1996 welfare reform act and the subsequent changes in the
    welfare programs of nearly every state constitute the greatest shift in
    social policy for low-income families with children since the Social
    Security Act of 1935. Since the passage of welfare reform legislation,
    welfare caseloads have dropped 40 percent. Yet we know very little
    about how these changes will affect these children and families. Both
    positive and negative scenarios can be constructed.
        The positive scenario is that leaving welfare for a job will make a
    mother feel more self-sufficient, raise her self-esteem, bolster her
    parenting behavior and provide a better role model for her children to
    emulate. Critics point to the challenges of combining employment and
    parenting for single parents with few economic resources. Jobs are
    difficult to find, low paying, and often do not provide health
    insurance. Good and affordable child-care may be difficult to obtain.
    The risk for children is increased parental distress, poorer parenting,
    inadequate childcare and greater economic hardship.
        We simply do not know which scenario will prove most accurate over
    time. NICHD is supporting several projects to study the effects of
    welfare reform on children and families. The NICHD supported studies in
    several cities should provide us with a clearer understanding of the
    ways that children and their families are affected by this momentous
    change in social policy. These in depth community based studies will
    examine the impact of support from family, community networks, and
    public programs in helping families make the transition to self-
    sufficiency while assessing the impact on child health and development.
    Research on Immigration
        Understanding the trends in immigration and the characteristics of
    immigrants is vital for making informed policy decisions. NICHD, the
    Immigration and Naturalization Service (INS), the National Science
    Foundation (NSF), and the National Institute on Aging (NIA) have
    cooperatively funded a New Immigrant Survey Pilot Study (NIP). This
    study will provide immediate policy relevant information on immigrants
    in the U.S. and also serve as the foundation for long-term research on
    immigrants.
        Much of the conventional wisdom on immigrants has been repudiated
    in recent NICHD supported studies. For example, legal immigrants are
    better schooled, on average, than the native born; the proportion with
    postgraduate education is almost three times larger than among the
    native born, at the same time, there is also a substantial group
    without a high school education. Overall, however, the quality of legal
    immigrants entering the U.S. is improving. Influenced by changes in
    immigration laws and changing economic conditions, the skill
    composition of immigrants to the U.S. has risen.
    Family and Child Well-Being Research Network
        We would also like to bring you up-to-date on NICHD's Family and
    Child Well-Being Research Network--an interdisciplinary data system
    focusing on child- and family-related research that relies on cross-
    agency cooperation. This year the network has been renewed and
    expanded. The new network is comprised of scientists from nine
    universities collaboratively working with federal officials from NICHD,
    the Office of the Assistant Secretary for Health, of the Department of
    Health and Human Services (HHS), the Administration of Children and
    Families of HHS, the Census Bureau and the Department of Education.
    This network currently addresses a variety of questions about the
    interrelations between parent characteristics, family structure and
    organization, neighborhood attributes and different forms of social
    support. The network is committed to increasing the visibility of basic
    research findings to those involved in formulating public policy.
    Projects such as the Family and Child Well-Being Research Network
    perform the important task of helping synthesize research into sensible
    policy solutions.
        The Network, in cooperation with federal statistical agencies and
    the research community developed a comprehensive set of indicators of
    child well-being. The information from these indices are compiled
    annually in the report America's Children: Key National Indicators of
    Well Being. This report provides a much improved information base that
    summarizes the changes in the overall well-being of American children
    and families on an annual basis.
        PAA and APC enthusiastically support initiatives such as NICHD's
    Family and Child Well-Being Research Network that provide quick access
    to data and are efficient and effective resources for time sensitive
    policy-related research in cross-disciplinary fields.
                     the national institute on aging (nia)
        The NIA also has a well established and widely respected
    demographic research program, which provides crucial information on the
    implications of an aging of the American population for our country.
    Currently, the NIA is funded at $687.8 million, with approximately
    $39.6 million of that budget dedicated to demographic research--
    training, career development, and demographic, economic and
    epidemiological research. As the U.S. population ages and Congress
    contemplates sweeping changes in Medicare and Social Security, the
    demography of the elderly steadily becomes more important. The NIA has
    a strong history of supporting the collection of data, which allows
    demographers to study questions of concern to policymakers. Chief among
    these is the NIA-supported studies, the Health and Retirement Study
    (HRS) and its auxiliary survey, the Asset and Health Dynamics of the
    Oldest-Old (AHEAD) study. You have been a solid supporter of these
    studies over the years, Mr. Chairman, and we would like to express our
    gratitude for your support.
    Health and Retirement Study
        The Health and Retirement Study (HRS) was launched in 1992 with
    baseline interviews for a representative sample of persons born between
    1931 and 1941. These respondents were interviewed again in 1994, 1996
    and 1998. The most recent round of data collection, HRS2000, is now in
    the field. Starting in 1993, the HRS was augmented by the AHEAD (Asset
    and Health Dynamics of the Oldest-old--those born before 1924). The
    AHEAD respondents were interviewed in 1995, 1998 and the survivors are
    being contacted now as part of HRS2000. In 1998, samples of two other
    cohorts were added, those born between 1924 and 1930, the so-called
    children of the Depression, and those born between 1942 and 1947, or
    the ``early baby-boomer cohort''. With the addition of these cohorts,
    HRS is nationally representative of the population over age 50. Since
    1998, the entire study is now referred to at the HRS.
        The original HRS focused on mid-life work and health dynamics.
    Biennial data are now available for all respondents on health,
    disability, work, health insurance, pensions and retirement plans, and
    transfers to and from family. Using the original HRS data, researchers
    have been able to explore issues related to health, work and
    retirement; prospects for economic security; cognitive changes, health
    insurance coverage and use of health care services.
        Researchers have long known that persons with higher levels of
    wealth and income have better health and live longer. The reasons for
    this relationship are not well understood. Is it that income and wealth
    cause better health through better access to health care? Or is it that
    poor health causes lower levels of wealth and income by decreasing
    work, reducing earnings, and increasing health care expenditures? HRS
    panel data are shedding some light on these difficult questions. An
    economist from RAND has recently shown, for example, that out-of-pocket
    health expenses account for only a small share of the reductions in
    wealth after an adverse health event. Furthermore, those with health
    insurance have just as large a decline in wealth as those without
    health insurance. Subsequent to a major health event, middle-aged
    persons tend to reduce their work hours or retire completely and use
    their accumulated savings in place of earnings. These results have
    important implications for spend-down to Medicaid eligibility and old-
    age poverty, especially for older women who tend to outlive their
    spouses.
        Education also is linked to health as well as wealth and income.
    Analyses of HRS by researchers suggest that education appears to have
    an enduring effect on health decisions. Among respondents who suffered
    a heart attack between the first two waves of the HRS, 90 percent of
    college graduates quit smoking compared with only 10 percent of those
    with less than high school education. Related HRS research also shows
    that, among middle-aged diabetics, education raises their health
    investment in managing their disease through diet.
    Asset and Health Dynamics of the Oldest-Old (AHEAD)
        The companion survey of HRS, AHEAD, provides unique information on
    the dynamics of health, economic resources and health care services.
    The study provides badly needed data on the costs and burdens of
    chronic disease and the consequences for the extended family. AHEAD
    provides data on how families redistribute their resources across
    generations, and how these flows interact with public sector transfers.
    AHEAD informs policy decisions on initiatives such as Medicare/Medicaid
    coverage for community long-term care and prescription drug benefits.
        In addition to economic factors, sustained activity, such as part
    time work and volunteering, are thought to affect the well-being and
    health of the very old. AHEAD data indicate that there is a beneficial
    effect of volunteer work on cognition, health and survivorship.
    Volunteer work also is associated with higher education and wealth
    suggesting that social activities may be yet another pathway by which
    socio-economic status affects health, even in advanced old age.
        AHEAD data also corroborate improvements in old age health,
    respondents have shown little overall decline in basic cognitive
    functioning. Higher education is protective of cognitive ability in old
    age.
        Finally, PAA and APC are interested in and support the current
    efforts to strengthen the Federal Forum on Aging Related Statistics
    that coordinates data across federal agencies. The forum is an example
    of NIA's interest in supporting NIH's innovative endeavor of
    streamlining federal databases and making data accessible to
    researchers from varied fields.
                                   conclusion
        PAA and APC would like to thank you for the opportunity to present
    this information. Demographic data and research are important tools for
    policymakers that can both save public funds and promote more informed
    decision-making. If this vital research is to continue producing
    relevant and timely information, adequate funding and Congressional
    support are needed. The Population Association of America and the
    Association Population Centers support an increase in the range of 15
    percent to sustain the momentum of demographic research in the National
    Institutes of Health as part of the broadly based support to double the
    funding for the NIH over the next 5 years. However, the increases that
    NIH has enjoyed have not been evenly applied amongst the various
    institutes; in particular, budgetary growth at NICHD, while
    significant, has not kept pace with many of the other institutes. PAA
    and APC also support a more even distribution of any increase in
    funding for NIH.
                                     ______

              Prepared Statement of the Parkinson's Action Network

        I am one of a million Americans afflicted with Parkinson's disease
    and related disorders. I also am President of the Parkinson's Action
    Network, which was created in 1991 to give a voice to our community in
    the effort to speed research delivering breakthroughs and a cure for
    this dreadful disorder.
        I have the job today of focusing your attention on the particular
    needs of my community, and to convince you that the 2001 budget of the
    Labor-HHS Appropriation must--yes, must--include a substantial increase
    for Parkinson's-focused research funding.
        Why am I so emphatic?
      --Because the current federal policy on Parkinson's wastes billions
            in public and private dollars coping with its effects, when
            millions would produce a therapy that would restore function,
            and bring us back into the world.
      --Because the disparity in funding attributable to variations,
            invisibility or political clout cannot continue.
        Parkinson's--the disorder.--Parkinson's is a movement disorder
    caused by the degeneration of brain cells that produce dopamine, a
    neurochemical controlling motor function. By the time 80 percent of
    those cells stop functioning, symptoms of stiffness, tremor and
    slowness of movement begin to emerge.
        The conventional treatment for Parkinson's is a 30-year-old drug
    commonly known as ``L-dopa'' which attempts to replace the missing
    dopamine with an artificial substitute. It usually restores function to
    a certain extent and it may seem at first like a miracle drug. But it
    works inefficiently, it produces side-effects, and eventually it does
    not work at all. As the dopamine cell degeneration advances, it strips
    away automatic movements needed to walk, talk, swallow, even move at
    all.
        Despite the common myth that Parkinson's only affects the oldest
    sector of the country, in fact the average age of symptom onset is 57,
    with a third of all victims' symptoms starting in their 20's, 30's and
    40's. As a result, Parkinson's-caused early retirements and forced
    disability are the norm. Some lose their jobs simply due to the stigma.
    The financial impact is enormous.
        In my case, as a practicing lawyer and now running am advocacy
    organization for our community, these are my daily struggles: worrying
    about getting to a morning meeting and wondering when my first dose of
    medication will ``kick in,'' enabling me to function; needing to make a
    phone call, but not being able to hold the telephone still with a
    shaking hand; seeing others put off by my lurching gait, or my
    trembling hand.
        The impact on daily functioning.--At some point the symptoms become
    an impossible hurdle, as the tiny number of dopamine neurons left
    functioning just can't team up with the medication any more, and are
    complicated by drug side-effects. At that point, the swing between too
    little and too much movement is just too much to manage in the outside
    world. We may continue living for a long time, but we drop out of
    sight.
        As a consequence, we have been neglected. For decades, NIH funding
    of Parkinson's research has languished far behind many other diseases,
    and far short of the level warranted by the research promise. Estimated
    1999 Parkinson's-focused spending totaled less than $45 million, or $45
    per patient. Although the NIH reports higher figures, independent
    analysis of the actual projects NIH classifies as ``Parkinson's
    research'' shows that only about one third of funding supports research
    actually focused on understanding or curing the disease. This is a
    serious ongoing concern and I hope Congress will take steps to ensure
    more accurate accounting of NIH research funding.
        There is another important reason the Congress must increase
    Parkinson's funding in 2000. As federal taxpayers, we are owed a
    rational health spending policy. That requires spending money to cure
    us rather than just care for us.
        The cost to America.--The cost of Parkinson's in America is
    massive. In testimony before the Senate Special Committee on Aging in
    1995, Dr. Ole Isacson of Harvard estimated the cost to be in excess of
    $25 billion. The Network's surveys of the costs Parkinson's disability
    incurs on the country--in treatment, physical therapy, hospitalization,
    disability payments, lost productivity, and assisted living--indicate
    an equal or greater amount, which translates into a massive burden on
    public sources such as Medicare, Medicaid, and Social Security
    disability.
        The cost is so high because we typically live in a disabled state
    for a long time, and the battle against loss of function is ongoing,
    and expensive. Parkinson's medication alone is very expensive, probably
    costing Americans well over a billion dollars. The largest costs can be
    due simply to losing the ability to work or care for oneself, which is
    absorbed by the government through higher Social Security, Medicare and
    Medicaid spending. This takes a huge toll on the American families hit
    by Parkinson's, but it also burdens the society and hits the taxpayer.
        This massive financial waste will rise steeply if Parkinson's is
    not cured before my generation of ``Baby Boomers'' hits the years when
    Parkinson's symptoms are most prevalent. Imagine the additional burden
    of lost tax revenue, medical care and disability from Baby Boomers with
    Parkinson's.
        The scientific promise.--An examination of the scientific promise
    of this disorder shows that an investment in Parkinson's research would
    return many-fold. The Dana Alliance for Brain Initiatives describes
    Parkinson's as ``one of the brightest spots in brain research.'' There
    is no doubt that huge, revolutionary breakthroughs are coming, and they
    will drive breakthroughs for many other neurological and non-
    neurological disorders--Huntington's, ALS, Alzheimer's, spinal cord
    injury, diabetes and more. Consider:
      --Neural growth factors, animal studies have shown growth factors are
            capable of reviving dormant cells and producing dramatic
            symptomatic improvement. Further research, including human
            clinical trials, is needed.
      --Neural cell transplantation, from a variety of sources, has shown
            that symptomatic improvement results from the flourishing of
            transplanted dopamine neurons. A few patients are now symptom-
            free without medication.
      --Advances in evidence and understanding of the links between
            Parkinson's and environmental factors and chemical compounds
            such as heavy metals, herbicides and pesticides.
      --Steady increase in insights into the exact disease process, in
            which the cells appear to self-destruct after assaults from one
            or more of those causative factors.
        But without question, these discoveries are coming in slower than
    they need to. Many scientists describe immense frustration with the
    slow pace of working on these breakthroughs because of the tiny
    research investment. That translates directly into a breakthrough
    deferred into the future.
        According to testimony before the Senate Labor-HHS Appropriations
    Subcommittee last year by NINDS Director Dr. Gerald Fischbach, a
    focused and adequately funded research agenda could produce new
    Parkinson's treatments or even an effective therapy or cure within 5 to
    10 years. According to a study by Dr. Roger Kurlan of the University of
    Rochester, even a 10 percent slowing of progression will save $327
    million per year.
        In recognition of both the current costs and tremendous scientific
    potential of Parkinson's disease, Congress requested the NIH develop a
    Parkinson's-focused research agenda including professional judgment
    funding projections for the next 5 years. The NIH held a 2-day
    interdisciplinary workshop that included a cross section of some of our
    nation's top scientists, clinicians and advocates. This broad,
    interdisciplinary approach to evaluating the current state of
    Parkinson's research must be continued to stimulate new ideas and
    ensure that the limited federal funding is supporting the best, most
    promising research.
        Although this research agenda is a good first step and acknowledges
    the need for substantially increased federal research investment, it is
    not a complete and comprehensive plan. For example, while the NIH
    research agenda calls for a $71.4 million increase in Parkinson's
    research in fiscal year 2001, the Parkinson's Action Network has worked
    in concert with the scientific community to identify $244 million in
    research projects that could and should be funded in 2001. The NIH
    needs to work in close consultation with the research community,
    clinicians and patient advocates to expand, revise and update the
    research agenda in order to remain relevant and identify the most
    promising areas of research.
        Congress should encourage the NIH to expand its use of innovative
    funding mechanisms such as accelerated review, targeted research,
    research supplements and young investigator awards to attract a new
    generation of researchers into the field.
        And the resources are available to implement this increase. I
    applaud the hard work Congress has done the past two years to put the
    NIH budget on track to double over five years because of the benefits
    to all categories of medical research, and also because it allows for
    the needed expansion in Parkinson's-focused research.
        Conclusion.--The human suffering that results from Parkinson's is
    immense and incalculable. That alone is a good reason to invest in a
    cure. The fiscal drain compels it. At the request of Congress, the NIH
    has produced an initial plan to pursue a Parkinson's cure. Congress
    must now follow through by providing the increase called for--at least
    and additional $71.4 million in fiscal 2001--to capitalize on the
    unprecedented scientific opportunity. This directed increase for
    Parkinson's is a small fraction of the projected overall NIH increase,
    and it would bring us one step closer to relieving the enormous burden
    Parkinson's places on individuals, families and our nation as a whole.
                                     ______

             Prepared Statement of the Cure For Lymphoma Foundation

        Dear Chairman Specter and Senator Harkin: Thank you for this
    opportunity to participate in the fiscal year 2001 process. I am a
    survivor of non-Hodgkin's lymphoma--the second fastest rising cancer in
    the United States. I am also the founder and President of the Cure For
    Lymphoma Foundation (CFL), a nationwide, not-for-profit organization
    dedicated to funding research and supporting those whose lives have
    been touched by Hodgkin's disease and non-Hodgkin's lymphoma. While
    other cancers are on the decline, non-Hodgkin's lymphoma is one of two
    cancers where mortality rates continue to increase. The number of
    persons diagnosed with non-Hodgkin's lymphoma has doubled since the
    early 1970's. Despite exceptional breakthroughs in understanding the
    biology of lymphomas, the causes remain unknown. Therefore, as the baby
    boomer population ages, this disease is expected to dramatically
    increase. For this reason, CFL asks for your assistance in increasing
    funding for lymphoma research so that we can find a cure for lymphoma
    before it becomes a national epidemic.
                 your constituents want more lymphoma research
        Last year, in order to help heighten lymphoma awareness in
    Congress, CFL launched ``CAMPAIGN 64,000''--a national letter writing
    campaign. In response, hundreds of advocates sent letters to you and
    your colleagues asking to make lymphoma a national priority. Patients
    from more than 31 states shared their hopes for new research, as
    highlighted below:
        Susan of Wallingford, Pennsylvania.--``I am writing to urge your
    support for making Hodgkin's disease and non-Hodgkin's lymphoma cancers
    of the lymphatic system--a national health priority. I care very deeply
    about breakthroughs in lymphoma research because I am the sister of a
    person with low-grade lymphoma.''
        Patricia of Iowa City, Iowa.--``My brother was recently diagnosed
    with non-Hodgkin's lymphoma and currently there is only a 51 percent
    survival rate after 5 years. More money for biomedical research will
    bring us one step closer toward finding a cure for lymphoma . . . and
    all other cancers.''
        Sharyn of Bothell, Washington.--``I . . . urge your support for
    making Hodgkin's disease and non-Hodgkin's lymphoma . . . a national
    health priority. I am a spouse of a survivor. My husband received
    chemotherapy in 1995, which severely damaged his heart. Plus the chemo
    failed. He got into a clinical trial in 1996 and remained in total
    remission until his death in January 1999, which was from heart failure
    caused by the chemotherapy. Had the clinical trial drug (now FDA
    approved) been available at the time he went through chemotherapy he
    would still be with me today.''
        LeVonia of Orange, Texas.--``I have been fighting lymphoma for the
    past three years. When lymphoma strikes someone, her entire family is
    affected; it really takes a toll on the family--physically,
    emotionally, financially. It is my hope that you . . . will work toward
    funding resources for finding better treatments and, ultimately a cure
    for lymphoma.''
        Marvin of Wisconsin Rapids, Wisconsin.--``Personally, I am 75 years
    old and have been in remission for the past ten months with non-
    Hodgkin's lymphoma which has no known cure. It is only because of a
    caring oncologist . . . and the professional staff that I have a new
    chance and outlook on life. It is most likely that the cancer will
    return. My second oldest son, 48 years of age, has been diagnosed with
    non-Hodgkin's lymphoma/lymphomcetic leukemia, which according to
    authorities is not hereditary. His case is far worse than mine. Your
    support for the much needed funds will be greatly appreciated not only
    by researchers but by the thousands of persons searching for a cure.''
        Patricia of Phoenix, Arizona.--``My father was diagnosed with non-
    Hodgkin's lymphoma (low-grade, B-cell) in 1992 and has undergone
    various treatments over the past 7 years. Fortunately, he has been able
    to take advantage of some of the newly developed and approved
    treatments and medications, which have prolonged his life. He's been
    lucky in that respect, but there is no cure yet. Please take the next
    step by making finding the cause and cure for lymphoma a national
    priority!''
        Earl of Los Altos, California.--``I am a survivor (so far). The
    follicular type I have is currently incurable, and I have suffered with
    it for over 12 years. There are very exciting new possible treatments
    such as antiangiogenisis inhibitors and other approaches that offer
    hope of real cures. Increased funding would offer new hope for finding
    a cure before I die.''
       increased nci funding has improved the lives of lymphoma patients
        As Dr. Richard Klausner, Director of the NCI shared in his written
    testimony submitted to your subcommittee in March, increased funding
    for the NCI led to the development of a new tool, called the
    ``Lymphomachip.'' This will assist doctors in identifying which
    patients will respond to chemotherapy and which patients should
    consider instead alternative therapies like bone marrow or stem cell
    transplant. Thanks to this new tool, many patients will not have to
    undergo unnecessary chemotherapy treatment as they have in the past.
        With your encouragement the NCI has taken an important initial step
    towards ``identifying disease specific priorities'' by undertaking a
    Progress Review Group (PRG) on Lymphoma, Leukemia and Myeloma, this
    fall. The PRGs are important because they are comprised of researchers,
    health professionals, industry and advocates who together (1) assess
    the state of knowledge, (2) identify scientific opportunity and need
    and (3) chart a course for further research. We are hopeful this PRG
    will help outline and prioritize a national research agenda for these
    three hematologic malignancies.
     your subcommittee has twice endorsed lymphoma report language--it is
                           time to take the next step
        Your Subcommittee endorsed lymphoma-specific language last year
    that was adopted as part of Senate Report 106-166 and the previous year
    as part of Senate Report 105-300. This year we ask that you continue
    your support in funding the research essential to improving treatments
    and finding a cure for lymphoma. Specifically, we ask you:
      --To encourage the National Cancer Institute (NCI), National
            Institute of Environmental Health Sciences (NIEHS), Centers for
            Disease Control and Prevention (CDC), Department of Defense
            (DOD), Veterans Administration (VA), as well as other key
            agencies to develop a national agenda for lymphoma and to
            expand research into lymphoid malignancies;
      --To ensure funds are available to support new research
            opportunities; and
      --To further investigate potential environmental, bacterial and viral
            factors associated with development of lymphoma.
        Finally, we thank you for your consideration in this matter. Should
    you have any questions, please feel free to contact us.
                                     ______

                   Prepared Statement of Mended Hearts, Inc.

        My name is Warren Greenberg. I am a professor of health economics
    and of health care sciences at The George Washington University. I am
    married and have a 25-year-old daughter.
        I advocate an increased appropriation for the National Heart, Lung,
    and Blood Institute. I am a victim of heart disease and as a
    beneficiary of the efforts of medical researchers to overcome this
    disease. I might also add that I am a member of Mended Hearts, Inc., a
    support group of 24,000 members throughout the United States. I have
    been appointed lobbying and legislation chairperson of that group--a
    volunteer position.
        I am 57 years old. I was born with aortic stenosis, a narrowing of
    the heart valve. Throughout my entire life I have lived with heart
    disease, often incredibly severe.
        When I was in my early teens, my physicians did not allow me to
    play high-school inter-mural sports, although I was a fine young
    athlete. At the age of eighteen I was told not to play ball under any
    circumstances. In my early 20s I was told to climb no more than two
    flights of stairs. By my early and mid-thirties I began to climb steps
    more and more slowly, often pausing to rest. I never carried an attache
    case home from work. It was too heavy. I would often balance a large
    book on my hips, rather than carrying it outright, in order to blunt
    the weight. I would walk two or three blocks on a level street to avoid
    going up three or four steps at the end of particular blocks. I could
    barely lift my newborn child; I could not help my wife take in the
    grocery bags.
        On May 7, 1982, at the age of 39, I had open-heart surgery at the
    Cleveland Clinic to replace my diseased valve with the valve of a pig.
    After my six-week recuperative period I was amazed to find that not
    only was I able to walk, but was also able to play tennis, to jog, and
    to exercise. I was able to live a normal life.
        By August 1988, however, my new valve had failed. On August 31, I
    again had cardiac surgery at the Cleveland Clinic to replace the failed
    pig valve with an artificial plastic valve, known as the St. Jude's
    valve. I am again able to live a relatively normal, very productive
    life. And I am deeply thankful for it.
        I still take a blood-thinning medicine, coumadin, which helps
    prevent clots on my new valve. At the same time, because of the
    medicine, I must be cognizant and careful of excessive bleeding. In
    1983 I contracted bacterial endocarditis, an infection of the heart
    valve, from dental surgery which kept me in the hospital for six weeks.
    Whenever, I have dental work, I now get intravenous penicillin to
    protect me against such infections. I realize that my valve, as a
    mechanical device, may fail at any time in the future.
        For nearly 18 years, thanks to the fruits of medical research, I
    have been able to travel abroad at least once a year, to jog in the
    park, to be a productive author of many scholarly articles and a number
    of books on the health care economy. I have been quoted often on my
    views of the U.S. health care system and have made many television
    appearances. If it were not for the advances in research leading to
    improved techniques in open-heart surgery, I would not have seen my
    fortieth birthday. I would not be able to look forward to a life of
    many rewards and enjoyments.
        As an economist. I observe continually the link between monetary
    resources and the development of innovation and technology. Health care
    research, and cardiovascular research in particular, is no exception. I
    also understand as an economist that there are always competing uses
    for appropriated monies. However, cardiovascular diseases last year
    killed more than 950,000 Americans, more than 151,000 of whom are under
    age 65. Despite advances in medical research, these diseases remain the
    number one killer in the United States and a leading cause of
    disability. From my personal perspective and for those in Mended Hearts
    Inc. and others in the United States who have heart disease or will get
    it in their lifetime, consistent with congressional resolutions for the
    National Institutes of Health, I ask for a doubling of National Heart,
    Lung, and Blood Institute budget by year 2003. To reach this funding
    goal, I advocate a fiscal year 2001 appropriation of $2.330 billion for
    the NHLBI to help reduce further the incidence and degree of heart
    disease.
                                     ______

                        Prepared Statement of Erin Bosch

        I am submitting this testimony because I am convinced that together
    we can make a difference. I submit this testimony on behalf of the
    almost one million Americans that are living today with consequences of
    congenital heart disease in our nation. For the last four years I have
    worked as an advocate for the American Heart Association and during
    that time I have seen the difference that being a public advocate can
    make in people's lives.
        Since my diagnosis of hypertrophic cardiomyopathy at age eight, I
    have been through many procedures, both for the purpose of diagnosis
    and treatment, including open heart surgery at the Mayo Clinic. I have
    had numerous doctor and hospital visits and I will take medication
    every day for the rest of my life. I will never compete in athletics
    again, which I dearly loved. I face the possibility of many more
    procedures during my lifetime. Clearly, the success of additional
    research could make my adult years more hopeful. I anticipate that when
    the day comes for me to bear a child of my own, I will be able to say
    with certainty he or she will be born free of heart disease.
        Most people know that heart disease is the number one killer and a
    leading cause of disability in adults, but few recognize that
    congenital heart defects are the most common defect in new born babies.
    Every year thirty two thousand children are born with a congenital
    heart defect. I was one of them. Twenty one hundred of these children
    will die before their first birthday. I am one of the lucky ones.
        I am confident these statistics can be changed. I have addressed
    the Committee for the last three years about the importance of
    continued research for heart disease and every year you have come
    through with critical research dollars. It was funding that this
    Committee provided that has allowed for the successful research and
    development of surgical procedures, pacemakers and intracardiac
    defibrillators that myself and other children depend on. Other devices
    and procedures are in the throws of development as we speak which
    depend on the continuance of these research dollars. I have great faith
    in the determination of our scientific researchers who work day and
    night to find new treatment methods for those who suffer with illness
    and disease. I also have great faith in you as the doorkeepers of
    governmental funding to continue to provide the necessary funds for
    children who have been born with heart defects.
                                     ______

                            DEPARTMENT OF EDUCATION

                   Prepared Statement of the CORE Foundation

                            key issues for hiv/aids
        We are at a critical point in the care of patients with HIV/AIDS.
    We have achieved major goals in our basic science understanding of the
    course of HIV disease and have applied this understanding to the care
    of patients. Recent breakthroughs in drug therapies give reason to be
    hopeful for the successful treatment of HIV/AIDS.
        Throughout the country, we have witnessed a steady decline in the
    number of hospital admissions for AIDS care and outpatient clinics are
    experiencing a dramatic increase in the demand for out-patient care and
    services. These successes have led to increased numbers of AIDS
    patients surviving longer and once again becoming productive members of
    society. Although science has taken big steps toward making AIDS a
    long-term manageable disease, by no means do we have a cure for the
    largest public health crisis of the century.
        These favorable trends can be attributed in part to advances in
    opportunistic infection prevention and to highly active antiretroviral
    therapy (HAART). There are over 200 potent combinations of
    antiretroviral treatments that can be used in the fight against HIV/
    AIDS. For each of these different regimens and drug combinations, there
    is a wide variation in a patient's adherence.
        With the hectic pace of the development and release of new drug
    treatments and care regimens for HIV/AIDS patients, it can be difficult
    even for specialty-care providers, and much more so for community-based
    care providers, to keep abreast of the most recent advances in care and
    medication usage. Without the ability to keep up with new drug
    developments, disease management is difficult, if not impossible, for
    community-based providers and patients.
        While the technology exists to implement sophisticated education
    networks for HIV/AIDS, there is no successful system in place that
    provides caregivers and patients the education and scientific tools
    needed to ensure that they make the most of the advances in care.
        Additionally, recent research has shown that the disproportionate
    incidence of HIV/AIDS among inner-city, minority populations is due in
    large part to low rates of adherence and lack of effective community-
    based, comprehensive, health education and training systems for
    providers and patients.
        Lack of access to up-to-date information also hinders the ability
    of patients to fully understand the importance of adhering to their
    prescribed therapy. Unfortunately, incomplete adherence with medication
    regimens greatly increases the risk of the emergence of strains that
    are resistant to the newest therapies thus increasing the likelihood of
    the spread of HIV/AIDS.
        Low rates of adherence can most often be attributed to the
    following:
        Cost.--The cost for HAART therapy is enormous, as much as $10,000-
    $15,000 per patient per year. Although the federal program, AIDS Drug
    Assistance Program (ADAP), is designed to provide financial assistance
    for uninsured or underinsured HIV/AIDS patients in purchasing required
    medications, it has been unable to keep up with the increasing demands;
        Testing.--Many individuals are still hesitant to be tested for HIV
    and often go without a diagnosis. As a result, patients go without care
    until the symptoms become evident and they are in need of immediate
    services. Delays in testing result in patients who are much sicker when
    they present for therapy.
        Education.--Many HIV infected patients are unable to get timely
    clinical care or to adhere to complex and difficult drug regimens.
    Often patients have little or no understanding of newer therapies and
    their potential benefit, resulting in low levels of adherence and
    decreased health status.
        Disparities among inner city, minority populations are also evident
    in the effectiveness of HAART therapies. While there have been dramatic
    new developments in HIV care due to these new and more powerful
    medications, including a 42 percent decrease in the death rate from
    AIDS,\1\ the outcomes have not been as positive for minority
    populations.
    ---------------------------------------------------------------------------
        \1\ Centers for Disease Control HIV/AIDS Surveillance Report, June
    1998.
    ---------------------------------------------------------------------------
        This disparity in opportunistic infection trends between population
    groups most reflects differences in access to the full range of new
    therapies now available. It is also indicative of a lack of targeted
    outreach, education and adherence enforcement efforts aimed at high
    risk populations and at those lifestyles which contribute significantly
    to the transmission of HIV.
        The treatment of patients with HIV/AIDS in Chicago and other urban
    areas is made more difficult by the large number of patients receiving
    care and the large number of potential patients whose infections have
    not been diagnosed who will ultimately need care.
        Specialists alone are not able to provide primary care for all
    affected patients, especially those in underserved communities. This
    means that other providers need to be trained in the complicated care
    of patients with HIV/AIDS to insure that the new HIV medications are
    used appropriately and to the greatest benefit for all patients.
        To be effective, these community providers must have current
    medical data and protocols at their fingertips. They must be able to
    access immediate expertise to ensure the most accurate interventions
    and care for patients. Today, due to the lack of use of computerized
    clinical information systems in health care, especially for HIV/AIDS
    care, they are often unable to access this type of critical information
    or feedback in a timely fashion.
                21st century technology for education as the key
        While many piecemeal technology based health education systems for
    HIV/AIDS exist throughout the United States, there are none that are
    taking full advantage of today's cutting-edge scientific landscape.
        The adoption of computerized clinical information systems in health
    care lags behind the use of computers in most other sectors of the
    economy. There is no HIV educational system that provides care,
    clinical assistance and interactive education, while integrating the
    patients and community-based providers into the care giving and
    decision-making process. Especially given today's technological
    advances, this is a striking deficiency in health education systems for
    HIV/AIDS.
        At this critical time in the evolution of the long-term treatment
    of HIV/AIDS, it is important that we focus on the creation and
    implementation of comprehensive provider and patient education and
    training systems. This focus will:
      --Improve ability to manage disease and related conditions;
      --Improve treatment and prevention efforts;
      --Increase the rate of the early detection of HIV;
      --Increase the rate of treatment adherence; and,
      --Decrease the spread of HIV.
        The Department of Health and Human Services has recognized that
    effective education of providers and patients as well as adherence
    management programs are the only way to prevent those behaviors that
    lead to the spread of resistant strains of HIV. It is critical that the
    Federal Government continue to focus its resources on creating
    comprehensive HIV education and training systems that fully integrate
    specialists, community-based providers and patients and evaluate the
    outcomes of those systems.
        The CORE Center believes that the most effective educational system
    is one which uses today's state-of-the-art technology and creates
    interactive networks of education that provide real-time feedback and
    enables providers to optimize care for HIV/AIDS patients.
        Thus, the Center has proposed the Community and Minority Education
    and Training Initiative (COMET) for HIV/AIDS which maximizes the
    Center's extensive technological resources and care expertise to create
    and implement a unique, regional HIV/AIDS education and training
    network for HIV/AIDS providers and patients in community based
    settings, especially minority communities.
          the community and minority education and training initiative
        To address this significant health crises in the minority
    communities specifically, the African American community, The CORE
    Center in Chicago, Illinois, proposes the implementation of its
    ``Community and Minority Education and Training (COMET) Initiative''.
    This initiative will demonstrate the significant improvements in care,
    prevention and education services through the use of a regional
    computer network. COMET will expand upon existing technology at the
    CORE Center to provide computer assisted patient shared decision making
    and HIV/AIDS education, training and care feedback to providers and
    patients in the Chicago metropolitan area.
        This demonstration project will create a national model of a
    technology-based education and training system for specialty and non-
    specialty, community-based HIV/AIDS care providers as well as the
    education of HIV/AIDS patients. It will address an existing national
    need in minority communities for the effective integration of
    educational programs to enhance provider performance and improve
    provider and patient ability to manage disease. It will improve patient
    response and adherence to treatment regimens and place emphasis on the
    incorporation of patients into a shared decision making process.
        The Community and Minority Education and Training Initiative will
    result in several key outcomes including:
      --Improve non-specialist and patient access to the most current
            information on HIV/AIDS care, treatment, and drug protocols
      --Provide critical and, as of yet non-existing, access to immediate
            feedback for providers to proposed patient care regimens
      --Facilitate the supervised integration of community-based providers
            into the care of HIV/AIDS--thus expanding patient access to
            care for HIV/AIDS
      --Provide a model for computer assisted patient shared decision
            making
      --Improve physician's and patient's ability to manage HIV/AIDS and
            related infectious diseases.
      --Improve patient adherence to complex care regimens
      --Improve surveillance and response efforts at the local, state and
            federal levels
      --Increase providers' ability to identify population specific
            treatment and care issues
      --Reduce the emergence of additional resistant strains of HIV/AIDS
      --Provide nationally relevant outcomes data that will be useful to
            cities across the United States as they grapple with issues of
            access, adherence, and cost and quality of care.
        Through the implementation of a community-wide HIV education and
    training network, this initiative will provide nationally relevant
    outcomes data which will be useful to cities across the United States
    as they grapple with issues of access, adherence, and cost and quality
    of care.
        The CORE Center, with its location in the heart of an inner-city,
    minority neighborhood, its single-site location for comprehensive HIV
    outpatient services, screening clinic, and its state-of-the-art
    information system, is uniquely positioned to implement this
    technology-based provider and patient education initiative.
    Additionally, because the Center's population is predominately African
    American and Latino, it will provide a unique model for improving the
    quality, efficacy and cost of care for minority populations through the
    use of a technology based education system for providers and patients
    of HIV/AIDS care.
        Project COMET will demonstrate the efficacy of the technology-based
    education and training system in the following areas:
        Education.--Demonstrate the ability of a technology based
    educational system (or distance learning system) to update and educate
    specialty and community-based providers and to educate and involve
    patients in a shared decision-making process.
        Early Intervention.--Demonstrate the effect of a technology based
    educational system on the ability of the community-based and specialty
    care providers to target HIV screening of inner-city populations with
    sexually transmitted diseases (STDs), so that advances in HIV care will
    be made available as early as possible in the course of HIV disease and
    prevent risky behaviors that result in the spread of the HIV and
    related infectious diseases;
        Adherence.--Demonstrate the ability of the system to enable non-
    specialty and community-based care providers to implement an aggressive
    adherence program to ensure the application of sound treatment
    principles and protocols, medication adherence and clinical follow-up
    of inner-city, minority patients; and,
        Outcomes Research.--Collect and analyze data to measure patient
    outcomes, the cost of care by different specialty and community-based
    providers as well as patient and provider adherence. In addition, this
    initiative will disseminate these findings.
        Mr. Chairman, thank you for this opportunity to submit testimony
    for the record. We very much appreciated your support in fiscal year
    2000 in securing the initial $1.25 million for this important
    initiative. We look forward to working with you to secure the remaining
    $8.75 million in federal funding to complete this nationally
    significant initiative that will thoroughly examine the effectiveness
    of a technology based educational system on the improvement of care and
    treatment of HIV/AIDS. Lessons learned from this important initiative
    will be beneficial not only to the Federal Government as it endeavors
    to develop appropriate HIV/AIDS policy, but to cities across the nation
    as they grapple with this very complex issue, especially as it pertains
    to minority communities where the epidemic is expanding most rapidly.
                                     ______

          Prepared Statement of the Pinon Community School Board, Inc.

        Thank you for this opportunity to submit testimony regarding the
    fiscal year 2001 Labor, Health and Human Services, and Education
    budget. We are pleased with the long-overdue emphasis that has been
    placed on Indian programs in the proposed fiscal year 2001 budget. The
    critical needs of Indian Country's educational system in particular
    rise above partisanship, recognized by leaders on both sides of the
    aisle as a pressing concern worthy of renewed attention by the U.S.
    Congress. With this in mind we ask that, at a minimum, your committee
    fully support the direct and indirect funds for services to Indian
    students contained in the Administration's request, including the
    following:
      --$115.5 million overall for Indian Education
      --$10 million for continuation of the Indian Teacher Corps program
      --$5 million to create an American Indian Administrator Corps
      --$2.7 million to support comprehensive Federal research on Indian
            education
      --$20 million for Special Programs for Indian Children
      --$50 million earmark for Title I grants to 119 LEAs with at least 50
            percent of their students residing on Indian lands
      --$200 million earmark under the School Modernization Bonds proposal
            for renovations and repairs to Indian schools
      --$175 million for Indian Head Start programs
      --$460 for bilingual education including Native language instruction
            materials.
        Our community of 11,000 is comprised of Pinon and seven other
    Chapters of the Navajo Nation. While we have made much progress in
    recent years, our community suffers many of the same problems that
    plague tribal communities nationwide. In 1990, more than one-third of
    all Indian children ages 5 to 17 were living below the poverty level.
    The high school completion rate for Indians ages 20 to 24 is 12.5
    percent below the national average. The problems we face are deeply
    entrenched and will not change overnight, but your full support for
    budget increases in the areas listed above will represent a critical
    step toward empowering tribal schools in our efforts to confront and
    reverse these troubling statistics.
                            department of education
        Indian Education.--The Administration's request for $115.5 million
    for Indian Education in fiscal year 2001 represents an important step
    toward addressing long-time shortfalls in this area. We urge you to
    fully support this request and related funding to benefit educational
    efforts in Indian Country.
        We strongly support the Administration's fiscal year 2001 request
    for $92.8 million in Grants to LEAs for activities to improve the
    educational achievement of Indian students. The proposed budget also
    contains $20 million for Special Programs for Indian Children, a much-
    needed increase for which we also ask your full support.
        American Indian Teachers and Administrators.--We are particularly
    excited about the Administration's request for funding to recruit,
    train, and provide in-service professional development for American
    Indian teachers and administrators. In support of the President's 1998
    Executive Order on Indian Education, the proposed budget includes $10
    million for continuation of the Indian Teacher Corps program and a new
    $5 million initiative to create an American Indian Administrator Corps
    to recruit, train, and provide professional development for American
    Indians in the field of school administration. We strongly support this
    request.
                                   head start
        A critical element in any effort to raise the academic achievement
    level of students in Indian Country must be high-quality early
    childhood education programs. There is overwhelming evidence that
    programs like Head Start lay the groundwork for developing effective
    learning skills that can have a lifelong impact on a child's education.
    Therefore, we urge the Subcommittee to take the following actions with
    respect to Head Start:
      --Fully fund the Administration's fiscal year 2001 budget request of
            $6.3 billion for the Head Start program, including at least the
            requested level of $175 million for Indian Head Start programs
      --Prioritize the construction of badly-needed tribal Head Start
            facilities; and,
      --Encourage the Department of Health and Human Services (HHS) to
            allow tribal organizations to administer Head Start programs
            under Public Law 93-638 self-determination contracts.
        Program Access for More Eligible Children.--At the Pinon Community
    School, we see regular, concrete evidence that children who have
    attended Head Start are more prepared to learn when they graduate to
    our school. Unfortunately, the current funding level does not allow us
    to serve all of our area's Head Start-eligible children. The Pinon Head
    Start program serves 20 children, plus another 30 children though home-
    based instruction. That said, at least 391 children are eligible for
    comprehensive Head Start services, but we lack the funding and
    facilities to expand our program. They are falling through the cracks,
    and there is no second-chance at these critical learning years.
        We want every child in our community to have the early educational
    attention they deserve. We strongly support the Administration's long-
    range goal of increasing Head Start enrollment to one million. If the
    Subcommittee fully funds the Administration's fiscal year 2001 budget
    request of $6.3 billion, nearly 950,000 children can be reached by Head
    Start, and 54,000 toddlers could reap the benefits of Early Head Start.
    These are not just numbers, they are each individual lives being
    shaped, someone's child that will have a better chance at fulfilling
    their dreams in life. We ask your support for these children at the
    onset of their educational journey.
        Replacement Facility Construction.--Without funding to build new--
    and safe--facilities, the goal of increasing Head Start enrollment to
    one million will be meaningless to Pinon. Currently, our Head Start
    program is located in a 20-year-old classroom that only accommodates 20
    students. In order to expand services to even a fraction of the 391
    children who are eligible for Head Start in our area, we will need an
    additional building. Other areas suffer similar facilities constraints
    on their programs. We ask you to allocate a specific portion of the
    fiscal year 2001 Head Start appropriation for facility needs to break
    down this barrier to access for additional eligible children.
        Tribal Administration of Local Head Start Programs.--Section 102 of
    the Indian Self-Determination Act (Public Law 93-638) directs the
    Secretary of Health and Human Services (HHS) to contract with tribes to
    operate federally-funded programs for their members. DHHS, however, has
    interpreted this provision narrowly to require contracting only of
    programs ``operated for the benefit of Indians because of their status
    as Indians.'' Thus, only Indian Health Service programs are deemed
    contractible by DHHS.
        We would like to be able to contract to administer Head Start
    programs as a direct grantee under the American Indian Programs Branch
    of the Head Start Bureau. The Pinon Community School Board has
    successfully contracted education programs since 1988 and has
    continually improved student services during this time period. The
    Board believes that administering a tribal Head Start program through a
    self-determination contract would be beneficial to the community and
    the participating children. It would decrease the amount of federal
    bureaucracy that we must navigate by allowing us to receive all of our
    funds directly from Head Start using one funding document and would
    give us the flexibility to run our local programs to meet local needs.
    Currently, we receive our funding from the Chinle Agency, which in turn
    receives the funding through the Navajo Nation, Division of Dine
    Education, Department of Head Start.
        We ask you to consider including report language in the fiscal year
    2001 LHHS-Ed Appropriations bill that would encourage the Secretary to
    work with tribes to fully implement the Indian Self-Determination Act
    so that tribal organizations may contract Head Start.
                              bilingual education
        We urge your Committee to provide the full $460 million requested
    for Bilingual and Immigrant Education. In addition, we ask that you
    take steps to ensure funding within this budget for the dissemination
    of instruction materials in Native languages.
        In 1994, Congress authorized the Secretary of Education to provide
    grants to develop, publish, and disseminate instructional materials in
    Indian, Native Hawaiian, Pacific Islander, and outlying territories
    languages. This program has never been funded. We urge the Subcommittee
    to include report language instructing the Secretary to allocate fiscal
    year 2001 funding for this purpose.
        At Pinon, 86 of our students are considered to have Limited English
    Proficiency. It is our goal to provide these children with
    comprehensive bilingual education so that they can learn English and
    meet challenging academic standards while maintaining a knowledge of
    and respect for their native language. To meet this goal, it is
    critical that we have funding to train personnel and develop innovative
    bilingual education programs at the local level.
                                   conclusion
        Thank you for considering our concerns and comments. The Pinon
    Community School appreciates the funding that the Subcommittee has
    provided in the past to programs of concern to our school, and we look
    forward to your continued support.
                                     ______

                Prepared Statement of Elmira College, Elmira, NY

        Mr. Chairman, thank you for this opportunity to submit testimony
    for the record regarding Elmira College's proposed Technology
    Enhancement Initiative.
        Today, unlike any other time in history, we have a substantial
    opportunity to apply the information age technologies to schools that
    are so effective outside the classroom for educational purposes. For
    schools to make the most of this opportunity, they must rethink
    education from the ground up.
        The power of information technologies to reshape education is
    already becoming unmistakable. In scattered locations around the
    country, schools are using state-of-the-art technologies and
    interactive multi-media to engage students more actively in learning
    and to teach them skills they will need to thrive in an information
    based workplace and world. This is particularly true with non-
    traditional students who have little if any access to traditional
    classrooms and educational services.
        As information age infrastructure is developed, more and more
    students and teachers will gain access to a global web of information
    and exchange ideas, services and education globally.
        The Internet and other information technologies are bringing
    interactive instruction to schools in our cities and suburbs.
    Importantly, the past several years have witnessed a stronger focus on
    providing those information technologies in rural areas of the country.
    These technologies are allowing students to build ``communities'' with
    their counterparts around the world and create lifelong beneficial
    links between schools and the communities around them.
        Taking advantage of this new capability will require profound
    changes in the roles of teachers, students and schools. Instead of
    being the repository of knowledge, teachers will be guides who will
    help students navigate through electronically accessible information.
    They will use the new technologies to build networks with each other,
    with parents and students, with academic and industrial experts and
    with other professionals.
        In order to ensure that students (K-12, undergraduate, graduate,
    continuing education or professional development students, students in
    rural areas) receive the full potential of the technology age, the
    technological access must exist in flexible locations and provide
    continuous access to their extended communities. Equally as important,
    teachers must receive extensive training in how to use existing and
    emerging information technologies and how to design and implement
    appropriate curricula for a state-of-the-art 21st Century classroom.
        To make technology a viable instructional and professional
    development tool requires schools to have enough computers to provide
    full easy access for all students including students with disabilities.
        Institutions of higher education are central to the national effort
    to ensure that all students and teachers are equipped to take full
    advantage of the technology era. By providing education, training, and
    technical assistance these institutions can work in partnership with
    local school districts, human service agents and professionals to
    address problems associated with the rapid onset of the information
    age, including: educational, economic and social infrastructure of
    their surrounding communities.
        Elmira College is an institution of higher education that accepts
    that responsibility willingly, recognizing the benefit to its students,
    students in surrounding school systems and community colleges, and
    individuals in nearby communities in need of continuing education or
    professional development. As such, it is implementing its ``Technology
    Enhancement Initiative'' to address its own and regional educational
    and technology training needs.
          the ``technology enhancement initiative'' at elmira college
        As it approaches the 21st Century, Elmira College, in Elmira New
    York, stands at an important crossroads in the development and
    expansion of its educational resources. To ensure its continued
    strength as a four-year institution of higher education the College is
    proposing the implementation of its ``Technology Enhancement
    Initiative'' to relocate and improve its technology infrastructure.
        This initiative will address the ever-growing need in the southern
    tier of New York and northern tier of Pennsylvania for access to higher
    education, teacher technology education and training and professional
    development services. It will provide the College the opportunity to
    expand its technology resources and to meet its own and regional
    technological and services demands.
        Elmira College proposes to establish a partnership with the Federal
    Government that will:
      --Relocate, consolidate and improve all student and administrative
            computing services from McGraw Hall, which is handicapped
            inaccessible, to the Gannett-Tripp Library which is handicapped
            accessible;
      --Upgrade existing ``hub'' hardware to state-of-the-art technology
            which will be able to meet and manage the demands of the
            upgraded system; and,
      --Wire every dormitory, classroom and administrative meeting room as
            well as every faculty, academic, and administrative office
            building for direct access to the Gannett-Tripp Library, the
            Steele Memorial Public Library and an interface with the local
            public library system and with the Internet.
        As a result of the improvement to its technological infrastructure,
    Elmira College will have the opportunity to expand existing and
    implement several new educational and training programs in partnership
    with local school systems and human service agencies. Specifically, the
    initiative will enable the College to:
      --Offer access to higher education courses in 12 rural and
            underserved counties and 21 K-12 school districts (58,308
            students), 8 community colleges and a variety of community
            sites via distance learning;
      --Offer access to Elmira College library resources, including the
            federal depository at the College, at a variety of community
            sites via distance learning to underserved counties;
      --Provide teacher technology education and training both on and off
            campus;
      --Provide expanded professional development and technology education
            and training services;
      --Provide leadership and technical assistance to local K-12 systems
            in the development of state-of-the-art technologically advanced
            classrooms and prepare its Education students (future teachers)
            and regional teachers to teach effectively in this
            technologically advanced era.
        In addition to the obvious educational benefits that the Elmira
    College ``Technology Enhancement Initiative'' will have for the College
    and its students, there are several significant benefits for teachers
    in the regional community.
        As a result of the Technology Enhancement Initiative, Elmira
    College will have the opportunity to work in partnership with regional
    school systems to address the education and training needs of their
    teachers and staff.
        Elmira College will work to identify technology education and
    training expertise in the region and the nation and work with local
    school districts to develop critical professional linkages needed for
    the local school system to take full advantage of that expertise for
    their students.
        In addition, as part of its own curricula, Elmira will provide
    expanded in-depth technology education and training for students in its
    Masters of Education programs.
        The Technology Enhancement Initiative will provide Elmira College
    the ability to offer these teacher education and training courses
    through any of its distance learning capabilities to teachers in the
    classroom, on-site at their own schools, at local libraries, community
    colleges or even in the home. Graduate students at Elmira will continue
    their training within the local schools, but will have an increased
    ability to conduct classroom observations, information exchanges and
    training as a result of the Technology Enhancement Initiative.
        To do so, the College will expand existing and implement new
    education, training and professional development programs, including
    courses such as Computers in Education, Interactive Media for
    Educators, The Internet for Educators, Video Production for Educators,
    and Microcomputer Applications for Educators. Finally, it will provide
    the College with the opportunity to play a leading role in improving
    the social and economic infrastructure of the region.
        The Technology Enhancement Initiative will create an expanded
    opportunity for cooperation in the provision of higher education
    courses between Elmira College and local community colleges. It will
    help those institutions to provide timely and relevant programming at
    the same time it helps to prevent unnecessary duplication of academic
    programs and/or courses at Elmira or the community colleges.
        As it is proposed, the relocation, expansion, and consolidation of
    all computing functions at Elmira College will provide three methods of
    distance learning in the future, including:
      --Computer Based Research
      --Internet Conferencing
      --Compressed Video
        Students and professionals in the field will have the ability to
    access education, training or professional development from home (if
    the connection exists) from libraries, other designated community sites
    or from any of the eight sites where Elmira currently provides minimal
    programming including:
      --Bath
      --Corning
      --Ithica
      --Owego
      --Penn-Yan
      --Watkins Glen
      --Rome
      --Syracuse (adult education)
        Elmira College will have the ability to share faculty experiences
    across institutions and establish partnerships on select courses with
    regional community colleges, including general education courses,
    courses to support selected major requirements, and coursework
    providing a valuable supplement to existing offerings. Elmira College
    currently holds articulation agreements with three regional community
    colleges that will be expanded as a result of the Technology
    Enhancement Initiative. Those institutions include:
      --Tompkins Cortland Community College
      --Corning Community College
      --Broome Community College
        To enable the completion of this important initiative, Elmira
    College is seeking $3,399,000 million in federal support. To date, the
    College has invested $500,000 in campus infrastructure in preparation
    for the implementation of this initiative (these dollars are not
    counted as part of the official project cost, but are calculated into
    the College's contribution). The College is firmly committed to the
    completion of the project and the implementation of this important and
    enabling technology infrastructure and therefore will contribute an
    additional $1 million towards the total cost of the initiative. Total
    project cost is $5,923,680 million.
        Mr. Chairman, this initiative is critical to the long-term economic
    viability of Elmira College as well as the regional the K-12,
    undergraduate, graduate, continuing education and professional
    development systems in the southern tier of New York and the southern
    tier of Pennsylvania. We look forward to working with you to secure the
    final phase of funding for this very important initiative in fiscal
    year 2001.
        Again, thank you for the opportunity to present this testimony for
    the record.
                                     ______

      Prepared Statement of the Northwest Regional Educational Laboratory

        My name is Dr. Ethel Simon-McWilliams, and I am the CEO and
    Executive Director of the Northwest Regional Educational Laboratory
    (NWREL), in Portland, Oregon. I take this opportunity to share with you
    the need for trained Retired and Senior Citizen Reading Tutors; and, a
    program that the NWREL has proposed for training these citizens so that
    they can serve more effectively as reading tutors for children, youth
    and adults.
        America now enjoys not only the largest and fastest-growing group
    of older adults in our history, but the healthiest, most vigorous, and
    best educated. According to a 1999 survey of older Americans, engaging
    in community service is an important part of the retirement plans of
    most seniors. More than half of older Americans polled have volunteered
    within the past year in their communities, and working with children
    and youth has been a top priority for their time and talent.
        At the same time, school districts are struggling to meet the needs
    of low performing students to increase their reading achievement. Local
    school districts across the nation are faced with restricted budgets,
    larger class sizes and reduced services for students with special
    needs. Thirty-eight percent of fourth-graders read below basic level
    and lack even partial mastery of reading skills needed for proficient
    grade-level work. By 12th grade, 23 percent of students remain below
    basic level. These struggling readers are disproportionately from
    families living in poverty.
        The experience of the federal America Reads Challenge in 1998 and
    1999 clearly showed that adults who are effectively prepared to be
    reading tutors can have a positive effect on students' achievement. The
    Northwest Regional Educational Laboratory has provided a range of
    supports to volunteer service programs since 1995, and in 1998-1999 was
    selected by the Corporation for National Service as the national
    provider of training and technical assistance to education-focused
    senior programs. The Northwest Laboratory examined reading tutor
    programs across the country and found, among other things, that the
    success of a tutoring program rides on the abilities, energy, and
    commitment of its volunteer tutors, as well as a strong school capacity
    and support for tutors.
        One-on-one tutoring is clearly shown to be the most effective use
    of retired and senior volunteers. Senior tutors provide children with
    an important caring adult and an intergenerational presence that is
    often missing in today's mobile society.
        Our research shows that volunteers are more likely to continue
    volunteering if they feel that their efforts are well-utilized. Well-
    trained senior volunteers, armed with research-based skills and
    strategies, offer an important boost toward helping children learn to
    read and gain academic and social success.
        There are many successful tutoring programs in schools across the
    nation. We know with some confidence the elements of these programs
    that make them successful, or on the other hand, what lacking elements
    cause them to be less successful.
        Therefore, I urge the support of a demonstration program, funded
    through the U.S. Department of Education's Fund for the Improvement of
    Education (FIE), that will validate the combination of elements of a
    model tutoring program that effectively taps the human resource pool of
    senior citizens. At the same time, such a demonstration project will
    result in the necessary resources to assist and guide states and
    schools across the nation implementing the model: a guide for statewide
    implementation for use by state education agencies, a tutor training
    package, and a project resource kit for schools. The Northwest Regional
    Educational Laboratory has the unique combination of experience and
    capabilities in technical assistance to school-based tutor programs,
    training of seniors as tutors, and evaluation of effectiveness of tutor
    programs to conduct this demonstration program in collaboration with
    school districts and senior volunteer organizations in Alaska, Oregon,
    and Washington.
        Our analysis of 61 effective volunteer reading tutoring programs
    across the country has shown that, to be successful, they must have:
      --A clear definition of the roles, responsibilities, and
            accountability
      --A plan for sustainability and capacity building
      --A pro-active, well-qualified program director and an effective
            advisory committee
      --Strong school and teacher commitment
      --Effective and sustainable tutor recruitment
      --Access to groups of tutors via universities, civic organizations,
            businesses, etc.
        The operation of effective senior reading tutor programs needs to
    include:
      --Consistent onsite supervision of tutors
      --Tutoring sessions that support district curriculum and classroom
            instruction
      --Tutor commitment
        It is critical that tutor training be provided, based on a clearly
    defined, research-based training model. Training must accommodate
    tutors' varying expertise, learning styles, and schedules, and ongoing
    training and onsite support should include: (1) tutor consultations
    with a seasoned tutor, reading specialist, or teacher; (2) support and
    guidance for tutoring session planning; and (3) recognition and
    appreciation of tutors. Reading tutor programs must utilize high-
    quality materials, including a program-specific handbook and resource
    library for tutors, tutor-training manual, materials that support
    school standards, and record-keeping and assessment tools.
        The benefits of effective tutoring programs in schools is well
    documented. In general, tutoring:
      --Increases students' mastery of academic skills
      --Improves self-esteem and self-confidence
      --Improves students' attitude toward school and reduces dropout
            rates, truancies, and tardies
      --Breaks down social barriers and creates new friendships
      --Adds emotional support and provides positive role models
        It is also clear that seniors who are tutors receive: (1) a sense
    of pride and accomplishment for having helped someone else, (2)
    increased self-esteem, confidence, and sense of adequacy as a result of
    being a tutor, (3) new or increased sense of responsibility and
    awareness for what teachers must do to transmit knowledge to students,
    and (4) empathy for students for whom learning may be much more of a
    struggle.
        The Northwest Regional Educational Laboratory has trained senior
    program staff in supporting and training reading volunteers, reading
    tutoring strategies, and partnering effectively with schools. Utilizing
    these experiences and capabilities in conducting a demonstration
    program on seniors tutoring students in reading with federal support
    provided by the U.S. Department of Education's Fund for the Improvement
    of Education will be an important step to implementing effective senior
    tutoring programs in schools across the country.
        I urge the Members of the Subcommittee to provide $1,000,000 in the
    fiscal year 2001 Labor/HHS/Education Appropriations bill for the
    Northwest Regional Educational Laboratory to carry out this program to
    train Retired Senior volunteers in Oregon, Washington and Alaska to
    serve as reading tutors in the most needy schools according to reading
    scores. The resulting model will be shared with other states.
        Thank you for your affording me this opportunity to share the
    details of the NWREL's proposed retired and senior tutor training
    demonstration project.
                                     ______

     Prepared Statement of the Federation of Behavioral, Psychological and
                               Cognitive Sciences

        Mr. Chairman, members of the Subcommittee, my name is Patrice
    O'Toole. I am the Assistant Director of the Federation of Behavioral,
    Psychological, and Cognitive Sciences. I am testifying today on behalf
    of the scientific societies that comprise the Federation, the American
    Psychological Association, the Society for Research in Child
    Development, and the Consortium for Social Science Associations. Our
    organizations represent most of the scientists who carry out the
    nation's educational research and many of the scientists who carry out
    its health-related research. My testimony will, therefore, be directed
    at the funding requests for those two areas of research.
        I want to begin by thanking Senator Specter for his support and
    efforts on behalf of the scientific community. During his entire tenure
    in Congress, Mr. Specter has been a champion of biomedical and
    behavioral and social science research. The American people are
    healthier today because of the basic and applied research Mr. Specter's
    work has made possible.
                 office of educational research and improvement
        The Office of Educational Research and Improvement has been
    profiting from the leadership shown by Assistant Secretary Kent
    McGuire. The quality of peer review, which has been a concern both to
    Congress and to the scientific community has increased markedly, and
    further strengthening is taking place. Dr. McGuire has been giving
    direction and form to the initiatives of OERI. We are particularly
    pleased that the second round of proposal solicitations for the
    Interagency Education Research Initiative has just begun. One of the
    problems in educational research has always been that there has not
    been enough money to carry out research on large-scale applications.
    The combined funding of OERI, the National Science Foundation, and the
    National Institute of Child Health and Human Development is helping to
    make such research a possibility. The funds available even from three
    sources hardly approaches the funds that go into clinical trials of new
    pharmaceuticals, but this program is a big step in the right direction.
    As you know, NICHD was not able to contribute funds to the first round
    of grants. NICHD's requested funding for this effort for fiscal year
    2001 is still less than that contributed by the other partners. We ask
    that NICHD's contribution be raised to $20 million to make it an equal
    partner in this important undertaking both in terms of intellectual
    effort and in terms of funds.
        NICHD and OERI are also cooperating in an initiative to identify
    the factors that lead to acquisition of English reading and writing
    skills for children whose first language is Spanish. The statistics
    that reflect the difficulty Spanish speaking children encounter in
    school are well known. We think the OERI/NICHD partnership to improve
    this situation are to be welcomed and fully supported.
        We also believe OERI is on track with its implementation of
    Comprehensive School Reform Demonstrations and its general effort to
    measure the impact of school reforms. It has so often been the case in
    education that new approaches are implemented with little concern for
    the research base supporting them and even less concern about
    evaluating outcomes. There are some positive signs that OERI is helping
    to change that, and these efforts need to be encouraged.
        Before the last reauthorization of OERI, one of the most glaring
    omissions from OERI's research programs was a robust program of field-
    initiated research. We have been delighted to see the gradual change
    that has occurred over the years of the current authorization. From
    less than $1 million before the reauthorization, the field-initiated
    research program has grown to about $15 million. It is a small amount
    when compared to the amounts NSF, and NIH spend on research whose
    subject matter has been determined by researchers rather than by
    federal directives, but again, the steps have been in the right
    direction.
        While we believe that much more emphasis is needed on basic,
    applied, and development research to improve teaching and learning, we
    are strongly supporting the requested $30 million funding increase for
    research and statistics by OERI. Space does not permit a thorough
    treatment of the value of the statistics gathering work of the National
    Center for Education Statistics. It is this work, however, that tells
    us enough about teaching, learning, and their lifelong effects to make
    it possible to devise evidence-based public policies that address real
    problems in effective ways. These statistics have been valuable
    precisely because they are measures of the state of education and
    learning. We have been concerned for years that NCES has been brought
    into the effort to design national tests. Our concern has been and
    remains that NCES's involvement in development of high-stakes testing
    will undermine the ability of NCES to be perceived across the nation as
    an objective, impartial evaluator of the state of education in the
    country. There is room to debate the wisdom of national tests. It is
    unfortunate, however, that we have been unable so far to keep that
    divisive issue from endangering the ability of NCES to keep its finger
    on the nation's educational pulse.
        Finally with respect to OERI, we are disturbed that the Department
    of Education has chosen to present its request for OERI research
    programs as a single line item, a move that is consistent with the
    design for OERI being proposed in OERI's reauthorization draft, but
    that is inconsistent with the current structure. There are items of the
    proposed reauthorization with which we take issue. We support the
    overall request, but note that it is out of place to make assumptions
    in the budget presentation about the future structure of OERI before an
    authorization has been passed in either house.
                         national institutes of health
        The administration is requesting a $1 billion increase this year
    for the National Institutes of Health (NIH). This would increase NIH's
    budget to nearly $19 billion. This is an increase that is substantially
    lower than needed to stay on track to doubling the research budget over
    five years. We are asking Congress to stay on track toward doubling the
    budget by increasing the budget by 15 percent which would bring the
    fiscal year 2001 budget to $20.5 billion. Beyond the expressed
    commitment of many in Congress to accomplish this doubling, we also
    base our recommendation on several observations.
        (1) Fulfilling NIH's priorities for fiscal year 2001, which include
    increased attention to health disparities research, requires the
    increased funding. (2) Solid funding has increased the pace of
    discovery across the health sciences, and nothing should slow that
    momentum. (3) Health care costs have become unbearable for millions.
    The best way to control those costs is to keep people healthy. The
    ultimate purpose of health research, including health research in the
    behavioral and social sciences, is to make the citizens of this country
    healthier throughout their life span.
        Let me mention just a few of the uses to which the funding increase
    would be put.
        NIH has established a working group, led by NIH Acting Deputy
    Director Yvonne Maddox and National Institute of Allergy and Infectious
    Diseases Director Anthony Fauci, to examine health disparities. In
    addition, NIH's fiscal year 2001 budget contains a request for $20
    million to establish within the Office of Research on Minority Health
    (ORMH) a Coordinating Center for Health Disparities. We support this
    request.
        The Human Genome Project is expected to complete human gene
    sequencing by this summer. Already NIH has been at the forefront of
    research in genetics and neuroscience. That research is helping us
    understand many diseases including Parkinson's, Alzheimer's, drug
    addiction and diabetes. With sequencing nearing completion, we are
    poised for an explosive growth in discoveries in the years ahead.
        Scientific advances in knowledge about brain disease have been
    possible because of new methods for the study of the nervous system,
    such as neuroimaging. Identifying the molecules that guide the
    formation of the brain and increasing understanding of how the
    processes occur are allowing neurobiologists to visualize how the
    developing nervous system organizes itself, to explain complex
    behaviors, and to describe neurological and psychiatric diseases with a
    new level of precision. However, equally important is the role that
    behavioral, psychological, socio-cultural, and environmental factors
    play in health. Our beliefs, our emotions, our behavior, our thoughts,
    our family and cultural systems, our socio-economic status, as well as
    the environmental context in which we live, are all as relevant to our
    health as our genetic inheritance and our physiology.
        The emergence of cross-disciplinary collaboration has been a major
    component in the fast-paced research developments in these arenas.
    Across the NIH-supported sciences, the growing tendency for scientists
    from many disciplines to come together to solve research problems has
    shown significant results.
        AIDS has not been cured, but research has shown how a mixture of
    treatments can ward off the worst effects of AIDS, for many years.
    These treatments involve the use of a variety of drugs in combination
    and they involve a demanding level of discipline on the part of the
    patient to take the medications properly--a discipline that can be
    trained by application of techniques developed through behavioral
    research.
        Similarly, recent NIH-supported behavioral research has produced
    useful new knowledge, including a better understanding of basic
    behavioral and social processes and how they interact with biological
    processes. This understanding is coming from many lines of research:
    studies of lifestyle choices, dietary habits, the desire and ability to
    maintain exercise or medication regimens, psychological functioning,
    and influences of one's social and cultural environment on behavior.
        All these lines of research converge to give us a picture of the
    factors that can affect an individual's ability to remain healthy or to
    recover from disease or to function well despite a chronic condition.
    And that knowledge leads to treatments and other interventions to
    maintain health throughout the life span.
        NIH's Office of Behavioral and Social Sciences Research (OBSSR),
    created in 1995 has been pivotal in supporting these studies and
    translating the findings into effective prevention and treatment
    strategies. OBSSR, under the purview of the Office of the Director of
    NIH, coordinates all the institutes and centers in marshaling their
    individual resources to collaborate on behavioral and social sciences
    research. OBSSR's congressionally mandated primary mission is to foster
    the development of cross-disciplinary communication and research
    collaboration among behavioral and social sciences and between the
    behavioral and social sciences and biomedical sciences.
        OBSSR, under the auspices of its first Director, Norman Anderson,
    has achieved great success in its short existence. We believe it can
    accomplish a great deal more with the continued support of Congress and
    the necessary resources to do so. A key role for OBSSR has been
    assuring that development of effective behavioral interventions is
    keeping pace with technological advances.
        OBSSR has been successful, yet continues to operate with a small
    staff and a small budget. Last year, Congress approved a $7 million
    increase for OBSSR to continue its efforts to encourage cross-institute
    collaboration and research in the behavioral and social sciences. This
    money is being used to fund a trans-NIH initiative on adherence to
    medical and behavioral interventions across a number of diseases and
    conditions. OBBSR is also funding a trans-NIH initiative seeking
    effective interventions to curb youth violence. And as episodes of
    violence between children mounts, the need for these programs is
    critical to reducing the overall level of violence. More research is
    needed on children and youth at risk. We need a richer understanding of
    the social, environmental, psychological, developmental and biological
    factors involved in risk as well as a deeper understanding of how the
    factors interact.
        Despite the pressing need for this research, the President's
    request for fiscal year 2001 provides no increase for OBSSR's budget.
    OBSSR's current budget is $19.86 million. The Federation supports an
    increase of ten percent for OBSSR, bringing its budget to $21.84
    million for fiscal year 2001. This increase would significantly augment
    OBSSR's ability to continue coordinating research across institutes.
    This is an efficient use of resources and a beneficial mode of
    operation, because it links areas of related knowledge that might
    otherwise remain separated.
        A prime example of benefits of behavioral research has been the
    identification of factors that aid in protection from disease and that
    promote recovery from illness. They include certain personal attributes
    such as optimism, effective strategies for coping with stress, and
    meaningful sources of social support and affiliation.
        NIH funding has permitted us to use research wisely, that is, in
    the combinations that will be most efficient in reaching solutions to
    typically multifaceted health problems. To continue successful
    biomedical and behavioral research at this level requires Congress'
    ongoing commitment to finding resources for expanding NIH's budget.
        With increased support, the current pace of discovery and
    collaboration can be sustained. The largest per person expenditures for
    health care occur near the end of life. One goal of research is to
    understand what interventions through the life span will have the
    greatest promise of assuring that the period of great illness before
    the end of life is minimized. As more of the U.S. population reaches
    advanced age--the number of Americans aged 65 and older is expected to
    double by the year 2030 to nearly 68 million--it becomes increasingly
    vital to the health of our entire society that we age well. Many of the
    problems that accompany aging, especially chromic diseases, stem from
    behaviors that place individuals at risk of negative outcomes.
        The National Institute of Child Health and Human Development
    (NICHD) conducts research on human growth and development from
    conception through birth, infancy, childhood, adolescence,
    reproduction, and through maturity to old age. As such, NICHD addresses
    some of the most important health and development problems facing our
    children and families.
        Based on this broad spectrum of research, we believe that NICHD's
    fiscal year 2001 budget should be increased by 23.9 percent, bringing
    its budget to $1,064,800. Historically and chronically, NICHD has been
    one of the lowest funded institutes even though it conducts research
    that has immediate, proven and successful applications through
    behavioral intervention. We urge the subcommittee to press for higher
    funding of NICHD.
        Behavioral research has a large role to play in contributing to the
    nation's health, because controllable choices and behaviors in life
    have a heavy impact on the quality of life. Obviously, such behavioral
    choices as to smoke or not to smoke, what foods and quantities of food
    to consume, and how regularly one exercises are among the most
    important choices we make in determining our health. But each of us
    knows how difficult it is to do the right thing.
        Behavioral researchers in cooperation with nutritional researchers,
    neuroscientists, epidemiologists and a host of other specialists are
    working to find ways to make it easier for people to make the right
    choices about their health. The payoff for finding solutions to these
    problems will be not only a healthier population, but also the
    shrinkage of health care costs to a manageable size without sacrificing
    the well-being of the country's citizens. Through research it is
    becoming possible to maintain good health and keep health care costs
    down at the same time.
        We strongly urge the Subcommittee to recommend a 15 percent
    increase for NIH because the investment in knowledge will result in
    healthier citizens and health care cost savings that far exceed the
    research investment. Slighting research will assure that rising health
    care costs will remain among our most serious national crises.
        We thank the Subcommittee for the opportunity to present our views.
                                     ______

              Prepared Statement of the United Negro College Fund

        Mr. Chairman and Members of the Subcommittee. My name is William H.
    Gray, III and I am President and Chief Executive Officer of the United
    Negro College Fund (UNCF). I thank you for the opportunity to bring
    UNCF's fiscal year 2001 recommendations for higher education programs
    before you.
        UNCF is America's oldest and most successful black higher education
    assistance organization, representing 39 private, four-year
    historically black colleges and universities with either independent or
    religious affiliations. UNCF has been committed to increasing and
    improving access to college for African Americans since 1944. The
    organization remains steadfast in its commitment to enroll, nurture,
    and graduate students who often do not have the social and educational
    advantages of other college bound populations.
        Since its inception, the fundamental mission of UNCF has been to
    raise critical operating funds for member institutions and their
    students, faculty, and staff. Mr. Chairman, I am proud to say that over
    the years, this mission has broadened to include over 450 successful
    scholarship programs, internships, research and study abroad
    opportunities for all historically black colleges and universities
    (HBCUs), Hispanic-serving institutions (HSIs), Tribally-controlled
    colleges, and majority institutions. We also provide technical
    assistance to our trustee programs such as the fiscal and strategic
    technical assistance program (FASTAP) and faculty training, for
    institutions both domestic and abroad.
        UNCF is committed to educating tomorrow's workforce. America's
    markets are growing more diverse, and demographic trends indicate that
    early in the 21st Century, African Americans and other racial and
    ethnic minority groups will constitute a major part of the workforce.
        The more than 55,000 students enrolled at UNCF institutions are
    from diverse backgrounds. Our schools mirror the mosaic that is
    America; we are African American, White, Hispanic, Asian, and Native
    American. While our student body consists of varied economic
    backgrounds, approximately 34 percent of all UNCF students come from
    families with incomes below $25,000 (compared with 17 percent of
    students attending four years colleges nationwide). Approximately 90
    percent of UNCF students require some form of financial assistance.
    Forty percent are the first in their families to attend college
    compared with the national average of 35 percent.
        In spite of these challenges, UNCF students and members
    institutions have accomplished much. They are noted for their
    consistent standards of excellence and outstanding achievements. HBCUs
    are the major source of African American college graduates and black
    professionals in America. In fact, 16 Members of Congress are alumni of
    HBCUs. HBCUs contribute significantly to the production of African
    American baccalaureate degree holders in the sciences. HBCUs also
    graduate the most African American doctoral degree recipients. In
    addition, more than 50 percent of the nation's African American public
    school teachers and 70 percent of African American dentists and
    physicians earned degrees at HBCUs. These are but some of the
    extraordinary roles HBCUs have played in educating minority Americans.
        Mr. Chairman and Members of the Subcommittee, the impressive
    achievements that I noted have an even greater significance at UNCF
    institutions in that our schools have accomplished all this for a
    fraction of the cost compared to that of majority institutions. The
    average cost of attending a UNCF institution in 1997-1998 was $13,368,
    which is substantially below the average cost of $21,424 at four-year
    private colleges nationwide. In fact, UNCF's tuition increased only
    43.5 percent over the last decade compared to a 51.6 percent increase
    at all private, four-year colleges during the same period. However,
    this cost still remains above the financial means of most of our
    students and their parents. Furthermore, keeping the costs of a college
    education down while educating ``at-risk'' students comes at a
    financial price for UNCF member institutions.
        Consistent with our commitment to providing access to higher
    education to economically disadvantaged, first generation students, we
    applaud federal efforts to make college affordable for all. As you
    know, students from low-income backgrounds, when compared to all other
    students attending four-year colleges and universities, are more likely
    to drop out and less likely to earn a degree. In fact, according to a
    recent survey of beginning postsecondary students released by the U.S.
    Department of Education, 42 percent of students from the nation's
    poorest families (with incomes less than $20,000) received a bachelor's
    degree within five years while 35 percent--a significant portion of
    similarly situated students--had dropped out entirely.
        Additionally, students have increasingly turned to borrowing in
    order to manage rising education costs. More full time undergraduate
    students are also working while enrolled. The burden of borrowing and
    working plays a significant role in how students pay for their
    education and whether they graduate.
        Clearly, students with adequate financial resources have an
    increased chance of obtaining a degree over those without access to
    similar means. However, most research on the subject indicates that
    simply increasing financial aid to low income students does not appear
    to have any particular significance in determining successful outcomes
    (i.e., improving the chances of staying in college and graduating). We
    know that a freshman or sophomore, low-income student may choose to
    leave college rather than face the prospect of assuming loan debt. Mr.
    Chairman, Congress should recognize that certain types of aid actually
    serve as a disincentive for the nation's neediest students! Congress
    should be mindful that what is important is the type of aid low-income
    students receive; when it is given; and what other services are
    afforded to them.
        For these reasons, UNCF strongly supports increased student
    financial assistance. Specifically we support the funding
    recommendations of the Student Aid Alliance of which UNCF is a member.
    Most important to our students is increased Pell Grant aid, preferably
    awarded to a student in their earlier years of college, with a maximum
    award of $3700 in fiscal year 2001. Moreover, we support the
    Administration's proposal to enhance college persistence and completion
    through the College Completion Challenge Grant. This is a new program
    supporting a comprehensive approach to increasing minority retention
    and completion rates through such activities as a pre-freshmen summer
    program, support services, and increased grant aid to students. This
    program would be funded at $35 million and operated under the
    successful TRIO program, which UNCF also recommends receive an
    increased $70 million in overall funding for fiscal year 2001. Other
    student financial assistance programs we advocate higher funding for
    are: SEOG ($731 million); LEAP ($100 million); Perkins Loans ($200
    million); and the Federal Work Study Program ($1.1 billion).
        Mr. Chairman, it is important to note, for the record, that growing
    debate about making college affordable and providing a means to a
    college education centers on the premise of providing tax credits for
    students and their parents. Findings, however, support the position
    that, while such tax credits benefit middle income and affluent
    families, low-income families are better served by grant and
    scholarship aid. UNCF firmly believes that a better of use of tax
    dollars to achieve access to college would be to provide more grant
    support in the manner that I recommended earlier.
        In terms of institutional support, UNCF strongly recommends
    increasing Title III, Part B, section 323 to $175 million and Title
    III, Part B, section 326 to $40 million. These programs have been the
    mainstay of UNCF schools through the years. For many UNCF institutions
    in particular, Title III grants are the only form of institutional
    assistance received from the Federal Government. These grants are used
    for academic program enhancement, faculty development, student
    services, and the construction, maintenance, and renovation of
    buildings. We also support increases to the other institutional aid
    programs under Title III.
        Mr. Chairman, at a time when the education of tomorrow's workforce
    tops agenda's nationwide, minorities are underrepresented in numerous
    professions across the board--science, engineering, law, teaching.
    Thus, UNCF strongly supports the Administration's proposed new Dual
    Degree Programs at Minority Serving Institutions initiative that
    addresses this very issue. This program complements existing curricula
    at HBCUs and other minority-serving institutions and channels students
    into careers in which minorities are underrepresented. Funding for this
    new effort is $40 million. Several other programs provide critical
    institutional support to UNCF member institutions that educate a
    preponderant number of minority professionals while addressing these
    shortages. Accordingly, UNCF recommends increases for these
    initiatives, including the Minority Science and Engineering Improvement
    Program (MSEIP) to $40 million, Title VI International and Graduate
    Programs to $82.5 million (and the Institute for International Public
    Policy/IIPP), the Thurgood Marshall Legal Education Opportunity Program
    $5 million, and Teacher Quality Enhancement Grants to $140 million.
    UNCF also stands firmly behind increased funding for the Department of
    Education Office of Civil Rights at $78.605 million.
        Minorities are also underrepresented in the international arena
    while our country competes increasingly in a global marketplace. To
    counteract this trend, UNCF believes Congress should increase its
    support of IIPP to $2.5 million in fiscal year 2001. Currently,
    entering its fifth year, IIPP will serve more minority students with
    more programs than ever before. However, this program is increasing its
    impact with only a 2 percent increase in its funding since the
    program's creation in 1992. Surely, there is a need to have a diverse
    cadre of international professionals in this global community.
        Mr. Chairman, it is clear that UNCF member institutions leverage
    federal dollars to the maximum potential. Even though we have smaller
    endowments and a greater percentage of students needing financial aid,
    UNCF institutions capitalize on our federal partnerships in
    extraordinary ways to address national concerns. Currently, like the
    rest of the nation, UNCF is facing the digital divide challenge, a
    problem that is greater in higher education than it is among the
    nation's households. A great many of the programs I have mentioned
    today help us address this challenge--particularly the Minority Science
    and Engineering Improvement Program. This important program provides a
    critical resource for baccalaureate granting institutions like UNCF
    member schools that miss out on the majority of federal dollars
    allocated to science, engineering, and related areas, since funds are
    traditionally targeted to majority research-performing institutions.
    Consequently, our schools are hampered early on in their ability to
    qualify and compete for funds--even though we contribute so much. For
    this reason, it is imperative that Congress show leadership by funding
    those proven programs that are designed to not only increase access and
    opportunity for African American students and the HBCUs they attend,
    but also those programs that have demonstrated a capacity to have
    considerable impact on this nation's future.
        Mr. Chairman, on behalf of the United Negro College Fund member
    institutions, I thank you for the opportunity to provide testimony on
    the fiscal year 2001 appropriations for higher education programs and
    look forward to working with you to ensure strong alliances between our
    schools and the Federal Government.
                                     ______

                 Prepared Statement of Florida State University

        Mr. Chairman, I would like to thank you and the Members of the
    Subcommittee for this opportunity to present testimony before this
    Committee. I would like to take a moment to briefly acquaint you with
    Florida State University.
        Florida State University is a comprehensive Research I university
    with a liberal arts base. The University's primary role is to serve as
    a center for advanced graduate and professional studies while
    emphasizing research and providing excellence in undergraduate
    programs. Faculty at FSU have been selected for their commitment to
    excellence in teaching, for their ability to perform research and
    creative activities, and for their commitment to public service. Among
    the faculty are numerous recipients of national and international
    honors, including four Nobel laureates and eight members of the
    National Academy of Sciences. Our scientists and engineers do excellent
    research, and often they work closely with industry to commercialize
    their results. Florida State ranks third this year among all U.S.
    universities in revenues generated from its patents and licenses,
    trailing only Columbia University and the entire University of
    California system. Having been designated as a Carnegie Research I
    University several years ago, Florida State University currently
    exceeds $100 million per year in research expenditures. With no
    agricultural or medical school, few institutions can match our success.
        Florida State attracts students from every county in Florida, every
    state in the nation, and more than 100 foreign countries. The
    University is committed to high admission standards that ensure quality
    in its student body, which currently includes some 192 National Merit
    and National Achievement scholars, as well as students with superior
    creative talent. We consistently rank in the top 25 among U. S.
    colleges and universities in attracting National Merit Scholars. At
    Florida State University, we are very proud of our successes as well as
    our emerging reputation as one of the nation stop public universities.
        Mr. Chairman, let me tell you about a project we are pursuing this
    year involving the U.S. Department of Education and distance learning.
    Florida State University is pioneering the use of distance education to
    provide access to baccalaureate degrees for students with Associate of
    Arts degrees who, due to family or work situations, may not be able to
    relocate to a college or university to complete their degree work. FSU
    is currently offering three programs entirely on line for students to
    receive their baccalaureate degree: Computer Science, Information
    Studies, and Software Engineering. A new program in Social Science will
    begin in Fall 2000 with other undergraduate programs to be developed.
    This 2 + 2 program is being offered in cooperation with 18 community
    colleges in Florida, which provide computer labs and proctored testing
    facilities where needed. Florida State University's distance learning
    initiative has focused not only on a quality course development model
    based on that of the British Open University, but has placed a major
    emphasis on student support for the distance education teaching and
    learning environment. This ranges from having all major student
    administrative services available on line, to partnering with
    Blackboard, Inc. in the development of Course Info Enterprise Edition
    for course development and delivery of courses. Students can do
    everything on line from applying, getting their dial up e-mail account,
    registering in courses, checking grades, to getting a copy of their
    transcript.
        But most important for student support and student success is our
    use of mentors in addition to the faculty teaching the course. Mentors
    take a proactive stance toward the students, contacting them on a
    regular basis to see if they can provide help with any problems the
    student is having, and are available electronically at any time to deal
    with students questions and concerns. Student support is a key factor
    in insuring student motivation to complete distance courses and do
    well.
        This program can be scaled up to constitute a model of effective
    distance learning anywhere at the undergraduate level. Our focus has
    been on Florida, though we have a small number of out-of-state students
    in our distance degree programs. With additional support, more majors
    can be added, and the program can be expanded to serve a wider range of
    students geographically. Front-end development activities are essential
    for quality courses and require significant expenditure to add majors,
    train mentors and offer degree programs on a larger scale. Granting
    such front-end funds will have a major pay off in terms of providing
    access to a college degree to many place-bound individuals who
    represent a significant and diverse part of our population.
        Florida State as a research university is heavily invested in new
    technologies and learning ideally positioned to provide further
    leadership in student supported high quality distance learning. The
    University was recognized in 1999 as one of the 100 most wired campuses
    in America and the U.S. Department of Education has selected FSU as one
    of its 15 demonstration projects on distance learning and financial
    aid.
        We are seeking an appropriation of $2 million within the Department
    of Education's Higher Education account for this activity in fiscal
    year 2001.
        Mr. Chairman, this is just one of the many exciting activities
    going on at Florida State University that will make important
    contributions to solving some key problems and concerns our Nation
    faces today. Your support would be appreciated, and, again, thank you
    for an opportunity to present these views for your consideration.
                                     ______

                 Prepared Statement of the University of Tulsa

        It is proposed that the Department of Education support an
    information technology center for the University of Tulsa. We are
    seeking $15 million for building and equipment needs.
           the university of tulsa center for information technology
        It is a reality that economies are increasingly linked to
    technology. In February 2000, Oklahoma Governor Keating hosted a round
    table discussion of technology, educational, and commerce leaders in
    Tulsa. As a result of that meeting, a Center of Excellence in
    Information Technology and Telecommunications was formed. Participants
    in the Center include the University of Tulsa, Oklahoma State
    University-Tulsa, the University of Oklahoma's Tulsa operations, Oral
    Roberts University, Tulsa Community College and Tulsa Technology
    Center.
        The University of Tulsa is poised to help ensure that the Center of
    Excellence in Information Technology and Telecommunications meets the
    needs of industry and fulfills its mission of advancing the industry
    through research and educational programs. However, we are in need of a
    state of the art technology center to optimize our educational and
    research opportunities.
        There are a number of significant benefits that will flow to the
    State of Oklahoma and the Tulsa community from an investment in a TU
    Center for Information Technology (IT). These include:
      --Attracting and retaining quality students
      --Enhanced educational opportunities
      --Research opportunities for both faculty and students
    Attracting and Retaining Quality Students
        TU is committed to quality education. The University of Tulsa
    faculty is nationally recognized. For example, last year the Carnegie
    Foundation honored two University of Tulsa professors for the
    Advancement of Teaching and Learning. One was named a Carnegie
    Professor of the Year and one was named a Pew Scholar. In the past five
    years, The University of Tulsa, MIT and Stanford produced an equal
    number of Goldwater Scholars, tying for seventh place in the nation.
    The TU Center for IT would provide the infrastructure to maximize the
    potential of integrating these quality students with quality faculty.
    However, the Center would prove beneficial even before students arrive
    on campus. The recruiting competition for quality students is fierce.
    Students judge the technology infrastructure of a college or university
    when selecting an institution of higher learning. Students often make
    the decision to stay at a college or university based on opportunities
    for access to state of the art technology. TU wants to educate the
    technology knowledge workers to enter the digital economy work force
    and the Center would allow us to nationally recruit quality students to
    Oklahoma.
    Enhanced Educational Opportunities
        The TU Center for Information Technology will enhance educational
    opportunities in three areas:
      --by providing tools/resources to enhance learning in all academic
            areas and disciplines,
      --by providing an infrastructure for technology based program
            students (such as management information systems, computer
            information systems, and computer science) students to
            complement in class learning by applying their classroom
            learning, and
      --by enabling TU to deliver education to a broader range of
            constituents--students in divers geographic regions. It will
            also enable TU to reinforce the lifelong learning we encourage
            our alumni to pursue.
    Research Opportunities
        The TU Center for Information Technology will provide resource
    opportunities for both University of Tulsa faculty, and graduate/
    undergraduate students. Due to the number of industry leaders located
    in Tulsa, TU researchers have access to a significant volume of
    relevant subjects and data. TU's research program for undergraduate
    students (known as TURC--the Tulsa Undergraduate Research Challenge) is
    nationally recognized and acclaimed. Students have won a variety of
    national scholarships and grants from prestigious organizations such as
    the National Science Foundation and the Department of Energy. The
    enhanced research labs available in the TU Center for IT would further
    enhance the success of this program.
        In summary, the combination of quality professor, students, and
    technology infrastructure will result in a win-win proposition for
    students of higher education in Oklahoma and the Oklahoma economy.
                                     ______

               Prepared Statement of Fight Crime: Invest in Kids

        Littleton, Paducah, Springfield, and Mount Morris. In the wake of
    each of these tragedies, the American public has clamored for
    solutions.
        No one can say with certainty how each particular terrible tragedy
    could have been prevented. But a great deal is known about how to
    sharply reduce the incidence of school and youth violence. That is why
    it is frustrating to those of us who represent law enforcement and
    victims of violence when public officials wring their hands and pretend
    they can do nothing to prevent the next tragedy. Law enforcement is
    virtually unanimous about the steps that can help prevent future
    incidents, and have issued a 4-point School and Youth Violence
    Prevention Plan that calls on public officials to:
      --Assure all kids access to after-school programs that connect them
            with caring adults during the peak hours of violent juvenile
            crime;
      --Assure all families access to quality early childhood development
            programs;
      --Prevent child abuse and neglect and help heal those who have been
            abused and neglected;
      --Assure that troubled kids get early, effective help.
        Our members, more than 700 police chiefs, sheriffs, prosecutors,
    leaders of police organizations, and crime survivors, know that this
    committee's decisions will have a profound impact on juvenile crime
    rates in the years to come.
        As a first step towards implementing our School and Youth Violence
    Prevention Plan, we urge that you provide for fiscal year 2001 at
    least:
      --$6.3 billion for Head Start, so that the program can expand to
            serve more eligible children, and further strengthen its
            quality.
      --$2 billion for an Early Learning Trust Fund so communities can fund
            parenting-education programs and quality child development
            services to children under five.
      --$7.5 billion for the Child Care and Development Block Grant,
            maintaining appropriate set-asides for quality, infants and
            toddlers, school-age care, and resource and referral agencies.
            The discretionary portion of these funds should be increased by
            at least $818 million to be made available October 1, 2000.
      --$1 billion for the 21st Century Community Learning Centers to
            expand after-school programs that provide constructive
            activities and connect kids with caring adults during the peak
            hours of violent juvenile crime.
      --$2.38 billion for the Title XX Social Services Block Grant. Recent
            drastic cuts in this program have shortchanged child care (15
            percent of state spending under the block grant), child abuse
            prevention, removal and placement of abused children, drug
            treatment, and other critical crime-prevention investments.
      --$10.5 billion for Title I--Education for the Disadvantaged.
      --$250 million for Title V of the Juvenile Justice Act for local
            delinquency prevention programs.
        Those on the front lines of the battle against crime know that
    these investments are among our most powerful weapons against crime.
    That's why over the last year, virtually every major national law
    enforcement organization--including the Major Cities [Police] Chiefs
    Organization, the Police Executive Research Forum, the National
    Sheriffs' Association, and the National District Attorneys'
    Association--have all adopted forceful calls for boosting critical
    crime-prevention investments, such as educational child care and after-
    school programs, preventing child abuse, and providing intensive
    services to help troubled kids get back on track.
        A recent poll of police chiefs conducted for Fight Crime by George
    Mason University professors Scott Keeter and Steve Mastrofski showed
    that nearly nine out of ten of police chiefs agreed that ``expanding
    after-school programs and educational child care programs like Head
    Start would greatly reduce youth crime and violence.'' Nine out of ten
    agreed that if America fails to make greater investments in these
    programs now, ``we will pay far more later in crime, welfare and other
    costs.'' Police chiefs picked these investments as ``most effective''
    in reducing youth violence by a margin of four to one over such
    alternatives as trying more juveniles as adults or hiring more police
    officers, and by seventy-to-one over installing more metal detectors.
        Collectively, the four steps mentioned in our School and Youth
    Violence Prevention Plan would dramatically reduce violent juvenile
    crime. There are no substitutes for loving parents, but, government's
    fundamental responsibility is to protect the public safety, and it
    can't meet that responsibility by pointing fingers and saying parents
    should do a better job.
        The evidence is clear that well-designed programs for kids can
    dramatically reduce crime and violence, and keep kids from becoming
    criminals. But these programs remain so under-funded they reach only a
    fraction of the youngsters who need them. For example:
      --In a five-city study, half of a group of at-risk high-school kids
            were assigned to participate in the Quantum Opportunities
            after-school program. The boys left out of that program were
            six times more likely to be convicted of a crime in their high-
            school years. Yet roughly seven million youngsters under
            twelve, and millions more teens, lack after-school programs
            that put them in touch with caring adults providing supervision
            and constructive activities.
      --A High/Scope Foundation study at the Perry Preschool in Michigan
            randomly chose half of a group of at-risk toddlers to receive a
            quality Head Start-style preschool program, supplemented by
            weekly in-home coaching for parents. Twenty-two years later,
            the toddlers left out of the program were five times more
            likely to have grown up to be chronic lawbreakers, with five or
            more arrests. Yet inadequate funding for Head Start and the
            Child Care Development Block Grant leaves millions of at-risk
            children without critical early childhood services.
      --A Montreal study showed that providing disruptive first- and
            second-grade boys with social skills training and counseling
            cut in half the odds that they would later be in special
            classes, rated highly disruptive by a teacher or by peers, or
            have been required to repeat a grade in school--all signs that
            the risk of future violence has been sharply reduced.
      --The Prenatal and Early Infancy Project randomly assigned half of a
            group of at-risk mothers to receive visits by specially trained
            nurses who provide coaching in parenting skills and other
            advice and support. Rigorous studies show the program not only
            reduced child abuse by 80 percent in the first two years, but
            that fifteen years after the services ended, these mothers had
            only one-third as many arrests, and their children were only
            half as likely to be delinquent.
        Many of our members are conservatives who believe we should, in the
    long run, be able to cut taxes. Our experience and hard scientific
    evidence prove, however, that boosting investments in children now will
    save lives and tax dollars, leaving far more money for tax cuts, paying
    down the debt, and preserving social security down the road. For
    example:
      --Economist Steven Barnett found that the High/Scope Foundation's
            Perry Preschool study saved $150,000 per participant in crime
            costs alone. Even after subtracting the interest that could
            have been earned by investing the program's funding in
            financial markets, the project produced a net savings of
            $7.16--including more than six dollars in crime savings--for
            every dollar invested.
      --A study by Professor Mark A. Cohen of Vanderbilt University
            estimated that for each high-risk youth prevented from adopting
            a life of crime, the country would save between $1.7 million
            and $2.3 million.
      --A Rand Corporation report showed that, even without counting the
            savings to crime victims and society, the resulting savings to
            government alone from effective early childhood programs
            exceeded by two to four times the cost of the programs.
        Yet these dollars savings do not measure the greatest savings of
    all.
        One child was killed in Mount Morris, 12 in Littleton. In an
    average week, 40 children are killed in America by violence. About 98
    percent of these killings take place outside of school. That's over 150
    Littletons a year if we do nothing.
        The Fight Crime: Invest in Kids School and Youth Violence
    Prevention Plan will not prevent every incident of violence, but it can
    save thousands of lives--whether from school shootings or the out-of
    school tragedies that take an even more massive toll on our children--
    in the years ahead, all the programs for which we are calling for
    funding increases are consistent with our School and Youth Violence
    Prevention Plan.
        The programs for which we are calling for increased investments are
    consistent with the recommendations made by the Bi-Partisan Working
    Group on Youth Violence. Speaker Hastert and Minority Leader Gephardt
    created the working group to examine the evidence on measures to curb
    youth violence and to recommend a plan of action for Congress to take.
    Not surprisingly, the working group's conclusions to cut you violence
    echo the recommendations of law enforcement and crime survivor leaders:
      --``Effective federal programs must be fully funded to achieve the
            largest impact on early childhood development and, ultimately
            youth violence. Studies have estimated that for every dollar
            invested in quality early education, about seven dollars are
            saved in later costs.''
      --``Congress should increase funding for high quality effective early
            childhood programs, evaluate all federally-subsidized early
            childhood programs, and identify areas for improvement and
            where new areas could be implemented.''
      --``The subgroup recommends that Congress provide increased support
            for a range of prevention and early intervention strategies
            targeted toward at-risk youth and their families, including
            school-based and after-school programs.''
      --``Congress needs to take steps to ensure that every child has
            access to high quality after-school activity. . . . We agree
            with the nation's police chiefs that after-school programs for
            youngsters are a more effective way to fight crime.''
      --``We need to make sure that child protective services staff have
            sufficient resources to identify and treat abused and neglected
            children. We must also act before children are hurt by
            expanding programs proven to reduce cases of abuse and
            neglect.''
        Speaker Hastert promised that the working group's recommendations
    ``which are legislative in nature would follow the normal committee
    process but be addressed promptly.'' Now it is time to act.(A copy of
    the report can be found on Jennifer Dunn's website http://
    www.house.gov/dunn/workinggroup/wkg.htm.)
        We hope that you choose to put Congress this year on a path to full
    implementation of our School and Youth Violence Prevention Plan and of
    the recommendations of the Bi-Partisan Working Group on Youth Violence.
    Following this path will produce massive cuts in crime and violence.
        Thank you for your consideration.
                                     ______

         Prepared Statement of the National Military Family Association

        NMFA and the families we represent are grateful to this
    Subcommittee and to the United States Senate for its actions on behalf
    of military children and the Impact Aid Program. We thank all the
    Congressional supporters of Impact Aid, especially the members of the
    House and Senate Impact Aid Coalitions, for securing another increased
    appropriation for the program for fiscal year 2000. Your continued
    support of this program translates into better education for
    approximately 550,000 military children and several million of their
    civilian classmates in school districts across the country.
                               the military child
        NMFA presents this statement on behalf of military families, or
    more specifically on behalf of military children:
      --Military children move every 2 to 4 years and attend an average of
            six different schools. Less than 20 percent of these children
            attend Department of Defense Schools; the overwhelming majority
            of military children attend civilian schools dependent on
            Impact Aid.
      --Military children bring a wealth of cultural experiences gained
            from living in many parts of the world to their new schools.
            They also frequently come with gaps in their education that
            their new teachers must quickly fill while moving the rest of
            the class ahead. Sometimes they are far ahead of their new
            classmates, adding boredom to the list of reasons why they hate
            moving to yet another new school.
      --Because of varying course standards, school schedules, and state
            graduation requirements, they sometimes lose credits needed for
            graduation or they must take state accountability tests on
            subject matter they never learned. A change of schools at any
            time is traumatic, but a change in the middle of the school
            year is especially so. A mid-year transfer can place some
            children so far behind, they cannot catch up the rest of the
            school year, especially if a district does not have the
            resources for a good transition program.
      --Because of the high operations tempo of today's military, the
            military child often has to adjust to the new school, face that
            week of standardized tests, fight for the spot on the newspaper
            staff, play the basketball game before a crowd of strangers all
            without the support of their military parent. Worry about the
            safety of a parent in a place far from home where people are
            shooting at each other makes for a powerful distraction from
            the business of education.
        Military families want to be involved in their children's education
    and list education as one of their top quality of life issues. While a
    concern about the quality of their children's education is rarely the
    sole reason military members leave the service, the stress caused to a
    child by one-too-many moves, the special services not received when
    needed, or the prospect of an assignment at an installation where the
    schools have a poor reputation may be enough to convince a service
    member that it is time to leave the military.
                   why impact aid? the federal responsibility
        Military families understand that the Impact Aid program supports
    basic education services provided by their local school districts. They
    understand the impact the federal presence has on the tax base of these
    local districts and their states. They understand the impact their
    children and the transient military lifestyle can have on their local
    schools.
      --Children living on Fort Belvoir, Virginia attend the Fort Belvoir
            Elementary School, operated by Fairfax County. In school year
            1998-1999, the school's highest enrollment was 1,320 students.
            During the year, the school experienced a turnover rate of over
            50 percent. Not counting the summer rotations, 706 students
            came in and out of the school. Think of the records that must
            be prepared, the evaluations and testing for special programs
            that must occur, the children unable to concentrate because
            another best friend has moved away, the anxiety faced when the
            newcomers don't know anyone who will eat lunch with them!
      --The average soldier at Fort Hood, Texas deployed 120-160 days in
            fiscal year 1999. The average airman at Offutt Air Force Base,
            Nebraska deployed over 120 days. Think of the Parent-Teacher
            conferences missed, the volunteers unavailable to support
            school activities, the families stretched too thin. Research
            shows that involved parents promote academic achievement.
            Deployment makes that involvement more difficult both for the
            deployed servicemember and the spouse trying to keep things
            together at home.
        Military families hold the government, and the citizens they have
    sworn to serve and protect, accountable for living up to their promise
    to provide a quality education for their children. The districts have
    accepted the responsibility to educate military children; the Federal
    Government must provide the resources it has promised to support that
    education.
      --The intent of the original Impact Aid legislation (Public Law 81-
            874) was ``to provide financial assistance for those local
            educational agencies upon which the United States has placed
            financial burden.'' It originally provided an ``in-lieu-of-
            tax'' payment equal to the local per-pupil costs for students
            whose military parent both lived and worked on a federal
            installation (these students were designated A students) and
            one-half of the local per-pupil cost for students whose
            military parent worked on a federal installation but lived in
            the civilian community (B students).
      --It costs an average of over $6,000 to educate a child in the United
            States today. But the current average Impact Aid payment for an
            A child is approximately $2,000; the average payment for a B
            child (now set at only .10 of the amount for the military A
            students) is $200, nowhere near the original intent or actual
            cost of educating a child.
        Once again, NMFA thanks this Subcommittee for its continued funding
    of Impact Aid for the military children who live off the installation,
    the ``military Bs.'' Although military families living in the civilian
    community pay property taxes to help support local schools, they often
    do not contribute to other sources of education funding. States provide
    an increasingly larger share of local districts' funding. Many military
    members pay no state tax on their military income. They also shop in
    military exchanges and commissaries, thus paying no sales tax. Under
    the provisions of the Soldiers' and Sailors' Relief Act, they are often
    exempt from paying personal property taxes or license fees for
    automobiles if they are on military orders away from their home state.
      --The local tax base for the Bellevue, Nebraska school district that
            educates the children living on or near Offutt Air Force Base
            generates only $12 million of the district's $54 million annual
            budget. Each year the county loses $5 million in license plate
            fees because military members stationed at Offutt may license
            their vehicles in their home states rather than Nebraska.
      --The Copperas Cove Independent School District serves children whose
            parents are assigned to Fort Hood, Texas. All but about 100 of
            the district's 2,700 military children live in the civilian
            community adjacent to Fort Hood and approximately 30 percent of
            the district's budget comes from Impact Aid. If funding for
            military B students was discontinued, district officials
            estimate they would have to raise property taxes 51.3 cents per
            $100 of valuation.
      --As the military services look to the civilian community to provide
            more housing for military families, the number of B students
            will increase, thus raising the burden on districts charged
            with educating them.
                              fix the schoolhouse
        For a newly-arrived family in a military community, the sight of a
    well-maintained, safe, child-friendly school building can calm many
    anxieties about their latest move. Unfortunately, too many military
    children must deal with those anxieties in a school facility that has
    seen better days.
      --Although Impact Aid provides much of a heavily-impacted district's
            working capital, it cannot be stretched to fund the facility
            maintenance and improvements old school buildings need.
            Military families at many installations voice concerns about
            the repairs needed for these buildings and the lack of
            available funds. At Grand Forks Air Force Base, for example,
            parents with children at the combined elementary/middle school
            note the work needed. The district only recently allocated
            funds to meet accessibility laws. The building has no
            handicapped-accessible bathroom, entrance or exit ramps, or
            lift or elevator to the second floor. Designed as an elementary
            school, the building has no adequate gym space for middle
            school programs and needs a new boiler. It has windows that are
            boarded up and frosted over or, as described by one military
            spouse, ``windows that have been re-caulked so many times there
            is more caulk than window sill.''
      --NMFA remains concerned about the upgrade and maintenance needs of
            school buildings owned by the Department of Education. The
            Waynesville R-VI School District, for example, operates seven
            buildings owned by the Department of Education on Fort Leonard
            Wood, Missouri. Although one school has been recently
            renovated, the district estimates that it needs approximately
            one million dollars per school to bring the rest up to
            standard. The district used its own funds to wire the
            Department of Education buildings for the Internet so that the
            military children attending these schools would not fall behind
            their peers in district-owned buildings. In addition to facing
            pressing maintenance and renovation needs, the district is also
            coping with the addition of 600 Army children it received from
            units moved to Fort Leonard Wood following the closure of Fort
            McClellan, Alabama. To a district with only 5,100 students in
            old school buildings, an additional 600 children becomes a
            strain on the system.
                            one child, many schools
        The education of a military child is a continuum. As the military
    child moves from school district to district--from a school receiving
    Impact Aid in Texas, to another Impact Aid school in Virginia, to a
    Department of Defense school in Germany to another Impact Aid school in
    Illinois--the quality of education she receives in each school will
    affect the education she and her classmates receive in the next.
    Children whose schools are unable to provide the necessary educational
    services could easily fall behind their peers in other districts.
    Schools serving these children could face difficulties in maintaining
    accreditation as tough new standards are implemented in many states. A
    smooth transition into their next school, whether across the state or
    across the country, benefits military children, their classmates, and
    their communities.
        The Impact Aid program enables districts affected by the presence
    of a military installation to offer not only a quality basic education
    program, but also the support services needed by military children as
    they transition from school to school.
      --Over 50 percent of the 3,783 students in the Indian River Central
            School District in New York are military children whose parents
            are stationed at Fort Drum. Because of Impact Aid, the district
            can afford the Reading Recovery program to help first graders
            master important reading skills to reach grade level. At the
            high school level, the district is developing a remediation
            system to help newly-transferred students prepare for the New
            York Regents exams, which will soon be required for graduation.
            Impact Aid funds help buy stringed instruments for the
            district's orchestra program. They provide for the support
            system--the counselors, psychologists, and social workers--
            often needed by children when their military parent deploys.
            The 10th Mountain Division recently returned to Fort Drum after
            its deployment to Bosnia. While the school administration was
            initially concerned about a flight from the community during
            the deployment, it found that most military families chose to
            remain in the area. The strong assistance system at Fort Drum
            and the community support as evidenced in the school programs
            funded through Impact Aid persuaded families to stay.
      --School districts serving military children recognize their
            interdependence and their shared responsibility for the
            education of those children. They are increasing their
            communication with each other to ease the transition of
            military children in and out of different school systems.
      --Recognizing that service members view quality education as an
            important quality of life factor and a retention issue, the
            military services have stepped up their efforts to establish
            partnership programs with local schools, to train installation
            school liaison officers, to provide better information to
            families about local schools, and to study the problems faced
            by military children as they move. They are working across the
            services on common issues and are reaching out to military-
            related and education organizations, such as NMFA, the National
            Association of Partners in Education, and the Military Child
            Education Coalition.
        Military parents view the partnerships between their schools and
    the military services--from the unit adopting the local elementary
    school to the presence of service and DOD leadership at annual
    educational conferences on ``Serving the Military Child''--as progress
    toward relieving some of the anxieties about their children's
    education. The educational focus of these efforts is a legacy of a
    successful, well-funded Impact Aid program. When the Federal Government
    fulfills its responsibility to provide funding for basic education to
    districts serving military children, the schools can concentrate on
    providing a high-quality education program for all students. We thank
    you, the Members of this Subcommittee, for your leadership in this
    partnership for the education of military children. We ask you to
    continue this role by fully funding Impact Aid.
                                     ______

     Prepared Statement of the National Indian Impacted Schools Association

        The National Indian Impacted Schools Association represents public
    school districts which contain Indian trust land and Alaska Native
    lands. The Impact Aid program provides federal funds for public school
    operations that would have otherwise been provided by local tax
    revenues but for the presence of federal property--in our case,
    primarily lands held in trust by the federal government for Indian
    tribes.
        Approximately 90 percent of Indian and Alaska Native elementary and
    secondary students nationwide attend public schools. Most of the
    remaining 10 percent of students attend Bureau of Indian Affairs-system
    schools whose operating budgets come through BIA appropriations.
        Summary of Request.--We ask the Subcommittee to recommend the
    following with regard to the fiscal year 2001 Department of Education
    budget:
      --Impact Aid Basic Support Payments.--$818 million for Impact Aid
            Basic Support payments under Section 8003(b) of the Impact Aid
            statute. This is the same as the request of the National
            Association of Federally Impacted Schools (NAFIS) and is 10.9
            percent over the fiscal year 2000 enacted level.
      --Impact Aid Facility Repair.--$25 million under the authority of
            Section 8007 of the Impact Aid statute for payments for
            facility repair, renovation and construction. This is the same
            as the request of NAFIS and compares to the fiscal year 2000
            enacted level of $10.1 million and the Administration's request
            of $5 million. While this is termed a ``construction'' account
            in the authorizing statute, the funds are distributed by
            formula to schools, making the amount individual school
            districts receive so miniscule that it cannot make a
            significant impact on facility construction needs. In fiscal
            year 2000, $3 million was earmarked by Congress for three
            specific schools.
      --Forward Funding of Impact Aid.--Impact Aid is one of the few major
            federal education programs which are not forward funded. Even
            if we were not experiencing delays in distribution of Impact
            Aid funds as we are now, it would be enormously helpful for
            planning and budgeting purposes for the program to be forward
            funded.
        The Impact Aid Program in Indian Country.--For Indian country, the
    Impact Aid program is a vital element of the public policy of providing
    every child a free public education. Signed into law in 1950, the
    Impact Aid program is one of the oldest federal education programs.
    Simply put, it provides federal funds for public school operations that
    would have otherwise been provided by local tax revenues but for the
    presence of federal property--in our case, lands held in trust by the
    federal government for Indian tribes. One of the great attributes about
    the Impact Aid program is that it provides flexible funds to school
    districts. Because Impact Aid funds are actually in lieu of a property
    tax base, it is logical that they are not geared toward specific
    program use.
        The Impact Aid program is an example of the U.S. government
    carrying out its trust responsibility--in this case, for education--for
    Indian and Alaska Native peoples. Some facts about the Impact Aid
    program in Indian Country:
      --There are over 600 school districts throughout the country which
            receive Impact Aid funds for Indian lands schools.
      --Funds for Indian lands students represent nearly 50 percent of the
            federal Impact Aid appropriation.
      --The Indian Country land base that generates Impact Aid funds
            consists of 53 million acres of Indian trust land in the lower
            48 states and 44 million acres included in the Alaska Native
            Claims Settlement Act.
      --The Impact Aid program provides a formal link between tribal
            governments and public schools, providing for school district
            consultation with Indian tribes and tribal communities. This is
            especially important because public schools are State
            institutions, but located within tribal boundaries. School
            districts must consult with tribes and the Indian community to
            develop Indian Policies and Procedures (IPP). Tribes and
            parents of Indian students are able to comment on whether
            Indian students are equal participants in educational programs
            and school activities, and to request modifications in school
            programs and materials. Tribes also have administrative appeal
            rights under the statute.
        The Level of Impact Aid Effects Student Performance--the Santee
    School Experience.--We would like to give you an example of how
    increased Impact Aid funds resulted in dramatic academic improvement
    for the students of the Santee School District.
        On March 17, 1999 the House Education and the Workforce
    Subcommittee on Early Childhood, Youth and Families held a hearing on
    reauthorization of the Impact Aid program at which Chuck Squier,
    Superintendent of the Santee School, testified. The Santee School
    District in northeast Nebraska is made up of entirely Indian trust
    lands and its students are Santee Sioux. Superintendent Squier
    testified about the impressive student gains which have been made since
    his school district has received an increase in Impact Aid funds.
        Prior to 1995 the school district had been receiving only 60 to 70
    percent of the amount of Impact Aid for which it was eligible. Reading
    scores had dropped during the previous three years: 1st grade scores
    dropped from 1.8 to 1.2 GME; \1\ 8th grade scores dropped from 7.4 to
    5.9 GME, and 11th grade scores dropped from 10.2 to 9.4 GME. In an
    effort to reverse this trend, the school district formed a Curriculum
    Committee composed of school staff, parents and other community
    members. They reviewed current research on ways to improve student
    reading and decided on a plan of action which included teacher
    training, a reading management system, multiple copies of books, a
    daily focus on reading and ninth hour tutoring. Specific programs
    included reading recovery, accelerated reader, school at the center,
    foss science, and project read. However, the recommendations of the
    Curriculum Committee were not able to be implemented because of lack of
    money.
    ---------------------------------------------------------------------------
        \1\ GME stands for Grade Means Equivalency.
    ---------------------------------------------------------------------------
        But when the Impact Aid program was re-authorized in 1994, Impact
    Aid funding increased for the Santee Sioux school. The school district
    was able to use that money to leverage additional grant dollars for
    teacher training and research-based reading programs and the rest of
    the plan recommended by the Curriculum Committee. The plan was
    implemented. Students are tested in the fall and in the spring, and the
    results have been very impressive. Last year, 28 percent of the
    students in grades 3-12 increased their reading level two grade levels.
    Another 25 percent of students raised their reading level 1.5 or more
    grade levels, and 36 percent of students raised their reading level 1
    or more grade levels. Particularly gratifying was the 9th grade
    results, as this class had declining scores for the previous three
    years. Expansions of the school-wide reading program are planned for
    next year, along with rewriting the math/science studies/language arts
    curriculum--financial resources permitting.
        The Santee School District program is shared through the Nebraska
    Native American consortium, which serves 98 percent of all students in
    Nebraska living on tribal lands.
        The Impact Aid Program Should Be Forward Funded.--We urge Congress
    to take the long overdue step of providing appropriations to forward
    fund the Impact Aid program. Other major education programs, e.g.,
    Title I, Individuals with Disabilities Education Act, and Bureau of
    Indian Affairs school operations, are forward funded. Public school
    administrators in heavily impacted districts must make very difficult
    and risky program and personnel decisions for the upcoming school year
    or the next school year without knowing how much Impact Aid funding
    they will be receiving. For many Indian lands schools, Impact Aid is
    the primary source of school operations funding and the schools would
    close without it.
        While school administrators cope with this system, it makes much
    more sense for a school administrator to know 6-12 months prior to the
    beginning of the school year what its budget will be. For example, in
    Minnesota we are required to sign contracts for tenured teachers by
    April 15th for the upcoming school year. For non-tenured teachers, we
    must sign contracts by June 1 for the Fall term. Because Impact Aid is
    not forward funded, we must sign contracts for tenured teachers 4\1/2\
    months prior to the knowing the amount of money we will receive--and
    that is under circumstances when we have a Labor-HHS-Education
    Appropriations bill which is signed by October 1st--a rare occurrence,
    as you know.
        When the government shut down several years ago, Impact Aid schools
    had to borrow money just to stay open and had to pay large amounts of
    interest--tens of thousands of dollars for some schools--for which they
    were not reimbursed. Some Impact Aid schools are in the position now of
    having to borrow money because of problems at the Department of
    Education resulting in chronically late Impact Aid payments. We know
    that Congress understands this problem because it has made most federal
    education programs forward funded. Impact Aid is a program of basic
    support for schools--it hires the teachers, pays the utility bills,
    transports students, etc. and this makes it all the more urgent for it
    to be forward funded.
        We realize that the first year of forward funding will strain the
    appropriations process as Congress would have to make available two
    years worth of funding. On the other hand, we have a budget surplus and
    there is support from the Administration and both parties in Congress
    for increased federal education funding.
        If the Impact Aid program cannot be forward funded in total, we
    suggest that the Basic Support and the Disabilities portions of the
    program could be forward funded or Congress could look at the
    possibility of a phased-in approach to forward funding.
        School Facilities.--School facilities construction and renovation,
    including making facilities ready for education technology, is a high
    priority for our organization. We urge you to appropriate at least $25
    million for school facility repair as authorized under Section 8007 of
    the Impact Aid law. Ultimately however, we need more than a band aid
    approach to school construction needs.
        NIISA has and will continue to work with Congress on pending school
    construction proposals to make them responsive to the needs of our
    schools--Indian lands public schools. School construction bills have
    been introduced in a steady stream during the last two Congresses and
    also the current Congress. We have seen in these bills a growing
    recognition that there needs to be accommodation for public school
    districts which have little, if any, bonding capacity (including those
    schools in the Bureau of Indian Affairs system). For instance, there
    are now bills which would allow a state to issue school construction
    bonds (not just the LEA) and which would require the state application
    to explain how they will assist schools that lack the fiscal capacity
    to issue bonds on their own. This could be helpful to some school
    districts with Indian lands. To the extent that a school district has
    limited ability to generate revenues because of a federal presence
    (e.g., the existence of Indian trust land or federal property in the
    school district), there is a clear federal responsibility toward the
    education of the children attending those schools.
        The condition of public and Bureau of Indian Affairs school
    facilities has been documented in General Accounting Office (GAO)
    surveys. Because the GAO surveys did not report data specific to Indian
    lands public schools, our organization, in October, 1996, undertook a
    survey of school districts which receive Indian lands Impact Aid
    funding. Some of the findings from the survey, which we have previously
    reported to this Subcommittee, are:
      --65 percent of buildings are over 20 years old, including 38.2
            percent over 30 years old;
      --$6,872,000 is the average estimated costs necessary for repairs,
            renovations, modernization and construction to put schools in
            overall good condition;
      --the average cost per student to make school buildings meet health
            and safety standards is $1,947;
      --to accommodate expected increased enrollment over the next 5 years,
            the schools responding to the survey will need 13.1 percent
            more space. Within 10 years, the space needs are expected to
            increase by 27.9 percent;
      --71 percent of school districts have had no school construction bond
            issued since 1985, and 23 percent of school districts have
            never had a bond issued;
      --Of schools with 70 percent LOT MOD and higher, the need for
            construction, renovation, and repair funding is two thirds
            higher per pupil than in the other respondents to the NIISA
            survey. (Note: LOT MOD is a Department of Education measure of
            need of school districts affected by the presence of federal
            property);
      --42 percent of respondents have unhoused students;
      --59 percent of school buildings have inadequate laboratory science
            space;
      --63 percent of schools are not well served for before/after school
            care.
        Thank you for your interest in the need of our public schools which
    educate children from Indian country. We ask you to always keep in mind
    the trust responsibility for the education of Indian and Alaska Native
    children and the federal responsibility regarding school districts
    which contain Indian and federal property.
                                     ______

           Prepared Statement of the United Stribes Technical College

        Summary of Request.--For thirty years United Tribes Technical
    College \1\ (UTTC) has been providing postsecondary vocational
    education, job training and family services to Indian students from the
    Great Plains and throughout the nation. UTTC was assisting Indian
    people in moving from public assistance to economic self-sufficiency
    long before the 1996 welfare reform act. We have a sustained placement
    rate of well over 80 percent. Our request for fiscal year 2001 funding
    for tribally controlled postsecondary vocational institutions as
    authorized under Carl Perkins Vocational and Applied Technology Act is:
    ---------------------------------------------------------------------------
        \1\ The college is owned and operated by five federally-recognized
    tribes situated wholly or in part in North Dakota--Spirit Lake Sioux
    Tribe, Sisseton-Wahpeton Sioux Tribe, Standing Rock Sioux Tribe, three
    Affiliated Tribes of the Fort Berthold Reservation, and Turtle Mountain
    Band of Chippewa. Control of the institution is vested in a ten-member
    board of directors comprised of elected Tribal Chairpersons and Tribal
    council members.
    ---------------------------------------------------------------------------
      --$5 million, or $400,000 over the fiscal year 2000 enacted level and
            the Administration's request. This funding is essential to our
            survival as we receive no state-appropriated vocational
            education monies.
      --Committee Report language asking for the report required of the
            Department by the Vocational and Applied Technology Education
            Act regarding training, facilities and housing needs of the
            tribally controlled postsecondary vocational institutions. (20
            USCA Sec. 2327(g) (2) and (3). This report should be undertaken
            in close collaboration with the affected institutions. Attached
            is the statutory provision.
        Funding Authority.--Section 117 of the Carl Perkins Vocational
    Education and Applied Technology Education Act Amendments of 1998
    authorizes funding for tribally controlled postsecondary vocational
    technical institutions. Under this authority funding is currently
    provided to UTTC and one other tribally controlled postsecondary
    vocational institution, the Crownpoint Institute of Technology. The
    Administration's fiscal year 2001 request is $4.6 million, the same as
    the fiscal year 2000 enacted level. There is a glitch in the Perkins
    Act in that it caps funding for Tribally Controlled Postsecondary
    Vocational Institutions at $4 million instead of ``such sums as may be
    necessary'' in the out years as is the case for other vocational
    education programs. This was inadvertent and we ask for a technical
    correction to provide for ``such sums as may be necessary'' for fiscal
    year 2000 and the out years.
        A Unique Inter-Tribal Educational Organization.--United Tribes
    Technical College is the only inter-tribally controlled, campus-based,
    postsecondary vocational institution for Indian people. Our campus is
    the site of the Fort Lincoln Amy Post, an 110-acre area near Bismarck,
    North Dakota. We currently enroll 367 students from 32 tribes and 14
    states. And we serve 159 children in our pre-school programs and 148
    children in our elementary school, for a direct services population of
    654.
        Educating Students and Placing Them in Jobs.--We are proud of the
    education, skills and services provided by UTTC for our students and
    their families. And we are proud that this education is taking place in
    a setting they where can maintain and strengthen their tribal heritage.
    We have had a sustained job placement rate exceeding 80 percent over
    the last 10 years. This success is all the more gratifying in light of
    the background of our students, most of whom come from tribal areas
    where poverty and unemployment are the norm. Many of our students are
    from the 14 tribes in the Dakotas, where unemployment among Indian
    people is chronic. BIA Labor Force data reports the percentage of
    potential Indian labor force on and near reservations in the Aberdeen
    Area who are jobless is 71 percent. Of those persons who are employed
    33 percent are still living below the poverty guidelines. (Source:
    Interior Department 1997 Labor Market Information On the Indian Labor
    Force.)
        UTTC New Course Offerings.--We offer 9 Certificate and 15 Associate
    of Applied Science degree programs (see attached list). We are very
    excited about the recent additions to our course offerings, and the
    particular relevance they hold for Indian communities. The modest
    increases in our Department of Education funding has helped make these
    new programs possible. These new programs are:
      --Injury Prevention
      --Dietetics Technician
      --Tribal management, including gaming management
      --Computer Science Technology
      --Distance Learning programs for the Denver Indian Community
        Dietetics/Diabetes.--Through collaborative efforts with the
    American Diabetes Association, UTTC will develop the only accredited
    Dietetics Technician's Degree program in the state. We will meet the
    challenge of fighting diabetes through education. As this Subcommittee
    knows, the rate of diabetes is very high in Indian county, and with
    some tribal areas experiencing the highest incidence of diabetes in the
    word. About half of Indian adults have diabetes (``Diabetes in American
    Indians and Alaska Natives, NIH Publication 99-4567, October, 1999).
        Injury Prevention.--Through our Injury Prevention Program we are
    addressing the injury death rate among Indians which is 2.8 times that
    of the U.S. population (Source: IHS fiscal year 1999 Budget
    Justification). We received assistance through the IHS to establish the
    only degree-granting Injury Prevention program in the nation.
        Distance Learning.--We are bridging the ``digital divide'' by
    providing critical computer and Internet skills from our North Dakota
    campus to American Indians residing in the Denver area. Technology
    training allows all American Indians an opportunity to overcome
    barriers such as geographic isolation and access to information.
    Through technology partnership programs, UTTC is meeting the challenge
    of providing technology skills and training to Indian country.
        UTTC has been, in addition, a member since 1994 of the Interactive
    Video Network of North Dakota's colleges, universities and tribal
    colleges. This allows for articulation agreements with other college
    and universities, expanding the educational opportunities for our
    students.
        Job Training and Economic Development.--UTTC is a designated Indian
    Minority Business Center serving Montana and the Dakotas. We also
    administer a Workforce Investment Act program and an internship program
    with private employers. And we are assisting tribes and tribal members
    in the Aberdeen Area with rebuilding buffalo herds.
        Coordination with State Welfare-to-Work Efforts.--UTTC is working
    in cooperation with the state of North Dakota on welfare reform. We are
    serving state-referred Temporary Assistance for Need Families (TANF)
    recipients who are able to participate in our Cooperative Education
    internship program with private employers. By attending UTTC, these
    TANF recipients can meet their work, training and volunteer
    requirements. And we are providing child care for 20 children of state-
    referred TANF recipients.
        In North Dakota, only 30 percent of state TANF recipients are
    allowed schooling as a work activity. And we also take exception to the
    12-month statutory limit on the length of time a TANF recipient can be
    enrolled in a vocational education course and still be eligible for
    TANF. This limits TANF recipients to taking one-year certificate
    courses at UTTC. Our experience shows that the students who graduate
    from a two-year, rather than a one-year, course have significantly
    higher earning power. Many of our students come to UTTC planning to
    take a one-year course, and then, finding themselves in a supportive
    environment and seeing the economic benefit of the longer course,
    decide to work for the two-year degree.
        Serving Families Contributes to Education and Job Placement.--We
    believe that a primary reason for UTTC student success is that we serve
    the students' social, academic and cultural needs. Many of our students
    are the first generation in their family to attend college, and for
    many it is their first experience in living away from home. Many
    students are on public assistance and many have families of their own.
    Some of our services are:
      --Early childhood services for 145 children, ages birth to five years
            and an additional 15 elementary children for extended care;
      --Theodore Jamerson Elementary School serving 148 Indian students;
      --A health clinic whose services includes immunization, health
            education, eye and dental exams, and referrals to other health
            care providers;
      --Family housing and dormitories for solo parents and for students
            without children;
      --A local transportation system for students for school activities
            and necessary appointment e.g., (doctor appointments) outside
            the campus. Most UTTC students do not have cars.
        UTTC Seeks Non-Perkins Funds.--UTTC is aggressive in seeking non-
    Perkins funding for special needs, e.g., we combined Department of
    Agriculture, Economic Development Administration and state Community
    Development Block Grant funds and replaced our aging water, sewer and
    gas systems in 1997.
        Our elementary school received a Department of Education grant for
    computer technology, and was one five BIA-system schools to receive
    this funding. We also received a Kellogg Foundation grant to develop
    buffalo management skills for the tribes and their members throughout
    the Aberdeen Area, as they attempt to rebuild herds of buffalo
    decimated more than 100 years ago. And this year we received a $75,000
    grant from U.S. West to assist us in developing a series of distance
    learning classes at the Indian Center in Denver. Additionally, our
    Injury Prevention Program has been assisted through a grant from the
    IHS.
        The above mentioned grants are highly competitive, restrictive,
    one-time grants, and they cannot provide for day-to-day operations. We
    cannot survive without the basic operating funds which come through the
    Perkins Act.
        Facility Study/Current Needs.--We are dismayed that the Department
    of Education has paid no attention to the requirement in the 1998
    Perkins Act Amendments to undertake a study of our housing, facility,
    and training needs. Discussions with the Department shows that it is
    not even on its radar screen. Such a study would certainly be of
    benefit to us in planning and in seeking funds. Below are some of our
    financial needs of which we want you to be aware:
      --Housing.--We need new and rehabilitated campus housing so that we
            can increase student enrollment. Many of our buildings are of
            historic importance. The College occupies the old Fort Lincoln
            Army Post, and many people visit our campus to see these
            buildings. Other than the more recently constructed skills
            center and the community center, UTTC's core facilities are 90
            years old. Estimates for new facilities total over $12 million,
            according to a 1993 Dept. of Education report.
      --Salaries.--We were able to provide a cost-of-living increase for
            our employees last year. However, our faculty still receive
            salaries that are lower than in any state college system.
      --Emergency Repair.--We need funding for emergency repair on student
            housing and instructional facilities. Funding is also needed
            for maintenance and repair related to damaged caused by
            inclement weather, including blizzards, high winds and
            extremely low temperatures.
      --Course Offerings/Student Services.--We want to change some of our
            courses to better meet new market demands, e.g, training to
            increase the number of students in the allied health
            professions, updating of technology. We also need to expand our
            diagnostic capabilities in tribal-specific areas and in the
            areas of literacy and math-science background. And we want to
            make improvements in our student follow up, career development,
            and job market research efforts.
        Thank you for your consideration of our request.
                                     ______

                       RELATED AGENCIES/GENERAL TESTIMONY

    Prepared Statement of the National Federation of Community Broadcasters

        Thank you for providing me the opportunity to submit testimony to
    this Subcommittee regarding the appropriation for the Corporation for
    Public Broadcasting (CPB). As the President and CEO of the National
    Federation of Community Broadcasters I speak on behalf of 150 community
    radio stations across the country. NFCB is the sole national
    organization representing this group of stations which provide service
    in the smallest communities of this country as well as the largest
    metropolitan areas. Nearly half of our members are rural stations and
    half are minority controlled stations.
        In summary, the points we wish to make to this Subcommittee are
    that NFCB:
      --Supports the CPB request of $365 million for fiscal year 2003;
      --Requests the Subcommittee to ensure that CPB utilizes digital funds
            it receives for radio as well as television needs;
      --Supports CPB activities in facilitating programming services to
            Latino and Native American radio stations;
      --Supports CPB's efforts to help public radio stations utilize new
            distribution technologies and requests that the Subcommittee
            ensure that these technologies are available to all public
            radio services and not just the ones with the greatest
            resources.
        Community radio fully supports $365 million for the Corporation for
    Public Broadcasting in fiscal year 2003.--Federal support distributed
    through the CPB is an essential resource for rural stations and for
    those stations serving minority communities. These stations provide
    critical, life-saving information to their listeners. Yet they are
    often in communities with very small populations and limited economic
    bases so that the ability of the community to financially support the
    station is insufficient without federal funds.
        In larger towns and cities, sustaining grants from CPB enable
    community radio stations to provide a reliable source of noncommercial
    programming about the communities themselves. Local programming is an
    increasingly rare commodity in a nation that is dominated by national
    program services and concentrated ownership of the media.
        In the last year, CPB has increased supported to rural stations and
    committed resources to helping public radio take advantage of new
    technologies. We commend these activities but want to be sure that the
    smaller stations with more limited resources are not left out of this
    technological transition. We ask that the Subcommittee include language
    in the appropriation that will ensure that funds are available to help
    the entire public radio system utilize the new technologies,
    particularly rural and minority stations.
        NFCB would like to commend CPB for the leadership it has shown in
    supporting and fostering the programming services to Latino stations
    and to Native American stations. Satelite Radio Bilingue provides 24
    hours of programming to stations across the United States and Puerto
    Rico addressing issues of particular interest to the Latino population.
    In the same way, American Indian Radio on Satellite (AIROS) is
    distributing programming for the Native American stations, arguably the
    fastest growing groups of stations. There are now over 30 stations
    controlled by and serving Native Americans, primarily on Indian
    reservations.
        CPB plays a very important role for the public and community radio
    system. They are the convener of discussions on critical issues facing
    us as a system. They support research so that we have a better
    understanding of how we are serving listeners. And they provide funding
    to programming, new ventures, expansion to new listeners, and projects
    that improve the efficiency of the system. This is particularly
    important at a time when there are so many changes in the radio and
    media environment with new distribution technologies and media
    consolidation.
        Finally, community radio supports funding for conversion to digital
    broadcasting by public radio and television.--While public television's
    needs are more immediate, the Federal Communications Commission is now
    in the process of identifying a standard for digital radio
    transmission. We expect that there will be funds available for radio
    conversion as well as television conversion. More immediately, the
    television conversion process is already having an impact on public
    radio stations. As television stations increase the space they need on
    their towers to accommodate both analog and digital signals, radio
    stations that rent space on TV towers are losing their leases and being
    forced to move to other towers--sometimes with very short notice. This
    situation will only get worse over the next three years as we approach
    the FCC deadline for television conversion. We would like to see
    emergency funding to help public radio stations who lose their tower
    space do the necessary engineering studies and move to new tower
    locations.
        We appreciate Congress' direction to CPB that it utilize its
    digital conversion fund for both radio and television and ask that you
    ensure that the funds are used for both media. Congress stated, with
    regard to fiscal year 2001 digital conversion funds:

        ``The required (digital) conversion will impose enormous costs on
    both individual stations and the public broadcasting system as a whole.
    Because television and radio infrastructures are closely linked, the
    conversion of television to digital will create immediate costs not
    only for television, but also for public radio stations (emphasis
    added). Therefore, the Committee has included $15,000,000 to assist
    radio stations and television stations in the conversion to
    digitalization . . .'' (S. Rpt. 105-300)

        This is a period of tremendous change. Digital is transforming the
    way we do things; new distribution avenues like digital satellite
    broadcasting and the Internet are changing how we define the business
    we are in; the concentration of ownership in commercial radio makes
    public radio and particularly community radio, more unique and more
    important as a local voice than we have ever been. During this time,
    the role of CPB as a convener of the system becomes even more
    important. And the funding that it provides will allow the smaller
    stations to participate along with the larger stations who have more
    resources, as we move into a new ear of communications.
        Thank you for your consideration of our testimony.
                                     ______

     Prepared Statement of the National Association of Foster Grandparent
                                    Program

        We are pleased to submit this testimony in support of fiscal year
    2001 funding for the Foster Grandparent Program (FGP), the oldest and
    most well-known of the three programs known collectively as the
    National Senior Volunteer Corps, which are authorized by Title II of
    the Domestic Volunteer Service Act of 1973, as amended (DVSA) and
    administered by the Corporation for National and Community Service
    (CNS).
        NAFGPD is a membership-supported professional organization whose
    roster includes the majority of more than 350 directors who administer
    Foster Grandparent Programs nationwide, as well as local sponsoring
    agencies who support the work of FGP.
                                   thank you
        Senator Specter, before we begin our testimony, we must first thank
    you for the courage and leadership you showed during the fiscal year
    2000 appropriations process in preserving the original mission and
    purpose of the Foster Grandparent Program: to enable seniors living on
    incomes less than 125 percent of the national poverty level to serve as
    Foster Grandparents and contribute to their communities. Your clear
    direction to the Corporation for National and Community Service--that
    funds appropriated by Congress may not be used to pay a non-taxable,
    non-income payment to individuals whose incomes exceed 125 percent of
    the national poverty level--has preserved our program for those low-
    income seniors for whom it was originally intended. Again, thank you
    for your leadership.
                                fgp: an overview
        Established in 1965, the Foster Grandparent Program was the first
    federally funded, organized program to engage older volunteers in
    significant service to others. From the 20 original programs based
    totally in institutions for children with severe mental and physical
    disabilities, FGP now comprises nearly 350 programs in every state, the
    District of Columbia, Puerto Rico, and the Virgin Islands. All programs
    are now primarily based in community volunteer sites--where most
    special needs children can be found today--and are administered locally
    through a non-profit organization or agency and an Advisory Council
    comprised of community citizens dedicated to FGP and its mission. FGP
    represents the best in the federal partnership with local communities,
    with federal dollars flowing directly to local sponsoring agencies,
    which in turn determine how the funds are used. There are currently
    28,500 Foster Grandparent volunteers who give over 24 million hours
    annually to more than 180,000 children.
        The Foster Grandparent Program is unique. We are one of only two
    volunteer programs in existence that enable seniors living on very
    limited incomes to serve their communities as volunteers by providing a
    small non-taxable stipend and other support which allow volunteers to
    serve at little or no cost to themselves. Our volunteers provide
    intensive, consistent service--20 hours every week, usually four hours
    every day. FGP provides extensive pre-service orientation and at least
    48 hours of on-going training annually to keep volunteers informed on
    how to work with children who have special needs. And our volunteers
    provide one-to-one service to their assigned children, exactly what is
    required to help prepare our nation's neediest children to become self-
    sufficient adults.
        The rapidly growing number of older people living at poverty-level
    incomes across the country represent a virtually untapped resource that
    must be utilized to help address the serious problems of today's
    children. In order to continue to provide these cost-effective services
    in even more local communities the Foster Grandparent Program requires
    more volunteers, and more locally-based programs. We need funding
    levels that will enable us to keep pace with the ever-increasing number
    of income eligible seniors--currently 6,000,000, a number which will
    grow to 13,200,000 by the year 2030--and the countless number of at
    risk children who will need the one-to-one attention of an older person
    with the time to help show them the way to independence and productive
    adulthood.
             the administration's fiscal year 2001 request for fgp
        Unfortunately, in a budget which requests increases in excess of 23
    percent ($100 million) for AmeriCorps and related programs, the
    Administration has, for the second year in a row, proposed an increase
    of $1.79 million (1.87 percent) for the Foster Grandparent Program--
    again, for the second year in a row, the smallest increase requested
    for any of the programs administered by CNS. Rather than investing
    federal funds in increasing the number of FGP volunteers serving
    nationwide, the Administration's request appears to set as a priority a
    67 percent increase for senior demonstration targeted mainly to make
    grants to national organizations which have nothing to do with FGP or
    the other two senior volunteer programs. The largest, oldest and most
    well-known of the three senior volunteer programs--the Foster
    Grandparent Program--is virtually ignored in this budget, as it was in
    the Administration's fiscal year 2000 budget.
        In addition, by way of a never-before-used interpretation of
    Section 225 of the Domestic Volunteer Service Act of 1993 (Programs of
    National Significance, or PNS, grants), which was enacted in 1989, the
    Administration fails to designate at least one-third of the fiscal year
    2001 increase requested for FGP for PNS expansion grants for existing
    programs. The intent of Sec. 225 when enacted was to ensure that at
    least one-third of any increases would be made available to current
    FGP, SCP, and RSVP projects to expand the number of volunteers in their
    communities. In fact, since 1989 the one-third PNS set-aside has been
    the ONLY mechanism by which current programs have been able to expand
    their volunteer numbers and meet their communities' needs. CNS even
    held fast to the one-third PNS set-aside in fiscal year 1997, when the
    increases received by the three programs represented only a restoration
    to fiscal year 1995 levels after the programs experienced
    appropriations cuts in fiscal year 1996. This new interpretation is
    whimsical and unacceptable, and will establish a dangerous precedent
    for the use of future appropriations if allowed to stand.
        The Administration's budget also fails to request funds to increase
    the non-taxable, non-income stipend provided to our low income
    volunteers. While the stipend has not increased since January, 1998;
    the increase in the cost-of living since then has caused the costs of
    volunteering to escalate dramatically, especially the price of gasoline
    and other costs associated with daily transportation. We believe that
    the current stipend of $2.55/hour is no longer adequate to cover the
    costs associated with volunteering.
     the administration's fiscal year 2001 request for senior demonstration
        Although fiscal year 2000 appropriations conference and bill
    language has effectively stopped the payment of a non-taxable, non-
    income stipend to people whose incomes exceed the income eligibility
    requirements set in the DVSA for FGP and SCP, the administration is
    again requesting demonstration funds to continue to pay RSVP Leaders in
    fiscal year 2001, using the rationale that RSVP has no statutory income
    requirements for its volunteers. We are very aware that Congress
    intended to exclude from those receiving a non-taxable, non-income
    stipend all FGP, SCP and RSVP volunteers whose incomes exceed the
    income requirements set in the DVSA for FGP and SC (125 percent of the
    national poverty level). Both NAFGPD and the National Association of
    RSVP Directors believe the Administration's request is a flagrant
    violation of the intent of Congress as expressed in fiscal year 2000
    appropriations law, and should not be funded.
        The Administration also requests demonstration funds for grants to
    national organizations to develop plans to use more senior volunteers
    to further their missions. We believe that these challenge grants will
    be used by the national organizations to implement programs that will,
    in essence, be the beginning of a 4th senior volunteer program that
    will use non-federal funds to continue the practice of paying non-
    taxable, non-income stipends to people meeting no income eligibility
    requirements.
        NAFGPD is not opposed to demonstration efforts which will improve
    the way FGP, SCP, or RSVP deliver services, or which will help to test
    innovative program and volunteer activities which will improve the
    existing programs. We are opposed to demonstration activities that will
    be used to start a 4th--and totally unnecessary--senior volunteer
    program, especially one designed to pay volunteers who can afford to
    volunteer without a financial enabler. We are also opposed to using
    scarce federal dollars to fund efforts that will in no way improve the
    three existing senior volunteer programs. In fact, this new 4th program
    will actually duplicate the services performed by the 25 year old RSVP
    program, which now engages nearly \1/2\ million volunteers who serve
    without any payment at all! The federal demonstration dollars requested
    by the Administration for national organizations are better invested in
    FGP to enable low-income seniors to serve.
       nafgpd's fiscal year 2001 request for fgp and senior demonstration
        Given the growing number of eligible low-income seniors and the
    staggering number of troubled and challenged children in America today,
    we believe that the Administration's request does not invest adequately
    for the future in the Foster Grandparent Program, and actually diverts
    funds which could be invested in FGP into demonstration activities we
    cannot support. We ask that you (1) adopt a different fiscal year 2001
    funding allocation for FGP, one which will more properly address the
    important role our programs must play in engaging more of our nation's
    low-income elders in addressing serious community needs in more
    communities nationwide; and (2) refrain from appropriating any federal
    dollars to senior demonstration. Our fiscal year 2001 request is as
    follows:

                            [In millions of dollars]

    Foster Grandparent Program....................................   107.177
    Senior Demonstration....................................................

        This request represents an $11.189 million increase over
    FGP's fiscal year 2000 level. We also request that the
    Committee include report language accompanying the fiscal year
    2001 funding measure which supports and specifies the following
    allocation priorities for use of the fiscal year 2001 increase:
        First, for the Foster Grandparent and Senior Companion
    Programs, increase the stipend which enables low income
    volunteers to serve from $2.55/hour to $2.65/hour. Funds should
    be available to pay for the additional $.10 per hour for non-
    federally funded volunteers for one year;
        Second, award an administrative cost increase of 3 percent
    to each existing FGP in order to maintain quality and sustain
    the work already being done by programs;
        Third, allocate funds for the $1.1 million requested by the
    Administration to allow programs to increase their
    technological capabilities to meet standards set by CNS;
        Fourth, in accordance with the Domestic Volunteer Service
    Act (DVSA), use 1/3 of the increase over the fiscal year 2000
    level to fund Program of National Significance (PNS) expansion
    grants to allow existing FGP programs to expand the number of
    volunteers serving in areas of critical need as identified by
    Congress in the DVSA; areas which may not be limited to America
    Reads activities, and with no minimum or maximum grant size
    specified by CNS;
        Finally, begin 20 new Foster Grandparent Program projects
    in geographic areas currently unserved.
        This funding proposal will generate opportunities for more
    than 4,000 new low-income senior volunteers contributing in
    excess of 4.1 million hours of service annually to more than
    15,900 additional children. In addition, 20 more communities
    will receive the multifaceted services of FGP, a small step
    toward NAFGPD's fiscal year 2000 goal of beginning 100 new
    Foster Grandparent Programs nationwide by 2004.
        A New York Times article (March 21, 1999) on volunteers and
    retirement stated that ``. . . Thousands of older people are on
    the waiting list for the Foster Grandparent program, in which
    25,000 older adults whose income is below the poverty line
    receive a small stipend for volunteering 20 hours a week to be
    grandparents for disabled or disadvantaged youngsters. Many
    young people need mentors and foster grandparents, but lack of
    money precludes more participation.'' Our experiences strongly
    support this statement. In communities that already have a
    Foster Grandparent Program, unfilled requests from local
    organizations for more Foster Grandparents are the rule, not
    the exception. And when Congress provided funds for 25 new
    Foster Grandparent Programs in fiscal year 1998--the first new
    programs in 18 years--125 high-quality applications were
    submitted by local community organizations nationwide.
        In addition, a 1998 AARP survey conducted by Roper Starch
    Worldwide indicated a ``sea change'' in retirement patterns:
    the majority of ``babyboomers'' intend to continue to keep
    their jobs and never retire from work! The 1998 Independent
    Sector study showed that seniors who are still working are more
    likely to volunteer on an informal basis than to volunteer in a
    program like FGP that requires a commitment of 20 hours of
    service every week. It will be the ``boomers'' who have not
    acquired the skills needed to keep their jobs as they age or
    who have worked at low-paying jobs who will be available to
    volunteer every day, who will need FGP to provide them with
    opportunities to stay active.
        Please help us tap one of the nation's only increasing
    national resources--our low-income seniors--by supporting a
    total fiscal year 2001 appropriation of $107.177 million for
    the Foster Grandparent Program, and allocating no funds to
    senior demonstration for fiscal year 2001.
                                    ------

          Prepared Statement of the American Museum of Natural History

        Thank you, Mr. Chairman, for allowing me to testify before the
    Subcommittee today. My name is Craig Morris, and I am speaking on
    behalf of the American Museum of Natural History and in support of the
    Institute of Museum and Library Services.
                  about the american museum of natural history
        Founded in 1869, the American Museum of Natural History [AMNH] is
    one of the nation's preeminent institutions for scientific research and
    public education. Throughout its history, the Museum has pursued its
    joint missions of science and education, of examining critical
    scientific issues and educating the public about them. It is renowned
    for its exhibitions and collections, which serve as a field guide to
    the entire planet and present a panorama of the world's cultures.
    Museum collections of some 32 million natural specimens and cultural
    artifacts provide an irreplaceable record of life on earth. Its
    explorers and scientists have pioneered discoveries and offered us new
    ways of looking at nature and human civilization. The Museum's power to
    interpret wide-ranging scientific discoveries and convey them
    imaginatively has inspired generations of visitors to its grand
    exhibition halls and educated its three million annual visitors--
    500,000 of them schoolchildren--about the natural world and the
    vitality of human culture.
        Since 1887 the Museum has sponsored thousands of expeditions,
    sending scientists and explorers to every continent; currently more
    than 100 field projects are conducted each year, including ongoing
    research in such countries as Chile, China, Cuba, Madagascar, Mongolia,
    and New Guinea. Some of the most influential scientists of the
    twentieth century, including Margaret Mead, George Gaylord Simpson, Roy
    Chapman Andrews, and Ernst Mayr were either staff members of or
    affiliated with the Museum.
        Today more than 200 active Museum scientists with internationally
    recognized expertise, led by 47 curators, conduct laboratory and
    collections-based research programs as well as field work and training.
    Scientists in five divisions (Anthropology; Earth, Planetary, and Space
    Sciences; Invertebrate Zoology; Paleontology; and Vertebrate Zoology)
    are sequencing DNA and creating new computational tools to retrace the
    evolutionary tree, documenting changes in the environment, making new
    discoveries in the fossil record, and describing human culture in all
    its variety. The Museum also conducts graduate training programs in
    conjunction with a host of distinguished universities, support doctoral
    and postdoctoral scientists with highly competitive fellowships, and
    offer talented undergraduates an opportunity to work with Museum
    scientists.
        In many ways, the AMNH is similar to a research university, with
    its scientific faculty from diverse fields such anthropology, earth and
    planetary sciences, astrophysics, and all branches of zoology. Yet the
    Museum is distinct in that its mission extends beyond research and
    training. Museum curators are also deeply engaged as exhibition and
    education advisors and as caretakers of the Museum's ever growing
    collections. They help to promote public understanding of science, of
    where we come from and where we may be headed.
        In exhibitions, which are among the Museum's most potent
    educational tools, AMNH scientific knowledge and discovery are
    translated into three dimensions. The Museum is proud to continue its
    tradition of creating some of the world's greatest scientific
    exhibitions. Last month, in one of the most exciting chapters in the
    Museum's long and distinguished history of advancing science and
    education, it opened the spectacular new Rose Center for Earth and
    Space. The Rose Center includes a newly rebuilt and updated Hayden
    Planetarium that allows visitors to journey among the stars and planets
    in our own and in other galaxies; and the Lewis B. and Dorothy Cullman
    Hall of the Universe, where interactive technology and participatory
    displays elucidate important astronomy and astrophysics principles. The
    adjoining Gottesman Hall of Planet Earth, which opened in 1999,
    explores the processes that determine how the Earth works; it in turn
    leads to the recently opened Hall of Biodiversity. Together, the new
    planetarium and halls provide visitors a seamless educational journey
    from the universe's beginnings to the formation and processes of Earth
    to the extraordinary diversity of life on our planet.
        The Museum's Education Department spearheads the AMNH's commitment
    to promoting public education, particularly in an informal setting. It
    builds on the Museum's unique resources to offer rich educational
    programming dedicated to increasing scientific literacy, to encouraging
    students to pursue science and museum careers, and to providing a forum
    for exploring the world's cultures. The Department targets its efforts
    particularly to New York City's diverse and often underserved
    communities and school districts, to those populations traditionally
    poorly served by schools, those underrepresented in science, and those
    for whom museums typically are not a welcoming destination.
        Each year hundreds of thousands of students, teachers, and schools
    participate in workshops, courses for college credit, and visits to the
    Museum. Annually, more than 500,000 students and teachers visit on
    school trips, prepared and supported by curriculum resources and
    workshops. For schools that cannot get to the Museum, Moveable Museums
    offer off-site access, free of charge. As well, Education Department
    lectures, field trips and workshops on subjects ranging from birding to
    earthquakes, gospel music to Native American culture, and Hudson River
    geology to gorilla conservation attract large audiences of adults,
    children, and families.
        In 1997 the Museum launched in partnership with NASA the National
    Center for Science Literacy, Education, and Technology to advance
    science literacy throughout the United States and to extend the
    Museum's educational reach and impact to a national audience, including
    local communities. In creating the National Center, the Museum and NASA
    recognized an opportunity to combine and leverage their incomparable
    resources, and through new technologies to bring learning and
    discovery, materials, and programs into homes, schools, museums, and
    community organizations around the nation.
            support for the institute of museum and library services
        The American Museum of Natural History supports the goals and
    accomplishments of the Institute of Museum and Library Services [IMLS].
    The Museum's own collections of more than 32 million artifacts and
    specimens are considered to be the largest non-federal Museum
    collection in America, and one of the largest and most significant
    biological collections in the world. Its Library houses one of the
    world's preeminent collections of natural history and anthropology
    materials. It shares IMLS commitments to increasing technological
    access to the nation's museum and library resources and to building
    partnerships to address community needs; and it urges increased
    investment in IMLS so as to advance public access to these vital
    educational institutions.
    Scientific and Cultural Collections
        The cumulative result of 130 years of exploration, collecting, and
    research, the AMNH collections are a major scientific resource
    providing the foundation for the Museum's interrelated research,
    education, and exhibition missions. Those collections are organized
    around the departments of Entomology, Herpetology, Ichthyology,
    Invertebrates, Mammalogy, Ornithology, and Vertebrate Paleontology.
    They often include endangered and extinct species as well as many of
    the only known ``type specimens,'' or examples of species by which all
    other finds are compared. Within the collections are many spectacular
    individual collections, including the world's most comprehensive
    collections of dinosaurs; fossil mammals; Northwest Coast and Siberian
    cultural artifacts; North American butterflies; spiders; Australian and
    Chinese amphibians; reptiles; fishes outside of their home countries;
    and one of the most important bird collections. Collections such as
    these are historical libraries of expertly identified examples of
    species and artifacts, associated with data about when and where they
    were collected. Such collections provide essential baseline data for
    Museum scientists as well as more than 250 national and international
    visiting scientists each year. And the collections are all located on-
    site to allow scientists' with ease of access.
        The Museum's halls of vertebrate evolution provide an excellent
    example of the relationship among science, collections, education, and
    exhibition. In these halls, visitors walk directly along a phylogenetic
    tree indicated by a pathway on the floor. At each branch in the tree, a
    visitor can stop and view fossils that exemplify sets of anatomical
    features that inform scientists about natural groups of organisms. The
    collections are also the source of the extraordinary ``Spectrum of
    Life'' exhibit in the new Hall of Biodiversity. This exhibit features
    more than a 1,000 expertly mounted specimens from 28 scientific
    classifications; it is perhaps the world's most comprehensive display
    of the diversity and evolution of life. It includes interactive
    computer kiosks that visitors use to identify and interrelate organisms
    on evolutionary trees. The confluence of collections, evolutionary
    research, and beautiful exhibition makes these halls among the Museum's
    most compelling educational features.
    Natural History Library
        The American Museum of Natural History is also home to the largest
    unified natural history library in the Western Hemisphere. In addition
    to supporting the work of the Museum's scientific staff, the Library
    serves the world's scientific and scholarly communities as well as
    students from the colleges and universities in the tri-state area and
    interested members of the public. Each year thousands of users visit
    the Library, and its staff answer more than 26,000 reference questions.
        The Library contains over 485,000 volumes, including pamphlets,
    reprints, books, journals, photos, several hundred films, and rare
    books dating to the fifteenth century. It also houses the Museum's
    astronomy collections, including the Perkins Library of more than
    35,000 volumes and the Bliss Collection of rare and ancient scientific
    instruments. The archives contain more than 1,900 linear feet of
    materials and 250 reels of microfilm. Additionally, the Library
    maintains approximately 1,000,000 photographic images documenting
    specimens and scientific work, 3,000 documentary films, and over 2,700
    art objects and memorabilia.
        Other highlights of the Library collection include over 300
    manuscript collections of notable naturalists and scientists; a unique
    collection of 13,000 rare books that spans over 500 years of scientific
    and expedition literature; and diaries and logs, including Captain
    James Cook's account of Australia (1783) and Charles Darwin's zoology
    of the voyage of ``H.M.S. Beagle'' (1839-1843).
    Preservation and Access
        By assuming stewardship of these irreplaceable Library holdings and
    scientific collections, the Museum serves as custodian of one of the
    most important records of life on earth. And as steward and custodian,
    it places the highest possible priority on preservation and access, so
    that the collections will be protected and available for research, for
    exhibit, and for education for generations to come.
        The Library is engaged in a major pilot effort, with private
    foundation support, to digitize its holdings and link them to the
    scientific collections. This model project, illustrative of the
    digitization initiatives the IMLS supports, will help to pave the way
    in transforming access to and ways to use the Museum's collections and
    holdings. An expansion of the digitization project would increase
    access enormously for researchers, students, teachers, and the general
    public to the Museum and Library holdings.
        The Museum has also undertaken major efforts to improve storage,
    preservation, and access of its vast collections. This year Museum
    departments will move into a new nine-story Natural Science Building.
    This facility will significantly increase exhibition and collections
    storage space, with 30,000 sq. ft. of climate-controlled compact
    storage facilities for portions of the scientific collections, along
    with a digital imaging laboratory.
        The Anthropology Division is also nearing completion of a 25-year
    collection storage upgrade and related digitization project. Scheduled
    for completion in 2002, and with support from the National Endowment
    for the Humanities, this upgrade will ensure scholarly access to these
    vital and magnificent collections. The new digital image database and
    accompanying electronic catalog will facilitate access for staff,
    visiting scholars, and off-site researchers.
         biological collection storage upgrade and digitization project
        With the successful Anthropology storage upgrade and digitization
    project nearly complete, the Museum now turns its focus to critical
    improvement of other storage facilities and to digitizing the
    biological collections for upgraded preservation and wider access. The
    IMLS has a distinguished history of supporting cutting edge collection
    and technological practices. We do seek partnerships with IMLS that
    will allow us to provide leadership in collection practices and serve
    as a national model in improving public access to museum and library
    resources through technology.
    Technological Innovation for Greater Public Access
        Biological science at the Museum centers on expert documentation of
    species and investigation of their evolutionary and ecological
    relationships. The collections therefore provide essential baseline
    data for scientific inquiry. Due to the unparalleled interest in the
    Museum's biological collections and unwieldliness of the specimens,
    comprehensive digital imaging and electronic cataloging of many of
    these collections will allow the Museum readily to share our resources
    through technology with a national and international audience. We would
    like to develop a database, with a web front end for worldwide general
    audience access, to allow digitized specimens and field data to be
    searched across many fields (for instance, by locality or age).
    Detailed digital renderings would allow ready and safe access to often
    fragile archival material and allow off-site researchers and users to
    peruse the collection and strategically plan Museum visits. These last
    two matters are key. If using the database can help researchers can
    plan Museum visits, the productivity of their visits will be
    significantly enhanced.
    Collection Storage Facilities
        Collections preservation and access are top Museum priorities. The
    Museum's collections are the heart and soul of our scientific research,
    permanent and temporary exhibitions, and education programs. Access to
    the collections allows undergraduate, graduate, post-graduate, and even
    high school students to conduct real research projects in intensive
    learning programs. As the collections grow, questions about how to
    curate them, including how to use limited physical storage space,
    arise. While many similar institutions house their collections
    separately from their faculty, the Museum is committed to keeping its
    scientists, educators and collections together by expanding on site.
    The new Natural Sciences Building, for example, can accommodate a
    substantial amount of new compact storage, including a unique super-
    cold storage facility to allow for the preservation of tissue samples
    for future of DNA study.
        As these endeavors demonstrate, the American Museum of Natural
    History supports the important goals of IMLS to preserve and expand
    access to library and museum resources and to reach out to broad
    audiences and diverse communities.
                                     ______

           Prepared Statement of the Colonial Williamsburg Foundation

        Chairman Specter and members of the Senate Appropriations
    Subcommittee on Labor, Health and Human Services, Education, and
    Related Agencies, I want to thank you for the opportunity to submit the
    following two proposals that we at Colonial Williamsburg are excited
    about and feel could help to re-calibrate our national compass and
    engage future generations in a stimulating discussion about the basic
    principles of democratic government that have made this country a world
    leader.
        You may know Colonial Williamsburg as John D. Rockefeller, Jr.'s
    famous restored eighteenth century town. But the significance of this
    town goes far beyond the bricks and cobblestones. We are the nation's
    largest outdoor living museum. Our conservancy museums have one of the
    largest collections of eighteenth century Antiquities in the world.
    There are over 600 original and restored eighteenth century buildings
    in our 173 acre Historic Area. We also have a large and talented
    interpretive staff who can bring American history and the democratic
    principles of our forefathers to life in a fun and stimulating learning
    environment. Quite simply, Colonial Williamsburg is an educational
    institution. Its significance is both public and personal, educational
    and experimental. Its mission is to tell the story of a diverse group
    of people who fought to create a new community in a new land, based on
    new ideals.
        Our living history approach creates the environment of the past--a
    colonial town--and populates the streets, homes, and shops with
    costumed interpreters. Visitors can actually touch history. They can
    talk with tradesmen, ask them questions, and examine their crafts. They
    can sit as a local magistrate at the colonial county courthouse. They
    can eat a meal in an authentic eighteenth century colonial tavern, help
    make bricks for the foundation of a house, even engage in a political
    discussion with George Washington, Thomas Jefferson, or the royal
    governor. They hear the echoes of Patrick Henry's denunciation of the
    Stamp Act resonate throughout the halls of the Colonial Capitol.
    Visitors can literally immerse themselves in the past. The result is a
    dynamic method of history education that generates an excitement for
    learning about the ideas and principles upon which our democracy is
    based.
        Over three million people visit our site each year from all 50
    states and from many other countries. But our goal of fulfilling
    Jefferson's objective of an educated populace does not stop with just
    those guests who are able to visit Colonial Williamsburg in person.
        Colonial Williamsburg has long been the leader in providing
    distance learning with a variety of educational programming activities
    for over fifty years. Today, with the best technological communication
    resources at our command, we are able to reach millions of students and
    teachers throughout the country through broadcast, internet,
    interactive media and digital satellite. One of the results of these
    advances in technology is our award winning Electronic Filed Trips that
    allow students and teachers to ``visit'' Williamsburg via interactive
    television programs, while our www.history.org web site offers
    convenient access to our educational and research resources on the
    Internet.
        Our Electronic Field Trips provide a live, interactive format by
    Colonial Williamsburg to over one million registered students. These
    programs are also viewed by another three million students on a delayed
    basis courtesy of local PBS stations. We provide seven Electronic Field
    Trip programs each year. The programs deal with a variety of topics
    from methods of travel in the eighteenth century, to slavery,
    apprenticeships, and indentured servitude, to tradesmen rebuilding the
    houses and structures of Colonial Williamsburg. Schools that register
    for the program receive printed lesson plans, resource materials,
    internet activities, and other materials to prepare students during the
    month preceding the program. The program comes live into the classroom
    and registered students can phone in questions to interpretive staff
    who appear in the program segment. Over 30 other interpretive and
    research staff take calls, email, and internet messages and respond to
    the students. Material remains on our web site for 30 days after the
    program. During one of our most recent programs, over 1,300 calls from
    across the country were received.
        While we currently reach over four million students with these
    award-winning, state-of-the-art programs, we feel we have an obligation
    to help more schools and students meet national standards of learning.
    We have been informed that in schools using the Electronic Field Trips
    these scores have gone up. The programs address more than just history
    SOL's--they cover science, math, and other subjects as well.
        We would like to be able to offer our Electronic Field Trips, free
    of charge to an additional 10,000 schools across the country. This
    would mean reaching an additional five million students a year. We have
    already developed the facilities and the high tech programmatic
    infrastructure for these programs. We have proven how successful they
    can be in exciting and educating students. We believe that if we can
    reach these additional 10,000 schools, the programs will become self-
    supporting. We believe we can convince these schools and others that
    the seven programs are worth $500 a year. As stewards of an important
    segment of our American heritage, we are asking for a one-time
    appropriation of $3 million to reach an additional five million
    students and to help students, teachers, and schools in all 50 states
    provide the type of state-of-the-art programs that teachers want and
    that will use twenty-first century technology to develop an
    understanding in the students of timeless eighteenth century
    principles.
        We want to expand our educational programs to many more areas and
    students across the country. The Electronic Field Trips offer
    stimulating, state-of-the-art, fun, yet challenging programs. They have
    allowed millions of students and teachers to learn and understand the
    events that have shaped the nation's history. They also ensure we keep
    alive John D. Rockefeller Jr.'s goal for Colonial Williamsburg ``that
    the future may learn from the past.''
        You may accuse me of bias, but I believe Mr. Rockefeller would be
    proud of our educational programs. He would also encourage us to do
    more with his vision in mind. The advent of the twenty-first century
    provides an appropriate time to reflect on America, the democratic
    values that have influenced representative government, and the legal
    principles that have always protected a free society. Indeed, the onset
    of the new century in an opportune time to focus on the History of
    America.
        Responding to the challenge to learn from the past and prepare new
    generations of American leaders, the College of William and Mary and
    Colonial Williamsburg, two of the most prestigious educational
    institutions in America and preeminent stewards of early American
    history, are collaborating to establish a unique and challenging
    residential program for scholarly historical research at Virginia's
    Colonial Capital. We are tentatively calling it the Institute of
    American History and Democracy.
        The goal of the institute will be to assist the nation in re-
    calibrating its internal compass to enhance the understanding of
    college and high school students in our nation's historic journey and
    to encourage the ongoing review of America's founding principles. The
    Institute would be open to visiting undergraduates from colleges and
    universities across the United States and from the international
    community. Academic credit would be provided by the College of William
    and Mary.
        Joint William and Mary and Colonial Williamsburg faculty, as well
    as nationally-recognized historians would develop the curriculum and
    present the courses. Course topics would include early American
    history, constitutional history, governmental institutions, social
    history, military history, archeology, and museum-related fields.
        During the summer, this joint faculty would provide a similar
    program of courses for outstanding high school students from across the
    country. Summer high school students would be able to earn advance
    college credit for these courses. Colonial Williamsburg has been
    providing a similar program for teachers for the last ten years. Our
    Teacher Institutes have helped to avoid teacher burnout and have
    instead rekindled the passion for history and raised the teaching
    skills of those attending, several of whom have later been named
    teacher of the year in their states.
        Both Colonial Williamsburg and the College of William and Mary have
    developed some of this country's most advanced and interactive methods
    of education. College and high school students who attend the proposed
    Institute would become involved in interactive and hands-on learning
    experiences, as well as being exposed to extensive original research
    materials. These teaching methods along with state-of-the-art
    technology will engage the students and bring history alive. It is our
    hope that the curriculum developed for the Institute could also be
    adapted to our outreach capabilities and thereby made available to an
    even wider audience.
        We are seeking a one-time award of $5 million to cover the initial
    start-up costs for the Institute including curriculum development,
    staff training, program marketing, and facility modifications. Housing
    will be provided by Colonial Williamsburg at existing facilities.
    Classroom space will be provided by Colonial Williamsburg and the
    College of William and Mary at existing facilities. Once established,
    the program will be self-supporting through tuition and private
    donations.
        I should note that Colonial Williamsburg has never sought this type
    of federal funding support before. We are seeking this assistance now
    because we believe these two programs will add significantly to future
    generations' understanding of basic democratic principles and will help
    to keep those principles alive and well for many generations to come.
    We want to help keep the ship of state pointed in the right direction
    by ensuring all of our citizens understand and can apply the basic
    principles and ideals of democracy that were established in this
    country in the late 1700's by the founders of our nation.
        Again, thank you for the opportunity to submit what we believe are
    two very exciting proposals. We hope you will agree and will help us
    make them a reality.
                                     ______

        Prepared Statement of the National Minority Public Broadcasting
                                   Consortia

        The National Minority Public Broadcasting Consortia (Minority
    Consortia) submits this statement on the fiscal year 2003 appropriation
    for the Corporation for Public Broadcasting (CPB). Our primary missions
    are to bring a significant amount of programming from our communities
    into the mainstream of PBS and public broadcasting. In summary, we
    request that the Committee support:
      --The Administration's request of $365 million for CPB for fiscal
            year 2003, a $15 million increase over fiscal year 2002;
      --The Administration's request of $20 million in CPB fiscal year 2001
            funds for digital conversion; and we request that some of this
            funding be available to independent minority producers for
            conversion to digital production;
      --With regard to the Minority Consortia and multicultural programming
            we request that the Committee support--
        An increased allocation of CPB program funds to expand our
                programming, including a 15 percent increase in the
                Multicultural Program Fund (currently at $3.2 million)
                which we administer;
        An increased allocation of CPB system support funds to expand our
                administrative capacity, at an amount at least commensurate
                with the overall CPB increase;
        Increased CPB outreach efforts to promote the multicultural
                television productions expected to air on PBS this year.
        The National Minority Public Broadcasting Consortia consists of the
    National Asian American Telecommunications Association, the National
    Black Programming Consortium, Native American Public
    Telecommunications, Pacific Islanders in Communications and the Latino
    Public Broadcasting Project.
        A federal appropriation of $365 million as requested by the
    Administration for CPB would be a reasonable, albeit modest,
    contribution toward our national treasure of public broadcasting. The
    debate of the past several years regarding public television and public
    radio has highlighted the great esteem in which they are held. We urge
    Congress to provide at least as much as has been requested by the
    Administration for CPB for fiscal year 2003.
        Public broadcasting, including PBS and NPR, is particularly
    important for minority and ethnic communities. While there is a niche
    in the commercial broadcast and cable world for quality programming
    about our communities and our concerns, it is in the public
    broadcasting industry where minority communities and producers are more
    able to bring quality programming for national audiences. Additionally,
    public television and radio is universally available. In 1994, CPB
    initiated research among Asian American and Native American communities
    which documented that respondents felt their communities were
    negatively stereotyped on commercial television and that that PBS had
    more realistic portrayals. (REACHING COMMON GROUND: PUBLIC
    BROADCASTING'S SERVICES TO MINORITIES AND OTHER GROUPS, July 1, 1994,
    pages 41-41 of the Appendix). This survey also revealed that both
    groups wanted increased visibility in public television and further
    recommended that there be expanded promotion of public broadcast
    programming utilizing Asian American and community groups and tribal
    organizations. Earlier CPB surveys of Latino and African American
    communities showed similar findings.
        This is the Optimum Time to Increase Resources for CPB's Mission of
    Diversity.--The Minority Consortia works closely with CPB. We value our
    relationship with President Coonrod and the CPB staff and appreciate
    the financial and technical assistance provided to us by that
    organization. We do not doubt CPB's commitment to increasing the
    diversity of programming on public television and radio, but also
    believe they can do more with the resources at hand. The stated
    commitment of CPB and Congress for increased multicultural programming
    combined with three years of funding increases make this an ideal time
    for significant progress. It may be now or never.
        Since 1988, ten Congressional authorizing and appropriations
    reports have expressed support for the Minority Consortia and/or for
    increased multicultural programming on public television.
        The CPB fiscal year 2000 funding received by the Minority Consortia
    organizations--$1.53 million for institutional support ($307,000 per
    organization--a $28,000 increase per organization over fiscal year
    1999) and $3.2 million in programming funds ($636,000 per
    organization)--is certainly modest compared to the cost of producing an
    increased amount of quality multicultural programming for public
    broadcast. Our programming and administrative support funding combined
    is 1.56 percent of the CPB fiscal year 2000 budget (Fiscal years 2001
    and 2002 funds have not yet been distributed). We appreciate that CPB
    has identified an additional $2.5 million in program funds which we,
    along with others, can compete, but the commitment for diverse
    programming should be larger than that.
        The Minority Consortia shared in the CPB fiscal year 1997 and 1998
    budget reductions. Now, however, we are in a period for which Congress
    has appropriated increased funding for CPB. The CPB fiscal year 2001
    appropriation, which has not yet been distributed, is $340 million, a
    $40 million increase over fiscal year 2000. And the fiscal year 2002
    appropriation is $350 million, an increase of $10 million over fiscal
    year 2001.
        The testimony of CPB President Bob Coonrod before this Subcommittee
    on March 28, 2000 discussed the need to increase the diversity of
    public broadcasting offerings, including multicultural programming. He
    also noted that the younger segment of our society is even more
    ethnically diverse than the older population. We applaud CPB's public
    discussion of this need, and intend to work collaboratively with them
    and the entire public broadcasting community to help make this a
    reality. But in order to do this, the amount of funding allocated for
    the development of multicultural programming must substantially
    increase. And at a minimum, the administrative funding for the
    Consortia should increase commensurate with the overall CPB budget (a
    proposed 4.2 percent increase for fiscal year 2003).
        Audience Building.--We ask your support in encouraging CPB to
    increase its efforts to build audiences for PBS programs presented by
    the Minority Consortia. The good news is that number of programs
    presented by the Minority Consortia on public television are
    increasing. On the other hand, the small administrative an program
    budgets of the Minority Consortia are not sufficient to do the kind of
    community and national outreach we would like for building audiences
    for these programs. Obviously, we engage in audience building, but much
    more can and should be done.
        The most recent shows on national public television from the
    Minority Consortia organizations include regret to inform, homecoming--
    sometimes I am haunted by memories of red dirt and clay, and warrior in
    two worlds.
        Digital Conversion Assistance.--Much attention was given at the
    March 28, 2000 House appropriations hearing regarding the opportunities
    which digital technology will provide in the area of programming. With
    stations able to broadcast on multiple channels, there will be a need
    for a tremendous amount of new, quality public broadcasting
    programming. There are costs involved in the conversion which go beyond
    the significant equipment and hardware needs of stations. It will also
    take additional money to produce programming for digital broadcast. All
    producers will face these new, higher costs. Film producers will need
    to use equipment that is high definition quality, and that is an
    expensive proposition. Most producers with whom we work do have not the
    finances for this new equipment. CPB is currently providing some
    technical assistance to producers regarding digital conversion.
    However, independent producers also need financial assistance in
    acquiring or accessing the means to produce programming for digital
    broadcast.
        We also point out that the Minority Consortia organizations are
    jointly seeking non-federal sources of funding to support digital
    production for independent producers, and like their counterparts in
    public television and radio stations, independent producers also need
    federal assistance to make this transition.
        Work of the Minority Consortia.--The Minority Consortia
    organizations work both individually and collaboratively. In the past
    twenty years the Consortia organizations have individually provided to
    public broadcasting's schedule hundreds of hours of programming
    addressing the cultural, social and economic issues of the country's
    racial and ethnic communities. Individually, each Consortia
    organization has been engaged in cultivating ongoing relationships with
    the independent producers community by providing technical assistance,
    program funding, programming support and distribution. We also provide
    numerous hours of programming to individual public television and radio
    stations.
        On the collaborative front, the five organizations comprising the
    Minority Consortia are working to jointly write and publish a catalog,
    newspaper ads, Open Calls for Proposals, and a newsletter.
        Perhaps of most potential significance is our planned joint
    production of a four-part series which will explore the complex demands
    of our rapidly changing multiracial, multicultural society in America.
    We will work with many film producers and with CPB and PBS on the
    production, and CPB will provide some financial assistance. The
    production is entitled Matters of Race, and we have engaged noted
    producer/writer Orlando Bagwell (Malcom X: Make it Plain, Eyes on the
    Prize, A Hymn for Alvin Alley, Fredrick Douglass: When the Lion Wrote
    History) to produce this series. The project will result in more than
    television programming. The project will utilize an advisory group of
    teachers and will be designed so that modules that can be pulled out
    for classroom use. It will also be formatted for radio broadcast and
    for the internet, and will include such broadcast applications as
    extended interviews. There will be great opportunity for extensive and
    diverse community outreach and collaboration on this project throughout
    its development, distribution and use.
        Currently the five consortia groups are in discussion with other
    public broadcast entities to pool and share resources to increase
    awareness of PBS's and public broadcasting diversity initiative. Some
    of these collaborations include centralizing program distribution with
    American Public Television, creating minority outreach for stations
    with the Public Television Outreach Alliance, and working with CPB and
    PBS to formulate a long range strategy for minority programming for
    public broadcasting. The Minority Consortia organizations work
    collaboratively with a number of television stations, and hope to
    increase such working relationships.
        Thank you for your consideration of our recommendations. We see new
    opportunities to increase diversity in programming, production,
    audience, and employment in the new media environment, and we as
    minority communities in public broadcasting thank you for your long
    time support of our work on behalf of our communities.
                                     ______

        Prepared Statement of the National Congress of American Indians

                                  introduction
        Good morning Chairman Specter, Senator Harkin and distinguished
    members of the Appropriations Subcommittee on Labor, Health and Human
    Services, Education, and Related Agencies. My name is Susan Masten and
    I am the President of the National Congress of American Indians (NCAI),
    the oldest and largest Indian advocacy organization in the United
    States and Chairperson of the Yurok Tribe. On behalf of the 250 member
    tribes of NCAI, I would like to thank you for this opportunity to
    submit this statement regarding the President's budget request for
    fiscal year 2001.
        NCAI is extremely optimistic about this year's budget process. For
    the first time in a generation, the President has requested a total of
    $9.4 billion for new and existing Indian programs. If preserved through
    the appropriations process, this request will provide an increase of
    $1.2 billion over the fiscal year 2000 budget. The last time the
    Federal Government enacted an increase of a similar scope, was in the
    mid-1970's, as a part of President Nixon's Tribal Self-Determination
    policy. The President's fiscal year 2001 budget request represents a
    commitment to Indian programs and will better serve Indian communities.
    It also exemplifies a meaningful step toward honoring the Federal
    Government's treaty and trust obligations to Indian nations. As
    Congress advances the appropriations process for fiscal year 2001, NCAI
    seeks support from this Subcommittee to fully fund the Indian programs
    in the Departments of Education, Health and Human Services, and Labor.
                            department of education
        For fiscal year 2001, the President's budget request for the
    Department of Education Office of Indian Education (OIE) is $116
    million, a 50 percent increase over the fiscal year 2000 enacted level.
    NCAI fully supports this request as it will allow the Department's OIE
    to fund formula grants to Local Education Agencies (LEAs), fund new
    discretionary programs for OIE, and start a new program for American
    Indian administrators. Additionally, NCAI fully endorses the
    Administration's effort to fund the initiatives under the 1998
    Executive Order on Indian Education.
        For fiscal year 2001, $92.8 million is requested for OIE's formula
    grant program to public schools, an increase of $30 million over fiscal
    year 2000. These funds are provided to BIA supported schools for the
    improvement of educational achievements of Indian students by allowing
    for the initiation and expansion of Indian specific programs and
    services. Within the fiscal year 2001 requested budget is a $20 million
    request for Special Programs, an increase of $6.7 million over fiscal
    year 2000, for awards for school readiness demonstrations, educator
    professional development grants, and continuation of the American
    Indian Teacher Corps. NCAI supports President Clinton's commitment to
    recruit and train 1,000 new Indian teachers over a five-year period who
    will then teach in schools with high concentrations of Indian students.
    Additionally, the President has requested $5 million for the American
    Indian Administrator Corps. Within the President's fiscal year 2001
    proposed budget for Higher Education, $40 million has been requested
    for a new dual degree program. NCAI strongly supports these funding
    initiatives to advance Indian education and develop an educational
    system responsive to the needs of Native students and teachers.
                    department of health and human services
        The fiscal year 2001 budget requests $44 million for the
    Administration for Native Americans (ANA), an increase of $9 million
    over the fiscal year 2000 enacted level. In awarding grants in fiscal
    year 2001, ANA will give special attention to energy development and
    the creation of tribal codes and ordinances. NCAI urges Congress to
    support this much-needed increase that will support tribal government
    infrastructure and increase tribal government capacity to administer
    programs.
        The fiscal year 2001 request for the Administration for Children
    and Families (ACF) Federal Administration line-item is $165 million, an
    increase of $17 million over fiscal year 2000. From this total, funding
    is provided to the Division of Tribal Services (DTS). The DTS provides
    programmatic support to 22 tribal TANF programs, which directly affects
    94 tribes and Alaska Native villages. It is estimated that by fiscal
    year 2001, approximately 50 percent of all federally-recognized tribes
    will either administer or be served by a tribal TANF program. While the
    ACF has tried to provide necessary funding to carry out these duties,
    without line-item funding authorization for the DTS, the increasing
    needs of Indian tribes surrounding these social support programs will
    not be met. NCAI requests a $10 million line-item funding for DTS.
        While the fiscal year 2001 budget requests $2 billion for the
    discretionary Child Care Development Block Grant (CCDBG), an increase
    of $817 million dollars over the fiscal year 2000 enacted level, tribal
    governments, who receive a 2 percent set aside of the CCDBG, will still
    fall far short of meeting child care needs on their reservations. There
    is a critical need for safe, healthy, nurturing child care
    environments, particularly on Indian reservations, where parents have a
    higher median number of children than the national average. NCAI
    request an increase in tribal child care funding from its current level
    of 2 percent of the total appropriation.
        The fiscal year 2001 budget boosts funding for Head Start by $1
    billion in fiscal year 2001, the largest funding increase ever. The
    budget also provides a total of $175 million, including a $30 million
    increase over fiscal year 2000, for Indian Head Start. NCAI strongly
    supports this much-needed increase to Indian Head Start programs, many
    of which are stretched to capacity.
        Three provisions under the purview of the Administration on Aging,
    authorized in the Older Americans Act (Pub. L. 89-73, as amended), are
    of special importance to American Indian and Alaska Native elders. The
    first is Aging Grants for Native Americans authorized in Title VI. The
    President's fiscal year 2001 budget requests $24 million, an increase
    of $5 million over the fiscal year 2000 enacted level, for Title VI
    grants to tribes and tribal organizations. Current grantees report a 20
    percent increase in the number of elders eligible for the service
    between 1996 and 1999. Because of this growing population of Native
    elders, NCAI requests that the full $30 million authorized for Title VI
    be appropriated in fiscal year 2001.
        The second provision is Aging Research and Training, also
    authorized in Title VI. For fiscal year 2001, NCAI requests an
    appropriation of $630,000 with at least $130,000 earmarked for a
    continuing grant to NICOA to gather information on Indian elders and to
    quantify their needs. The remainder should be directed to grants for
    training Title VI service providers to better serve Indian elders.
        The third provision is ombudsman/elder abuse prevention authorized
    in Title VII: Allotments for Vulnerable Elder Rights Protection
    Activities, Subtitle B: Native American Organization Provisions.
    Prevention programs for tribes are desperately needed--yet no funds
    have ever been provided for Subtitle B, despite an authorization level
    of $5 million. State programs currently receive $4.5 million for
    ombudsman services and $4.7 million for prevention of elder abuse
    programs. However, these programs seldom, if ever, reach Indian
    Country. NCAI seeks full funding of $5 million in fiscal year 2001,
    specifically for tribal programs as authorized in Subtitle B of Title
    VII.
        In fiscal year 2001, there is a need of $600,000 for special HIV
    surveillance studies to be undertaken in order to better understand the
    extent of the HIV epidemic in the Native American population, and to
    supplement the existing AIDS case and HIV infection data presently
    available. Additionally, $200,000 is needed to contract out a series of
    meetings between states, CDC, IHS, tribal representatives, and
    epidemiologist to make recommendations on improving the disease
    surveillance system in Native America. NCAI seeks the support of this
    Subcommittee in this request.
        The President's fiscal year 2001 budget request for the Centers for
    Substance Abuse Prevention is $48.8 million. NCAI seeks the support of
    this Subcommittee in securing a targeted funding program whose purpose
    is to involve Native American substance abuse prevention treatment
    programs more actively in the effort to slow the spread of HIV.
        The President's fiscal year 2001 budget request for the National
    Institute of Health (NIH) is $3 million. Unfortunately, there is a
    shortage of funding for research related to HIV in Native America
    within NIH. NCAI requests the support of this Subcommittee in seeking
    critical funding for behavioral research in particular, to help better
    understand the underlying components of risk behavior leading to HIV
    infection in the Native American population.
                              department of labor
        Under the Workforce Investment Act (WIA) at least $55 million can
    be appropriated for the Indian Comprehensive Services program. In
    fiscal year 2001, the Administration has requested $55 million. NCAI
    regards WIA as an opportunity to more effectively provide job training
    services and urges Congress to fully fund this program.
        The fiscal year 2001 budget proposal includes $255 million for a
    new ``Fathers Work/Families Win'' initiative, $10 million of which is
    set aside to provide grants to help Native American low-income
    families. These proposed funds are aimed at addressing the working poor
    and fathers, in the aftermath of no new WtW funding. NCAI supports the
    $10 million set aside for applicants from the Native American workforce
    agencies.
        The fiscal year 2001 budget request also provides $15 million for
    the tribal supplemental youth employment services program that replaces
    the former JTPA Summer Youth Program, and supports year-round
    activities. In addition, the President proposes to increase the Youth
    Opportunity Grant (YOG) program from its current $250 million funding
    level to $375 million in fiscal year 2001. NCAI requests sufficient
    funding to provide reliable and consistent opportunities for youth.
    NCAI also supports adequate funding of other DOL programs that benefit
    American Indians, including the Administrations's Disabilities Services
    request for $43 million in the fiscal year 2001 budget. NCAI asks that
    these work incentive grants and services be extend to tribes.
                                   conclusion
        Mr. Chairman, we urge the Congress to fulfill its fiduciary duty to
    American Indians and Alaska Native people and to uphold the trust
    responsibility as well as preserve the Government-to-Government
    relationship, which includes the fulfillment of health, education and
    welfare needs of all Indian tribes in the United States. This
    responsibility should never be compromised or diminished because of any
    Congressional agenda or party platform. Tribes throughout the nation
    relinquished their lands as well as their rights to liberty and
    property in exchange for this trust responsibility. The President's
    fiscal year 2001 budget request acknowledges the fiduciary duty owed to
    tribes. We ask that the Congress maintain the federal trust
    responsibility to Indian Country and continue to aid tribes on our
    journey toward self-sufficiency. Thank you for allowing me to present
    for the record the National Congress of American Indians' comments
    regarding the President's fiscal year 2001 budget request.
                                     ______

        Prepared Statement of the National Alliance to End Homelessness

        The National Alliance to End Homelessness is a national membership
    organization with nearly 2,000 members around the country. Most are
    local nonprofit community-based and faith-based organizations that are
    doing the hands-on work to end homelessness for families and
    individuals. As our name implies, our primary focus is ending
    homelessness, not simply making it easier to manage. There is nothing
    inevitable about homelessness in the United States. We know more about
    homelessness and how to address it than we ever have before. We know
    what program models are effective for what kinds of people. It remains
    only to bring these solutions to a scale commensurate with the problem,
    and to focus them on bringing homelessness to an end.
        It is our contention that an end to homelessness is a goal that we
    can achieve by the end of the decade. To do so we need to pursue four
    lines of attack simultaneously. We must:
      --Plan for outcomes
      --Close the front door in to homelessness
      --Open the back door out of homelessness and in to housing
      --Build the infrastructure.
                             planning for outcomes
        We have an extensive system for dealing with homelessness. Too
    often, however, this system focuses only on managing the problem and
    not on a permanent solution. To change this focus we need to be sure we
    have accurate information on who homeless people are, how they become
    homeless, and what works to allow them to secure and stay in housing.
    We need to commit ourselves to ending homelessness as the outcome of
    the system's activities. And we need to use the data to plan
    strategically to bring about the result we want.
        Recommendation.--Encourage all programs to collect information
    about homelessness among those the programs serve. Much of the recent
    explosion of information and know-how about homelessness has come as a
    result of research funded by this subcommittee. This effort needs to be
    extended to the state and local level.
        Recommendation.--Encourage federal agencies and state governments
    funded by programs such as the substance abuse and mental health block
    grants to plan for reducing homelessness among the population served.
    An important mandatory spending item in the Administration's budget
    request is a $10 million initiative to provide money to a small number
    of states to coordinate services for homeless people by programs not
    specifically targeted to homeless people. The request is in the budget
    for the Health Care Financing Administration, partly because Medicaid
    is such an important program for homeless people. We urge the
    subcommittee to encourage agencies under its jurisdiction to cooperate
    with the initiative and work to make their services better coordinated
    and more accessible to homeless people.
                   closing the front door in to homelessness
        We need to hold government-funded systems accountable for, at the
    very least, ensuring that the Americans they serve do not become
    homeless. We must treat homelessness among people with mental illness
    as sign that the mental health system needs improvement; homelessness
    among former foster children as a similar sign for the child protection
    system; homelessness among people with addiction disorders for the
    substance abuse treatment system.
        Recommendation.--Encourage mainstream programs such as the
    substance abuse and mental health block grants to address homelessness
    and housing stability among their target populations. Over the past few
    years this subcommittee has encouraged agencies that oversee large
    ``mainstream'' (i.e. not homeless-targeted) programs to pay attention
    to the amount of homelessness among the populations they serve. This
    has led to important work by the agencies involved, to examine ways to
    make these programs more conscious of housing stability as an end to be
    achieved. More remains to be done, and the subcommittee should continue
    its diligence in this regard.
          opening the back door out of homelessness and in to housing
        Most people who become homeless find housing on their own in
    relatively short order. We need to speed up that process, and prevent
    disruptions during the period of homelessness. A minority, however,
    remains homeless for a long time. Among this group, disabilities are
    prevalent, including mental illness, substance addiction, and HIV/AIDS.
        This subcommittee's work can have a huge impact on efforts to
    rehouse people who are chronically homeless and chronically ill.
    Besides housing, they need treatment and services:
      --Outreach, particularly to long-term homeless people with mental
            health and substance abuse problems, to ensure that they make
            use of the services that are available.
      --Short-term treatment in a residential setting aimed at stabilizing
            these individuals and transitioning them into permanent
            housing.
      --Treatment and long-term aftercare linked with permanent housing,
            creating permanent supportive housing, a powerful model that
            improves the lives of long-term homeless people while saving
            public money that would otherwise be spent on hospital
            emergency rooms, emergency detoxification, acute mental health
            care, shelters and jails.
      --Help with employment, as soon as homeless people are stabilized in
            a residential setting.
      --Case management to ensure that all services are available.
      --Preparing people with few skills for success, once their housing
            situation has been stabilized.
      --Assistance, particularly with children, to avoid disruption of
            family life during times of homelessness.
        Recommendation.--Appropriate $100 million for the Grants for the
    Benefit of Homeless Individuals program. This program, first authorized
    in 1992, has the potential to fill the most gaping hole in the system
    of supports for chronically homeless people--the lack of effective
    substance abuse treatment services. The program would provide
    competitive grants from the Substance Abuse and Mental Health Services
    Administration to local agencies, to provide specific services for
    homeless people with addictive disorders and/or mental illnesses. GBHI
    would provide an ideal mechanism for linking HHS-funded services with
    HUD-funded supportive housing. There is not an existing appropriation
    for this program, but we request that the subcommittee pass a new
    appropriation for it because it fills such a crucial need, for
    substance abuse treatment and for treatment for mental illnesses that
    are not considered ``severe'' (i.e. schizophrenia, bipolar disorder,
    major depression).
        The Grants for the Benefit of Homeless Individuals program was
    authorized by Section 506 of the Public Health Service Act. As is true
    of all other SAMHSA programs, its authorization has expired, but we
    urge Congress to respond to this as it has responded for other SAMHSA
    programs, by making year-to-year appropriations until the
    reauthorization process can be completed. The Senate-passed bill to
    reauthorize SAMHSA programs, S. 976, would reauthorize the GBHI
    program.
        Recommendation.--Appropriate $75 million for Projects for
    Assistance in Transition from Homelessness. PATH provides formula
    grants to each state for outreach, case management and treatment for
    homeless people with severe mental illnesses, including those with a
    dual diagnosis of mental illness and drug or alcohol addiction. PATH is
    ideal for funding outreach and case management, allowing people with
    severe mental illness to be brought into the system of care, their
    treatment stabilized, and services to continue once they are
    permanently housed.
        Recommendation.--Provide $129 million for Health Care for the
    Homeless (through a $1.5 billion appropriation for Consolidated Health
    Centers). Health Care for the Homeless is part of the Consolidated
    Health Centers line item in the budget for the Health Resource Services
    Administration. The program funds clinics that specialize in the unique
    treatment challenges presented by people who are homeless, often for
    long periods of time. Clinics provide primary care, as well as
    diagnostic, preventive, emergency medical, pharmaceutical, addiction,
    and mental health services. They also conduct intensive outreach and
    case management, linking patients to housing, income and
    transportation. HCH projects are ideal to provide outreach and to
    stabilize the worst-off homeless people.
        Recommendation.--Appropriate $120 million for the Runaway and
    Homeless Youth Programs. The Administration for Children and Families
    within HHS operates coordinated competitive grant programs addressing
    the problems of homeless and runaway youth. Runaway and Homeless Youth
    programs support cost-effective, community-based services that protect
    youth from the harms of life on the streets and either reunify them
    safely with family or find alternative placements. RHYP ends
    homelessness by engaging in outreach, and quickly rehouses as many
    homeless youth as possible. For others, it provides services that will
    prepare them to enter adulthood housed.
        Recommendation.--Appropriate $15 million for the Homeless Veterans
    Reintegration Program. The Homeless Veterans Reintegration Program,
    within the Department of Labor's Veterans Employment and Training
    Service, provides job placement and related services to homeless
    veterans. Homeless veterans have many barriers to employment. According
    to DoL, HVRP helps overcome those barriers and places veterans in jobs
    at a rate of about $1430 per placement, making it extremely cost-
    effective. While successful, HVRP has been able to serve only a small
    portion of the homeless veteran population, due to insufficient
    funding. Last year an increase for this program received bipartisan
    support. This year, the Administration has requested, and we support,
    the full authorization level of $15 million.
        Recommendation.--Appropriate $50 million for Education for Homeless
    Children and Youth. A struggle for homeless service providers who serve
    families with children is to maintain the children's stability during a
    time when their lives are turned upside down. Even if new housing can
    be found in a short time, the lasting effects of a spell of
    homelessness can be devastating, if everything in their lives is
    disrupted. The most important potential source of stability for these
    children is school--but only if they can continue to attend school.
    That is the mission of the Education for Homeless Children and Youth
    program. EHCY removes obstacles to enrollment and retention by
    establishing liaisons between schools and shelters and providing
    funding for transportation, tutoring, school supplies, and the
    coordination of statewide efforts to remove barriers. As a result, the
    percentage of homeless school age children attending school increased
    from 50 percent prior to establishment of the program to 88 percent in
    1997. This encourages quick rehousing of families by retaining ties to
    their communities.
                            build the infrastructure
        In addition to initiatives that focus on homelessness, bringing
    homelessness to an end will require larger systemic reforms to improve
    the incomes of the poorest Americans, to make housing more affordable,
    and to make services widely available to those who need them. This
    subcommittee's efforts in areas such as child care, education and
    employment are critical in this regard. Two programs under this
    subcommittee's jurisdiction are particularly important:
        Recommendation.--Fully fund the Labor Department's ``Fathers Work/
    Families Win'' initiative. The Department of Labor has made great
    strides over the last few years in making it's programs work better for
    the lowest income people, including homeless people. The proposal in
    the DoL budget for the ``Fathers Work/Families Win'' initiative
    provides great promise to continue the work begun by the mandatory
    Welfare to Work Grants Program--making sure the poorest Americans have
    the tools they need to succeed in the workplace. We urge the
    subcommittee to approve that initiative while encouraging the
    Department to continue to make those services, and the services of
    Workforce Investment Act programs, fully available to people who are
    struggling with homelessness.
        Recommendation.--Appropriate $1.4 billion for the Low-Income Home
    Energy Assistance Program. Inability to pay for utilities is second
    only to inability to pay rent as an economic cause of homelessness.
    LIHEAP has for many years proven an effective program with bipartisan
    support, designed to help low-income people afford these charges and
    avoid homelessness. We encourage Congress to provide adequate funding
    for this important program.

           LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS

                                  ----------
                                                                       Page
    Alexander, Dr. Duane, Director, National Institute of Child
      Health and Human Development, National Institutes of Health,
      Department of Health and Human Services........................   127
        Prepared statement...........................................   158
    American:
        Academy of Physician Assistants, prepared statement..........   375
        Association of Colleges of Nursing, prepared statement.......   441
        Chemical Society, prepared statement.........................   414
        College of Chest Physicians, prepared statement..............   433
        Gastroenterological Association, prepared statement..........   436
        Heart Association, prepared statement........................   396
        Medical Association, prepared statement......................   328
        Museum of Natural History, prepared statement................   537
        Physiological Society, prepared statement....................   414
        Public Power Association, prepared statement.................   342
        Public Transportation Association, prepared statement........   352
        Society for Microbiology, prepared statement...............393, 403
        Society of Clinical Oncology, prepared statement.............   456
        Society of Mechanical Engineers, prepared statement..........   419
        Society of Tropical Medicine and Hygiene, prepared statement.   475
    Association of:
        American Universities, prepared statement....................   495
        Population Centers, prepared statement.......................   497
        Women's Health, Obstetric and Neonatal Nurses, prepared
          statement..................................................   400

    Babyland Family Services, Inc., prepared statement...............   383
    Battey, Dr. James F., Jr., Director, National Institute on
      Deafness and Other Communication Disorders, National Institutes
      of Health, Department of Health and Human Services.............   127
        Prepared statement...........................................   178
    Bosch, Erin, prepared statement..................................   505
    Breast Cancer Action, letter from................................   277
        Fund, letter from............................................   275
    Byrd, Hon. Robert C., U.S. Senator from West Virginia, questions
      submitted by..............................................67, 80, 117

    Campbell, Hon. Ben Nighthorse, U.S. Senator from Colorado,
      questions submitted by.........................................    98
    Cancer Leadership Council, prepared statement....................   459
    Cassman, Dr. Marvin, Director, National Institute of General
      Medical Services, National Institutes of Health, Department of
      Health and Human Services......................................   127
        Prepared statement...........................................   155
    Children's Heart Foundation, prepared statement..................   424
    Cochran, Hon. Thad, U.S. Senator from Mississippi:
        Opening statement............................................   216
        Prepared statement...........................................   217
        Questions submitted by.......................................   302
    Collins, Dr. Francis S., Director, National Human Genome Research
      Institute, National Institutes of Health, Department of Health
      and Human Services.............................................   128
        Prepared statement...........................................   192
    Colonial Williamsburg Foundation, prepared statement.............   540
    Condell Medical Center, prepared statement.......................   332
    CORE Foundation, prepared statement..............................   505
    Council for Chemical Research, prepared statement................   452
    Cowin, Jessica, prepared statement...............................   425
    Craig, Hon. Larry, U.S. Senator from Idaho, questions submitted
      by.............................................................    79
    Cure For Lymphoma Foundation, prepared statement.................   502

    Domenici, Hon. Pete V., U.S. Senator from New Mexico, questions
      submitted by...................................................   101
    Doris Day Animal League, prepared statement......................   428

    Elmira College, Elmira, NY, prepared statement...................   510
    Epilepsy Foundation, prepared statement..........................   388

    Facioscapulohumeral Society, Inc., prepared statement............   488
    Fauci, Dr. Anthony S., Director, National Institute of Allergy
      and Infectious Diseases, National Institutes of Health,
      Department of Health and Human Services........................   127
        Prepared statement...........................................   152
    FDA-NIH Council, prepared statement..............................   471
    Federation of:
        American Societies for Experimental Biology, prepared
          statement..................................................   430
        Behavioral, Psychological and Cognitive Sciences, prepared
          statement..................................................   514
    Feinstein, Hon. Dianne, U.S. Senator from California:
        Prepared statements.........................................45, 217
        Questions submitted by......................................87, 120
    Fight Crime: Invest in Kids, prepared statement..................   522
    Fischbach, Dr. Gerald D., Director, National Institute of
      Neurological Disorders and Stroke, National Institutes of
      Health, Department of Health and Human Services................   127
        Prepared statement...........................................   149
    Florida State University, prepared statement.....................   520

    Gordis, Dr. Enoch, Director, National Institute on Alcohol Abuse
      and Alcoholism, National Institutes of Health, Department of
      Health and Human Services......................................   128
        Prepared statement...........................................   186
    Gorton, Hon. Slade, U.S. Senator from Washington, prepared
      statement......................................................    65
    Grady, Dr. Patricia A., Director, National Institute of Nursing
      Research, National Institutes of Health, Department of Health
      and Human Services.............................................   128
        Prepared statement...........................................   189

    Harkin, Hon. Tom, U.S. Senator from Iowa:
        Opening statements...........................................3, 213
        Prepared statements..........................................4, 214
        Questions submitted by.......................................   305
    Herman, Hon. Alexis M., Secretary, Office of the Secretary,
      Department of Labor............................................     1
        Prepared statement...........................................     7
        Summary statement............................................     4
    Hodes, Dr. Richard J., Director, National Institute on Aging,
      National Institutes of Health, Department of Health and Human
      Services.......................................................   127
        Prepared statement...........................................   167
    Hollings, Hon. Ernest F., U.S. Senator from South Carolina,
      questions submitted by.........................................    76
    Hrynkow, Dr. Sharon, Ph.D., Acting Associate Director for Program
      Coordination, Fogarty International Center, National Institutes
      of Health, Department of Health and Human Services.............   128
    Humane Society, prepared statement...............................   444
    Hutchison, Hon. Kay Bailey, U.S. Senator from Texas, questions
      submitted by.............................................66, 105, 112
    Hyman, Dr. Steven E., Director, National Institute of Mental
      Health, National Institutes of Health, Department of Health and
      Human Services.................................................   128
        Prepared statement...........................................   180

    Idaho State University, prepared statement.......................   381
    Inouye, Hon. Daniel K., U.S. Senator from Hawaii, question
      submitted by...................................................    77
    International Brain Injury Association, prepared statement.......   385

    Joslin Diabetes Center, prepared statement.......................   453

    Katz, Dr. Stephen I., Director, National Institute of Arthritis
      and Musculoskeletal and Skin Diseases, National Institutes of
      Health, Department of Health and Human Services................   127
        Prepared statement...........................................   175
    Kennedy Krieger Institute, prepared statement....................   482
    Keusch, Dr. Gerald T., Director, Fogarty International Center,
      prepared statement.............................................   202
    Kirschstein, Dr. Ruth L., Acting Director, National Institutes of
      Health, Department of Health and Human Services................   127
        Prepared statement...........................................   130
        Summary statement............................................   129
    Klausner, Dr. Richard D., Director, National Cancer Institute,
      National Institutes of Health, Department of Health and Human
      Services.......................................................   127
        Letter from..................................................   279
        Prepared statement...........................................   136
    Kohl, Hon. Herb, U.S. Senator from Wisconsin:
        Prepared statement...........................................   242
        Questions submitted...............................69, 105, 114, 314
    Kupfer, Dr. Carl, Director, National Eye Institute, National
      Institutes of Health, Department of Health and Human Services..   127
        Prepared statement...........................................   161

    Lenfant, Dr. Claude Director, National Heart, Lung, and Blood
      Institute, National Institutes of Health, Department of Health
      and Human Services.............................................   127
        Prepared statement...........................................   140
    Leshner, Dr. Alan I., Director, National Institute on Drug Abuse,
      prepared statement.............................................   183
    Lindberg, Dr. Donald A.B., Director, National Library of
      Medicine, National Institutes of Health, Department of Health
      and Human Services.............................................   128
        Prepared statement...........................................   205
    Lovelace Respiratory Research Institute, prepared statement......   454
    Lymphoma Research Foundation, prepared statement.................   460

    Maddox, Dr. Yvonne T., Acting Director, National Institutes of
      Health, Department of Health and Human Services................   127
        Prepared statement...........................................   133
    Malz, Rachel, Madison, WI, prepared statement....................   243
    Marin Breast Cancer Watch, letter from...........................   274
    Mended Hearts, Inc., prepared statement..........................   504
    Mikulski, Hon. Barbara A., U.S. Senator from Maryland, questions
      submitted by...................................................   321
    Millstein, Richard, Deputy Director, National Institute on Drug
      Abuse, National Institutes of Health, Department of Health and
      Human Services.................................................   128
    Montefiore Medical Center, prepared statement....................   337
    Murray, Hon. Patty, U.S. Senator from Washington:
        Opening statement............................................    53
        Questions submitted by..................................71, 77, 115

    Nathanson, Dr. Neal, Director, Office of AIDS Research, National
      Institutes of Health, Department of Health and Human Services..   128
        Prepared statement...........................................   208
    National:
        Alliance for Eye and Vision Research, prepared statement.....   473
            For the Mentally Ill, prepared statement.................   347
        To End Homelessness, prepared statement......................   547
        Association for State Community Services Programs, prepared
          state-
          ment.......................................................   372
            Of Foster Grandparent Program, prepared statement........   534
        Center for Learning Disabilities, prepared statement.........   450
        Coalition for Cancer Research, prepared statement............   421
        Congress of American Indians, prepared statement.............   545
        Consumer Law Center, prepared statement......................   345
        Council on Independent Living, prepared statement............   356
        Depressive and Manic-Depressive Association, prepared
          statement..................................................   438
        Federation of Community Broadcasters, prepared statement.....   533
        Indian Impacted Schools Association, prepared statement......   528
        Jewish Medical and Research Center, prepared statement.......   378
        Military Family Association, prepared statement..............   525
        Minority Public Broadcasting Consortia, prepared statement...   542
        Multiple Sclerosis Society, prepared statement...............   415
        Nutritional Foods Association, prepared statement............   463
        Prostate Cancer Coalition, prepared statement................   457
        Sleep Foundation, prepared statement.........................   448
        Treasury Employees Union, prepared statement.................   335
    New York University, prepared statement..........................   368
    New York-Presbyterian Hospital, prepared statement...............   417
    Newark, NJ, city of, prepared statement..........................   362
    Northwest Regional Educational Laboratory, prepared statement....   513
    NYU School of Medicine, prepared statement.......................   466

    Olden, Dr. Kenneth, Director, National Institute of Environmental
      Health Sciences, National Institutes of Health, Department of
      Health and Human Services......................................   127
        Prepared statement...........................................   164

    Parkinson's Action Network, prepared statement...................   500
    Persons United Limiting SubStandards & Errors in Healthcare of
      Colorado, prepared statement...................................   325
    Pinon Community School Board, Inc., prepared statement...........   508
    Piwowar, Andrea, prepared statement..............................   425
    Population Association of America, prepared statement............   497

    Riley, Hon. Richard W., Secretary, Office of the Secretary,
      Department of Education........................................    30
        Prepared statement...........................................    33
    Roberts, Denise, board member, PULSE of Colorado, prepared
      statement......................................................   343
    Rotary International, prepared statement.........................   390

    Santa:
        Marta Hospital, prepared statement...........................   408
        Rosa Memorial Hospital, prepared statement...................   330
    Scleroderma Research Foundation, prepared statement..............   493
    Shalala, Hon. Donna, Secretary, Office of the Secretary,
      Department of Health and Human Services........................    15
        Prepared statement...........................................    18
    Slavkin, Dr. Harold, Director, National Institute of Dental and
      Craniofacial Research, National Institutes of Health,
      Department of Health and Human Services........................   127
        Prepared statement...........................................   143
    Society for Animal Protective Legislation, prepared statement....   485
    Society of Toxicology, prepared statement........................   477
    Specter, Hon. Arlen, U.S. Senator from Pennsylvania:
        Opening statements...........................................1, 128
        Questions submitted by.................................73, 106, 284
    Spiegel, Dr. Allen M., Director, National Institute of Diabetes
      and Digestive and Kidney Diseases, National Institutes of
      Health, Department of Health and Human Services................   127
        Prepared statement...........................................   146
    St. Joseph's Hospital Health Center, prepared statement..........   340
    Stevens, Hon. Ted, U.S. Senator from Alaska:
        Opening statements..........................................37, 247
        Prepared statement...........................................    39
    Stokes, Louis, former Congressman, prepared statement............   480
    Straus, Dr. Stephen E., Director, National Center for
      Complementary and Alternative Medicine, National Institutes of
      Health, Department of Health and Human Services................   128
        Prepared statement...........................................   198
    Taylor, Teresa, prepared statement...............................   427
    Texas:
        Neurofibromatosis Foundation, prepared statement.............   467
        Tech University Health Sciences Center, prepared statement...   406
    United:
        Negro College Fund, prepared statement.......................   518
        Stribes Technical College, prepared statement................   530
    University of:
        Medicine and Dentistry of New Jersey, prepared statement.....   365
        Miami School and the Lovelace Respiratory Research Institute,
          prepared statement.........................................   371
        Michigan, prepared statement.................................   411
        Tulsa, prepared statement....................................   521
    Vaitukaitis, Dr. Judith L., Director, National Center for
      Research Resources, National Institutes of Health, Department
      of Health and Human Services...................................   128
        Prepared statement...........................................   196
    Van Pelt, Megan, prepared statement..............................   426
    Wake Forest University Baptist Medical Center, prepared statement   469
    Williams, Dennis P., Deputy Assistant Secretary, Budget, National
      Institutes of Health, Department of Health and Human Services..   128

                                 SUBJECT INDEX

                                  ----------

                            DEPARTMENT OF EDUCATION

                            Office of the Secretary

    Accountability, increased........................................    34
    Additional committee questions...................................    66
    Basics, mastering the............................................    35
    Budget:
        Request......................................................    31
            Balance with resources...................................    39
    CDC's buildings and facilities...................................    44
    Class size:
        School violence..............................................    54
        Reduction....................................................   106
            Funding..................................................    53
            Program--teachers hired..................................   115
            Use of program funds.....................................    54
    Clinical trials data base........................................    45
    College:
        Making more affordable.......................................    37
        New pathways to..............................................    36
        Opportunities tax cut........................................    33
    Community learning centers, 21st century.........................    32
    Delta:
        Regional authority...........................................    63
        Rural health centers in the..................................    64
    Education........................................................    46
        Federal share of costs.......................................   108
        Good news about..............................................    31
        Incarcerated youth...........................................   110
        Immigrant funds..............................................   122
        Importance of technology in..................................    38
        Long-distance................................................    39
        Merit-based student financial assistance.....................   117
            Needs-based..............................................   117
        Recognizing higher institutions with effective reduction in
          impact aid.................................................   122
        State of American............................................    30
        Tax incentives...............................................   117
    Head Start...................................................49, 72, 87
        Cognitive skills in early childhood, focus on................    51
            Standards in.............................................    50
        Customer satisfaction in.....................................    50
        HHS and ED coordination on..................................52, 124
        Program......................................................   123
        Staff salaries..............................................53, 125
        Teaching of cognitive skills.................................   124
        Transferred from HHS to ED?..................................    50
    Heavily impacted districts, payments for.........................   123
    Impact aid funding and the administration's construction proposal   113
    OIG report.......................................................    60
    Pell Grant maximum award.........................................    33
    Pensions paid via lump sum vs. annuity...........................    43
    Professional development programs and early intervention address
      the achievement gap............................................   109
    Programs:
        Alcohol and drug prevention..................................   120
        Byrd Scholarship.............................................   117
        Children's health insurance..................................    32
        Civilian-based ``troops-to-teachers''........................   112
        Flexibility in reduction...................................107, 122
        Flexibility of block grants over targeted....................   114
        Implementation of Teacher Recruitment and professional
          development................................................   110
        Low Income Home Energy Assistance (LIHEAP)...................    73
        Role of Federal Education....................................    54
        Voluntary single-sex school and classroom....................   112
    Safe:
        Drug-free schools and communities............................    32
        Schools/healthy students initiative..........................    32
    Schools:
        Construction...............................................107, 118
        Districts, meeting diverse needs of..........................    42
        Improving low-performing.....................................    34
        Modernization................................................33, 35
        Safety and discipline........................................    32
        Small, safe and successful high schools initiative...........    32
        Turning around failing.......................................   114
    Student:
        Financial assistance, rewarding excellence in................   118
        Debt--growing imbalance of student education loans to grants
          in paying for college......................................   116
    Teachers:
        Certification--National Board for professional teaching
          standards..................................................   118
        Improving quality............................................    36
        12-month working year for....................................   111
        Recruitment and professional development programs............   109
        Recruitment and retention....................................    31
        Shortages and the budget proposal............................   119
    Technology literacy challenge fund programs and preparing
      tomorrow's teachers to use technology..........................   115
        Training programs as a percentage of all Federal training....   109
    Title I:
        Hold harmless................................................   120
        Reauthorization proposal to increase accountability..........   121
        Strengthening accountability provisions to increase academic
          achievement................................................   121
    Youth violence:
        Mass media entertainment and.................................    42
        Prevention...................................................   111
    Washington Post, quote from the..................................    57

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                         National Institutes of Health

    Acquired immune deficiency syndrome (AIDS).......................   153
        Vaccine development..........................................   239
    Additional committee questions...................................    73
    Adolescent alcohol use...........................................   189
        Outreach.....................................................   189
        Prevention and treatment, advances in........................   188
    Adulthood........................................................   180
    Advocates on comittees...........................................   309
    Aging, biology of................................................   168
        Research...................................................167, 241
    America:
        Creating a healthier.........................................    26
        Road map to a better.........................................    29
    Appropriations language, reports requested in last year's........    92
    Battered women and children......................................    77
    Basic services...................................................   207
    Bedside application, bench to....................................   219
    Behavioral research..............................................   160
    BIDIS............................................................    90
    Bioterrorism.....................................................    41
    Bioengineering, computers, and advanced instrumentation..........   197
    Budget:
        1997 emergency supplemental..................................   275
        Increases....................................................   273
        Indian Health Service........................................   100
        Institute/centers............................................   246
        NHLBI........................................................   244
        NIDCR'S......................................................   245
        NIND'S.......................................................   245
        President's................................................143, 211
    Building:
        Nursing research capacity....................................   192
        On recent accomplishments....................................   184
    Cancer:
        Burden of....................................................   136
        Challenges...................................................   218
        Chronology of Freedom of Information Act (FOIA) request
          regarding $15 million emergency appropriation for breast
          and environmental factors research.........................   276
        Environmental risk factors...................................    94
        Imaging......................................................   138
        Quality care--a research agenda..............................   139
        Registries...................................................    94
        State of care................................................   220
    Career development...............................................   198
    CDC, fiscal management at........................................    29
    Chapter 6........................................................   281
    Child care.......................................................47, 78
    Children and depression..........................................   297
    Chromosome 22....................................................   193
    Clinical research..............................................175, 191
        Networks.....................................................   141
        Trials--A Cornerstone of Progress for Patients...............   139
            Data base................................................    93
    Complementary and alternative medicine...........................   250
        Funding for..................................................   250
    Conference Report 105-119........................................   281
    Co-occurring disorders...........................................   309
    Dental and craniofacial diseases and disorders, burden of........   143
    Detection and diagnosis, new approaches to.......................   137
    Development......................................................   178
    Diabetes..................................................102, 317, 304
        Juvenile.....................................................   242
    Discovering solutions to complex problems........................   143
    Diseases:
        Alzheimer....................................................   315
        Autoimmune.................................................176, 311
        Brain, working together to fight.............................   151
        Chronic--a long-range view about long-term illness...........   190
        Duchenne Muscular Dystrophy..................................   316
        Emerging infectious, novel approaches to treatment and
          control of.................................................   203
        Epilepsy...................................................241, 314
        Fibromyalgia.................................................   176
        Hantavirus...................................................    99
        Immune-mediated..............................................   154
        Multiple Myeloma.............................................   319
        Muscle.......................................................   176
        Muscular Dystrophy...........................................   301
        Neurodegeneration, halting the process of....................   150
        Neurofibromatosis............................................   142
        Neuroscience.................................................   187
        Osteoarthritis...............................................   176
        Osteogenesis Imperfecta......................................   299
        Osteoporosis..........................................176, 299, 300
            Consensus conference on..................................   298
            Screening and treating...................................   299
        Skin.........................................................   177
        Parkinson's..................................................   304
        Research, benefits to other..................................   210
        Schizophrenia................................................   308
        Systemic, oral infection linked to...........................   145
    Drugs of abuse, long-term neurobehavioral effects of.............   184
    Drug use preferences and patterns, determinants of...............   184
    Drug user to addict, understanding the transition from...........   185
    Emerging epidemics of noncommunicable disease: Fiscal year 2001
      initiatives, taking steps to address...........................   204
    End of life--an emerging research focus..........................   191
    Environmental factors............................................   275
    Expanded health care coverage....................................    19
    Exposure assessment..............................................   166
    Fiscal year 2000 increase, uses of...............................   149
    Fly Genome, finishing the........................................   194
    Fogarty International Center...................................258, 271
    Future:
        Direction of vision research.................................   163
        Research plans...............................................   148
        Scientific plans and projects................................   201
    Gene:
        Discoveries: the rapid rate of progress......................   144
        Inflammation and tooth loss..................................   145
        Sequencing...................................................   248
    Genetics.........................................................   187
        Information, safeguarding the fair use of....................   195
        Medicine...................................................197, 207
        Tooth agenesis...............................................   145
    Global health....................................................   152
    Government Performance and Results Act....................143, 186, 192
    Grants review process............................................   286
    Health:
        Access for the uninsured.....................................    74
        Care.........................................................    47
        Centers waivers..............................................    77
        Disparities, addressing...............................142, 155, 185
        Disparities......................................159, 177, 198, 206
            Closing the gap..........................................   191
        Information for the public...................................   205
        Initiative...................................................   134
        Status of American Indians...................................    98
    HIV/AIDS.........................................................    89
        Developing cost-effective methods of preventing..............   202
        Research.....................................................   160
    Healthy brain for life...........................................   150
    Heart attack, using MRI to diagnose..............................   141
    HHS youth violence prevention activities.........................    23
    Human:
        DNA sequencing...............................................   193
        Genetic Variation............................................   193
        Genome................................................238, 295, 296
            Tools for understanding the..............................   195
        Sequence, beyond the.........................................   193
        Subject protection...........................................   309
    Immunizations....................................................    89
    Individual patient, focus on the.................................   142
    Injectable drugs and biologics, coverage of......................    76
    Indian health:
        Research...................................................100, 101
        Service funding..............................................    92
    Infancy and childhood............................................   178
    Infectious:
        Disease......................................................   302
        Diseases: Challenges and opportunities.......................   152
    Information dissemination........................................   201
    Liver allocation policies........................................    76
    Low Vision.......................................................   161
    Magnetic therapy.................................................   302
    Major Initiatives................................................   156
    Medical:
        Errors.......................................................    75
        Informatics..................................................   206
    Medicare:
        Osteoporosis.................................................   300
        Reimbursement of ambulance services..........................    87
    Mental:
        Health research..............................................   305
        Illness, heightened public awareness of......................   181
        Retardation..................................................   158
    Methamphetamine..................................................   249
    Minority representation..........................................   321
    Molecular Targets--New Approaches to Prevention & Treatment......   138
    Mouse genome.....................................................   296
    Multi-modal treatment assessment of ADHD.........................   183
    National:
        Aging Institute..............................................   225
        Cancer Institute.................................221, 250, 259, 290
            Budget...................................................   243
            Extramural research on breast cancer and proud history...    18
        Library of Medicine..........................................   272
        Center for:
            Complementary and Alternative Medicine...................   269
            Research Resources.....................................227, 270
        Eye Institute.........................................224, 254, 264
        Heart, Lung, and Blood Institute......................222, 251, 260
        Human Genome Research Institute............................227, 271
        Institute of:
            Allergy and Infectious Diseases...................223, 253, 262
            Arthritis and Musculoskeletal and Skin Diseases...226, 255, 266
            Child Health and Human Development................224, 254, 264
            Dental and Craniofacial Research..................222, 252, 261
            Diabetes and Digestive and Kidney Diseases........222, 252, 261
            Environmental Health Sciences.....................225, 254, 265
            General Medical Sciences...............................224, 263
            Health/Department of Energy Partnership..................   101
            Mental Health.....................................226, 256, 267
                Research agenda......................................   307
            Neurological Disorders and Stroke............223, 252, 262, 298
            Nursing Research..................................227, 257, 270
        Institute on:
            Aging..................................................255, 266
            Alcohol Abuse and Alcoholism...........................227, 269
            Deafness and other Communication Disorders........226, 256, 257
            Drug abuse........................................227, 257, 268
    Nervous system, repairing the injured............................   150
    New clinical effectiveness trials................................   182
    New investment, areas of.........................................   180
    NIH............................................................102, 103
        Buildings and facilities.....................................   289
        Doubling: Future implications................................   284
        OEO, workplace environment of................................   321
        Salary cap...................................................    91
    OD activities....................................................   135
    Office of:
        Behavioral and Social Sciences Research......................   134
        Disease Prevention...........................................   134
        Research on Women's Health...................................   135
    Past and future accomplishments..................................   259
    Pediatric trauma rehabilitation..................................   160
    Possible accomplishments.........................................   245
    Powerful research tools..........................................   146
    Priority:
        Better therapies.............................................   209
        Health disparities in the United States......................   209
        HIV prevention...............................................   210
        International research.......................................   209
        Vaccines.....................................................
    Programs:
        Family Caregiver.............................................    74
        Genomic Analysis.............................................   140
        Gene Therapy, of excellence in...............................   141
        Performance, rigorously evaluating...........................    28
    Promise of Pathogen Genomics.....................................   153
    Public Health and Social Services Emergency Fund.................   281
    Public Law 105-18................................................   281
    Reducing:
        Disease and disability.......................................   169
        Health disparities.........................................151, 169
    Renewed support for children and families........................    22
    Reports, status of...............................................    80
    Research:
        Advances: PKD, Hepatitis C, and diabetes.....................   146
        Bringing about shifts in national strategy...................   185
        Capacity.....................................................   198
        Children's mental health disorders...........................   306
        Dissemination efforts, rapid and authoritative...............   186
        Grants.......................................................   211
        Health disparities...........................................   183
        Minority mental health.......................................   306
        Progress in basic............................................   137
        Studies, current.............................................   200
        Youth violence...............................................   182
    Rural aging, international conference on.........................    85
    Scientific advancement, greater..................................    25
    Sequencing:
        Of the human genome..........................................   296
        The laboratory mouse.........................................   194
    Snapshot of the cell's protein factory...........................   155
    State Children's Health Insurance Program (SCHIP) enrollment.....    91
    Stem cells.......................................................   286
        Diabetes...................................................215, 235
        Research...................................................214, 221
            And diabetes.............................................    65
    Study of:
        Adverse health effects of air pollutants, particulate matter
          and ozone..................................................   283
        Gene-environment interaction in the etiology of breast
          cancer, in high-risk areas of the United States............   282
    Susceptibility to environmental toxicants........................   165
    Systemic Lupus Erythematosus.....................................   177
    Technologies, high throughput....................................   165
    Thirty years of accomplishment...................................   161
    Toxicology.......................................................   188
    Translational:
        Research.....................................................   162
        Science, centers for.........................................   181
    Treatment:
        Dually diagnosed individuals, options for....................   310
        Juvenile diabetes............................................   234
        Research on Autism...........................................   182
    United States, evolving epidemic in the..........................   208
    Unrelenting Pandemic.............................................   208
    Vaccine development..............................................   153
    Visual health disparities........................................   162
    Vulnerability genes for mental disorders, identifying............   182
    Welfare recipients, training and.................................    54
    West Virginia, obesity in........................................    86
    Worker health....................................................    73
    Youth:
        Prevention of violence.......................................    42
        Violence...............................................75, 229, 230
        Safety and health............................................    65

                              DEPARTMENT OF LABOR

                            Office of the Secretary

    Bonus Incentive Act..............................................    66
    Convention 176...................................................    68
    Homeless veterans programs.......................................    11
        Job training highlights of the 2001 request..................    71
    National Mine Safety and Health Academy..........................    67
    Pay equity.......................................................    72
    Quality workplaces...............................................    12
    Strategic goals..................................................     8
    Transportation funding for welfare workers.......................    41
    Traveling sales crew industry....................................    70
    Workforce:
        Prepared.....................................................     8
        Secure.......................................................    11
    Worker Adjustment and Retraining Notification Act................    69
    Workforce Investment Act impact..................................    70
    Working families, helping at a time of unprecedented prosperity..     7

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